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  1. Direct oral anticoagulants: An update.

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    Franco Moreno, Ana Isabel; Martín Díaz, Rosa María; García Navarro, María José

    2017-12-30

    Vitamin K antagonists were the only choice for chronic oral anticoagulation for more than half a century. Over the past few years, direct oral anticoagulants have emerged, including one direct thrombin inhibitor (dabigatran etexilate) and three factor Xa inhibitors (apixaban, edoxaban and rivaroxaban). In randomised controlled trials comparing direct oral anticoagulants with traditional vitamin K antagonists, the direct oral anticoagulants all showed a favourable benefit-risk balance in their safety and efficacy profile, in prevention of thromboembolic events in patients with atrial fibrillation and in the prevention and treatment of venous thromboembolism and acute coronary syndrome. In 2008, dabigatran was the first direct oral anticoagulant approved by the European Medicine Agency. Subsequently, rivaroxaban, apixaban and edoxaban were also authorised. This article reviews the evidence related to the use of these drugs. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  2. Association between Oral Anticoagulation Knowledge ...

    African Journals Online (AJOL)

    Association between Oral Anticoagulation Knowledge, Anticoagulation Control, and Demographic Characteristics of Patients Attending an Anticoagulation Clinic in Saudi Arabia: A Cross-Sectional Prospective Evaluation.

  3. Economic evaluation of the new oral anticoagulants for the prevention of thromboembolic events: a cost-minimization analysis

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    Milena Soriano Marcolino

    Full Text Available ABSTRACT CONTEXT AND OBJECTIVE: Randomized clinical trials have shown that the new oral anticoagulants have at least similar impact regarding reduction of thromboembolic events, compared with warfarin, with similar or improved safety profiles. There is little data on real costs within clinical practice. Our aim here was to perform economic analysis on these strategies from the perspective of Brazilian society and the public healthcare system. DESIGN AND SETTING: Cost-minimization analysis; anticoagulation clinic of Hospital Municipal Odilon Behrens, Belo Horizonte, MG, Brazil. METHODS: Patients at the anticoagulation clinic were recruited between August and October 2011, with minimum follow-up of four weeks. Operational and non-operational costs were calculated and corrected to 2015. RESULTS: This study included 633 patients (59% women of median age 62 years (interquartile range 49-73. The mean length of follow-up was 64 ± 28 days. The average cost per patient per month was $ 54.26 (US dollars. Direct costs accounted for 32.5% of the total cost. Of these, 69.5% were related to healthcare professionals. With regards to indirect costs, 52.4% were related to absence from work and 47.6% to transportation. Apixaban, dabigatran and rivaroxaban were being sold to Brazilian public institutions, on average, for $ 49.87, $ 51.40 and $ 52.16 per patient per month, respectively, which was lower than the costs relating to warfarin treatment. CONCLUSION: In the Brazilian context, from the perspective of society and the public healthcare system, the cumulative costs per patient using warfarin with follow-up in anticoagulation clinics is currently higher than the strategy of prescribing the new oral anticoagulants.

  4. Direct oral anticoagulants and venous thromboembolism

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    Massimo Franchini

    2016-09-01

    Full Text Available Venous thromboembolism (VTE, consisting of deep vein thrombosis and pulmonary embolism, is a major clinical concern associated with significant morbidity and mortality. The cornerstone of management of VTE is anticoagulation, and traditional anticoagulants include parenteral heparins and oral vitamin K antagonists. Recently, new oral anticoagulant drugs have been developed and licensed, including direct factor Xa inhibitors (e.g. rivaroxaban, apixaban and edoxaban and thrombin inhibitors (e.g. dabigatran etexilate. This narrative review focusses on the characteristics of these direct anticoagulants and the main results of published clinical studies on their use in the prevention and treatment of VTE.

  5. New oral anticoagulants: their advantages and disadvantages compared with vitamin K antagonists in the prevention and treatment of patients with thromboembolic events.

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    Mekaj, Ymer H; Mekaj, Agon Y; Duci, Shkelzen B; Miftari, Ermira I

    2015-01-01

    Despite the discovery and application of many parenteral (unfractionated and low-molecular-weight heparins) and oral anticoagulant vitamin K antagonist (VKA) drugs, the prevention and treatment of venous and arterial thrombotic phenomena remain major medical challenges. Furthermore, VKAs are the only oral anticoagulants used during the past 60 years. The main objective of this study is to present recent data on non-vitamin K antagonist oral anticoagulants (NOACs) and to analyze their advantages and disadvantages compared with those of VKAs based on a large number of recent studies. NOACs are novel direct-acting medications that are selective for one specific coagulation factor, either thrombin (IIa) or activated factor X (Xa). Several NOACs, such as dabigatran (a direct inhibitor of FIIa) and rivaroxaban, apixaban and edoxaban (direct inhibitors of factor Xa), have been used for at least 5 years but possibly 10 years. Unlike traditional VKAs, which prevent the coagulation process by suppressing the synthesis of vitamin K-dependent factors, NOACs directly inhibit key proteases (factors IIa and Xa). The important indications of these drugs are the prevention and treatment of deep vein thrombosis and pulmonary embolisms, and the prevention of atherothrombotic events in the heart and brain of patients with acute coronary syndrome and atrial fibrillation. They are not fixed, and dose-various strengths are available. Most studies have reported that more advantages than disadvantages for NOACs when compared with VKAs, with the most important advantages of NOACs including safety issues (ie, a lower incidence of major bleeding), convenience of use, minor drug and food interactions, a wide therapeutic window, and no need for laboratory monitoring. Nonetheless, there are some conditions for which VKAs remain the drug of choice. Based on the available data, we can conclude that NOACs have greater advantages and fewer disadvantages compared with VKAs. New studies are required

  6. New oral anticoagulants: their advantages and disadvantages compared with vitamin K antagonists in the prevention and treatment of patients with thromboembolic events

    Directory of Open Access Journals (Sweden)

    Mekaj YH

    2015-06-01

    Full Text Available Ymer H Mekaj,1,2 Agon Y Mekaj,3 Shkelzen B Duci,4 Ermira I Miftari5 1Institute of Pathophysiology, Faculty of Medicine, University of Prishtina, 2Department of Hemostasis and Thrombosis, National Blood Transfusion Center of Kosovo, 3Clinic of Neurosurgery, Faculty of Medicine, University of Prishtina, 4Clinic of Plastic and Reconstructive Surgery, Faculty of Medicine, University of Prishtina, 5The Hospital and University Clinical Service of Kosovo, Prishtina, Kosovo Abstract: Despite the discovery and application of many parenteral (unfractionated and low-molecular-weight heparins and oral anticoagulant vitamin K antagonist (VKA drugs, the prevention and treatment of venous and arterial thrombotic phenomena remain major medical challenges. Furthermore, VKAs are the only oral anticoagulants used during the past 60 years. The main objective of this study is to present recent data on non-vitamin K antagonist oral anticoagulants (NOACs and to analyze their advantages and disadvantages compared with those of VKAs based on a large number of recent studies. NOACs are novel direct-acting medications that are selective for one specific coagulation factor, either thrombin (IIa or activated factor X (Xa. Several NOACs, such as dabigatran (a direct inhibitor of FIIa and rivaroxaban, apixaban and edoxaban (direct inhibitors of factor Xa, have been used for at least 5 years but possibly 10 years. Unlike traditional VKAs, which prevent the coagulation process by suppressing the synthesis of vitamin K-dependent factors, NOACs directly inhibit key proteases (factors IIa and Xa. The important indications of these drugs are the prevention and treatment of deep vein thrombosis and pulmonary embolisms, and the prevention of atherothrombotic events in the heart and brain of patients with acute coronary syndrome and atrial fibrillation. They are not fixed, and dose-various strengths are available. Most studies have reported that more advantages than disadvantages

  7. Mechanical mitral valve prosthesis: Should the INR be above 2 when aspirin is added to the oral anticoagulant?

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    Ashraf Fawzy

    2017-12-01

    Conclusions: Aspirin added to oral anticoagulants post MVR had the advantages of being safe, convenient and reliable with no need to frequently adjust the oral anticoagulants doses or fear of thrombo-embolic events.

  8. Self management of oral anticoagulation: randomised trial

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    Fitzmaurice, D A; Murray, E T; McCahon, D; Holder, R; Raftery, J P; Hussain, S; Sandhar, H; Hobbs, F D R

    2005-01-01

    Objective To determine the clinical effectiveness of self management compared with routine care in patients on long term oral anticoagulants. Design Multicentre open randomised controlled trial. Setting Midlands region of the UK. Participants 617 patients aged over 18 and receiving warfarin randomised to intervention (n = 337) and routine care (n = from 2470 invited; 193/337 (57%) completed the 12 month intervention. Intervention Intervention patients used a point of care device to measure international normalised ratio twice a week and a simple dosing chart to interpret their dose of warfarin. Main outcome measure Percentage of time spent within the therapeutic range of international normalised ratio. Results No significant differences were found in percentage of time in the therapeutic range between self managment and routine care (70% v 68%). Self managed patients with poor control before the study showed an improvement in control that was not seen in the routine care group. Nine patients (2.8/100 patient years) had serious adverse events in the self managed group, compared with seven (2.7/100 patient years) in the routine care arm (χ2(df = 1) = 0.02, P = 0.89). Conclusion With appropriate training, self management is safe and reliable for a sizeable proportion of patients receiving oral anticoagulation treatment. It may improve the time spent the therapeutic range for patients with initially poor control. Trial registration ISRCTN 19313375. PMID:16216821

  9. Oral surgery in patients on anticoagulant therapy.

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    Scully, Crispian; Wolff, Andy

    2002-07-01

    Surgery is the main oral healthcare hazard to the patient with a bleeding tendency, which is mostly caused by the use of anticoagulants. The traditional management entails the interruption of anticoagulant therapy for dental surgery to prevent hemorrhage. However, this practice may increase the risk of a potentially life-threatening thromboembolism. Because this issue is still controversial, it is the aim of this paper to review the evidence, to highlight the areas of major concern, and to suggest management regimens for patients on the 3 main types of anticoagulants: coumarins, heparins, and aspirin. MATERIALS REVIEWED: The pertinent literature and clinical protocols of hospital dentistry departments have been extensively reviewed and discussed. Several evolving clinical practices in the last years have been detected: anticoagulant use is generally not discontinued; oral surgery is performed despite laboratory values showing significant bleeding tendency; new effective local methods are used to prevent bleeding; and patients at risk are referred to hospital-based clinics. The management of oral surgery procedures on patients treated with anticoagulants should be influenced by several factors: extent and urgency of surgery, laboratory values, treating physician's recommendation, available facilities, dentist expertise, and patient's oral, medical, and general condition.

  10. Novel oral anticoagulants in acute coronary syndrome.

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    Costopoulos, Charis; Niespialowska-Steuden, Maria; Kukreja, Neville; Gorog, Diana A

    2013-09-10

    Coronary artery disease (CAD) is a leading cause of morbidity and mortality worldwide with a prevalence that has now reached pandemic levels as a consequence of the rapid modernization of the developing world. Its presentation as an acute coronary syndrome (ACS) is a frequent reason for hospital admission and of profound implications for personal, societal and global health. Despite improvements in the management of ACS with anti-platelet and anticoagulant therapy and revascularization techniques, many patients continue to suffer recurrent ischemic events. The need to reduce future cardiovascular events has led to the development of novel therapies to prevent coronary thrombosis, targeting thrombin-mediated pathways. These include direct Xa inhibitors (apixaban, rivaroxaban and darexaban), direct thrombin inhibitors (dabigatran) and PAR 1 antagonists (vorapaxar and atopaxar). This article critically reviews the comparative mechanisms of action, the risks and benefits, together with the clinical evidence base for the use of these novel oral agents in the management of ACS patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  11. Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system.

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    Raschi, Emanuel; Poluzzi, Elisabetta; Koci, Ariola; Salvo, Francesco; Pariente, Antoine; Biselli, Maurizio; Moretti, Ugo; Moore, Nicholas; De Ponti, Fabrizio

    2015-08-01

    We assessed the hepatic safety of novel oral anticoagulants (NOACs) analyzing the publicly available US-FDA adverse event reporting system (FAERS). We extracted reports of drug-induced liver injury (DILI) associated with NOACs, including acute liver failure (ALF) events. Based on US marketing authorizations, we performed disproportionality analyses, calculating reporting odds ratios (RORs) with 95% confidence interval (CI), also to test for event- and drug-related competition bias, and case-by-case evaluation for concomitant medications. DILI reports represented 3.7% (n = 146) and 1.7% (n = 222) of all reports for rivaroxaban and dabigatran, respectively. No statistically significant association was found for dabigatran, in primary and secondary analyses. Disproportionality signals emerged for rivaroxaban in primary analysis (ALF: n = 25, ROR = 2.08, 95% CI 1.34, 3.08). In a large proportion of DILI reports concomitant hepatotoxic and/or interacting drugs were recorded: 42% and 37% (rivaroxaban and dabigatran, respectively), especially statins, paracetamol and amiodarone. Among ALF reports, fatal outcome occurred in 49% of cases (44% and 51%, rivaroxaban and dabigatran, respectively), whereas rapid onset of the event (<1 week) was detected in 46% of patients (47% and 44%, respectively). The disproportionality signal for rivaroxaban calls for further comparative population-based studies to characterize and quantify the actual DILI risk of NOACs, taking into account drug- and patient-related risk factors. As DILI is unpredictable, our findings strengthen the role of (a) timely pharmacovigilance to detect post-marketing signals of DILI through FAERS and other data sources, (b) clinicians to assess early, on a case-by-case basis, the potential responsibility of NOACs when they diagnose a liver injury. © 2015 The British Pharmacological Society.

  12. INR self-monitoring and oral anticoagulants.

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    2010-06-01

    The international normalised ratio (INR) must be measured regularly in order to maximise the benefit's and minimise the risks of oral articoagulant therapy. Devices are now available for INR measurement at home, by the patient or a caregiver. We examined whether these devices help to prevent bleeding or thromboembolism by reviewing the relevant literature using the standard Prescrire methodology. INR self-measurement is reproducible and consistent with values obtained in medical laboratories. Three meta-analyses of randomised trials show that a strategy based on patient training, INR self-measurement all mortality and the number of thromboembolic events compared with conventional laboratory monitoring. In contrast, there was no impact on the frequency of serious bleeding.The INR was measured once every one or two weeks in the self-measurement groups. This benefit probably resulted from a combination of several factors, such as better patient awareness of the importance of regular INR measurement, easier access to INR measurement, more rapid treatment adjustment, and more frequent INR measurement. It remains to be seen whether a similar benefit will be observed in France, a country with a dense network of medical laboratories. nique and, if necessary, to interpret the results and adjust the dose regimen. Depending on the trial, between 10% and 95% of eligible patients agreed to be trained in self-measurement and to adopt it in practice. However, in a British trial only half of the patients who agreed to be trained were actually capable of INR self-measurement and dose adjustment for at least one year. In practice, it appears that oral anticoagulant therapy can be optimised by INR measurement at least every two weeks, with immediate dose adjustment, whether the INR is measured in a laboratory or by the patients at home. INR self-measurement can help to ensure that these conditions are respected.

  13. Novel oral anticoagulants and exodontia: the evidence.

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    Nathwani, S; Wanis, C

    2017-04-21

    Background Haemostasis is crucial for the success of oral surgical treatment as bleeding problems can cause complications both pre- and post-operatively. Patients on anticoagulant drugs present a challenge due to their increased risk of bleeding.Aims To review the evidence for the management of oral surgery patients on novel oral anticoagulant therapy.Methods A literature review was conducted in May 2016 of free-text and MESH searches (keywords: apixaban, dabigatran, rivaroxaban and dental extractions) in the Cochrane Library, PubMed and CINAHL. Trial registers, professional bodies for guidelines and OpenGrey for unpublished literature were also searched. Studies were selected for appraisal after limits were applied (adult, human and English only studies) and inclusion/exclusion criteria imposed.Results Five studies were identified for critical appraisal using the CASP tools. These were a combination of systematic reviews and case series. Two case series were excluded due to low quality evidence. Curtin et al., Davis et al. and Constantinides et al. together with guidelines from the Scottish Dental Clinical Effectiveness Programme, have highlighted a protocol in managing these patients in a dental surgical setting.Conclusion Patients on novel anticoagulant therapy requiring dental surgery can be managed appropriately either without discontinuation of therapy or a delay in dose. For those patients at higher risks of postoperative bleeding complications, it is advised to liaise with the specialist physician.

  14. Time trends in intracranial bleeding associated with direct oral anticoagulants: a 5-year cohort study.

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    Hogg, Kerstin; Bahl, Bharat; Latrous, Meriem; Scaffidi Argentina, Sarina; Thompson, Jesse; Chatha, Aasil Ayyaz; Castellucci, Lana; Stiell, Ian G

    2015-01-01

    Over the past 5 years, dabigatran, rivaroxaban and apixaban were approved for stroke prevention. Phase III studies have shown a lower risk of intracranial bleeding with these direct oral anticoagulants than with warfarin; however, there is a lack of real-life data to validate this. We analyzed time trends in atraumatic intracranial bleeding from 2009 to 2013 among patients prescribed oral anticoagulants and those not prescribed oral anticoagulants. We used ICD-10-CA (enhanced Canadian version of the 10th revision of the International Statistical Classification of Diseases and Related Health Problems) codes to identify all patients with atraumatic intracranial bleeding who presented to our neurosurgical centre (serving a population of more than 1.2 million). Trained researchers extracted data on anticoagulant medications used in the week before diagnosis of the intracranial bleed. Provincial prescription data for oral anticoagulants were obtained from IMS Brogan CompuScript Market Dynamics. The primary outcome was the time trend in incident intracranial bleeds associated with oral anticoagulation during the period 2009-2013. The secondary outcomes were the time trend in intracranial bleeds not associated with oral anticoagulation and the provincial prescribing patterns for oral anticoagulants during the same period. A total of 2050 patients presented with atraumatic intracranial bleeds during the study period. Of the 371 (18%) prescribed an anticoagulant in the week before presentation, 335 were prescribed an oral anticoagulant. There was an increasing time trend in intracranial bleeding associated with oral anticoagulants (p = 0.009; 6 additional events per year) and in intracranial bleeding not associated with oral anticoagulation (p = 0.06). During 2013, prescriptions for warfarin decreased to 70% of all oral anticoagulant prescriptions in the province, whereas those for dabigatran and rivaroxaban increased to 17% and 12%, respectively. We observed increasing

  15. PHARMACOGENETIC ASPECTS OF NEW ORAL ANTICOAGULANTS APPLICATION

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    A. V. Kryukov

    2017-01-01

    Full Text Available The aim of this review is to assess the effect of genetic factors on the pharmacokinetic parameters of new oral anticoagulants. The review presents data from studies investigating the effect of gene polymorphisms that encode biotransformation enzymes and transporter proteins of new oral anticoagulants on the pharmacokinetics of these drugs. RE-LY study showed a 15% decrease in trough dabigatran concentration and 27% lower risk of bleeding in carriers of CES1 gene rs2244613 polymorphism, there was also a tendency to reduce the risk of major bleeding. Further study of CES1 gene rs8192935 polymorphism showed a 3% decrease in trough dabigatran concentration in heterozygotes and 11% in homozygotes. There was found a 2% and 3% decrease in trough concentrations in hetero- and homozygotes for the minor allele of CES1 gene rs2244613 polymorphism, respectively. There was no significant effect of ABCB1 gene rs2032582 and rs1045642 polymorphisms on dabigatran pharmacokinetics. It is known the case of gastrointestinal bleeding in the carrier of allelic variants of ABCB1 gene rs2032582 and rs1045642 polymorphisms. However, there was no significant effect of genotype on rivaroxaban pharmacokinetics in the study involving the carriers of ABCB1 gene rs2032582 and rs1045642 polymorphisms. ABCB1 gene rs4148738 polymorphism was associated with higher apixaban peak concentration. But groups of patients with acute cardioembolic stroke showed no statistically significant difference of apixaban peak concentration depending on ABCB1 gene rs1045642 polymorphism genotype. ABCB1 gene rs1045642 and SLCO1B1 gene rs4149056 polymorphisms have no effect on edoxaban pharmacokinetics. Elevation of edoxaban metabolite concentration in carriers of SLCO1B1 gene allelic variants was not clinically significant because the proportion of metabolite is about 10% of the concentration of the main substance. It is necessary to provide large population studies with control of treatment

  16. New oral anticoagulants--a review.

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    Ghanima, Waleed; Atar, Dan; Sandset, Per Morten

    2013-10-01

    Dabigatran, rivaroxaban and apixaban are three new oral anticoagulants that have recently been approved in Norway. The aim of this article is to provide an overview of the mechanisms of action, the most important indications and practical advice on the use of these drugs. The review is based on published phase 3 studies, a literature search in PubMed and the authors' clinical experience. Indications for use of the new anticoagulants include thromboprophylaxis after total hip and knee replacement surgery (all three), prevention of stroke and systemic embolism in non-valvular atrial fibrillation (all three), treatment of acute venous thrombosis and secondary prophylaxis after venous thrombosis (currently only rivaroxaban). For the aforementioned indications, these drugs have proven to be non-inferior to standard established anticoagulation therapy. For atrial fibrillation, all three drugs have also shown a lower incidence of intracranial bleeding compared with standard treatment. It is important to limit the use of these drugs to approved indications, to select patients who show good compliance, to rule out contraindications and to identify drug interactions. Monitoring of coagulation is not required, but patients should be followed up regularly to detect conditions that may lead to changes in the expected efficacy or safety.

  17. Dyslipidemia and Risk of Cardiovascular Events in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Therapy: Insights From the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) Trial.

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    Pol, Tymon; Held, Claes; Westerbergh, Johan; Lindbäck, Johan; Alexander, John H; Alings, Marco; Erol, Cetin; Goto, Shinya; Halvorsen, Sigrun; Huber, Kurt; Hanna, Michael; Lopes, Renato D; Ruzyllo, Witold; Granger, Christopher B; Hijazi, Ziad

    2018-02-01

    Dyslipidemia is a major risk factor for cardiovascular events. The prognostic importance of lipoproteins in patients with atrial fibrillation is not well understood. We aimed to explore the association between apolipoprotein A1 (ApoA1) and B (ApoB) and cardiovascular events in patients with atrial fibrillation receiving oral anticoagulation. Using data from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, ApoA1 and ApoB plasma levels were measured at baseline in 14 884 atrial fibrillation patients. Median length of follow-up was 1.9 years. Relationships between continuous levels of ApoA1 and ApoB and clinical outcomes were evaluated using Cox models adjusted for cardiovascular risk factors, medication including statins, and cardiovascular biomarkers. A composite ischemic outcome (ischemic stroke, systemic embolism, myocardial infarction, and cardiovascular death) was used as the primary end point. Median (25th, 75th) ApoA1 and ApoB levels were 1.10 (0.93, 1.30) and 0.70 g/L (0.55, 0.85), respectively. In adjusted analyses, higher levels of ApoA1 were independently associated with a lower risk of the composite ischemic outcome (hazard ratio, 0.81; PURL: http://www.clinicaltrials.gov. Unique identifier: NCT00412984. © 2018 The Authors and Bristol‐Myers Squibb. Published on behalf of the American Heart Association, Inc., by Wiley.

  18. Postoperative bleeding risk for oral surgery under continued rivaroxaban anticoagulant therapy.

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    Hanken, Henning; Gröbe, Alexander; Heiland, Max; Smeets, Ralf; Kluwe, Lan; Wikner, Johannes; Koehnke, Robert; Al-Dam, Ahmed; Eichhorn, Wolfgang

    2016-07-01

    The purpose of this study was to assess the risk of postoperative bleeding complications after oral procedures performed under continued mono or dual anticoagulation therapy with rivaroxaban (and aspirin). This retrospective single-center observational study included 52 oral procedures performed under continued oral anticoagulant therapy with rivaroxaban (20 mg/day). Among them, two procedures were performed under continued dual therapy with aspirin (100 mg/day) added to the regimen. Postoperative bleeding events were compared with 285 oral procedures in patients without any anticoagulation/antiplatelet therapy. Postoperative bleeding complications after oral surgery occurred significantly more often in patients under continued rivaroxaban therapy (11.5 %) than in the control cases without anticoagulation/antiplatelet medication (0.7 %). All of the bleeding events were manageable: Two of them were treated with local compression, three by applying new fibrin glue with (one case) or without (two cases) secondary sutures, one occurred during a weekend and was therefore treated under inpatient conditions with suture replacement. All postoperative bleeding episodes occurred during the first postoperative week. According to our data, continued anticoagulation therapy with rivaroxaban significantly increases postoperative bleeding risk for oral surgical procedures, although the bleeding events were manageable. Oral surgeons, cardiologists, general physicians, and patients should be aware of the increased bleeding risk after oral surgical procedures. Close observation up to 1 week postoperatively is advisable to prevent excessive bleeding.

  19. New oral anticoagulants: key messages for clinicians

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    Matteo Giorgi-Pierfranceschi

    2013-12-01

    Full Text Available New oral anticoagulants are an effective and safe alternative to vitamin K antagonists in many fields of clinical practice. The use of the direct inhibitors of activated Factor II (dabigatran and activated Factor X (apixaban and rivaroxaban, both in patients with non-valvular atrial fibrillation (NVAF and those with acute venous thromboembolism (VTE, is of great interest for internal medicine physicians. This paper aims to give practical guidance on management (starting therapy, follow up and bleeding complications of patients treated with dabigatran, rivaroxaban or apixaban for NVAF or acute VTE providing practical tables concerning the phases of therapy, management of complications, drug interaction and dose adjustment if renal impairment occurs.

  20. Managing dentoalveolar surgical procedures in patients taking new oral anticoagulants.

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    Sivolella, Stefano; De Biagi, Marleen; Brunello, Giulia; Berengo, Mario; Pengo, Vittorio

    2015-09-01

    The development of new orally administered anticoagulants, such as dabigatran, rivaroxaban, and apixaban, in the past few years has focused on avoiding some of the drawbacks associated with warfarin. This work aims to illustrate the main features of the most commonly used new oral anticoagulants, reviewing the current literature on the management of patients taking these drugs and needing oral and implant surgery, and discussing the currently proposed related guidelines.

  1. [Restraints to anticoagulation prescription in atrial fibrillation and attitude towards the new oral anticoagulants].

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    Pereira-Da-Silva, Tiago; Souto Moura, Teresa; Azevedo, Luísa; Sá Pereira, Margarida; Virella, Daniel; Alves, Marta; Borges, Luís

    2013-01-01

    To evaluate the prescription rate of oral anticoagulants in atrial fibrillation, the factors associated with non-prescription, the reasons referred by the physicians for not prescribing anticoagulants including the new generation anticoagulants, and to perform a medium term follow-up assessment. Prospective study on consecutive patients with atrial fibrillation with hospital discharge. The CHA2DS2VASc and HASBLED scores, associated comorbidities and medication prescribed before and at discharge were assessed. At discharge, the reason for not prescribing oral anticoagulants and the new oral anticoagulants was indicated by the physician in a questionnaire. Exclusion: absolute contraindication for anticoagulation, CHA2DS2VASc = 1 and valvular disease. Follow-up data were obtained one year after the recruitment of the first patient. 103 candidates for oral anticoagulants were identified (79.6 ± 8.0 years; CHA2DS2VASc 5.8 ± 1.4; HASBLED 2.6 ± 1.0; HASBLED = 3 in 55.3%); the anticoagulants were prescribed in 34.0% of the candidates. The factors associated with non-prescription were, in decreasing order of relevance: previous use of antiplatelet agents, bedridden and/or demented patient, absence of heart failure and number of bleeding risk factors. The reasons referred by physicians for non-prescription were, in decreasing order of frequency: high bleeding risk, small benefit, inability to comply with the treatment regimen and difficulty in monitoring the international normalized ratio (INR). The new anticoagulants were not prescribed and the referred reasons were, in decreasing order of frequency: insufficient information on the drugs, high bleeding risk, high cost and small benefit. At 8.2 ± 2.5 months of follow-up 33.3% of the patients were on anticoagulation and the new anticoagulants had not been prescribed. In this sample, the anticoagulants prescription rate was low and the factor most associated with non-prescription was the previous use of antiplatelet agents

  2. Utilization of Oral Anticoagulation in a Teaching Hospital in Nigeria

    African Journals Online (AJOL)

    vitamin K-dependent clotting factors, which include factors. II, VII, IX, and X, and the anticoagulant proteins C and S. Vitamin K is an essential cofactor for the post ribosomal synthesis of the vitamin K-dependent clotting factors. Utilization of Oral Anticoagulation in a Teaching. Hospital in Nigeria. Anakwue RC, Ocheni S1, ...

  3. Self-monitoring and self-management of oral anticoagulation.

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    Heneghan, Carl J; Garcia-Alamino, Josep M; Spencer, Elizabeth A; Ward, Alison M; Perera, Rafael; Bankhead, Clare; Alonso-Coello, Pablo; Fitzmaurice, David; Mahtani, Kamal R; Onakpoya, Igho J

    2016-07-05

    The introduction of point-of-care devices for the management of patients on oral anticoagulation allows self-testing by the patient at home. Patients who self-test can either adjust their medication according to a pre-determined dose-INR (international normalized ratio) schedule (self-management), or they can call a clinic to be told the appropriate dose adjustment (self-monitoring). Increasing evidence suggests self-testing of oral anticoagulant therapy is equal to or better than standard monitoring. This is an updated version of the original review published in 2010. To evaluate the effects on thrombotic events, major haemorrhages, and all-cause mortality of self-monitoring or self-management of oral anticoagulant therapy compared to standard monitoring. For this review update, we re-ran the searches of the Cochrane Central Register of Controlled Trials (CENTRAL), 2015, Issue 6, the Cochrane Library, MEDLINE (Ovid, 1946 to June week 4 2015), Embase (Ovid, 1980 to 2015 week 27) on 1 July 2015. We checked bibliographies and contacted manufacturers and authors of relevant studies. We did not apply any language restrictions . Outcomes analysed were thromboembolic events, mortality, major haemorrhage, minor haemorrhage, tests in therapeutic range, frequency of testing, and feasibility of self-monitoring and self-management. Review authors independently extracted data and we used a fixed-effect model with the Mantzel-Haenzel method to calculate the pooled risk ratio (RR) and Peto's method to verify the results for uncommon outcomes. We examined heterogeneity amongst studies with the Chi(2) and I(2) statistics and used GRADE methodology to assess the quality of evidence. We identified 28 randomised trials including 8950 participants (newly incorporated in this update: 10 trials including 4227 participants). The overall quality of the evidence was generally low to moderate. Pooled estimates showed a reduction in thromboembolic events (RR 0.58, 95% CI 0.45 to 0

  4. Adherence to a new oral anticoagulant treatment prescription: dabigatran etexilate

    Directory of Open Access Journals (Sweden)

    L Bellamy

    2009-07-01

    Full Text Available L Bellamy1, N Rosencher1, BI Eriksson21Anaesthesiology Department, Hôpital Cochin (AP-HP, René Descartes University, Paris 75014 France; 2Orthopaedic Department, University Hospital Sahlgrenska/Ostra, Gothenburg, SwedenAbstract: The recent development of new oral anticoagulants, of which dabigatran etexilate is currently at the most advanced stage of development, is the greatest advance in the provision of convenient anticoagulation therapy for many years. A new oral anticoagulation treatment, dabigatran etexilate, is already on the market in Europe. The main interest probably will be to improve the prescription and the adherence to an effective thromboprophylaxis in medical conditions such as atrial fibrillation without bleeding side effects, without the need for monitoring coagulation, and without drug and food interactions such as vitamin K anticoagulant (VKA treatment. Dabigatran is particularly interesting for extended thromboprophylaxis after major orthopedic surgery in order to avoid daily injection for a month. However, oral long-term treatments such as VKA are not systematically associated with a higher compliance level than injected treatments such as low-molecular-weight heparins. Indeed, adherence to an oral treatment, instead of the usual daily injection in major orthopedic surgery, is complex, and based not only on the frequency of dosing but also on patient motivation, understanding, and socio-economic status. New oral anticoagulants may be useful in this way but education and detection of risk factors of nonadherence to treatment are still essential.Keywords: oral anticoagulant, adherence, compliance, education, dabigatran

  5. Dental extraction for patients on oral anticoagulant therapy.

    Science.gov (United States)

    Martinowitz, U; Mazar, A L; Taicher, S; Varon, D; Gitel, S N; Ramot, B; Rakocz, M

    1990-09-01

    Dental extraction in patients receiving long-term oral anticoagulant therapy is a controversial issue. Continuation of anticoagulation exposes the patient to serious hemorrhage, whereas cessation of therapy increases the risk of thromboembolism. Forty patients treated by coumarin underwent 63 tooth extractions, without a change in the therapeutic protocol of anticoagulation. The biologic adhesive Beriplast was used successfully to achieve local hemostasis at the site of the surgical wound. Apart from one patient who had mild oozing, there were no incidences of postsurgical hemorrhage.

  6. Adherence to oral anticoagulant therapy in secondary stroke prevention – impact of the novel oral anticoagulants

    Directory of Open Access Journals (Sweden)

    Luger S

    2015-11-01

    Full Text Available Sebastian Luger,1 Carina Hohmann,2 Daniela Niemann,1 Peter Kraft,3 Ignaz Gunreben,3 Tobias Neumann-Haefelin,2 Christoph Kleinschnitz,3 Helmuth Steinmetz,1 Christian Foerch,1 Waltraud Pfeilschifter1 1Department of Neurology, University Hospital Frankfurt, Frankfurt am Main, 2Department of Neurology, Klinikum Fulda gAG, Fulda, 3Department of Neurology, University Hospital Würzburg, Würzburg, Germany Background: Oral anticoagulant therapy (OAT potently prevents strokes in patients with atrial fibrillation. Vitamin K antagonists (VKA have been the standard of care for long-term OAT for decades, but non-VKA oral anticoagulants (NOAC have recently been approved for this indication, and raised many questions, among them their influence on medication adherence. We assessed adherence to VKA and NOAC in secondary stroke prevention. Methods: All patients treated from October 2011 to September 2012 for ischemic stroke or transient ischemic attack with a subsequent indication for OAT, at three academic hospitals were entered into a prospective registry, and baseline data and antithrombotic treatment at discharge were recorded. At the 1-year follow-up, we assessed the adherence to different OAT strategies and patients’ adherence to their respective OAT. We noted OAT changes, reasons to change treatment, and factors that influence persistence to the prescribed OAT. Results: In patients discharged on OAT, we achieved a fatality corrected response rate of 73.3% (n=209. A total of 92% of these patients received OAT at the 1-year follow-up. We observed good adherence to both VKA and NOAC (VKA, 80.9%; NOAC, 74.8%; P=0.243 with a statistically nonsignificant tendency toward a weaker adherence to dabigatran. Disability at 1-year follow-up was an independent predictor of lower adherence to any OAT after multivariate analysis, whereas the choice of OAT did not have a relevant influence. Conclusion: One-year adherence to OAT after stroke is strong (>90% and patients

  7. Effects of novel oral anticoagulants on left atrial and left atrial appendage thrombi: an appraisal.

    Science.gov (United States)

    Marsico, Fabio; Cecere, Milena; Parente, Antonio; Paolillo, Stefania; de Martino, Fabiana; Dellegrottaglie, Santo; Trimarco, Bruno; Perrone Filardi, Pasquale

    2017-02-01

    Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and predisposes to an increased risk of thromboembolic events. Patients affected by AF exhibit an increased risk of stroke compared with those in sinus rhythm, with the most common location of thrombi in the left atrial appendage. Until 2009, warfarin and other vitamin K antagonists were the only class of oral anticoagulants available. More recently, dabigatran, rivaroxaban, apixaban, and edoxaban have been approved by regulatory authorities for prevention of stroke in patients with non-valvular AF. Few data are available about the efficacy of novel oral anticoagulants for the treatment of left atrial and left atrial appendage thrombosis. Aim of this review is to summarize available evidence regarding the effectiveness of novel oral anticoagulants on left atrial appendage thrombosis.

  8. Major Bleeding Complications and Persistence With Oral Anticoagulation in Non-Valvular Atrial Fibrillation

    DEFF Research Database (Denmark)

    Lamberts, Morten; Staerk, Laila; Olesen, Jonas Bjerring

    2017-01-01

    BACKGROUND: The nonvitamin K antagonist oral anticoagulants have recently become available as an alternative to warfarin as stroke prophylaxis in atrial fibrillation, but data on real-life patient experience, including bleeding risk, are lacking. Our objective was to compare major bleeding events...

  9. [Tranexamic acid gel in patients treated with oral anticoagulants].

    Science.gov (United States)

    Ripollés-de Ramón, Jorge; Muñoz-Corcuera, Marta; Bravo-Llatas, Carmen; Bascones-Martínez, Antonio

    2014-12-09

    Patients treated with oral anticoagulants have increased susceptibility to bleeding, and therefore any surgical medical procedure and especially oral surgery requires a therapeutic approach that minimizes bleeding effects in these patients. The working hypothesis was based on studies of local application of tranexamic acid after maxillofacial interventions as effective therapeutic alternative for the prevention and control of bleeding. The aim was to assess the effectiveness of the application of a gel solution tranexamic acid after tooth extraction in anticoagulated patients in terms of healing time and degree of healing. The results indicate that application of tranexamic acid gel is very effective for consistency and maintenance in the place of action and shows its efficacy as a procoagulant material. The application of a gel solution of tranexamic acid in oral anticoagulants patients ameliorates healing time and the bleeding time within the first 48-72 h. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

  10. Optimal antiplatelet and anticoagulant therapy in patients with oral anticoagulation in coronary stenting

    NARCIS (Netherlands)

    Dewilde, W.J.M.

    2014-01-01

    Chronic oral anticoagulation (OAC) is necessary in patients with mechanical heart valves and in most patients with atrial fibrillation (AF). A large subgroup of these patients has concomitant coronary artery disease (CAD). When these patients have to undergo percutaneous coronary intervention (PCI),

  11. Self-management of oral anticoagulant therapy in two centers

    DEFF Research Database (Denmark)

    Nilsson, Hanna; Grove, E; Larsen, Torben Bjerregaard

    Self-management of oral anticoagulant therapy in two centers: 11.000 patient-years of follow-up H Nilsson1,2,3, EL Grove2, TB Larsen3, M Maegaard1, TD Christensen1 1Department of Cardiothoracic and Vascular Surgery & Institute of Clinical Medicine, Aarhus University Hospital, Aarhus; 2Department...... of Cardiology, Aarhus University Hospital, Aarhus; 3Department of Cardiology, Aalborg Hospital & Department of Health Science and Technology, Aalborg University, Aalborg, Denmark haana_86@hotmail.com Objectives: Patient-self-management (PSM) of oral anticoagulant therapy with vitamin K antagonists have...

  12. Effects of computer-assisted oral anticoagulant therapy

    DEFF Research Database (Denmark)

    Rasmussen, Rune Skovgaard; Corell, Pernille; Madsen, Poul

    2012-01-01

    the therapeutic target range compared to traditional oral anticoagulant therapy by physicians. METHODS: 54 patients were randomized equally into 3 groups. Patients in two groups used CoaguChek® systems to measure international normalized ratio (INR) values and had dosages of anticoagulation treatment calculated...... in a computer system by an algorithm specific to each group. The third group received traditional anticoagulation treatment by physicians. The obtained INR values were compared regarding the time to reach, and the time spent within, the therapeutic target range, corresponding to INR values from 2 to 3. RESULTS......: Patients randomized to computer-assisted anticoagulation and the CoaguChek® system reached the therapeutic target range after 8 days compared to 14 days by prescriptions from physicians (p = 0.04). Time spent in the therapeutic target range did not differ between groups. The median INR value measured...

  13. Spinal subarachnoid hemorrhage complicating oral anticoagulant therapy

    Energy Technology Data Exchange (ETDEWEB)

    Cihangiroglu, Mutlu E-mail: mmutlucihan@hotmail.com; Bulut, Serpil; Nayak, Sundeep

    2001-09-01

    Spinal subarachnoid hemorrhage (SAH) is rare clinical entity possible owing to the diluting and fibrinolytic effects of cerebrospinal fluid (CSF). When it occurs, it is most commonly encountered in the thoracic segment of the subarachnoid space. We present a case of a 50-year-old man who sustained spinal SAH in the cervical and thoracic segments related to anticoagulant therapy. He progressed to significant neurological deficit since he was inoperable, an observation that supports the need for decompression surgery. We should be aware of potential hematomyelia should a patient on anticoagulant therapy develop neurological symptoms localized to the spinal cord. When available, magnetic resonance (MR) imaging is the modality of choice to diagnose and follow-up spinal SAH.

  14. Practical introduction of novel oral anticoagulants through an anticoagulation nurse. The Leeuwarden model.

    Science.gov (United States)

    Folkeringa, R J; Geven, L M; Veldhuis, T; Hoogendoorn, M; Hofma, S H; Van Roon, E

    2014-06-01

    This paper describes the implementation of novel oral anticoagulants (NOACs) through an anticoagulation nurse. Logistics and tasks of this new function are described and preliminary data are presented. Indications for NOACs are explained by the treating cardiologists. Thereafter, the patient is referred to the anticoagulation nurse before starting a NOAC. After providing a patient with information and checking the creatinine clearance, co-medication and medical history, a prescription for NOAC is made. In 3 months, 51 patients were referred for NOAC therapy. Mean age was 68 years, CHA2DS2-VASc score was 2.9. Renal function was impaired in 28 %. Only 63 % of the patients had an uneventful start-up. NOAC therapy was withheld or prematurely stopped in 22 %. 30 % of patients needed a reduced NOAC dose. In 37 %, the anticoagulation nurse had extended patient contact, mainly because of (presumed) side effects. Given the number of interactions that were made using a separate patient contact through the anticoagulation nurse, this seems to be an important improvement in the quality of care and deserves further expansion.

  15. Traumatic events involving elderly patients treated with anticoagulants for atrial fibrillation: the downside of stroke prevention

    Directory of Open Access Journals (Sweden)

    Alessandro Riccardi

    2016-08-01

    Full Text Available A group of oral anticoagulant-treated patients affected by permanent atrial fibrillation was evaluated after their access to the emergency room as a result of a traumatic accident. In these patients, the re-evaluation of their risk of thromboembolism and bleeding was performed together with the evaluation of their risk of falling and institutionalization. Results show that the emergency department identifies a cohort of very elderly frail patients, who should be carefully reconsidered for anticoagulant therapy after a traumatic event.

  16. Pharmacology of new oral anticoagulants: mechanism of action, pharmacokinetics, pharmacodynamics

    Directory of Open Access Journals (Sweden)

    Luca Masotti

    2013-12-01

    Full Text Available Due to their mechanism of action, the new oral anticoagulants are named direct oral anticoagulants (DOACs. Dabigatran is a selective, competitive, direct inhibitor of thrombin (Factor IIa while rivaroxaban, apixaban and edoxaban act by directly inhibiting the activated Factor X (FXa in a selective and competitive manner. DOACs have a relatively short half-life and almost immediate anticoagulant activity, and rapidly reach the plasma peak concentration. Therefore, they do not need a phase of overlapping with parenteral anticoagulants. After their withdrawal, their removal is sufficiently rapid, although influenced by renal function. Dabigatran is the only DOACs to be administered as a pro-drug and becomes active after drug metabolization. The route of elimination of dabigatran is primarily renal, whereas FXa inhibitors are mainly eliminated by the biliary-fecal route. The drug interactions of DOACs are mainly limited to drugs that act on P-glycoprotein for dabigatran and on P-glycoprotein and/or cytochrome P3A4 for anti-Xa. DOACs have no interactions with food. Given their linear pharmacodynamics, with a predictable dose/response relationship and anticoagulant effect, DOACs are administered at a fixed dose and do not require routine laboratory monitoring.

  17. Self-management of oral anticoagulation in the elderly: rationale, design, baselines and oral anticoagulation control after one year of follow-up. A randomized controlled trial.

    Science.gov (United States)

    Siebenhofer, Andrea; Rakovac, Ivo; Kleespies, Caroline; Piso, Brigitte; Didjurgeit, Ulrike

    2007-03-01

    Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre, open, randomised controlled trial, patients aged 60 years or more were randomised into the self-management group (SMG) (N = 99) or routine care group (RCG) (N = 96). We describe the rationale, design, baseline characteristics and interim analyses of oral anticoagulation control quality within the first year of follow-up. The medians of the squared international normalised ratio (INR) value deviations after six and 12 months were significantly lower in the SMG with medians of 0.16 and 0.16 compared to the RCG with medians of 0.25 and 0.25. The percentage of time within target range and the percentage of INR measurements within target range were significantly higher in the SMG versus the RCG within the first six months (medians 71% vs. 58% and 69% vs. 57%), and during the second six months of the study (75% vs. 67% and 72% vs. 57%). The numbers of all thromboembolic events requiring hospitalisation, major bleeding events, and deaths were similar in both groups. These preliminary results suggest that self-management of oral anticoagulation is safe and feasible for elderly patients willing to participate in a structured training programme.

  18. Scores to predict major bleeding risk during oral anticoagulation therapy: a prospective validation study.

    Science.gov (United States)

    Donzé, Jacques; Rodondi, Nicolas; Waeber, Gérard; Monney, Pierre; Cornuz, Jacques; Aujesky, Drahomir

    2012-11-01

    Clinical scores may help physicians to better assess the individual risk/benefit of oral anticoagulant therapy. We aimed to externally validate and compare the prognostic performance of 7 clinical prediction scores for major bleeding events during oral anticoagulation therapy. We followed 515 adult patients taking oral anticoagulants to measure the first major bleeding event over a 12-month follow-up period. The performance of each score to predict the risk of major bleeding and the physician's subjective assessment of bleeding risk were compared with the C statistic. The cumulative incidence of a first major bleeding event during follow-up was 6.8% (35/515). According to the 7 scoring systems, the proportions of major bleeding ranged from 3.0% to 5.7% for low-risk, 6.7% to 9.9% for intermediate-risk, and 7.4% to 15.4% for high-risk patients. The overall predictive accuracy of the scores was poor, with the C statistic ranging from 0.54 to 0.61 and not significantly different from each other (P=.84). Only the Anticoagulation and Risk Factors in Atrial Fibrillation score performed slightly better than would be expected by chance (C statistic, 0.61; 95% confidence interval, 0.52-0.70). The performance of the scores was not statistically better than physicians' subjective risk assessments (C statistic, 0.55; P=.94). The performance of 7 clinical scoring systems in predicting major bleeding events in patients receiving oral anticoagulation therapy was poor and not better than physicians' subjective assessments. Copyright © 2012 Elsevier Inc. All rights reserved.

  19. Novel oral anticoagulants in the treatment of cerebral venous thrombosis

    DEFF Research Database (Denmark)

    Feher, G; Illes, Z; Komoly, S

    2015-01-01

    (NOACs) have been extensively studied in patients with deep vein thrombosis (DVT), pulmonary embolism (PE) and non-valvular atrial fibrillation (NVAF). The aim of our work to review the available evidence for NOACs in the treatment of CVT. Based on our literature search there is insufficient evidence......Cerebral venous thrombosis (CVT) is an uncommon cause of stroke with extremely diverse clinical features, predisposing factors, brain imaging findings, and outcome. Anticoagulation is the cornerstone of CVT management, however, it is not supported by high-quality evicence. Novel oral anticoagulants...

  20. New oral anticoagulants in patients with chronic kidney disease.

    Science.gov (United States)

    Belmar Vega, Lara; de Francisco, A L M; Bada da Silva, Jairo; Galván Espinoza, Luis; Fernández Fresnedo, Gema

    Patients with chronic kidney disease (CKD) develop bleeding and thrombotic tendencies, so the indication of anticoagulation at the onset of atrial fibrillation (AF) is complex. AF is the most common chronic cardiac arrhythmia, and thromboembolism and ischemic stroke in particular are major complications. In recent years, new oral anticoagulant drugs have been developed, and they have shown superiority over the classical AVK in preventing stroke, systemic embolism and bleeding risk, constituting an effective alternative to those resources. Copyright © 2016 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

  1. Direct oral anticoagulants in the treatment of pulmonary embolism.

    Science.gov (United States)

    Eldredge, Joanna B; Spyropoulos, Alex C

    2018-01-01

    The objective of this review is to examine the management strategies for pulmonary embolism (PE) with an emphasis of the role of direct oral anticoagulants (DOACs). PubMed was searched to identify relevant journal articles published through April 2017. Additional references were obtained from articles discovered during the database search. Initial heparinization followed by long-term anticoagulation with vitamin K antagonists has been considered the mainstay for the treatment of PE. However, DOACs now offer comparably effective and potentially safer alternatives for both acute and long-term treatment of PE using a monotherapy approach without the need for initial heparinization for rivaroxaban or apixaban. Advantages to using DOACs include oral availability, rapid onset of action, minimal drug and food interactions, predictable pharmacokinetics, and lack of need for routine monitoring. Limitations of using these agents include a limited availability of assays to quickly and efficiently measure their anticoagulant effects and the lack of widely available reversal agents for the direct oral factor Xa inhibitors; although idarucizumab has recently been approved for the reversal of dabigatran's anticoagulant effects. Advantages to using DOACs render them an attractive alternative to conventional therapy in PE treatment that may simplify acute and long-term treatment paradigms, improve patient outcomes, and increase patient compliance. However, questions remain pertaining to the use of DOACs in PE patients with high-risk features and in cancer patients and fragile populations. Clinical studies are under way to address many of these issues.

  2. Age is not associated with intracranial haemorrhage in patients with mild traumatic brain injury and oral anticoagulation.

    Science.gov (United States)

    Sauter, Thomas C; Ziegenhorn, Stephan; Ahmad, Sufian S; Hautz, Wolf E; Ricklin, Meret E; Leichtle, Alexander Benedikt; Fiedler, Georg-Martin; Haider, Dominik G; Exadaktylos, Aristomenis K

    2016-06-01

    Patients admitted to emergency departments with traumatic brain injury (TBI) are commonly being treated with oral anticoagulants. In contrast to patients without anticoagulant medication, no guidelines, scores or recommendations exist for the management of mild traumatic brain injury in these patients. We therefore tested whether age as one of the high risk factors of the Canadian head CT rule is applicable to a patient population on oral anticoagulants. This cross-sectional analysis included all patients with mild TBI and concomitant oral anticoagulant therapy admitted to the Emergency Department, Inselspital Bern, Switzerland, from November 2009 to October 2014 (n = 200). Using a logistic regression model, two groups of patients with mild TBI on oral anticoagulant therapy were compared - those with and those without intracranial haemorrhage. There was no significant difference in age between the patient groups with (n = 86) and without (n = 114) intracranial haemorrhage (p = 0.078). In univariate logistic regression, GCS (OR = 0.419 (0.258; 0.680)) and thromboembolic event as reason for anticoagulant therapy (OR = 0.486 (0.257; 0.918)) were significantly associated with intracranial haemorrhage in patients with mild TBI and anticoagulation (all p clopidogrel ((both p > 0.05; 0.552 (0.139; 2.202) and 0.256 (0.029; 2.237), respectively). Our study found no association between age and intracranial bleeding. Therefore, until further risk factors are identified, diagnostic imaging with CCT remains necessary for mild TBI patients on oral anticoagulation of all ages, especially those with therapeutic anticoagulation because of thromboembolic events.

  3. Recurrent life-threatening thromboembolism and catastrophic antiphospholipid syndrome in a patient despite sufficient oral anticoagulation.

    Science.gov (United States)

    Miesbach, W; Scharrer, I; Asherson, R A

    2004-06-01

    We report on a 32-year old female patient with primary antiphospholipid syndrome (PAPS) and several thromboembolic events despite stable doses of oral anticoagulation, good patient compliance and maintained INR values of >3. Over the preceding 3 years the patient had presented a wide spectrum of manifestations of APS, including recurrent venous and arterial thromboses, cardiac, gynecological (HELLP syndrome), neurological involvements, livedo reticularis, a mild thrombocytopenia and the most feared manifestation of the catastrophic antiphospholipid syndrome (CAPS). Life-threatening bilateral subdural bleeding occurred while she was anticoagulated. The clinical features appeared to be refractory to oral anticoagulation with phenprocoumon. They were life threatening on each occasion and she developed repetitive episodes of organ damage with cardiac insufficiency (NYHA III), pulmonary hypertension and other residual defects. Even during heparinization recurrent thromboembolism supervened as well as livedo reticularis of the extremities. Lupus anticoagulants (LAC), anticardiolipin (aCL) antibodies and anti-beta(2)-glycoprotein-1 (beta(2)GPI) titers were all markedly elevated. This case report shows that recurrent episodes of thrombosis can occur despite seemingly adequate anticoagulation in patients with CAPS.

  4. The Role of Anticoagulation Clinics in the Era of New Oral Anticoagulants

    Directory of Open Access Journals (Sweden)

    Sophie Testa

    2012-01-01

    Full Text Available Anticoagulation Clinics (ACs are services specialized in management of patients on anticoagulant treatment. At present, ACs manage patients chiefly on antivitamin K antagonists (AVKs, but patient population has already changed in the last few years, because of an increase of treatments with other anticoagulant drugs, which require different management systems. The strong increase in the number of patients at AC, mainly on long-term treatment, has determined the development of web management, through telemedicine systems, improving the quality of life and maintaining the same clinical quality levels. New oral anticoagulants (NOAs have shown to be as effective as AVK antagonists in stroke prevention in atrial fibrillation and for treatment of venous thromboembolism in addition to VTE prophylaxis in orthopaedic surgery, when administered at a fixed dose, but patient adherence and compliance are crucial for good quality treatment. At present, lacking data from the real world, an oversimplification of treatment with NOAs could cause unjustified risks for patients and also a possible future underuse of good drugs. For these reasons the vigilance must be high and ACs can have a crucial role in defining which is the best management for NOA patients and how to do it, as it happened for AVKs.

  5. Direct Oral Anticoagulants: An Overview for the Interventional Radiologist

    Energy Technology Data Exchange (ETDEWEB)

    Kumar, Pradesh, E-mail: pradeshkumar@doctors.org.uk; Ravi, Rajeev, E-mail: rajeev.ravi@aintree.nhs.uk; Sundar, Gaurav, E-mail: gaurav.sundar@aintree.nhs.uk [Aintree University Hospitals NHS Foundation Trust, Radiology Department (United Kingdom); Shiach, Caroline, E-mail: caroline.shiach@aintree.nhs.uk [Aintree University Hospitals NHS Foundation Trust, Haematology Department (United Kingdom)

    2017-03-15

    The direct oral anticoagulants (DOACs) have emerged as a good alternative for the treatment of thromboembolic diseases, and their use in clinical practice is increasing rapidly. The DOACs act by blocking the activity of one single step in the coagulation cascade. These drugs act downstream in the common pathway of the coagulation cascade by directly antagonising the action of thrombin or factor Xa. The development of DOACs represents a paradigm shift from the oral vitamin K antagonists such as warfarin. This article aims to describe the properties of the currently available DOACs including pharmacology and dosing. We also address the strategies for periprocedural management and reversal of anticoagulation of patients treated with these agents.

  6. Management of antiplatelet and anticoagulant therapy for endoscopic procedures: introduction to novel oral anticoagulants

    Directory of Open Access Journals (Sweden)

    Martha L. González-Bárcenas

    Full Text Available The development of novel antithrombotic therapy in the past few years and its prescription in patients with cardiovascular and circulatory disease has widened the spectrum of drugs that need to be considered when performing an endoscopic procedure. The balance between the thrombotic risk patients carry due to their medical history and the bleeding risk involved in endoscopic procedures should be thoroughly analyzed by Gastroenterologists. New oral anticoagulants (NOACs impose an additional task. These agents, that specifically target factor IIa or Xa, do not dispose of an anticoagulation monitoring method nor have an antidote to revert their effect, just as with antiplatelet agents. Understanding the fundamental aspects of these drugs provides the necessary knowledge to determine the ideal period the antithrombotic therapy should be interrupted in order to perform the endoscopic procedure, offering maximum safety for patients and optimal results.

  7. Novel oral anticoagulants in patients with chronic kidney disease and atrial fibrillation.

    Science.gov (United States)

    Stamellou, Eleni; Floege, Jürgen

    2017-12-01

    Atrial fibrillation (AF) is the most frequent arrhythmia in common clinical practice and its prevalence is markedly increased among patients with chronic kidney disease (CKD). The presence of CKD increases the incidence of AF and vice versa. Both AF and CKD increase the risk of stroke or systemic thromboembolism and oral anticoagulation is the mainstay for thromboembolic event prevention in patients with AF. Novel oral anticoagulants (NOACs) are nowadays often used in patients with AF and CKD, but they display a variable degree of renal elimination and the risk of accumulation and bleeding increases among patients with CKD in particular as kidney disease progresses. While recent data have demonstrated that patients with Stage 3 CKD benefit even more from oral anticoagulation therapies in comparison with patients with normal renal function, relatively little is known about the best choice of anticoagulation in patients with advanced and, in particular, end-stage renal disease, as these patients were excluded from all pivotal Phase 3 NOACs trials. This review summarizes current knowledge on the efficacy and safety of these agents in individuals with CKD and provides CKD stage-specific recommendations. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

  8. Periodontal and biochemical bone metabolism assessment on a chronic oral anticoagulation population treated with dicoumarins

    OpenAIRE

    López Lacomba, Daniel; Roa, Antonio; González Jaranay, Maximino; Gómez Moreno, Gerardo; Moreu Burgos, Gerardo

    2017-01-01

    Background The aim is to evaluate periodontal alteration and biochemical markers associated with bone turnover in chronic oral with dicoumarins anticoagulant treatment patients. Material and Methods 80 patients treated with oral anticoagulants were divided into 2 cohort: Group A (n=36) 6 month to 1 year with anticoagulant treatment and Group B (n=44) > 2 years with anticoagulant treatment. Clinical evaluation included: Clinical attachment level (CAL), plaque index (PI) and gingival index (GI)...

  9. Use of novel oral anticoagulants in patients with heart failure.

    Science.gov (United States)

    Shantsila, Eduard; Lip, Gregory Y H

    2014-02-01

    Pathophysiologically, there is a prothrombotic state evident in heart failure (HF). This is particularly evident within atria in patients whose course of the disease is complicated by concomitant atrial fibrillation (AF). A predisposition for thrombogenesis exists in patients with dilated dysfunctional cardiac chambers, such as those seen in patients with large myocardial infarction, left ventricular (LV) aneurysm or dilated cardiomyopathy. Based on subgroup analyses of recent phase 3 randomized trials, the novel oral anticoagulants are equally effective and safe in AF patients with HF or without HF. This appears to be true regarding both HF with systolic LV dysfunction and with preserved LVEF. However, patients with HF with preserved LVEF with more strict definition (ie, LVEF ≥ 55 %) have not been analyzed specifically. There is no information from clinical trial regarding possible utility of the novel oral anticoagulants in HF patients in sinus rhythm. Further research is required to cover gaps in knowledge on utility of these medications in a substantial proportion of HF patients not included in major clinical trials on novel oral anticoagulants.

  10. Possible failure of novel direct-acting oral anticoagulants in management of pulmonary embolism: a case report.

    Science.gov (United States)

    Rankin, James; Nagar, Menachem; Crosby, Jonathan; Toomari, Nojan; Pietras, Richard; Ben-Zur, Uri M

    2016-12-03

    The relative effectiveness of vitamin K antagonists compared with novel oral anticoagulants in treating pulmonary embolism remains unclear. Recent trials comparing the efficacy of vitamin K antagonists with factor Xa inhibitors for the treatment of pulmonary emboli have been non-inferiority studies based primarily on risk reduction (such as bleeding events), rather than resolution of specific diseases such as pulmonary embolism. Consequently, there is a lack of evidence indicating which of these agents are more effective. Here, we present a case where pulmonary emboli were treated with novel oral anticoagulants followed by warfarin to discuss the potential limitations in the use of novel oral anticoagulants as prevention or treatment of thromboembolism and the continued role for warfarin in this setting. A 34-year-old African American woman presented to our clinic with shortness of breath and pleuritic chest pain several months post-surgery. She was identified as having multiple bilateral pulmonary embolisms and was treated with several novel oral anticoagulants, which failed to resolve the clots. Complete resolution was achieved upon switching to warfarin. The patient described in this report failed to respond to novel oral anticoagulant therapy, but her emboli resolved when she was treated with warfarin. This study challenges the notion that factor Xa inhibitors are better alternatives to vitamin K anticoagulants in the treatment of pulmonary emboli based on their safety profile and ease of use alone. As a result, further post-marketing investigations into the efficacy of these agents in the management of pulmonary emboli may be warranted.

  11. Oral Anticoagulant Use After Bariatric Surgery: A Literature Review and Clinical Guidance.

    Science.gov (United States)

    Martin, Karlyn A; Lee, Craig R; Farrell, Timothy M; Moll, Stephan

    2017-05-01

    Bariatric surgery may alter the absorption, distribution, metabolism, or elimination (disposition) of orally administered drugs via changes to the gastrointestinal tract anatomy, body weight, and adipose tissue composition. As some patients who have undergone bariatric surgery will need therapeutic anticoagulation for various indications, appropriate knowledge is needed regarding anticoagulant drug disposition and resulting efficacy and safety in this population. We review general considerations about oral drug disposition in patients after bariatric surgery, as well as existing literature on oral anticoagulation after bariatric surgery. Overall, available evidence on therapeutic anticoagulation is very limited, and individual drug studies are necessary to learn how to safely and effectively use the direct oral anticoagulants. Given the sparsity of currently available data, it appears most prudent to use warfarin with international normalized ratio monitoring, and not direct oral anticoagulants, when full-dose anticoagulation is needed after bariatric surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Comparison of Oral Anticoagulants for Stroke Prevention in Nonvalvular Atrial Fibrillation: A Multicriteria Decision Analysis.

    Science.gov (United States)

    Tervonen, Tommi; Ustyugova, Anastasia; Sri Bhashyam, Sumitra; Lip, Gregory Y H; Verdecchia, Paolo; Kwan, Ryan; Gropper, Savion; Heinrich-Nols, Jutta; Marsh, Kevin

    2017-12-01

    Decision on the most appropriate oral anticoagulation therapy for stroke prevention in patients with nonvalvular atrial fibrillation is difficult because multiple treatment options are available, and these vary in their clinical effects and relevant nonclinical characteristics. To use a multicriteria decision analysis (MCDA) to compare the oral anticoagulants apixaban, dabigatran, edoxaban, rivaroxaban, and vitamin K antagonist (VKAs; specifically warfarin) in patients with nonvalvular atrial fibrillation. We identified the evaluation criteria through a targeted literature review and clinical judgment. The final evaluation model included nine clinical events and four other criteria. We ranked possibly fatal clinical event criteria on the basis of the differences in risks of fatal events and the corresponding window of therapeutic opportunity, as observed in clinical trials. Clinical judgment was used to rank other criteria. Full criteria ranking was used to calculate centroid weights, which were combined with individual treatment performances to estimate the overall value score for each treatment. Using such an MCDA, dabigatran yielded the highest overall value, approximately 6% higher than that of the second-best treatment, apixaban. Dabigatran also had the highest first-rank probability (0.72) in the probabilistic sensitivity analysis. Rivaroxaban performed worse than the other non-VKA oral anticoagulants, but better than VKAs (with both having 0.00 first-rank probability). The results were insensitive to changes in model structure. When all key oral anticoagulant value criteria and their relative importance are investigated in an MCDA, dabigatran appears to rank the highest and warfarin the lowest. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  13. Anticoagulation in Pulmonary Embolism: Update in the Age of Direct Oral Anticoagulants.

    Science.gov (United States)

    Rosovsky, Rachel; Merli, Geno

    2017-09-01

    The emergence of direct oral anticoagulants (DOACs) represents a major advancement and paradigm shift in the treatment of venous thromboembolism. Currently, dabigatran, rivaroxaban, apixiban, and edoxoban are approved and used routinely for the prevention and treatment of patients with venous thromboembolism. Because each of the DOACs has different doses and dosing regimens, clinicians need to become familiar with their use. This article focuses on the practical considerations of how and when to use the DOACs. It also aims to explore follow-up monitoring, use in special populations, reversal agents, periprocedural management, and how to handle bleeding complications with the DOACs. Copyright © 2017. Published by Elsevier Inc.

  14. Current evidence of oral anticoagulant reversal: A systematic review.

    Science.gov (United States)

    Tornkvist, Max; Smith, J Gustav; Labaf, Ashkan

    2017-12-06

    Approximately 4-6% of patients treated with oral anticoagulants (OAC) will suffer from major hemorrhage or be in need of urgent surgery necessitating anticoagulant reversal therapy. Several new oral anticoagulants and reversal agents have been introduced that make it difficult for physicians to stay updated on the current evidence of reversal management. This study aims to review the recent literature on oral anticoagulation reversal therapy and to present the current evidence in an easily approachable manner. A systematic literature search was conducted using PubMed and EMBASE to identify the latest publications on both vitamin K antagonist (VKA) and direct oral anticoagulant (DOAC) reversal strategies. All studies on humans who received any acute reversal management of VKA treatment were included, except case studies. Since only two studies on acute reversal of DOAC treatment have been published, clinical trials on healthy volunteers were also included. Twenty-one studies with a total of 4783 VKA treated patients, and 12 studies with a total of 529 DOAC treated patients were included. Elevated INR values due to VKA treatment could be reversed (INR≤1.5) in 63.1% (95% CI: 61.0-65.2) of study subjects after treatment with 4F-PCC, as compared with 12.2% (95% CI: 8.2-16.2) after treatment with fresh frozen plasma (FFP), (p<0.001). Thromboembolism occurred in 1.6% (95% CI: 1.2-2.1) of VKA-patients treated with 4F-PCC, and in 4.5% (95% CI: 2.3-6.7) of FFP-treated patients. To date, reversal of laboratory parameters has been demonstrated for two reversal agents specific to DOACs: idarucizumab for dabigatran reversal and andexanet-alfa for factor Xa-inhibitor reversal. This review supports the use of PCC for VKA reversal, specifically for 4F-PCC over FFP for laboratory reversal. There are no studies on clinical efficacy of non-specific agents for DOAC reversal and the evidence for laboratory reversal is not consistent. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. Therapeutic achievement with long-term oral anticoagulants in post-myocardial infarction patients

    NARCIS (Netherlands)

    A.J. Azar (Aida)

    1993-01-01

    textabstractTreatment with oral anticoagulant therapy entails a delicate balance between over( risk of bleeding) and under- (risk of thrombemboli) anticoagulation. Therapy is therefore monitored to maintain its anticoagulant effect within a narrow range. The main aim of this research was to

  16. Does novel oral anticoagulant improve anticoagulation for non-valvular atrial fibrillation associated stroke: An inpatient registration study in Shanghai

    Directory of Open Access Journals (Sweden)

    Feng-Di Liu

    2015-12-01

    Full Text Available Abstracts: Objective: To summarize the use rate, safety, efficacy of antithrombotics in stroke/transient ischemic attack (TIA prevention, and reasons for not using dabigatran etexilate (DE in Shanghai, China. Methods: Non-valvular atrial fibrillation (NVAF-associated stroke patients were prospectively registered as an electronic database. Use rate of antithrombotics and reasons for not using DE were extracted during follow-up. Patients' baseline characteristics, recurrent ischemic stroke/TIA events and bleeding complications were analyzed. Patients: From April 2012 to August 2014, 110 inpatients with NVAF-associated stroke were studied in our hospital. NVAF was diagnosed by 12-lead electrocardiogram, 24 h Holter and echocardiography. Results: Before introduction of DE (April 2013, use rates of warfarin and antiplatelets were 28.9% (11/38 and 60.5% (23/38 respectively; after that, use rates of warfarin, DE, and antiplatelets were 20.8% (15/72, 12.5% (9/72, and 43.1% (31/72. The DE did not improve use of anticoagulants (P = 0.639. There were 19 (17.3% recurrent ischemic stroke events up to October 2015; two (9.5% in the non-user group, 10 (18.5% in the antiplatelet group, and seven (20.0% in the anticoagulants group (P = 0.570. Furthermore, recurrence rates were similar between the DE group (20.0% and the Warfarin group (20.0%, P = 1.000. The most common reason for not using DE was financial concerns (61.0%, followed by inconvenience to purchase (14.0% and hemorrhage concerns (11.0%. Two patients using warfarin found fecal occult blood so they stopped warfarin and began to use antiplatelet drugs. No bleeding event occurred in the other groups. Only one patient had side effects (dyspepsia and gastroesophageal reflux from DE. Conclusion: The use rate of either DE or warfarin in Shanghai was low; DE had not improved anticoagulation therapy for NVAF patients in Shanghai mainly because DE had not been covered by health insurance. Keywords

  17. New Oral Anticoagulants in the Treatment of Pulmonary Embolism: Efficacy, Bleeding Risk, and Monitoring

    Directory of Open Access Journals (Sweden)

    Kelly M. Rudd

    2013-01-01

    Full Text Available Anticoagulation therapy is mandatory in patients with pulmonary embolism to prevent significant morbidity and mortality. The mainstay of therapy has been vitamin-K antagonist therapy bridged with parenteral anticoagulants. The recent approval of new oral anticoagulants (NOACs: apixaban, dabigatran, and rivaroxaban has generated significant interest in their role in managing venous thromboembolism, especially pulmonary embolism due to their improved pharmacokinetic and pharmacodynamic profiles, predictable anticoagulant response, and lack of required efficacy monitoring. This paper addresses the available literature, on-going clinical trials, highlights critical points, and discusses potential advantages and disadvantages of the new oral anticoagulants in patients with pulmonary embolism.

  18. Current guidelines and prospects for using novel oral anticoagulants for nonvalvular atrial fibrillation

    Directory of Open Access Journals (Sweden)

    A. V. Fonyakin

    2014-01-01

    Full Text Available The capabilities of antithrombotic therapy to prevent systemic thromboembolic events in nonvalvular atrial fibrillation (AF are substantially extended after clinically introducing novel oral anticoagulants (NOACs, such as dabigatran, rivaroxaban, and apixaban. World clinical experience with NOACs in AF has confirmed their efficacy and safety in both primary and secondary stroke prevention. At the same time, apixaban additionally reduces the risk of fatal outcomes and it is the safest among the NOACs against hemorrhagic events. The low risks of intracranial hemorrhage typical of NOACs should be taken into account when choosing oral anticoagulant therapy after hemorrhagic stroke in patients athigh risk for thromboembolic events due to AF. Whether NOACs may be used in acute myocardial infarction and during coronary stenting in the presence of nonvalvular AF, left ventricular thromboses, and cardiomyopathies is considered. In real clinical practice, nonvalvular AF may be accompanied by different cardiovascular diseases, by creating the situations where there are no specific guidelines for the use of NOACs. The results of comparing the clinical efficiency of different antithrombotic therapy regimens, the subanalysis of randomized trials, and experts’ opinions may assist a physician to substantiate their decisions. Thus, just a few NOACs that are similar and/or superior to warfarin in efficacy and safety have emerged to date. There are grounds to believe that many physicians will prefer direct anticoagulants to warfarin not only because of their proven efficacy, but also the rapid onset of their anticoagulant effect, neither interaction with a number of foods or drugs, and above all, nor need for regular laboratory blood testing. World post-marketingsurveillance and new clinical tests will be helpful in better estimating the benefits and risks of treatment with NOACs and in expanding indications for their use, which will considerably

  19. Direct Oral Anticoagulant Drugs in Dental Clinical Practice

    Directory of Open Access Journals (Sweden)

    Stasko J.

    2017-08-01

    Full Text Available The direct oral anticoagulant drugs (DOAC are generally safe and effective in several clinical settings including acute venous thromboembolic disease, prophylaxis in the postoperative setting, prevention of thromboembolism in patients with non-valvular atrial fibrillation, and in the management of acute coronary syndrome. The relatively short half-life, rapid onset of action, and predictable pharmacokinetics should simplify periprocedural use of the DOAC. The aim of this work is to propose and summarize periprocedural management of patients treated with the DOAC in dental practice and to inform about the principal specifications of this treatment.

  20. Novel oral anticoagulants for stroke prevention in atrial fibrillation

    DEFF Research Database (Denmark)

    Lip, Gregory Y H; Bongiorni, Maria Grazia; Dobreanu, Dan

    2013-01-01

    The purpose of this European Heart Rhythm Association (EHRA) survey was to assess clinical practice in relation to stroke prevention in atrial fibrillation (AF), particularly into the use of novel oral anticoagulants (NOACs) for stroke prevention, among members of the EHRA electrophysiology (EP......) research network. In this EP Wire survey, we have provided some insights into current practice in Europe for the use of NOACs for stroke prevention in AF. There were clear practice differences evident, and also the need for greater adherence to the guidelines, especially since guideline adherent management...

  1. Evaluation life quality of oral anticoagulated patients following oral surgical interventions

    OpenAIRE

    Dimova, Cena; Zdravkovska, Milka

    2016-01-01

    INTRODUCTION. The aim of this study was to evaluate patients on oral anticoagulants about their experience of life quality following different oral surgery interventions. MATERIAL AND METHOD. The study consisted of 260 patients referred for oral surgical treatment. An equal number of patients were assigned to each group (60 individuals). Group 1 was with deep venous thrombosis, Group 2 was with myocardial infarct, Group 3 with cerebrovascular insult and Group 4 with artificial heart valve...

  2. Life quality evaluation of oral anti-coagulated patients following oral surgical interventions

    OpenAIRE

    Dimova, Cena; Zdravkovska, Milka

    2015-01-01

    INTRODUCTION. The aim of this study was to evaluate patients on oral anticoagulants about their experience of life quality following different oral surgery interventions. MATERIAL AND METHOD. The study consisted of 260 patients referred for oral surgical treatment.. An equal number of patients were assigned to each group (60 individuals). Group 1 was with deep venous thrombosis, Group 2 was with myocardial infarct, Group 3 with cerebrovascular insult and Group 4 with artificial heart valv...

  3. Vitamin K Antagonists Versus Novel Oral Anticoagulants for Elective Electrical Cardioversion of Atrial Fibrillation.

    Science.gov (United States)

    Ţînţ, Diana; Petriş, Antoniu O; Pop, Ioana; Melnic, Rimma; Ignat, Andreea-Mihaela; Rogozea, Liliana M

    The management strategy for patients with atrial fibrillation (AF) is often very complex, electrical cardioversion (EC) being often used to restore sinus rhythm in those patients. The increased risk of thromboembolic complications was lowered using anticoagulation therapy. Usually, the anticoagulation was achieved using vitamin K antagonists (VKAs), but over the last years we witnessed a wide implementation of the novel oral anticoagulants (NOACs). Study question was to compare the efficacy of NOACs versus VKAs in patients undergoing elective EC for persistent AF, by assessing the presence of left atrial spontaneous contrast and left atrial thrombi (LACS), as well as the occurrence of the thromboembolic events in the first month after the procedure. A prospective study, including patients with persistent AF enrolled between January 1, 2015 and December 31, 2016, was conducted in 2 tertiary cardiology clinics. In all these patients, a management strategy based on EC was considered for the treatment of the disease. All patients received anticoagulant therapy for at least 3 weeks before cardioversion. The data of 103 patients were analyzed. The patients were divided into 2 groups: group A-VKAs treated-included 45 patients (43.68%), mean age 65.3 ± 12.47, 36% women; group B-NOACs treated-included 58 patients (56.31%), mean age 66.4 ± 9.79, 46% women. There was a trend toward higher incidence of left atrial thrombi in group B (16.28%) versus group A (7.69%), but the difference was not statistically significant (P = 0.5). The incidence of LACS was 40% in group A and 29% in group B, (P = 0.54). There are no statistically significant differences between the transesophageal echocardiography characteristics of left atrium and left atrial appendage examinations in the patients who received anticoagulation with VKAs as compared to patients who received anticoagulation with NOACs.

  4. Patients' knowledge on oral anticoagulant treatment in Hungary.

    Science.gov (United States)

    Viola, Reka; Fekete, Helga; Csoka, Ildiko

    2017-12-01

    Background A key element for an effective and safe oral anticoagulant treatment (OAT) is to have the relevant information delivered to patients in an easy-to-understand way and thus have them apply this knowledge in their own therapy. Objective To assess knowledge about OAT, reveal knowledge gaps and identify at-risk patients in terms of limited knowledge about their anticoagulant therapy. Setting Community pharmacies in Hungary. Methods This descriptive cross-sectional study used a structured, validated, self-developed questionnaire to assess patients' knowledge about OAT. Scores were calculated on each domain and the association between knowledge and patients' or treatment characteristics were analysed. Responses in all domains were assessed to identify at-risk patients and knowledge gaps. Main outcome measures Knowledge and knowledge gaps on OAT, and risk factors for limited knowledge. Results The questionnaire developed based on four validated questionnaires passed the field test and had a good internal consistency (Cronbach α = 0.795). Our full patient population (N = 427) had a mean percentage score of 59.39 (29.7% good, 41.2% average, 29.0% poor knowledge on OAT). Poor knowledge level was found to significantly correlate with advanced age (> 75 years), lower education, diagnosis of atrial fibrillation, and unawareness of the indication of OAT. The lowest frequency of correct answers regarded the questions on drug interactions (10.2%) and diet (11.4%). Pharmacists were infrequently indicated as the healthcare professionals to share information with regarding OAT (12.7%). Conclusion Findings of our study offer a valuable insight into the required directions of developing new strategies for patient education to improve knowledge on the treatment with oral anticoagulants.

  5. Use of Oral Anticoagulation Therapy in Atrial Fibrillation after Stroke

    DEFF Research Database (Denmark)

    Jespersen, Stine Funder; Christensen, Louisa M; Christensen, Anders

    2013-01-01

    Background. The knowledge is still sparse about patient related factors, influencing oral anticoagulation therapy (OAC) rates, in stroke patients with atrial fibrillation (AF). Aims. To assess the use of OAC in ischemic stroke patients diagnosed with AF and to identify patient related factors inf...... were positive predictors of OAC, while excessive alcohol consumption, smoking, and institutionalization were negative predictors of OAC (P values......Background. The knowledge is still sparse about patient related factors, influencing oral anticoagulation therapy (OAC) rates, in stroke patients with atrial fibrillation (AF). Aims. To assess the use of OAC in ischemic stroke patients diagnosed with AF and to identify patient related factors...... predictors of OAC. Results. 17.1% (n = 9,482) of ischemic stroke patients had AF. OAC prescription rates were increasing, and in 2011 46.6% were prescribed OAC, 42.5% had a contraindication, and 3.7% were not prescribed OAC without a stated contraindication. Younger age, less severe stroke, and male gender...

  6. Percutaneous left atrial appendage occlusion in atrial fibrillation patients with a contraindication to oral anticoagulation: a focused review.

    Science.gov (United States)

    Nishimura, Marin; Sab, Shiv; Reeves, Ryan R; Hsu, Jonathan C

    2017-12-08

    Stroke is the most feared complication of atrial fibrillation (AF). Although oral anticoagulation with non-vitamin K antagonist and non-vitamin K antagonist oral anticoagulants (NOACs) have been established to significantly reduce risk of stroke, real-world use of these agents are often suboptimal due to concerns for adverse events including bleeding from both patients and clinicians. Particularly in patients with previous serious bleeding, oral anticoagulation may be contraindicated. Left atrial appendage occlusion (LAAO), mechanically targeting the source of most of the thrombi in AF, holds an immense potential as an alternative to OAC in management of stroke prophylaxis. In this focused review, we describe the available evidence of various LAAO devices, detailing data regarding their use in patients with a contraindication for oral anticoagulation. Although some questions of safety and appropriate use of these new devices in patients who cannot tolerate anticoagulation remain, LAAO devices offer a significant step forward in the management of patients with AF, including those patients who may not be able to be prescribed OAC at all. Future studies involving patients fully contraindicated to OAC are warranted in the era of LAAO devices for stroke risk reduction. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

  7. Initiation of oral anticoagulant therapy in orthopedic and surgical patients : an algorithm compared with routine dosing

    NARCIS (Netherlands)

    van den Bemt, PMLA; Beinema, M; van Roon, EN; Sijtsma, J; Baars, WA; Mencke, HJ; Brouwers, JRBJ

    Oral anticoagulant therapy is initiated in most hospitals in The Netherlands by clinicians who routinely dose oral anticoagulants (without using an algorithm). This may explain the low proportion of patients leaving the hospital stabilized. To test this hypothesis this study compared the dosing of

  8. Comparing Direct Oral Anticoagulants and Warfarin for Atrial Fibrillation, Venous Thromboembolism, and Mechanical Heart Valves.

    Science.gov (United States)

    Marcy, Todd R; Truong, Teresa; Rai, Andrea

    2015-11-01

    To summarize available data for use of direct oral anticoagulants in nonvalvular atrial fibrillation, venous thromboembolism, and mechanical heart valves including dose-response consistency to offer considerations for pharmacotherapeutic decision-making for oral anticoagulants. A Medline search of English-language studies published between 2000 and March 2015 was conducted to identify pertinent papers using combinations of the following words: apixaban, atrial fibrillation, dabigatran, direct oral anticoagulant, edoxaban, factor IIa inhibitors, factor Xa inhibitors, mechanical heart valves, novel oral anticoagulant, rivaroxaban, venous thromboembolism, and warfarin. Original studies, guidelines, and approved prescribing information were evaluated and included if contributing new or complementary data toward the objective. References for all identified studies were reviewed and entries included if contributory. Randomized controlled trials have established the safety and efficacy of direct oral anticoagulants in atrial fibrillation and venous thromboembolism for most patient groups. Direct oral anticoagulants should not be used in patients with mechanical heart valves until proven safe and effective. There are groups for which questions remain regarding inter-patient dose-response consistency for direct oral anticoagulants. There are postmarketing data suggesting poorer real-world performance of dabigatran relative to clinical trial data. Direct oral anticoagulants offer several advantages over warfarin, and large clinical trial data establish the appropriateness of their use in broad populations. There remain groups for whom the relative benefit and risk of these agents relative to warfarin are uncertain. A patient-specific approach in pharmacotherapeutic decision-making is appropriate.

  9. Anticoagulation

    Science.gov (United States)

    ... Defects Updated:Sep 12,2017 Many people with congenital heart defects need to take anticoagulants (blood-thinners). Common reasons for this type of treatment include heart valve replacements, heart rhythm ...

  10. Left Atrial Appendage Thrombi Formation in Japanese Non-Valvular Atrial Fibrillation Patients During Anticoagulation Therapy - Warfarin vs. Direct Oral Anticoagulants.

    Science.gov (United States)

    Kawabata, Mihoko; Goya, Masahiko; Sasaki, Takeshi; Maeda, Shingo; Shirai, Yasuhiro; Nishimura, Takuro; Yoshitake, Takakatsu; Shiohira, Shinya; Isobe, Mitsuaki; Hirao, Kenzo

    2017-04-25

    Atrial fibrillation (AF) is a common cardiac arrhythmia, associated with increased cardiovascular morbidity and mortality including thromboembolic events. The aims of this study were to assess the prevalence of left atrial appendage (LAA) thrombi in Japanese non-valvular atrial fibrillation (NVAF) patients undergoing preprocedural transesophageal echocardiography (TEE) during anticoagulation therapy, and to compare the efficacy of warfarin and direct oral anticoagulants (DOAC).Methods and Results:This retrospective study reviewed records of 559 consecutive NVAF patients (445 men; age, 62±11 years) undergoing preprocedural TEE following at least 3 weeks of anticoagulation therapy. Of these, 275 patients had non-paroxysmal AF (49%). LAA thrombus was observed in 15 patients (2.7%). The prevalence of LAA thrombi was similar between the DOAC group (2.6%) and the warfarin group (2.8%, P=0.86). No patients with CHA2DS2-VASc score=0, or paroxysmal AF without prior stroke or transient ischemic attack, had LAA thrombi. On univariate analysis, non-paroxysmal AF, structural heart disease, antiplatelet therapy, larger left atrium, higher brain natriuretic peptide (BNP), reduced LAA flow, and higher CHA2DS2-VASc score were all associated with LAA thrombi. On multivariate analysis, BNP ≥173 pg/mL remained the only independent predictor of LAA thrombi. LAA thrombi were found in 2.7% of Japanese NVAF patients scheduled for procedures despite ongoing oral anticoagulation therapy. Incidence of thrombi was similar for patients on DOAC and on warfarin.

  11. Intracranial hemorrhage risk with the new oral anticoagulants: a systematic review and meta-analysis.

    Science.gov (United States)

    Caldeira, Daniel; Barra, Márcio; Pinto, Fausto J; Ferreira, Joaquim J; Costa, João

    2015-03-01

    The new oral anticoagulants/non-vitamin K antagonists oral anticoagulants (NOACs) have recently reached the market and less is known about their safety in comparison to their efficacy. Therefore, we aimed to evaluate intracranial hemorrhage (ICH) risk with NOACs, the most feared adverse event of anticoagulation treatment. This is a systematic review and meta-analysis of phase III randomized controlled trials (RCTs) comparing NOACs versus any control and reporting ICH events. Studies were searched through Medline and Cochrane Library (April 2014). Reviews and reference lists were also screened. Random effects' meta-analysis was performed to derive pooled estimates expressed as relative risk (RR) and 95 % CI. Number needed to treat/harm (NNT/NNH) taking into account the baseline risk was also calculated. Heterogeneity was evaluated with I (2) test. 18 RCTs evaluating 148,149 patients were included. NOAC significantly reduced ICH risk compared to vitamin K antagonists (VKA) (RR 0.44; 95 % CI 0.36-0.54; I (2) = 37 %; NNT: 137 during 2 years) and to sequential treatment with low molecular weight heparin and VKA (RR 0.28; 95 % CI 0.12-0.65; I (2) = 0 %; NNT: 463 patients during 7 months). Compared to placebo, NOACs were associated with an increased ICH risk (RR 3.31; 95 % CI 1.59-6.90; I (2) = 0 %; NNH: 433 during 1 year). Results were similar for the different NOAC drugs and across the different clinical conditions. In patients requiring anticoagulation treatment, the risk of ICH is about half with the NOACs in comparison to standard antithrombotic treatment. This safer profile found in RCTs should be confirmed in real-world database studies.

  12. Gastrointestinal bleedings during therapy with new oral anticoagulants are rarely reported

    DEFF Research Database (Denmark)

    Bay-Nielsen, Morten; Kampmann, Jens Peter; Bisgaard, Thue

    2014-01-01

    INTRODUCTION: Post-marketing surveillance of drugs relies on spontaneous reporting of adverse drug events to the Danish Health and Medicines Authority. A number of new oral anticoagulants (NOAC) have recently been marketed in Denmark. The purpose of this study was to evaluate the reporting......, Surgical Section, Hvidovre Hospital, during a one-year-period. Patients in treatment with NOAC and admitted for gastrointestinal bleeding were identified. Relevant patients were cross-checked for a reported adverse drug event in the Danish Health and Medi-cines Authority's database on adverse medical...... events. RESULTS: A total of 20 patients were acutely admitted for gastrointestinal bleeding while in treatment with a NOAC, an adverse medical event was reported for one of these patients (5%; 95% confidence interval: 0-25%). CONCLUSION: Serious adverse events in patients treated with NOAC...

  13. Detection of lupus anticoagulant in the era of direct oral anticoagulants.

    Science.gov (United States)

    Hoxha, Ariela; Banzato, Alessandra; Ruffatti, Amelia; Pengo, Vittorio

    2017-02-01

    Lupus anticoagulant (LAC) is an in vitro phenomenon determining a phospholipid-dependent elongation of clotting times. The presence of LAC associated with anticardiolipin (aCL) and anti-β2 glycoprotein I (anti-β2GPI) antibodies is strongly associated with thrombosis and pregnancy morbidity. Direct oral anticoagulants (DOACs) targeting thrombin and factor Xa are currently widely use to prevent and treat venous and arterial thromboembolism. Some concern has, however, been expressed about the possibility of false laboratory results during LAC assessment in patients taking these drugs. Several in vitro studies, spiking DOACs into normal plasma as well as ex vivo at peak levels in treated patients, led in false-positive LAC. The dilute Russell Viper Venom time is the assay that is most influenced by rivaroxaban, edoxaban, dabigatran and less by apixaban. Both screening and confirmatory tests have resulted equally prolonged for activated partial thromboplastin time and have not led to false-positive results, but this may depend on the type of reagent used for the test. Taipan/Ecarin snake venoms ratios, has been recommend by some investigators as they do not seem to be affected by rivaroxaban or edoxaban, but these tests are neither standardized nor generally available in clinical practice. In conclusion, for the time being it does not seem advisable to carry out LAC testing during anti-factor Xa and anti-factor IIa treatment because of the risk of false-positive results. Whenever needed in deciding the suspension of DOACs or in case of recurrent thrombosis, LAC determination should be carried out at trough better if DOAC concentration is known. Copyright © 2016 Elsevier B.V. All rights reserved.

  14. [Oral anticoagulation in chronic kidney disease with atrial fibrillation].

    Science.gov (United States)

    Expósito, Víctor; Seras, Miguel; Fernández-Fresnedo, Gema

    2015-05-21

    Atrial fibrillation is a common finding in patients with chronic kidney disease (CKD), which increases markedly the embolism risk. The CHADS2 and HAS-BLED scales, used in the general population to assess the risk/benefit of oral anticoagulation (OAC), underestimate respectively the risk of embolism and haemorrhage in CKD, making it difficult to decide whether to use OAC or not. Based on the available evidence, it seems indicated to use OAC in stage 3 CKD, while it is controversial in advanced stages. New OAC such as dabigatran and rivaroxaban have been approved in stage 3 CKD but their role is still somewhat uncertain. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

  15. Non-vitamin K antagonist oral anticoagulation agents in anticoagulant naïve atrial fibrillation patients

    DEFF Research Database (Denmark)

    Olesen, Jonas Bjerring; Sørensen, Rikke; Hansen, Morten Lock

    2015-01-01

    AIMS: Non-vitamin K antagonist oral anticoagulation (NOAC) agents have been approved for stroke prophylaxis in atrial fibrillation (AF). We investigated 'real-world' information on how these drugs are being adopted. METHODS AND RESULTS: Using Danish nationwide administrative registers, we...

  16. The HIPOGAIA study: Monitoring of oral anticoagulation with vitamin K antagonists in the municipality of Gaia.

    Science.gov (United States)

    Guedes, Marta; Rego, Catarina

    2016-09-01

    Anticoagulant therapy is an effective measure in preventing thromboembolic adverse events. Of the diseases in which this treatment is indicated, atrial fibrillation (AF) has the highest incidence worldwide, with a prevalence of 1.5-2%. To assess the quality of monitoring of patients with non-valvular AF under oral anticoagulation with vitamin K antagonists in Vila Nova de Gaia healthcare units. This was a retrospective observational analytical study of the population registered at the 37 healthcare units of the Vila Nova de Gaia and Espinho health center area under oral anticoagulation with vitamin K antagonists during 2014. The data were collected using TAONet(®) software. The variables studied were health units, age, gender, INR value, time in therapeutic range (TTR) and medication. TTR was calculated for each patient using the Rosendaal linear interpolation method. It was stipulated that each patient should have undergone at least six INR measurements. Data were analyzed using Microsoft Excel(®) 2010 and SPSS(®) version 21, using descriptive and inferential statistical techniques. A total of 479 patients with non-valvular AF were studied, corresponding to 5883 INR tests. Mean TTR was 67.4±6.5%, and 35.3% of patients exhibited poor control (TTR <60%). Our study showed moderate control of coagulation parameters, but better than in many international clinical trials and in another Portuguese observational study. Nevertheless, there is still room for improvement in anticoagulation monitoring in primary health care. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT): a randomised controlled trial.

    Science.gov (United States)

    Halkes, P H A; van Gijn, J; Kappelle, L J; Koudstaal, P J; Algra, A

    2007-02-01

    Oral anticoagulants are better than aspirin for secondary prevention after myocardial infarction and after cerebral ischaemia in combination with non-rheumatic atrial fibrillation. The European/Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT) aimed to determine whether oral anticoagulation with medium intensity is more effective than aspirin in preventing future vascular events in patients with transient ischaemic attack or minor stroke of presumed arterial origin. In this international, multicentre trial, patients were randomly assigned within 6 months after a transient ischaemic attack or minor stroke of presumed arterial origin either anticoagulants (target INR range 2.0-3.0; n=536) or aspirin (30-325 mg daily; n=532). The primary outcome was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever occurred first. In a post hoc analysis anticoagulants were compared with the combination of aspirin and dipyridamole (200 mg twice daily). Treatment was open, but auditing of outcome events was blinded. Primary analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN73824458) and with ClinicalTrials.gov (NCT00161070). The anticoagulants versus aspirin comparison of ESPRIT was prematurely ended because ESPRIT reported previously that the combination of aspirin and dipyridamole was more effective than aspirin alone. Mean follow-up was 4.6 years (SD 2.2). The mean achieved INR was 2.57 (SD 0.86). A primary outcome event occurred in 99 (19%) patients on anticoagulants and in 98 (18%) patients on aspirin (hazard ratio [HR] 1.02, 95% CI 0.77-1.35). The HR for ischaemic events was 0.73 (0.52-1.01) and for major bleeding complications 2.56 (1.48-4.43). The HR for the primary outcome event comparing anticoagulants with the combination treatment of aspirin and dipyridamole was 1.31 (0.98-1.75). Oral

  18. Is point-of-care accurate for indicating thrombolysis in anticoagulated patients on oral anticoagulation treatments?

    Directory of Open Access Journals (Sweden)

    Tatiana P. Bruch

    Full Text Available The use of oral anticoagulation treatment (OAT in patients with an international normalized ratio (INR higher than 1.7 is a contraindication to thrombolysis in acute ischemic stroke. The aim of the present study is to compare the use of point-of-care (POC coagulometers to the standard coagulation analysis (SCA procedure of the INR as a decision-making test for use with patients taking OAT. Method: Eighty patients on chronic OAT underwent a POC and an SCA during a regular outpatient evaluation. Results: When comparing the abilities of the POC test and the SCA test to identify adequate levels for thrombolysis (≤1.7, the POC had a sensitivity of 96.6% (95%CI 88.4-99.1 and a specificity of 60.0% (95%CI 38.6-78. POC overestimated INR levels by 0.51 points compared to the SCA test. Conclusion: POC has a high sensitivity compared to the SCA test for the identification of patients within the cut-off point for thrombolysis.

  19. Treatment Changes among Users of Non-Vitamin K Antagonist Oral Anticoagulants in Atrial Fibrillation

    DEFF Research Database (Denmark)

    Hellfritzsch, Maja; Husted, Steen Elkjaer; Grove, Erik Lerkevang

    2016-01-01

    Patients with atrial fibrillation discontinuing anticoagulant therapy are left unprotected against ischaemic stroke. Further, switching between oral anticoagulants may be associated with a transiently increased risk of bleeding or thromboembolism. However, there is a paucity of real-life data on ...

  20. Implant surgery and oral anticoagulant therapy: case report.

    Science.gov (United States)

    Miranda, M; Bollero, P; D'Ovidio, N; Marsango, V; Barlattani, A

    2014-01-01

    This work aims to assess the risks both thromboembolic that bleeding of a management protocol "non-conservative" in patients on oral anticoagulant therapy (OAT) to be undergoing implant surgery. We decided to take a surgical "non-conservative" protocol, to insert four implants in the aesthetic zone, without using flapless surgery and the surgical template. In accordance with the hematologist, the value of INR is lowered and warfarin was replaced with heparin low molecular weight, to have a better coagulation's control. The modern guidelines impose a protocol of conservative management in patients with OAT, with minimally invasive surgery, flapless, and use of surgical template to reduce the risk of uncontrolled bleeding. This, thanks to the team-work between dentist and hematologist, thanks to careful adjustment of INR and the use of local haemostatic agents, were not encountered any problems with bleeding or intra or postoperative. Surgical treatment of patients with OAT is a real problem for the oral surgeon, to treat every time in association with the hematologist. Applying this type of surgical procedure, different from today's guidelines, in our experience there were no post-operative complications (bleeding or bleeding); osseointegration has not been compromised and the prosthetic rehabilitation was completed successfully.

  1. Assessment of novel oral anticoagulant use within a community teaching hospital

    Directory of Open Access Journals (Sweden)

    Sultan Alghadeer

    2017-01-01

    Full Text Available Background: Novel oral anticoagulants (NOACs are considered to be at least as effective and safe as warfarin with several advantages such as predictable pharmacokinetics, allowing for standardized dosing without monitoring, a lack of food interactions and fewer drug interactions; however, their misuse could potentially result in patient harm. Objective: To evaluate the appropriate use of the NOACs within a community teaching hospital. Setting: A community teaching hospital in the United States. Method: A retrospective chart review of patients that were prescribed dabigatran, rivaroxaban, or apixaban at our institution from October 2012 through November 2014 was conducted. Main outcome measure: The primary objective was to determine the percentage of patients that were appropriately prescribed NOACs. Secondary objectives were to determine the number of patients who were inappropriately transitioned from warfarin or parenteral anticoagulants to a NOAC or vice versa, the number of incidents when a NOAC was held or discontinued inappropriately before a procedure and the number of bleeding or thrombotic events while taking a NOAC. Results: Of the 113 patients receiving therapy with an NOAC, appropriate prescribing was observed in 79.7%. Dabigatran, rivaroxaban, and apixaban were appropriately prescribed in 73.8%, 88.3%, and 85.8% of patients respectively. Lack of renal dose-adjustment in patients with reduced renal function was the most common reason for inappropriate use (8.8%. Ten out of 38 patients (26% were inappropriately transitioned from/to other anticoagulants. Two out of six patients underwent a procedure without holding NOACs as recommended prior to surgery. Of all patients receiving NOACs, a total of 3 bleeding incidents were observed, one with each NOAC. Conclusion: The NOACs were appropriately prescribed for the majority of patients within our institution. Future efforts however should focus on ensuring appropriate dose adjustments for

  2. Stability of direct oral anticoagulants in whole blood and plasma from patients in steady state treatment

    DEFF Research Database (Denmark)

    McGrail, Rie; Revsholm, Jesper; Nissen, Peter H

    2016-01-01

    Using functional haemostasis assays, we demonstrated important differences in stability of direct oral anticoagulants (DOACs) in citrated whole blood and plasma from DOAC treated patients. Laboratories and clinicians should take this into consideration and adjust clinical practices accordingly....

  3. The potential interaction between oral anticoagulants and acetaminophen in everyday practice

    NARCIS (Netherlands)

    van den Bemt, PMLA; Geven, LM; Kuitert, NA; Risselada, A; Brouwers, JRBJ

    2002-01-01

    Objective: The drug-drug interaction between oral anticoagulants (especially warfarin) and acetaminophen has been described, but evidence is conflicting and evidence for a similar interaction between acenocoumarol or phenprocoumon and acetaminophen is limited. Therefore, a study was performed to

  4. Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison

    NARCIS (Netherlands)

    Cromheecke, M. E.; Levi, M. [=Marcel M.; Colly, L. P.; de Mol, B. J.; Prins, M. H.; Hutten, B. A.; Mak, R.; Keyzers, K. C.; Büller, H. R.

    2000-01-01

    BACKGROUND: Vitamin K antagonist treatment is effective for prevention and treatment of thromboembolic events but frequent laboratory control and dose-adjustment are essential. Small portable devices have enabled patient self-monitoring of anticoagulation and self-adjustment of the dose. We compared

  5. Monitoring the Effects and Antidotes of the Non-vitamin K Oral Anticoagulants

    DEFF Research Database (Denmark)

    Rahmat, Nur A; Lip, Gregory Y H

    2015-01-01

    In the last decade, we have witnessed the emergence of the oral non-vitamin K oral anticoagulants (NOACs), which have numerous advantages compared with the vitamin K antagonists, particularly their lack of need for monitoring; as a result their use is increasing. Nonetheless, the NOACs face two...... major challenges: the need for reliable laboratory assays to assess their anticoagulation effect, and the lack of approved antidotes to reverse their action. This article provides an overview of monitoring the anticoagulant effect of NOACs and their potential specific antidotes in development....

  6. Direct-Acting Oral Anticoagulants: Practical Considerations for Emergency Medicine Physicians

    Directory of Open Access Journals (Sweden)

    W. Frank Peacock

    2016-01-01

    Full Text Available Nonvalvular atrial fibrillation- (NVAF- related stroke and venous thromboembolism (VTE are cardiovascular diseases associated with significant morbidity and economic burden. The historical standard treatment of VTE has been the administration of parenteral heparinoid until oral warfarin therapy attains a therapeutic international normalized ratio. Warfarin has been the most common medication for stroke prevention in NVAF. Warfarin use is complicated by a narrow therapeutic window, unpredictable dose response, numerous food and drug interactions, and requirements for frequent monitoring. To overcome these disadvantages, direct-acting oral anticoagulants (DOACs—dabigatran, rivaroxaban, apixaban, and edoxaban—have been developed for the prevention of stroke or systemic embolic events (SEE in patients with NVAF and for the treatment of VTE. Advantages of DOACs include predictable pharmacokinetics, few drug-drug interactions, and low monitoring requirements. In clinical studies, DOACs are noninferior to warfarin for the prevention of NVAF-related stroke and the treatment and prevention of VTE as well as postoperative knee and hip surgery VTE prophylaxis, with decreased bleeding risks. This review addresses the practical considerations for the emergency physician in DOAC use, including dosing recommendations, laboratory monitoring, anticoagulation reversal, and cost-effectiveness. The challenges of DOACs, such as the lack of specific laboratory measurements and antidotes, are also discussed.

  7. Cost effectiveness of novel oral anticoagulants for stroke prevention in atrial fibrillation depending on the quality of warfarin anticoagulation control.

    Science.gov (United States)

    Janzic, Andrej; Kos, Mitja

    2015-04-01

    Vitamin K antagonists, such as warfarin, are standard treatments for stroke prophylaxis in patients with atrial fibrillation. Patient outcomes depend on quality of warfarin management, which includes regular monitoring and dose adjustments. Recently, novel oral anticoagulants (NOACs) that do not require regular monitoring offer an alternative to warfarin. The aim of this study was to evaluate whether cost effectiveness of NOACs for stroke prevention in atrial fibrillation depends on the quality of warfarin control. We developed a Markov decision model to simulate warfarin treatment outcomes in relation to the quality of anticoagulation control, expressed as percentage of time in the therapeutic range (TTR). Standard treatment with adjusted-dose warfarin and improved anticoagulation control by genotype-guided dosing were compared with dabigatran, rivaroxaban, apixaban and edoxaban. The analysis was performed from the Slovenian healthcare payer perspective using 2014 costs. In the base case, the incremental cost-effectiveness ratio for apixaban, dabigatran and edoxaban was below the threshold of €25,000 per quality-adjusted life-years compared with adjusted-dose warfarin with a TTR of 60%. The probability that warfarin was a cost-effective option was around 1%. This percentage rises as the quality of anticoagulation control improves. At a TTR of 70%, warfarin was the preferred treatment in half the iterations. The cost effectiveness of NOACs for stroke prevention in patients with nonvalvular atrial fibrillation who are at increased risk for stroke is highly sensitive to warfarin anticoagulation control. NOACs are more likely to be cost-effective options in settings with poor warfarin management than in settings with better anticoagulation control, where they may not represent good value for money.

  8. Utilization of oral anticoagulation in a teaching hospital in Nigeria ...

    African Journals Online (AJOL)

    Background: Anticoagulation is an essential lifesaving management practice indicated for arterial, venous and intracardiac thromboembolism. Aim: This study was undertaken to examine the utilization of anticoagulation services in University of Nigeria Teaching Hospital, Enugu (UNTH) Nigeria. Materials and Methods: This ...

  9. Use of Oral Anticoagulation in the Management of Atrial Fibrillation in Patients with ESRD: Pro

    Science.gov (United States)

    Ball, Timothy; Cox, Katy Mathews; Assar, Manish D.

    2016-01-01

    Warfarin has had a thin margin of benefit over risk for the prevention of stroke and systemic embolism in patients with ESRD because of higher bleeding risks and complications of therapy. The successful use of warfarin has been dependent on the selection of patients with nonvalvular atrial fibrillation at relatively high risk of stroke and systemic embolism and lower risks of bleeding over the course of therapy. Without such selection strategies, broad use of warfarin has not proven to be beneficial to the broad population of patients with ESRD and nonvalvular atrial fibrillation. In a recent meta-analysis of use of warfarin in patients with nonvalvular atrial fibrillation and ESRD, warfarin had no effect on the risks of stroke (hazard ratio, 1.12; 95% confidence interval, 0.69 to 1.82; P=0.65) or mortality (hazard ratio, 0.96; 95% confidence interval, 0.81 to 1.13; P=0.60) but was associated with increased risk of major bleeding (hazard ratio, 1.30; 95% confidence interval, 1.08 to 1.56; P<0.01). In pivotal trials, novel oral anticoagulants were generally at least equal to warfarin for efficacy and safety in nonvalvular atrial fibrillation and mild to moderate renal impairment. Clinical data for ESRD are limited, because pivotal trials excluded such patients. Given the very high risk of stroke and systemic embolism and the early evidence of acceptable safety profiles of novel oral anticoagulants, we think that patients with ESRD should be considered for treatment with chronic anticoagulation provided that there is an acceptable bleeding profile. Apixaban is currently indicated in ESRD for this application and may be preferable to warfarin given the body of evidence for warfarin and its difficulty of use and attendant adverse events. PMID:27797888

  10. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data.

    Science.gov (United States)

    Heneghan, Carl; Ward, Alison; Perera, Rafael; Bankhead, Clare; Fuller, Alice; Stevens, Richard; Bradford, Kairen; Tyndel, Sally; Alonso-Coello, Pablo; Ansell, Jack; Beyth, Rebecca; Bernardo, Artur; Christensen, Thomas Decker; Cromheecke, M E; Edson, Robert G; Fitzmaurice, David; Gadisseur, Alain P A; Garcia-Alamino, Josep M; Gardiner, Chris; Hasenkam, J Michael; Jacobson, Alan; Kaatz, Scott; Kamali, Farhad; Khan, Tayyaba Irfan; Knight, Eve; Körtke, Heinrich; Levi, Marcel; Matchar, David; Menéndez-Jándula, Bárbara; Rakovac, Ivo; Schaefer, Christian; Siebenhofer, Andrea; Souto, Juan Carlos; Sunderji, Rubina; Gin, Kenneth; Shalansky, Karen; Völler, Heinz; Wagner, Otto; Zittermann, Armin

    2012-01-28

    Uptake of self-testing and self-management of oral anticoagulation [corrected] has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in the evidence, including an estimate of the effect on time to death, first major haemorrhage, and thromboembolism. We searched Ovid versions of Embase (1980-2009) and Medline (1966-2009), limiting searches to randomised trials with a maximally sensitive strategy. We approached all authors of included trials and requested individual patient data: primary outcomes were time to death, first major haemorrhage, and first thromboembolic event. We did prespecified subgroup analyses according to age, type of control-group care (anticoagulation-clinic care vs primary care), self-testing alone versus self-management, and sex. We analysed patients with mechanical heart valves or atrial fibrillation separately. We used a random-effect model method to calculate pooled hazard ratios and did tests for interaction and heterogeneity, and calculated a time-specific number needed to treat. Of 1357 abstracts, we included 11 trials with data for 6417 participants and 12,800 person-years of follow-up. We reported a significant reduction in thromboembolic events in the self-monitoring group (hazard ratio 0·51; 95% CI 0·31-0·85) but not for major haemorrhagic events (0·88, 0·74-1·06) or death (0·82, 0·62-1·09). Participants younger than 55 years showed a striking reduction in thrombotic events (hazard ratio 0·33, 95% CI 0·17-0·66), as did participants with mechanical heart valve (0·52, 0·35-0·77). Analysis of major outcomes in the very elderly (age ≥85 years, n=99) showed no significant adverse effects of the intervention for all outcomes. Our analysis showed that self-monitoring and self-management of oral coagulation is a safe option for suitable patients of all ages

  11. Safety and efficacy of bone wax in patients on oral anticoagulant therapy.

    Science.gov (United States)

    Krasny, Marta; Krasny, Kornel; Fiedor, Piotr

    2014-01-01

    Cardiovascular conditions, apart from neoplastic diseases, remain the major cause of death in developed countries; therefore, the number of patients receiving oral anticoagulants is constantly increasing. Anticoagulant therapy considerably reduced mortality in patients with history of myocardial infarction among others. Although many interventions may be performed without withdrawal of the anticoagulant and tooth extraction was qualified as a procedure of low hemorrhage risk, a majority of dentists refer the patient to a cardiologist several days before the elective tooth extraction to withdraw anticoagulants. The aim of the study was to evaluate the efficacy and safety of bone wax used to stop bleeding after dental procedures in a group of patients on chronic anticoagulant therapy and find an answer to a question, whether it is justified to temporarily withdraw anticoagulants for this type of procedures. The study involved 176 patients on chronic anticoagulant therapy undergoing tooth extraction (154 subjects) or surgical extraction of a retained tooth (48 subjects). After the procedure, in each case the alveolus was filled with bone wax to stop bleeding. In all patients involved in the study bleeding from the alveolus was successfully stopped during the procedure. None of the subjects reported increased bleeding from the operational site after coming back home. Bone wax is a good, efficient, and safe material to block bleeding from the alveolus following tooth extractions, also in patients on chronic anticoagulant therapy. The study demonstrated that withdrawal or adjustment of anticoagulant therapy is not necessary before an elective tooth extraction.

  12. Dawn of the direct-acting oral anticoagulants: trends in oral anticoagulant prescribing in Wales 2009-2015.

    Science.gov (United States)

    Protty, M B; Hayes, J

    2017-04-01

    Oral anticoagulants (OACs) have been used for decades for the long-term prevention of arterial and venous thromboembolic disease. These include warfarin and the newer direct-acting OACs (DOACs). Data on 'real-life' prescribing patterns for DOACs are limited. In this commentary, we report the prescribing patterns for OACs in Wales, as a representative country within the UK. A retrospective analysis of anonymized OAC prescribing data in Wales from June 2009 to December 2015. Results reveal that the number of OAC prescription items increased from 40·48 to 65·26 per 1000 prescribing unit (PU). Average cost increased from £87·41 to £529·31 per 1000 PU. The share of warfarin prescribing declined from 100% to 68%, with the a rising share for the DOACs, made up of rivaroxaban (19%), apixaban (9%) and dabigatran (3%) WHAT IS NEW AND CONCLUSION: Analysis of real-life data demonstrates that there has been an increase in the overall numbers and costs of OAC prescriptions, with a rising proportion of DOACs to warfarin prescribing. © 2016 John Wiley & Sons Ltd.

  13. Clinical consequences of hospital variation in use of oral anticoagulant therapy after first-time admission for atrial fibrillation

    DEFF Research Database (Denmark)

    Hansen, M L; Gadsbøll, N; Rasmussen, S

    2009-01-01

    -Copenhagen University Hospital; Glostrup Hospital; Rigshospitalet-Copenhagen University Hospital; University of Copenhagen; Copenhagen, Denmark). Clinical consequences of hospital variation in use of oral anticoagulant therapy after first-time admission for atrial fibrillation. J Intern Med 2009; doi:10.1111/j.1365......-2796.2008.02061.xObjective. To analyse how hospital factors influence the use of oral anticoagulants (OAC) in atrial fibrillation (AF) patients and address the clinical consequences of hospital variation in OAC use. Design and subjects. By linkage of nationwide Danish administrative registers we conducted...... use, respectively. Cardiology departments had the highest use of OAC, but neither tertiary university hospitals nor high volume hospitals had higher OAC use than local community hospitals and low volume hospitals. Risk of a thromboembolic event was significantly increased amongst patients from...

  14. Status of oral anticoagulant treatment in patients with nonvalvular atrial fibrillation in Spain. REACT-AF Study.

    Science.gov (United States)

    de Andrés-Nogales, F; Oyagüez, I; Betegón-Nicolás, L; Canal-Fontcuberta, C; Soto-Álvarez, J

    2015-03-01

    Oral anticoagulant therapy is complex due to the need for control and the hemorrhagic risk the therapy entails. This study aims to determine the standard clinical practice in the treatment for preventing stroke in patients with nonvalvular atrial fibrillation (NVAF) in Spain. The Real Evidence of Anti Coagulation Treatment in AF is a European, multicenter, multinational, observational, retrospectively monitored cohort of patients with NVAF. This study included patients recruited in Spain with at least one visit during the period of inclusion (May 2010/April 2012). The study evaluated the following: a) persistence of oral anticoagulant treatment (time to discontinuation); b) persistence rate (% of patients in treatment) at 6, 12 and 24 months and at 5 years; c) therapeutic compliance (medication possession ratio); d) the correlation between the treatment followed and that recommended by the European Society of Cardiology; and the incidence of stroke and hemorrhagic events. The patients treated with oral anticoagulants (n=7,526) had a median time to discontinuation of treatment of 1.99 years and a persistence rate at 5 years of 26% (discontinuation ≥3 months). The compliance (mean MPR) was 0.54±0.36. The incidence of stroke was 0.3/100 person-years, and the incidence of hemorrhagic events was 2.4/100 person-years. Fifty-eight percent of the patients with NVAF (n=12,514) followed the recommendations of the European Society of Cardiology. Forty-two percent of the patients with NVAF did not follow the recommendations of the European Society of Cardiology. We detected low persistence and treatment compliance rates for oral anticoagulants. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

  15. Oral anticoagulation and antiplatelets in atrial fibrillation patients after myocardial infarction and coronary intervention

    DEFF Research Database (Denmark)

    Lamberts, Morten; Gislason, Gunnar H.; Olesen, Jonas Bjerring

    2013-01-01

    Objectives The purpose of this study was to investigate the risk of thrombosis and bleeding according to multiple antithrombotic treatment regimens in atrial fibrillation (AF) patients after myocardial infarction (MI) or percutaneous coronary intervention (PCI). Background The optimal......, and bleeding according to antithrombotic treatment regimen was estimated by Cox regression models. Results Within 1 year, MI or coronary death, ischemic stroke, and bleeding events occurred in 2,255 patients (18.5%), 680 (5.6%), and 769 (6.3%), respectively. Relative to triple therapy (oral anticoagulation.......05, respectively). When compared to triple therapy, bleeding risk was nonsignificantly lower for OAC plus clopidogrel (HR: 0.78, 95% CI: 0.55 to 1.12) and significantly lower for OAC plus aspirin and aspirin plus clopidogrel. Conclusions In real-life AF patients with indication for multiple antithrombotic drugs...

  16. Rivaroxaban as an oral anticoagulant for stroke prevention in atrial fibrillation

    Directory of Open Access Journals (Sweden)

    Turpie AGG

    2014-03-01

    Full Text Available Alexander GG Turpie Department of Medicine, McMaster University, Hamilton, ONT, Canada Abstract: Atrial fibrillation (AF is the most common cardiac arrhythmia in the developed world and is associated with a fivefold increase in the risk of stroke, accounting for up to 15% of strokes in the general population. The European Society of Cardiology now recommends direct oral anticoagulants, such as rivaroxaban, apixaban, and dabigatran, in preference to vitamin K antagonist therapy for the prevention of stroke in patients with AF. This review focuses on the direct Factor Xa inhibitor rivaroxaban, summarizing the properties that make rivaroxaban appropriate for anticoagulant therapy in this indication (including its predictable pharmacokinetic and pharmacodynamic profile and once-daily dosing regimen and describing data from the Phase III ROCKET AF trial, which showed once-daily rivaroxaban to be noninferior to warfarin for the prevention of stroke in patients with nonvalvular AF. In this trial, similar rates of major and nonmajor clinically relevant bleeding were observed; however, when compared with warfarin, rivaroxaban was associated with clinically significant reductions in intracranial and fatal bleeding. On the basis of these results, rivaroxaban was approved in both the United States and the European Union for the prevention of stroke and systemic embolism in patients with nonvalvular AF. Subanalyses of ROCKET AF data showed rivaroxaban to have consistent efficacy and safety across a wide range of patients, and studies to confirm these results in real-world settings are underway. This review also describes practical considerations for treatment with rivaroxaban in clinical practice (including dose reductions in specific high-risk patients, eg, those with renal impairment, recommendations for the transition from vitamin K antagonists to rivaroxaban, the management of bleeding events, and the measurement of rivaroxaban exposure. Keywords: atrial

  17. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data

    NARCIS (Netherlands)

    Heneghan, Carl; Ward, Alison; Perera, Rafael; Bankhead, Clare; Fuller, Alice; Stevens, Richard; Bradford, Kairen; Tyndel, Sally; Alonso-Coello, Pablo; Ansell, Jack; Beyth, Rebecca; Bernardo, Artur; Christensen, Thomas Decker; Cromheecke, M. E.; Edson, Robert G.; Fitzmaurice, David; Gadisseur, Alain P. A.; Garcia-Alamino, Josep M.; Gardiner, Chris; Hasenkam, J. Michael; Jacobson, Alan; Kaatz, Scott; Kamali, Farhad; Khan, Tayyaba Irfan; Knight, Eve; Körtke, Heinrich; Levi, Marcel; Matchar, David; Menéndez-Jándula, Bárbara; Rakovac, Ivo; Schaefer, Christian; Siebenhofer, Andrea; Souto, Juan Carlos; Sunderji, Rubina; Gin, Kenneth; Shalansky, Karen; Völler, Heinz; Wagner, Otto; Zittermann, Armin

    2012-01-01

    Background Uptake of self-testing and self-management of oral coagulation has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in

  18. Stroke Prevention in Atrial Fibrillation: Understanding the New Oral Anticoagulants Dabigatran, Rivaroxaban, and Apixaban

    Directory of Open Access Journals (Sweden)

    Tan Ru San

    2012-01-01

    Full Text Available Unlike vitamin K antagonists (VKAs, the new oral anticoagulants (NOACs—direct thrombin inhibitor, dabigatran, and direct activated factor X inhibitors, rivaroxaban, and apixaban—do not require routine INR monitoring. Compared to VKAs, they possess relatively rapid onset of action and short halflives, but vary in relative degrees of renal excretion as well as interaction with p-glycoprotein membrane transporters and liver cytochrome P450 metabolic enzymes. Recent completed phase III trials comparing NOACs with VKAs for stroke prevention in atrial fibrillation (AF—the RE-LY, ROCKET AF, and ARISTOTLE trials—demonstrated at least noninferior efficacy, largely driven by significant reductions in haemorrhagic stroke. Major and nonmajor clinically relevant bleeding rates were acceptable compared to VKAs. Of note, the NOACs caused significantly less intracranial haemorrhagic events compared to VKAs, the mechanisms of which are not completely clear. With convenient fixed-dose administration, the NOACs facilitate anticoagulant management in AF in the community, which has hitherto been grossly underutilised. Guidelines should evolve towards simplicity in anticipation of greater use of NOACs among primary care physicians. At the same time, the need for caution with their use in patients with severely impaired renal function should be emphasised.

  19. Risk of insomnia with non-vitamin K oral anticoagulants: systematic review and meta-analysis.

    Science.gov (United States)

    Caldeira, Daniel; Barra, Márcio; Santos, Ana Teresa; de Abreu, Daisy; Costa, João; Ferreira, Joaquim J

    2015-09-01

    Insomnia is an important adverse event of mechanical thromboprophylaxis. This sleep disorder has been reported as one of the commonest adverse events of the new oral anti-Xa anticoagulant darexaban, with similar rates to mechanical thromboprophylaxis in a randomized controlled trial (RCT). However, the perceived effect could have been biased because it was an open-label RCT. Therefore, we aimed to review the incidence of insomnia with non-vitamin K antagonist oral anticoagulants (NOACs). We performed a systematic review and meta-analysis of Phase III RCTs. Electronic databases MEDLINE and CENTRAL (inception to September 2013) were searched as well as review articles and references of included studies. We included phase III RCTs which compared NOACs with any other control group. Data were analyzed and pooled to estimate risk ratio (RR) with 95% confidence intervals (95%CI) for insomnia using inverse variance method. Statistical heterogeneity was evaluated with I(2) test. We included seven studies (two apixaban RCTs, two dabigatran RCTs, one darexaban RCTs, and two rivaroxaban RCTs), enrolling a total of 23,023 patients. Overall, NOACs were not associated to an increased risk of insomnia: RR 0.94 (95%CI 0.83-1.08; I(2) = 0%). In blinded studies (six studies), NOACs also did not show increased risk of insomnia (RR 0.94, 95%CI 0.83-1.08; I(2) = 0%). Results were similar irrespective of the comparators. NOACs (apixaban, dabigatran, darexaban, rivaroxaban) did not show increased risk of insomnia. Results according to study design (blinded vs. open-label trials) overlap the main analysis.

  20. Combination of a new oral anticoagulant, aspirin and clopidogrel after acute coronary syndrome: new therapeutic standard?

    Science.gov (United States)

    Rubboli, Andrea; Oldgren, Jonas; Marìn, Francisco; Lip, Gregory

    2013-12-01

    Effective secondary prevention after acute coronary syndrome (ACS) is largely dependent on dual antiplatelet therapy (DAPT). Despite DAPT, however, patients remain at substantial risk of major adverse cardiovascular events (i.e., cardiovascular death, myocardial infarction, stroke), and, therefore, combination therapy of oral anticoagulant and antiplatelets has been previously proposed. Because of the increase in bleeding and the cumbersome management of vitamin K antagonists, such combination therapy has never gained much popularity. The recent development of new, non vitamin K antagonists, direct oral anticoagulants (NOACs), including dabigatran, apixaban, rivaroxaban, and darexaban, which have more favorable pharmacokinetics and pharmacodynamics, as well as higher safety, has renewed the interest on combination therapy. Whereas phase II trials with dabigatran, apixaban, rivaroxaban, and darexaban have consistently shown an increased bleeding risk with combination therapy, a potential increased efficacy has emerged for apixaban and rivaroxaban, thereby prompting phase III studies. Both APPRAISE-2 and ATLAS ACS 2-TIMI 51 trials confirm a dose-dependent increase in major bleeding events, including intracranial, with apixaban and rivaroxaban when combined with DAPT. Low-dose (2.5 mg twice daily) rivaroxaban on the other hand, is associated with a significantly higher efficacy on the occurrence of combined cardiovascular death, myocardial infarction, stroke, and of stent thrombosis. Owing to the persistent uncertainty regarding the net clinical benefit of combined therapy of NOAC, namely low-dose (2.5 mg twice daily) rivaroxaban and DAPT of aspirin and clopidogrel, further studies are warranted to identify the ACS patient who will benefit most from such treatment, also in comparison to the current therapeutic standard represented by DAPT of aspirin and ticagrelor (or prasugrel).

  1. Oral anticoagulant dosing, administration, and storage: a cross-sectional survey of Canadian health care providers.

    Science.gov (United States)

    Piran, Siavash; Schulman, Sam; Panju, Mohamed; Pai, Menaka

    2017-11-23

    Direct oral anticoagulant (DOAC) use is increasing worldwide. However, if not taken or prescribed correctly, DOACs have serious side effects. It is crucial that healthcare providers (HCPs) offer patients accurate information and counselling around DOACs, to optimize safe and effective use. To assess knowledge around oral anticoagulant indication, dosing, storage, and administration, an electronic survey was distributed to HCPs across Canada from June to August 2017, with 18 questions on the practical use of oral anticoagulants. A total of 191 responses were received: 100 from nurse practitioners, 42 from pharmacists, 27 from Hematologists, 5 from Thrombosis specialists, 4 from internists, 9 from residents and fellows, and 2 each from family physicians and registered nurses. Only 51 (26.7%) of the respondents correctly identified all the approved indications for warfarin and 4 DOACs. Only 101 (52.9%) correctly identified that DOACs are not approved for treatment of heparin-induced thrombocytopenia, cerebral sinus venous thrombosis, or mechanical prosthetic valves. 112 (58.6%) felt comfortable or very comfortable prescribing oral anticoagulants. Half of the respondents knew that dabigatran should not be crushed, however only 85 (44.5%) knew that it should not be exposed to moisture. 94 (49%) knew that higher dose rivaroxaban should be taken with food. The results of our study demonstrate that there are important knowledge gaps around HCPs' practical understanding of oral anticoagulants. Future research should focus on educational interventions to improve HCPs' knowledge around indications, dosing, storage, and administration, with the goal of enhancing patient safety.

  2. [Use of non-vitamin K antagonist oral anticoagulants in Primary Care: ACTUA study].

    Science.gov (United States)

    Barrios, V; Escobar, C; Lobos, J M; Polo, J; Vargas, D

    2017-10-01

    Approximately 40% of patients with non-valvular auricular fibrillation (NVAF) who receive vitamin K antagonists (VKA) in Primary Care in Spain have poor anticoagulation control. The objective of the study Actuación en antiCoagulación, Tratamiento y Uso de anticoagulantes orales de acción directa (ACOD) en Atención primaria (ACTUA) (Action in Coagulation, Treatment and Use of direct oral anticoagulants [DOACs]) in Primary Care) was to analyse the current situation regarding the use of VKA and non-vitamin K antagonist oral anticoagulants (NOACs) in patients with NVAF in Primary Care in Spain and the possible issues arising from it. An online survey was created covering various aspects of the use of oral anticoagulants in NAFV. A two-round modified Delphi approach was used. Results were compiled as a set of practical guidelines. Forty-four experts responded to the survey. Consensus was reached in 62% (37/60) of the items. Experts concluded that a considerable number of patients with NVAF who receive VKA do not have a well-controlled INR and that a substantial group of patients who could benefit from being treated with NOACs do not receive them. The use of NOACs increases the probability of having good anticoagulation control and decreases the risk of severe and intracranial haemorrhage. Current limitations to the use of NOACs include administrative barriers, insufficient knowledge about the benefits and risks of NOACs, limited experience of doctors in using them, and their price. Renal insufficiency influences the choice of a particular anticoagulant. The ACTUA study highlights the existing controversies about the use of oral anticoagulants for the treatment of NVAF in Primary Care in Spain, and provides consensus recommendations that may help to improve the use of these medications. Copyright © 2016 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

  3. close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design.

    Science.gov (United States)

    Mas, Jean-Louis; Derumeaux, Geneviève; Amarenco, Pierre; Arquizan, Caroline; Aubry, Pierre; Barthelet, Martine; Bertrand, Bernard; Brochet, Eric; Cabanes, Laure; Donal, Erwan; Dubois-Randé, Jean-Luc; Durand-Zaleski, Isabelle; Ernande, Laura; Finet, Gérard; Fraisse, Alain; Giroud, Maurice; Guérin, Patrice; Habib, Gilbert; Juliard, Jean-Michel; Leys, Didier; Lièvre, Michel; Lusson, Jean-René; Marcon, François; Michel, Patrick; Moulin, Thierry; Mounier-Vehier, François; Pierard, Luc; Piot, Christophe; Rey, Christian; Rodier, Gilles; Roudaut, Raymond; Schleich, Jean-Marc; Teiger, Emmanuel; Turc, Guillaume; Vuillier, Fabrice; Weimar, Christian; Woimant, France; Chatellier, Gilles

    2016-08-01

    Currently available data do not provide definitive evidence on the comparative benefits of closure of patent foramen ovale, oral anticoagulants and antiplatelet therapy in patients with patent foramen ovale-associated cryptogenic stroke To assess whether transcatheter patent foramen ovale closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy, for secondary stroke prevention in patients aged 16 to 60 years with a large patent foramen ovale or a patent foramen ovale associated with an atrial septal aneurysm, and an otherwise unexplained ischaemic stroke or retinal ischaemia. Six hundred and sixty-four patients were included in the study. CLOSE is an academic-driven, multicentre, randomized, open-label, three-group, superiority trial with blinded adjudication of outcome events. The trial has been registered with Clinical Trials Register (Clinicaltrials.gov, NCT00562289). Patient recruitment started in December 2007. Patient follow-up will continue until December 2016. Expected mean follow-up = 5.6 years. The primary efficacy outcome is the occurrence of fatal or nonfatal stroke. Safety outcomes include fatal, life-threatening or major procedure- or device-related complications and fatal, life-threatening or major haemorrhagic complications. CLOSE is the first specifically designed trial to assess the superiority of patent foramen ovale closure over antiplatelet therapy alone and the superiority of oral anticoagulants over antiplatelet therapy to prevent stroke recurrence in patients with patent foramen ovale-associated cryptogenic stroke. © 2016 World Stroke Organization.

  4. Non-Vitamin K Antagonist Oral Anticoagulants for Cardioversion in Atrial Fibrillation: An Updated Meta-analysis.

    Science.gov (United States)

    Renda, Giulia; Ricci, Fabrizio; De Caterina, Raffaele

    2017-04-01

    Non-vitamin K oral anticoagulants are now proven alternatives to vitamin K antagonists for stroke prevention in atrial fibrillation. However, there are few data on the efficacy and safety of their use for cardioversion, in which the risk of thromboembolic events is heightened. We performed a random-effects meta-analysis of patients undergoing both electrical and pharmacologic cardioversion for atrial fibrillation in the RE-LY, ROCKET-AF, ARISTOTLE, ENGAGE AF-TIMI 48, X-VeRT, and ENSURE-AF trials. We assessed Mantel-Haenszel pooled estimates of risk ratios (RRs) and 95% confidence intervals (CIs) for stroke/systemic embolism and major bleeding at ≤42 days of follow-up. The analysis pooled 6148 patients in whom 6854 cardioversions for atrial fibrillation were performed. Compared with vitamin K antagonists, non-vitamin K antagonist oral anticoagulant therapy was associated with a similar risk of stroke/systemic embolism (RR, 0.82; 95% CI, 0.38-1.75) and major bleeding (RR, 0.98; 95% CI, 0.51-1.87). We found no significant statistical heterogeneity among studies (Cochrane Q P = .75, I2 = 0% for stroke/systemic embolism; P = .54; I2 = 0% for major bleeding). The short-term incidence of thromboembolism and major bleeding after cardioversion on non-vitamin K antagonist oral anticoagulants was comparable to the incidence observed on dose-adjusted vitamin K antagonist therapy. Non-vitamin K antagonist oral anticoagulants are a reasonable alternative to vitamin K antagonists in patients undergoing cardioversion. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Bosentan and oral anticoagulants in HIV patients: what we can learn of cases reported so far

    Directory of Open Access Journals (Sweden)

    José Antonio Morales-Molina

    2011-10-01

    Full Text Available Pulmonary arterial hypertension is an infrequent but nevertheless serious life-threatening severe complication of HIV infection. It can be treated with bosentan and oral anticoagulants. Bosentan could induce the acenocoumarol metabolism and it increases the INR values. Until now, no study of interaction between bosentan and oral anticoagulants in HIV patients has reported. So we present a case of this interaction between these drugs and we reviewed MEDLINE to identify all the papers published so far. In our case, several weeks after increasing dose of bosentan acenocoumarol dose had to be progressively increased to 70 mg/week (+33% without obtaining an adequate INR level (2.0-3.0. Forty-nine days later, we achieved a therapeutic INR with 90 mg/week of warfarin. The use of bosentan and oral anticoagulants together in these patients require a closer monitoring during first weeks of treatment, after increasing the bosentan dose and even during longer periods of time.

  6. Management of the Bleeding Patient Receiving New Oral Anticoagulants: A Role for Prothrombin Complex Concentrates

    Directory of Open Access Journals (Sweden)

    Lisa M. Baumann Kreuziger

    2014-01-01

    Full Text Available Ease of dosing and simplicity of monitoring make new oral anticoagulants an attractive therapy in a growing range of clinical conditions. However, newer oral anticoagulants interact with the coagulation cascade in different ways than traditional warfarin therapy. Replacement of clotting factors will not reverse the effects of dabigatran, rivaroxaban, or apixaban. Currently, antidotes for these drugs are not widely available. Fortunately, withholding the anticoagulant and dialysis are freqnently effective treatments, particularly with rivaroxaban and dabigatran. Emergent bleeding, however, requires utilization of Prothrombin Complex Concentrates (PCCs. PCCs, in addition to recombinant factor VIIa, are used to activate the clotting system to reverse the effects of the new oral anticoagulants. In cases of refractory or emergent bleeding, the recommended factor concentrate in our protocols differs between the new oral anticoagulants. In patients taking dabigatran, we administer an activated PCC (aPCC [FELBA] due to reported benefit in human in vitro studies. Based on human clinical trial evidence, the 4-factor PCC (Kcentra is suggested for patients with refractory rivaroxaban- or apixaban-associated hemorrhage. If bleeding continues, recombinant factor VIIa may be employed. With all of these new procoagulant agents, the risk of thrombosis associated with administration of factor concentrates must be weighed against the relative risk of hemorrhage.

  7. Age is not associated with intracranial haemorrhage in patients with mild traumatic brain injury and oral anticoagulation

    OpenAIRE

    Sauter, Thomas C.; Ziegenhorn, Stephan; Ahmad, Sufian S.; Hautz, Wolf E.; Ricklin, Meret E.; Leichtle, Alexander Benedikt; Fiedler, Georg-Martin; Haider, Dominik G.; Exadaktylos, Aristomenis K.

    2016-01-01

    BACKGROUND Patients admitted to emergency departments with traumatic brain injury (TBI) are commonly being treated with oral anticoagulants. In contrast to patients without anticoagulant medication, no guidelines, scores or recommendations exist for the management of mild traumatic brain injury in these patients. We therefore tested whether age as one of the high risk factors of the Canadian head CT rule is applicable to a patient population on oral anticoagulants. METHODS This cr...

  8. Utilization of Oral Anticoagulation in a Teaching Hospital in Nigeria

    African Journals Online (AJOL)

    or patients monitored outside the teaching hospital were excluded from this survey. Anticoagulation monitoring was with INR. Recommended therapeutic ranges of INR are 2.0-3.0 for most disease indications, and 2.0-3.5 with cardiac valve prostheses.[1,2]. Target INR was defined by the attainment of therapeutic ranges of ...

  9. Vitamin K and stability of oral anticoagulant therapy

    NARCIS (Netherlands)

    Rombouts, Eva Karolien

    2011-01-01

    One of the causes of unstable anticoagulation is a variable vitamin K intake. The main objective of this thesis was to test the hypothesis that the INR is particularly sensitive to changes in vitamin K intake when vitamin K status is low, and that patients with a low vitamin K intake would therefore

  10. Coagulation Testing in Acute Ischemic Stroke Patients Taking Non-Vitamin K Antagonist Oral Anticoagulants.

    Science.gov (United States)

    Purrucker, Jan C; Haas, Kirsten; Rizos, Timolaos; Khan, Shujah; Poli, Sven; Kraft, Peter; Kleinschnitz, Christoph; Dziewas, Rainer; Binder, Andreas; Palm, Frederick; Jander, Sebastian; Soda, Hassan; Heuschmann, Peter U; Veltkamp, Roland

    2017-01-01

    In patients who present with acute ischemic stroke while on treatment with non-vitamin K antagonist oral anticoagulants (NOACs), coagulation testing is necessary to confirm the eligibility for thrombolytic therapy. We evaluated the current use of coagulation testing in routine clinical practice in patients who were on NOAC treatment at the time of acute ischemic stroke. Prospective multicenter observational RASUNOA registry (Registry of Acute Stroke Under New Oral Anticoagulants; February 2012-2015). Results of locally performed nonspecific (international normalized ratio, activated partial thromboplastin time, and thrombin time) and specific (antifactor Xa tests, hemoclot assay) coagulation tests were documented. The implications of test results for thrombolysis decision-making were explored. In the 290 patients enrolled, nonspecific coagulation tests were performed in ≥95% and specific coagulation tests in 26.9% of patients. Normal values of activated partial thromboplastin time and international normalized ratio did not reliably rule out peak drug levels at the time of the diagnostic tests (false-negative rates 11%-44% [95% confidence interval 1%-69%]). Twelve percent of patients apparently failed to take the prescribed NOAC prior to the acute event. Only 5.7% (9/159) of patients in the 4.5-hour time window received thrombolysis, and NOAC treatment was documented as main reason for not administering thrombolysis in 52.7% (79/150) of patients. NOAC treatment currently poses a significant barrier to thrombolysis in ischemic stroke. Because nonspecific coagulation test results within normal range have a high false-negative rate for detection of relevant drug concentrations, rapid drug-specific tests for thrombolysis decision-making should be established. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01850797. © 2016 American Heart Association, Inc.

  11. Newer non-vitamin K-antagonist direct oral anticoagulants in acute coronary syndromes

    Directory of Open Access Journals (Sweden)

    Andrea Rubboli

    2013-12-01

    Full Text Available standard dual antiplatelet therapy (DAPT of aspirin and clopidogrel is associated with a substantial absolute incidence of adverse events, including death, myocardial infarction and stroke after an acute coronary syndrome (ACs. Combination therapy of an oral anticoagulant and DAPT has been previously proposed in order to improve efficacy, but has not gained popularity owing to the cumbersome management of vitamin K-antagonists (VKA. The recent introduction of newer, non-VKA, direct oral anticoagulants (NOAC, including dabigatran, apixaban, and rivaroxaban, has renewed the interest in combination therapy, owing to the more favorable pharmacokinetic and pharmacodynamic profiles of these drugs. Whereas phase II studies with dabigatran, apixaban, and rivaroxaban have consistently shown an increased bleeding risk with combination therapy, a potential increased efficacy has emerged for apixaban and rivaroxaban, thereby prompting phase III studies, namely APPRAIsE-2 with apixaban and ATLAs ACs 2-TIMI 51 with rivaroxaban. Both APPRAIsE-2 and ATLAs ACs 2-TIMI 51 studies confirmed a dose-dependent increase in major, including intracranial, bleeding with apixaban and rivaroxaban when combined with DAPT. Low-dose rivaroxaban on the other hand, was associated with significantly higher efficacy on the occurrence of combined cardiovascular death, myocardial infarction, or stroke, as well as of cardiovascular death, myocardial infarction and stent thrombosis. Owing to the persistent uncertainty regarding the net clinical benefit of combined therapy of NOAC, namely low-dose rivaroxaban, and DAPT, further studies are warranted to identify the ACs patient who will benefit most from such treatment, also in comparison to current standard DAPT of aspirin and prasugrel or ticagrelor.

  12. Chronic kidney disease and anticoagulation

    DEFF Research Database (Denmark)

    Sciascia, Savino; Radin, Massimo; Schreiber, Karen

    2017-01-01

    Anticoagulation in patients with impaired kidney function can be challenging since drugs' pharmacokinetics and bioavailability are altered in this setting. Patients with chronic kidney disease (CKD) treated with conventional anticoagulant agents [vitamin K antagonist (VKA), low-molecular weight...... are eliminated via the kidneys pose additional challenges. More recently, two classes of direct oral anticoagulant agents (DOACs) have been investigated for the prevention and management of venous thromboembolic events: the direct factor Xa inhibitors rivaroxaban, apixaban and edoxaban, and the direct thrombin...

  13. Shifting to a non-vitamin K antagonist oral anticoagulation agent from vitamin K antagonist in atrial fibrillation

    DEFF Research Database (Denmark)

    Fosbøl, Emil L; Vinding, Naja Emborg; Lamberts, Morten

    2017-01-01

    Aims: After non-vitamin K antagonist (VKA) oral anticoagulation agents (NOAC) have been approved for thrombo-embolic prophylaxis in non-valvular atrial fibrillation (NVAF), utilization of oral anticoagulants (OAC) in NVAF has changed. Contemporary shifting from a VKA to a NOAC (dabigatran...

  14. Antithrombotic management in patients with percutaneous coronary intervention requiring oral anticoagulation

    Directory of Open Access Journals (Sweden)

    Jarosław Zalewski

    2016-11-01

    Full Text Available The dynamic evolution of therapeutic options including the use of vitamin K antagonists (VKA, non-vitamin K oral anticoagulants (NOAC, more potent antiplatelet drugs as well as new generation drug-eluting stents could lead to the view that the current recommendations on the management of patients with percutaneous coronary intervention (PCI requiring oral anticoagulation do not keep up with the results of several clinical studies published within the last 5 years. In the present overview, we summarize the recent advances in antithrombotic management used in atrial fibrillation patients undergoing PCI for stable coronary artery disease or acute coronary syndrome (ACS. The safety and efficacy of prasugrel and ticagrelor taken with oral anticoagulants also remain to be established in randomized trials; therefore the P2Y12 inhibitor clopidogrel on top of aspirin or without is now recommended to be used together with a VKA or NOAC. It is still unclear which dose of a NOAC in combination with antiplatelet agents and different stents should be used in this clinical setting and whether indeed NOAC are safer compared with VKA in such cardiovascular patients. Moreover, we discuss the use of anticoagulation in addition to antiplatelet therapy for secondary prevention in patients with ACS. To minimize bleeding risk in anticoagulated patients following PCI or ACS, the right agent should be prescribed to the right patient at the right dose and supported by regular clinical evaluation and laboratory testing, especially assessment of renal function when a NOAC is used.

  15. Evaluation of the predictive performance of bleeding risk scores in patients with non-valvular atrial fibrillation on oral anticoagulants.

    Science.gov (United States)

    Beshir, S A; Aziz, Z; Yap, L B; Chee, K H; Lo, Y L

    2017-10-13

    Bleeding risk scores (BRSs) aid in the assessment of oral anticoagulant-related bleeding risk in patients with atrial fibrillation. Ideally, the applicability of a BRS needs to be assessed, prior to its routine use in a population other than the original derivation cohort. Therefore, we evaluated the performance of 6 established BRSs to predict major or clinically relevant bleeding (CRB) events associated with the use of oral anticoagulant (OAC) among Malaysian patients. The pharmacy supply database and the medical records of patients with non-valvular atrial fibrillation (NVAF) receiving warfarin, dabigatran or rivaroxaban at two tertiary hospitals were reviewed. Patients who experienced an OAC-associated major or CRB event within 12 months of follow-up, or who have received OAC therapy for at least 1 year, were identified. The BRSs were fitted separately into patient data. The discrimination and the calibration of these BRSs as well as the factors associated with bleeding events were then assessed. A total of 1017 patients with at least 1-year follow-up period, or those who developed a bleeding event within 1 year of OAC use, were recruited. Of which, 23 patients experienced a first major bleeding event, whereas 76 patients, a first CRB event. Multivariate logistic regression results show that age of 75 or older, prior bleeding and male gender are associated with major bleeding events. On the other hand, prior gastrointestinal bleeding, a haematocrit value of less than 30% and renal impairment are independent predictors of CRB events. All the BRSs show a satisfactory calibration for major and CRB events. Among these BRSs, only HEMORR2 HAGES (C-statistic = 0.71, 95% CI 0.60-0.82, P performance for major bleeding events. All the 6 BRSs, however, lack acceptable predictive performance for CRB events. To the best of our knowledge, this is the first evaluation study of the predictive performance of these 6 BRSs on clinically relevant bleeding events applied to

  16. Advances in stroke prevention in atrial fibrillation: enhanced risk stratification combined with the newer oral anticoagulants

    NARCIS (Netherlands)

    Verheugt, F.W.A.

    2013-01-01

    Patients with atrial fibrillation (AF) have an increased stroke risk compared with those in sinus rhythm, although the absolute risk for individual patients is modulated by the presence of various additional risk factors. Patient selection for oral anticoagulation for stroke prevention is based on

  17. Improved control of oral anticoagulant dosing : A randomized controlled trial comparing two computer algorithms

    NARCIS (Netherlands)

    van Leeuwen, Y; Rombouts, E K; Kruithof, C J; van der Meer, F J M; Rosendaal, F R

    BACKGROUND: Efforts to improve dosing quality in oral anticoagulant control include the use of computer algorithms. As current algorithms are simplistic and give dosage proposals in a small fraction of patients, we developed an algorithm based on principles of system and control engineering that

  18. Home management of oral anticoagulation via telemedicine versus conventional hospital-based treatment

    DEFF Research Database (Denmark)

    Christensen, Henry; Lauterlein, Jens-Jacob; Sørensen, Patricia D

    2011-01-01

    We have developed an expert computer system for the control of oral anticoagulation therapy, accessible by the patients via their own computer. To investigate if the weekly measurement and dosing of international normalized ratio (INR) at home using the online Internet-based system was superior t...

  19. Non-Vitamin K antagonist oral anticoagulation usage according to age among patients with atrial fibrillation

    DEFF Research Database (Denmark)

    Staerk, L.; Fosbøl, E L; Gadsbøll, K.

    2016-01-01

    Among atrial fibrillation (AF) patients, Danish nationwide registries (2011-2015) were used to examine temporal trends of initiation patterns of oral anticoagulation (OAC) treatment according to age. Overall, 43,299 AF patients initiating vitamin K antagonists (VKA) (42%), dabigatran (29...

  20. Non-vitamin K antagonist oral anticoagulation usage according to age among patients with atrial fibrillation

    DEFF Research Database (Denmark)

    Staerk, Laila; Fosbøl, Emil Loldrup; Gadsbøll, Kasper

    2016-01-01

    Among atrial fibrillation (AF) patients, Danish nationwide registries (2011-2015) were used to examine temporal trends of initiation patterns of oral anticoagulation (OAC) treatment according to age. Overall, 43,299 AF patients initiating vitamin K antagonists (VKA) (42%), dabigatran (29...

  1. Underuse of Anticoagulation in Older Patients with Atrial Fibrillation and CHADS2 Score ≥ 2: Are We Doing Better Since the Marketing of Direct Oral Anticoagulants?

    Science.gov (United States)

    Henrard, Séverine; Vandenabeele, Caroline; Marien, Sophie; Boland, Benoit; Dalleur, Olivia

    2017-11-01

    Our objectives were to (1) describe the evolution of the underuse of anticoagulants in older people with atrial fibrillation (AF) and a CHADS2 score ≥ 2 since direct oral anticoagulants (DOACs) were introduced to the market and (2) describe factors associated with this underuse. We conducted a retrospective cross-sectional study including geriatric patients admitted during the pre-DOAC (2008-2011) and post-DOAC (2013-2015) periods in an academic hospital in Belgium. Five inclusion criteria were met: age ≥ 75 years, diagnosis of AF, indication for anticoagulation (CHADS2 score ≥ 2), risk of functional decline (Identification of Seniors At Risk [ISAR] score ≥ 2), and comprehensive geriatric assessment. The use of anticoagulants and antiplatelets at home before admission was recorded. Risks of stroke and bleeding were calculated using CHADS2 and HEMORR2HAGES scores, respectively. Three different logistic regression models were performed to describe the evolution of and factors associated with the underuse of anticoagulants after DOAC marketing. Anticoagulant underuse, present in 209 of 614 (34%) geriatric patients with AF, was lower in patients with a history of stroke (28.5%) or congestive heart failure (26.9%) but higher in those receiving antiplatelets (56.2%) and in older individuals. Anticoagulant underuse decreased significantly from the pre-DOAC (37.3%) to the post-DOAC (29.7%) era, as shown by two analyses using propensity scores. In older patients with AF, anticoagulant underuse was mainly associated with antiplatelet use. Anticoagulant underuse and antiplatelet use have both decreased since DOAC marketing. Underuse of anticoagulants was still a concern for three in ten geriatric patients with AF at high risk of stroke (CHADS2 score ≥ 2).

  2. Risk of gastrointestinal bleeding with direct oral anticoagulants: a systematic review and network meta-analysis.

    Science.gov (United States)

    Burr, Nick; Lummis, Katie; Sood, Ruchit; Kane, John Samuel; Corp, Aaron; Subramanian, Venkataraman

    2017-02-01

    Direct oral anticoagulants are increasingly used for a wide range of indications. However, data are conflicting about the risk of major gastrointestinal bleeding with these drugs. We compared the risk of gastrointestinal bleeding with direct oral anticoagulants, warfarin, and low-molecular-weight heparin. For this systematic review and meta-analysis, we searched MEDLINE and Embase from database inception to April 1, 2016, for prospective and retrospective studies that reported the risk of gastrointestinal bleeding with use of a direct oral anticoagulant compared with warfarin or low-molecular-weight heparin for all indications. We also searched the Cochrane Library for systematic reviews and assessment evaluations, the National Health Service (UK) Economic Evaluation Database, and ISI Web of Science for conference abstracts and proceedings (up to April 1, 2016). The primary outcome was the incidence of major gastrointestinal bleeding, with all gastrointestinal bleeding as a secondary outcome. We did a Bayesian network meta-analysis to produce incidence rate ratios (IRRs) with 95% credible intervals (CrIs). We identified 38 eligible articles, of which 31 were included in the primary analysis, including 287 692 patients exposed to 230 090 years of anticoagulant drugs. The risk of major gastrointestinal bleeding with direct oral anticoagulants did not differ from that with warfarin or low-molecular-weight heparin (factor Xa vs warfarin IRR 0·78 [95% CrI 0·47-1·08]; warfarin vs dabigatran 0·88 [0·59-1·36]; factor Xa vs low-molecular-weight heparin 1·02 [0·42-2·70]; and low-molecular-weight heparin vs dabigatran 0·67 [0·20-1·82]). In the secondary analysis, factor Xa inhibitors were associated with a reduced risk of all severities of gastrointestinal bleeding compared with warfarin (0·25 [0.07-0.76]) or dabigatran (0.24 [0.07-0.77]). Our findings show no increase in risk of major gastrointestinal bleeding with direct oral anticoagulants compared with

  3. Risk of Substantial Intraocular Bleeding With Novel Oral Anticoagulants: Systematic Review and Meta-analysis.

    Science.gov (United States)

    Caldeira, Daniel; Canastro, Mário; Barra, Márcio; Ferreira, Adriana; Costa, João; Pinto, Fausto J; Ferreira, Joaquim J

    2015-07-01

    In noninferiority trials, novel oral anticoagulants (NOACs), also known as non-vitamin K oral anticoagulants, were at least noninferior to standard care in the prevention of most prothrombotic conditions. However, differences exist in the safety profile of antithrombotic drugs, and little is known about their intraocular bleeding risk. To evaluate the risk of substantial intraocular bleeding associated with NOACs. MEDLINE, Cochrane Library, SciELO collection, and Web of Science databases were searched from inception to November 2014, as well as other systematic reviews and regulatory agencies documentation. All phase 3 randomized clinical trials (RCTs) comparing NOACs with any other control that reported intraocular bleeding events. Data were extracted independently by 2 of the authors and pooled using random-effects meta-analysis. Heterogeneity was assessed with the I2 test. Substantial intraocular bleeding was evaluated with pooled risk ratios (RRs) and 95% CIs. Seventeen RCTs were included. In patients with atrial fibrillation, no difference was identified between NOACs and vitamin K antagonists (RR, 0.84; 95% CI, 0.59-1.19; I2 = 35%; 5 RCTs), and no increased risk was identified compared with acetylsalicylic acid (RR, 14.96; 95% CI, 0.85-262.00; 1 RCT). In patients with venous thromboembolism, no increased risk of substantial intraocular bleeding compared with sequential treatment with low-molecular-weight heparin and a vitamin K antagonist (RR, 0.67; 95% CI, 0.37-1.20; I2 = 0%; 5 RCTs) was identified. Regarding patients who underwent orthopedic surgery, the risk was not different between NOACs and low-molecular-weight heparin (RR, 2.13; 95% CI, 0.22-20.50; I2 = 0%; 5 RCTs). Randomized data suggest that no differences exist in the risk of substantial intraocular bleeding between NOACs and other antithrombotic drugs. However, the number of events was scarce so that additional studies from larger databases that monitor patients under conditions of

  4. New oral anticoagulants-TURKey (NOAC-TURK): Multicenter cross-sectional study.

    Science.gov (United States)

    Altay, Servet; Yıldırımtürk, Özlem; Çakmak, Hüseyin Altuğ; Aşkın, Lütfü; Sinan, Ümit Yaşar; Beşli, Feyzullah; Gedikli, Ömer; Özden Tok, Özge

    2017-05-01

    New oral anticoagulants (NOACs) are increasingly used both for prevention of stroke in non-valvular atrial fibrillation (NVAF) and the treatment of venous thromboembolism (VTE). In this study, we aimed to evaluate the current patterns of NOACs treatment in Turkey. Moreover, demographic and clinical parameters and bleeding and/or embolic events under NOACs treatment were analyzed. The New Oral Anticoagulants-TURKey (NOAC-TURK) study was designed as a multicenter cross-sectional study. A total of 2,862 patients from 21 different centers of Turkey under the treatment of NOACs for at least three months were included in this study. Demographic, clinical, and laboratory characteristics of study participants with their medications used were obtained through the NOAC-TURK survey database. Additional necessary medical records were obtained from electronic health records of participating centers. Of the 2. 862 patients, 1.131 (39.5%) were male and the mean age was 70.3±10.2 years. Hypertension was found as the most frequent comorbidity (81%). The most common indication for NOACs was permanent atrial fibrillation (83.3%). NOACs were mainly preferred because of inadequate therapeutic range or overdose during warfarin usage. The most frequent complication was bleeding (n=217, 7.6%), and major bleeding was observed in 1.1% of the patients. Embolic events were observed in 37 patients (1.3%). Rivaroxaban and dabigatran were both more preferred than apixaban. Almost half of the patients (47.6%) were using lower doses of NOACs, which is definitely much more than expected. The NOAC-TURK study showed an important overview of the current NOACs treatment regimens in Turkey. Although embolic and bleeding complications were lower than or similar to previous studies, increased utilization of low-dose NOACs in this study should be considered carefully. According to the results of this study, NOACs treatment should be guided through CHA2DS2-VASc and HASBLED scores to ensure more benefit and

  5. Differences in the INR evaluation of two different thromboplastins in patients with positivity to lupus anticoagulant in ongoing oral anticoagulation.

    Science.gov (United States)

    Ferrazzi, Paola; Colombo, Anna; Di Micco, Pierpaolo; Lodigiani, Corrado; Librè, Luca; Rota, Lidia Luciana; Montanelli, Alessandro; Quaglia, Ilaria

    2010-01-01

    A possible interference between lupus anticoagulant (LAC), a well characterized clotting inhibitor, in the International Normalized Ratio (INR) determination during oral anticoagulation (OA) has been reported in the literature. Few data are available about the relationship between this kind of interference and the daily clinical management of oral anticoagulation. The aim of the study is to evaluate the role of two different thromboplastins-RecombiPlasTin 2G and HepatoComplex-in the determination of INR values of several patients' ongoing OA for a previous thrombotic disorder with and without positivity to LAC, and to evaluate possible interferences in the daily therapeutic approach. We selected 16 patients (13 females and 3 males, mean age 59 ± 16 years) with LAC positivity ongoing OA and 11 control subjects (7 females and 4 males, mean age 58 ± 14.5 years) with similar characteristics (ie, ethnic background and weight) with LAC negativity ongoing OA. 165 assays for INR determination were analyzed from both groups. Statistical analysis was performed using STATA 10 software. P values were considered significant if LAC positivity were 3.79 ± 1.63 when tested with RecombiPlasTin 2G vs 3.18 ± 1.15 when tested with HepatoComplex (P LAC negativity were 3.54 ± 1.39 when tested with RecombiPlasTin 2G vs 3.23 ± 1.14 when tested with HepatoComplex (P than 4.5 was found in 31/165 samples in 9 subjects, 8 patients with LAC positivity, and 1 control group subject with LAC negativity. There was a great difference in INR values in these subjects if we use the common thromboplastin (ie, RecombiPlasTin 2G) with a INR range varying from 5.14 ± 0.35 vs 3.79 ± 0.38 if we use another thromboplastin (ie, HepatoComplex) (P LAC positivity, when the INR value is LAC positivity if we use a different thromboplastin for the INR determination. For this reason values obtained by RecombiPlasTin 2G need to be confirmed and matched with another thromboplastin (ie, HepatoComplex). This

  6. Stroke prevention in the elderly atrial fibrillation patient with comorbid conditions: focus on non-vitamin K antagonist oral anticoagulants

    Directory of Open Access Journals (Sweden)

    Turagam MK

    2015-09-01

    Full Text Available Mohit K Turagam, Poonam Velagapudi, Greg C FlakerDivision of Cardiovascular Medicine, University of Missouri School of Medicine, Columbia, MO, USAAbstract: Stroke prevention in elderly atrial fibrillation patients remains a challenge. There is a high risk of stroke and systemic thromboembolism but also a high risk of bleeding if anticoagulants are prescribed. The elderly have increased chronic kidney disease, coronary artery disease, polypharmacy, and overall frailty. For all these reasons, anticoagulant use is underutilized in the elderly. In this manuscript, the benefits of non-vitamin K antagonist oral anticoagulants compared with warfarin in the elderly patient population with multiple comorbid conditions are reviewed.Keywords: non-vitamin K antagonist oral anticoagulants, novel oral anticoagulants, warfarin, dabigatran, rivaroxaban, apixaban, edoxaban

  7. Effective management of venous thromboembolism in the community: non-vitamin K antagonist oral anticoagulants

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    Patel R

    2016-05-01

    Full Text Available Raj Patel Department of Haematological Medicine, King's Thrombosis Centre, King's College Hospital, London, UK Abstract: Anticoagulation therapy is essential for the effective treatment and secondary prevention of venous thromboembolism (VTE. For many years, anticoagulation for acute VTE was limited to the use of initial parenteral heparin, overlapping with and followed by a vitamin K antagonist. Although highly effective, this regimen has several limitations and is particularly challenging when given in an ambulatory setting. Current treatment pathways for most patients with deep-vein thrombosis typically involve initial hospital or community-based ambulatory care with subsequent follow-up in a secondary care setting. With the introduction of non-vitamin K antagonist oral anticoagulants (NOACs into routine clinical practice, it is now possible for the initial acute management of patients with deep-vein thrombosis to be undertaken by primary care. As hospital admissions associated with VTE become shorter, primary care will play an increasingly important role in the long-term management of these patients. Although the NOACs can potentially simplify patient management and improve clinical outcomes, primary care physicians may be less familiar with these new treatments compared with traditional therapy. To assist primary care physicians in further understanding the role of the NOACs, this article outlines the main differences between NOACs and traditional anticoagulation therapy and discusses the benefit–risk profile of the different NOACs in the treatment and secondary prevention of recurrent VTE. Key considerations for the use of NOACs in the primary care setting are highlighted, including dose transition, risk assessment and follow-up, duration of anticoagulant therapy, how to minimize bleeding risks, and the importance of patient education and counseling. Keywords: venous thromboembolism, oral anticoagulant, prevention, treatment, primary

  8. Efficacy and Safety of Non-Vitamin K Antagonist Oral Anticoagulants versus Vitamin K Antagonist Oral Anticoagulants in Patients Undergoing Radiofrequency Catheter Ablation of Atrial Fibrillation: A Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Giuseppe Santarpia

    Full Text Available Use of the non-vitamin K antagonist oral anticoagulants (NOACs is endorsed by current guidelines for stroke prevention in patients with atrial fibrillation (AF. However efficacy and safety of NOACs in patients undergoing catheter ablation (RFCA of AF has not been well established yet.To perform a meta-analysis of all studies comparing NOACs and vitamin K antagonist oral anticoagulants (VKAs in patients undergoing RFCA.Studies were searched for in PubMed and Google Scholar databases.Studies were considered eligible if: they evaluated the clinical impact of NOACs versus VKAs; they specifically analyzed the use of anticoagulants during periprocedural phase of RFCA; they reported clinical outcome data.25 studies were selected, including 9881 cases. The summary measure used was the risk ratio (RR with 95% confidence interval (CI. The random-effects or the fixed effect model were used to synthesize results from the selected studies.There was no significant difference in thromboembolic complications (RR 1.39; p=0.13. Bleeding complications were significantly lower in the NOACs-treated arm as compared to VKAs (RR=0.67, p<0.001. Interestingly, a larger number of thromboembolic events was found in the VKAs-treated arm in those studies where VKAs had been interrupted during the periprocedural phase (RR=0.68; p=ns. In this same subgroup a significantly higher incidence of both minor (RR=0.54; p=0.002 and major bleeding (RR=0.41; p=0.01 events was recorded. Conversely, the incidence of thromboembolic events in the VKAs-treated arm was significantly lower in those studies with uninterrupted periprocedural anticoagulation treatment (RR=1.89; p=0.02.As with every meta-analysis, no patients-level data were available.The use of NOACs in patients undergoing RFCA is safe, given the lower incidence of bleedings observed with NOACs. On the other side, periprocedural interruption of VKAs and bridging with heparin is associated with a higher bleeding rate with no

  9. Combining Taipan snake venom time/Ecarin time screening with the mixing studies of conventional assays increases detection rates of lupus anticoagulants in orally anticoagulated patients

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    Moore Gary W

    2007-09-01

    Full Text Available Abstract Background Oral anticoagulation compromises conventional lupus anticoagulant (LA screening assays. Mixing studies can counteract the oral anticoagulant effect but the dilution reduces sensitivity and can generate false negative results. A firm diagnosis can be made from mixing studies when an elevated screen ratio is accompanied by a confirm ratio that generates significant correction to demonstrate phospholipid dependence, but also returns into the reference range, indicating complete normalisation of the oral anticoagulant effect. Taipan snake venom time (TSVT with Ecarin time (ET as a confirmatory test comprises an oral anticoagulant insensitive LA detection system and this study investigates the potential impact on detection rates when coupled with mixing studies on standard assays. Methods Eighty patients known to have LA who were receiving oral anticoagulation were tested with TSVT/ET and 1:1 mixing studies with normal plasma by dilute Russell's viper venom time (DRVVT and dilute activated partial thromboplastin time (DAPTT to assess detection rates by single and multiple assays. Results Thirty three of the 80 samples from known LA positive patients were positive in all three assays and 15 were positive in combinations of DRVVT, DAPTT or TSVT/ET. The remainder were positive in only one assay; 12 by DRVVT, 4 by DAPTT and 16 by TSVT/ET. Although all DRVVT and DAPTT positive mixing studies generated significant correction of the screen ratio by the confirm ratio, not all confirm ratios corrected back into the reference range. This was the case for 87.5% of the DRVVT results, 44.7% of the DAPTT results and 13.3% of the TSVT/ET positive mixing tests. Conclusion Addition of TSVT/ET screening for LA in orally anticoagulated patients could increase diagnostic efficacy either by detecting antibodies diluted in the mixing tests of conventional assays or those that do not react in DRVVT or DAPTT. Additionally, TSVT/ET can affirm the presence

  10. Menstrual problems and contraception in women of reproductive age receiving oral anticoagulation.

    Science.gov (United States)

    Huq, Farah Yasmine; Tvarkova, Katerina; Arafa, Aliaa; Kadir, Rezan A

    2011-08-01

    Oral anticoagulation is associated with increased bleeding complications. The aim of this study was to assess the changes in menstrual loss and pattern in women taking anticoagulant treatment. Women on oral anticoagulant (OA) treatment at the Royal Free Hospital were interviewed and completed a questionnaire about their menstrual cycle before and after commencing oral anticoagulation treatment. They were then asked to complete a pictorial bleeding assessment chart (PBAC) during their next menstrual bleeding episode. Fifty-three women between the ages of 20 and 50 years participated in the study. Of these, 47 women completed a PBAC. The mean duration of menstruation increased from 5 days before starting OA therapy to 7 days after the commencement of treatment. Thirty-one (66%) of the 47 women who completed the PBAC had a score that was greater than 100. The number of women who experienced flooding or clots during menstruation and intermenstrual or postcoital bleeding also increased. In total, 29 (54.7%) women changed their method of contraception during OA treatment. Seventeen women who did not want to become pregnant were not using contraception, including 10 women who were on hormonal contraception prior to starting anticoagulant therapy. Women of reproductive age experience heavy and prolonged menstrual bleeding whilst on OA therapy. Women of reproductive age on OA therapy should be monitored for menstrual disorders to ensure that prompt and appropriate treatment is instituted. Advice about appropriate contraception should also be part of the medical care provided for these women. Barrier contraception, sterilization and progestin-only contraception are all suitable methods of contraception in this patient group. Copyright © 2011 Elsevier Inc. All rights reserved.

  11. An observational study of direct oral anticoagulant awareness indicating inadequate recognition with potential for patient harm.

    Science.gov (United States)

    Olaiya, A; Lurie, B; Watt, B; McDonald, L; Greaves, M; Watson, H G

    2016-05-01

    Essentials Ignorance of direct oral anticoagulants' effects on coagulation tests may be a safety issue. An electronic questionnaire was sent to prescribers in NHS Grampian with 143 respondents. We found widespread evidence of inappropriate interpretation of the clinical scenarios given. The study suggests potential for patient harm due to lack of knowledge and education is required. Background Lack of awareness of the nature of the direct oral anticoagulants (DOACs) combined with the poor correlation between routine coagulation test prolongation and the activity of these drugs represents a potential for patient harm. Objectives To establish the level of awareness of the different DOACs, and to assess whether prescribers were able to recognize the state of anticoagulation in a hypothetical patient. Methods and results An electronic questionnaire was sent by email to prescribers in our health board. Among 143 respondents, we found significant differences in awareness of the currently licensed drugs. Of the respondents, 88%, 80% and 50%, respectively, recognized rivaroxaban, dabigatran, and apixaban. When provided with a routine clinical situation, only 13.5%, 17.5% and 16.8%, respectively, recognized that the hypothetical patient was anticoagulated, and only 55-58% recognized that it was unsafe to proceed with an invasive procedure. Conclusion These results indicate a significant risk for patient harm related to lack of knowledge about this new group of frequently used drugs, and indicate that additional education and training on this subject are required. © 2016 International Society on Thrombosis and Haemostasis.

  12. From a direct oral anticoagulant to warfarin: reasons why patients switch.

    Science.gov (United States)

    Barrett, Aisling; Moore, Margaret; Ferrins, Patricia; Thornton, Patrick; Murphy, Philip; Quinn, John

    2017-12-21

    The introduction of the direct oral anticoagulants (DOACs) has led to their widespread use for stroke prevention and venous thromboembolism, but little is known about the numbers of patients switching from a DOAC to (or back to) a warfarin or the reasons for doing so. This study was an analysis of prospectively collected data from a 4-year period surveying a warfarin dose adjustment clinic in a large city centre hospital with the primary objective to identify these reasons. In our clinic with 1791 patients annually under review, 40 patients were identified as having switched from a DOAC to warfarin with the most common reasons for switching being bleeding, re-thrombosis and renal deterioration. Other reasons included medication interactions, side effects, antiphospholipid syndrome, valvular replacement or arterial embolism. Clinical events following warfarin commencement were also recorded. Overall, these data suggest that switching from a DOAC to warfarin is seldom deemed necessary by clinicians. However, as the number of patients receiving DOACs continues to increase, it is vital that health care professionals remain vigilant regarding medication interactions, bleeding risk and changing renal function.

  13. Transforming oral anticoagulation by combining international normalized ratio (INR) self testing and online automated management.

    Science.gov (United States)

    Bussey, Henry I

    2011-04-01

    Because of the number and complexity of issues addressed, this manuscript is divided into two major sections. The first section focuses on how new technology can transform vitamin K antagonist therapy. Specifically, evidence suggest that combining INR self testing with online automated management (STOAM) can greatly reduce the time, expense, and hassle of managing VKA therapy; improve the quality of INR control to a degree that, in large studies, has been associated with a 50% or more reduction in major events (such as stroke, myocardial infarction, major hemorrhage, and death); reduce health care costs by an estimated $4 million per 1,000 patients per year; and improve quality of life and patient satisfaction. Such improved VKA therapy should be safer, more effective, and more cost-effective than the new oral anticoagulants. The improved efficiency and outcomes also should prompt reconsideration of indications in which VKA therapy may not be the current standard of care. Although new reimbursement models are clearly needed for STOAM, the current Medicare reimbursement model for patient self testing can be utilized to make VKA management financially viable and sustainable. The second section of this article focuses on additional considerations that may be important in optimizing VKA therapy and/or selecting an online management system. A brief review is provided to examine why a recent meta analysis and a large randomized trial of self testing did not find the same degree of improvement as reported in the four STOAM trials described in the first section of this article.

  14. Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT) : a randomised controlled trial

    NARCIS (Netherlands)

    Halkes, P H A; van Gijn, J; Kappelle, L J; Algra, A; Koudstaal, P J

    BACKGROUND: Oral anticoagulants are better than aspirin for secondary prevention after myocardial infarction and after cerebral ischaemia in combination with non-rheumatic atrial fibrillation. The European/Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT) aimed to determine

  15. Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT): a randomised controlled trial

    NARCIS (Netherlands)

    Halkes, P. H. A.; van Gijn, J.; Kappelle, L. J.; Koudstaal, P. J.; Algra, A.; Banga, J. D.; Boiten, J.; van der Bom, J. G.; Boon, A. E.; Dippel, D. W. J.; Donders, R. C. J. M.; Eefting, F. D.; Franke, C. L.; Frenken, C. W. G. M.; Frijns, C. J. M.; van Gemert, H. M. A.; de Jaegere, P. P. Th; Kamp, O.; Kwa, V. I. H.; de Leeuw, F.-E.; Linn, F. H. H.; van der Meer, W. K.; Mosterd, A.; Pop, G. A. M.; Raaymakers, T. W. M.; van Schooneveld, M. J.; Stam, J.; Verheugt, F. W. A.; van der Worp, H. B.; Zijlstra, F.; Boekweit, M. P.; van Buuren, M.; Greebe, P.; Mooibroek, G. E.; Slabbers, D. C. V.; Beijer, I. S.; van den Bergh, W. M.; Biessels, G. J.; de Schryver, E. L. L. M.; van Dijk, G. W.; Dorhout-Mees, S. M.; Ferrier, C. H.; Gorter, J. W.; Hofmeijer, J.; Hop, J. W.; Klijn, C. J. M.; Manschot, S. M.; Nieuwkamp, D. J.; van Oers, C. A. M.; Pruissen, D. M. O.; Ruigrok, Y. M.; Schaafsma, J. D.; Slooter, A. J.; Tjeerdsma, H. C.; Wermer, M. J.; van Wijk, I.; Collins, R.; Donnan, G. A.; Rosendaal, F. R.; Vermeulen, M.; Warlow, C. P.; Wheatly, K.; Aichner, F.; Bogousslavsky, J.; Chamorro, A.; Chen, C. P. L. H.; Ferro, J. M.; Hankey, G. J.; Hertzberger, L. I.; Leys, D.; Ricci, S.; Ringelstein, E. B.; Vanhooren, G.; Venables, G. S.; Fazekas, F.; Kleinert, G.; Depondt, C.; Derijck, O.; Dobbelaere, K.; Foncke, E.; Simons, P.; Verhoeven, K.; Girot, M.; Henon, H.; Lucas, C.; Arquizan, C.; Calvet, D.; Mas, J. L.; Decavel, D.; Schilling, M.; Muhs, A.; Postert, T.; Caso, V.; Paciaroni, M.; Grazia Celani, M.; Righetti, E.; Guccione, A.; Sterzi, R.; Cenciarelli, S.; Girelli, L.; Aisa, G.; Freddo, M.; Polidori, M. C.; Cavallini, A.; Marcheselli, S.; Micieli, G.; Rimondi, B.; Landini, G.; Gandolfo, C.; Nanninga-van den Neste, V. M. H.; Bakker, S. L. M.; van Kooten, F.; Berntsen, P. J. I. M.; Feenstra, B.; den Hartog, G. W. A.; Boon, A. M.; Doelman, J. C.; Lieuwens, W. H. G.; Sips, H. J. W. A.; Visscher, F.; Brouwers, P. J. A. M.; Nihom, J.; Poels, P. J. E.; Prick, J. J. W.; Koehler, P. J. J.; Jöbsis, G. J.; van der Sande, J. J.; ten Houten, R.; Veering, M. M.; Bernsen, P. L. J. A.; Boringa, J. B.; van der Meulen, W. D. M.; Tans, J. Th J.; Wagner, G. L.; Blankenvoort, J. B.; Christiaans, M. H.; Kuiper, H.; Mallo, G. N.; Keyser, A. J. M.; Klaver, M. M.; Bouwsma, C.; Kienstra, G. E. M.; Rutgers, A. W. F.; Snoek, J. W.; Bulens, C.; Vermeij, F. H.; Baal, M. G.; van der Steen, A.; van der Wielen-Jongen, J. C. F.; Feikema, W. J.; Lohmann, H. J. M. M.; Sie, L. T. L.; Driesen, J. J. M.; Verhey, J. C. B.; Mulleners, W. M.; Lindeboom, S. F.; Nijmeijer, H. W.; Geervliet, J. P.; Tans, R. J. J.; Verweij, R. D.; Linssen, W. H. J. P.; Vanneste, J. A. L.; Weinstein, H. C.; Zijlmans, J. C. M.; Sie, T. H.; Bertelsmann, F. W.; Lanting, P.; Herderschêe, D.; Leyten, Q. H.; Heerema, J.; Saxena, R.; Böttger, H. R. F.; Driessen-Kletter, M. F.; Alting van Geusau, R. B.; Glimmerveen, W. F.; Henriques, I.; Rebocho, L.; Calado, S.; Viana Baptista, M.; Grilo Goncalves, J. A.; Canhao, P.; Obach, V.; Vila, N.; Hambraeus, J.; Nilsson, S. A.; Nordmark, O.; Terent, A.; Devuyst, G.; Michel, P.; Vuadens, Ph; Mehrzad, A.; Curless, R.; Kalra, L.; Perez, I.; Bates, D.; Cartledge, N.; Dorman, P.; Rodgers, H.; Lees, K. R.; Watt, M.; Enevoldson, P.; Humphrey, P.; Brown, M. M.; Coward, L.; Featherstone, R.; Werring, D.; Young, G.; Bath, P.; Weaver, C.; Dennis, M.; Lindley, R.; Jenkins, C.; Overstall, P. W.; Potter, J.; Eames, P.; Zhang, W. W.; Chang, H. M.; Wong, M. C.; Verro, P.

    2007-01-01

    BACKGROUND: Oral anticoagulants are better than aspirin for secondary prevention after myocardial infarction and after cerebral ischaemia in combination with non-rheumatic atrial fibrillation. The European/Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT) aimed to determine

  16. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial.

    Science.gov (United States)

    Menéndez-Jándula, Bárbara; Souto, Juan Carlos; Oliver, Arturo; Montserrat, Isabel; Quintana, Mireia; Gich, Ignasi; Bonfill, Xavier; Fontcuberta, Jordi

    2005-01-04

    Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control. To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management. Randomized, controlled trial. University-affiliated hospital in Spain. 737 patients with indications for anticoagulant treatment. The self-management group (n = 368) received simple instructions for using a portable coagulometer weekly and self-adjusting treatment dose. The conventional management group (n = 369) received usual care in an anticoagulation clinic (monthly measurement and control of international normalized ratio [INR], managed by hematologists). Percentage of INR values within the target range and major related complications. The median follow-up period was 11.8 months (range, 0.3 to 16.9 months). The unadjusted percentages of in-range INRs were 58.6% in the self-management group and 55.6% in the conventional management group (difference, 3.0 percentage points [95% CI, 0.4 to 5.4 percentage points]). Twenty-seven patients (7.3%) in the conventional management group and 8 (2.2%) in the self-management group had major complications related to anticoagulant treatment. The unadjusted risk difference for major complications between groups was 5.1 percentage points (exact 95% CI, 1.7 to 8.5 percentage points). Fewer patients had minor hemorrhages in the self-management group (14.9%) than in the conventional management group (36.4%). Fifteen patients (4.1%) in the conventional management group and 6 (1.6%) in the self-management group died (unadjusted risk difference, 2.5 percentage points [exact 95% CI, 0.0 to 5.1 percentage points]). The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%. Compared with conventional management by an anticoagulation clinic, self-management of oral

  17. Novel Oral Anticoagulants and the Risk of Major Hemorrhage in Elderly Patients With Chronic Kidney Disease: A Nested Case-Control Study.

    Science.gov (United States)

    Harel, Ziv; Mamdani, Muhammad; Juurlink, David N; Garg, Amit X; Wald, Ron; Yao, Zhan; Gomes, Tara

    2016-08-01

    The novel oral anticoagulants, including dabigatran and rivaroxaban, differ in their degree of renal excretion. We conducted a population-based nested case-control study in patients 66 years and older with chronic kidney disease (CKD) (excluding patients undergoing chronic dialysis) who received an oral anticoagulant between April 2006 and March 2013. We calculated odds ratios for hospitalization with a major hemorrhagic event and receipt of dabigatran, rivaroxaban, or warfarin in the preceding 60 days. We also performed a sensitivity analysis to investigate whether a relationship exists between major hemorrhage and advanced age (age elderly patients with CKD, exposure to dabigatran or rivaroxaban was not associated with a statistically significant increased risk of major hemorrhagic events compared with exposure to warfarin. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  18. Use of oral anticoagulants after intramedullary nailing of femur and tibial fractures in trauma department

    Directory of Open Access Journals (Sweden)

    A. K. Dulaev

    2014-01-01

    Full Text Available The authors evaluated of the effectiveness of new oral anticoagulants in patients with diaphyseal fractures of the femur and tibia.We analyzed the effectiveness of thromboprophylaxis in 85 patients with diaphyseal fractures of the femur and tibia in the early postoperative period. Patients were divided into 3 groups: group 1 - patients, who was taking enoxaparin, group 2 - dabigatran etexilate, group 3 - rivaroxaban. We evaluated the frequency of thromboembolic complications and bleeding for 4 weeks after intramedullary nailing of femur and tibia.The lowest frequency of postoperative bleeding was observed in patients treated with dabigatran etexilate. In addition, the minimum frequency of complications was observed among patients of the second group of the study (9.7% in the group receiving dabigatran etexilati compared with 27.8% for the combined group I and III.Statistically significant differences between groups of patients taking oral or parenteral anticoagulants was not obtained.

  19. Oral anticoagulants in coronary heart disease (Section IV). Position paper of the ESC Working Group on Thrombosis - Task Force on Anticoagulants in Heart Disease

    NARCIS (Netherlands)

    Caterina, R. De; Husted, S.; Wallentin, L.; Andreotti, F.; Arnesen, H.; Bachmann, F.; Baigent, C.; Collet, J.P.; Halvorsen, S.; Huber, K.; Jespersen, J.; Kristensen, S.D.; Lip, G.Y.; Morais, J.; Rasmussen, L.H.; Ricci, F.; Sibbing, D.; Siegbahn, A.; Storey, R.F.; Berg, J ten; Verheugt, F.W.A.; Weitz, J.I.

    2016-01-01

    Until recently, vitamin K antagonists (VKAs) were the only available oral anticoagulants evaluated for long-term treatment of patients with coronary heart disease (CHD), particularly after an acute coronary syndrome (ACS). Despite efficacy in this setting, VKAs are rarely used because they are

  20. Evaluation of the Ciba Corning Biotrack 512 coagulation monitor for the control of oral anticoagulation.

    OpenAIRE

    Jennings, I; Luddington, R J; Baglin, T.

    1991-01-01

    The Ciba Corning Biotrack 512 coagulation monitor requires a minimal degree of technical expertise to operate, and is already in use for near-patient testing. This study evaluated the monitor for possible use in decentralised control of oral anticoagulant treatment. The monitor compared well with Manchester Reagent, suggesting that it could be used in areas where this thromboplastin is used for centralised control. The inability of the monitor to allow for locally determined geometric mean no...

  1. Non-vitamin K antagonist oral anticoagulants versus warfarin for cardioversion of atrial fibrillation in clinical practice: A single-center experience.

    Science.gov (United States)

    Shibata, Naoki; Morishima, Itsuro; Okumura, Kenji; Morita, Yasuhiro; Takagi, Kensuke; Yoshida, Ruka; Nagai, Hiroaki; Tomomatsu, Toshiro; Ikai, Yoshihiro; Terada, Kazushi; Tsuzuki, Kazuhito; Tsuboi, Hideyuki; Sone, Takahito; Murohara, Toyoaki

    2017-02-01

    Anticoagulation therapy with the vitamin K antagonist (VKA) warfarin has been demonstrated to reduce thromboembolic risk after electrical cardioversion (ECV). However, data concerning ECV with non-VKA oral anticoagulants (NOACs) is limited. The objective of this study was to determine the efficacy and safety of NOACs in patients undergoing ECV in a real-world clinical practice at a single center in Japan. We retrospectively analyzed the data of 406 consecutive patients who underwent ECV for atrial fibrillation (AF) or flutter under anticoagulation with one of the three NOACs (n=149) or with a VKA (n=257). The CHADS2 and HAS-BLED scores were significantly higher in the VKA group, whereas the NOACs group had a tendency toward greater spontaneous echo contrast grades. After ECV, ischemic stroke occurred in three patients of the VKA group and one patient in the NOAC group, all of whom had persistent AF, indicating no significant difference in the thromboembolic event rate within 30 days following ECV. No other thromboembolic events, major bleeding, or death occurred in either group. Among the NOAC and VKA patients in whom we newly introduced an oral anticoagulant to perform ECV, the number of days leading to ECV was significantly lesser for the NOAC patients. NOACs may be used as an alternative to VKAs for ECV and may allow prompt ECV in clinical practices.

  2. Prescription of oral anticoagulation for patients with atrial fibrillation and previous hospitalization in a cardiology department. Experience in actual practice in a tertiary hospital.

    Science.gov (United States)

    Fabregat-Andrés, Ó; Cubillos-Arango, A; Chacón-Hernández, N; Montagud, V; Morell, S; Fácila, L

    2015-01-01

    Atrial fibrillation is the main reason for oral anticoagulation in our community. New oral anticoagulants (NOACs) overcome the disadvantages of vitamin K antagonists (VKAs), although there are scarce data on its use in our community. The aim of our study was to assess the use of NOACs and anticoagulation control using VKA as measured by the time within the therapeutic range (TTR) in an actual clinical scenario. A retrospective cohort analysis was conducted of 816 patients admitted to cardiology over a period of 3 years, with a diagnosis of atrial fibrillation and anticoagulant treatment at discharge. We assessed the percentage of patients prescribed NOACs and the TTR with VKA. We compared safety and efficacy events during the 15-month follow-up among the patients prescribed NOAC, those prescribed VKA with a good TTR and those with a poor TTR. The percentage of patients prescribed NOAC was 7.6%. Serial INR measurements found that 71.3% of patients had a poor TTR. Although the groups were not comparable, a higher incidence of the combined event was observed in those treated with VKA and a poor TTR compared with those prescribed NOAC (p=.01). For patients with a previous hospitalization in cardiology in a tertiary hospital and a diagnosis of atrial fibrillation, the rate of NOAC prescription is low, and the TTR with VKA was poor. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  3. Safety of endovascular treatment in acute stroke patients taking oral anticoagulants.

    Science.gov (United States)

    Uphaus, Timo; Singer, Oliver C; Berkefeld, Joachim; Nolte, Christian H; Bohner, Georg; Niederkorn, Kurt; Deutschmann, Hannes; Haring, Hans-Peter; Trenkler, Johannes; Neumann-Haefelin, Tobias; Hofmann, Erich; Stoll, Anett; Bormann, Albrecht; Bussmeyer, Matthias; Mpotsaris, Aanastasios; Reich, Arno; Wiesmann, Martin; Petzold, Gabor C; Urbach, Horst; Jander, Sebastian; Turowski, Bernd; Weimar, Christian; Schlamann, Marc; Liebeskind, David S; Gröschel, Sonja; Boor, Stephan; Gröschel, Klaus

    2017-06-01

    Background The endovascular treatment of acute cerebral ischemia has been proven beneficial without major safety concerns. To date, the role of endovascular treatment in patients treated with oral anticoagulants, which may be associated with periprocedural intracranial bleeding, remains uncertain. Aims The objective of the current analysis is to evaluate the safety of endovascular treatment in patients treated with oral anticoagulants. Methods The ENDOSTROKE-Registry is a commercially independent, prospective observational study in 12 stroke centers in Germany and Austria collecting pre-specified variables about endovascular stroke therapy. Results Data from 815 patients (median age 70 (interquartile range (IQR) 20), 57% male) undergoing endovascular treatment with known anticoagulation status were analyzed. A total of 85 (median age 76 (IQR 8), 52% male) patients (10.4%) took vitamin-K-antagonists prior to endovascular treatment. Anticoagulation status as measured with international normalized ratio was above 2.0 in 31 patients. Intracranial hemorrhage occurred in 11.8% of patients taking vitamin-K-antagonists compared to no-vitamin-K-antagonists (12.2%, p = 0.909). After adjustment for confounding factors which were unbalanced at univariate level such as NIHSS and age, anticoagulation status was not found to significantly influence clinical outcome (modified Rankin Scale 3-6) and occurrence of intracranial hemorrhage in a multivariate logistic regression analysis. Conclusion Prior use of vitamin-K-antagonists was not associated with a higher rate of periprocedural intracranial hemorrhage after endovascular treatment or worse outcome. Endovascular treatment should be considered as an important treatment option in patients taking vitamin-K-antagonists.

  4. Effects of oral anticoagulation with various INR levels in deep vein thrombosis cases

    Directory of Open Access Journals (Sweden)

    Karabay Özalp

    2004-02-01

    Full Text Available Abstract Aim In order to avoid the complications associated with thromboembolic disease, patients with this condition typically are placed on long-term anticoagulant therapy. This report compares bleeding complications in this patient population by level of achieved INR. Materials and Methods During the 6-year period between January 1997 and January 2003, 386 patients with venous thromboembolism of the lower extremities were admitted to the Cardiovascular Surgery Outpatient Clinic of Alsancak State Hospital. Of the 386 patients, 198 (51.2% were women, and the average age was 52.3 years. All diagnoses of venous thromboembolism were confirmed by means of Doppler ultrasonography. Further investigation showed occult neoplasms in 22 (5.6% of the cases. We excluded the patients with occult disease, and the remaining 364 constituted our study population. Results Oral anticoagulation was standardized at 6 months' duration in all cases. We divided the patients into two groups. Group I consisted of 192 patients (52.7% with INR values between 1.9 and 2.5; Group II comprised 172 patients with INR values between 2.6 and 3.5. Complications in each group were assessed and compared. The minor hemorrhage rate was 1.04% in Group I and 4.06% in Group II. The major hemorrhage rate was also 1.04% in Group I and was 6.3% in Group II. We determined that the complication rates for both minor and major hemorrhage were significant in patients with INR values above 2.5. Conclusion Oral anticoagulation must be followed closely in patients with venous thromboembolism. Higher INR levels are associated with significant increases in hemorrhage and associated complications. INR values of 2.0 to 2.5 are sufficient for long-term anticoagulant therapy, ensuring ideal anticoagulation levels and minimizing the complication rate.

  5. Implementing evidence-based patient and family education on oral anticoagulation therapy: a community-based participatory project.

    Science.gov (United States)

    Shaha, Maya; Wüthrich, Erika; Stauffer, Yvonne; Herczeg, Franziska; Fattinger, Karin; Hirter, Kathrin; Papalini, Marianne; Herrmann, Luzia

    2015-06-01

    This study aimed at developing and implementing evidence-based patient and family education on oral anticoagulation therapy. The number of persons with chronic diseases who live at home is increasing. They have to manage multiple diseases and complex treatments. One such treatment is oral anticoagulation therapy, a high risk variable dose medication. Adherence to oral anticoagulation therapy is jeopardised by limited information about the medications, their risk and complications, the impact of individual daily routine and the limited inclusion of family members in education. Hence, improved and tailored education is essential for patients and families to manage oral anticoagulation therapy at home. A community-based participatory research design combined with the Precede-Proceed model was used including a systematic literature review, posteducation analysis, an online nurse survey, a documentation analysis and patient/family interviews. The study was conducted between April 2010-December 2012 at a department of general internal medicine in a teaching hospital in Switzerland. Participants were the department's nursing and medical professionals including the patients and their families. The evidence-based patient and family education on oral anticoagulation therapy emerged comprising a learning assessment, teaching units, clarification of responsibilities of nurse professionals and documentation guidelines. The inclusion of the whole department has contributed to the development and implementation of this evidence-based patient family education on oral anticoagulation therapy, which encompasses local characteristics and patient preferences. This education is now being used throughout the department. © 2015 John Wiley & Sons Ltd.

  6. ANMCO Position Paper: the use of non-vitamin K dependent new oral anticoagulant(s) in pulmonary embolism therapy and prevention

    Science.gov (United States)

    Roncon, Loris; Azzarito, Michele; Becattini, Cecilia; Bongarzoni, Amedeo; Casazza, Franco; Cuccia, Claudio; D’Agostino, Carlo; Rugolotto, Matteo; Vatrano, Marco; Vinci, Eugenio; Fenaroli, Paride; Formigli, Dario; Silvestri, Paolo; Nardi, Federico; Vedovati, Maria Cristina; Scherillo, Marino

    2017-01-01

    Abstract The new oral anticoagulants (NOACs) have radically changed the approach to the treatment and prevention of thromboembolic pulmonary embolism. The authors of this position paper face, in succession, issues concerning NOACs, including (i) their mechanism of action, pharmacodynamics, and pharmacokinetics; (ii) the use in the acute phase with the ‘double drug single dose’ approach or with ‘single drug double dose’; (iii) the use in the extended phase with demonstrated efficacy and with low incidence of bleeding events; (iv) the encouraging use of NOACs in particular subgroups of patients such as those with cancer, the ones under- or overweight, with renal insufficiency (creatinine clearance > 30 mL/min), the elderly (>75 years); (v) they propose a possible laboratory clinical pathway for follow-up; and (vi) carry out an examination on the main drug interactions, their potential bleeding risk, and the way to deal with some bleeding complications. The authors conclude that the use of NOACs both in the acute phase and in the extended phase is equally effective to conventional therapy and associated with fewer major bleeding events, which make their use in patients at higher risk of recurrences safer. PMID:28751847

  7. Dabigatran: A new oral anticoagulant. Guidelines to follow in oral surgery procedures. A systematic review of the literature

    Science.gov (United States)

    Ramírez-Martínez-Acitores, Lucía; López-Pintor, Rosa Mª; Casañas-Gil, Elisabeth; Hernández-Vallejo, Gonzalo

    2016-01-01

    Background Dabigatran is a newly commercialized drug that is replacing other anticoagulants in the prevention of venous thromboembolism, stroke and systemic arterial valve embolism. It acts directly on thrombin presenting in a dynamic and predictable way, which does not require monitoring these patients. Therefore, we consider the need to assess whether their use increases the risk of bleeding involved before any dental treatment. Material and Methods We performed a systematic review with a bibliographic search in PubMed/Medline along with the Cochrane Library. We excluded articles dealing with all anticoagulants other than dabigatran, and works about surgical treatments in anatomical locations other than the oral cavity. Results We included a total of 13 papers of which 1 was a randomized clinical trial, 9 narrative literature reviews, 1 case series, 2 clinical cases and 1 expert opinion. Because we did not obtain any properly designed clinical trials, we were unable to conduct a meta-analysis. Conclusions Currently, there is no consensus on the procedure to be followed in patients taking dabigatran. However, all authors agree to treat each case individually in accordance to the risk of embolism, postoperative bleeding and renal function. Also, it is necessary to perform minimally invasive interventions, and take the appropriate local anti-hemolytic measures. Key words:Oral anticoagulants, dabigatran, risk of bleeding, oral surgery, dentistry. PMID:27694780

  8. POST-NOAC: Portuguese observational study of intracranial hemorrhage on non-vitamin K antagonist oral anticoagulants.

    Science.gov (United States)

    Marques-Matos, Cláudia; Alves, José Nuno; Marto, João Pedro; Ribeiro, Joana Afonso; Monteiro, Ana; Araújo, José; Silva, Fernando; Grenho, Fátima; Viana-Baptista, Miguel; Sargento-Freitas, João; Pinho, João; Azevedo, Elsa

    2017-08-01

    Background There is a lower reported incidence of intracranial hemorrhage with non-vitamin K antagonist oral anticoagulants compared with vitamin K antagonist. However, the functional outcome and mortality of intracranial hemorrhage patients were not assessed. Aims To compare the outcome of vitamin K antagonists- and non-vitamin K antagonist oral anticoagulants-related intracranial hemorrhage. Methods We included consecutive patients with acute non-traumatic intracranial hemorrhage on oral anticoagulation therapy admitted between January 2013 and June 2015 at four university hospitals. Clinical and demographic data were obtained from individual medical records. Intracranial hemorrhage was classified as intracerebral, extra-axial, or multifocal using brain computed tomography. Three-month functional outcome was assessed using the modified Rankin Scale. Results Among 246 patients included, 24 (9.8%) were anticoagulated with a non-vitamin K antagonist oral anticoagulants and 222 (90.2%) with a vitamin K antagonists. Non-vitamin K antagonist oral anticoagulants patients were older (81.5 vs. 76 years, p = 0.048) and had intracerebral hemorrhage more often (83.3% vs. 63.1%, p = 0.048). We detected a non-significant trend for larger intracerebral hemorrhage volumes in vitamin K antagonists patients ( p = 0.368). Survival analysis adjusted for age, CHA2DS2VASc, HAS-BLED, and anticoagulation reversal revealed that non-vitamin K antagonist oral anticoagulants did not influence three-month mortality (hazard ratio (HR) = 0.83, 95% confidence interval (CI) = 0.39-1.80, p = 0.638). Multivariable ordinal regression for three-month functional outcome did not show a significant shift of modified Rankin Scale scores in non-vitamin K antagonist oral anticoagulants patients (odds ratio (OR) 1.26, 95%CI 0.55-2.87, p = 0.585). Conclusions We detected no significant differences in the three-month outcome between non-vitamin K antagonist oral anticoagulants- and

  9. A multicenter study on amidolytic factor X evaluation in oral anticoagulant therapy.

    Science.gov (United States)

    Berthier, A M; Pommereuil, M; Scarabin, P Y; Conard, J

    1985-06-24

    For laboratory control of oral anticoagulation, amidolytic factor X (F X) determination may offer an alternative to standardization difficulties of prothrombin time (PT). In order to validate this amidolytic assay on a large scale, a multicenter study was undertaken in 6 French laboratories using the same chromogenic substrate (Stachrom X Stago) and different automated instruments. Intra and between laboratory reproducibility of factor X was estimated on fresh and lyophilized patients plasmas and was found to be highly satisfactory. Standardization of the method did not seem to depend on the chromogenic substrate used, as investigated in two different centers. Results of PT and factor X were compared in over 500 patients on a long-term stabilized oral anticoagulant treatment: there was a strong positive correlation between the 2 tests in each center. The therapeutic range for factor X was evaluated from therapeutic PT values reported by Duckert and Marbet for the different thromboplastin reagents: the estimated mean range was 21 to 32%. Pooling the results of the six different centers a concordant information for prothrombin time and factor X amidolytic assay was found in 76% of patients and a fully discordant response was present in 0.6%. The results suggest that amidolytic factor X may be suitable for monitoring long-term anticoagulation. However, prospective trials are needed to evaluate its usefulness as compared to conventional methods.

  10. Efficacy and safety of outpatient treatment with direct oral anticoagulation in pulmonary embolism.

    Science.gov (United States)

    Ghazvinian, R; Gottsäter, A; Elf, J L

    2018-01-05

    Anticoagulant treatment of acute pulmonary embolism (PE) has traditionally been hospital-based. The lesser need for monitoring with the increasingly used direct acting oral anticoagulants (DOAC) in comparison to warfarin potentially facilitates outpatient treatment of PE with these drugs. This study aimed to evaluate efficacy and safety of outpatient treatment of PE with DOAC. We extracted data from the Swedish quality registry for patients on oral anticoagulation (AuriculA) for all 245 patients in the southernmost hospital region in Sweden (1.3 million inhabitants) selected for outpatient treatment with of PE with DOAC during 2013-2015. Comorbidites, risk factors, and simplified pulmonary embolism severity index were evaluated at baseline, and death, recurrent venous thromboembolism (VTE), and bleeding was recorded during 6 months of follow-up. Outpatient treatment was defined as discharge from the emergency department within 24 h. During 6 months of follow-up, one patient died during DOAC therapy, the cause of death was unrelated to VTE. No VTE recurrences occured, whereas, one patient experienced major bleeding, and five patients experienced minor bleedings. Outpatient treatment of PE with DOAC is efficient and safe in selected patients.

  11. THE PROBLEM OF THE USE OF NEW ORAL ANTICOAGULANTS IN CANCER PATIENTS RECEIVING CHEMOTHERAPY

    Directory of Open Access Journals (Sweden)

    A. A. Rumyantsev

    2014-01-01

    Full Text Available Despite large number of known risk factors of venous thromboembolism (VTE in cancer patients existing prediction models do not allow definite identification of cancer patients that have indications for anticoagulant prevention. Besides, heparin and warfarin use for VTE prevention in cancer is accompanied by some problems. New oral anticoagulants (NOAC are promising drugs for use in oncology practice; however their use is complicated by the lack of data on efficacy and safety in these patients, potential drug interactions and the possibility of unpredictable changes in effect during chemotherapy. Widespread use of NOAC for the prevention and treatment of tumor-associated VTE prior to phase III trials is not recommended. However, the criteria for selection of patients for whom the study of the efficacy and safety of NOAC is a priority can now be developed.

  12. Feasibility Study of a Mobile Health Intervention for Older Adults on Oral Anticoagulation Therapy

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    Jung-Ah Lee PhD, RN

    2016-10-01

    Full Text Available Background: Oral anticoagulation treatment (OAT such as warfarin therapy is recommended for older adults with atrial fibrillation, heart failure, or who are at risk for venous thromboembolism. Despite its proven benefits, older adults report both dissatisfaction with OAT and reduced quality of life that can potentially lead to low adherence to OAT and decreased treatment efficacy. Objective: To test the feasibility of Mobile Applications for Seniors to enhance Safe anticoagulation therapy (MASS, a mobile-based health technology intervention designed to promote independence and self-care. Method s: This pilot study used a single-arm experimental pre–post design to test the feasibility of a 3-month intervention using MASS in 18 older adults (male: n = 14; White: n = 9; Hispanic: n = 7; Other: n = 2; M age = 67. MASS was available in English or Spanish. Participants completed surveys about their OAT knowledge, attitudes, quality of life with OAT, and adherence at baseline and at a 3-month follow-up. Satisfaction with the MASS intervention was also assessed at follow-up. Results: Anticoagulation knowledge significantly improved from baseline to follow-up ( M base = 12.5 ± 5.51, M follow-up = 14.78 ± 3.93, p = .007. Other outcomes were not different, pre- and post-tests. Participants reported they were generally satisfied with MASS, its ease of use and its usefulness. Conclusion: The results showed use of MASS improved older adults’ knowledge of OAT. Using mHealth apps may enhance self-care among older adults with chronic conditions who are also taking oral anticoagulants.

  13. Early, real-world experience with direct oral anticoagulants in the treatment of intermediate-high risk acute pulmonary embolism.

    Science.gov (United States)

    Santos, Sónia Martins; Cunha, Susana; Baptista, Rui; Monteiro, Sílvia; Monteiro, Pedro; Gonçalves, Francisco; Pêgo, Mariano

    2017-11-01

    Intermediate-high risk pulmonary embolism (IHR-PE) has a poor prognosis, but is under-represented in trials of direct oral anticoagulants (DOACs) in venous thromboembolic disease (VTE). We aimed to assess whether the administration of DOACs was equivalent to the conventional (CONV) treatment of low-molecular weight heparin bridged with warfarin for treating IHR-PE. We conducted a retrospective cohort study including 59 consecutive patients admitted with IHR-PE and followed for up to three months after discharge. Two groups were created based on the anticoagulant strategy: CONV (n=35) and DOAC (n=24). The efficacy endpoints were death, recurrent PE, estimated pulmonary artery systolic pressure (PASP), right ventricular systolic function (RVSF) at discharge, and length of stay; the safety endpoint was major bleeding. The two groups were similar regarding demographics, PE etiology and markers of clinical severity. There were four in-hospital deaths in the CONV group and none in the DOAC group. No recurrent PE or major bleeding event was recorded in either group. At discharge, neither PASP nor RVSF was different between the groups. Patients in the DOAC group were discharged 1.7 days earlier on average than patients in the CONV group (4.7±2.4 vs. 3.0±1.5 days, p=0.002). The adoption of a DOAC treatment strategy in this real-world cohort of IHR-PE patients was associated with similar efficacy and safety to the CONV approach. The fact that monitoring of anticoagulation effect was unnecessary probably led to the significant reduction in length of stay. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  14. Transitions of care in anticoagulated patients

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    Michota F

    2013-06-01

    Full Text Available Franklin Michota Department of Hospital Medicine, Cleveland Clinic, Cleveland, OH, USA Abstract: Anticoagulation is an effective therapeutic means of reducing thrombotic risk in patients with various conditions, including atrial fibrillation, mechanical heart valves, and major surgery. By its nature, anticoagulation increases the risk of bleeding; this risk is particularly high during transitions of care. Established anticoagulants are not ideal, due to requirements for parenteral administration, narrow therapeutic indices, and/or a need for frequent therapeutic monitoring. The development of effective oral anticoagulants that are administered as a fixed dose, have low potential for drug-drug and drug-food interactions, do not require regular anticoagulation monitoring, and are suitable for both inpatient and outpatient use is to be welcomed. Three new oral anticoagulants, the direct thrombin inhibitor, dabigatran etexilate, and the factor Xa inhibitors, rivaroxaban and apixaban, have been approved in the US for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; rivaroxaban is also approved for prophylaxis and treatment of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery. This review examines current options for anticoagulant therapy, with a focus on maintaining efficacy and safety during transitions of care. The characteristics of dabigatran etexilate, rivaroxaban, and apixaban are discussed in the context of traditional anticoagulant therapy. Keywords: hemorrhagic events, oral anticoagulation, parenteral anticoagulation, stroke, transitions of care

  15. Evaluation of a decision support system for initiation and control of oral anticoagulation in a randomised trial.

    OpenAIRE

    Vadher, B.; Patterson, D. L.; Leaning, M.

    1997-01-01

    OBJECTIVE: To determine whether a computerised decision support system for initiation and control of oral anticoagulant treatment improves quality of anticoagulant control achieved by trainee doctors. DESIGN: Randomised controlled trial. SETTING: District general hospital in North London. SUBJECTS: 148 inpatients requiring start of warfarin treatment. INTERVENTIONS: Management by trainee doctors (to achieve therapeutic range of international normalised ratio of 2 to 3) with indirect assistanc...

  16. [Which anticoagulation therapy in old atrial fibrillation patients?].

    Science.gov (United States)

    Taieb, Jérôme

    2013-06-01

    ESC recommends treating all AF patients over 75 years old with Vitamin K antagonist or new oral anticoagulation treatments because of the benefit on ischemic events. The challenge is to deal with hemorrhagic risk which should be carefully evaluated. It increases in case of renal disturbance and low weight, especially with new oral anticoagulation therapy. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  17. Initiation of oral anticoagulant therapy in orthopedic and surgical patients: an algorithm compared with routine dosing.

    Science.gov (United States)

    van den Bemt, P M L A; Beinema, M; van Roon, E N; Sijtsma, J; Baars, W A; Mencke, H J; Brouwers, J R B J

    2002-06-01

    Oral anticoagulant therapy is initiated in most hospitals in The Netherlands by clinicians who routinely dose oral anticoagulants (without using an algorithm). This may explain the low proportion of patients leaving the hospital stabilized. To test this hypothesis this study compared the dosing of acenocoumarol in orthopedic and surgical patients using an algorithm with routine dosing. Because of the routine administration of low molecular weight heparin for at least the first 5 days of acenocoumarol therapy, the study focused on supratherapeutic INR-values during this period. The study included 103 patients and was performed on orthopedic surgery and general surgery wards of a Dutch hospital over 5 months. The patients received acenocoumarol as an oral anticoagulant to prevent venous thromboembolism after general of orthopedic surgery. Patients were randomized into a group routinely dosed by physicians (n=54) and a group dosed using a dosing algorithm (n=49). A patient was defined as stable if he had two consecutive INR values within the range of 2-3 during hospitalization with the first (of the two consecutive INR values within range) having been measured on day 5 or later. The groups did not differ significantly in proportion of patients stabilized, time to stabilization, or length of hospitalization. In the first period (days 1-5) the routine dosing group had significantly more INR values above therapeutic range than the algorithm group, while the algorithm group had more INR values below the therapeutic range. There were two bleeding episodes in the routine dosing group and none in the algorithm group. Despite the lack of differences in stabilization between the two groups, this study suggests an advantage of dosing acenocoumarol using an algorithm in a study population consisting of prophylactically treated, mostly elderly orthopedic patients. The algorithm provides a safe dosing schedule for elderly postoperative patients who use low molecular weight heparin

  18. New predictive model for acute gastrointestinal bleeding in patients taking oral anticoagulants: A cohort study.

    Science.gov (United States)

    Shimomura, Akira; Nagata, Naoyoshi; Shimbo, Takuro; Sakurai, Toshiyuki; Moriyasu, Shiori; Okubo, Hidetaka; Watanabe, Kazuhiro; Yokoi, Chizu; Akiyama, Junichi; Uemura, Naomi

    2018-01-01

    The study developed a predictive model of long-term gastrointestinal (GI) bleeding risk in patients receiving oral anticoagulants and compared it with the HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratios, Elderly, Drugs/alcohol concomitantly) score. The study periodically followed a cohort of 508 patients taking oral anticoagulants (66 direct oral anticoagulants users and 442 warfarin users). Absence of GI bleeding at an initial examination and any subsequent GI bleeding were confirmed endoscopically. The bleeding model was developed by multivariate survival analysis and evaluated by Harrell's c-index. During a median follow-up of 31.4 months, 42 GI bleeds (8.3%) occurred: 42.8% in the upper GI tract, 50.0% in the lower GI tract, and 7.1% in the middle GI tract. The cumulative 5 and 10-year probability of GI bleeding was 12.6% and 18.5%, respectively. Patients who bled had a significantly higher cumulative incidence of all-cause mortality (hazard ratio 2.9, P ulcer disease, and liver cirrhosis predicted GI bleeding. The c-statistic for the new predictive model using these five factors was 0.65 (P acute GI bleeding risk based on five factors (no-proton pump inhibitor use, chronic kidney disease, chronic obstructive pulmonary disease, history of peptic ulcer disease, and liver cirrhosis), which was superior to the HAS-BLED score. © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

  19. Acute management of stroke patients taking non-vitamin K antagonist oral anticoagulants Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) Registry: Design and rationale.

    Science.gov (United States)

    Xian, Ying; Hernandez, Adrian F; Harding, Tina; Fonarow, Gregg C; Bhatt, Deepak L; Suter, Robert E; Khan, Yosef; Schwamm, Lee H; Peterson, Eric D

    2016-12-01

    Non-vitamin K antagonist oral anticoagulants (NOACs, dabigatran, rivaroxaban, apixaban, and edoxaban) have been increasingly used as alternatives to warfarin for stroke prophylaxis in patients with atrial fibrillation. Yet there is substantial lack of information on how patients on NOACs are currently treated when they have an acute ischemic stroke and the best strategies for treating intracerebral hemorrhage for those on chronic anticoagulation with warfarin or a NOAC. These are critical unmet needs for real world clinical decision making in these emergent patients. The ARAMIS Registry is a multicenter cohort study of acute stroke patients who were taking chronic anticoagulation therapy prior to admission and are admitted with either an acute ischemic stroke or intracerebral hemorrhage. Built upon the existing infrastructure of American Heart Association/American Stroke Association Get With the Guidelines Stroke, the ARAMIS Registry will enroll a total of approximately 10,000 patients (5000 with acute ischemic stroke who are taking a NOAC and 5000 with anticoagulation-related intracerebral hemorrhage who are on warfarin or a NOAC). The primary goals of the ARAMIS Registry are to provide a comprehensive picture of current treatment patterns and outcomes of acute ischemic stroke patients on NOACs, as well as anticoagulation-related intracerebral hemorrhage in patients on either warfarin or NOACs. Beyond characterizing the index hospitalization, up to 2500 patients (1250 ischemic stroke and 1250 intracerebral hemorrhage) who survive to discharge will be enrolled in an optional follow-up sub-study and interviewed at 3 and 6 months after discharge to assess longitudinal medication use, downstream care, functional status, and patient-reported outcomes. The ARAMIS Registry will document the current state of management of NOAC treated patients with acute ischemic stroke as well as contemporary care and outcome of anticoagulation-related intracerebral hemorrhage. These

  20. Emergency Coagulation Assessment During Treatment With Direct Oral Anticoagulants: Limitations and Solutions.

    Science.gov (United States)

    Ebner, Matthias; Birschmann, Ingvild; Peter, Andreas; Härtig, Florian; Spencer, Charlotte; Kuhn, Joachim; Blumenstock, Gunnar; Zuern, Christine S; Ziemann, Ulf; Poli, Sven

    2017-09-01

    In patients receiving direct oral anticoagulants (DOACs), emergency treatment like thrombolysis for acute ischemic stroke is complicated by insufficient availability of DOAC-specific coagulation tests. Conflicting recommendations have been published concerning the use of global coagulation assays for ruling out relevant DOAC-induced anticoagulation. Four hundred eighty-one samples from 96 DOAC-treated patients were tested using prothrombin time (PT), activated partial thromboplastin time (aPTT) and thrombin time (TT), DOAC-specific assays (anti-Xa activity, diluted TT), and liquid chromatography-tandem mass spectrometry. Sensitivity and specificity of test results to identify DOAC concentrations 95% specificity and a specific TT cutoff enhanced sensitivity for dabigatran to 84%. For apixaban, no cutoffs could be established. Even if highly DOAC-reactive reagents are used, normal results of global coagulation tests are not suited to guide emergency treatment: whereas normal PT and aPTT lack specificity to rule out DOAC-induced anticoagulation, the low sensitivity of normal TT excludes the majority of eligible patients from treatment. However, reagent-specific cutoffs for global coagulation tests ensure high specificity and optimize sensitivity for safe emergency decision making in rivaroxaban- and dabigatran-treated patients. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT02371044 and NCT02371070. © 2017 American Heart Association, Inc.

  1. Self management of oral anticoagulant therapy in children with congenital heart disease

    DEFF Research Database (Denmark)

    Christensen, Thomas D; Attermann, Jørn; Hjortdal, Vibeke E.

    2001-01-01

    , hypothesizing self-management of oral anticoagulation is also possible in this subset of patients. Our aim was to assess the quality of self-management. Methods: We trained 14 children aged from 2.2 to 15.6 years, with a mean age of 9.7 years, and their parents, in domiciliary analysis of the International...... Normalized Ratio and necessary adjustment of dosage of coumarin. The curriculum for training lasted for 27 weeks, and the patients and their parents were followed for a period of up to 31 months by weekly measurement of the values obtained for the International Normalized Ratio. Results: The patients were...

  2. Preadmission oral anticoagulant therapy and clinical outcome in patients hospitalised with acute stroke and atrial fibrillation

    DEFF Research Database (Denmark)

    Ottosen, Tobias Pilgaard; Svendsen, Marie Louise; Hansen, Morten Lock

    2014-01-01

    INTRODUCTION: Information about the effect of preadmission oral anticoagulant therapy (OAT) on stroke outcome in patients with atrial fibrillation (AF) is scarce. A systematic review was done of the existing data on the association between preadmission OAT and stroke outcome in patients with AF....... METHOD: We performed a systematic search in the PubMed Database, the Embase Database and the Cochrane Database of Systematic Reviews identifying 13 studies that met the inclusion criteria. RESULTS: The studies included a total of 18,523 patients with AF and admission with stroke. Of these, 1,169 had...

  3. Outpatient treatment of low-risk venous thromboembolism with monotherapy oral anticoagulation: patient quality of life outcomes and clinician acceptance

    Directory of Open Access Journals (Sweden)

    Kline JA

    2016-04-01

    Full Text Available Jeffrey A Kline,1,2 Zachary P Kahler,1,3 Daren M Beam1,2 1Department of Emergency Medicine, 2Department of Cellular and Integrative Physiology, Indiana University School of Medicine, Indianapolis, IN, 3Department of Emergency Medicine, University of South Carolina Greenville School of Medicine, Greenville, SC, USA Background: Oral monotherapy anticoagulation has facilitated home treatment of venous thromboembolism (VTE in outpatients. Objectives: The aim of this study was to measure efficacy, safety, as well as patient and physician perceptions produced by a protocol that selected VTE patients as low-risk patients by the Hestia criteria, and initiated home anticoagulation with an oral factor Xa antagonist. Methods: Patients were administered the Venous Insufficiency Epidemiological and Economic Study Quality of life/Symptoms ques­tionnaire [VEINEs QoL/Sym] and the physical component summary [PCS] from the Rand 36-Item Short Form Health Survey [SF36]. The primary outcomes were VTE recurrence and hemorrhage at 30 days. Secondary outcomes compared psychometric test scores between patients with deep vein thrombosis (DVT to those with pulmonary embolism (PE. Patient perceptions were abstracted from written comments and physician perceptions specific to PE outpatient treatment obtained from structured survey. Results: From April 2013 to September 2015, 253 patients were treated, including 67 with PE. Within 30 days, 2/ 253 patients had recurrent DVT and 2/253 had major hemor­rhage; all four had DVT at enrollment. The initial PCS scores did not differ between DVT and PE patients (37.2±13.9 and 38.0±12.1, respectively and both DVT and PE patients had similar improvement over the treatment period (42.2±12.9 and 43.4±12.7, respectively, consistent with prior literature. The most common adverse event was menorrhagia, present in 15% of women. Themes from patient-written responses reflected satisfaction with increased autonomy. Physicians’ (N=116

  4. Oral anticoagulation and antiplatelets in atrial fibrillation patients after myocardial infarction and coronary intervention.

    Science.gov (United States)

    Lamberts, Morten; Gislason, Gunnar H; Olesen, Jonas Bjerring; Kristensen, Søren Lund; Schjerning Olsen, Anne-Marie; Mikkelsen, Anders; Christensen, Christine Benn; Lip, Gregory Y H; Køber, Lars; Torp-Pedersen, Christian; Hansen, Morten Lock

    2013-09-10

    The purpose of this study was to investigate the risk of thrombosis and bleeding according to multiple antithrombotic treatment regimens in atrial fibrillation (AF) patients after myocardial infarction (MI) or percutaneous coronary intervention (PCI). The optimal antithrombotic treatment strategy is unresolved in patients with multiple indications. A total of 12,165 AF patients hospitalized with MI and/or undergoing PCI between 2001 and 2009 were identified by nationwide registries (60.7% male; mean age 75.6 years). Risk of MI/coronary death, ischemic stroke, and bleeding according to antithrombotic treatment regimen was estimated by Cox regression models. Within 1 year, MI or coronary death, ischemic stroke, and bleeding events occurred in 2,255 patients (18.5%), 680 (5.6%), and 769 (6.3%), respectively. Relative to triple therapy (oral anticoagulation [OAC] plus aspirin plus clopidogrel), no increased risk of recurrent coronary events was seen for OAC plus clopidogrel (hazard ratio [HR]: 0.69, 95% confidence interval [CI]: 0.48 to 1.00), OAC plus aspirin (HR: 0.96, 95% CI: 0.77 to 1.19), or aspirin plus clopidogrel (HR: 1.17, 95% CI: 0.96 to 1.42), but aspirin plus clopidogrel was associated with a higher risk of ischemic stroke (HR: 1.50, 95% CI: 1.03 to 2.20). Also, OAC plus aspirin and aspirin plus clopidogrel were associated with a significant increased risk of all-cause death (HR: 1.52, 95% CI: 1.17 to 1.99 and HR: 1.60, 95% CI: 1.25 to 2.05, respectively). When compared to triple therapy, bleeding risk was nonsignificantly lower for OAC plus clopidogrel (HR: 0.78, 95% CI: 0.55 to 1.12) and significantly lower for OAC plus aspirin and aspirin plus clopidogrel. In real-life AF patients with indication for multiple antithrombotic drugs after MI/PCI, OAC and clopidogrel was equal or better on both benefit and safety outcomes compared to triple therapy. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. The prevalence of oral anticoagulation in patients with atrial fibrillation in Portugal: Systematic review and meta-analysis of observational studies.

    Science.gov (United States)

    Caldeira, Daniel; Barra, Márcio; David, Cláudio; Costa, João; Ferreira, Joaquim J; Pinto, Fausto J

    2014-09-01

    Oral anticoagulation (OAC) is an effective treatment in the prevention of thromboembolic events in patients with atrial fibrillation (AF). The aim of this review was to estimate the prevalence of OAC therapy in patients with AF in Portugal. MEDLINE, the Index of Portuguese Medical Journals and SIBUL (the Bibliographic Catalog of the Integrated Library System of the University of Lisbon) were searched for Portuguese observational studies reporting the proportion of anticoagulated patients with AF. The pooled estimated prevalence of anticoagulated patients and respective 95% confidence interval (CI) were determined by means of a meta-analysis. Seven studies were included for analysis, of which four were conducted in a hospital environment and three in the general community. These studies enrolled a total of 891 patients with AF. The pooled estimated prevalence of anticoagulated patients was 40% (95% CI: 32-48%). The prevalence of OAC in Portuguese AF patients is low. There is a need to promote change in OAC prescribing habits for AF patients in Portugal, in accordance with international guidelines. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

  6. Direct oral anticoagulants and antiplatelet agents. Clinical relevance and options for laboratory testing.

    Science.gov (United States)

    Sibbing, D; Spannagl, M

    2014-01-01

    Oral anticoagulants and platelet receptor blockers are widely used in clinical practice with the aim of reducing the risk of thrombotic complications in patients with cardiovascular diseases. Their regular intake and adequate antithrombotic action is vital and this is way numerous assays have been developed for laboratory testing and monitoring of these agents. Available assays can be stratified into pharmacokinetic and pharmacodynamic assays. Such assays are increasingly used in clinical routine and their daily use is triggered by the advent of the novel direct oral anticoagulants (DOACs) as an alternative for vitamin K antagonist (VKA) treatment, which are dabigatran, rivaroxaban and apixaban, and by the advent of prasugrel or ticagrelor as an alternative for clopidogrel with regard to platelet P2Y12 receptor inhibition. In this review the most important and most commonly used laboratory assays are summarized as well as their clinical implications with the focus on DOACs as an alternative for VKAs and the different P2Y12 receptor blockers for antiplatelet treatment.

  7. Thromboembolic risk in 16 274 atrial fibrillation patients undergoing direct current cardioversion with and without oral anticoagulant therapy

    DEFF Research Database (Denmark)

    Hansen, Morten Lock; Jepsen, Rikke Malene H G; Olesen, Jonas Bjerring

    2015-01-01

    AIMS: To study the risk of thromboembolism in a nationwide cohort of atrial fibrillation patients undergoing direct current (DC) cardioversion with or without oral anticoagulant coverage. METHODS AND RESULTS: A retrospective study of 16 274 patients in Denmark discharged from hospital after a first...... therapy was 2.21; 95% CI, 0.79-6.77 and 2.40; 95% CI, 1.46-3.95 with CHA2DS2-VASc score 0-1 and CHA2DS2-VASc score 2 or more, respectively. CONCLUSION: Direct current cardioversion for atrial fibrillation without oral anticoagulation is associated with a high risk of thromboembolism. Notably, the risk...

  8. The business case for quality improvement: oral anticoagulation for atrial fibrillation.

    Science.gov (United States)

    Rose, Adam J; Berlowitz, Dan R; Ash, Arlene S; Ozonoff, Al; Hylek, Elaine M; Goldhaber-Fiebert, Jeremy D

    2011-07-01

    The potential to save money within a short time frame provides a more compelling "business case" for quality improvement than merely demonstrating cost-effectiveness. Our objective was to demonstrate the potential for cost savings from improved control in patients anticoagulated for atrial fibrillation. Our population consisted of 67 077 Veterans Health Administration patients anticoagulated for atrial fibrillation between October 1, 2006, and September 30, 2008. We simulated the number of adverse events and their associated costs and utilities, both before and after various degrees of improvement in percent time in therapeutic range (TTR). The simulation had a 2-year time horizon, and costs were calculated from the perspective of the payer. In the base-case analysis, improving TTR by 5% prevented 1114 adverse events, including 662 deaths; it gained 863 quality-adjusted life-years and saved $15.9 million compared with the status quo, not accounting for the cost of the quality improvement program. Improving TTR by 10% prevented 2087 events, gained 1606 quality-adjusted life-years, and saved $29.7 million. In sensitivity analyses, costs were most sensitive to the estimated risk of stroke and the expected stroke reduction from improved TTR. Utilities were most sensitive to the estimated risk of death and the expected mortality benefit from improved TTR. A quality improvement program to improve anticoagulation control probably would be cost-saving for the payer, even if it were only modestly effective in improving control and even without considering the value of improved health. This study demonstrates how to make a business case for a quality improvement initiative.

  9. Consistency of safety and efficacy of new oral anticoagulants across subgroups of patients with atrial fibrillation.

    Directory of Open Access Journals (Sweden)

    Jean-Christophe Lega

    Full Text Available AIMS: The well-known limitations of vitamin K antagonists (VKA led to development of new oral anticoagulants (NOAC in non-valvular atrial fibrillation (NVAF. The aim of this meta-analysis was to determine the consistency of treatment effects of NOAC irrespective of age, comorbidities, or prior VKA exposure. METHODS AND RESULTS: All randomized, controlled phase III trials comparing NOAC to VKA up to October 2012 were eligible provided their results (stroke/systemic embolism (SSE and major bleeding (MB were reported according to age (≤ or >75 years, renal function, CHADS2 score, presence of diabetes mellitus or heart failure, prior VKA use or previous cerebrovascular events. Interactions were considered significant at p <0.05. Three studies (50,578 patients were included, respectively evaluating apixaban, rivaroxaban, and dabigatran versus warfarin. A trend towards interaction with heart failure (p = 0.08 was observed with respect to SSE reduction, this being greater in patients not presenting heart failure (RR = 0.76 [0.67-0.86] than in those with heart failure (RR = 0.90 [0.78-1.04]; Significant interaction (p = 0.01 with CHADS2 score was observed, NOAC achieving a greater reduction in bleeding risk in patients with a score of 0-1 (RR 0.67 CI 0.57-0.79 than in those with a score ≥2 (RR 0.85 CI 0.74-0.98. Comparison of MB in patients with (RR 0.97 CI 0.79-1.18 and without (RR 0.76 CI 0.65-0.88 diabetes mellitus showed a similar trend (p = 0.06. No other interactions were found. All subgroups derived benefit from NOA in terms of SSE or MB reduction. CONCLUSIONS: NOAC appeared to be more effective and safer than VKA in reducing SSE or MB irrespective of patient comorbidities. Thromboembolism risk, evaluated by CHADS2 score and, to a lesser extent, diabetes mellitus modified the treatment effects of NOAC without complete loss of benefit with respect to MB reduction.

  10. Risk of bleeding and stroke with oral anticoagulation and antiplatelet therapy in patients with atrial fibrillation in Taiwan: a nationwide cohort study.

    Directory of Open Access Journals (Sweden)

    Pei-Chun Chen

    Full Text Available Data on the use of oral anticoagulation (OAC and antiplatelet therapy and the risk of bleeding and stroke amongst Asian patients with atrial fibrillation (AF are limited. We investigated the risks of bleeding and stroke with use of oral anticoagulation (OAC and antiplatelet therapy as mono- or combination therapy, in patients with AF from a Chinese nationwide cohort study.We studied a cohort of 10384 patients (57.2% men, age 67.8 ± 13.2 yrs between 1999 and 2010 from the National Health Insurance Research Database in Taiwan. Records of prescriptions were obtained during follow-up. The main outcome was a recurrent stroke during the follow-up period. Time-dependent Cox proportional hazards models were used for this analysis.We documented 1009 events for bleeding, as well as 224 hemorrhagic stroke and 1642 ischemic stroke events during a median 3.2 (interquartile range, 1.05-6.54 years' follow-up. Compared with warfarin users, patients with antiplatelet therapy had a lower risk of bleeding (adjusted relative risk [RR], 0.59, 95% confidence interval [CI], 0.49-0.71, p<0.001 whilst combination therapy had a non-statistically significant higher bleeding risk (RR, 1.33, 95%, 0.91-1.94, p = 0.20. Patients on antiplatelet monotherapy had a similar risk for ischemic stroke compared with OAC (RR 1.05, 95% CI, 0.89-1.25, p = 0.50, whilst those on combination therapy had a significantly higher risk (RR 1.90, 95% CI, 1.34-2.70, p<0.001.In a national representative cohort, antiplatelet therapy had no significant difference in ischemic stroke risk to warfarin. For bleeding, aspirin had a lower risk compared to warfarin. This may reflect poor anticoagulation control, highlighting important missed opportunities for improved stroke prevention, especially in countries where anticoagulation management is suboptimal.

  11. Management of Venous Thromboembolism in Patients with Advanced Gastrointestinal Cancers: What Is the Role of Novel Oral Anticoagulants?

    Directory of Open Access Journals (Sweden)

    Ludmila Katherine Martin

    2012-01-01

    Full Text Available Venous thromboembolism (VTE is a frequent complication of gastrointestinal cancers that increases morbidity and may impact mortality. Low-molecular-weight heparins (LMWHs and vitamin K antagonists (VKAs are standard anticoagulation options for the ambulatory gastrointestinal cancer patient with VTE, but both of these agents are challenging to use for various reasons. Novel oral anticoagulants (NOAs are new, orally available anticoagulants designed to be easier to administer with more reliable pharmacokinetics that eliminate the need for frequent monitoring of various laboratory parameters. This paper reviews the existing efficacy and safety data for the use of NOAs dabigatran etexilate, rivaroxaban, and apixaban and discusses the potential role of these agents in the management of gastrointestinal cancer-related VTE.

  12. SAMe-TT2R2 Score in the Outpatient Anticoagulation Clinic to Predict Time in Therapeutic Range and Adverse Events

    Directory of Open Access Journals (Sweden)

    Fernando Pivatto Júnior

    Full Text Available Abstract Background: The SAMe-TT2R2 score was developed to predict which patients on oral anticoagulation with vitamin K antagonists (VKAs will reach an adequate time in therapeutic range (TTR (> 65%-70%. Studies have reported a relationship between this score and the occurrence of adverse events. Objective: To describe the TTR according to the score, in addition to relating the score obtained with the occurrence of adverse events in patients with nonvalvular atrial fibrillation (AF on oral anticoagulation with VKAs. Methods: Retrospective cohort study including patients with nonvalvular AF attending an outpatient anticoagulation clinic of a tertiary hospital. Visits to the outpatient clinic and emergency, as well as hospital admissions to the institution, during 2014 were evaluated. The TTR was calculated through the Rosendaal´s method. Results: We analyzed 263 patients (median TTR, 62.5%. The low-risk group (score 0-1 had a better median TTR as compared with the high-risk group (score ≥ 2: 69.2% vs. 56.3%, p = 0.002. Similarly, the percentage of patients with TTR ≥ 60%, 65% or 70% was higher in the low-risk group (p < 0.001, p = 0.001 and p = 0.003, respectively. The high-risk group had a higher percentage of adverse events (11.2% vs. 7.2%, although not significant (p = 0.369. Conclusions: The SAMe-TT2R2 score proved to be effective to predict patients with a better TTR, but was not associated with adverse events.

  13. Spontaneous sublingual and intramural small-bowel hematoma in a patient on oral anticoagulation

    Directory of Open Access Journals (Sweden)

    Mohamed Moftah

    2012-08-01

    Full Text Available Spontaneous sublingual hematoma and intramural small bowel hematoma are rare and serious complications of anticoagulant therapy. Though previously reported individually, there has been no previous report of the same two complications occurring in a single patient. A 71-year-old Caucasian man, who was on warfarin for atrial fibrillation, presented with difficulty in swallowing due to a sublingual hematoma. He was observed in our intensive care unit, his warfarin was held and he recovered with conservative management. He represented two months later with a two day history of abdominal pain and distension. An abdominopelvic computed tomography (CT scan now showed small bowel obstruction due to intramural small bowel hematoma and haemorrhagic ascites. Again, this was treated expectantly with a good outcome. In conclusion, life threatening haemorrhagic complications of oral anticoagulant therapy can recur. Conservative treatment is successful in most cases, but an accurate diagnosis is mandatory to avoid unnecessary surgery. CT scan is the investigation of choice for the diagnosis of suspected haemorrhagic complications of over coagulation.

  14. A Study of the Management of Patients Taking Novel Oral Antiplatelet or Direct Oral Anticoagulant Medication Undergoing Dental Surgery in a Rural Setting

    Directory of Open Access Journals (Sweden)

    Steven Johnston

    2015-10-01

    Full Text Available Purpose: Novel oral antiplatelet (NOAP (prasugrel and ticagrelor and direct oral anticoagulant drugs (DOAC (dabigatran, rivaroxaban and apixaban have emerged in the last decade. This study was undertaken to determine current approaches taken to the management of patients taking these agents in dental practice in a remote and rural setting. Methods: A small retrospective study was carried out in a small island population that identified patients taking one of the above drugs. All national health service and private dental records were examined to determine the type of treatment carried out and whether drug therapy, treatment plans or actual treatment were modified as a result of NOAP or DOAC therapy. In addition other outcomes such as referral to another service for advice or treatment and any adverse bleeding events were noted. Results: 156 dental encounters for 95 patients taking one of the drugs were identified. Significant events were identified in sixteen encounters and the management of patients taking each drug type differed significantly between cases but no patients returned with troublesome post-operative bleeding. Conclusions: The approaches taken by dental surgeons in Orkney in the management of the NOAPs and DOACs varied and this is likely to be a reflection of the limited literature available.

  15. 'Ins' and 'outs' of triple therapy: Optimal antiplatelet therapy in patients on chronic oral anticoagulation who need coronary stenting.

    NARCIS (Netherlands)

    Dewilde, W.; Verheugt, F.W.A.; Breet, N.; Koolen, J.J.; Berg, J.M. ten

    2010-01-01

    Chronic oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and in patients with atrial fibrillation with CHADS2 score >1. When these patients undergo percutaneous coronary intervention with placement of a stent, there is also an indication for treatment

  16. Dynamics of vitamin K antagonist and new oral anticoagulants use in atrial fibrillation: a Danish drug utilization study

    DEFF Research Database (Denmark)

    Pottegård, Anton; Poulsen, B. K.; Larsen, Michael Due

    2014-01-01

    BackgroundDetailed data on real-life utilization of vitamin K antagonists (VKAs) and new oral anticoagulants (NOACs) in atrial fibrillation are sparse. ObjectivesTo describe the dynamics of VKA and NOAC use: that is, (i) how patients moved in and out of, as well as between, use of VKAs and NOACs...

  17. The recent clinical trials on use of the novel direct oral anticoagulants in patients with venous thromboembolism: a review

    Directory of Open Access Journals (Sweden)

    Gualtiero Palareti

    2014-10-01

    Full Text Available Venous thromboembolism (VTE, encompassing deep vein thrombosis and pulmonary embolism, requires an immediate anticoagulation, that has been carried out so far by administering a parenteral anticoagulant drug (heparin or derivatives overlapped with an oral vitamin K antagonist (VKA, more often warfarin. Several new direct oral anticoagulants (DOACs, with a mechanism of action completely different than VKA, have been developed in recent years. Recent clinical trials have investigated their use in VTE patients showing results at least equal for efficacy and safety, and sometime even better, as the standard anticoagulant treatment. There are differences in the design of the trials. In two cases the involved DOAC was administered immediately after VTE diagnosis as a single drug treatment (rivaroxaban and apixaban, whereas in the other trials (involving dabigatran and edoxaban the DOAC was administered after an initial course of approximately 7 days with heparin or derivatives. Some clinical trials have also investigated the use of DOACs for extended anticoagulant treatment after the acute phase. Aim of this article is to review the results of the currently available clinical trials that have compared the use of DOACs versus the standard of care in patients with VTE.

  18. Dabigatran: A new oral anticoagulant. Guidelines to follow in oral surgery procedures. A systematic review of the literature.

    Science.gov (United States)

    Muñoz-Corcuera, M; Ramírez-Martínez-Acitores, L; López-Pintor, R-M; Casañas-Gil, E; Hernández-Vallejo, G

    2016-11-01

    Dabigatran is a newly commercialized drug that is replacing other anticoagulants in the prevention of venous thromboembolism, stroke and systemic arterial valve embolism. It acts directly on thrombin presenting in a dynamic and predictable way, which does not require monitoring these patients. Therefore, we consider the need to assess whether their use increases the risk of bleeding involved before any dental treatment. We performed a systematic review with a bibliographic search in PubMed/Medline along with the Cochrane Library. We excluded articles dealing with all anticoagulants other than dabigatran, and works about surgical treatments in anatomical locations other than the oral cavity. We included a total of 13 papers of which 1 was a randomized clinical trial, 9 narrative literature reviews, 1 case series, 2 clinical cases and 1 expert opinion. Because we did not obtain any properly designed clinical trials, we were unable to conduct a meta-analysis. Currently, there is no consensus on the procedure to be followed in patients taking dabigatran. However, all authors agree to treat each case individually in accordance to the risk of embolism, postoperative bleeding and renal function. Also, it is necessary to perform minimally invasive interventions, and take the appropriate local anti-hemolytic measures.

  19. Adverse drug events in the oral cavity.

    Science.gov (United States)

    Yuan, Anna; Woo, Sook-Bin

    2015-01-01

    Adverse reactions to medications are common and may have a variety of clinical presentations in the oral cavity. Targeted therapies and the new biologic agents have revolutionized the treatment of cancers, autoimmune diseases, and inflammatory and rheumatologic diseases but have also been associated with adverse events in the oral cavity. Some examples include osteonecrosis, seen with not only bisphosphonates but also antiangiogenic agents, and the distinctive ulcers caused by mammalian target of rapamycin inhibitors. As newer therapeutic agents are approved, it is likely that more adverse drug events will be encountered. This review describes the most common clinical presentations of oral mucosal reactions to medications, namely, xerostomia, lichenoid reactions, ulcers, bullous disorders, pigmentation, fibrovascular hyperplasia, white lesions, dysesthesia, osteonecrosis, infection, angioedema, and malignancy. Oral health care providers should be familiar with such events, as they will encounter them in their practice. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. "Zeus" a new oral anticoagulant therapy dosing algorithm: a cohort study.

    Science.gov (United States)

    Cafolla, A; Melizzi, R; Baldacci, E; Pignoloni, P; Dragoni, F; Campanelli, M; Caraccini, R; Foà, R

    2011-10-01

    The demand for oral anticoagulant therapy (OAT) has constantly increased during the last ten years with an extended use of computer assistance. Many mathematical algorithms have been projected to suggest doses and time to next visit for patients on OAT. We designed a new algorithm: "Zeus". A "before-after" study was planned to compare the efficacy and safety of this algorithm dosing OAT with manual dosage decided by the same expert physicians according to the target of International Normalized Ratio (INR). The study analysed data of 1876 patients managed with each of the two modalities for eight months, with an interval of two years between them. The aim was to verify the increased quality of therapy by time spent in INR target and efficiency and safety of Zeus algorithm. Time in therapeutic range (TTR) was significantly (p Zeus algorithm. Copyright © 2011 Elsevier Ltd. All rights reserved.

  1. [Measurement of Prothrombin Fragment 1+2 for the Assessment of Anticoagulant Activity in Patients Treated with Warfarin or Non-vitamin K Antagonist Oral Anticoagulant].

    Science.gov (United States)

    Tomoda, Masanori; Yasaka, Masahiro; Nakanishi, Yasuyuki; Takaguchi, Goh; Nakamura, Asako; Gotoh, Seiji; Kuwashiro, Takahiro; Okada, Yasushi

    2017-05-01

    [Background and purpose] Prothrombin fragment 1+2 (PF1+2) is a sensitive marker for blood coagulation system. In order to evaluate anticoagulant activity in patients treated with warfarin or non-vitamin K antagonist oral anticoagulant (NOAC), we measured plasma levels of PF1+2 and evaluated anticoagulant activity by each anticoagulant agent. [Methods] Subjects were 28 patients, 17 men and 11 women, 77±6 year old, with oral anticoagulant therapy for secondary prevention of stroke. We measured plasma levels of PF1+2 in 70 times in 7 patients treated with warfarin, and 154 times in 27 patients treated with NOAC. PT-INR was simultaneously measured in patients treated with warfarin. [Results] In warfarin treatment groups, PT-INR values were median 1.96 (IQR 1.8-2.1) and PF1+2 levels were median 111 pmol/l (IQR 95-141). All PF1+2 levels were below the upper limit of normal range, but 12 values (17%) of them in 5 patients were below the lower limit of normal range. 8 of the 12 values were at PT-INR below 2.5, and 1 of whom developed intracerebral hemorrhage. Plasma levels of PF1+2 in patients treated with dabigatran 150mg BID, dabigatran 110mg BID, rivaroxaban 15mg QD, rivaroxaban 10mg QD, apixaban 5mg BID, apixaban 2.5mg BID, and edxaban 30mg QD were median 116 pmol/l (IQR 99-136), 132 pmol/l (IQR 99-162), 109 pmol/l (IQR 100-125), 133 pmol/l (IQR 100-177), 88 pmol/l (IQR 76-102), 148 pmol/l (IQR 93-167), 221 pmol/l (IQR 208-234). They were all above the lower limit of the normal range, 3 of which were above the upper limit of the normal range. Excessive suppression of thrombin production was more frequently seen in warfarin treatment than in NOAC treatment (p<0.05). [Conclusion] In warfarin treatment, thrombin production was suppressed excessively in 17%, although it was not in NOAC treatment. (Received September 21, 2016; Accepted December 26, 2016; Published May 1, 2017).

  2. How prepared are pharmacists to support atrial fibrillation patients in adhering to newly prescribed oral anticoagulants?

    Science.gov (United States)

    Hamedi, Nadya; da Costa, Filipa Alves; Horne, Robert; Levitan, Michael; Begley, Amanda; Antoniou, Sotiris

    2017-12-01

    Background The New Medicines Service (NMS) was implemented in the United Kingdom in 2011 and first evaluated in 2014, showing 10% increase on adherence. Objective To assess community pharmacists' current practice, knowledge and confidence in supporting patients' adherence as part of the NMS for patients on Oral Anti-Coagulants (OACs) for stroke prevention in Atrial Fibrillation. Setting Community pharmacists in London. Method An online cross-sectional survey was sent to pharmacists from their Local Pharmaceutical Committees and advertised by the Royal Pharmaceutical Society. Analysis was undertaken in SPSs v23 considering a confidence level of 95%. Main outcome measures pharmacists reported confidence of providing the NMS on OACs; training needs and skills for supporting adherence. Results A total of 257 valid responses were analysed (6.8% response rate; {Cronbach's α = 0.676-0.892}). Data indicates that over a 2-month period, 25% of pharmacists had completed ≥6 NMS consultations for all OACs, of which 11% for new oral anticoagulants (NOACs). The key priorities in counselling items during the NMS consultation were to discuss actions to take when bleeding occurs, followed by supporting adherence. Pharmacists were more confident in their knowledge, skills and access to resources for Vitamin-K Antagonists (VKAs) than for NOACs (p < 0.005). Results also highlight pharmacists' unfamiliarity with alert cards, lower for NOACs than VKAs (p < 0.001), albeit perceived as critically important. Half the sample mentioned to use the British National Formulary as information resource. Conclusion Results suggest the provision of NMS for NOACs is low. Supporting pharmacists with tailored education and adherence support might foster dissemination.

  3. Battle of oral anticoagulants in the field of atrial fibrillation scrutinized from a clinical practice (the real world perspective

    Directory of Open Access Journals (Sweden)

    Vidal Hector O

    2011-07-01

    Full Text Available Abstract Warfarin has a long history of benefit and has become the gold standard medication for the prevention of ischemic stroke in patients with atrial fibrillation. Nevertheless, it is far from perfect and there is no doubt that new drugs must be found to replace warfarin. The new oral anticoagulants that are on the market or awaiting approval or under research offer some benefits but not enough to replace warfarin until results of additional studies can show an adequate balance between effectiveness/safety and cost/benefit. There are several issues concerning the new oral anticoagulants. It is essential that the effect of any anticoagulant can be measured in plasma. But to date, there is no test to assess the effect or therapeutic range for the new oral anticoagulants. There is no antidote to neutralize the action of the new drugs in cases of bleeding or when acute surgical intervention is necessary. Dabigatran requires dose adjustment in patients with moderate renal impairment and is contraindicated in patients with severe renal failure. Rivaroxaban should be used with caution in patients with severe renal impairment. Apixaban excretion is also partly dependent on renal function, although the impact of renal insufficiency has not yet been determined. How anticoagulant bridging can be done before surgery has not yet been established. In conclusion, although thousands of patients have been treated in phase III studies, additional data are necessary before conclusions can be drawn on the potential for these new anticoagulant drugs to replace warfarin in patients with atrial fibrillation.

  4. 'Ins' and 'outs' of triple therapy: Optimal antiplatelet therapy in patients on chronic oral anticoagulation who need coronary stenting.

    Science.gov (United States)

    Dewilde, W; Verheugt, F W A; Breet, N; Koolen, J J; Ten Berg, J M

    2010-09-01

    Chronic oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and in patients with atrial fibrillation with CHADS2 score >1. When these patients undergo percutaneous coronary intervention with placement of a stent, there is also an indication for treatment with aspirin and clopidogrel. Unfortunately, triple therapy is known to increase the bleeding risk. For this group of patients, the bottom line is to find the ideal therapy in patients with indications for both chronic anticoagulation therapy and percutaneous intervention to prevent thromboembolic complications such as stent thrombosis without increasing the risk of bleeding. (Neth Heart J 2010;18:444-50.).

  5. Vitamin K antagonists: relative strengths and weaknesses vs. direct oral anticoagulants for stroke prevention in patients with atrial fibrillation.

    Science.gov (United States)

    Zirlik, Andreas; Bode, Christoph

    2017-04-01

    Vitamin K antagonists (VKAs) have been the mainstay of anticoagulation therapy for more than 50 years. VKAs are mainly used for the prevention of stroke in patients with atrial fibrillation (AF) and the treatment and secondary prevention of venous thromboembolism. In the past 5 years, four new agents-the direct factor Xa inhibitors apixaban, edoxaban and rivaroxaban and the direct thrombin inhibitor dabigatran [collectively known as direct oral anticoagulants (DOACs) or non-VKA oral anticoagulants]-have been approved for these and other indications. Despite these new treatment options, the VKA warfarin currently remains the most frequently prescribed oral anticoagulant. The availability of DOACs provides an alternative management option for patients with AF, especially when the treating physician is hesitant to prescribe a VKA owing to associated limitations, such as food and drug interactions, and concerns about bleeding complications. Currently available real-world evidence shows that DOACs have similar or improved effectiveness and safety outcomes compared with warfarin. Treatment decisions on which DOAC is best suited for which patient to maximize safety and effectiveness should take into account not only clinically relevant patient characteristics but also patient preference. This article reviews and highlights real and perceived implications of VKAs for the prevention of stroke in patients with non-valvular AF, with specific reference to their strengths and weaknesses compared with DOACs.

  6. Oral anticoagulants in coronary heart disease (Section IV). Position paper of the ESC Working Group on Thrombosis - Task Force on Anticoagulants in Heart Disease.

    Science.gov (United States)

    De Caterina, Raffaele; Husted, Steen; Wallentin, Lars; Andreotti, Felicita; Arnesen, Harald; Bachmann, Fedor; Baigent, Colin; Collet, Jean-Philippe; Halvorsen, Sigrun; Huber, Kurt; Jespersen, Jørgen; Kristensen, Steen Dalby; Lip, Gregory Y H; Morais, João; Rasmussen, Lars Hvilsted; Ricci, Fabrizio; Sibbing, Dirk; Siegbahn, Agneta; Storey, Robert F; Ten Berg, Jurriën; Verheugt, Freek W A; Weitz, Jeffrey I

    2016-04-01

    Until recently, vitamin K antagonists (VKAs) were the only available oral anticoagulants evaluated for long-term treatment of patients with coronary heart disease (CHD), particularly after an acute coronary syndrome (ACS). Despite efficacy in this setting, VKAs are rarely used because they are cumbersome to administer. Instead, the more readily manageable antiplatelet agents are the mainstay of prevention in ACS patients. This situation has the potential to change with the introduction of non-VKA oral anticoagulants (NOACs), which are easier to administer than VKAs because they can be given in fixed doses without routine coagulation monitoring. The NOACs include dabigatran, which inhibits thrombin, and apixaban, rivaroxaban and edoxaban, which inhibit factor Xa. Apixaban and rivaroxaban were evaluated in phase III trials for prevention of recurrent ischaemia in ACS patients, most of whom were also receiving dual antiplatelet therapy with aspirin and clopidogrel. Although at the doses tested rivaroxaban was effective and apixaban was not, both agents increased major bleeding. The role for the NOACs in ACS management, although promising, is therefore complicated, because it is uncertain how they compare with newer antiplatelet agents, such as prasugrel, ticagrelor or vorapaxar, and because their safety in combination with these other drugs is unknown. Ongoing studies are also now evaluating the use of NOACs in non-valvular atrial fibrillation patients, where their role is established, with coexistent ACS or coronary stenting. Focusing on CHD, we review the results of clinical trials with the NOACs and provide a perspective on their future incorporation into clinical practice.

  7. Oral anticoagulation with vitamin K inhibitors and determinants of successful self-management in primary care.

    Science.gov (United States)

    Tamayo Aguirre, E; Galo-Anza, A; Dorronsoro-Barandiaran, O; Del Burgo, E Uranga-Saez; Ostiza Irigoyen, A; Garcia-Carro, A; Lopez-Fernandez, I; Colera, N; Saez-Garbayo, P; Tamayo-Uria, I

    2016-09-13

    Self-management may be an option to monitor oral anticoagulant therapy in health systems, but before recommending it, we need to assess patients' ability to take on this task. The purpose of the study was to describe patients' ability to self-manage and associated factors. This was a 3-year prospective quasi-experimental study with a control group. Overall, 333 patients on anticoagulant therapy from seven primary care health centres of the Basque Health Service were included in the intervention group and followed up for 6 months after the intervention, assessing their ability to self-test and self-manage. The intervention consisted of a patient training programme, providing detailed information on their condition and its treatment, and practical training in how to use a portable blood coagulation monitor and adjust their anticoagulant dose. Comparisons were made with a control group (333 patients receiving OAT under usual care from the same seven health centres). Outcome variables were ability to self-manage, quality of the outcome (in terms of time in therapeutic range), and quality of life in the intervention group, and general patient characteristics (age and sex), clinical variables (reason for OAT, INR range), and quality of the outcome (in terms of percentage of INR measurements in range and complications) in both groups. Overall, 26.13 % of patients invited to participate in the intervention agreed. Of these, 99 % successfully learned to self-manage their OAT. Just 4.2 % did not complete the follow-up, in all cases for reasons unrelated to self-management, and 4.5 % required additional learning support. Outcomes were better than under usual care in terms of percentage of INR measurements in range (12 %), rate of complications (4 %) and quality of life (9.2 %). Patients were only followed-up period for 6 months and the study was conducted in a single health organization. Though patients eligible to participate were selected randomly, they were not randomly

  8. Direct oral anticoagulants and digestive bleeding: therapeutic management and preventive measures.

    Science.gov (United States)

    Deutsch, David; Boustière, Christian; Ferrari, Emile; Albaladejo, Pierre; Morange, Pierre-Emmanuel; Benamouzig, Robert

    2017-06-01

    The use of direct oral anticoagulants (DOACs) was an important step forward in the management of atrial fibrillation and venous thromboembolism (VTE). The DOACs, anti-IIa for dabigatran and anti-Xa for rivaroxaban, apixaban and edoxaban, all have a rapid onset of action and a short half life. There is no need for routine hemostasis testing for treatment monitoring of a DOAC. Compared with vitamin K antagonists (VKAs), DOACs may increase the risk of gastrointestinal bleeding (relative risk 1.25). Withholding the DOAC treatment, evaluating the time of the last intake and estimating the patient's renal function are the first steps in the management of gastrointestinal bleeding. For patients without impaired renal function, achieving low coagulation takes around 24 h after the last intake of a DOAC. The use of DOAC antagonists will be helpful in controlling bleeding in the most severe and urgent situations. Idarucizumab is available for clinical use for dabigatran and andexanet is currently being reviewed by drug agencies for rivaroxaban, apixaban and edoxaban. It is important to assess the bleeding risk associated with the planned procedure, and the patient's renal function before withholding DOAC therapy for a scheduled intervention. It is mandatory to strengthen the local hemostasis strategies in DOAC-treated patients undergoing a therapeutic endoscopic procedure. Resuming or not resuming anticoagulation with a DOAC after bleeding or a risky procedure depends on the thrombotic and bleeding risk as well as the procedure involved. This discussion should always involve the cardiologist and decisions should be taken by a pluridisciplinary team.

  9. Managing venous thromboembolism in Asia: winds of change in the era of new oral anticoagulants.

    Science.gov (United States)

    Cohen, Alexander; Chiu, Kuan Ming; Park, Kihyuk; Jeyaindran, Sinnadurai; Tambunan, Karmel L; Ward, Christopher; Wong, Raymond; Yoon, Sung-Soo

    2012-09-01

    Despite advances in the management of venous thromboembolism (VTE), treatment of many patients worldwide, especially in Asia, remains inadequate and/or discordant with prevailing guidelines. Although epidemiological studies consistently report lower incidences of VTE in Asians than Caucasians, VTE rates in Asia have probably been gravely underestimated, partly due to comparatively lesser ascertainment. It is becoming evident that Asians are at much higher risk of VTE than was hitherto supposed. Nevertheless, VTE risk-assessment is not routine in Asia and thromboprophylaxis rates are much lower than in Western nations. It is important to base decisions about anticoagulation on individual circumstances and weigh the potential benefits and risks. The conventional VTE management paradigm is not ideal. New oral anticoagulants offer advantages over current modalities that may help to streamline patient care and reduce healthcare costs. Initially, they will be mainly used in uncomplicated cases and, in the absence of clear differences in efficacy or safety, convenience, tolerability/adherence and cost will determine treatment choice. There is clear scope to improve VTE prevention and treatment in Asia. Key priorities are raising awareness of best practice and properly implementing guidelines. Uncertainty about the burden of VTE and concern about bleeding are barriers. High-quality Asian epidemiological data are needed to guide healthcare policy and evidence-based practice. More data on the occurrence and management of bleeding complications in Asian patients are also required. Meanwhile, physicians should remain vigilant and strive to act early, decisively and appropriately to diagnose and treat VTE, particularly in patients at high risk. Copyright © 2012 Elsevier Ltd. All rights reserved.

  10. Characteristics of Symptomatic Intracranial Hemorrhage in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulant Therapy.

    Directory of Open Access Journals (Sweden)

    Hisanao Akiyama

    Full Text Available The first non-vitamin K antagonist oral anticoagulant (NOAC introduced to the market in Japan was dabigatran in March 2011, and three more NOACs, rivaroxaban, apixaban, and edoxaban, have since become available. Randomized controlled trials of NOACs have revealed that intracranial hemorrhage (ICH occurs less frequently with NOACs compared with warfarin. However, the absolute incidence of ICH associated with NOACs has increased with greater use of these anticoagulants, and we wanted to explore the incidence, clinical characteristics, and treatment course of patients with NOACs-associated ICH.We retrospectively analyzed the characteristics of symptomatic ICH patients receiving NOACs between March 2011 and September 2014.ICH occurred in 6 patients (5 men, 1 woman; mean ± SD age, 72.8 ± 3.2 years. Mean time to onset was 146.2 ± 111.5 days after starting NOACs. Five patients received rivaroxaban and 1 patient received apixaban. None received dabigatran or edoxaban. Notably, no hematoma expansion was observed within 24 h of onset in the absence of infusion of fresh frozen plasma, activated prothrombin complex concentrate, recombinant activated factor VIIa or hemodialysis. When NOAC therapy was initiated, mean HAS-BLED and PANWARDS scores were 1.5 ± 0.5 and 39.5 ± 7.7, respectively. Mean systolic blood pressure was 137.8 ± 15.9 mmHg within 1 month before spontaneous ICH onset.Six symptomatic ICHs occurred early in NOAC therapy but hematoma volume was small and did not expand in the absence of infusion of reversal agents or hemodialysis. The occurrence of ICH during NOAC therapy is possible even when there is acceptable mean systolic blood pressure control (137.8 ± 15.9 mmHg and HAS-BLED score ≤ 2. Even stricter blood pressure lowering and control within the acceptable range may be advisable to prevent ICH during NOAC therapy.

  11. Management recommendations for invasive dental treatment in patients using oral antithrombotic medication, including novel oral anticoagulants

    NARCIS (Netherlands)

    van Diermen, D.E.; van der Waal, I.; Hoogstraten, J.

    2013-01-01

    Objective The aims were (1) to search the scientific literature from 2007 to 2012 for guidelines and new studies on the dental management of patients using oral antithrombotic medication; (2) to summarize the articles' evidence and recommendations; and (3) to propose an updated clinical practice

  12. Incidence of a first thromboembolic event in carriers of isolated lupus anticoagulant.

    Science.gov (United States)

    Pengo, Vittorio; Testa, Sophie; Martinelli, Ida; Ghirarduzzi, Angelo; Legnani, Cristina; Gresele, Paolo; Passamonti, Serena M; Bison, Elisa; Denas, Gentian; Jose, Seena Padayattil; Banzato, Alessandra; Ruffatti, Amelia

    2015-01-01

    Among the so called antiphospholipid (aPL) antibodies Lupus Anticoagulant (LAC) is considered the strongest risk factor for thromboembolic events. In individuals without a previous thromboembolic event (carriers), LAC is a risk factor when associated with the presence of anticardiolipin (aCL) and aβ2-Glycoprotein I (aβ2GPI) antibodies. On the other hand, data on carriers of isolated LAC positivity are sparse and inconclusive. The aim of this study was to prospectively determine the incidence of thrombosis in a cohort of carriers of isolated LAC positivity. One-hundred seventy-nine carriers of LAC confirmed twelve weeks apart and in a reference laboratory were studied. During a total follow up of 552 person-years, there were seven thromboembolic events (1.3% person-y). All the seven patients had at least one adjunctive major risk factor for thrombosis. The cumulative incidence of thromboembolic events was 3.1% (95% CI 0.6-5.6) after 2years, and 5.9% (95% CI 1.2-10.6) after 5 and 10years. On a multivariate regression analysis considering age, sex, autoimmune disease, risk factors for arterial and venous thrombosis, use of aspirin, only age was found to be an independent predictor of thromboembolic events (HR=1.1, 95% CI 1.0-1.2, p=0.02). These data might be relevant in clinical practice and underline the importance of differentiating LAC carriers in terms of isolated positivity or positivity associated with the presence of antibodies to aCL and β2-glycoprotein I. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. Tratamento da superdosagem de anticoagulantes orais Reversal of excessive oral anticoagulation

    Directory of Open Access Journals (Sweden)

    Dayse Maria Lourenço

    1998-01-01

    Full Text Available OBJETIVO: Verificar a resposta de 73 pacientes com superdosagem de droga anti-vitamina K (AVK a 3 esquemas de tratamento. MÉTODOS: Os 73 pacientes foram avaliados em 94 ocasiões e divididos em 3 grupos: grupo A (N=32 , suspensão do AVK por 2 dias e introdução de dose menor; grupo B (N=37, suspensão do AVK e reavaliação em 4 dias; grupo C (N=25, vitamina K por via oral. A razão normalizada internacional (RNI final foi considerada adequada quando entre 2,0 e 4,0. RESULTADOS: Não houve diferença entre os tratamentos (chi²=2,352, p=0,671 para 61 pacientes com RNI inicial 8. Cinco dos 7 pacientes do grupo B que continuaram com superdosagem tinham RNI PURPOSE: To evaluate the response of 73 patients with antivitamin K (AVK overdose to 3 different therapeutic regimens. METHODS: Seventy three patients were evaluated in 94 occasions: group A (N=32, consisted of drug withdrawal for 2 days followed by reduced dosage; group B (N=37, drug withdrawal and reassessment within 4 days; group C (N=25, oral administration of vitamin K. Therapeutic range was set between INR-values of 2 and 4. RESULTS: Reversal regimens did not result in differences among 61 patients who had initial INR 4, but 5 of them were bellow 4.5, without increased bleeding risk. There were 10 patients in group C bellow therapeutic range, 6 of them with INR < 1.6, with risk of thromboembolism. Thirteen patients bled, but none required transfusion. CONCLUSION: Reversal of excessive oral anticoagulation can be safely performed by initial withdrawal of the drug, followed by lower doses. Vitamin K administration may lead to INR bellow the therapeutic range. This should be reserved for patients with high INR or in the presence of bleeding.

  14. Two monitoring methods of oral anticoagulant therapy in patients with mechanical heart valve prothesis: a meta-analysis.

    Science.gov (United States)

    Xu, Zhe; Wang, Zhiping; Ou, Jingsong; Xu, Yingqi; Yang, Song; Zhang, Xi

    2012-01-01

    Oral anticoagulant therapy (OAT) with warfarin has become the standard therapy for the patients with mechanical heart valve prothesis. The monitoring method of self-monitoring or self-management was promising to optimize the use of warfarin, but most of previous studies have included patients with various indications of OAT, which made it difficult to extrapolate the results to the specific patient population with mechanical heart valve prostheses. This study was intended to evaluate the new and traditional monitoring methods in patients with mechanical heart valve prostheses. Relevant literature finished before Dec. 2010 were searched through a number of digital databases. And then they were pooled by RevMan 4.2 and R 2.13.0 in three fields: rate within the target range, test frequency and occurrence rate of poor events. Five randomized control trials with a total of 2,219 patients were identified. Pooled estimates showed reductions in thromboembolic events (OR 0.52, 95% CI 0.35-0.77; P = 0.0012) and all-cause mortality (OR 0.50, 95% CI 0.29-0.86; P = 0.0115). No difference was noted in major and minor haemorrhage. All trials reported improvements in the mean proportion of international normalized ratios in range. Self-monitoring and self-management can improve the quality of OAT in the patients with mechanical heart valve prostheses. The patients spend more time within the therapeutic range resulting in decreases in thromboembolic events and mortality, with no increase in haemorrhage. However, self-monitoring and self-management was not feasible for all patients, and require identification and education of suitable candidates. The success of self-monitoring and self-management method depends on consistent, regular, and frequent testing.

  15. Financial Impact of Direct-Acting Oral Anticoagulants in Medicaid: Budgetary Assessment Based on Number Needed to Treat.

    Science.gov (United States)

    Fairman, Kathleen A; Davis, Lindsay E; Kruse, Courtney R; Sclar, David A

    2017-04-01

    Faced with rising healthcare costs, state Medicaid programs need short-term, easily calculated budgetary estimates for new drugs, accounting for medical cost offsets due to clinical advantages. To estimate the budgetary impact of direct-acting oral anticoagulants (DOACs) compared with warfarin, an older, lower-cost vitamin K antagonist, on 12-month Medicaid expenditures for nonvalvular atrial fibrillation (NVAF) using number needed to treat (NNT). Medicaid utilization files, 2009 through second quarter 2015, were used to estimate OAC cost accounting for generic/brand statutory minimum (13/23%) and assumed maximum (13/50%) manufacturer rebates. NNTs were calculated from clinical trial reports to estimate avoided medical events for a hypothetical population of 500,000 enrollees (approximate NVAF prevalence × Medicaid enrollment) under two DOAC market share scenarios: 2015 actual and 50% increase. Medical service costs were based on published sources. Costs were inflation-adjusted (2015 US$). From 2009-2015, OAC reimbursement per claim increased by 173 and 279% under maximum and minimum rebate scenarios, respectively, while DOAC market share increased from 0 to 21%. Compared with a warfarin-only counterfactual, counts of ischemic strokes, intracranial hemorrhages, and systemic embolisms declined by 36, 280, and 111, respectively; counts of gastrointestinal hemorrhages increased by 794. Avoided events and reduced monitoring, respectively, offset 3-5% and 15-24% of increased drug cost. Net of offsets, DOAC-related cost increases were US$258-US$464 per patient per year (PPPY) in 2015 and US$309-US$579 PPPY after market share increase. Avoided medical events offset a small portion of DOAC-related drug cost increase. NNT-based calculations provide a transparent source of budgetary-impact information for new medications.

  16. Interpreting the quality of health care database studies on the comparative effectiveness of oral anticoagulants in routine care

    Directory of Open Access Journals (Sweden)

    Schneeweiss S

    2013-09-01

    Full Text Available Sebastian Schneeweiss, Krista F Huybrechts, Joshua J Gagne Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA Background: Dabigatran, an oral direct thrombin inhibitor, has now been available for 2 years in the US for the prevention of stroke in patients with nonvalvular atrial fibrillation, and direct Xa inhibitors are also starting to enter the market. Studies examining the effects of new oral anticoagulants in health care databases are beginning to emerge. The purpose of this study was to describe the validity of early published observational studies on the comparative safety and effectiveness of new oral anticoagulants in patients with atrial fibrillation. Methods: We identified published nonrandomized post-marketing studies (articles or conference abstracts or posters and critically appraised their internal validity, with a particular focus on their ability to control confounding and other biases. Results: Two full-length journal articles, three conference posters, two conference presentation abstracts, and a US Food and Drug Administration analysis form the basis of the early comparative effectiveness and safety experience with new oral anticoagulants. Some published studies exhibit substantial biases and have insufficient precision for several important endpoints. Several studies suffer from biases arising from comparing ongoing users of the older drug, warfarin, who seem to tolerate it, to initiators of the new treatment who may have switched from warfarin or have had no prior experience with anticoagulants. Analyses tended to not adjust or not adjust adequately for confounding, and unsound propensity score application was also observed. Several studies introduced selection bias by excluding patients who died during follow-up and by restricting the study population to those with continuous database enrollment following cohort entry. We

  17. Efficacy and Safety of Triple Therapy and Dual Therapy With Direct Oral Anticoagulants Compared to Warfarin.

    Science.gov (United States)

    Amano, Hideo; Saito, Daiga; Yabe, Takayuki; Okubo, Ryo; Toda, Mikihito; Ikeda, Takanori

    2017-08-03

    The efficacy and safety of direct oral anticoagulants (DOAC) with antiplatelet therapy compared to warfarin are unclear. The subjects were 280 patients who received antiplatelet therapy with oral anticoagulation (OAC) for the treatment of or protection from thromboembolism between January 2012 and September 2015. Among the 280 subjects, 79 (28.2%) received dual therapy (OAC plus aspirin or P2Y12 inhibitor) with DOAC, 75 (26.8%) dual therapy with warfarin, 46 (16.4%) triple therapy (OAC plus aspirin and P2Y12 inhibitor) with DOAC, and 80 (28.6%) triple therapy with warfarin.Compared to triple therapy with warfarin, triple therapy with DOAC had slightly lower bleeding (3.5 versus 12.0/100 persons-years, HR: 0.24, 95%CI: 0.03 to 1.96, P = 0.183), and similar benefit outcomes (cardiac death, acute myocardial infarction or stroke) and thromboembolism (7.0 versus 10.5, HR: 0.53, 95%CI: 0.10 to 2.75, P = 0.453; 7.0 versus 7.5, HR: 0.96, 95%CI: 0.18 to 5.22, P = 0.964, respectively). Compared to dual therapy with warfarin, dual therapy with DOAC had slightly lower bleeding (3.0 versus 8.4, HR: 0.38, 95%CI: 0.07 to 2.18, P = 0.279), and similar benefit outcomes and thromboembolism (4.6 versus 4.2, HR: 1.66, 95%CI: 0.30 to 9.25, P = 0.565; 4.6 versus 1.4, HR: 3.11, 95%CI: 0.23 to 42.84, P = 0.397, respectively). Bleeding mainly occurred after 3 months (16/17, 94.1%).Triple therapy and dual therapy with DOAC were not inferior to triple therapy and dual therapy with warfarin in terms of major bleeding, benefit outcomes, and thromboembolism. Bleeding mainly occurred in the late phase.

  18. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention : an open-label, randomised, controlled trial

    NARCIS (Netherlands)

    Dewilde, Willem J. M.; Oirbans, Tom; Verheugt, Freek W. A.; Kelder, Johannes C.; De Smet, Bart J. G. L.; Herrman, Jean-Paul; Adriaenssens, Tom; Vrolix, Mathias; Heestermans, Antonius A. C. M.; Vis, Marije M.; Tijsen, Jan G. P.; van 't Hof, Arnoud W.; ten Berg, Jurrien M.

    2013-01-01

    Background If percutaneous coronary intervention (PCI) is required in patients taking oral anticoagulants, antiplatelet therapy with aspirin and clopidogrel is indicated, but such triple therapy increases the risk of serious bleeding. We investigated the safety and efficacy of clopidogrel alone

  19. Appropriateness of Oral Anticoagulants for the Long-Term Treatment of Atrial Fibrillation in Older People: Results of an Evidence-Based Review and International Consensus Validation Process (OAC-FORTA 2016)

    NARCIS (Netherlands)

    Wehling, M.; Collins, R.; Gil, V.M.; Hanon, O.; Hardt, R.; Hoffmeister, M.; Monteiro, P.; Quinn, T.J.; Ropers, D.; Sergi, G.; Verheugt, F.W.A.

    2017-01-01

    BACKGROUND: Age appropriateness of anticoagulants for stroke prevention in atrial fibrillation is uncertain. OBJECTIVE: To review oral anticoagulants for the treatment of atrial fibrillation in older (age >65 years) people and to classify appropriate and inappropriate drugs based on efficacy,

  20. Monitoring strategies for patients treated with the new oral anticoagulants and the need for laboratory evaluation of hemostasis

    Directory of Open Access Journals (Sweden)

    Andrea Fontanella

    2013-12-01

    Full Text Available New oral anticoagulants that directly inhibit Factor IIa (dabigatran or Factor Xa (rivaroxaban, apixaban are currently available for prevention of venous thromboembolism (VTE after orthopedic surgery, treatment of acute VTE, and prevention of arterial thromboembolism in non-valvular atrial fibrillation. These agents offer advantages over vitamin K antagonists including rapid onset, shorter half-lives, fewer drug interactions, and the lack of a need for routine monitoring. The fact that monitoring is not required should not, however, lead to lack of surveillance or a fire and forget medicine approach because there are several medical conditions that require careful clinical surveillance and, sometimes, laboratory monitoring. The main situations that require close monitoring are major bleeding, assessment of compliance (in particular during comorbidities other than vascular disease, e.g. dementia, overdose, sudden or progressive renal dysfunction, extreme body weight, concomitant use of other drugs that may induce impairment of new oral anticoagulants, need for urgent surgery.

  1. Psychological effects of treatment with new oral anticoagulants in elderly patients with atrial fibrillation: a preliminary report.

    Science.gov (United States)

    Fumagalli, Stefano; Cardini, Francesca; Roberts, Anna T; Boni, Serena; Gabbai, Debbie; Calvani, Silvia; Casalone Rinaldi, Marta; Manetti, Stefania; Tarantini, Francesca; Marchionni, Niccolò

    2015-02-01

    Atrial fibrillation (AF) is the most common arrhythmia in elderly people, yet oral anticoagulation is underused in the aged. We tried to determine whether new oral anticoagulants (NOA) have greater psychological tolerability than warfarin. Age-, gender-matched groups of AF patients receiving NOA (N = 15) or warfarin (N = 15) were assessed with the Anti-Clot Treatment Scale (ACTS) and the Perceived Stress Scale (PSS). Patients were old (81 ± 9 years). NOA group showed greater psychological satisfaction, with lower therapy-related burden (ACTS burdens: 16.3 ± 4.5 vs. 32.9 ± 10.2, p psychological impact compared with warfarin in elderly patients.

  2. Good quality of oral anticoagulation treatment in general practice using international normalised ratio point of care testing

    DEFF Research Database (Denmark)

    Løkkegaard, Thomas; Pedersen, Tina Heidi; Lind, Bent

    2015-01-01

    INTRODUCTION: Oral anticoagulation treatment (OACT) with warfarin is common in general practice. Increasingly, international normalised ratio (INR) point of care testing (POCT) is being used to manage patients. The aim of this study was to describe and analyse the quality of OACT with warfarin in...... practices using INR POCT in the management of patients in warfarin treatment provided good quality of care. Sampling interval and diagnostic coding were significantly correlated with treatment quality.......INTRODUCTION: Oral anticoagulation treatment (OACT) with warfarin is common in general practice. Increasingly, international normalised ratio (INR) point of care testing (POCT) is being used to manage patients. The aim of this study was to describe and analyse the quality of OACT with warfarin...

  3. Renal function and risk of stroke and bleeding in patients undergoing catheter ablation for atrial fibrillation: Comparison between uninterrupted direct oral anticoagulants and warfarin administration.

    Science.gov (United States)

    Yanagisawa, Satoshi; Inden, Yasuya; Fujii, Aya; Ando, Monami; Funabiki, Junya; Murase, Yosuke; Takenaka, Masaki; Otake, Noriaki; Ikai, Yoshihiro; Sakamoto, Yusuke; Shibata, Rei; Murohara, Toyoaki

    2018-03-01

    The effect of uninterrupted oral anticoagulant use in patients with chronic kidney disease (CKD) during catheter ablation for atrial fibrillation (AF) is not fully understood. The present study aimed to evaluate the safety and efficacy of periprocedural uninterrupted direct oral anticoagulant (DOAC) use compared with those of uninterrupted warfarin use in patients undergoing catheter ablation for AF stratified by various renal function groups. A total of 2091 patients were retrospectively included in this study. The study population was divided into 4 groups: creatinine clearance level ≥80 mL/min (n = 1086), 50-79 mL/min (n = 774), 15-49 mL/min (n = 209), and <15 mL/min (n = 22). We investigated periprocedural complications and compared them between uninterrupted DOAC and warfarin groups. There was no significant difference in thromboembolic events among the 4 groups (0.6%, 0.6%, 1.0%, and 0%, respectively; P = .792). However, major bleeding events (0.9%, 1.4%, 4.8%, and 4.5%; P < .001) and minor bleeding events (4.1%, 6.1%, 11.5%, and 13.6%; P < .001) primarily occurred in patients with CKD. The rate of periprocedural complications in the DOAC group was similar to that in the warfarin group for each renal function category. Adverse events did not differ after adjustment using propensity score-matched analysis. Multivariate analysis showed that lower body weight, antiplatelet drug use, initial ablation session, and CKD were independent predictors of adverse events. The periprocedural bleeding risk was increased in patients with CKD. Uninterrupted DOAC and warfarin administration during catheter ablation for AF in patients with CKD is feasible and effective. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  4. Clinical Significance of Hematuria in Atrial Fibrillation With Oral Anticoagulation Therapy.

    Science.gov (United States)

    Yu, Hee Tae; Kim, Tae-Hoon; Uhm, Jae-Sun; Kim, Jong-Youn; Pak, Hui-Nam; Lee, Moon-Hyoung; Joung, Boyoung

    2017-01-25

    Hematuria is a common and important complication in atrial fibrillation (AF) patients on oral anticoagulation therapy (OAT). This study evaluated the clinical significance of hematuria and its relationship with genitourinary disease in AF patients receiving OAT.Methods and Results:Among 20,456 consecutive AF patients who visited a tertiary hospital from January 2005 to April 2015, 5,833 had hematuria. Of these 5,833 patients, 3,798 were on OAT (OAT(+) group) and 2,035 were not (OAT(-) group). A total of 1,785 patients from each group were then matched on propensity score analysis. The prevalence of cancer and other diseases in the genitourinary tract was evaluated. While there was no difference in the prevalence of genitourinary stones or urinary tract infection, genitourinary cancer was significantly more common in the OAT(+) group than in the OAT(-) group (1.6% vs. 0.7%, P=0.011). Bladder cancer was the most common genitourinary malignancy, and it was significantly more common in the OAT(+) group (1.2% vs. 0.5%, P=0.019). Subjects on warfarin were more likely to have bladder cancers of lower pathologic grade (63.6% vs. 33.3%, P=0.124). OAT was associated with a higher prevalence and early detection of genitourinary cancer in AF patients with hematuria. Meticulous evaluation of the cause of hematuria is necessary in AF patients with hematuria receiving OAT.

  5. Drug interactions between antiplatelet or novel oral anticoagulant medications and antiretroviral medications.

    Science.gov (United States)

    Egan, Gregory; Hughes, Christine A; Ackman, Margaret L

    2014-06-01

    To review potential drug interactions between antiretroviral (ARV) medications and antiplatelets or novel oral anticoagulants (NOACs). A literature search of MEDLINE, PubMed, EMBASE, International Pharmaceutical Abstracts, and Google Scholar was performed using the search terms (1) clopidogrel or ticagrelor or prasugrel, (2) dabigatran or rivaroxaban or apixaban, and (3) antiretrovirals. Any English language study or case report describing a drug interaction between an ARV and an antiplatelet or NOAC was included. Additional information was taken from pharmacokinetic studies of individual agents alone or information from similar drug interactions. Two studies were identified through the literature search: one reporting an in vivo interaction between ritonavir and prasugrel and the other an in vitro interaction between efavirenz and clopidogrel. A case report describing a drug interaction between nevirapine and rivaroxaban was also located. Information from pharmacokinetic studies and from similar drug interactions allowed for a comprehensive review of potential drug interactions. There are potential drug interactions between ARVs, antiplatelet agents or NOACs. Management of these interactions may include selecting ARVs with a lower potential for drug interactions or choosing antiplatelet agents or NOACs least likely to interact with ARVs. With protease inhibitors or cobicistat, clopidogrel and dabigatran do not appear to have clinically significant interactions. Nonnucleoside reverse transcriptase inhibitors have a low potential for interactions with prasugrel and dabigatran. Clinically significant drug interactions are unlikely to occur between antiplatelet agents or NOACs and nucleoside reverse transcriptase inhibitors raltegravir, dolutegravir, or maraviroc.

  6. Safety of non-vitamin K antagonist oral anticoagulants - coronary risks.

    Science.gov (United States)

    Caldeira, Daniel; Ferreira, Joaquim J; Pinto, Fausto J; Costa, João

    2016-06-01

    Since the approval and commercialization of non-vitamin K antagonist oral anticoagulants (NOACs; apixaban, dabigatran, edoxaban, and rivaroxaban) several studies and meta-analyses have raised safety concerns regarding myocardial infarction (MI) risk among NOAC-treated patients, particularly with dabigatran. Uncertainty remains regarding the coronary risk associated with dabigatran, and whether this putative risk also applies to the other NOACs. In this review, the coronary risks of NOACs based on findings from placebo-controlled trials are discussed, and randomized controlled trials and major cohort studies in AF patients are also appraised. We performed a random-effect meta-analysis, including both interventional trials and observational studies ("real-world" data). Further estimates were retrieved from the meta-analysis of coronary risk among NOAC-treated patients with concomitant AF and coronary disease. Currently, the best available data from both clinical trials and observational studies do not support the claim that patients treated with NOACs, including dabigatran, are at increased coronary risk. However, a definitive conclusion cannot be made (especially regarding dabigatran) and further data are required to address the coronary risks, mostly of high-risk patients. As with any therapeutic intervention, the possible complications should be balanced against the potential benefits at an individual patient level.

  7. Direct oral anticoagulants: analysis of worldwide use and popularity using Google Trends.

    Science.gov (United States)

    Lippi, Giuseppe; Mattiuzzi, Camilla; Cervellin, Gianfranco; Favaloro, Emmanuel J

    2017-08-01

    Four direct oral anticoagulants (DOACs) have been approved for clinical use by many medicines regulatory agencies around the world. Due to increasing use of these drugs in routine practice, we planned an original study to investigate their worldwide diffusion using a popular Web-search engine. Two electronic searches were performed using Google Trends, the former using the keywords "warfarin" AND "heparin" AND "fondaparinux", and the latter using the keywords "warfarin" AND "dabigatran" AND "rivaroxaban" AND "apixaban" AND "edoxaban", both using the search criterion "prescription drug". No language restriction was applied, and the searches were carried out from the first date available in Google Trends (January 1 st , 2004) to present time (June 1 st , 2017). The median Google Trends score of warfarin (i.e., 86) was consistently higher than that of heparin (54; PGoogle searches for DOACs were performed in North America, central-eastern Europe and Australia. The results of our analysis suggest that the popularity of DOACs is constantly increasing around the world, whereas that of warfarin has exhibited a constant and inexorable decline.

  8. Meta-analysis of randomized controlled trials and adjusted observational results of use of clopidogrel, aspirin, and oral anticoagulants in patients undergoing percutaneous coronary intervention

    DEFF Research Database (Denmark)

    D'Ascenzo, Fabrizio; Taha, Salma; Moretti, Claudio

    2015-01-01

    The optimal antiaggregant therapy after coronary stenting in patients receiving oral anticoagulants (OACs) is currently debated. MEDLINE and Cochrane Library were searched for studies reporting outcomes of patients who underwent PCI and who were on triple therapy (TT) or dual-antiplatelet therapy......% confidence interval [CI] 0.39 to 0.68, I2 60% and OR 0.36, 95% CI 0.28 to 0.46) compared to TT. No increased risk of major adverse cardiac events (MACE: death, MI, stroke, and stent thrombosis) was reported (OR 0.71, 95% CI 0.46 to 1.08), although not deriving from randomized controlled trials...... when including clinical data from randomized controlled trials or multivariate analysis. In conclusion, compared to TT, both aspirin and clopidogrel and clopidogrel and OAC reduce bleeding. No difference in major adverse cardiac events is present for clopidogrel and OAC, whereas only low-grade evidence...

  9. Tolerability and Acceptability of Non-Vitamin K Antagonist Oral Anticoagulants in Atrial Fibrillation: Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Caldeira, Daniel; Gonçalves, Nilza; Ferreira, Joaquim J; Pinto, Fausto J; Costa, João

    2015-08-01

    The non-vitamin K antagonist oral anticoagulants (NOACs) overcame some limitations of vitamin K antagonists (VKAs), and are at least as effective in stroke prevention, with an additional decrease of intracranial bleeding risk. The transferability of these benefits to the real world requires tolerability (related to adverse events) and acceptability (drug discontinuation) profiles at least similar to VKAs. We performed a systematic review with meta-analysis of randomized controlled trials (RCTs) evaluating NOACs versus VKAs in patients with non-valvular atrial fibrillation (AF). Studies were searched in April 2015 through MEDLINE, the Cochrane Collaboration's Database, Health Technology Assessment (HTA), Web of Science, and regulatory agencies' documents. Serious adverse events (SAEs) as well as drug-related and patient-related discontinuation rates were the outcomes of interest. Random-effects meta-analysis was performed, and the results expressed as risk ratios (RRs) and 95 % confidence intervals (CIs). Heterogeneity was evaluated with I (2) test. Five RCTs evaluating four NOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) and 72,720 patients were included. Overall, NOACs were associated with a 4 % risk reduction of SAEs (95 % CI 2-6; I (2) = 0 %). Drug-related and patient-related discontinuation rates were similar between NOACs and VKAs (RR 1.03 [0.88-1.21] and RR 0.99 [0.89-1.10], respectively). Significant heterogeneity (I (2) ≥ 75 %) was found among studies results, which could be, at least partially, explained by the findings of the open-label dabigatran trial. NOACs were associated with a small, yet significant, risk reduction of SAEs in patients with AF. NOACs' drug-related and patient-related acceptability profiles were similar to those for VKAs. The results were heterogeneous mainly because of the increased rate of discontinuation associated with dabigatran. Pragmatic trials and cohort studies should be conducted to further address these

  10. [No role for oral anticoagulants (target INR: 2.0-3.0) after transient ischaemic attack or cerebral infarction of arterial origin; the 'European/Australasian stroke prevention in reversible ischaemia trial' (ESPRIT)].

    Science.gov (United States)

    De Schryver, E L L M; Halkes, P H A

    2008-02-23

    The 'European/Australasian stroke prevention in reversible ischaemia trial' (ESPRIT) aimed to determine whether oral anticoagulation of moderate intensity (target international normalised ratio (INR): 2.0-3.0) is more effective than acetylsalicylic acid in preventing future vascular events in patients with transient ischaemic attack (TIA) or minor stroke of arterial origin. International, multicentre randomised clinical trial. Patients were randomised within 6 months of TIA or minor stroke of arterial origin to oral anticoagulants (target INR: 2.0-3.0; n = 536) or acetylsalicylic acid (30-325 mg daily; n = 532). The primary endpoint was a composite of vascular death, non-fatal stroke, non-fatal myocardial infarction or major bleeding complications. In a post hoc analysis, the efficacy of anticoagulants was compared with that of the combination of acetylsalicylic acid and dipyridamole (200 mg twice daily), a third arm of ESPRIT. Treatment was unblinded, but auditing of endpoints was blinded. Data were analysed on an intent-to-treat basis. The comparison of anticoagulants and acetylsalicylic acid was stopped prematurely because the combination of acetylsalicylic acid and dipyridamole was found to be more effective than acetylsalicylic acid alone. The mean duration of follow-up was 4.6 years (SD: 2.2). The mean INR was 2.57 (SD: 0.86; nearly 70% of the time within target range). The primary endpoint occurred in 99 patients (19%) in the anticoagulation group and 98 patients (18%) in the acetylsalicylic acid group (hazard ratio: 1.02; 95% CI: 0.77-1.35). The hazard ratio was 0.73 (95% CI: 0.52-1.01) for ischaemic events and 2.56 (95% CI: 1.48-4.43) for major bleeding complications. The hazard ratio for the primary outcome event comparing anticoagulants with the combination of acetylsalicylic acid and dipyridamole was 1.31 (95% CI: 0.98-1.75). Oral anticoagulants (target INR: 2.0-3.0) were not more effective than acetylsalicylic acid in the secondary prevention of

  11. Prothrombin Time Tests for the Monitoring of Direct Oral Anticoagulants and Their Evaluation as Indicators of the Reversal Effect.

    Science.gov (United States)

    Nagakari, Kunihiko; Emmi, Mari; Iba, Toshiaki

    2017-09-01

    The prompt assessment and the reversal of direct oral anticoagulants (DOACs) are urgent matters in the emergency care setting. Thus, we planned to elucidate the adequate prothrombin time (PT) test for the evaluation of the anticoagulant effects of various DOACs. The anticoagulant effects of rivaroxaban, apixaban, and edoxaban were measured with 3 PT tests (Triniclot PT Excel S, Neoplastin R, and Thromborel S). Human plasma was spiked with each DOAC at a range of 0 to 1000 ng/mL, and the PT was measured using each PT test. In another series, the reversal effect of either 4-factor prothrombin complex concentrate (PCC) or activated PCC (aPCC) was evaluated with each PT test. All PT reagents correlated with the concentrations of each DOAC, however, the reactivity was considerably different between the DOACs and the PT tests. A prolonged PT with DOACs was reversed both by PCC and aPCC in a dose-dependent manner; however, Triniclot PT Excel S showed reprolongation of the PT with a higher dose of PCC. The proper choice of PT test is necessary for the assessments of the anticoagulant activity of DOACs. It is also important to understand the different characteristics of each PT test for the assessment of the reversal effects of PCC.

  12. Cost-effectiveness of new oral anticoagulants in the treatment and secondary prevention of venous thromboembolism

    Directory of Open Access Journals (Sweden)

    A. V. Rudakova

    2015-01-01

    Full Text Available Aim. To assess the cost-effectiveness of apixaban in the treatment and secondary prevention of venous thromboembolism (VTE compared with low molecular weight heparin (LMWH/warfarin and other new oral anticoagulants (NOACs. Material and methods. Cost-effectiveness analysis was performed using a Markov model, developed on the basis of the results of AMPLIFY AMPLIFY-Ext trials, and network meta-analyzes on the use of antithrombotic drugs in acute VTE and long-term administration after VTE. Markov cycle duration was 3 months. The duration of therapy in the simulation was 6 and 12 months. The time horizon of the study was 5 years. Life expectancy and costs were discounted by 3.5% per year. The costs on drugs were estimated based on the registered marginal cost price. Besides, the analysis was performed to the weighted average auctions prices for NOACs. The costs of monitoring and treatment of complications were calculated on the basis of the collective agreement of compulsory health insurance system (St. Petersburg, 2015. Results. Apixaban provided significant cost savings compared with other modes of anticoagulant therapy for hospital treatment. Apixaban provided cost savings compared with other NOACs with a minimal increase in life expectancy with regard to quality in long-term analysis. Apixaban provided an increase in life expectancy compared with the appointment of LMWH/warfarin, but required some increase in costs. At therapy duration of 6 months, the costs per one additional year of life with regard to quality and to one additional calendar year of life were 309.8-403.7 and 481.6-627.4 thousand rubles, respectively; at therapy duration of 12 months – 1254.4-1476.9 and 649.0-764.1 thousand rubles, respectively. Conclusion. Apixaban provided a reduction in the incidence of bleeding compared with other NOACs and LMWH/warfarin with comparable efficacy in treatment and secondary prevention of VTE. Apixaban therapy costs were lower than these

  13. A Multilevel Analysis of Real-World Variations in Oral Anticoagulation Initiation for Atrial Fibrillation in Valencia, a European Region

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    Aníbal García-Sempere

    2017-08-01

    Full Text Available Introduction: Beyond clinical trials, clinical practice guidelines, and administrative regulation, treatment decision-making can be influenced by individual and contextual factors. Our goal was to describe variations in the patterns of initiation of anticoagulation therapy in patients with atrial fibrillation by Health Areas (HA in the region of Valencia in Spain and to quantify the influence of the HAs on variations in treatment choice.Methods: We conducted a population-based retrospective cohort study of all atrial fibrillation patients who started treatment with oral anticoagulants between November 2011 and February 2014 in each of the region's 24 HAs. We described patient and utilization characteristics per HA and initiation patterns over time, and we identified contextual and individual factors associated with differences in initiation patterns.Results: 21,879 patients initiated treatment with an oral anticoagulant in the 24 HAs. Initiation with direct oral anticoagulants (DOAC in the first year was 14.6%. In November 2013 the ratio was 25.4%, with HA ratios ranging from 3.8 to 57.1%. DOAC-initiating patients had less comorbidity but were more likely to present episodes of previous ischemic stroke, hemorrhagic stroke, or TIA when compared with patients initiating with VKA treatment. Variability among HAs was statistically significant, with the majority of HAs ranking above or below the regional initiation average (ICC ≈ 8%.Conclusion: There was high variability in the percentage of DOAC initiation and in the choice of DOAC among HAs. Interventions aimed to improve DOAC initiation decision-making and to reduce variations should take into account the Health Area component.

  14. Impact of self-funding on patient experience of oral anticoagulation self-monitoring: a qualitative study.

    Science.gov (United States)

    Tompson, Alice; Heneghan, Carl; Sutton, Stephen; Fitzmaurice, David; Ward, Alison

    2016-12-23

    To explore the impact self-funding has on patient experience of oral anticoagulation therapy self-monitoring. Semistructured, qualitative interviews were conducted. Transcripts were analysed thematically using constant comparison. England. Interviewees were participants of the Cohort Study of Anticoagulation Self-Monitoring (CASM). Cohort members were recruited as they bought a monitor from the major manufacturer in the UK. A purposive sample was invited to be interviewed on completion of the 12-month cohort follow-up. Patient narratives on their experiences of self-monitoring their oral anticoagulation therapy in non-trial conditions. 26 interviews were completed. Interviewees viewed purchasing the monitoring device as a long-term commitment balancing the limitations of clinic-based monitoring against the cost. They were unable to try out the monitor prior to purchase and therefore had to be confident in their own ability to use it. The variable provision of self-monitoring equipment caused resentment, and interviewees were uncomfortable negotiating with healthcare professionals. High test strip usage while learning how to use the monitor caused anxiety that was exacerbated by worries about their cost. However, self-funding did mean that interviewees felt a sense of ownership and were determined to persevere to overcome problems. Self-funding has negative implications in terms of equity of access; however, the money invested acts as a barrier to discontinuation. If oral anticoagulation therapy self-monitoring devices and consumables were provided free of charge in routine care, the training and support available in England may need to be reviewed to prevent discontinuation rates rising to those observed in clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  15. [Update on the control of patients on treatment with vitaminK antagonist oral anticoagulants in Primary Care].

    Science.gov (United States)

    Fernández López, P; López Ramiro, M I; Merino de Haro, I; Cedeño Manzano, G; Díaz Siles, F J; Hermoso Sabio, A

    In Spain, more than 80% of patients with atrial fibrillation (AF) receive oral anticoagulant therapy (OAT), and 72% of these patients are followed up in the Primary Care (PC) setting. Recent studies have shown that there is insufficient control of patients on OAT. The objective of the present study was to obtain more detailed information on the state of control of patients on treatment with vitaminK antagonist (VKA) oral anticoagulants (OAC), on the diseases for which the therapy was indicated and on concomitant diseases. This was a retrospective, cross-sectional, observational study with the participation of patients from a single health area included in an OAT programme throughout 2014. In patients on treatment with OAC, International Normalised Ratio (INR) control was considered insufficient when the percentage time in therapeutic range (TTR) was below 65% during an evaluation period of at least 6months. A total of 368 patients were included in the study, where the most frequent indication for oral anticoagulation was non-valvular AF. A total of 5,128 INR controls were performed, of which 2,359 (46%) were outside the therapeutic range, and 2,769 (54%) were within range. The risk of thromboembolism was very high in 91% of patients on treatment with VKA OAC. The indication for anticoagulation is correct in our population, assuming a low-intermediate risk of haemorrhage in the majority of patients. Measurement of the TTR using the Rosendaal method shows that the control of patients on treatment with VKA OAC is insufficient. Copyright © 2016 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

  16. New orally active anticoagulants in critical care and anesthesia practice: The good, the bad and the ugly

    Directory of Open Access Journals (Sweden)

    Vishal Sehgal

    2013-01-01

    Full Text Available With the adoption of dabigatran, rivaroxaban, and apixaban into clinical practice, a new era has arrived in the practice of oral anticoagulants. Venous thromboembolism (VTE has traditionally been underdiagnosed and under treated in Asia. With increasing longevity, the diagnosis and the need for management of atrial fibrillation (AF and VTE is likely to increase significantly. The new orally active anticoagulants (NOACs have reasonably filled the lacunae that clinicians traditionally faced when treating patients with vitamin K antagonist (VKA. Unlike VKA, NOACs do not need frequent monitoring. Therefore, more patients are likely to get therapeutic effects of anticoagulation and thus reduce morbidity and mortality associated with VTE and AF. However, the clinicians need to be circumspect and exercise caution in use of these medications. In particular (in geriatric population, the clinicians should look out for drug-drug interactions and underlying renal insufficiency. This would ensure therapeutic efficacy and minimize bleeding complications. Here, it is important to note that the antidote for NOACs is not available and is a major concern if emergency surgical procedure is required in their presence.

  17. Critique on the use of the standardized avian acute oral toxicity test for first generation anticoagulant rodenticides

    Science.gov (United States)

    Vyas, Nimish B.; Rattner, Barnett A.

    2012-01-01

    Avian risk assessments for rodenticides are often driven by the results of standardized acute oral toxicity tests without regards to a toxicant's mode of action and time course of adverse effects. First generation anticoagulant rodenticides (FGARs) generally require multiple feedings over several days to achieve a threshold concentration in tissue and cause adverse effects. This exposure regimen is much different than that used in the standardized acute oral toxicity test methodology. Median lethal dose values derived from standardized acute oral toxicity tests underestimate the environmental hazard and risk of FGARs. Caution is warranted when FGAR toxicity, physiological effects, and pharmacokinetics derived from standardized acute oral toxicity testing are used for forensic confirmation of the cause of death in avian mortality incidents and when characterizing FGARs' risks to free-ranging birds.

  18. Multicentre randomised placebo-controlled trial of oral anticoagulation with apixaban in systemic sclerosis-related pulmonary arterial hypertension: the SPHInX study protocol.

    Science.gov (United States)

    Calderone, Alicia; Stevens, Wendy; Prior, David; Nandurkar, Harshal; Gabbay, Eli; Proudman, Susanna M; Williams, Trevor; Celermajer, David; Sahhar, Joanne; Wong, Peter K K; Thakkar, Vivek; Dwyer, Nathan; Wrobel, Jeremy; Chin, Weng; Liew, Danny; Staples, Margaret; Buchbinder, Rachelle; Nikpour, Mandana

    2016-12-08

    Systemic sclerosis (SSc) is a severe and costly multiorgan autoimmune connective tissue disease characterised by vasculopathy and fibrosis. One of the major causes of SSc-related death is pulmonary arterial hypertension (PAH), which develops in 12-15% of patients with SSc and accounts for 30-40% of deaths. In situ thrombosis in the small calibre peripheral pulmonary vessels resulting from endothelial dysfunction and an imbalance of anticoagulant and prothrombotic mediators has been implicated in the complex pathophysiology of SSc-related PAH (SSc-PAH), with international clinical guidelines recommending the use of anticoagulants for some types of PAH, such as idiopathic PAH. However, anticoagulation has not become part of standard clinical care for patients with SSc-PAH as only observational evidence exists to support its use. Therefore, we present the rationale and methodology of a phase III randomised controlled trial (RCT) to evaluate the efficacy, safety and cost-effectiveness of anticoagulation in SSc-PAH. This Australian multicentre RCT will compare 2.5 mg apixaban with placebo, in parallel treatment groups randomised in a 1:1 ratio, both administered twice daily for 3 years as adjunct therapy to stable oral PAH therapy. The composite primary outcome measure will be the time to death or clinical worsening of PAH. Secondary outcomes will include functional capacity, health-related quality of life measures and adverse events. A cost-effectiveness analysis of anticoagulation versus placebo will also be undertaken. Ethical approval for this RCT has been granted by the Human Research Ethics Committees of all participating centres. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. The findings of this RCT are to be published in open access journals. ACTRN12614000418673, Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence

  19. New Oral Anticoagulants in Acute Coronary Syndrome: Is There Any Advantage Over Existing Treatments?

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    Andrea Messori

    2014-09-01

    Full Text Available Background: After an acute coronary syndrome, dual antiplatelet therapy with clopidogrel plus aspirin is still a standard of care, but several new approaches have been investigated. Objectives: The present study re-examined the studies published thus far on this topic to evaluate the effectiveness of dual antiplatelet therapy in comparison to some of these new approaches (mainly, ticagrelor + aspirin and dual therapy plus a new oral anticoagulant [NOAC]; i.e., “triple therapy”. Materials and Methods: The clinical material was directly derived from that reported in recent meta-analyses. Our re-analysis relied on standard equivalence methods in which interpretation is based on Relative Risks (RRs along with their 95% Confidence Intervals (CI. The equivalence margins employed in our statistical testing were directly derived from those reported in randomized studies. Results: The equivalence margins were initially set at RR ranging from 0.775 to 1.29. According to these margins, triple therapy based on any NOAC proved to be superior to dual therapy alone, but at the same time demonstrated its equivalence with dual therapy. The results for apixaban-based triple therapy were inconclusive (not superior, not not-inferior, not equivalent and, of course, not inferior to the controls. Those for rivaroxaban-based triple therapy showed that this combination treatment was superior to dual therapy alone and failed to meet the criterion of equivalence. In the comparison between rivaroxaban-based triple therapy and ticagrelor + aspirin, the RR was 1 and its 95% CI remained within a post-hoc margin of ± 15%. Conclusions: Even if one considers the most effective NOAC in combination with clopidogrel + ticagrelor, this triple therapy is not more effective than ticagrelor + aspirin. On the other hand, the increased risk of bleeding with triple regimens is well demonstrated. We therefore conclude that these triple regimens did not play any important roles in the

  20. A sensitivity comparison of the Quick and Owren prothrombin time methods in oral anticoagulant therapy

    Directory of Open Access Journals (Sweden)

    Juha Eero Horsti

    2009-09-01

    Full Text Available Prothrombin time (PT is the leading test for monitoring oral anticoagulation therapy (OAT. According to the World Health Organization recommendation, International Normalized Ratio (INR results obtained from the same patient samples with the major PT methods (Quick and Owren should be the same when the therapeutic range is the same. In our study blood samples were obtained from 207 OAT patients. We analyzed the samples using two Quick and two Owren PT (combined thromboplastin reagents for INR and assessed the sensitivity and true coagulation activity using a new-generation PT method. The INR values with the Quick PT and Owren PT methods were very similar around the normal range, while unacceptable differences were seen within the therapeutic range and at higher INR values. The Quick PT results as INR are clearly lower than those given by Owren PT and the difference increases toward higher INR. The new PT method functions well with both Owren PT reagents, and we can calculate the true active INR. The Quick PT methods show no sensitivity to coagulation inhibition measurement. The harmonization of the INR is an important goal for the safety of OAT patients. More accurate INR results reduce morbidity and mortality, and the therapeutic ranges should be similar worldwide. In this study we found unacceptable differences in INR results produced by the two PT methods. The new method showed a lack of sensitivity to Quick PT. For the global harmonization of OAT therapy and for INR accuracy only the more sensitive Owren PT method should be used.

  1. Novel oral anticoagulants for stroke prevention in atrial fibrillation: a focus on the older patient

    Directory of Open Access Journals (Sweden)

    Yates SW

    2013-03-01

    Full Text Available Scott W YatesCenter for Executive Medicine, Plano, TX, USAAbstract: Atrial fibrillation (AF is a common arrhythmia that is associated with an increased risk of stroke, particularly in the elderly. Traditionally, a vitamin K antagonist such as warfarin is prescribed for stroke prevention. Warfarin is effective at lowering stroke risk but has several limitations due to food restrictions, drug interactions, and a narrow therapeutic window. Various novel oral anticoagulants (NOACs are available or under development to provide alternative treatment options. This article reviews the efficacy and safety of three NOACs (dabigatran etexilate, rivaroxaban, and apixaban in addition to warfarin and aspirin, for prevention of stroke in patients with AF, focusing on the elderly population. Results of clinical trials demonstrate that the efficacy of NOACs for stroke prevention in patients with AF is as good as or better than that of warfarin. The NOACs are also associated with an equivalent or lower risk of bleeding. Regardless of the medication chosen, older patients with AF must be treated cautiously due to an increased risk of stroke and bleeding, as well as potential challenges related to drug interactions and monitoring requirements. NOACs may be suitable alternatives to warfarin for stroke prevention in older patients due to several advantages, including a faster onset of action, few drug or food interactions, and no requirement for regular monitoring. However, dose adjustments may be required for certain patients, such as those with severe renal impairment or in the setting of drug interactions.Keywords: aspirin, warfarin, dabigatran etexilate, rivaroxaban, apixaban

  2. Efficacy and Safety Outcomes of Direct Oral Anticoagulants and Amiodarone in Patients with Atrial Fibrillation.

    Science.gov (United States)

    Lupercio, Florentino; Romero, Jorge; Peltzer, Bradley; Maraboto, Carola; Briceno, David; Villablanca, Pedro; Ferrick, Kevin; Gross, Jay N; Kim, Soo; Fisher, John; Di Biase, Luigi; Krumerman, Andrew

    2017-12-21

    Direct oral anticoagulants (DOACs) and amiodarone are widely used in the treatment of non-valvular atrial fibrillation. The DOACs are P-glycoprotein (P-gp) and cytochrome p-450 (CYP3A4) substrates. DOAC levels may be increased by the concomitant use of potent dual P-gp/CYP3A4 inhibitors such as amiodarone, which can potentially translate into adverse clinical outcomes. We aimed to assess the efficacy and safety of drug-drug interaction by the concomitant use of DOACs and amiodarone. We performed a systematic review of MEDLINE, Cochrane and Embase limiting our search to randomized controlled trials of patients with atrial fibrillation that have compared DOACs vs warfarin for prophylaxis of stroke or systemic embolism in order to analyze the impact on stroke or systemic embolism, major bleeding and intracranial bleeding risk in patients with concomitant use of amiodarone. Risk ratio (RR) 95% confidence intervals were measured using the Mantel-Haenszel method. The fixed effects model was used due to heterogeneity (I2) trials with a total of 71,683 patients were analyzed from which 5% (n= 3,212) of patients were concomitantly on DOAC and amiodarone. We found no statistically significant difference for any of the clinical outcomes (stroke or systemic embolism (RR, 0.85; 95% CI 0.67-1.06), major bleeding (RR, 0.91; 95% CI 0.77-1.07) or intracranial bleeding (RR, 1.10; 95% CI 0.68-1.78)) among patients on DOAC and amiodarone versus DOAC without amiodarone. Based on the results of this meta-analysis, co-administration of DOACs and amiodarone, a dual P-gp/CYP3A4 inhibitor, does not appear to affect efficacy or safety outcomes in patients with atrial fibrillation. Copyright © 2017. Published by Elsevier Inc.

  3. Patients' perspectives on self-testing of oral anticoagulation therapy: Content analysis of patients' internet blogs

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    Robinson Ian

    2011-02-01

    Full Text Available Abstract Background Patients on oral anticoagulant therapy (OAT require regular testing of the prothrombin time (PT and the international normalised ratio (INR to monitor their blood coagulation level to avoid complications of either over or under coagulation. PT/INR can be tested by a healthcare professional or by the patient. The latter mode of the testing is known as patient self-testing or home testing. The objective of this study was to elicit patients' perspectives and experiences regarding PT/INR self-testing using portable coagulometer devices. Methods Internet blog text mining was used to collect 246 blog postings by 108 patients, mainly from the USA and the UK. The content of these qualitative data were analysed using XSight and NVivo software packages. Results The key themes in relation to self-testing of OAT identified were as follows: Patient benefits reported were time saved, personal control, choice, travel reduction, cheaper testing, and peace of mind. Equipment issues included high costs, reliability, quality, and learning how to use the device. PT/INR issues focused on the frequency of testing, INR fluctuations and individual target (therapeutic INR level. Other themes noted were INR testing at laboratories, the interactions with healthcare professionals in managing and testing OAT and insurance companies' involvement in acquiring the self-testing equipment. Social issues included the pain and stress of taking and testing for OAT. Conclusions Patients' blogs on PT/INR testing provide insightful information that can help in understanding the nature of the experiences and perspectives of patients on self-testing of OAT. The themes identified in this paper highlight the substantial complexities involved in self-testing programmes in the healthcare system. Thus, the issues elicited in this study are very valuable for all stakeholders involved in developing effective self-testing strategies in healthcare that are gaining

  4. Cost-utility analysis of oral anticoagulants for nonvalvular atrial fibrillation patients at the police general hospital, Bangkok, Thailand.

    Science.gov (United States)

    Jarungsuccess, Siriporn; Taerakun, Satadon

    2014-10-01

    The genetic polymorphism was one of the major considerations for adjusting doses of warfarin in Thai individuals. As a result, new oral anticoagulants (NOACs) were introduced to achieve therapeutic goals in stroke prevention in atrial fibrillation (SPAF) patients. However, a cost-utility analysis in a population-specific model was lacking in Thailand. This study was performed to determine which NOACs yielded population-specific, cost-effective results for SPAF compared with warfarin from both governmental and societal perspectives in Thailand. A simplified Markov health state model was constructed to calculate the lifetime cost, life-years saved, and quality-adjusted life-years (QALYs) gained. Asia-specific clinical event parameters were defined from systematic searches of PubMed. Cost and utility input was obtained from hospital based data collection. Although NOACs produced more life-years saved and QALYs gained resulting from the base-case versus warfarin, the lifetime costs of new alternatives increased to >1.4 times the comparative cost of warfarin. This caused an incremental cost-effective ratio that exceeded Thailand's cost-effectiveness threshold. The probabilistic sensitivity analysis denoted the robustness of our model and revealed that dose-adjusted warfarin was the most cost-effective option in >99% of iterations. NOACs produced cost-effective results when the medication unit cost was decreased by at least 85%. According to the results of this first cost-utility analysis in Thailand, warfarin is still the most cost-effective medication for SPAF from any perspective in Thailand at the threshold recommended by our health technology assessment guidelines. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

  5. Systematic review and network meta-analysis of the relative efficacy and safety of edoxaban versus other nonvitamin K antagonist oral anticoagulants among patients with nonvalvular atrial fibrillation and CHADS2 score ⩾ 2

    Directory of Open Access Journals (Sweden)

    Maria M Fernandez

    2015-11-01

    Full Text Available Background: The nonvitamin K antagonist oral anticoagulants pivotal clinical trials for stroke prevention in atrial fibrillation have important differences in trial designs and baseline patient characteristics. Objective: We sought to evaluate the relative efficacy and safety of edoxaban versus other nonvitamin K antagonist oral anticoagulants in the management of stroke prevention in atrial fibrillation by adjusting for differences in baseline stroke risk and the length of follow-up among the four phase 3 randomized controlled trials. Methods: We conducted a systematic literature review of randomized controlled trials evaluating the nonvitamin K antagonist oral anticoagulants for stroke prevention in atrial fibrillation and performed a network meta-analysis using data from ENGAGE AF-TIMI 48, RE-LY, ROCKET-AF, and ARISTOTLE, with warfarin as a common comparator. To adjust for between-trial differences in CHADS2 score and length of follow-up, annualized event rates among patients with CHADS2 score ⩾ 2 were analyzed using a mixed Poisson’s regression model. Results: Once-daily high-dose edoxaban was associated with significant lower major bleeding episodes compared with once-daily rivaroxaban (risk ratio, 0.76; 95% confidence interval, 0.66–0.89, twice-daily dabigatran 150 mg (risk ratio, 0.78; 95% confidence interval, 0.61–0.84, and twice-daily dabigatran 110 mg (risk ratio, 0.83; 95% confidence interval, 0.71–0.98 and similar bleeding risk compared with twice-daily apixaban (risk ratio, 1.08; 95% confidence interval, 0.91–1.28. Risk of stroke and systemic embolism was similar for the high-dose edoxaban and other nonvitamin K antagonist oral anticoagulant regimens. The low-dose edoxaban regimen was associated with a significant lower risk of major bleeding than other nonvitamin K antagonist oral anticoagulants and a significant higher risk of stroke and systemic embolism compared with apixaban and dabigatran 150

  6. Triple Antithrombotic Therapy after Percutaneous Coronary Intervention (PCI in Patients with Indication for Oral Anticoagulation: Data from a Single Center Registry.

    Directory of Open Access Journals (Sweden)

    Dawid L Staudacher

    Full Text Available Antithrombotic therapy consisting of a dual anti-platelet therapy (DAPT and oral anti-coagulation (OAC with a vitamin k antagonist is often referred to as triple therapy. This combined anticoagulation is applied in patients undergoing coronary artery stent implantation while also having an indication for OAC. Triple therapy increases the risk for bleeding events compared to either DAPT or OAC alone and thereby might be associated with adverse outcomes. Clinical data on the frequency of bleeding events in patients on triple therapy from clinical trials derives from pre-selected patients and may differ from the real world patients. We report data on patient characteristics and bleeding incidence of patients dismissed on triple therapy from a single university hospital. Within the time span from January 2000 to December 2012, we identified a total of 213 patients undergoing PCI who were prescribed a triple therapy for at least 4 weeks (representing 0.86% of all patients treated. The usage of triple therapy significantly increased over the observed time period. The average CHA2DS2-VASc Score was 3.1 ± 1.1 with an average HAS-BLED score of 2.5 ± 0.86 representing a high-risk group for thromboembolic events as well as considerable risk for bleeding events. An on-treatment bleeding incidence of 9.4% was detected, with gastrointestinal and airway bleeding being the most frequent (5.1% and 1.4%, respectively. This is consistent with data from clinical trials and confirms the high risk of bleeding in patients on DAPT plus OAC. 29.0% of all patients receiving triple therapy had an indication for OAC other than non-valvular atrial fibrillation. This substantial patient group is underrepresented by clinical trials and needs further attention.

  7. [Treatment with inhibitors of new oral direct anticoagulants in patients with severe bleedings or urgent surgical procedures. The new dabigatran antidote: the place of idarucizumab in clinical practice].

    Science.gov (United States)

    Boda, Zoltán

    2016-03-20

    Only vitamin K antagonists could be applied as oral anticoagulants over the past six decades. Coumarols have narrow therapeutic range, and unpredictable anticoagulant effects are resulted by multiple drug interactions. Therefore, regular routine monitoring of the international normalized ratio is necessary. There are two groups of factor-specific anticoagulants: molecules with anti-FIIa (dabigatran) and anti-FXa (rivaroxaban, apixaban and edoxaban) effect. Author summarizes the most important clinical features of the new oral anticoagulants, their indications and the possibilities of laboratory controls. Bleedings are the most important side effects of anticoagulants. This review summarizes the current published evidences for new oral anticoagulants reversal (non-specific and specific) agents, especially in cases with severe acute bleedings or urgent surgery procedures. It reports on how to use inhibitors, the recommended doses and the most important clinical results. The review focuses on idarucizumab - already approved by the U.S. Food and Drug Administration and the European Medicines Agency - which has a key role as the first specific inhibitor of dabigatran.

  8. [Factors Associated with Direct Oral Anticoagulants versus Vitamin K Antagonists in Patients with Non-valvular Atrial Fibrillation].

    Science.gov (United States)

    Saliba, Layla; Mondoly, Pierre; Duparc, Alexandre; Bura-Rivière, Alessandra; Maury, Philippe; Calmels, Violaine; Sallerin, Brigitte; Pathak, Atul; Montastruc, Jean-Louis; Bagheri, Haleh

    2015-01-01

    Describing the factors associated with direct oral anticoagulants (DOA) prescription in patients with atrial fibrillation (AF). This study was performed in Toulouse on a cohort of patients received in rhythmology consultation, treated with vitamin K antagonists (VKA) or DOA for AF. A multivariate model was performed using logistic regression to describe the factors associated with DOA prescription and secondly, those associated with discontinuation of the anticoagulant. Among the 140 patients included, 96 (66%) were treated with VKA and 48 (34%) with DOA. Recent AF diagnosis (OR 7.52, 95% CI [2.41;23.29], p = 0.001), previous exposure to VKA (OR 17.11, 95% CI [4.48;60.91], pDOA prescription. Discontinuation of the anticoagulant (n=24) was associated to DOA intake (OR 2.71, 95% CI [1.21; 6.08], p = 0.016). DOA are less prescribed than VKA in patients treated with APA. DOA switch to VKA was not systematic in patients diagnosed for a long time. However, international normalized ratio (INR) values were stable in most of patients treated with VKA at the switching to DOA. A more powerful study would confirm the factors associated with DOA prescription. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  9. WARFARIN AND ITS IMPORTANCE IN THE ERA OF NEW ORAL ANTICOAGULANTS. ISSUES OF MONITORING THE EFFECTIVENESS AND SAFETY OF TREATMENT

    Directory of Open Access Journals (Sweden)

    S. Yu. Martsevich

    2017-01-01

    Full Text Available Oral anticoagulant (OAC therapy is currently gaining special importance due to the significant spread of atrial fibrillation (AF in the population (especially in older age groups. The use of OAC in AF has an extensive evidence base, which confirms a significant decrease in the number of strokes and total mortality in the context of anticoagulation therapy (ACT in AF. Currently, the "gold standard" of the OAC is warfarin, which has proved effectiveness in all categories of patients with AF. A whole group  of new OAC (NOAC also appeared. In Russia, dabigatran, rivaroxaban and apixaban have been registered. All NOAC were studied in randomized clinical trials (RCTs in comparison with warfarin, mainly in patients with non-valvular AF, therefore, in valvular AF, as well as in patients with severe renal failure, warfarin remains the drug of choice. Advantages of warfarin in comparison with NOAC are the presence of known  antidote and standardized indicator of the efficacy and safety of the anticoagulation therapy – International Normalized Ratio (INR, as well as low price of the drug. The leading problem in the treatment of warfarin is the complexity and, at the same time, a strong  need to maintain INR within the therapeutic "window" of at least 60% of the treatment time. Obviously, the optimal solution to this problem is the possibility of self-testing of this indicator by the patient himself and,  probably, the ability to adjust the dosage of warfarin independently, to achieve the necessary values of INR (self-management or titrate the dose with the help of a medical consultation by phone (self-monitoring. To date, several devices have been developed for self-monitoring of anticoagulation therapy – coagulometers. Their use leads to a decrease in the number of thromboembolic complications, and from the results of some RCTs – to a decrease in the number of large bleedings and total mortality, and to improve the quality of life of AF patients

  10. Good quality of oral anticoagulation treatment in general practice using international normalised ratio point of care testing

    DEFF Research Database (Denmark)

    Løkkegaard, Thomas; Pedersen, Tina Heidi; Lind, Bent

    2015-01-01

    INTRODUCTION: Oral anticoagulation treatment (OACT) with warfarin is common in general practice. Increasingly, international normalised ratio (INR) point of care testing (POCT) is being used to manage patients. The aim of this study was to describe and analyse the quality of OACT with warfarin...... collected retrospectively for a period of six months. For each patient, time in therapeutic range (TTR) was calculated and correlated with practice and patient characteristics using multilevel linear regression models. RESULTS: We identified 447 patients in warfarin treatment in the 20 practices using POCT...

  11. Good quality of oral anticoagulation treatment in general practice using international normalised ratio point of care testing

    DEFF Research Database (Denmark)

    Løkkegaard, Thomas; Pedersen, Tina Heidi; Lind, Bent

    2015-01-01

    in the management of patients in warfarintreatment provided good quality of care. Sampling intervaland diagnostic coding were significantly correlated withtreatment quality. FUNDING: The study received financial support from theSarah Krabbe Foundation, the General Practitioners’ Educationand Development Foundation......INTRODUCTION: Oral anticoagulation treatment (OACT)with warfarin is common in general practice. Increasingly,international normalised ratio (INR) point of care testing(POCT) is being used to manage patients. The aim of thisstudy was to describe and analyse the quality of OACT withwarfarin......, and Quality in PrimaryCare (KAP-H) – the Capital Region of Denmark. TRIAL REGISTRATION: not relevant....

  12. EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary.

    Science.gov (United States)

    Heidbuchel, Hein; Verhamme, Peter; Alings, Marco; Antz, Matthias; Hacke, Werner; Oldgren, Jonas; Sinnaeve, Peter; Camm, A John; Kirchhof, Paulus

    2013-07-01

    New oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with non-valvular atrial fibrillation (AF). Both physicians and patients will have to learn how to use these drugs effectively and safely in specific clinical situations. This text is an executive summary of a practical guide that the European Heart Rhythm Association (EHRA) has assembled to help physicians in the use of the different NOACs. The full text is being published in EP Europace. Practical answers have been formulated for 15 concrete clinical scenarios: (i) practical start-up and follow-up scheme for patients on NOACs; (ii) how to measure the anticoagulant effect of NOACs; (iii) drug-drug interactions and pharmacokinetics of NOACs; (iv) switching between anticoagulant regimens; (v) ensuring compliance of NOAC intake; (vi) how to deal with dosing errors; (vii) patients with chronic kidney disease; (viii) what to do if there is a (suspected) overdose without bleeding, or a clotting test is indicating a risk of bleeding?; (ix) management of bleeding complications; (x) patients undergoing a planned surgical intervention or ablation; (xi) patients undergoing an urgent surgical intervention; (xii) patients with AF and coronary artery disease; (xiii) cardioversion in a NOAC-treated patient; (xiv) patients presenting with acute stroke while on NOACs; (xv) NOACs vs. VKAs in AF patients with a malignancy. Since new information is becoming available at a rapid pace, an EHRA web site with the latest updated information accompanies the guide (www.NOACforAF.eu). It also contains links to the ESC AF Guidelines, a key message pocket booklet, print-ready files for a proposed universal NOAC anticoagulation card, and feedback possibilities.

  13. Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study

    Science.gov (United States)

    Jun, Min; Lix, Lisa M; Durand, Madeleine; Dahl, Matt; Paterson, J Michael; Dormuth, Colin R; Ernst, Pierre; Yao, Shenzhen; Renoux, Christel; Tamim, Hala; Wu, Cynthia; Mahmud, Salaheddin M

    2017-01-01

    Objective To determine the safety of direct oral anticoagulant (DOAC) use compared with warfarin use for the treatment of venous thromboembolism. Design Retrospective matched cohort study conducted between 1 January 2009 and 31 March 2016. Setting Community based, using healthcare data from six jurisdictions in Canada and the United States. Participants 59 525 adults (12 489 DOAC users; 47 036 warfarin users) with a new diagnosis of venous thromboembolism and a prescription for a DOAC or warfarin within 30 days of diagnosis. Main outcome measures Outcomes included hospital admission or emergency department visit for major bleeding and all cause mortality within 90 days after starting treatment. Propensity score matching and shared frailty models were used to estimate adjusted hazard ratios of the outcomes comparing DOACs with warfarin. Analyses were conducted independently at each site, with meta-analytical methods used to estimate pooled hazard ratios across sites. Results Of the 59 525 participants, 1967 (3.3%) had a major bleed and 1029 (1.7%) died over a mean follow-up of 85.2 days. The risk of major bleeding was similar for DOAC compared with warfarin use (pooled hazard ratio 0.92, 95% confidence interval 0.82 to 1.03), with the overall direction of the association favouring DOAC use. No difference was found in the risk of death (pooled hazard ratio 0.99, 0.84 to 1.16) for DOACs compared with warfarin use. There was no evidence of heterogeneity across centres, between patients with and without chronic kidney disease, across age groups, or between male and female patients. Conclusions In this analysis of adults with incident venous thromboembolism, treatment with DOACs, compared with warfarin, was not associated with an increased risk of major bleeding or all cause mortality in the first 90 days of treatment. Trial registration Clinical trials NCT02833987. PMID:29042362

  14. Hemostasis and Post-operative Care of Oral Surgical Wounds by Hemcon Dental Dressing in Patients on Oral Anticoagulant Therapy: A Split Mouth Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Kumar, K R Ashok; Kumar, Jambukeshwar; Sarvagna, Jagadesh; Gadde, Praveen; Chikkaboriah, Shwetha

    2016-09-01

    Hemostasis is a fundamental management issue post-operatively in minor oral surgical procedures. To ensure safety and therapeutic efficacy in patients, under oral anti coagulant therapy, is complicated by necessity for frequent determination of prothrombin time or international normalised ratio. The aim of the study was to determine whether early hemostasis achieved by using Hemcon Dental Dressing (HDD) will affect post-operative care and surgical healing outcome in minor oral surgical procedures. A total of 30 patients, aged 18 years to 90 years, except those allergic to seafood, who consented to participate, were enrolled into this study. Patients were required to have two or more surgical sites so that they would have both surgical and control sites. All patients taking Oral Anticoagulation Therapy (OAT) were included for treatment in the study without altering the anticoagulant regimens. Institutional Review Board approval was obtained for the same. The collected data was subjected to statistical analysis using unpaired t-test. All HDD surgically treated sites achieved hemostasis in 1.49 minutes and control wounds in 4.06 minutes (p wounds achieved statistically significant improved healing both at 1(st) and 3(rd) post-operative days (p surgical procedures under local anaesthesia, including those patients taking OAT. Patients receiving the HDD had improved surgical wound healing as compared to controls.

  15. Fatal Events in Cancer Patients Receiving Anticoagulant Therapy for Venous Thromboembolism

    Science.gov (United States)

    Farge, Dominique; Trujillo-Santos, Javier; Debourdeau, Philippe; Bura-Riviere, Alessandra; Rodriguez-Beltrán, Eva Maria; Nieto, Jose Antonio; Peris, Maria Luisa; Zeltser, David; Mazzolai, Lucia; Hij, Adrian; Monreal, Manuel

    2015-01-01

    Abstract In cancer patients treated for venous thromboembolism (VTE), including deep-vein thrombosis (DVT) and pulmonary embolism (PE), analyzing mortality associated with recurrent VTE or major bleeding is needed to determine the optimal duration of anticoagulation. This was a cohort study using the Registro Informatizado de Enfermedad TromboEmbólica (RIETE) Registry database to compare rates of fatal recurrent PE and fatal bleeding in cancer patients receiving anticoagulation for VTE. As of January 2013, 44,794 patients were enrolled in RIETE, of whom 7911 (18%) had active cancer. During the course of anticoagulant therapy (mean, 181 ± 210 days), 178 cancer patients (4.3%) developed recurrent PE (5.5 per 100 patient-years; 95% CI: 4.8–6.4), 194 (4.7%) had recurrent DVT (6.2 per 100 patient-years; 95% confidence interval [CI]: 5.3–7.1), and 367 (8.9%) bled (11.3 per 100 patient-years; 95% CI: 10.2–12.5). Of 4125 patients initially presenting with PE, 43 (1.0%) died of recurrent PE and 45 (1.1%) of bleeding; of 3786 patients with DVT, 19 (0.5%) died of PE, and 55 (1.3%) of bleeding. During the first 3 months of anticoagulation, there were 59 (1.4%) fatal PE recurrences and 77 (1.9%) fatal bleeds. Beyond the third month, there were 3 fatal PE recurrences and 23 fatal bleeds. In RIETE cancer patients, the rate of fatal recurrent PE or fatal bleeding was much higher within the first 3 months of anticoagulation therapy. PMID:26266353

  16. [Oral anticoagulants: a literature review of herb-drug interactions or food-drug interactions].

    Science.gov (United States)

    Bourget, S; Baudrant, M; Allenet, B; Calop, J

    2007-01-01

    To identify herbal medicines and food products which can interact with anticoagulant therapy. Literature review using key words: "anticoagulants", "herb-drug interaction", "food-drug interaction", "drug chinese herbal", "medicine herbal", "plant preparation", "dietary supplements". Medline (january 1966 to june 2006) and Pascal (1987 to 2006). Case reports, systematic reviews, in vitro studies, clinical studies published in french or in english (or with an english extract) have been undertaken. Eighty articles were selected (two both including a case report and a study): 14 systemic review, 43 case reports, 25 studies (17 studies in humans: nine randomized and controlled, three controlled), six controlled studies in animals and two in vitro studies. A wide range of herbal medicines and food products can interact with anticoagulants. Clinical relevance of these effects is difficult to characterise (nature of existing reports, contradiction between studies, difficult extrapolation to human). It is difficult to predict the incidence or severity of such interactions. However, awareness of these potential interactions is necessary to achieve optimal anticoagulation therapy: pharmacist can play a crucial role identifying such interactions in case of disturbed INR; clinicians should be informed to monitor closely the therapy, particularly when such products are started or discontinued.

  17. Local hemostatic measures in anticoagulated patients undergoing oral surgery: a systematized literature review

    Directory of Open Access Journals (Sweden)

    Fábio Wildson Gurgel Costa

    2013-01-01

    Full Text Available PURPOSE: To conduct a systematized review of the literature about the main local hemostatic measures to control postoperative bleeding in anticoagulated patients. METHODS: A systematized review of literature was performed in the electronic database Medline (PubMed without restriction of the publication date. The eligibility criteria were studies involving maintenance of the anticoagulant therapy, prospective studies, retrospective studies, randomized clinical trials, controlled clinical studies, comparative studies, multicentric studies or case-control studies. Studies discontinuing anticoagulant therapy, case reports, literature reviews, in vitro studies, animal experiments and articles written in language not compatible with the search strategy adopted in this work were excluded. RESULTS: Twenty-four articles that met the adopted eligibility criteria were selected, enrolling 3891 subjects under anticoagulant therapy. A total of 171 cases of hemorrhage was observed. Tranexamic acid was the main local hemostatic measure used to controlling of postoperative bleeding. CONCLUSION: The local hemostatic measures proved to be effective according to previously published studies. Nevertheless, further clinical studies should be conducted to confirm this effectiveness.

  18. Oral anticoagulant treatment with coumarin derivatives does not influence plasma homocysteine concentration.

    NARCIS (Netherlands)

    Willems, H.P.J.; Heijer, M. den; Gerrits, W.B.J.; Schurgers, L.J.; Havekes, M.; Blom, H.J.; Bos, G.M.

    2006-01-01

    BACKGROUND: High circulating levels of homocysteine are a risk factor for arterial and venous thrombosis. This association has been established in numerous case-control studies. In some of these studies, patients were treated with anticoagulants at the time of venapuncture. It is not clear whether

  19. How much does international normalized ratio monitoring cost during oral anticoagulation with a vitamin K antagonist? A systematic review.

    Science.gov (United States)

    Chambers, S; Chadda, S; Plumb, J M

    2010-08-01

    Next-generation oral anticoagulants offer the potential for effective prevention and treatment of thrombosis without the need for repeated monitoring of the international normalized ratio (INR). This systematic review evaluated the costs associated with INR monitoring tests performed as part of the standard management of oral anticoagulation with vitamin K antagonists. Studies published in or after 1990 reporting the costs of INR monitoring were identified from bibliographic databases and manual searches of reference lists. Cost data were extracted and inflated to the year 2006 before purchasing power parity conversion to US dollars. A total of 29 studies reported the cost of one INR test, which was shown to range from $6.19 to $145.70. Cost estimates were based on various combinations of direct medical costs, such as healthcare contacts, equipment, laboratory tests, clerical costs (postage and stationery), telephone calls, quality control, training/education and patient transportation, and indirect costs, such as time lost from work. In conclusion, the cost of INR monitoring varied substantially between studies depending on the monitoring modality and setting, and the cost categories included. When selecting a published estimate, healthcare decision makers should ensure that the chosen estimate reflects local service provision as closely as possible.

  20. Switching from acenocoumarol to warfarin in patients with unstable anticoagulation and its effect on anticoagulation control.

    Science.gov (United States)

    Undas, Anetta; Cieśla-Dul, Mariola; Zółciński, Marek; Tracz, Wiesława

    2009-06-01

    Unstable oral anticoagulation increases the risk of thrombotic events and bleedings. Acenocoumarol use has been reported to be associated with two-fold higher risk for instability of anticoagulation control compared to warfarin administration. The aim of the study was to evaluate the effect of introducing warfarin on anticoagulation control in patients with a variable response to acenocoumarol. Sixty-eight subjects treated with acenocoumarol for 5 months or more and displaying intraindividual variability of international normalized ratio (INR) results were switched to warfarin. Unstable anticoagulation was defined as a failure to achieve a target INR within the preceding 3 months, i.e. > or = 50% of 8 or more INR values below 2 or above 3.5. Patients with stable anticoagulation (switched from acenocoumarol to warfarin was 22 (32.4%) vs. 63 (92.6%) in patients on stable anticoagulation after 6 months of follow-up (pSwitching acenocoumarol to warfarin in patients with unstable anticoagulation can improve anticoagulation control.

  1. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial.

    Science.gov (United States)

    Vinereanu, Dragos; Lopes, Renato D; Bahit, M Cecilia; Xavier, Denis; Jiang, Jie; Al-Khalidi, Hussein R; He, Wensheng; Xian, Ying; Ciobanu, Andrea O; Kamath, Deepak Y; Fox, Kathleen A; Rao, Meena P; Pokorney, Sean D; Berwanger, Otavio; Tajer, Carlos; de Barros E Silva, Pedro G M; Roettig, Mayme L; Huo, Yong; Granger, Christopher B

    2017-10-14

    Oral anticoagulation is underused in patients with atrial fibrillation. We assessed the impact of a multifaceted educational intervention, versus usual care, on oral anticoagulant use in patients with atrial fibrillation. This study was a two-arm, prospective, international, cluster-randomised, controlled trial. Patients were included who had atrial fibrillation and an indication for oral anticoagulation. Clusters were randomised (1:1) to receive a quality improvement educational intervention (intervention group) or usual care (control group). Randomisation was carried out centrally, using the eClinicalOS electronic data capture system. The intervention involved education of providers and patients, with regular monitoring and feedback. The primary outcome was the change in the proportion of patients treated with oral anticoagulants from baseline assessment to evaluation at 1 year. The trial is registered at ClinicalTrials.gov, number NCT02082548. 2281 patients from five countries (Argentina, n=343; Brazil, n=360; China, n=586; India, n=493; and Romania, n=499) were enrolled from 48 clusters between June 11, 2014, and Nov 13, 2016. Follow-up was at a median of 12·0 months (IQR 11·8-12·2). Oral anticoagulant use increased in the intervention group from 68% (804 of 1184 patients) at baseline to 80% (943 of 1184 patients) at 1 year (difference 12%), whereas in the control group it increased from 64% (703 of 1092 patients) at baseline to 67% (732 of 1092 patients) at 1 year (difference 3%). Absolute difference in the change between groups was 9·1% (95% CI 3·8-14·4); odds ratio of change in the use of oral anticoagulation between groups was 3·28 (95% CI 1·67-6·44; adjusted p value=0·0002). Kaplan-Meier estimates showed a reduction in the secondary outcome of stroke in the intervention versus control groups (HR 0·48, 95% CI 0·23-0·99; log-rank p value=0·0434). A multifaceted and multilevel educational intervention, aimed to improve use of oral

  2. Four Thrombotic Events Over 5 Years, Two Pulmonary Emboli and Two Deep Venous Thrombosis, When Testosterone-HCG Therapy Was Continued Despite Concurrent Anticoagulation in a 55-Year-Old Man With Lupus Anticoagulant.

    Science.gov (United States)

    Glueck, Charles J; Lee, Kevin; Prince, Marloe; Jetty, Vybhav; Shah, Parth; Wang, Ping

    2016-01-01

    When exogenous testosterone or treatments to elevate testosterone (human chorionic gonadotropin [HCG] or Clomid) are prescribed for men who have antecedent thrombophilia, deep venous thrombosis and pulmonary embolism often occur and may recur despite adequate anticoagulation if testosterone therapy is continued. A 55-year-old white male was referred to us because of 4 thrombotic events, 3 despite adequate anticoagulation over a 5-year period. We assessed interactions between thrombophilia, exogenous testosterone therapy, and recurrent thrombosis. In 2009, despite low-normal serum testosterone 334 ng/dL (lower normal limit [LNL] 300 ng/dL), he was given testosterone (TT) cypionate (50 mg/week) and human chorionic gonadotropin (HCG; 500 units/week) for presumed hypogonadism. Ten months later, with supranormal serum T (1385 ng/dL, upper normal limit [UNL] 827 ng/dL) and estradiol (E2) 45 pg/mL (UNL 41 pg/mL), he had a pulmonary embolus (PE) and was then anticoagulated for 2 years (enoxaparin, then warfarin). Four years later, on TT-HCG, he had his first deep venous thrombosis (DVT). TT was stopped and HCG continued; he was anticoagulated (enoxaparin, then warfarin, then apixaban, then fondaparinux). One year after his first DVT, on HCG, still on fondaparinux, he had a second DVT (5/315), was anticoagulated (enoxaparin + warfarin), with a Greenfield filter placed, but 8 days later had a second PE. Thrombophilia testing revealed the lupus anticoagulant. After stopping HCG, and maintained on warfarin, he has been free of further DVT-PE for 9 months. When DVT-PE occur on TT or HCG, in the presence of thrombophilia, TT-HCG should be stopped, lest DVT-PE reoccur despite concurrent anticoagulation.

  3. Administración oral de preparado parenteral de vitamina K en anticoagulación excesiva por warfarina Oral administration of intravenous preparation of Vitamin K for excessive anticoagulation due to warfarin

    Directory of Open Access Journals (Sweden)

    Yoleima Lozada

    2012-04-01

    Full Text Available La warfarina es frecuentemente usada en la terapia anticoagulante actual, su acción debe ser monitorizada usando el tiempo de protrombina expresado como International Normalized Ratio (INR; cuando se excede el rango de seguridad se puede administrar vitamina K (Vit-K, preferentemente por vía oral. Dicha presentación no está disponible en Venezuela. Se realizó un ensayo clínico, doble ciego, donde a 20 pacientes, edad 18-60 años, sin sangrado e INR inicial de 6 a 10 inclusive; les fue suspendida la warfarina e inmediatamente agrupados al azar a recibir dosis única de Vit-K (oral 1.25mg de Vit-K fraccionada de una presentación parenteral o placebo. El punto final primario, INR Anticoagulation therapy with warfarin, a common clinical practice, needs to be monitored using protombine time expressed as the International Normalized Ratio (INR; when safety range is exceeded, Vitamin K (Vit-K could be administered with preference orally. In Venezuela the specific oral preparation for Vit-K is not available. This is a double blinded, randomized, placebo controlled, clinical trial; 20 patients, age 18-60 year with initial INR ≥ 6, ≤10, were randomized to oral Vit-K 1.25mg (prepared from intravenous presentation or placebo plus withholding warfarin. INR < 3.5 at 24 hours of treatment (the primary end point was achieved by 70% among Vit-K, and 20% among placebo patients; given an absolute risk reduction (ARR, of 50% (CI95%: 14.4-85.6 ρ = 0.028, NNT 2 (CI95%: 1.3 - 6.9. No adverse events were recorded including INR < 2 at 24 hours of treatment administration. Our results are consistent with studies where specific oral presentation of Vit-K was used. The results indicate that oral administration of Vit-K, prepared from an intravenous Vit-K preparation, is safe and more effective to revert excessive anticoagulation than simply withholding warfarin, in places where specific preparation of oral Vit-K is not available or too expensive.

  4. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines.

    Science.gov (United States)

    Veitch, Andrew M; Vanbiervliet, Geoffroy; Gershlick, Anthony H; Boustiere, Christian; Baglin, Trevor P; Smith, Lesley-Ann; Radaelli, Franco; Knight, Evelyn; Gralnek, Ian M; Hassan, Cesare; Dumonceau, Jean-Marc

    2016-04-01

    The risk of endoscopy in patients on antithrombotics depends on the risks of procedural haemorrhage vs. thrombosis due to discontinuation of therapy. P2Y12 receptor antagonists (clopidogrel, prasugrel, ticagrelor): For low-risk endoscopic procedures we recommend continuing P2Y12 receptor antagonists as single or dual antiplatelet therapy (low quality evidence, strong recommendation);For high-risk endoscopic procedures in patients at low thrombotic risk, we recommend discontinuing P2Y12 receptor antagonists five days before the procedure (moderate quality evidence, strong recommendation). In patients on dual antiplatelet therapy, we suggest continuing aspirin (low quality evidence, weak recommendation).For high-risk endoscopic procedures in patients at high thrombotic risk, we recommend continuing aspirin and liaising with a cardiologist about the risk/benefit of discontinuation of P2Y12 receptor antagonists (high quality evidence, strong recommendation). Warfarin: The advice for warfarin is fundamentally unchanged from BSG 2008 guidance. Direct Oral Anticoagulants (DOAC): For low-risk endoscopic procedures we suggest omitting the morning dose of DOAC on the day of the procedure (very low quality evidence, weak recommendation). For high-risk endoscopic procedures, we recommend that the last dose of DOAC be taken ≥ 48 hours before the procedure (very low quality evidence, strong recommendation). For patients on dabigatran with CrCl (or estimated glomerular filtration rate, eGFR) of 30 - 50 mL/min we recommend that the last dose of DOAC be taken 72 hours before the procedure (very low quality evidence, strong recommendation). In any patient with rapidly deteriorating renal function a haematologist should be consulted (low quality evidence, strong recommendation). © Georg Thieme Verlag KG Stuttgart · New York.

  5. Towards evidence-based guidelines for the prevention of venous thromboembolism: systematic reviews of mechanical methods, oral anticoagulation, dextran and regional anaesthesia as thromboprophylaxis.

    Science.gov (United States)

    Roderick, P; Ferris, G; Wilson, K; Halls, H; Jackson, D; Collins, R; Baigent, C

    2005-12-01

    To assess the benefits in terms of reductions in the risks of deep vein thrombosis (DVT) and of pulmonary embolism (PE), and hazards in terms of major bleeding, of: (i) mechanical compression; (ii) oral anticoagulants; (iii) dextran; and (iv) regional anaesthesia (as an alternative to general anaesthesia) in surgical and medical patients. Electronic databases, search of Antithrombotic Trialists' Collaboration database, contact with trialists and manufacturers. All trials identified as fitting the selection criteria were independently assessed. The primary outcomes were DVT, PE and major bleeding events, and proximal venous thrombosis (PVT) and fatal PE were secondary outcomes. Trials were subdivided into those that had assessed a method as the only means of thromboprophylaxis ('monotherapy') and those that had assessed the effects of adding a method to another form of thromboprophylaxis ('adjunctive therapy'). Mechanical compression methods reduced the risk of DVT by about two-thirds when used as monotherapy and by about half when added to a pharmacological method. These benefits were similar irrespective of the particular method used (graduated compression stockings, intermittent pneumatic compression or footpumps) and were similar in each of the surgical groups studied. Mechanical methods reduced the risk of PVT by about half and the risk of PE by two-fifths. Oral anticoagulants, when used as monotherapy, reduced the risk of DVT and of PVT by about half, and this protective effect appeared similar in each of the surgical groups studied. There was an apparently large four-fifths reduction in the role of PE, but not only was the magnitude of this reduction statistically uncertain, but also pulmonary embolism was reported by a minority of trials, so it may be subject to selection bias. Oral anticoagulant regimens approximately doubled the risk of major bleeding and appeared less effective at preventing DVT than heparin regimens, although were associated with less

  6. Photoselective vaporization of the prostate in men with a history of chronic oral anti-coagulation

    Directory of Open Access Journals (Sweden)

    Omer F. Karatas

    2010-04-01

    Full Text Available PURPOSE: A considerable percentage of patients with benign prostatic hyperplasia (BPH also have additional cardiac pathologies, which often require anticoagulant therapy. The aim of this study was to evaluate the efficacy and safety of photoselective vaporization of the prostate (PVP for BPH in cardiac patients receiving anticoagulant therapy. MATERIALS AND METHODS: A total of 67 patients suffering from BPH and high risk cardiac pathologies were operated on using laser prostatectomy. All patients had cardiac pathologies with bleeding disorders requiring anticoagulant use, and underwent standard urologic evaluation for BPH. Patients were treated with laser prostatectomy for relief of the obstruction using the KTP/532 laser energy at 80 W. RESULTS: The mean patient age was 71.4 years (range 55-80. Mean prostate volume on transrectal ultrasonography was 73.2 mL (range 44-120. Operation time ranged from 40 to 90 min, with an average value of 55 min. The average hospital stay was 48 hours (range 12-72 and the Foley catheters were removed within 48 hours, with a mean catheterization time of 34.2 ± 5.9 hours (0-48. No patient required an additional procedure due to severe bleeding necessitating intervention during the early postoperative phase. Mean International symptoms scoring system (IPSS values and post voiding residual volume decreased and peak urinary flow rate increased (p < 0.001. Our results showed that the mean prostate volume had decreased by 53% at 6 months. CONCLUSIONS: High-power photo selective laser vaporization prostatectomy is a feasible, safe, and effective alternative for the minimal invasive management of BPH, particularly in cardiac patients receiving anticoagulant therapy.

  7. Perioperative venous thromboembolic disease and the emerging role of the novel oral anticoagulants: An analysis of the implications for perioperative management

    Directory of Open Access Journals (Sweden)

    Martina Mookadam

    2015-01-01

    Full Text Available Venous thromboembolism includes 2 inter-related conditions: Deep venous thrombosis and pulmonary embolism. Heparin and low-molecular-weight heparin followed by oral anticoagulation with vitamin K agonists is the first line and current accepted standard therapy with good efficacy. However, this therapeutic strategy has many limitations including the significant risk of bleeding and drug, food and disease interactions that require frequent monitoring. Dabigatran, rivaroxaban, apixaban, and edoxaban are the novel oral anticoagulants that are available for use in stroke prevention in atrial fibrillation and for the treatment and prevention of venous thromboembolism (HYPERLINK\\l "1. Recent prospective randomized trials comparing the NOACs with warfarin have shown similar efficacy between the treatment strategies but fewer bleeding episodes with the NOACs. This paper presents an evidence-based review describing the efficacy and safety of the new anticoagulants compared to warfarin.

  8. Perioperative venous thromboembolic disease and the emerging role of the novel oral anticoagulants: an analysis of the implications for perioperative management.

    Science.gov (United States)

    Mookadam, Martina; Shamoun, Fadi E; Ramakrishna, Harish; Obeid, Hiba; Rife, Renee L; Mookadam, Farouk

    2015-01-01

    Venous thromboembolism includes 2 inter-related conditions: Deep venous thrombosis and pulmonary embolism. Heparin and low-molecular-weight heparin followed by oral anticoagulation with vitamin K agonists is the first line and current accepted standard therapy with good efficacy. However, this therapeutic strategy has many limitations including the significant risk of bleeding and drug, food and disease interactions that require frequent monitoring. Dabigatran, rivaroxaban, apixaban, and edoxaban are the novel oral anticoagulants that are available for use in stroke prevention in atrial fibrillation and for the treatment and prevention of venous thromboembolism (HYPERLINK\\l "1). Recent prospective randomized trials comparing the NOACs with warfarin have shown similar efficacy between the treatment strategies but fewer bleeding episodes with the NOACs. This paper presents an evidence-based review describing the efficacy and safety of the new anticoagulants compared to warfarin.

  9. Anticoagulation Drug Therapy: A Review

    Directory of Open Access Journals (Sweden)

    Harter, Katherine

    2015-01-01

    Full Text Available Historically, most patients who required parenteral anticoagulation received heparin, whereas those patients requiring oral anticoagulation received warfarin. Due to the narrow therapeutic index and need for frequent laboratory monitoring associated with warfarin, there has been a desire to develop newer, more effective anticoagulants. Consequently, in recent years many novel anticoagulants have been developed. The emergency physician may institute anticoagulation therapy in the short term (e.g. heparin for a patient being admitted, or may start a novel anticoagulation for a patient being discharged. Similarly, a patient on a novel anticoagulant may present to the emergency department due to a hemorrhagic complication. Consequently, the emergency physician should be familiar with the newer and older anticoagulants. This review emphasizes the indication, mechanism of action, adverse effects, and potential reversal strategies for various anticoagulants that the emergency physician will likely encounter. [West J Emerg Med. 2015;16(1:11–17.

  10. Non-vitamin K antagonist oral anticoagulants and major bleeding-related fatality in patients with atrial fibrillation and venous thromboembolism: a systematic review and meta-analysis.

    Science.gov (United States)

    Caldeira, Daniel; Rodrigues, Filipe B; Barra, Márcio; Santos, Ana Teresa; de Abreu, Daisy; Gonçalves, Nilza; Pinto, Fausto J; Ferreira, Joaquim J; Costa, João

    2015-08-01

    Non-vitamin K antagonist oral anticoagulants (NOACs) are efficacious and safe antithrombotic drugs but the non-availability of an antidote for potential fatal haemorrhagic events is clinically perceived as a strong limitation. We aimed at evaluating the risk of haemorrhage-related fatalities associated with NOACs in patients requiring long-term anticoagulation. MEDLINE, Cochrane Library and Web of Science databases were searched in November 2014 for atrial fibrillation (AF) or venous thromboembolism (VTE) phase III randomised controlled trials (RCT) comparing NOACs with vitamin K antagonists (VKAs) or low molecular weight heparin (LMWH) followed by VKAs. Pooled OR and 95% CIs were estimated through meta-analysis. Heterogeneity was assessed with the I(2) test. Eleven studies were included: 5 on AF and 6 on VTE. A total of 100 324 patients were evaluated in 4 rivaroxaban, 3 dabigatran, 2 apixaban and 2 edoxaban studies. NOAC-treated patients had a 47% odds reduction compared with VKA (OR 0.53; 95% CI 0.42 to 0.68; I(2)=0%; 3 events avoided per 1000 patients) and 64% odds reduction compared with LMWH-VKA (OR 0.36; 95% CI 0.15 to 0.84; I(2)=0%; 1 event avoided per 1000 patients) regarding fatal bleeding risk. Case fatality due to major bleeding was lower in NOAC-treated patients both in AF (OR 0.68; 95% CI 0.48 to 0.96; I(2)=37%; 1 death avoided per 39 major bleedings) and VTE (OR 0.54; 95% CI 0.22 to 1.32; I(2)=0%) patients. AF survivors of major bleeding events treated with NOACs had lower mortality compared with patients treated with VKAs (OR 0.57; 95% CI 0.45 to 0.73; I(2)=0%; 78 events avoided per 1000 survivors to major bleeding). These data suggest that NOACs decrease the risk of fatality cases related to major bleeding events, particularly in AF patients. These results support the safety profile of NOACs even without having a widely available drug-specific antidote. Published by the BMJ Publishing Group Limited. For permission to use (where not already

  11. Adherence to recommendations of the Therapeutic Positioning Report about treatment with oral anticoagulants in elderly patients with atrial fibrillation. The ESPARTA study.

    Science.gov (United States)

    Suárez Fernández, Carmen; Mostaza, Jose María; Castilla Guerra, Luis; Cantero Hinojosa, Jesus; Suriñach, Josep Maria; Acosta de Bilbao, Fernando; Tamarit, Juan José; Diaz Diaz, José Luis; Hernandez, Jose Luis; Cazorla, Daniel; Ràfols, Carles

    2017-10-06

    To evaluate the adherence to the recommendations in clinical practice performed by the Therapeutic Positioning Report (TPR) of the Spanish Agency of Medicines and Sanitary Products about the treatment with oral anticoagulants in patients aged≥75 years old with nonvalvular atrial fibrillation (NVAF) treated in Internal Medicine departments in Spain. Observational, cross-sectional and multicenter study in which 837 patients aged≥75 years old with NVAF, with stable treatment with oral anticoagulants at least 3 months before inclusion, and that had started treatment with oral anticoagulants before the inclusion period were included. Mean age was 83.0±5.0 years old, mean CHADS 2 score 3.2±1.2, mean CHA 2 DS 2 -VASc score 5.0±1.4, and mean HAS-BLED score 2.1±0.9. A percentage of 70.8 of patients were treated with vitamin K antagonists (VKA) and the rest of patients with direct oral anticoagulants (DOACs). A percentage of 65.6 of patients treated with VKA did not follow the recommendations made by the TPR compared with 43.0% of patients treated with DOACs (P<.0001). In the case of VKA, the main reason for being considered as not appropriate according to the TPR was having poor control of anticoagulation and not switching to DOACs, whereas in the case of DOACs, it was not receiving the adequate dose according to the TPR. In a high proportion of anticoagulated elderly patients with NVAF in Spain, the recommendations performed by the TPR are not followed, particularly with VKA, since patients are not switched to DOACs despite time in therapeutic range. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  12. Prevention of thromboembolic events in patients with atrial fibrillation – new anticoagulants

    Directory of Open Access Journals (Sweden)

    Alexandre Holthausen Campos

    2011-09-01

    Full Text Available The authors present alternatives for the treatment of cardiacarrhythmias. Its detection is based on the use of different methods that record the cardiac electrical activity. The treatment involves intervening in the underlying disorder, antiarrhythmic drugs, stimulation and cardiac defibrillation devices, and, less often, surgery. The technological advances in the last two decades have provided greater efficiency in diagnoses and therapy. Atrial fibrilation patients will benefit from a new set of anticoagulant drugs tested in the past three years. The potential advantages include greater safety and efficacy, as well as conveniencefor not requiring frequent laboratory controls.

  13. Sensitivity of routine coagulation assays to direct oral anticoagulants: patient samples versus commercial drug-specific calibrators.

    Science.gov (United States)

    Lim, Ming Sheng; Chapman, Kent; Swanepoel, Priscilla; Enjeti, Anoop K

    2016-12-01

    Most studies on the sensitivities of coagulation assays to direct oral anticoagulants (DOACs) are based on normal plasma spiked with anticoagulant in the laboratory. Recent studies have shown that reagent sensitivity varies significantly depending on whether spiked or patient samples are used. The aim of this study was to compare the sensitivities of routine coagulation assays in patient samples and commercial drug specific calibrators using commonly used activated partial thromboplastin time (APTT) and prothrombin time (PT) reagents (i.e., Actin FS and Neoplastine CI Plus for APTT and PT, respectively) in Australian laboratories. Samples collected at Pathology North Hunter (PN-H) for dabigatran (n=39), rivaroxaban, (n=56) or apixaban levels (n=22) between February 2013 and November 2015 were analysed and compared to two different commercial drug specific calibrators from different manufacturers for each DOAC. Our results show that dabigatran (Hyphen and Technoclone) and rivaroxaban (Stago) calibrators tend to overestimate the APTT but are similar to patient samples for PT. A cut-off DOAC level of 50 ng/mL based on results from patient samples within the laboratory can be used as the lower limit which will result in prolongation of APTT for dabigatran (sensitivity 96%, n=25) and PT for rivaroxaban (sensitivity 97%, n=29), respectively. Individual laboratories should be familiar with the sensitivity of their coagulation reagents to different DOACs including differences between patient samples versus different commercial drug specific calibrators. Copyright © 2016 Royal College of Pathologists of Australasia. All rights reserved.

  14. Oral Anticoagulation in Atrial Fibrillation: Development and Evaluation of a Mobile Health Application to Support Shared Decision-Making.

    Science.gov (United States)

    Stephan, Laura Siga; Almeida, Eduardo Dytz; Guimarães, Raphael Boesche; Ley, Antonio Gaudie; Mathias, Rodrigo Gonçalves; Assis, Maria Valéria; Leiria, Tiago Luiz Luz

    2018-02-01

    Atrial fibrillation is responsible for one in four strokes, which may be prevented by oral anticoagulation, an underused therapy around the world. Considering the challenges imposed by this sort of treatment, mobile health support for shared decision-making may improve patients' knowledge and optimize the decisional process. To develop and evaluate a mobile application to support shared decision about thromboembolic prophylaxis in atrial fibrillation. We developed an application to be used during the clinical visit, including a video about atrial fibrillation, risk calculators, explanatory graphics and information on the drugs available for treatment. In the pilot phase, 30 patients interacted with the application, which was evaluated qualitatively and by a disease knowledge questionnaire and a decisional conflict scale. The number of correct answers in the questionnaire about the disease was significantly higher after the interaction with the application (from 4.7 ± 1.8 to 7.2 ± 1.0, p mobile application during medical visits on anticoagulation in atrial fibrillation improves disease knowledge, enabling a shared decision with low decisional conflict. Further studies are needed to confirm if this finding can be translated into clinical benefit.

  15. Oral anticoagulant therapy and clinical outcomes in patients with atrial fibrillation: a pilot study from a single center registry.

    Science.gov (United States)

    Aksan, Gökhan; Soylu, Korhan; Demircan, Sabri; Aksoy, Olcay; Yanık, Ahmet; Gedikli, Ömer; Yüksel, Serkan; Şahin, Mahmut; Yılmaz, Özcan

    2014-10-01

    The data on the successful use of oral anticoagulation (OAC) in patients with atrial fibrillation are inconclusive. We aimed to describe the indications and the utilization patterns of OAC therapy in patients with atrial fibrillation who have been admitted to a quaternary hospital. Patients who were admitted to a quaternary hospital from January 2011 to January 2012 with atrial fibrillation were included in the study. The data on patient demographics, atrial fibrillation classification, CHA2DS2VASc scores, and the use of OAC were collected. Of the patients admitted, 301 patients met the inclusion criteria. Of these, 277 (92%) had a CHA2DS2VASc score at least 2. Of the patients who met criteria for treatment with OAC, 104 (36.6%) were not on OAC therapy. The reason for this discrepancy was tendency and history of bleeding (29.8%). Of those 180 patients who were on OAC, the time in therapeutic range was higher in those patients less than 50 years as compared with those between ages 65-74 and more than 75 (78.2 versus 42 and 36.1%, P < 0.05). The overall time in therapeutic range of patients on OAC was 47.4%. We found that approximately one-third of the patients who have indications for OAC are not being treated as per guidelines due to history of and tendency for bleeding. Furthermore, of those on OAC, only half of the patients achieved successful anticoagulation.

  16. Efficacy and Safety of Direct-Acting Oral Anticoagulants Use in Acute Portal Vein Thrombosis Unrelated to Cirrhosis

    Science.gov (United States)

    Nery, Filipe; Valadares, Diana; Morais, Sara; Gomes, Manuel Teixeira; De Gottardi, Andrea

    2017-01-01

    In acute portal vein thrombosis (APVT) unrelated to cirrhosis, anticoagulant therapy is classically started with low molecular weight heparin or vitamin K antagonists. New direct-acting oral anticoagulants (DOACs) are used in the treatment of venous thrombosis outside the splanchnic vascular bed, but not in the latter. We report a young female with APVT occurring in a non-cirrhotic liver linked to heterozygosity of factor V-Leiden and prothrombin G20210A gene mutations. Rivaroxaban was started, with total recanalization of the left and partial recanalization of the right portal vein branches, without complications. New DOACs do not need daily subcutaneous injections nor routinely blood coagulation control tests, making its use attractive, eventually increasing patient’s compliance. If proved to be safe and effective in the future studies, its use may be extended to PVT treatment. This case shows that rivaroxaban was safe, not only prevented the extension of thrombosis in the portal tract, but also resolved PVT, at least partially. PMID:28496539

  17. The Indian consensus guidance on stroke prevention in atrial fibrillation: An emphasis on practical use of nonvitamin K oral anticoagulants

    Directory of Open Access Journals (Sweden)

    Jamshed Dalal

    2015-12-01

    Full Text Available The last ten years have seen rapid strides in the evolution of nonvitamin K oral anticoagulants (NOACs for stroke prevention in patients with atrial fibrillation (AF. For the preparation of this consensus, a comprehensive literature search was performed and data on available trials, subpopulation analyses, and case reports were analyzed. This Indian consensus document intends to provide guidance on selecting the right NOAC for the right patients by formulating expert opinions based on the available trials and Asian/Indian subpopulation analyses of these trials. A section has been dedicated to the current evidence of NOACs in the Asian population. Practical suggestions have been formulated in the following clinical situations: (i Dose recommendations of the NOACs in different clinical scenarios; (ii NOACs in patients with rheumatic heart disease (RHD; (iii Monitoring anticoagulant effect of the NOACs; (iv Overdose of NOACs; (v Antidotes to NOACs; (vi Treatment of hypertrophic cardiomyopathy (HCM with AF using NOACs; (vii NOACs dose in elderly, (viii Switching between NOACs and vitamin K antagonists (VKA; (ix Cardioversion or ablation in NOAC-treated patients; (x Planned/emergency surgical interventions in patients currently on NOACs; (xi Management of bleeding complications of NOACs; (xii Management of acute coronary syndrome (ACS in AF with NOACs; (xiii Management of acute ischemic stroke while on NOACs.

  18. Subcutaneous low-molecular weight heparin or oral anticoagulants for the prevention of deep-vein thrombosis in elective hip and knee replacement?

    NARCIS (Netherlands)

    Hamulyak, K; Lensing, AWA; vanderMeer, J; Smid, WM; vanOoy, A; Hoek, JA

    1995-01-01

    Objective. To compare efficacy, safety, and feasibility of adjusted-dose oral anticoagulants (OAC) versus fixed-dose subcutaneous low molecular weight heparin (LMWH) for the prevention of deep venous thrombosis (DVT) in patients who have undergone elective hip or knee replacement. Desin.

  19. New Insights into the Pros and Cons of the Clinical Use of Vitamin K Antagonists (VKAs Versus Direct Oral Anticoagulants (DOACs

    Directory of Open Access Journals (Sweden)

    Rick H. van Gorp

    2015-11-01

    Full Text Available Vitamin K-antagonists (VKA are the most widely used anticoagulant drugs to treat patients at risk of arterial and venous thrombosis for the past 50 years. Due to unfavorable pharmacokinetics VKA have a small therapeutic window, require frequent monitoring, and are susceptible to drug and nutritional interactions. Additionally, the effect of VKA is not limited to coagulation, but affects all vitamin K-dependent proteins. As a consequence, VKA have detrimental side effects by enhancing medial and intimal calcification. These limitations stimulated the development of alternative anticoagulant drugs, resulting in direct oral anticoagulant (DOAC drugs, which specifically target coagulation factor Xa and thrombin. DOACs also display non-hemostatic vascular effects via protease-activated receptors (PARs. As atherosclerosis is characterized by a hypercoagulable state indicating the involvement of activated coagulation factors in the genesis of atherosclerosis, anticoagulation could have beneficial effects on atherosclerosis. Additionally, accumulating evidence demonstrates vascular benefit from high vitamin K intake. This review gives an update on oral anticoagulant treatment on the vasculature with a special focus on calcification and vitamin K interaction.

  20. A nationwide registry study to compare bleeding rates in patients with atrial fibrillation being prescribed oral anticoagulants.

    Science.gov (United States)

    Halvorsen, Sigrun; Ghanima, Waleed; Fride Tvete, Ingunn; Hoxmark, Cecilie; Falck, Pål; Solli, Oddvar; Jonasson, Christian

    2017-01-01

    We aimed to evaluate bleeding risk in clinical practice in patients with atrial fibrillation (AF) being prescribed dabigatran, rivaroxaban, or apixaban compared with warfarin. Using nationwide registries (Norwegian Patient Registry and Norwegian Prescription Database), we identified AF patients with a first prescription of oral anticoagulants between January 2013 and June 2015. Patients were followed until discontinuation or switching of oral anticoagulants, death, or end of follow-up. The primary endpoint was major or clinically relevant non-major (CRNM) bleeding. In total 32 675 AF patients were identified (58% men, median age 74 years): 11 427 patients used warfarin, 7925 dabigatran, 6817 rivaroxaban, and 6506 apixaban. After a median follow-up of 173 days (25th, 75th percentile 84, 340), 2081 (6.37%) patients experienced a first major or CRNM bleeding. Using a Cox proportional hazard model adjusting for baseline characteristics, use of apixaban [hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.61-0.80, P < 0.001] and dabigatran (HR 0.74, 95% CI 0.66-0.84, P < 0.001) were associated with a lower risk of major or CRNM bleeding compared with warfarin whereas use of rivaroxaban was not (HR: 1.05, 95% CI 0.94-1.17, P = 0.400). Use of dabigatran and rivaroxaban were associated with higher risk of gastrointestinal bleeding, whereas use of apixaban and dabigatran were associated with lower risk of intracranial bleeding, compared with warfarin. In this nationwide cohort study in AF patients, apixaban and dabigatran were associated with a lower risk of major or CRNM bleeding compared with warfarin. The risk of gastrointestinal bleeding was higher with rivaroxaban and dabigatran compared with warfarin. © The Author 2016. Published on behalf of the European Society of Cardiology.

  1. Oral Anticoagulants Initiation in Patients with Atrial Fibrillation: Real-World Data from a Population-Based Cohort.

    Science.gov (United States)

    Rodríguez-Bernal, Clara L; Hurtado, Isabel; García-Sempere, Aníbal; Peiró, Salvador; Sanfélix-Gimeno, Gabriel

    2017-01-01

    Objective: Little is known about initial prescription of currently used oral anticoagulants (OAC), and correlated characteristics in real-world practice. We aimed to assess patterns of initiation of Vitamin K antagonists (VKA) and non-VKA oral anticoagulants (NOAC) in naive patients with non-valvular atrial fibrillation and the factors associated with starting treatment with NOAC. Methods: Population-based retrospective cohort study of all patients with NVAF who had a first prescription of OAC from November 2011 to February 2014 in the Valencia region, Spain (n = 21,881). Temporal trends of OAC initiation are described for the whole population and by type of OAC and therapeutic agent. Factors associated with starting treatment with NOAC (vs. VKA) were identified using logistic multivariate regression models. Results: Among the patients initiating OAC, 25% started with NOAC 2 years after market release. Regarding temporal trends, prescription of NOAC doubled during the study period. VKA prescription also increased (by around 13%), resulting in a 30% rise in total treatment initiation with OAC during 2011-2014. NOAC initiation (vs. VKA) was associated with a lower baseline risk of thromboembolism and higher income. Conclusions: In this Spanish population-based cohort, initiation of OAC therapy saw a rapid increase, mainly but not exclusively, due to a two-fold rise in the use of NOAC. Initiation with NOAC was associated with a lower baseline risk of thromboembolism and higher income, which opposes the indications of NOAC use and reflects disparities in care. Inadequate prescription patterns might threaten the effectiveness and safety of these therapies, thus monitoring OAC prescription is necessary and should be setting-specific.

  2. Current Management in Transurethral Therapy of Benign Prostatic Obstruction in Patients on Oral Anticoagulation: A Worldwide Questionnaire.

    Science.gov (United States)

    Becker, Benedikt; Knipper, Sophie; Gross, Andreas J; Netsch, Christopher

    2017-02-01

    To assess the current treatment of benign prostatic obstruction (BPO) in patients on ongoing oral anticoagulation (OA). An Internet survey was sent to all active members of the Endourological Society. The survey contained 32 questions regarding transurethral treatment of BPO in patients on ongoing OA, different techniques, and arising complications. Out of all members (n = 2000) of the Endourological Society, 133 participated in our survey. Eighty-eight percent of the participants indicated to perform transurethral therapy of BPO on ongoing OA, whereas 60% of this group temporarily pause the OA during the intervention. Sixteen percent perform >30 transurethral interventions of BPO on ongoing OA per year. Most operations are performed under continuation of aspirin (58.2%). The continuation of adenosine diphosphate (ADP)-receptor inhibitors (22.1%), vitamin K antagonists (18.9%), factor Xa inhibitors (15.6%), or the combination of two oral anticoagulants (16.4%) is continued less often. The decision for the operation on ongoing OA is usually approved by the cardiologist (58%) or it cannot be stopped in case of emergency (29%). GreenLight laser (39%) was the most frequently used technique on ongoing OA, followed by monopolar or bipolar transurethral resection of the prostate (35%) as well as other sources of laser [holmium (12%), thulium (12%), diode laser (2%)]. Although OA was continued during the interventions, cardiovascular complications were observed in 31.6%. Current practice shows that the majority of a representative group of the Endourological Society members perform transurethral therapy of BPO in patients on ongoing OA. The incidence of perioperative complications under transurethral therapy of BPO on ongoing OA is lower than previously assumed.

  3. SAMe-TT2R2 Score in the Outpatient Anticoagulation Clinic to Predict Time in Therapeutic Range and Adverse Events.

    Science.gov (United States)

    Pivatto Junior, Fernando; Scheffel, Rafael Selbach; Ries, Lucas; Wolkind, Ricardo Roitman; Marobin, Roberta; Barkan, Sabrina Sigal; Amon, Luís Carlos; Biolo, Andréia

    2017-04-01

    The SAMe-TT2R2 score was developed to predict which patients on oral anticoagulation with vitamin K antagonists (VKAs) will reach an adequate time in therapeutic range (TTR) (> 65%-70%). Studies have reported a relationship between this score and the occurrence of adverse events. To describe the TTR according to the score, in addition to relating the score obtained with the occurrence of adverse events in patients with nonvalvular atrial fibrillation (AF) on oral anticoagulation with VKAs. Retrospective cohort study including patients with nonvalvular AF attending an outpatient anticoagulation clinic of a tertiary hospital. Visits to the outpatient clinic and emergency, as well as hospital admissions to the institution, during 2014 were evaluated. The TTR was calculated through the Rosendaal´s method. We analyzed 263 patients (median TTR, 62.5%). The low-risk group (score 0-1) had a better median TTR as compared with the high-risk group (score ≥ 2): 69.2% vs. 56.3%, p = 0.002. Similarly, the percentage of patients with TTR ≥ 60%, 65% or 70% was higher in the low-risk group (p vitamina K (AVKs) atingirão um tempo na faixa terapêutica (TFT) adequado (> 65%-70%) no seguimento. Estudos também o relacionaram com a ocorrência de eventos adversos. Descrever o TFT de acordo com o escore, além de relacionar a pontuação obtida com a ocorrência de eventos adversos adversos em pacientes com fibrilação atrial (FA) não valvar em anticoagulação oral com AVKs. Estudo de coorte retrospectivo incluindo pacientes com FA não valvar em acompanhamento em ambulatório de anticoagulação de um hospital terciário. Foi realizada uma avaliação retrospectiva de consultas ambulatoriais, visitas a emergência e internações hospitalares na instituição no período de janeiro-dezembro/2014. O TFT foi calculado aplicando-se o método de Rosendaal. Foram analisados 263 pacientes com TFT mediano de 62,5%. O grupo de baixo risco (0-1 ponto) obteve um TFT mediano maior em

  4. Perioperative Management of Anticoagulants.

    Science.gov (United States)

    Irizarry-Alvarado, Joan M; Seim, Lynsey A

    2017-08-21

    The prevalence of anticoagulant use has increased in the United States. Medical providers have the responsibility to explain to patients the management of anticoagulant regimens before an invasive procedure. The pharmacologic characteristics of these medications-specifically, their half-lives-are important in timing an interruption of anticoagulant therapy. The authors review the current guidelines and recommendations for therapeutic interruption of anticoagulants and the involved pharmacologic factors. Guidelines and other literature are summarized with discussion of the pharmacology of each medication. Recommendations on how and when to provide bridging for anticoagulants are discussed. Newer oral anticoagulants also are discussed, as well as interruption recommendations. Literature reveals a conservative approach at using bridging when anticoagulation is interrupted because of higher risks of bleeding. Caution is advised when resuming anticoagulant therapy when neuraxial anesthesia is used. Perioperative healthcare providers need to balance risks and benefits of anticoagulant therapy with its interruption preoperatively. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  5. Novos anticoagulantes orais no tromboembolismo venoso e fibrilhação auricular New oral anticoagulants in the treatment of venous thromboembolism and atrial fibrillation

    Directory of Open Access Journals (Sweden)

    Luís Silvestre

    2012-03-01

    Full Text Available Os antagonistas da vitamina K foram, durante mais de 50 anos, os únicos anticoagulantes orais disponiveis. A imprevisibilidade da farmacocinética e farmacodinâmica desta classe de fármacos, responsável pela dificuldade na sua utilização, conduziu à necessidade do desenvolvimento de novas moléculas anticoagulantes. Estão actualmente diponíveis os resultados dos estudos de novos anticoagulantes orais no tromboembolismo venoso e na fibrilhação auricular, que se revêem neste trabalho.For more than 50 years, vitamin K antagonists were the only oral anticoagulants available. The unpredictability of its pharmacokinetics and pharmacodynamics, responsible for its difficult clinical management, has raised the need of new anticoagulants. Results of trials involving the new anticoagulants in venous thromboembolism and atrial fibrillation are now available and reviewed in this paper.

  6. Technology-assisted self-testing and management of oral anticoagulation therapy: a qualitative patient-focused study.

    Science.gov (United States)

    Kuljis, Jasna; Money, Arthur G; Perry, Mark; Barnett, Julie; Young, Terry

    2017-09-01

    Oral anticoagulation therapy requires regular blood testing to ensure therapeutic levels are maintained and excessive bleeding/clotting is avoided. Technology-assisted self-testing and management is seen as one of the key areas in which quality of care can be improved whilst reducing costs. Nevertheless, levels of patient engagement in self-testing and management remain low. To date, little research emphasis has been placed on understanding the patients' perspectives for low engagement. The typical approach adopted by healthcare providers is to provide patient education programmes, with the expectation that individual patients will change their behaviour and adopt new self-care strategies. However, if levels of patient engagement are to be increased, healthcare providers must also develop a better understanding of how their clinical service provision is perceived by patients and make adaptations. To explore patient views, needs and expectations of an anticoagulation service and the self-testing and management services provided. Interviews were conducted with 17 patients who currently engage in international normalised ratio (INR) self-testing and management. Thematic coding and analysis were carried out on the interview transcripts. Four high-level themes emerged from interviews: (i) role of clinic, (ii) motivations for self-testing, (iii) managing INR and (iv) trust. The clinic was seen as adding value in terms of specifying testing frequency, dosage profiles and calibrating equipment. Prompt communication from clinic to patient was also valued, although more personalised/real-time communication would help avoid feelings of isolation. Patients felt more in control as self-tester/managers and often took decisions about treatment adjustments themselves. However, some also manipulated their own test results to avoid 'unnecessary' interventions. More personalised/real-time communication, pragmatic and collaborative patient-clinician partnerships and recognition of

  7. Cost-minimisation analysis of oral anticoagulant therapy monitoring methods: the case for prothrombin time self-monitoring.

    Science.gov (United States)

    Geitona, Mary; Hollandezos, Mark; Souliotis, Kyriakos; Athanasakis, Kostas; Kyriopoulos, John

    2008-01-01

    Anticoagulant therapy is usually chronic and is indicated for the treatment of several medical conditions. The most common of these include patients with mechanical heart valves and those suffering from atrial fibrillation. This study compares two methods of oral anticoagulant therapy (OAT) monitoring: traditional prothrombin time measurement and self-measuring or self-regulation by the patient. As numerous published studies indicate that the two methods are equally effective (while underlining significant deviations in the frequency of complications), a cost-minimisation analysis was applied. The methodology was based on the consensus of experts from different geographical regions and health service sets. All costs and benefits attributable to patient treatment were examined and analysed from the perspective of the Greek National Health System (NHS). From the analysis it was estimated that the savings from the use of self-monitoring could reach Euro 6,132,750 at market prices for a five-year period. The potential economic benefit from the expansion of self-monitoring to all eligible patients was equal to approximately 10% of the total treatment cost of the entire patient population under OAT in Greece. In addition, the social benefits resulting from higher prevention rates of possible complications, as well as the improvement in patients' quality of life should not be underestimated. The total reduction in private expenditure deriving from the expansion of self-monitoring was estimated at Euro 3,096,000, while savings for the NHS were estimated at Euro 2,473,317 over a five-year period. The benefit to the healthcare system from the use of self-monitoring is significant, and the further use of this technology could contribute to the rational allocation of healthcare resources.

  8. Is There an Obesity Paradox for Outcomes in Atrial Fibrillation? A Systematic Review and Meta-Analysis of Non-Vitamin K Antagonist Oral Anticoagulant Trials.

    Science.gov (United States)

    Proietti, Marco; Guiducci, Elisa; Cheli, Paola; Lip, Gregory Y H

    2017-04-01

    Obesity is a risk factor for all-cause and cardiovascular death but, despite this, an inverse relationship between overweight or obesity and a better cardiovascular prognosis in long-term follow-up studies has been observed; this phenomenon, described as obesity paradox, has also been found evident in atrial fibrillation cohorts. We performed a systematic review on the relationship between body mass index and major adverse outcomes in atrial fibrillation patients. Moreover, we provided a meta-analysis of non-vitamin K antagonist oral anticoagulants (NOACs) trials. An obesity paradox was found for cardiovascular death and all-cause death in the subgroup analyses of randomized trial cohorts; however, observational studies fail to show this relationship. From the meta-analysis of NOAC trials, a significant obesity paradox was found, with both overweight and obese patients reporting a lower risk for stroke/systemic embolic event (odds ratio [OR], 0.75; 95% confidence interval [CI], 0.66-0.84 and OR, 0.62; 95% CI, 0.54-0.70, respectively). For major bleeding, only obese patients were at lower risk compared with normal weight patients (OR, 0.84; 95% CI, 0.72-0.98). A significant treatment effect of NOACs was found in normal weight patients, both for stroke/systemic embolic event (OR, 0.66; 95% CI, 0.56-0.78) and for major bleeding (OR, 0.72; 95% CI, 0.54-0.95). Major bleeding risk was lower in overweight patients treated with NOACs (OR, 0.84; 95% CI, 0.71-1.00). There may be an obesity paradox in atrial fibrillation patients, particularly for all-cause and cardiovascular death outcomes. An obesity paradox was also evident for stroke/systemic embolic event outcome in NOAC trials, with a treatment effect favoring NOACs over warfarin for both efficacy and safety that was significant only for normal weight patients. © 2017 American Heart Association, Inc.

  9. A single-dose of oral nattokinase potentiates thrombolysis and anti-coagulation profiles.

    Science.gov (United States)

    Kurosawa, Yuko; Nirengi, Shinsuke; Homma, Toshiyuki; Esaki, Kazuki; Ohta, Mitsuhiro; Clark, Joseph F; Hamaoka, Takafumi

    2015-06-25

    Our aim was to determine the quantitative effects of a single-dose of Nattokinase (NK) administration on coagulation/fibrinolysis parameters comprehensively in healthy male subjects. A double-blind, placebo-controlled cross-over NK intervention study was carried out in 12 healthy young males. Following the baseline blood draw, each subject was randomized to receive either a single-dose of 2,000 FU NK (NSK-SD, Japan Bio Science Laboratory Co., Ltd) or placebo with subsequent cross-over of the groups. Subjects donated blood samples at 2, 4, 6 and 8 hours following administration for analysis of coagulation/fibrinolysis parameters. As a result, D-dimer concentrations at 6, and 8 hours, and blood fibrin/fibrinogen degradation products at 4 hours after NK administration elevated significantly (p < 0.05, respectively). Factor VIII activity declined at 4 and 6 hours (p < 0.05, respectively), blood antithrombin concentration was higher at 2 and 4 hours (p < 0.05, respectively), and the activated partial thromboplastin time prolonged significantly at 2 and 4 hours following NK administration (p < 0.05 and p < 0.01, respectively). All the changes, however, were within the normal range. In conclusion, thus, a single-dose of NK administration appears enhancing fibrinolysis and anti-coagulation via several different pathways simultaneously.

  10. The Quandary of Oral Anticoagulation in Patients With Atrial Fibrillation and Chronic Kidney Disease.

    Science.gov (United States)

    Schwartzenberg, Shmuel; Lev, Eli I; Sagie, Alexander; Korzets, Asher; Kornowski, Ran

    2016-02-01

    Compared to patients with normal renal function, the prevalence of atrial fibrillation (AF) in chronic kidney disease (CKD) is increased, as is consequently the stroke prevalence in these patients. This increased risk of stroke in patients with CKD is caused not only by the increased prevalence of AF, but also by associated co-morbidities, and inherent platelet and vascular dysfunction. Paradoxically, imbalance in the same factors also increases the bleeding risk, imposing a dilemma as to whether anticoagulation should be prescribed or deferred, particularly in patients with end-stage renal disease (ESRD), in whom the bleeding diathesis and thromboembolic predisposition are most recalcitrant. Unfortunately, it is in this vulnerable population, in whom therapeutic options are most limited, that evidence-based studies relating to stroke prophylaxis are scarce, discordant and based only on registry observations. Pending randomized controlled studies on this issue, we will review important epidemiologic data and major recent registry-based studies that the clinician has to weigh when making the best decision on the issue of the prophylactic use of warfarin in patients with CKD with AF, focusing on patients with end-stage renal disease. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Self-management of oral anticoagulant therapy for mechanical heart valve patients

    DEFF Research Database (Denmark)

    Christensen, Thomas D; Attermann, Jørn; Pilegaard, Hans K

    2001-01-01

    of self-management of OAT in patients with mechanical heart valve prostheses on a 4-year perspective in a prospective, non-randomized study. Design: Twenty-four patients with mechanical heart valves and on self-managed OAT were followed for up to 4 years. A matched, retrospectively selected group.......4%–2.9%) for the control group. Conclusion: Self-management of OAT is a feasible and safe concept for selected patients with mechanical heart valve prostheses also on a long-term basis. It provides at least as good and most likely better quality of anticoagulant therapy than conventional management assessed by time within...... of conventionally managed heart valve patients (control group) was used as reference. Results: The median observation time was 1175 days (range: 174–1428 days). The self-managed patients were within therapeutic INR target range for a mean of 78.0% (range: 36.1%–93.9%) of the time compared with 61.0% (range 37...

  12. Clinical Outcomes and History of Fall in Patients with Atrial Fibrillation Treated with Oral Anticoagulation: Insights From the ARISTOTLE Trial.

    Science.gov (United States)

    Rao, Meena P; Vinereanu, Dragos; Wojdyla, Daniel M; Alexander, John H; Atar, Dan; Hylek, Elaine M; Hanna, Michael; Wallentin, Lars; Lopes, Renato D; Gersh, Bernard J; Granger, Christopher B

    2017-11-06

    We assessed outcomes among anticoagulated patients with atrial fibrillation and a history of falling, and whether the benefits of apixaban vs warfarin are consistent in this population. Of the 18,201 patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) study, 16,491 had information about history of falling-753 with history of falling and 15,738 without history of falling. The primary efficacy outcome was stroke or systemic embolism; the primary safety outcome was major bleeding. When compared with patients without a history of falling, patients with a history of falling were older, more likely to be female and to have dementia, cerebrovascular disease, depression, diabetes, heart failure, osteoporosis, fractures, and higher CHA2DS2-VASc (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or TIA or thromboembolism, Vascular disease, Age 65-74 years, Sex category female) and HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratio, Elderly, Drugs or alcohol) scores. Patients with a history of falling had higher rates of major bleeding (adjusted hazard ratio [HR] 1.39; 95% confidence interval [CI], 1.05-1.84; P = .020), including intracranial bleeding (adjusted HR 1.87; 95% CI, 1.02-3.43; P = .044) and death (adjusted HR 1.70; 95% CI, 1.36-2.14; P history of falling. Among those with a history of falling, subdural bleeding occurred in 5 of 367 patients treated with warfarin and 0 of 386 treated with apixaban. Patients with atrial fibrillation and a history of falling receiving anticoagulation have a higher risk of major bleeding, including intracranial, and death. The efficacy and safety of apixaban compared with warfarin were consistent, irrespective of history of falling. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Outcomes of Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention Receiving an Oral Anticoagulant and Dual Antiplatelet Therapy: A Comparison of Clopidogrel Versus Prasugrel From the TRANSLATE-ACS Study.

    Science.gov (United States)

    Jackson, Larry R; Ju, Christine; Zettler, Marjorie; Messenger, John C; Cohen, David J; Stone, Gregg W; Baker, Brian A; Effron, Mark; Peterson, Eric D; Wang, Tracy Y

    2015-12-21

    The purpose of this study was to determine whether bleeding risk varies depending on which P2Y12 receptor inhibitor agent is used. Prior studies have shown significant bleeding risk among patients treated with triple therapy (i.e., oral anticoagulant, P2Y12 receptor inhibitor, and aspirin). We evaluated patients with acute myocardial infarction (MI) treated with percutaneous coronary intervention (PCI) at 233 hospitals in the United States enrolled in the TRANSLATE-ACS (Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) study (April 2010 to October 2012). Using inverse probability-weighted propensity modeling, we compared 6-month adjusted risks of Bleeding Academic Research Consortium (BARC) bleeding, stratifying by whether or not bleeding was associated with rehospitalization among patients discharged on aspirin + anticoagulant + clopidogrel (triple-C), aspirin + anticoagulant + prasugrel (triple-P), aspirin + clopidogrel (dual-C), or aspirin + prasugrel (dual-P). Of 11,756 MI patients, 526 (4.5%) were discharged on triple-C, 91 (0.8%) on triple-P, 7,715 (66%) on dual-C, and 3,424 (29%) on dual-P. Compared with dual-therapy patients, triple-therapy patients had significantly higher any BARC-defined bleeding. Triple-P was associated with a greater risk of any BARC-defined bleeding events compared with triple-C. This finding was driven mostly by an increased risk of bleeding events that were patient-reported only and did not require rehospitalization. There were no significant differences in bleeding requiring rehospitalization between the triple-P and -C groups. Among MI patients, the addition of an oral anticoagulant was associated with a significantly greater risk of any BARC-defined bleeding relative to dual antiplatelet therapy, regardless of which P2Y12 receptor inhibitor was selected. Among patients on triple therapy, prasugrel use was associated with higher patient

  14. Treatment Adherence as a New Choice Factor for Optimization of Oral Anticoagulation Therapy in Patients with Atrial Fibrillation and Hemostatic Gene Polymorphisms

    Directory of Open Access Journals (Sweden)

    Yu. P. Skirdenko

    2016-01-01

    Full Text Available Aim. To evaluate treatment adherence and prevalence of CYP2C9 and VKORC1 gene mutations in patients with atrial fibrillation (AF and provide rationale of choice for oral anticoagulation therapy.Material and methods. Treatment adherence was evaluated in 137 AF patients (aged 35-85 years with quantitative estimation of drug therapy adherence along with compliance to medical support and lifestyle modifications. Among them 82 patients underwent polymerase chain reaction (PCR analysis of CYP2C9 and VKORC1 gene polymorphisms.Results. Patients receiving anticoagulation therapy are characterized by lower level of adherence compared to patients without anticoagulants (65.2±19.3% vs 68.5±19.1%; Wald-Wolfowitz; p<0.05. Considering all studied parameters men are less adherent than women (54.7±18.6% vs 60.6±16.7%; Kolmogorov-Smirnov; p<0.05. Patients receiving new oral anticoagulants (NOAC have better compliance compared with patients of warfarin group. Mutations in CYP2C9 gene were detected in 32.9%, VKORC1 – in 68.3%, and their combination – in 21.9% of study participants. Warfarin therapy may be potentially dangerous in such patients due to low adherence.Conclusion. Considering high prevalence of CYP2C9 and VKORC1 gene mutations treatment adherence should be estimated to optimize choice of anticoagulation therapy. NOAC treatment should be considered in patients with low adherence for prevention of thromboembolic complications.

  15. New Prospective for the Management of Low-Risk Pulmonary Embolism: Prognostic Assessment, Early Discharge, and Single-Drug Therapy with New Oral Anticoagulants

    Science.gov (United States)

    2012-01-01

    Patients with pulmonary embolism (PE) can be stratified into two different prognostic categories, based on the presence or absence of shock or sustained arterial hypotension. Some patients with normotensive PE have a low risk of early mortality, defined as <1% at 30 days or during hospital stay. In this paper, we will discuss the new prospective for the optimal management of low-risk PE: prognostic assessment, early discharge, and single-drug therapy with new oral anticoagulants. Several parameters have been proposed and investigated to identify low-risk PE: clinical prediction rules, imaging tests, and laboratory markers of right ventricular dysfunction or injury. Moreover, outpatient management has been suggested for low-risk PE: it may lead to a decrease in unnecessary hospitalizations, acquired infections, death, and costs and to an improvement in health-related quality of life. Finally, the main characteristics of new oral anticoagulant drugs and the most recent published data on phase III trials on PE suggest that the single-drug therapy is a possible suitable option. Oral administration, predictable anticoagulant responses, and few drug-drug interactions of direct thrombin and factor Xa inhibitors may further simplify PE home therapy avoiding administration of low-molecular-weight heparin. PMID:24278706

  16. [The use of the new direct oral anticoagulants among older subjects: The limits of the evidence-based medicine?].

    Science.gov (United States)

    Vogel, T; Lang, P-O; Kaltenbach, G; Karcher, P

    2015-12-01

    The growing use of direct oral anticoagulants, in particular among older subjects, raises questions about the limits of the evidence-based medicine. The phase III studies that have validated the efficacy and the safety profile of these molecules (dabigatran, rivaroxaban, apixaban, edoxaban) in their both indications, the venous thromboembolic disease and the non-valvular atrial fibrillation raise concerns in four major fields: the financial support of pharmaceutical companies, the links of interest for many authors with the industry, the study design (exclusively non-inferiority studies), and the poor representativeness of the older subjects included. All these points are discussed, using data of sub-groups studies, post-marketing studies and recent meta-analysis. The lack of data for the very old subjects, with frailty or comorbidities, remains the main concern from these phase III studies. Copyright © 2015 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.

  17. Utilization of Standard and Target-Specific Oral Anticoagulants Among Adults in the United Kingdom With Incident Atrial Fibrillation.

    Science.gov (United States)

    Durham, Todd A; Hassmiller Lich, Kristen; Viera, Anthony J; Fine, Jason P; Mukherjee, Jayanti; Weinberger, Morris; Dusetzina, Stacie B

    2017-11-15

    New oral anticoagulants (OACs) and updated risk stratification have the potential to improve the quality of care for patients with atrial fibrillation (AF). To describe the time from AF diagnosis to the initiation of an OAC, characteristics associated with treatment, and the incidence of switching OACs, we conducted this retrospective cohort study of 23,018 adults with incident AF receiving care between 2010 and 2014 in 647 primary care practices participating in the United Kingdom Clinical Practice Research Datalink. In patients with moderate to high stroke risk (CHA2DS2-VASc ≥ 2), the median time from diagnosis to OAC initiation decreased from 10 to 2 months. Among 980 at very low stroke risk (CHA2DS2-VASc = 0), 29% received OAC prescriptions after 90 days. Being prescribed an OAC was associated with a history of stroke or transient ischemic attack (relative risk 1.3); severe dementia or psychosis was most associated with not being prescribed an OAC (relative risk 0.3). After 1 year, the risk of OAC switching was higher for patients initiating dabigatran (19%) than warfarin (6%), rivaroxaban (8%), or apixaban (9%). The prescribing of OACs in moderate-to-high-risk patients in the United Kingdom increased annually; 1/3 of very low-risk patients were prescribed OACs contrary to guidance. In conclusion, future research should refine decision-making tools to minimize the unwanted effects of underutilization and overutilization of OACs. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Non-vitamin K oral anticoagulants are non-inferior for stroke prevention but cause fewer major bleedings than well-managed warfarin: A retrospective register study.

    Directory of Open Access Journals (Sweden)

    Vilhelm Sjögren

    Full Text Available For patients with atrial fibrillation, non-vitamin K oral anticoagulants, or NOACs (dabigatran, rivaroxaban, edoxaban, and apixaban have been proven non-inferior or superior to warfarin in preventing stroke and systemic embolism, and in risk of haemorrhage. In the pivotal NOAC studies, quality of warfarin treatment was poor with mean time in therapeutic range (TTR 55-65%, compared with ≥70% in Swedish clinical practice.We compared NOACs (as a group to warfarin in non-valvular atrial fibrillation, studying all 12,694 patients starting NOAC treatment within the Swedish clinical register and dosing system Auricula, from July 1, 2011 to December 31, 2014, and matching them to 36,317 patients starting warfarin using propensity scoring. Endpoints were thromboembolic events and major bleedings that were fatal or required hospital care. Outcome data were collected from validated Swedish hospital administrative and clinical registers.Mean age was 72.2 vs 72.3 years, proportion of males 58.2% vs 57.0%, and mean follow-up time 299 vs 283 days for NOACs and warfarin. Distribution of NOACs was: dabigatran 40.3%, rivaroxaban 31.2%, and apixaban 28.5%. Mean TTR was 70%. There were no significant differences in rates of thromboembolic/thrombotic events or gastrointestinal bleeding. NOAC treated patients had lower rates of major bleeding overall, hazard ratio 0.78 (95% confidence interval 0.67-0.92, intracranial bleeding 0.59 (0.40-0.87, haemorrhagic stroke 0.49 (0.28-0.86, and other major bleeding 0.71 (0.57-0.89.For patients with atrial fibrillation, NOACs are as effective for stroke prevention as well-managed warfarin but cause fewer major bleedings.

  19. The European Heart Rhythm Association Practical Guide on the Use of New Oral Anticoagulants in Patients with Non-valvular Atrial Fibrillation – A Brief Summary

    Science.gov (United States)

    Kirchhof, Paulus

    2013-01-01

    New oral anticoagulants (NOACs) are an alternative to vitamin K antagonists (VKAs) in the prevention of stroke in patients with non-valvular atrial fibrillation (AF). The European Heart Rhythm Association (EHRA) has produced a practical guide to detail the use of NOACs in clinical practice. The guide includes a practical start-up and follow-up scheme, emphasising the importance of strict adherence to the regimen – the anticoagulant effect drops rapidly after 12–24 hours. There is also guidance on how to measure the anticoagulant effect of NOACs, switching between anticoagulant regimes and dealing with dosing errors. Physicians will have to consider the pharmacokinetic effect of drugs and co-morbidities when prescribing NOACs – plasma levels of NOACs may be affected by P-glycoprotein (P-gp) substrates, as well as cytochrome P450 (CYP3A4) inducers or inhibitors. In patients with chronic kidney disease, reduced doses of NOACs may be indicated. Guidance is also given on the management of bleeding complications, and the cessation and reinitiation of NOACs in patients undergoing surgical interventions. Finally, the use of NOACs in specific clinical situations is considered; these include patients with AF and coronary artery disease (CAD), patients presenting with acute stroke while taking NOACs and patients with cancer. PMID:26835051

  20. The European Heart Rhythm Association Practical Guide on the Use of New Oral Anticoagulants in Patients with Non-valvular Atrial Fibrillation - A Brief Summary.

    Science.gov (United States)

    Kirchhof, Paulus

    2013-11-01

    New oral anticoagulants (NOACs) are an alternative to vitamin K antagonists (VKAs) in the prevention of stroke in patients with non-valvular atrial fibrillation (AF). The European Heart Rhythm Association (EHRA) has produced a practical guide to detail the use of NOACs in clinical practice. The guide includes a practical start-up and follow-up scheme, emphasising the importance of strict adherence to the regimen - the anticoagulant effect drops rapidly after 12-24 hours. There is also guidance on how to measure the anticoagulant effect of NOACs, switching between anticoagulant regimes and dealing with dosing errors. Physicians will have to consider the pharmacokinetic effect of drugs and co-morbidities when prescribing NOACs - plasma levels of NOACs may be affected by P-glycoprotein (P-gp) substrates, as well as cytochrome P450 (CYP3A4) inducers or inhibitors. In patients with chronic kidney disease, reduced doses of NOACs may be indicated. Guidance is also given on the management of bleeding complications, and the cessation and reinitiation of NOACs in patients undergoing surgical interventions. Finally, the use of NOACs in specific clinical situations is considered; these include patients with AF and coronary artery disease (CAD), patients presenting with acute stroke while taking NOACs and patients with cancer.

  1. Adverse outcomes of anticoagulant use among hospitalized patients with chronic kidney disease: a comparison of the rates of major bleeding events between unfractionated heparin and enoxaparin.

    Directory of Open Access Journals (Sweden)

    Fatemeh Saheb Sharif-Askari

    Full Text Available BACKGROUND: Anticoagulation therapy is usually required in patients with chronic kidney disease (CKD for treatment or prevention of thromboembolic diseases. However, this benefit could easily be offset by the risk of bleeding. OBJECTIVES: To determine the incidence of adverse outcomes of anticoagulants in hospitalized patients with CKD, and to compare the rates of major bleeding events between the unfractionated heparin (UFH and enoxaparin users. METHODS: One year prospective observational study was conducted in patients with CKD stages 3 to 5 (estimated GFR, 10-59 ml/min/1.73 m(2 who were admitted to the renal unit of Dubai Hospital. Propensity scores for the use of anticoagulants, estimated for each of the 488 patients, were used to identify a cohort of 117 pairs of patients. Cox regression method was used to estimate association between anticoagulant use and adverse outcomes. RESULTS: Major bleeding occurred in 1 in 3 patients who received anticoagulation during hospitalization (hazard ratio [HR], 4.61 [95% confidence interval [CI], 2.05-10.35]. Compared with enoxaparin users, patients who received anticoagulation with unfractionated heparin had a lower mean [SD] serum level of platelet counts (139.95 [113] × 10(3/µL vs 205.56 [123] × 10(3/µL; P<0.001, and had a higher risk of major bleeding (HR, 4.79 [95% CI, 1.85-12.36]. Furthermore, compared with those who did not receive anticoagulants, patients who did had a higher in-hospital mortality (HR, 2.54 [95% CI, 1.03-6.25]; longer length of hospitalization (HR, 1.04 [95% CI, 1.01-1.06]; and higher hospital readmission at 30 days (HR, 1.79 [95% CI, 1.10-2.91]. CONCLUSIONS: Anticoagulation among hospitalized patients with CKD was significantly associated with an increased risk of bleeding and in-hospital mortality. Hence, intensive monitoring and preventive measures such as laboratory monitoring and/or dose adjustment are warranted.

  2. Antiplatelet Therapy for Stable Coronary Artery Disease in Atrial Fibrillation Patients on Oral Anticoagulant

    DEFF Research Database (Denmark)

    Lamberts, Morten; Gislason, Gunnar Hilmar; Lip, Gregory Y.H.

    2014-01-01

    of cardiovascular events and serious bleeding events (those that required hospitalization) was examined with adjusted Cox regression models according to ongoing antithrombotic therapy. A total of 8700 patients were included (mean age, 74.2 years; 38% women). During a mean follow-up of 3.3 years, crude incidence...... rates were 7.2, 3.8, and 4.0 events per 100 person-years for myocardial infarction/coronary death, thromboembolism, and serious bleeding, respectively. Relative to VKA monotherapy, the risk of myocardial infarction/coronary death was similar for VKA plus aspirin (hazard ratio, 1.12 [95% confidence...... interval, 0.94-1.34]) and VKA plus clopidogrel (hazard ratio, 1.53 [95% confidence interval, 0.93-2.52]). The risk of thromboembolism was comparable in all regimens that included VKA, whereas the risk of bleeding increased when aspirin (hazard ratio, 1.50 [95% confidence interval, 1...

  3. Gastrointestinal bleedings during therapy with new oral anticoagulants are rarely reported

    DEFF Research Database (Denmark)

    Bay-Nielsen, Morten; Kampmann, Jens Peter; Bisgaard, Thue

    2014-01-01

    , Surgical Section, Hvidovre Hospital, during a one-year-period. Patients in treatment with NOAC and admitted for gastrointestinal bleeding were identified. Relevant patients were cross-checked for a reported adverse drug event in the Danish Health and Medi-cines Authority's database on adverse medical...

  4. The c.-1639g>A polymorphism of the VKORC1 gene and his influence on the therapeutic response during oral anticoagulants use

    Directory of Open Access Journals (Sweden)

    Kovač Mirjana

    2009-01-01

    Full Text Available Background/Aim. A single nucleotide polymorphism c.- 1639G>A in the promoter region of vitamin K-epoxide reductase (VKORC1 gene has been found to account for most of the variability in response to oral anticoagulants (OA. The aim of the study was to determine the incidence and the effect of c.-1639G>A polymorphism on the acenocoumarol dosage requirements in the group of patients under stable anticoagulation, and to estimate the variability in response to OA. Methods. Our study included 200 consecutive patients requiring low (n = 43, medium (n = 127 and high (n = 30 acenocoumarol dose. Results. Out of 43 low dose patients, 40 (93 % carried the A allele. The A allele was less frequent in the group of 30 patients requiring high dose: among these patients 13 (43.3% carried the A allele in the heterozygous form and none of them carried AA genotype. The patients with GG genotype required 2.6 times higher dose than the patients carriers of AA genotype (p < 0.0001. In 33 patients (16.5% the overdose occurred during the initiation of anticoagulant therapy and in 11 patients (5.5% it was associated with bleeding. Out of the group of 33 overdosed patients, 27 and 6 patients carried AA and GA genotype, respectively (p < 0.000001. Conclusion. VKORC1 significantly influenced OA dose and predicted individuals predisposed to unstable anticoagulation. The carriers of AA genotype required 2.6 time lower doses of OA than the carriares of GG genotype. Pharmacogenetic testing could predict a high risk of overdose among 28.5 % of our patients - carriers of AA genotype, before anticoagulation therapy initiation.

  5. Point-of-Care International Normalized Ratio (INR) Monitoring Devices for Patients on Long-term Oral Anticoagulation Therapy: An Evidence-Based Analysis.

    Science.gov (United States)

    2009-01-01

    SUBJECT OF THE EVIDENCE-BASED ANALYSIS: The purpose of this evidence based analysis report is to examine the safety and effectiveness of point-of-care (POC) international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy (OAT). TARGET POPULATION AND CONDITION Long-term OAT is typically required by patients with mechanical heart valves, chronic atrial fibrillation, venous thromboembolism, myocardial infarction, stroke, and/or peripheral arterial occlusion. It is estimated that approximately 1% of the population receives anticoagulation treatment and, by applying this value to Ontario, there are an estimated 132,000 patients on OAT in the province, a figure that is expected to increase with the aging population. Patients on OAT are regularly monitored and their medications adjusted to ensure that their INR scores remain in the therapeutic range. This can be challenging due to the narrow therapeutic window of warfarin and variation in individual responses. Optimal INR scores depend on the underlying indication for treatment and patient level characteristics, but for most patients the therapeutic range is an INR score of between 2.0 and 3.0. The current standard of care in Ontario for patients on long-term OAT is laboratory-based INR determination with management carried out by primary care physicians or anticoagulation clinics (ACCs). Patients also regularly visit a hospital or community-based facility to provide a venous blood samples (venipuncture) that are then sent to a laboratory for INR analysis. Experts, however, have commented that there may be under-utilization of OAT due to patient factors, physician factors, or regional practice variations and that sub-optimal patient management may also occur. There is currently no population-based Ontario data to permit the assessment of patient care, but recent systematic reviews have estimated that less that 50% of patients receive OAT on a routine basis and that patients

  6. Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants.

    Science.gov (United States)

    Stolk, Leo M; de Vries, Frank; Ebbelaar, Chiel; de Boer, Anthonius; Schalekamp, Tom; Souverein, Patrick; Ten Cate-Hoek, Arina; Burden, Andrea M

    2017-08-01

    Direct-acting oral anticoagulants (DOACs) have become available for the prevention of stroke in patients with atrial fibrillation (AF). Conflicting results have been published on the risk of acute myocardial infarction (AMI) with the use of DOACs in comparison with vitamin K antagonists (VKAs). The objective of the present study was to evaluate the risk of AMI in patients with AF who are exposed to either VKAs, DOACs or low-dose (aspirin. We conducted a population-based cohort study using data from the Clinical Practice Research Datalink (2008-2014). The study population (n = 30 146) consisted of all patients ≥18 years with a diagnosis of AF who were new users of VKAs, DOACs (rivaroxaban and dabigatran) or aspirin. Cox proportional hazards models were used to estimate the hazard ratio (HR) of AMI for users of DOACs or aspirin vs. VKA. Adjustments were made for age, gender, lifestyle, risk factors, comorbidity and other drugs. The risk of AMI was doubled when we compared current use of DOACs with current use of VKAs [adjusted HR 2.11; 95% confidence interval (CI) 1.08, 4.12] and for current users of aspirin vs. current VKA users (adjusted HR 1.91; 95% CI 1.45, 2.51). There is a twofold increase in the risk of AMI for users of DOACs, in comparison with VKAs, in AF therapy. In addition, the results suggested that in patients with AF, the incidence of AMI is higher during aspirin monotherapy than during the use of VKAs. © 2017 The British Pharmacological Society.

  7. A novel prothrombin time method to measure all non-vitamin K-dependent oral anticoagulants (NOACs).

    Science.gov (United States)

    Lindahl, Tomas L; Arbring, Kerstin; Wallstedt, Maria; Rånby, Mats

    2017-08-01

    There is a clinical need for point-of-care (POC) methods for non-vitamin K-dependent oral anticoagulants (NOACs). We modified a routine POC procedure: Zafena's Simple Simon™ PT-INR, a room-temperature, wet-chemistry prothrombin time method of the Owren-type. To either increase or decrease NOAC interference, two assay variants were devised by replacing the standard 10 µL end-to-end capillary used to add the citrated plasma sample to 200 µL of prothrombin time (PT) reagent by either a 20 µL or a 5 µL capillary. All assay variants were calibrated to show correct PT results in plasma samples from healthy and warfarin-treated persons. For plasmas spiked with dabigatran, apixaban, or rivaroxaban, the 20 µL variant showed markedly higher PT results than the 5 µL. The effects were even more pronounced at room temperature than at +37 °C. In plasmas from patients treated with NOACs (n = 30 for each) there was a strong correlation between the PT results and the concentration of NOACs as determined by the central hospital laboratory. For the 20 µL variant the PT response of linear correlation coefficient averaged 0.90. The PT range was INR 1.1-2.1 for dabigatran and apixaban, and INR 1.1-5.0 for rivaroxaban. Using an INR ratio between the 20 µL and 5 µL variants (PTr20/5) made the NOAC assay more robust and independent of the patient sample INR value in the absence of NOAC. Detection limits were 80 µg/L for apixaban, 60 µg/L for dabigatran, and 20 µg/L for rivaroxaban. A wet-chemistry POC PT procedure was modified to measure the concentrations of three NOACs using a single reagent.

  8. Risk of renal failure with the non-vitamin K antagonist oral anticoagulants: systematic review and meta-analysis.

    Science.gov (United States)

    Caldeira, Daniel; Gonçalves, Nilza; Pinto, Fausto J; Costa, João; Ferreira, Joaquim J

    2015-07-01

    Vitamin K antagonists (VKA)-related nephropathy is a novel entity characterized by acute kidney injury related to International Normalized Ratio supratherapeutic levels. Non-vitamin K antagonists oral anticoagulants (NOACs) have a predictable dose-response relationship and an improved safety profile. We hypothesized that these drugs do not have an increased risk of incident renal failure, which may be detrimental for the use of NOACs. Systematic review and meta-analysis of phase III randomized controlled trials (RCTs). Trials were searched through Medline, Cochrane Library and public assessment reports in August 2014. Primary outcome was renal failure. NOACs were evaluated against any comparator. Random-effects meta-analysis was performed by default, and pooled estimates were expressed as Risk Ratio (RR) and 95%CI. Heterogeneity was evaluated with I(2) test. Ten RCTs fulfilled inclusion criteria (one apixaban RCT, three dabigatran RCTs, and six rivaroxaban RCTs), enrolling 75 100 patients. Overall NOACs did not increase the risk of renal failure with an RR 0.96, 95%CI 0.88-1.05 compared with VKA or Low-molecular weight heparin (LMWH), without significant statistical heterogeneity (I(2)  = 3.5%). Compared with VKA, NOACs did not increase the risk of renal failure (RR 0.96, 95%CI 0.87-1.07; I(2)  = 17.8%; six RCTs). Rivaroxaban did not show differences in the incidence of renal failure compared with LMWH (RR 1.20, 95%CI 0.37-3.94; four trials), but there was an increased risk of creatinine elevation RR 1.25, 95%CI 1.08-1.45; I(2)  = 0%. NOACs had a similar risk of renal failure compared with VKA/LMWH in phase III RCTs. Post-marketing surveillance should be warranted. Copyright © 2015 John Wiley & Sons, Ltd.

  9. Symptoms of depression and anxiety predict mortality in patients undergoing oral anticoagulation: Results from the thrombEVAL study program.

    Science.gov (United States)

    Michal, Matthias; Prochaska, Jürgen H; Keller, Karsten; Göbel, Sebastian; Coldewey, Meike; Ullmann, Alexander; Schulz, Andreas; Lamparter, Heidrun; Münzel, Thomas; Reiner, Iris; Beutel, Manfred E; Wild, Philipp S

    2015-01-01

    Depression and anxiety are highly prevalent in cardiovascular patients. Therefore, we examined whether the 4-item Patient Health Questionnaire (PHQ-4, measuring symptoms of depression and anxiety) predicts all-cause mortality in outpatients with long-term oral anticoagulation (OAC). The sample comprised n=1384 outpatients from a regular medical care setting receiving long-term OAC with vitamin K antagonists. At baseline, symptoms of anxiety and depression were assessed with the PHQ-4 and the past medical history was taken. The outcome was all-cause mortality in the 24 month observation period. The median follow-up time was 13.3 months. N=191 patients from n=1384 died (death rate 13.8%). Each point increase in the PHQ-4 score was associated with a 10% increase in mortality (hazard ratio [HR] 1.10, 95% confidence interval [95% CI] 1.05-1.16) after adjustment for age, sex, high school graduation, partnership, smoking, obesity, frailty according to the Barthel Index, Charlson Comorbidity Index and CHA2DS2-VASc score. The depression component (PHQ-2) increased mortality by 22% and anxiety (GAD-2) by 11% respectively. Neither medical history of any mental disorder, nor intake of antidepressants, anxiolytics or hypnotics predicted excess mortality. Elevated symptoms of depression and, to a lesser degree, symptoms of anxiety are independently associated with all-cause mortality in OAC outpatients. The PHQ-4 questionnaire provides valuable prognostic information. These findings emphasize the need for implementing regular screening procedures and the development and evaluation of appropriate psychosocial treatment approaches for OAC patients. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  10. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants.

    Science.gov (United States)

    Ebner, Matthias; Birschmann, Ingvild; Peter, Andreas; Spencer, Charlotte; Härtig, Florian; Kuhn, Joachim; Blumenstock, Gunnar; Zuern, Christine S; Ziemann, Ulf; Poli, Sven

    2017-02-15

    Point-of-care testing (POCT) of coagulation has been proven to be of great value in accelerating emergency treatment. Specific POCT for direct oral anticoagulants (DOAC) is not available, but the effects of DOAC on established POCT have been described. We aimed to determine the diagnostic accuracy of Hemochron® Signature coagulation POCT to qualitatively rule out relevant concentrations of apixaban, rivaroxaban, and dabigatran in real-life patients. We enrolled 68 patients receiving apixaban, rivaroxaban, or dabigatran and obtained blood samples at six pre-specified time points. Coagulation testing was performed using prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (aPTT), and activated clotting time (ACT+ and ACT-low range) POCT cards. For comparison, laboratory-based assays of diluted thrombin time (Hemoclot) and anti-Xa activity were conducted. DOAC concentrations were determined by liquid chromatography-tandem mass spectrometry. Four hundred and three samples were collected. POCT results of PT/INR and ACT+ correlated with both rivaroxaban and dabigatran concentrations. Insufficient correlation was found for apixaban. Rivaroxaban concentrations at 95% specificity at PT/INR POCT ≤1.0 and ≤1.1 and ACT+ POCT ≤120 and ≤130 s. Dabigatran concentrations at 95% specificity at PT/INR POCT ≤1.1 and ≤1.2 and ACT+ POCT ≤100 s. Hemochron® Signature POCT can be a fast and reliable alternative for guiding emergency treatment during rivaroxaban and dabigatran therapy. It allows the rapid identification of a relevant fraction of patients that can be treated immediately without the need to await the results of much slower laboratory-based coagulation tests. Unique identifier, NCT02371070 . Retrospectively registered on 18 February 2015.

  11. Efficacy and safety of the new oral anticoagulants in the treatment of venous thromboembolic complications: meta-analysis

    Directory of Open Access Journals (Sweden)

    V. I. Petrov

    2016-01-01

    Full Text Available Aim. Analysis of the efficacy and safety of the new oral anticoagulants (NOACs in the management of venous thromboembolism (VTE.Material and methods. This meta-analysis of randomized controlled trials (RCTs was made in accordance with the instructions “Preferred reporting items for systematic reviews and meta-analyses (PRISMA”.Results. The meta-analysis included 5 RCTs. NOACs were as effective as vitamin K antagonists (VKAs in preventing recurrent symptomatic VTE (RR=0.93; 95% CI 0.77-1.12; p=0.44. The incidence of recurrent thrombosis (RR=0.82; 95% CI 0.63-1.08; p=0.16 and deep vein thrombosis ± fatal or nonfatal pulmonary embolism (RR=1.06; 95% CI 0.81-1.40; p=0.66 was comparable in the groups of comparison. Meta-analysis of the safety of the NOACs suggested significant reduction of risk of major bleeding as compared with standard therapy (RR=0.54; 95% CI 0.42-0.69; р<0.00001. The incidence of all types of bleeding was significantly lower with NOACs (RR=0.70; 95% CI 0.51-0.95; p=0.02. All-cause mortality rate was comparable between the groups (RR=0.93; 95% CI 0.76-1.13; p=0.46.Conclusions. NOACs are as effective as the standard therapy, at that they are much safer in VTE treatment.

  12. Efficacy and safety of the drugs used to reverse direct oral anticoagulants: a systematic review and meta-analysis.

    Science.gov (United States)

    da Luz, Luis Teodoro; Marchand, Mylene; Nascimento, Bartolomeu; Tien, Homer; Nathens, Avery; Shah, Prakesh

    2017-07-01

    Direct oral anticoagulants (DOACs) are effective and safe for prophylaxis and treatment of thromboembolic phenomena. However, managing DOACs during bleeding emergencies is challenging. A systematic review and meta-analysis was conducted on studies addressing efficacy and safety of the drugs used for reversal of DOACs. Medline, Embase, Cochrane Library, and ClinicalTrials.gov were searched up to September 2016. Studies that examined clinical and laboratory effects of drugs used to reverse DOACs were included. Risk of bias was assessed using Newcastle-Ottawa scale and Cochrane Collaboration tool. Primary and secondary outcomes assessed were reversal of clinical bleeding, clotting assays, and safety, respectively. Overall effect estimates were pooled, and clinical and statistical heterogeneity were assessed. Meta-analysis was conducted using random-effects model. Four cohort studies in bleeding patients (n = 230) and eight randomized controlled trials in healthy volunteers (n = 381) were included, both with moderate risk of bias. Reversal of clotting assays in healthy volunteers was frequently reported, demonstrating that prothrombin complex concentrate (PCC) reversed prothrombin time (PT) and endogenous thrombin potential (ETP) substantially. For PT, pooled mean difference was 1.68 seconds (95% confidence interval [CI], -0.33 to 3.70 sec; p < 0.01; I(2)  = 97%). For ETP, pooled mean difference was 2.16 seconds (95% CI, 0.57 to 3.75 sec; p < 0.01; I(2)  =( ) 98%). Andexanet alfa and idarucizumab both reverse clotting assays. No important safety concerns were identified. Clotting assays are partially reversed by PCC in healthy volunteers. Idarucizumab and andexanet alfa have solid laboratory reversal effect and potential to be clinically efficacious and safe. However, clinical evidence is still lacking for all agents. © 2017 AABB.

  13. Nonvitamin K antagonist oral anticoagulants (NOACs: the tide continues to come in

    Directory of Open Access Journals (Sweden)

    Blann A

    2015-08-01

    Full Text Available Andrew Blann University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, UKThrombosis is the major common endpoint in most human diseases. In the coronary circulation, occlusive thrombi and/or the rupture of atherosclerotic plaque causes myocardial infarction, and in the cerebral circulation thrombosis, causes ischemic stroke. In the venous circulation, venous thromboembolism (VTE, manifesting clinically as pulmonary embolus and deep vein thrombosis (DVT, is a frequent complication among inpatients, and contributes to longer hospital stays with increased morbidity and mortality. Until perhaps 5 years ago, heparinoids (unfractionated heparin, low molecular weight heparin [LMWH], and fondaparinux and vitamin K antagonists (VKAs: warfarin, acenocoumarol, phenocoumarol were the only options for the prevention of thrombotic stroke in atrial fibrillation, and of VTE in general. Although effective, these traditional drugs have several practical, management, and clinical disadvantages, a fact that our colleagues in industry have not been slow to recognize and address by developing improved drugs, now collectively known as nonvitamin K antagonist oral anti coagulants (NOACs. These agents are steadily replacing the heparinoids and VKAs in both inpatient and outpatient prevention and treatment of thrombosis.

  14. Geriatric Patient Safety Indicators Based on Linked Administrative Health Data to Assess Anticoagulant-Related Thromboembolic and Hemorrhagic Adverse Events in Older Inpatients: A Study Proposal.

    Science.gov (United States)

    Le Pogam, Marie-Annick; Quantin, Catherine; Reich, Oliver; Tuppin, Philippe; Fagot-Campagna, Anne; Paccaud, Fred; Peytremann-Bridevaux, Isabelle; Burnand, Bernard

    2017-05-11

    Frail older people with multiple interacting conditions, polypharmacy, and complex care needs are particularly exposed to health care-related adverse events. Among these, anticoagulant-related thromboembolic and hemorrhagic events are particularly frequent and serious in older inpatients. The growing use of anticoagulants in this population and their substantial risk of toxicity and inefficacy have therefore become an important patient safety and public health concern worldwide. Anticoagulant-related adverse events and the quality of anticoagulation management should thus be routinely assessed to improve patient safety in vulnerable older inpatients. This project aims to develop and validate a set of outcome and process indicators based on linked administrative health data (ie, insurance claims data linked to hospital discharge data) assessing older inpatient safety related to anticoagulation in both Switzerland and France, and enabling comparisons across time and among hospitals, health territories, and countries. Geriatric patient safety indicators (GPSIs) will assess anticoagulant-related adverse events. Geriatric quality indicators (GQIs) will evaluate the management of anticoagulants for the prevention and treatment of arterial or venous thromboembolism in older inpatients. GPSIs will measure cumulative incidences of thromboembolic and bleeding adverse events based on hospital discharge data linked to insurance claims data. Using linked administrative health data will improve GPSI risk adjustment on patients' conditions that are present at admission and will capture in-hospital and postdischarge adverse events. GQIs will estimate the proportion of index hospital stays resulting in recommended anticoagulation at discharge and up to various time frames based on the same electronic health data. The GPSI and GQI development and validation process will comprise 6 stages: (1) selection and specification of candidate indicators, (2) definition of administrative data

  15. Amiodarone, anticoagulation, and clinical events in patients with atrial fibrillation: insights from the ARISTOTLE trial.

    Science.gov (United States)

    Flaker, Greg; Lopes, Renato D; Hylek, Elaine; Wojdyla, Daniel M; Thomas, Laine; Al-Khatib, Sana M; Sullivan, Renee M; Hohnloser, Stefan H; Garcia, David; Hanna, Michael; Amerena, John; Harjola, Veli-Pekka; Dorian, Paul; Avezum, Alvaro; Keltai, Matyas; Wallentin, Lars; Granger, Christopher B

    2014-10-14

    Amiodarone is an effective medication in preventing atrial fibrillation (AF), but it interferes with the metabolism of warfarin. This study sought to examine the association of major thrombotic clinical events and bleeding with the use of amiodarone in the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial. Baseline characteristics of patients who received amiodarone at randomization were compared with those who did not receive amiodarone. The interaction between randomized treatment and amiodarone was tested using a Cox model, with main effects for randomized treatment and amiodarone and their interaction. Matching on the basis of a propensity score was used to compare patients who received and who did not receive amiodarone at the time of randomization. In ARISTOTLE, 2,051 (11.4%) patients received amiodarone at randomization. Patients on warfarin and amiodarone had time in the therapeutic range that was lower than patients not on amiodarone (56.5% vs. 63.0%; p amiodarone-treated patients had a stroke or a systemic embolism (1.58%/year vs. 1.19%/year; adjusted hazard ratio [HR]: 1.47, 95% confidence interval [CI]: 1.03 to 2.10; p = 0.0322). Overall mortality and major bleeding rates were elevated, but were not significantly different in amiodarone-treated patients and patients not on amiodarone. When comparing apixaban with warfarin, patients who received amiodarone had a stroke or a systemic embolism rate of 1.24%/year versus 1.85%/year (HR: 0.68, 95% CI: 0.40 to 1.15), death of 4.15%/year versus 5.65%/year (HR: 0.74, 95% CI: 0.55 to 0.98), and major bleeding of 1.86%/year versus 3.06%/year (HR: 0.61, 95% CI: 0.39 to 0.96). In patients who did not receive amiodarone, the stroke or systemic embolism rate was 1.29%/year versus 1.57%/year (HR: 0.82, 95% CI: 0.68 to 1.00), death was 3.43%/year versus 3.68%/year (HR: 0.93, 95% CI: 0.83 to 1.05), and major bleeding was 2.18%/year versus 3.03%/year (HR: 0.72, 95

  16. Factors driving the use of warfarin and non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

    Directory of Open Access Journals (Sweden)

    Mu-Mei Hu

    2017-04-01

    Conclusion: Stroke history was associated with anticoagulant use, whereas comorbidities associated with increased risk of bleeding showed the opposite result. Patients with hepatic disease were less likely to use NOACs.

  17. Antithrombotic management and 1-year outcome of patients on oral anticoagulation undergoing coronary stent implantation (from the Registro Regionale Angioplastiche Emilia-Romagna Registry).

    Science.gov (United States)

    Rubboli, Andrea; Magnavacchi, Paolo; Guastaroba, Paolo; Saia, Francesco; Vignali, Luigi; Giacometti, Paola; Franco, Nicoletta; Benassi, Alberto; Varani, Elisabetta; Campo, Gianluca; Manari, Antonio; De Palma, Rossana; Marzocchi, Antonio

    2012-05-15

    Current recommendations for the antithrombotic management of patients receiving oral anticoagulation (OAC) who undergo percutaneous coronary intervention with stent implantation (PCI-S) are based on limited and relatively weak data. To broaden and strengthen available evidence, the management and 1-year outcomes of OAC patients who underwent PCI-S and were included in a prospective, multicenter registry from 2003 to 2007 were evaluated. Among the 632 patients receiving OAC, mostly because of atrial fibrillation (58%), who underwent PCI-S, mostly because of acute coronary syndromes (63%), dual-antiplatelet therapy with aspirin and clopidogrel was the most frequently prescribed at discharge (48%), followed by triple therapy with OAC, aspirin, and clopidogrel (32%) and OAC plus aspirin (18%). The choice of antithrombotic therapy largely matched the thromboembolic risk profiles of patients, with the prescription of regimens including OAC predicted by the presence of non-low-risk features. The cumulative 1-year occurrence of major adverse cardiovascular events was as high as 27% and was not significantly different among the 3 treatment groups. Stroke and stent thrombosis were limited to 2% and 3%, respectively, and although no significant differences were found among the 3 groups, stroke was 4 times less frequent when OAC, with either 1 or 2 antiplatelet agents, was administered. Major bleeding was also limited to 3%, with no significant differences among the 3 groups. In conclusion, these findings suggest overall real-world management of OAC patients who undergo PCI-S that is in accordance with their clinical risk profiles and give further support to the reported efficacy and safety of triple therapy for the optimal treatment of these patients. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. [Novel anticoagulants for stroke prevention in atrial fibrillation].

    Science.gov (United States)

    Baumhäkel, M; Schirmer, S H; Böhm, M

    2010-11-01

    The most frequent cardiac arrhythmia and main cause for cardio-embolic stroke is atrial fibrillation. Prophylaxis for thrombembolic events is performed regarding individual risk of patients with either ASS or vitamin-K-antagonists. Efficacy and safety of oral anticoagulation is limited by a narrow therapeutical range as well as by inter- and intraindividual variability of INR-values due to genetic disposition, differences in alimentation, dosage errors, rare control of INR-levels and drug-interactions. New oral anticoagulants with different mechanisms of action may be a promising therapeutic option in future. This review addresses the new anticoagulants Apixaban, Rivaroxban and Dabigatranetexilat with the design and as available the results of the corresponding phase-III-trials in atrial fibrillation (ARISTOTLE, ROCKET-AF, RE-LY). © Georg Thieme Verlag KG Stuttgart · New York.

  19. [Anticoagulation in atrial fibrillation - an update].

    Science.gov (United States)

    Antz, Matthias; Hullmann, Bettina; Neufert, Christian; Vocke, Wolfgang

    2008-12-01

    The correct anticoagulation regimen for prevention of thromboembolic events is essential in patients with atrial fibrillation. However, only a minority of patients receives anticoagulation according to the guidelines. The current guidelines are intended to make the indication for anticoagulation more simple and are summarized in the present article. This includes recommendations for chronic anticoagulation, prevention of thromboembolic events after cardioversion and in ablation of atrial fibrillation.

  20. A review of the clinical utility of INR to monitor and guide administration of prothrombin complex concentrate to orally anticoagulated patients

    DEFF Research Database (Denmark)

    Sølbeck, Sacha; Ostrowski, Sisse R; Johansson, Pär I

    2012-01-01

    the initiation steps of the haemostatic process. The objective of the present review was to reassess the evidence for using INR as a tool to guide administration of prothrombin complex concentrates (PCC) to OAC patients. A Medline and Cochrane database search was conducted using the following keywords......: prothrombin complex concentrate, reversal of oral anticoagulation and international normalized ratio (INR). Thirty-three articles were contracted and a total of ten studies were eligible after applying inclusion and exclusion criteria encompassing only 339 patients. No consensus regarding optimal target INR...

  1. Sangramento durante a anticoagulação oral: alerta sobre um mal maior Sangrado durante la anticoagulación oral: alerta sobre un mal mayor Bleeding during oral anticoagulant therapy: warning against a greater hazard

    Directory of Open Access Journals (Sweden)

    Paulo de Lara Lavítola

    2009-08-01

    del sexo femenino. La estenosis mitral estaba presente en 218 pacientes (64,4%, la prótesis biológica mitral en 64 (18,9% y la insuficiencia de la válvula mitral en 56 (16,5%. El sangrado ocurrió en 65 pacientes (19,2% y de forma grave en 7 (10%. En 38/65 pacientes (58,5%, se identificó nueva enfermedad asociada, facilitadora del sangrado. En el 100% de los pacientes con sangrado en el intervalo terapéutico, se encontró enfermedad asociada, contra el 49,05% de diagnóstico de enfermedades asociadas en aquellos con INR > 3,5 (p = 0,001. CONCLUSIÓN: El diagnóstico de enfermedad local asociada al sangrado fue frecuente entre los medicados con anticoagulante oral (58,5%. Hubo asociación entre sangrado con INR en el intervalo terapéutico (INR 2,0-3,5 y diagnóstico de patología predisponente a sangrado (p BACKGROUND: Bleeding is one of the main concerns in patients undergoing oral anticoagulation therapy. OBJECTIVE: To investigate the determinant causes of bleeding in patients undergoing oral anticoagulant therapy. METHODS: A total of 360 patients with atrial fibrillation (AF undergoing oral anticoagulant (ACo therapy, with a target INR of 2.0-3.5, were followed prospectively for a period of 48 ± 7.2 months. The patients were evaluated on average every 30 days and were investigated regarding the presence of associated pathology that could lead to bleeding. RESULTS: A total of 338 patients participated in the present study. Of these, 210 (62.13% were females. Mitral stenosis was present in 218 patients (64.4%, a mitral biological prosthesis in 64 (18.9% and mitral valve failure in 56 (16.5% patients. Bleeding occurred in 65 patients (19.2%, being severe in 7 (10% patients. In 38/65 patients, a new associated disease was identified, which facilitated bleeding. An associated disease was identified in 100% of the patients with bleeding within the therapeutic range, against 49.05% of associated disease diagnosis in those with an INR > 3.5 (p=0.001. CONCLUSION: The

  2. Quality of management of oral anticoagulation as assessed by time in therapeutic INR range in elderly and younger patients with low mean years of formal education: a prospective cohort study.

    Science.gov (United States)

    Costa, Gustavo Lamego de Barros; Ferreira, Diana Carvalho; Valacio, Reginaldo Aparecido; Vieira Moreira, Maria da Consolação

    2011-05-01

    despite the overwhelming evidence of its effectiveness, oral anticoagulation continues to be underused in the elderly, presumably due to physicians' misconceptions when estimating bleeding risk and ability to comply with treatment. to investigate the quality of anticoagulation control among deprived elderly and younger patients. prospective observational study. a public anticoagulation clinic in a developing country. all adult patients on intended long-term (>90 days) oral anticoagulation. We studied 171 patients (79 elderly and 92 non-elderly) with a mean follow-up of 273 ± 84.9 days. the main outcome measure was the quality of anticoagulation management as measured by the time in therapeutic (TTR) international normalised ratio (INR) range. Elderly patients (≥60 years) were compared with younger patients with respect to the educational level and co-morbidities. the mean number of years of formal education was 4.37 ± 3.2 years. The mean TTR was 62.50 ± 17.9% in non-elderly and 62.10 ± 16.6% in elderly (P = 0.862) subjects, despite the higher prevalence of co-morbidities in the latter group: heart failure (46.3 versus 28.6%, P = 0.042), diabetes mellitus (22.8 versus 8.7%, P = 0.011), renal failure (estimated glomerular filtration rate educational levels (3.42 ± 2.5 versus 5.55 ± 3.4 years of formal education, P quality management of oral anticoagulation is achievable in deprived populations attending an anticoagulation clinic. Elderly patients may experience similar quality of anticoagulation despite having higher levels of co-morbidities and polypharmacy. These results add evidence to the safety of such therapeutic interventions in the elderly.

  3. Left atrial appendage occlusion: A better alternative to anticoagulation?

    Science.gov (United States)

    Akin, Ibrahim; Nienaber, Christoph A

    2017-02-26

    Non-valvular atrial fibrillation is associated with a significantly increased risk of embolic stroke due to blood clot forming predominantly in the left atrial appendage (LAA). Preventive measures to avoid embolic events are permanent administration of anticoagulants or surgical closure of the LAA. Various clinical trials provide evidence about safety, effectiveness and therapeutic success of LAA occlusion using various cardiac occluder devices. The use of such implants for interventional closure of the LAA is likely to become a valuable alternative for stroke prevention, especially in patients with contraindication for oral anticoagulation as safety, clinical benefit and cost-effectiveness of LAA occlusion has recently been demonstrated.

  4. Direct oral anticoagulant reversal

    DEFF Research Database (Denmark)

    Dzeshka, Mikhail S; Pastori, Daniele; Lip, Gregory Y H

    2017-01-01

    to manage bleeding depending on severity, with a particular focus on specific reversal agents, are discussed. Expert commentary: Due to short half-life of NOACs compared to warfarin, discontinuation of drug, mechanical compression, and volume substitution are considered to be sufficient measures in most...... of bleeding cases. In case of life-threatening bleeding or urgent surgery, hemostasis can be achieved with non-specific reversal agents (prothrombin complex concentrates) in patients treated with factor Xa inhibitor until specific antidotes (andexanet α and ciraparantag) will receive approval. Thus far......, idarucizumab has been the only reversal agent approved for dabigatran....

  5. Efficacy and safety outcomes of oral anticoagulants and antiplatelet drugs in the secondary prevention of venous thromboembolism: systematic review and network meta-analysis.

    Science.gov (United States)

    Castellucci, Lana A; Cameron, Chris; Le Gal, Grégoire; Rodger, Marc A; Coyle, Doug; Wells, Philip S; Clifford, Tammy; Gandara, Esteban; Wells, George; Carrier, Marc

    2013-08-30

    To summarise and compare the efficacy and safety of various oral anticoagulants (dabigatran, rivaroxaban, apixaban, and vitamin K antagonists) and antiplatelet agents (acetylsalicylic acid) for the secondary prevention of venous thromboembolism. Systematic review and network meta-analysis. Literature search using Medline (1950 to present), Embase (1980 to present), and the Cochrane Register of Controlled Trials using the OVID interface. Publications from potentially relevant journals were also searched by hand. Randomised controlled trials of patients receiving anticoagulants, antiplatelet drugs, or placebo or observation for secondary prevention of venous thromboembolism. Selected outcomes were rates of recurrent venous thromboembolism and major bleeding. Two reviewers independently extracted data onto standardised forms. 12 articles met our inclusion criteria, with 11,999 patients evaluated for efficacy and 12,167 for safety. All treatments reduced the risk of recurrent venous thromboembolism. Compared with placebo or observation, vitamin K antagonists at a standard adjusted dose (target international normalised ratio 2.0-3.0) showed the highest risk difference (odds ratio 0.07; 95% credible interval 0.03 to 0.15) and acetylsalicylic acid showed the lowest risk difference (0.65; 0.39 to 1.03). Risk of major bleeding was higher with a standard adjusted dose of vitamin K antagonists (5.24; 1.78 to 18.25) than with placebo or observation. Fatal recurrent venous thromboembolism and fatal bleeding were rare. Detailed subgroup and individual patient level data were not available. All oral anticoagulants and antiplatelet agents investigated in this analysis were associated with a reduced recurrence of venous thromboembolism compared with placebo or observation, although acetylsalicylic acid was associated with the lowest risk reduction. Vitamin K antagonists given at a standard adjusted dose was associated with the greatest risk reduction in recurrent venous

  6. A review of the clinical utility of INR to monitor and guide administration of prothrombin complex concentrate to orally anticoagulated patients

    Directory of Open Access Journals (Sweden)

    Sølbeck Sacha

    2012-04-01

    Full Text Available Abstract Background and objectives The number of patients treated with oral anticoagulation (OAC is increasing and these patients are monitored by International Normalized Ratio (INR. Bleeding complications are common and we speculate if this is related to the limitation of INR only reflecting the initiation steps of the haemostatic process. The objective of the present review was to reassess the evidence for using INR as a tool to guide administration of prothrombin complex concentrates (PCC to OAC patients. A Medline and Cochrane database search was conducted using the following keywords: prothrombin complex concentrate, reversal of oral anticoagulation and international normalized ratio (INR. Thirty-three articles were contracted and a total of ten studies were eligible after applying inclusion and exclusion criteria encompassing only 339 patients. No consensus regarding optimal target INR value to aim for when reversing OAC was found. In three of the studies it was reported that patients reaching their target INR continued to bleed, whereas three studies reviewed reported good haemostatic response also in patients that did not reach their target INR. The present review found limited evidence for the usefulness of INR as a tool to monitor and guide reversal of OAC induced coagulopathy in patients with PCC, which is expected given that it is a plasma-based assay only reflecting a limited part of the haemostatic process.

  7. Association of insurance type with receipt of oral anticoagulation in insured patients with atrial fibrillation: A report from the American College of Cardiology NCDR PINNACLE registry.

    Science.gov (United States)

    Yong, Celina M; Liu, Yuyin; Apruzzese, Patricia; Doros, Gheorghe; Cannon, Christopher P; Maddox, Thomas M; Gehi, Anil; Hsu, Jonathan C; Lubitz, Steven A; Virani, Salim; Turakhia, Mintu P

    2018-01-01

    It is poorly understood whether insurance type may be a major contributor to the underuse of oral anticoagulation (OAC) among patients with atrial fibrillation (AF), particularly for novel oral anticoagulants (NOACs). We performed a retrospective cohort registry study of patients with insurance, AF, CHA2DS2-VASc ≥2, and at least one outpatient encounter recorded in the ACC NCDR's PINNACLE Registry between January 1, 2011 and December 31, 2014. We used hierarchical regression, adjusting for patient characteristics and clustering by physician, to evaluate the association of insurance type (Private, Military, Medicare, Medicaid, Other) with receipt of OAC (any OAC, warfarin, or NOAC). In 363,309 patients (age 75±10; 48% female), we found a significant difference in proportions of OAC and NOAC prescription across insurance types (OAC: Military 53%, Private 53%, Medicare 52%, Other 41%, Medicaid 41%, Pinsurance were independently associated with a lower odds of OAC prescription relative to Medicare, but military insured patients were not significantly different. After adjustment, military and private insurance were independently associated with a higher odds of NOAC prescription relative to Medicare, while Medicaid and other insurance were associated with a lower odds of NOAC prescription. In a contemporary US AF population, there was significant variation of OAC prescription across insurance plans, with the highest among private and Medicare insured patients. These differences may indicate that insurance plan, and its associated pharmacy benefits, affect the pace of diffusion of new therapies. Copyright © 2017. Published by Elsevier Inc.

  8. Anticoagulation in Older Adults with Multimorbidity.

    Science.gov (United States)

    Parks, Anna L; Fang, Margaret C

    2016-05-01

    The number of patients with atrial fibrillation (AF) who are of advanced age or have multiple comorbidities is expected to increase substantially. Older patients with AF generally gain a net benefit from anticoagulation. Guidelines typically recommend anticoagulation. There are multiple challenges in the safe use of anticoagulation in frail patients, including bleeding risk, monitoring and adherence, and polypharmacy. Although there are options for chronic oral anticoagulation, clinicians must understand the unique advantages and disadvantages of these medications when developing a management plan. This article reviews issues surrounding the appropriate use and selection of anticoagulants in complex older patients with AF. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. ANALYSIS OF THE INFLUENCE OF THROMBOEMBOLIC COMPLICATIONS PREVENTION WITH ORAL ANTICOAGULANTS ON BUDGET IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION

    Directory of Open Access Journals (Sweden)

    A. V. Rudakova

    2015-09-01

    Full Text Available Atrial fibrillation (AF is a risk factor for thromboembolic complications, requiring administration of vitamin K antagonists (warfarin or the new oral anticoagulants (apixaban, dabigatran and rivaroxaban.Aim. To assess the influence of apixaban use on the budget as an alternative to warfarin, dabigatran or rivaroxaban use in patients with non-valvular AF in the Russian Federation (RF.Material and methods. The analysis was performed with the perspective of the health care budget with 5 year horizon period and by the pharmacoeconomic model developed by Pharmerit International (Rotterdam, Netherlands and adapted for the RF. The cardiovascular complications rate in the model was in line with the results of comparative clinical trials: ARISTOTLE, AVERROES, RE-LY, ROCKET-AF. The analysis suggested that 100% of patients with atrial fibrillation were transferred on apixaban instead of warfarin, dabigatran or rivaroxaban. The analysis was based on the assumption that patients were fully committed to the therapy over the horizon of the study, ie, refusal of treatment was not considered. The possibility of episodes of ischemic and hemorrhagic strokes, the severity of which corresponded to previously published data for the Russian population, was considered in the study. The present study was performed based on two scenarios. In the first of them the cost of anticoagulation therapy was determined on the basis of the average weighted prices of public procurement for the period from 04.01.2014 to 01.04.2015. The alternative scenario purported to demonstrate potential savings of the budget of the health care system on the inclusion of apixaban in the list of essential drugs. This scenario took into account that the cost of dabigatran and rivaroxaban corresponded to registered maximum selling price including 10% VAT and 10% of the wholesale allowance and the cost of apixaban - presumed maximum selling price which the producer intends to register in case the

  10. ANALYSIS OF THE INFLUENCE OF THROMBOEMBOLIC COMPLICATIONS PREVENTION WITH ORAL ANTICOAGULANTS ON BUDGET IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION

    Directory of Open Access Journals (Sweden)

    A. V. Rudakova

    2015-01-01

    Full Text Available Atrial fibrillation (AF is a risk factor for thromboembolic complications, requiring administration of vitamin K antagonists (warfarin or the new oral anticoagulants (apixaban, dabigatran and rivaroxaban.Aim. To assess the influence of apixaban use on the budget as an alternative to warfarin, dabigatran or rivaroxaban use in patients with non-valvular AF in the Russian Federation (RF.Material and methods. The analysis was performed with the perspective of the health care budget with 5 year horizon period and by the pharmacoeconomic model developed by Pharmerit International (Rotterdam, Netherlands and adapted for the RF. The cardiovascular complications rate in the model was in line with the results of comparative clinical trials: ARISTOTLE, AVERROES, RE-LY, ROCKET-AF. The analysis suggested that 100% of patients with atrial fibrillation were transferred on apixaban instead of warfarin, dabigatran or rivaroxaban. The analysis was based on the assumption that patients were fully committed to the therapy over the horizon of the study, ie, refusal of treatment was not considered. The possibility of episodes of ischemic and hemorrhagic strokes, the severity of which corresponded to previously published data for the Russian population, was considered in the study. The present study was performed based on two scenarios. In the first of them the cost of anticoagulation therapy was determined on the basis of the average weighted prices of public procurement for the period from 04.01.2014 to 01.04.2015. The alternative scenario purported to demonstrate potential savings of the budget of the health care system on the inclusion of apixaban in the list of essential drugs. This scenario took into account that the cost of dabigatran and rivaroxaban corresponded to registered maximum selling price including 10% VAT and 10% of the wholesale allowance and the cost of apixaban - presumed maximum selling price which the producer intends to register in case the

  11. Oral anticoagulant persistence in patients with non-valvular atrial fibrillation: A cohort study using primary care data in Germany.

    Directory of Open Access Journals (Sweden)

    Shuk-Li Collings

    Full Text Available This study examined characteristics and treatment persistence among patients prescribed oral anticoagulants (OACs for stroke prevention in non-valvular atrial fibrillation (NVAF. We identified 15,244 patients (51.8% male, 72.7% aged ≥70 with NVAF and no prior OAC therapy who were prescribed apixaban (n = 1,303, rivaroxaban (n = 5,742, dabigatran (n = 1,622 or vitamin-K antagonists (VKAs, n = 6,577 between 1-Dec-2012 and 31-Oct-2014 in German primary care (IMS® Disease Analyzer. We compared OAC persistence using Cox regression over patients' entire follow-up and using a data-driven time-partitioned approach (before/after 100 days to handle non-proportional hazards. History of stroke risk factors (stroke/transient ischaemic attack [TIA] 15.2%; thromboembolism 14.1%; hypertension 84.3% and high bleeding risk (HAS-BLED score≥3 68.4% was common. Apixaban-prescribed patients had more frequent history of stroke/TIA (19.7% and high bleeding risk (72.6% than other OACs. 12-month persistence rates were: VKA 57.5% (95% confidence interval (CI 56.0-59.0%, rivaroxaban 56.6% (54.9-58.2%, dabigatran 50.1% (47.2-53.1%, apixaban 62.9% (58.8-67.0%. Over entire follow-up, compared to VKA, non-persistence was similar with apixaban (adjusted hazard ratio 1.08, 95% CI 0.95-1.24 but higher with rivaroxaban (1.21, 1.14-1.29 and dabigatran (1.53, 1.40-1.68. Using post-hoc time-partitioned approach: in first 100 days, non-persistence was higher with apixaban (1.37, 1.17-1.59, rivaroxaban (1.41, 1.30-1.53 and dabigatran (1.91, 1.70-2.14 compared to VKA. Compared to apixaban, rivaroxaban non-persistence was similar (1.03, 0.89-1.20, dabigatran was higher (1.39, 1.17-1.66. After 100 days, apixaban non-persistence was lower than VKA (0.66, 0.52-0.85; rivaroxaban (0.97, 0.87-1.07 and dabigatran (1.10, 0.95-1.28 were similar to VKA. Furthermore, rivaroxaban (1.46, 1.13-1.88 and dabigatran (1.67, 1.26-2.19 non-persistence was higher than apixaban. This study describes real

  12. A Multilevel Analysis of Real-World Variations in Oral Anticoagulation Initiation for Atrial Fibrillation in Valencia, a European Region

    OpenAIRE

    García-Sempere, Aníbal; Bejarano-Quisoboni, Daniel; Librero, Julián; Rodríguez-Bernal, Clara L.; Peiró, Salvador; Sanfélix-Gimeno, Gabriel

    2017-01-01

    Introduction: Beyond clinical trials, clinical practice guidelines, and administrative regulation, treatment decision-making can be influenced by individual and contextual factors. Our goal was to describe variations in the patterns of initiation of anticoagulation therapy in patients with atrial fibrillation by Health Areas (HA) in the region of Valencia in Spain and to quantify the influence of the HAs on variations in treatment choice. Methods: We conducted a population-based retrospect...

  13. A Multilevel Analysis of Real-World Variations in Oral Anticoagulation Initiation for Atrial Fibrillation in Valencia, a European Region

    OpenAIRE

    Aníbal García-Sempere; Aníbal García-Sempere; Daniel Bejarano-Quisoboni; Julián Librero; Julián Librero; Clara L. Rodríguez-Bernal; Clara L. Rodríguez-Bernal; Salvador Peiró; Salvador Peiró; Gabriel Sanfélix-Gimeno; Gabriel Sanfélix-Gimeno

    2017-01-01

    Introduction: Beyond clinical trials, clinical practice guidelines, and administrative regulation, treatment decision-making can be influenced by individual and contextual factors. Our goal was to describe variations in the patterns of initiation of anticoagulation therapy in patients with atrial fibrillation by Health Areas (HA) in the region of Valencia in Spain and to quantify the influence of the HAs on variations in treatment choice.Methods: We conducted a population-based retrospective ...

  14. NP-184[2-(5-methyl-2-furyl) benzimidazole], a novel orally active antithrombotic agent with dual antiplatelet and anticoagulant activities.

    Science.gov (United States)

    Kuo, Heng-Lan; Lien, Jin-Cherng; Chung, Ching-Hu; Chang, Chien-Hsin; Lo, Shyh-Chyi; Tsai, I-Chun; Peng, Hui-Chin; Kuo, Sheng-Chu; Huang, Tur-Fu

    2010-06-01

    The established antiplatelet and anticoagulant agents show beneficial effects in the treatment of thromboembolic diseases; however, these drugs still have considerable limitations. The effects of NP-184, a synthetic compound, on platelet functions, plasma coagulant activity, and mesenteric venule thrombosis in mice were investigated. NP-184 concentration-dependently inhibited the human platelet aggregation induced by collagen, arachidonic acid (AA), and U46619, a thromboxane (TX)A(2) mimic, with IC(50) values of 4.5 +/- 0.2, 3.9 +/- 0.1, and 9.3 +/- 0.5 microM, respectively. Moreover, NP-184 concentration-dependently suppressed TXA(2) formations caused by collagen and AA. In exploring effects of NP-184 on enzymes involved in TXA(2) synthesis, we found that NP-184 selectively inhibited TXA(2) synthase activity with an IC(50) value of 4.3 +/- 0.2 microM. Furthermore, NP-184 produced a right shift of the concentration-response curve of U46619, indicating a competitive antagonism on TXA(2)/prostaglandin H(2) receptor. Intriguingly, NP-184 also caused a concentration-dependent prolongation of the activated partial thromboplastin time (aPTT) with no changes in the prothrombin and thrombin time, indicating that it selectively impairs the intrinsic coagulation pathway. Oral administration of NP-184 significantly inhibited thrombus formation of the irradiated mesenteric venules in fluorescein sodium-treated mice without affecting the bleeding time induced by tail transection. However, after oral administration, NP-184 inhibited the ex vivo mouse platelet aggregation triggered by collagen and U46619 and also prolonged aPTT. Taken together, the dual antiplatelet and anticoagulant activities of NP-184 may have therapeutic potential as an oral antithrombotic agent in the treatment of thromboembolic disorders.

  15. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation.

    Science.gov (United States)

    Heidbuchel, Hein; Verhamme, Peter; Alings, Marco; Antz, Matthias; Hacke, Werner; Oldgren, Jonas; Sinnaeve, Peter; Camm, A John; Kirchhof, Paulus

    2013-05-01

    New oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with non-valvular atrial fibrillation (AF). Both physicians and patients will have to learn how to use these drugs effectively and safely in clinical practice. Many unresolved questions on how to optimally use these drugs in specific clinical situations remain. The European Heart Rhythm Association set out to coordinate a unified way of informing physicians on the use of the different NOACs. A writing group listed 15 topics of concrete clinical scenarios and formulated as practical answers as possible based on available evidence. The 15 topics are: (1) Practical start-up and follow-up scheme for patients on NOACs; (2) How to measure the anticoagulant effect of NOACs; (3) Drug-drug interactions and pharmacokinetics of NOACs; (4) Switching between anticoagulant regimens; (5) Ensuring compliance of NOAC intake; (6) How to deal with dosing errors; (7) Patients with chronic kidney disease; (8) What to do if there is a (suspected) overdose without bleeding, or a clotting test is indicating a risk of bleeding? (9) Management of bleeding complications; (10) Patients undergoing a planned surgical intervention or ablation; (11) Patients undergoing an urgent surgical intervention; (12) Patients with AF and coronary artery disease; (13) Cardioversion in a NOAC-treated patient; (14) Patients presenting with acute stroke while on NOACs; (15) NOACs vs. VKAs in AF patients with a malignancy. Since new information is becoming available at a rapid pace, an EHRA Web site with the latest updated information accompanies this text (www.NOACforAF.eu).

  16. How to Invest in Getting Cost-effective Technologies into Practice? A Framework for Value of Implementation Analysis Applied to Novel Oral Anticoagulants.

    Science.gov (United States)

    Faria, Rita; Walker, Simon; Whyte, Sophie; Dixon, Simon; Palmer, Stephen; Sculpher, Mark

    2017-02-01

    Cost-effective interventions are often implemented slowly and suboptimally in clinical practice. In such situations, a range of implementation activities may be considered to increase uptake. A framework is proposed to use cost-effectiveness analysis to inform decisions on how best to invest in implementation activities. This framework addresses 2 key issues: 1) how to account for changes in utilization in the future in the absence of implementation activities; and 2) how to prioritize implementation efforts between subgroups. A case study demonstrates the framework's application: novel oral anticoagulants (NOACs) for the prevention of stroke in the National Health Service in England and Wales. The results suggest that there is value in additional implementation activities to improve uptake of NOACs, particularly in targeting patients with average or poor warfarin control. At a cost-effectiveness threshold of £20,000 per quality-adjusted life-year (QALY) gained, additional investment in an educational activity that increases the utilization of NOACs by 5% in all patients currently taking warfarin generates an additional 254 QALYs, compared with 973 QALYs in the subgroup with average to poor warfarin control. However, greater value could be achieved with higher uptake of anticoagulation more generally: switching 5% of patients who are potentially eligible for anticoagulation but are currently receiving no treatment or are using aspirin would generate an additional 4990 QALYs. This work can help health services make decisions on investment at different points of the care pathway or across disease areas in a manner consistent with the value assessment of new interventions.

  17. Mechanical Prosthetic Valves and Pregnancy: A therapeutic dilemma of anticoagulation

    Directory of Open Access Journals (Sweden)

    Prashanth Panduranga

    2014-10-01

    Full Text Available Choosing the best anticoagulant therapy for a pregnant patient with a mechanical prosthetic valve is controversial and the published international guidelines contain no clear-cut consensus on the best approach. This is due to the fact that there is presently no anticoagulant which can reliably decrease thromboembolic events while avoiding damage to the fetus. Current treatments include either continuing oral warfarin or substituting warfarin for subcutaneous unfractionated heparin or low-molecular-weight heparin (LMWH in the first trimester (6–12 weeks or at any point throughout the pregnancy. However, LMWH, while widely-prescribed, requires close monitoring of the blood anti-factor Xa levels. Unfortunately, facilities for such monitoring are not universally available, such as within hospitals in developing countries. This review evaluates the leading international guidelines concerning anticoagulant therapy in pregnant patients with mechanical prosthetic valves as well as proposing a simplified guideline which may be more relevant to hospitals in this region.

  18. Risk of major bleeding and stroke associated with the use of vitamin K antagonists, nonvitamin K antagonist oral anticoagulants and aspirin in patients with atrial fibrillation: a cohort study

    NARCIS (Netherlands)

    Gieling, E.M.; Ham, H.A. van den; Onzenoort, H. van; Bos, J.; Kramers, C.; Boer, A. de; Vries, F de; Burden, A.M.

    2017-01-01

    AIMS: Nonvitamin K antagonist oral anticoagulants (NOACs) are now available for the prevention of stroke in patients with atrial fibrillation (AF) as an alternative to vitamin K antagonists (VKA) and aspirin. The comparative effectiveness and safety in daily practice of these different drug classes

  19. Prevention of one-year vein-graft occlusion after aortocoronary-bypass surgery : a comparison of low-dose aspirin, low-dose aspirin plus dipyridamole, and oral anticoagulants

    NARCIS (Netherlands)

    van der Meer, J; Hillege, H. L.; Kootstra, G. J.; Ascoop, C. A. P. L.; Pfisterer, M.; van Gilst, W. H.; Lie, K. I.

    1993-01-01

    Aspirin, alone or in combination with dipyridamole, is known to prevent occlusion of aortocoronary vein grafts. The benefit of dipyridamole in addition to aspirin remains controversial, and the efficacy and safety of oral anticoagulants for prevention of vein-graft occlusion have not been

  20. Anticoagulant Resistance

    DEFF Research Database (Denmark)

    Heiberg, Ann-Charlotte

    to represent different sewer rat management strategies i) no anticoagulants for approx. 20 years ii) no anticoagulants for the last 5 years and iii) continuous control for many years. Animals were tested for resistance to bromadiolone by Blood-Clotting Response test, as bromadiolone is the most frequently used...... agent in the sewers. Low level of resistance was found in locations regardless of management strategy. Mutations in the VKORC1 gene have been proposed to confer anticoagulant resistance and an Y139C VKORC1 mutation has been identified in Danish resistant rats. All animals were tested with an Y139C...... specific PCR to verify this genetic form of resistance, but in contrast to animals tested from various surface populations, we could not confirm the Y139C mutation in any of the sewer rats. Our findings could indicate that resistance in surface and sewer population may be caused by different mechanism...

  1. Radiocarbon test for demographic events in written and oral history.

    Science.gov (United States)

    Edinborough, Kevan; Porčić, Marko; Martindale, Andrew; Brown, Thomas Jay; Supernant, Kisha; Ames, Kenneth M

    2017-11-21

    We extend an established simulation-based method to test for significant short-duration (1-2 centuries) demographic events known from one documented historical and one oral historical context. Case study 1 extrapolates population data from the Western historical tradition using historically derived demographic data from the catastrophic European Black Death/bubonic plague (Yersinia pestis). We find a corresponding statistically significant drop in absolute population using an extended version of a previously published simulation method. Case study 2 uses this refined simulation method to test for a settlement gap identified in oral historical records of descendant Tsimshian First Nations communities from the Prince Rupert Harbour region of the Pacific Northwest region of British Columbia, Canada. Using a regional database of n = 523 radiocarbon dates, we find a significant drop in relative population using the extended simulation-based method consistent with Tsimshian oral records. We conclude that our technical refinement extends the utility of radiocarbon simulation methods and can provide a rigorous test of demographic predictions derived from a range of historical sources.

  2. Novel oral anticoagulants in non-valvular atrial fibrillation: Pharmacological properties, clinical trials, guideline recommendations, new antidote drugs and real-world data

    Directory of Open Access Journals (Sweden)

    Umut Kocabas

    2016-12-01

    Full Text Available Atrial fibrillation (AF is the most common sustained cardiac arrhythmia. Ischemic stroke and systemic thromboembolism are the most fatal complications of AF. Vitamin K antagonists (VKA are used in the prevention of AF-related stroke and systemic thromboembolism. However, the use of VKAs is associated with limitations such as their narrow therapeutic index, the need for monitoring, and numerous food-drug interactions. Novel oral anticoagulants (NOACs developed by researchers do not have those limitations and are better tolerated in patients with non-valvular atrial fibrillation. In this review, the pharmacological properties of NOACs, the results of NOAC clinical trials, the guideline recommendations, the important aspects of patient selection and clinical practice, new antidote drugs for NOACs and real-world data of NOACs in patients with non-valvular atrial fibrillation have been discussed.

  3. Use and Outcomes of Antiarrhythmic Therapy in Patients with Atrial Fibrillation Receiving Oral Anticoagulation: Results from the ROCKET AF Trial

    Science.gov (United States)

    Steinberg, Benjamin A.; Hellkamp, Anne S.; Lokhnygina, Yuliya; Halperin, Jonathan L.; Breithardt, Günter; Passman, Rod; Hankey, Graeme J.; Patel, Manesh R.; Becker, Richard C.; Singer, Daniel E.; Hacke, Werner; Berkowitz, Scott D.; Nessel, Christopher C.; Mahaffey, Kenneth W.; Fox, Keith A.A.; Califf, Robert M.; Piccini, Jonathan P.

    2014-01-01

    Background Antiarrhythmic drugs (AAD) and anticoagulation are mainstays of atrial fibrillation (AF) treatment. Objective We aimed to study the use and outcomes of AAD therapy in anticoagulated AF patients. Methods Patients in the ROCKET AF trial (n=14,264) were grouped by AAD use at baseline: amiodarone, other AAD, or no AAD. Multivariable adjustment was performed to compare stroke, bleeding, and death across groups, as well as across treatment assignment (rivaroxaban or warfarin). Results Of 14,264 patients randomized, 1681 (11.8%) were treated with an AAD (1144 [8%] with amiodarone, 537 [3.8%] with other AADs). Amiodarone-treated patients were less-often female (38% vs. 48%), had more persistent AF (64% vs. 40%), and more concomitant heart failure (71% vs. 41%) than patients receiving other AADs. Patients receiving no AAD more closely-resembled amiodarone-treated patients. Time in therapeutic range was significantly lower in warfarin-treated patients receiving amiodarone versus no AAD (50% vs. 58%, p<0.0001). Compared with no AAD, neither amiodarone (adjusted HR 0.98, 95% CI 0.74–1.31, p=0.9) nor other AADs (adjusted HR 0.66, 95% CI 0.37–1.17, p=0.15) were associated with increased mortality. Similar results were observed for embolic and bleeding outcomes. Rivaroxaban treatment effects in patients not on an AAD were consistent with the overall trial (primary endpoint adjusted HR 0.82, 95% CI 0.68–0.98, pinteraction=0.06; safety endpoint adjusted HR 1.12, 95% CI 0.90–1.24, pinteraction=0.33). Conclusion Treatment with AADs was not associated with increased morbidity or mortality in anticoagulated patients with AF. The influence of amiodarone on outcomes in patients receiving rivaroxaban requires further study. PMID:24833235

  4. THE ASSESSMENT OF COMPLIANCE TO THE USE OF NEW ORAL ANTICOAGULANTS IN PATIENTS WITH ATRIAL FIBRILLATION ACCORDING TO THE PROFILE REGISTER

    Directory of Open Access Journals (Sweden)

    S. Y. Martsevich

    2014-01-01

    Full Text Available Aim. To study in the PROFILE register the rate of new oral anticoagulants (NOAC taking in patients with atrial fibrillation (AF and to identify the factors influencing it.Material and methods. Patients with AF who applied to the Cardiology Center in 2013-2014 (n=111 were included into the study. The oral anticoagulants (OAC were recommended to patients at the reference visit (n=97. Inquiry in questionnaire format was performed to assess the compliance to recommended therapy at the follow-up visit. Patients were divided into two groups according to taking/not-taking NOAC. Analysis of the facts that influence the compliance to NOAC therapy was performed.Results. At the reference visit 70 patients desired to receive NOAC. At the follow-up visit 29 (41.4% patients refused to take NOAC. Leading causes of NOAC refusal were satisfactory with warfarin (32.6%, the high price of these drugs (23.9%, the description of adverse reactions in the patient information leaflet for medicines (15.2%, and withdrawal by physician in outpatient clinic/hospital (8.7%. Preferential provision of medicines and warfarin therapy at the time of reference visit had a negative impact on the taking of NOAC. Patients taking NOAC were more aware of the possible outcomes of their illness, the possible side effects of OAC and were more familiar with patient information leaflet for medicines.Conclusion. The study assessed NOAC taking rate and the factors influencing patients' compliance to NOAC therapy.

  5. ERA OF NEW ANTICOAGULANTS IN THE TREATMENT OF NON-VALVULAR ATRIAL FIBRILLATION: PROSPECTS AND CHALLENGES

    Directory of Open Access Journals (Sweden)

    Z. M. Safiullina

    2015-09-01

    Full Text Available Studies data on new anticoagulants, direct oral thrombin inhibitor (dabigatran and direct inhibitors of coagulation factor Xa (rivaroxaban, apixaban, in the treatment of nonvalvular atrial fibrillation are presented. Effects of these drugs on cardiovascular events in atrial fibrillation are analyzed based on the results of various studies. Prospects for further research are discussed.

  6. ERA OF NEW ANTICOAGULANTS IN THE TREATMENT OF NON-VALVULAR ATRIAL FIBRILLATION: PROSPECTS AND CHALLENGES

    Directory of Open Access Journals (Sweden)

    Z. M. Safiullina

    2013-01-01

    Full Text Available Studies data on new anticoagulants, direct oral thrombin inhibitor (dabigatran and direct inhibitors of coagulation factor Xa (rivaroxaban, apixaban, in the treatment of nonvalvular atrial fibrillation are presented. Effects of these drugs on cardiovascular events in atrial fibrillation are analyzed based on the results of various studies. Prospects for further research are discussed.

  7. [Intraoperative adverse events in minor oral surgery. Risk analysis].

    Science.gov (United States)

    Reich, W; Maurer, P; Schubert, J

    2005-11-01

    The aim of this prospective study was to evaluate oral surgical procedures performed as day surgery under local anesthesia. We examined patients' general condition, and besides checking for intraoperative complications we analyzed postoperative bleeding in patients with hemostatic disorders. The patient population consisted of 1540 patients (797 female, 743 male), who underwent a total of 2055 minor oral surgical procedures over a 5-year period (1998-2002). Before the treatment started a data file was made for each patient, which contained information on his or her past medical history, concomitant medication, why the operation was indicated, premedication, anesthetic and surgical techniques applied, and postoperative treatment. Systemic pathologies influencing surgical decisions were found in 316 patients (20.5%), affecting 676 interventions (32.9%). In 109 patients (5.3% of the 2055) altered hemostasis was found. The surgical procedures recorded were: (operative) tooth extraction (n=394), interventions for surgical conservation of teeth (n=272), treatment for cysts (n=140), surgical revisions (n=46) and preprosthetic surgery (n=19). Passing complications, mostly systemic in nature, occurred during 27 sessions of local anesthesia (1.3%). There were 87 adverse events intraoperatively (4,2%), most of which were confined to the surgical field; specifically 15% of these complications took the form of hemorrhage. We observed no significant correlation between the occurrence of intraoperative complications and patients' gender, predisposing systemic pathologies including bleeding disorders, or age. Postoperative hemorrhage was observed significantly more frequently in patients with impaired hemostasis and required admission to hospital for inpatient treatment in 2 cases. According to our investigation, oral surgery can be performed in patients with compromised general condition with as few intraoperative complications as in patients with no general medical problems

  8. Adverse effects of anticoagulation treatment: clinically significant upper gastrointestinal hemorrhage

    Directory of Open Access Journals (Sweden)

    Pavel Skok

    2006-12-01

    Full Text Available Background: Over the last years, the use of oral anticoagulant treatment has increased dramatically, principally for the prevention of venous thrombosis and thrombembolic events. This treatment is demanding, especially among the elderly with concommitant diseases and different medication. Aim of the study to evaluate the rate of serious complications, clinically significant hemorrhage from upper gastointestinal tract in patients treated with oral antiocoagulants in a prospective cohort study.Patients and methods: Included were patients admitted to our institution between January 1, 1994 and December 31, 2003 due to gastrointestinal hemorrhage. Emergency endoscopy and laboratory testing was performed in all patients.Results: 6416 patients were investigated: 2452 women (38.2 % and 3964 men (61.8 %, mean age 59.1 years, SD 17.2. Among our patients, 55 % were aged over 60 years. In 86.4 % of patients the source of bleeding was confirmed in the upper gastrointestinal tract. In the last week prior to bleeding, 20.4 % (1309/6416 of all patients were regularly taking nonsteroidal anti-inflammatory drugs, anticoagulant therapy or antiplatelet agents in single daily doses at least. 6.3 % of patients (82/1309 with abundant hemorrhage from upper gastrointestinal tract were using oral anticoagulant therapy and had INR > 5 at admission, 25.6 % of them had INR > 10. The mortality of patients using oral anticoagulants and INR > 5 was 17.1 %.Conclusions: Upper gastrointestinal hemorrhage is a serious complication of different medications, particularly in elderly patients. Safe use of anticoagulant therapy is based on careful selection of patients and correct intake of the prescribed drugs.

  9. Anticoagulant activity of ginger ( Zingiber officinale Rosc ...

    African Journals Online (AJOL)

    Background: Herbal medicines with anticoagulant therapeutic claims could serve as veritable sources of new oral anticoagulant drugs with possible wider safety margins than the currently available ones. Objectives: This work was aimed at evaluating a Ginger Rhizome Methanolic Extract in vivo in rats for its potential ...

  10. Anticoagulant Control Results among Patients with Mechanical ...

    African Journals Online (AJOL)

    Background: Patients with mechanical heart valves receive life long, oral anticoagulant therapy to prevent thromboembolic complications, but this treatment is associated with an increased risk of bleeding (1). However no study in Tanzania has been done to review the adequacy of anticoagulation monitoring and risk factors ...

  11. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial.

    Science.gov (United States)

    Sambola, Antonia; Montoro, J Bruno; Del Blanco, Bruno García; Llavero, Nadia; Barrabés, José A; Alfonso, Fernando; Bueno, Héctor; Cequier, Angel; Serra, Antonio; Zueco, Javier; Sabaté, Manel; Rodríguez-Leor, Oriol; García-Dorado, David

    2013-10-01

    Oral anticoagulation (OAC) is the recommended therapy for patients with atrial fibrillation (AF) because it reduces the risk of stroke and other thromboembolic events. Dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention and stenting (PCI-S). In patients with AF requiring PCI-S, the association of DAPT and OAC carries an increased risk of bleeding, whereas OAC therapy or DAPT alone may not protect against the risk of developing new ischemic or thromboembolic events. The MUSICA-2 study will test the hypothesis that DAPT compared with triple therapy (TT) in patients with nonvalvular AF at low-to-moderate risk of stroke (CHADS2 score ≤2) after PCI-S reduces the risk of bleeding and is not inferior to TT for preventing thromboembolic complications. The MUSICA-2 is a multicenter, open-label randomized trial that will compare TT with DAPT in patients with AF and CHADS2 score ≤2 undergoing PCI-S. The primary end point is the incidence of stroke or any systemic embolism or major adverse cardiac events: death, myocardial infarction, stent thrombosis, or target vessel revascularization at 1 year of PCI-S. The secondary end point is the combination of any cardiovascular event with major or minor bleeding at 1 year of PCI-S. The calculated sample size is 304 patients. The MUSICA-2 will attempt to determine the most effective and safe treatment in patients with nonvalvular AF and CHADS2 score ≤2 after PCI-S. Restricting TT for AF patients at high risk for stroke may reduce the incidence of bleeding without increasing the risk of thromboembolic complications. © 2013.

  12. Direct Oral Anticoagulants in Addition to Antiplatelet Therapy for Secondary Prevention After Acute Coronary Syndromes: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Chiarito, Mauro; Cao, Davide; Cannata, Francesco; Godino, Cosmo; Lodigiani, Corrado; Ferrante, Giuseppe; Lopes, Renato D; Alexander, John H; Reimers, Bernhard; Condorelli, Gianluigi; Stefanini, Giulio G

    2018-02-07

    Patients with acute coronary syndrome (ACS) remain at high risk for experiencing recurrent ischemic events. Direct oral anticoagulants (DOAC) have been proposed for secondary prevention after ACS. To evaluate the safety and efficacy of DOAC in addition to antiplatelet therapy (APT) after ACS, focusing on treatment effects stratified by baseline clinical presentation (non-ST-segment elevation ACS [NSTE-ACS] vs ST-segment elevation myocardial infarction [STEMI]). PubMed, Embase, BioMedCentral, Google Scholar, and the Cochrane Central Register of Controlled Trials were searched from inception to March 1, 2017. Randomized clinical trials on DOAC after ACS were evaluated for inclusion. Overall, 473 studies were screened, 19 clinical trials were assessed as potentially eligible, and 6 were included in the meta-analysis. Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines were used to abstract data and assess quality and validity. The risk of bias tool, version 2.0 (Cochrane) was used for risk of bias assessment. Data were pooled using random-effects models. The prespecified primary efficacy end point was the composite of cardiovascular death, myocardial infarction, and stroke. The prespecified primary safety end point was major bleeding. Six trials that included 29 667 patients were identified (14 580 patients [49.1%] with STEMI and 15 036 [50.7%] with NSTE-ACS). The primary efficacy end point risk was significantly lower in patients who were treated with DOAC as compared with APT alone (odds ratio [OR], 0.85; 95% CI, 0.77-0.93; P < .001). This benefit was pronounced in patients with STEMI (OR, 0.76; 95% CI, 0.66-0.88; P < .001), while no significant treatment effect was observed in patients with NSTE-ACS (OR, 0.92; 95% CI, 0.78-1.09; P = .36; P for interaction = .09). With respect to safety, DOACs were associated with a higher risk of major bleeding as compared with APT alone (OR, 3.17; 95% CI, 2.27-4.42; P < .001

  13. Safety and Efficacy of Under-dosing Non-vitamin K Antagonist Oral Anticoagulants in Patients Undergoing Catheter Ablation for Atrial Fibrillation.

    Science.gov (United States)

    Yamaji, Hirosuke; Murakami, Takashi; Hina, Kazuyoshi; Higashiya, Shunichi; Kawamura, Hiroshi; Murakami, Masaaki; Kamikawa, Shigeshi; Komatsubara, Issei; Kusachi, Shozo

    2016-11-22

    Some patients with atrial fibrillation (AF) received under-doses of non-vitamin K antagonist oral anticoagulants (NOACs) in the real world. Under-dosing is defined as administration of a dose lower than the manufacturer recommended dose. To identify the efficacy and safety of under-dosing NOACs as perioperative anticoagulation for AF ablation. We retrospectively analyzed patients who received rivaroxaban or dabigatran etexilate according to dosage: adjusted low-dosage (reduced by disturbed renal function; n = 30), under-dosage (n = 307), or standard-dosage (n = 683). NOACs and dosing decisions were at the discretion of treating cardiologists. Patients who received under-dosed NOACs were older, more often female, and had lower body weight, and lower renal function than those who received standard-dosages. Activated clotting time at baseline in patients who received adjusted low- or under-dosages was slightly longer than that in patients receiving standard-dosages (156 ± 23, 151 ± 224, and 147 ± 24 seconds, respectively). Meaningful differences were not observed in other coagulation parameters. Adjusted low-, under-, and standard-dosing regimens did not differ in perioperative thromboembolic complications (0/30, 0.0%; 1/307, 0.3%; and 0/683, 0%, respectively), or major (0/30, 0.0%; 2/307, 0.6%; 3/683, 0.4%) and minor (1/30, 3.3%; 13/307, 4.2%; 25/683, 3.6%) bleeding episodes. When comparisons were performed for each NOAC, similar results were observed. With consideration of patient condition, age, sex, body weight, body mass index, and renal function, under-dosing NOACs was effective and safe as a perioperative anticoagulation therapy for AF ablation. The therapeutic range of NOACs is potentially wider than manufacturer recommendations.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) , where it is permissible to download and share the work provided it is properly

  14. Impact of INR monitoring, reversal agent use, heparin bridging, and anticoagulant interruption on rebleeding and thromboembolism in acute gastrointestinal bleeding.

    Directory of Open Access Journals (Sweden)

    Naoyoshi Nagata

    Full Text Available Anticoagulant management of acute gastrointestinal bleeding (GIB during the pre-endoscopic period has not been fully addressed in American, European, or Asian guidelines. This study sought to evaluate the risks of rebleeding and thromboembolism in anticoagulated patients with acute GIB.Baseline, endoscopy, and outcome data were reviewed for 314 patients with acute GIB: 157 anticoagulant users and 157 age-, sex-, and important risk-matched non-users. Data were also compared between direct oral anticoagulants (DOACs and warfarin users.Between anticoagulant users and non-users, of whom 70% underwent early endoscopy, no endoscopy-related adverse events or significant differences were found in the rate of endoscopic therapy need, transfusion need, rebleeding, or thromboembolism. Rebleeding was associated with shock, comorbidities, low platelet count and albumin level, and low-dose aspirin use but not HAS-BLED score, any endoscopic results, heparin bridge, or international normalized ratio (INR ≥ 2.5. Risks for thromboembolism were INR ≥ 2.5, difference in onset and pre-endoscopic INR, reversal agent use, and anticoagulant interruption but not CHA2DS2-VASc score, any endoscopic results, or heparin bridge. In patients without reversal agent use, heparin bridge, or anticoagulant interruption, there was only one rebleeding event and no thromboembolic events. Warfarin users had a significantly higher transfusion need than DOACs users.Endoscopy appears to be safe for anticoagulant users with acute GIB compared with non-users. Patient background factors were associated with rebleeding, whereas anticoagulant management factors (e.g. INR correction, reversal agent use, and drug interruption were associated with thromboembolism. Early intervention without reversal agent use, heparin bridge, or anticoagulant interruption may be warranted for acute GIB.

  15. Patients' experiences of atrial fibrillation and non-vitamin K antagonist oral anticoagulants (NOACs), and their educational needs: A qualitative study.

    Science.gov (United States)

    Clarkesmith, Danielle E; Lip, Gregory Y H; Lane, Deirdre A

    2017-05-01

    Qualitative research on atrial fibrillation (AF) patient's experiences and perceptions of taking the non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention is limited. This study explores patients' experiences of dabigatran and their recommendations for development of educational materials. Semi-structured individual interviews with 8 warfarin-naive and 8 warfarin-experienced AF patients, using qualitative deductive thematic analysis. The four main overarching themes included: understanding the diagnosis; reaching a treatment decision; challenges of living with OAC; and patient perceptions of treatment. Patients discussed their shock of diagnosis, and seeking information and support at that time. Narratives suggest patients preferred to be led by the doctor when making treatment decisions, and would often compare dabigatran to warfarin. Patients reported side-effects and challenges with both treatment options, and discussed their beliefs surrounding medications, including misconceptions. In addition to the original framework, two further themes were added: challenges of living with AF, and patient recommendations. Generally patients found AF symptoms distressing, which impacted their quality of life. Patient recommendations included the content and delivery of educational materials and development of tools to help with their understanding of AF and anticoagulation, as well as treatment adherence and anxiety surrounding symptoms and side effects. Patient recommendations emphasised the need for interventions to relieve anxiety surrounding the diagnosis and possible treatment side effects. Tailored 'disease-specific' support is essential to ensure efficacious treatment. This qualitative study highlights the need for patient involvement in the development of educational materials and resources for patients commencing treatment with NOACs. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  16. Hospitalized patients with atrial fibrillation compared to those included in recent trials on novel oral anticoagulants: a population-based study.

    Science.gov (United States)

    Joppi, R; Cinconze, E; Mezzalira, L; Pase, D; Poggiani, C; Rossi, E; Pengo, V

    2013-06-01

    Nonvalvular atrial fibrillation is associated with a substantial risk of stroke. Novel oral anticoagulants (NOACs) with predictable anticoagulant effect and no need for routine coagulation monitoring have recently shown good results when compared with warfarin in phase III clinical trials. To describe clinical features and pharmacological treatments of a population-based cohort of patients with nonvalvular atrial fibrillation and ascertain whether they are comparable with those included in the three main phase III clinical trials on NOACs. Of the 2,862,264 subjects considered for this study 13,360 patients (0.47%) were recently discharged from the hospital with a diagnosis of nonvalvular atrial fibrillation. Mean age was 76.3 (SD 10.7), 49.8% were men and 64.6% were ≥75 years of age. 50% of patients were treated with warfarin and 44.1% with antiplatelet agents. The proportion of patients on antiplatelet therapy increased with age up to a rate of 54.3% in subjects ≥85 years. 92.9% of the studied cohort was on polypharmacy (mean 8 drugs/patient). Around 20% of the entire cohort was treated with amiodarone, a drug potentially interfering with NOACs, and 3.6% from a subgroup analysis had renal failure, which is an exclusion criterion in trials on NOACs. In patients recently discharged from the hospital with the diagnosis of nonvalvular AF, warfarin use decreases and aspirin treatment increases with patients' age. These patients are older, more frequently female, and on multiple medications. The benefit of NOACs in these subjects needs to be confirmed in phase IV clinical studies. Copyright © 2013 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  17. Has time come for the use of direct oral anticoagulants in the extended prophylaxis of venous thromboembolism in acutely ill medical patients? Yes.

    Science.gov (United States)

    Ageno, Walter

    2017-08-14

    Betrixaban is a direct factor Xa inhibitor with a renal excretion of only approximately 5-7%. On June 23rd 2017, it became the first direct oral anticoagulant to receive Food and Drug Administration approval for the prevention of venous thromboembolism in acutely ill medical patients, and the first anticoagulant agent to be approved for extended-duration thromboprophylaxis after hospital discharge in this setting. Approval followed the results of the APEX trial, a phase III clinical trial comparing betrixaban (80 mg) administered for 35-42 days with enoxaparin (40 mg) administered for 10 ± 4 days. This study for the first time applied a risk assessment model, integrating clinical factors and a laboratory marker to identify high risk patients. To improve safety, a dose reduction was used for patients with creatinine clearance between 15 and 30 mL/min (betrixaban 40 mg and enoxaparin 20 mg) and for patients receiving concomitant treatment with potent P-glycoprotein inhibitors (betrixaban 40 mg). The primary prespecified analysis tested the hypothesis that the benefit of extended thromboprophylaxis with betrixaban was greatest in patients with elevated D-dimer, but the 21% relative risk reduction failed to meet the prespecified threshold for statistical significance. However, the analysis of the overall study population showed a favorable net clinical benefit with betrixaban, with a statistically significant reduction in all efficacy outcomes and no increase in major bleeding rates. An ongoing trial, MARINER, is also assessing a combined approach for risk stratification comparing extended-duration rivaroxaban with standard duration low molecular weight heparin.

  18. [Clinical characteristics of patients with atrial fibrillation treated with direct oral anticoagulants attended in primary care setting. The SILVER-AP study].

    Science.gov (United States)

    de la Figuera, Mariano; Cinza, Sergio; Marín, Nuria; Egocheaga, Isabel; Prieto, Miguel Angel

    2017-07-29

    To analyse the clinical characteristics and management of patients with non-valvular atrial fibrillation (NVAF) treated with direct oral anticoagulants (DOAC). Observational, cross-sectional and multicentre study. Autonomous Communities in which the general practitioner can prescribe DOAC (n=9). The study included a total of 790 patients on chronic treatment with anticoagulants, and on whom therapy was changed, as well as being currently on treatment with DOAC for at least for 3 months. A record was made of the sociodemographic and clinical management date. Mean age was 78.6±8.4 years, and 50.5% of patients were men. Mean CHADS2 score was 2.6±1.2, mean CHA2DS2-VASc score was 4.3±1.6, and the mean HAS-BLED score was 2.3±1.0. Mean duration of treatment with DOAC was 15.8±12.5 months. Rivaroxaban was the DOAC most frequently prescribed (57.8%), followed by dabigatran (23.7%), and apixaban (18.5%). Of the patients receiving rivaroxaban, 70.2% were taking the dose of 20mg/daily. Of the patients receiving dabigatran, 41.7% were taking the dose of 150mg twice daily, and in the case of apixaban, 56.2% were taking the dose of 5mg twice daily. Satisfaction (ACTS Burdens scale 52.0±7.2 and ACTS Benefits scale 12.1±2.2), and therapeutic adherence (97.8% of patients took their medication regularly) with DOAC were high. Patients treated with DOAC in Spain have a high thromboembolic risk. A significant proportion of patients receive a lower dose of DOAC than that recommended according to their clinical profile. Satisfaction and medication adherence are high. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  19. Baseline characteristics and event rates among anticoagulated patients with atrial fibrillation in practice and pivotal NOAC trials

    Directory of Open Access Journals (Sweden)

    Peter A. Noseworthy

    2017-10-01

    Full Text Available The data report details the baseline characteristics and observed outcomes among patients included in a large US administrative claims database (Optum Labs Data Warehouse and those enrolled in the pivotal phase III clinical trials examining apixaban, dabigratan, edoxaban and rivaroxaban versus warfarin for the prevention of cardio embolism (Granger et al., 2011; Cannolly et al., 2009; Patel et al., 2011; Giugliano et al., 2013 [1–4]. These data are to be interpreted in the context of the linked publication (Noseworthy et al., 2017 [5]. These data illustrate baseline characteristics in patients treated in routine practice and those enrolled in clinical trials. For instance, patients treated with apixaban in practice tended to be slightly older and we more likely to be female than those enrolled in the apixaban clinical trial. Patient treated with rivaroxaban in practice tended to have lower CHADS2 scores than those included in the rivaroxaban clinical trial. Overall, and stratified by baseline CHADS2 scores, patients treated with NOACs in routine practice had comparable or slightly lower stroke risks than those in the clinical trials. Patients treated with NOACs in routine practice had slightly higher bleeding risk in practice, particularly in high-risk patients with CHADS2 ≥ 3, compared to those in the clinical trials. These data may serve as a benchmark for realized outcomes among anticoagulated patients with atrial fibrillation in the United States and may serve as a useful comparison to other datasets or countries.

  20. Consideraciones prácticas para el uso de los nuevos anticoagulantes orales Practical considerations for the use of new oral anticoagulants

    Directory of Open Access Journals (Sweden)

    Julián M Aristizábal

    2012-06-01

    Full Text Available A pesar de la eficacia comprobada acerca del uso de warfarina como terapia anticoagulante, las múltiples interacciones, el estrecho margen terapéutico y la necesidad de monitorización seriada han planteado el escenario para el desarrollo de nuevos medicamentos como dabigatran, rivaroxaban y apixaban que ofrecen nuevas alternativas para el tratamiento del paciente anticoagulado. El conocimiento de las características farmacológicas y farmacocinéticas así como el contexto específico en el cual pueden usarse se convierten en una necesidad para los médicos que se enfrentan a este tipo de pacientes.Despite the proven efficacy on the use of warfarin as anticoagulant therapy, the multiple interactions, narrow therapeutic index and the need for serial monitoring have raised the need for the development of new drugs such as dabigatran, rivaroxaban and apixaban, that offer new alternatives for treating the anticoagulated patient. Knowledge of the pharmacologic and pharmacokinetic characteristics and the specific context in which they can be used become a necessity for physicians faced with these patients.

  1. [The application effect of traditional monitoring and self-monitoring methods in oral anticoagulant patients with mechanical valve replacement patients: a meta-analysis].

    Science.gov (United States)

    Zhang, Y C; Li, Y T; Fan, Y F; Fang, Q; Fu, H Y; Xie, G H; Hu, K

    2016-10-01

    Objective: To evaluate the effects of traditional monitoring and self-monitoring in patients who take the oral anticoagulation medicine after mechanical valve replacement surgical operations. Methods: A great number of Chinese and English literatures about this subject were investigated in detail, and these literatures were selected from the Cochrane Central Register of Controlled Trials, EMBase, MEDLINE, Web of Knowledge, CNKI, CBM, VIP, and WanFang Data. It should be noted that all of the literatures were published before October, 2015. Based on the results of the literature investigation, several studies were selected as the candidates. Moreover, many aspects about these candidates such as the experimental designs, characteristics of the objects of the studies and the results of the studies were filtered and recorded by two researchers independently. Furthermore, RevMan 5.3 were employed to analyze the data of the candidates. Results: Eight randomized controlled trials were studied, which included 1 262 cases in self-monitoring group and 1 198 cases in traditional monitoring group. The results of meta-analysis indicated that compared with the traditional monitoring group, lower incidence of thromboembolism (Z=3.50, P=0.000) and lower mortality (Z=4.64, P=0.000) were observed, and the bleeding difference (Z=0.07, P=0.940) had no significant statistical meaning. Moreover, compared with the traditional monitoring, the international normalized ratio (INR) of the patients who were controlled in the range of treatment of the self-monitoring increased from 6% to 20.9%, and the total number of the INR tests was increased by 2.1 to 4.98 times. Conclusions: Self-monitoring could obviously reduce the possibilities of the thromboembolism and death of the patients who took the oral anticoagulation medicine after mechanical valve replacement surgical operations. Furthermore, self-monitoring could not only control the INR in the range of treatment but also increase the total

  2. Conhecimento sobre anticoagulantes orais e seu manejo por médicos de pronto atendimento Emergency-room doctors' knowledge about oral anticoagulants and its management

    Directory of Open Access Journals (Sweden)

    Larissa Periotto Borlina

    2010-06-01

    Full Text Available Contexto: Desde sua descoberta, os anticoagulantes orais (AO têm sido cada vez mais estudados e aplicados em diferentes doenças. No entanto, eles apresentam reações medicamentosas com fármacos que trazem riscos ao paciente. Objetivo: Identificar o nível de conhecimento dos médicos plantonistas de pronto atendimento sobre os AO e suas interações, medicamentosas ou não, e verificar se o médico frentista está preparado para integrar o conteúdo teórico com a rotina de urgências. Método: Aplicou-se um questionário a 100 médicos atuantes em pronto atendimentos de dois hospitais públicos e três privados em Curitiba. Visou-se saber se o médico frentista questiona ao paciente sobre o uso de AO. Também, avaliou-se o conhecimento do profissional e seu interesse em saber mais sobre: AO (quais deles conhecia; exames para controle; sinergismo com AO; e manejo das complicações. Resultados: Dos 100 entrevistados, 60% declararam perguntar ao paciente sobre o uso de AO, 81% tinham conhecimento insuficiente a respeito do sinergismo de algumas substâncias apresentadas e os AO, 15% desconheciam qual exame é utilizado para acompanhamento dos pacientes anticoagulados, 50,7% não sabiam os nomes comercias dos AO, 4% desconheciam seu antídoto, e 92% manifestaram interesse em melhorar seus conhecimentos sobre os AO. Conclusão: É BAIXo o número de médicos que atende em pronto atendimentos que conhece sobre os AO e que sabe manejar pacientes anticoagulados. É alta a porcentagem de médicos que não perguntam aos pacientes sobre o uso de AO e que desconhecem princípios do sinergismo medicamentoso, sendo que a maioria se interessou em melhorar seus conhecimentos sobre os anticoagulantes.Background: Since its discovery, oral anticoagulants (OA have been increasingly studied and used to treat different diseases. However, OA may cause adverse drug interactions that bring risks for patients. Objective: To identify the emergency room doctors

  3. Anticoagulant Therapy In Ischemic Stroke Or TIA

    Directory of Open Access Journals (Sweden)

    Kaveh Mehrvar

    2017-02-01

    Full Text Available Stroke is the leading cause of disability and the third leading cause of death  . Anticoagulants   have been used to treat patients with acute ischemic stroke for many years. Despite their widespread use, the usefulness of emergency anticoagulation is a subject of debate. Disagreements exist about the best agent to administer, the route of administration, the use of a bolus dose to start treatment, the level of anticoagulation required, and the duration of treatment. There are 2 types of anticoagulants: Parenteral and oral. Heparin is an anticoagulant that used parenteral. Oral anticoagulants are including Warfarin and new anticoagulants such as Dabigatrn,Rivaroxaban ,Apixaban and other newer drugs. In patients with noncardioembolic  ischemic stroke or TIA antiplatelet agents are treatment of choice and preferred to anticoagulants. In cardioembolic  ischemic stroke or TIA with high risk of reembolization  anticoagulants  are considered as preferred treatment.  Warfarin, apixaban10mg/d ,Rivaroxaban20mg/d, and dabigatran 150 mg/d are all indicated for the prevention of recurrent stroke in patients with nonvalvular AF, whether paroxysmal or permanent.Also anticoagulant therapy is recommended for ischemic stroke or TIA patients in the setting of acute MI, atrial or ventricular thrombosis or dilated and restricted cardiomyopathy. Some valvular heart diseases are other indication for anticoagulant therapy in ischemic stroke or TIA patients. Ischemic  Stroke or TIA in patients with Cerebral vein thrombosis and  known hypercoagulable state specially anti phospholipid antibody syndrome are other indications for anticoagulant treatment.

  4. Widening the path and window of opportunity for FDA approval of non-vitamin K oral anticoagulant specific antidotes and reversal agents.

    Science.gov (United States)

    Patel, Sunny; Steen, Dylan

    2016-02-01

    There remains a need for safe, immediately effective, and easy to administer antidotes for patients taking novel oral anticoagulants (NOACs) in the settings of major bleeding, need for emergency surgery, and accidental overdose. We review considerations for the successful safety and effectiveness evaluation of potential antidotes currently under development. These compounds are in expedited regulatory approval programs aimed at accelerating the preclinical and clinical evaluation and approval processes for treatments of serious conditions. We review the features of these expedited programs as well as the FDA's efforts to broadly advance the efficiency of drug development and increase the number of new compounds brought to market. The critical path initiative and regulatory science initiative have resulted in numerous successful programs to address current challenges such as a paucity of validated biomarkers and surrogate endpoints as well as unreliable animal models of toxicity. The FDA has also advocated for increased use of pharmacokinetic/pharmacodynamic modeling and adaptive trial design. These efforts foster collaboration between academia, industry and the public sector across interdisciplinary sciences and may continue to widen the pathway for NOAC-specific reversal agents and other novel compounds.

  5. Early administration of non-vitamin K antagonist oral anticoagulants for acute ischemic stroke patients with atrial fibrillation in comparison with warfarin mostly combined with heparin.

    Science.gov (United States)

    Nomura, Eiichi; Ohshita, Tomohiko; Imamura, Eiji; Wakabayashi, Shinichi; Kajikawa, Hiroshi; Hosomi, Naohisa; Matsumoto, Masayasu

    2015-01-01

    This study evaluated the rates of new lesions on diffusion-weighted images (DWIs) of magnetic resonance imaging (MRI) and hemorrhagic transformation (HT) during 2 weeks after acute ischemic stroke (AIS) in patients with atrial fibrillation (Af) who were given one of the non-vitamin K antagonist oral anticoagulants (NOACs); this was then compared with those who were given warfarin. Consecutive AIS patients with Af were enrolled between January 2008 and June 2013, and those selected were patients who had a MRI that included DWIs both on admission and after 2 weeks, and those given only wafrarin (warfarin group) or only one of the NOACs (NOAC group) within 2 weeks of admission. Of all 257 enrolled patients, 50 patients were selected for the NOAC group (median age of 80.0 years) and 125 patients for the warfarin group (median age of 80.0 years). Both NOAC and warfarin were started at a median of the second day after admission. There was no significant difference in the rates of new lesions on DWIs (26.0% vs. 28.0%, P=0.7888) and HT (30.0% vs. 39.2%, P=0.2536) between the NOAC and warfarin groups. The NOAC group had a lower rate of concomitant use of heparin (44.0% vs. 92.8%, P<0.0001) than the warfarin group. This study suggests that NOACs are suitable for AIS patients with Af, perhaps even better than warfarin, given their simplicity.

  6. Discrepant sensitivity of thromboplastin reagents to clotting factor levels explored by the prothrombin time in patients on stable oral anticoagulant treatment: impact on the international normalized ratio system.

    Science.gov (United States)

    Testa, Sophie; Morstabilini, Giampietro; Fattorini, Annalisa; Galli, Laura; Denti, Nadia; D'Angelo, Armando

    2002-12-01

    We tested the principle of local International Normalized Ratio (INR) calibration using INR calibrator plasmas (PT Calibration Plasma Kit, Behring), two thomboplastin reagents (Neoplastin plus, rabbit brain, Stago, and Recombiplastin, recombinant human tissue factor, Ortho Diagnostics) and the same coagulometer (STA, Stago) on 92 patients on stable oral anticoagulant treatment. A four-point calibration was obtained with each reagent by linear regression (sec/INR) on a log-log scale (r > or = 0.999). The bias between the two reagents (Recombiplastin - Neoplastin Plus) was reduced from 31.7% to 17.5% and 7.5% (p=0.001) when results were expressed, respectively, as PT ratio (using the mean normal prothrombin time as denominator term), INR (using instrument-specific ISI supplied by the manufacturers) and calibrated INR, but there was a consistently significant regression of the differences over the average values even after log transformation (r > or = 0.586). The bias between the reagents was reduced to 1% (p=ns) when assuming Recombiplastin as the reference thromboplastin and applying Tomenson's correction, but limits of agreements were as large as 20%. Factor VII, X, V and II activity was measured with the two thromboplastin reagents in all plasma samples using immunodepleted plasmas (Stago). Statistically significant biases were observed for all clotting factors with the two reagents (Recombiplastin Neoplastin Plus) and ranged from 3.5 % (FII) to 37.2% (FVII). In addition, for FVII and FV there was a significant regression of the difference over the average value (after log-transformation, r > or = 0.282). The patients were divided into 3 groups according to their degree of anticoagulation (INR 3.5). Factor levels differed significantly with the two reagents throughout the 3 groups of patients. In addition, the relative distributions of the 3 vitamin K-dependent factors also differed in the 3 groups with the two thromboplastin reagents. The discrepant sensitivity

  7. Transurethral bipolar plasmakinetic vapo-enucleation of the prostate: Is it safe for patients on chronic oral anticoagulants and/or platelet aggregation inhibitors?

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    Waleed El-Shaer

    2017-12-01

    Full Text Available Objectives: To assess the safety and efficacy of bipolar plasmakinetic enucleation and resection of the prostate (PKERP for the management of benign prostatic hyperplasia (BPH in patients on oral anticoagulant (OAC therapy and/or platelet aggregation inhibitors (PAIs. Patients and methods: In all, 91 patients were recruited and underwent PKERP whilst they were receiving PAIs (aspirin, 56 patients; clopidogrel, three; aspirin and clopidogrel, 11. In all, 15 patients were receiving an OAC drug perioperatively, whilst another six patients were on dual PAIs and OACs. The primary outcomes were the perioperative morbidity and mortality rates. The secondary outcomes were functional outcomes including maximum urinary flow rate (Qmax, International Prostate Symptoms Score (IPSS, and post-void residual urine volume (PVR. Results: The mean (SD age of the patients was 65 (5.9 years, preoperative adenoma volume was 80.9 (30.4 mL, and the operative time was 67 (23 min. No patient developed serious perioperative cardiovascular complications. The mean (SD duration of hospital stay was 1.79 (1 days and the postoperative catheterisation time was 1.14 (0.76 days. The mean (SD haemoglobin drop was 0.74 (0.61 g/dL, blood transfusion rate was 2.2%, and the clot retention rate was 2.2%. The mean (SD postoperative Qmax was 18.6 (4.37 mL/s as compared to 7.2 (3.2 mL/s preoperatively (P < 0.001, and the preoperative IPSS was reduced from 24.3 (6.1 to 5.7 (2.3 postoperatively (P < 0.05. Prostate volume measured by transrectal ultrasonography was significantly reduced from a mean (SD of 80.9 (30.4 mL preoperatively to 29.5 (10.6 mL postoperatively (P < 0.001. Conclusion: Minimally invasive PKERP may be considered as a safe and effective treatment option for managing patients with BPH receiving OAC/PAI drugs. Keywords: Anticoagulant, BPH, LUTS, PKERP

  8. [Anticoagulation after an acute pulmonary embolism].

    Science.gov (United States)

    Le Mao, Raphael; Tromeur, Cécile; Couturaud, Francis

    In order to determine the optimal duration of anticoagulation after an acute pulmonary embolism, the benefit risk balance needs to be analysed based on the risk of recurrent venous thromboembolism in the absence of anticoagulation and the risk of bleeding while on anticoagulant therapy. Such evaluation take in account the frequency and the severity of the risks; clinical variables appear more informative to predict recurrent venous thromboembolism than biochemical or morphological variables. Three major results are now available: (1) the minimal duration of anticoagulation for pulmonary embolism is 3 months; (2) after pulmonary embolism that was provoked by a major transient risk factor, the risk of recurrence is low and does not justify to prolong anticoagulation beyond 6 months; and (3), in patients with an unprovoked pulmonary embolism (high risk of recurrence), the prolongation of anticoagulation up to 1 or 2 years as compared to 3 or 6 months is not associated with a long term reduction in the risk of recurrence and, consequently, these patients should be treated either during 3 to 6 months or indefinitely. This last observation has two major implications: first, to identify, among patients with unprovoked pulmonary embolism, those who have a low risk of recurrence and who do not require indefinite anticoagulation; and second, in those who are eligible for indefinite anticoagulation, to reduce the risk of bleeding. If direct oral anticoagulant therapies are promising, however, additional clinical trials are needed to help physician for the daily practice. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  9. Oral adverse events in cancer patients treated with VEGFR-directed multitargeted tyrosine kinase inhibitors.

    Science.gov (United States)

    Yuan, Anna; Kurtz, Sharyn L; Barysauskas, Constance M; Pilotte, Amy P; Wagner, Andrew J; Treister, Nathaniel S

    2015-11-01

    This study characterized the incidence and clinical features of oral adverse events among cancer patients who received VEGFR-directed multitargeted tyrosine kinase inhibitor (VR-TKI) therapies. Electronic medical records of adult cancer patients treated with sunitinib, sorafenib, regorafenib, pazopanib, cabozantinib, imatinib, and bevacizumab therapy at Dana-Farber Cancer Institute from 2009 to 2012 were reviewed. Data collected included patient characteristics, oral and non-oral adverse events, and time to onset. Time oral adverse event-free was the primary outcome. A total of 747 patients with 806 individual courses of therapy were treated for a median of 3.9months with sunitinib (n=161), sorafenib (n=172), regorafenib (n=15), pazopanib (n=132), cabozantinib (n=23), imatinib (n=144), or bevacizumab (n=159) for lung cancer (21%), gastrointestinal stromal tumor (15%), and metastatic renal cell carcinoma (13%). An oral adverse event was reported in 23.7% of patients at a median of 1.9months after starting therapy. The most commonly reported oral adverse event was oral mucosal sensitivity (dysesthesia), occurring in 12% of patients, typically without clinical findings. Multivariate models showed patients who received VR-TKI therapy were at greater risk of any oral adverse event compared with patients treated with imatinib or bevacizumab. Patients receiving VR-TKI therapy who developed an oral adverse event were also at increased risk for hand-foot skin reaction (15.9%). VR-TKI associated oral adverse events are characterized primarily by dysesthesia with lack of clinical signs. Oral dysesthesia is more commonly associated with VR-TKIs than with bevacizumab or imatinib. Management is largely empirical and requires further investigation. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. Multivariate relationships between international normalized ratio and vitamin K-dependent coagulation-derived parameters in normal healthy donors and oral anticoagulant therapy patients

    Directory of Open Access Journals (Sweden)

    Golanski Jacek

    2003-11-01

    Full Text Available Abstract Background and objectives International Normalized Ratio (INR is a world-wide routinely used factor in the monitoring of oral anticoagulation treatment (OAT. However, it was reported that other factors, e. g. factor II, may even better reflect therapeutic efficacy of OAT and, therefore, may be potentialy useful for OAT monitoring. The primary purpose of this study was to characterize the associations of INR with other vitamin K-dependent plasma proteins in a heterogenous group of individuals, including healthy donors, patients on OAT and patients not receiving OAT. The study aimed also at establishing the influence of co-morbid conditions (incl. accompanying diseases and co-medications (incl. different intensity of OAT on INR. Design and Methods Two hundred and three subjects were involved in the study. Of these, 35 were normal healthy donors (group I, 73 were patients on medication different than OAT (group II and 95 were patients on stable oral anticoagulant (acenocoumarol therapy lasting for at least half a year prior to the study. The values of INR and activated partial thromboplastin time (APTT ratio, as well as activities of FII, FVII, FX, protein C, and concentration of prothrombin F1+2 fragments and fibrinogen were obtained for all subjects. In statistical evaluation, the uni- and multivariate analyses were employed and the regression equations describing the obtained associations were estimated. Results Of the studied parameters, three (factors II, VII and X appeared as very strong modulators of INR, protein C and prothrombin fragments F1+2 had moderate influence, whereas both APTT ratio and fibrinogen had no significant impact on INR variability. Due to collinearity and low tolerance of independent variables included in the multiple regression models, we routinely employed a ridge multiple regression model which compromises the minimal number of independent variables with the maximal overall determination coefficient. The best

  11. Non-vitamin K antagonist oral anticoagulants in the cardioversion of patients with atrial fibrillation: systematic review and meta-analysis.

    Science.gov (United States)

    Caldeira, Daniel; Costa, João; Ferreira, Joaquim J; Lip, Gregory Y H; Pinto, Fausto J

    2015-07-01

    Non-vitamin K antagonist oral anticoagulants (NOACs) are at least non-inferior to Vitamin K Antagonists (VKAs) for stroke prevention on patients with non-valvular atrial fibrillation (AF). We aimed to evaluate the efficacy and safety of NOACs in patients undergoing cardioversion through a systematic review and meta-analysis. MEDLINE, Cochrane Library, and Web of Science(®) databases (until September 2014) were searched for studies fulfilling inclusion criteria. Two reviewers independently selected randomized controlled trials (RCTs) evaluating NOACs and VKA in patients with AF undergoing cardioversion. The primary outcome was ischemic stroke or systemic embolism (IS/SE). Secondary outcomes were major bleeding, myocardial infarction, and mortality. Risk ratio (RR) and 95 % confidence intervals were derived through random-effects meta-analysis. Heterogeneity was evaluated through I (2) test. Four RCTs (3 post-hoc analysis) evaluating apixaban, dabigatran, and rivaroxaban in 3,512 patients with AF were included. The risk of IS/SE with NOACs was similar to VKA (RR 0.60, 95 % CI 0.20-1.80; I (2) = 17 %). There was no significant increase in major bleeding (RR 1.27, 95 % CI 0.58-2.81; I (2) = 0 %), myocardial infarction (RR 0.71, 95 % CI 0.10-5.04; I (2) = 0 %), or mortality (RR 0.87, 95 % CI 0.24-3.08; I (2) = 0 %) with NOACs. This systematic review and meta-analysis suggests that NOACs may be as safe as VKAs in the setting of AF cardioversion.

  12. Non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation and valvular heart disease: systematic review and meta-analysis.

    Science.gov (United States)

    Caldeira, Daniel; David, Cláudio; Costa, João; Ferreira, Joaquim J; Pinto, Fausto J

    2017-09-06

    The non-vitamin K antagonist oral anticoagulants (NOACs) were approved for non-valvular atrial fibrillation (AF) but this term may be misnomer. Thus, the term non-mechanical and rheumatic mitral valvular (non-MARM) AF was proposed to exclude patients with valvular heart disease (VHD) without contraindications for NOACs. We aimed to review the efficacy and safety of NOACs in patients with AF and VHD compared to Vitamin K Antagonists (VKA). A systematic review with meta-analysis (PROSPERO CRD42015024837) including data from randomized controlled trials (RCTs) retrieved in November 2016. The efficacy and safety data were pooled using random-effects meta-analyses using the hazard ratio (HR) with the 95% confidence interval (95%CI). Trial sequential analysis (TSA) was performed in statistical significant results to evaluate whether cumulative sample size was powered for the obtained effect. In 5 RCTs (with 12653 VHD AF patients), NOACs significantly reduced the risk of stroke and systemic embolism (HR 0.73, 95%CI:0.60-0.90; TSA showed estimate was robust - O'Brien-Fleming α-spending boundary crossed before reaching the estimated information size) and intracranial hemorrhage (HR 0.45, 95%CI:0.24-0.87) compared with VKA. Major bleeding risk was not significantly different. In patients with bioprosthesis (3 trials-280 patients) the risks of thromboembolism (HR 0.65, 95%CI:0.20-2.08) and major bleeding (HR 0.94, 95%CI:0.28-3.18) with NOACs were similar to VKA. NOACs are efficacious and safe in patients with non-MARM VHD AF, showing significant reduction in the risk of stroke and systemic embolism and intracranial hemorrage compared with VKA.

  13. [Evaluation of the pilot programme for the descentralization of control of oral anticoagulant treatment in the Osasunbidea Healthcare Service (Navarra, Spain)].

    Science.gov (United States)

    Nuin Villanueva, M Angeles; Arroyo Aniés, M Pilar; Yurss Arruga, Ignacio; Granado Hualde, Ana; Calvo Herrado, Concepción; Elía Pitillas, Fernando; Ayerdi Navarro, Karmele

    2005-03-12

    The objective of this study was the evaluation of the pilot programme of decentralization of oral anticoagulant therapy (OAT) in eight basic health zones (ZBS) for the first six months and then a year after the programme was put into practice. Descriptive transversal study. It includes all patients aged 14 years or older in the OAT (540 in the initial period and then 640 more) in eight ZBS (five urban and three rural). The evaluation was done including: prevalence of INR in control (2-3 or 2.5-3.5, according to indications), clinically suitable INR (INR in control +/- 0.2) and INR in control +/- 0.5, accumulated thrombosis and bleeding incidence. Source data: ANTICOAGN computer programme. Comparison of INR control between both periods: 59% against 63.9% of INR in the range of INR in control (p < 0.001), 72.8% against 78.8% for clinically suitable INR (p < 0.001), and 86.6% against 91.4% for INR in control +/- 0.5 (p < 0.001). Accumulated incidence of bleeding episodes in 6 months: Pilot: 1.1% (0.7% majors and 0.4% minors). Subsequent period: 3.6% (0.6% majors and 3% minors). The decentralization of control of the OAT with adequate resources implies a greater accessibility for the patient. The control of INR is acceptable and has improved significantly over the second period. We have detected an improvement in the increase of the INR below that of the range of the control INR. The incidence of minor hemorrhages has increased, owing probably to a better recording.

  14. Percutaneous closure of the left atrial appendage for prevention of thromboembolism in atrial fibrillation for patients with contraindication to or failure of oral anticoagulation: a single-center experience.

    Science.gov (United States)

    Faustino, Ana; Paiva, Luís; Providência, Rui; Trigo, Joana; Botelho, Ana; Costa, Marco; Leitão-Marques, António

    2013-06-01

    In non-valvular atrial fibrillation 90% of thrombi originate in the left atrial appendage (LAA). Percutaneous LAA closure has been shown to be non-inferior to warfarin for prevention of thromboembolism. To evaluate the initial experience of a single center in percutaneous LAA closure in patients with high thromboembolic risk and in whom oral anticoagulation was impractical or contraindicated or had failed. Patients with non-valvular atrial fibrillation and CHADS2 score ≥2 in whom oral anticoagulation was impractical or contraindicated or had failed underwent percutaneous LAA closure according to the standard technique. After the procedure, dual antiplatelet therapy was maintained for one month, followed by single antiplatelet therapy indefinitely. Patients were followed by clinical assessment and transthoracic and transesophageal echocardiography. The procedure was performed in 22 of the 23 selected patients (95.7%), mean age 70±9 years, CHADS2 score 3.2±0.9 and CHA2DS2-VASC score 4.7±1.4. Intraprocedural device replacement was necessary only in the first patient, due to oversizing. The following periprocedural complications were observed: one femoral pseudoaneurysm, three femoral hematomas and two minor oropharyngeal bleeds, resolved by local hemostatic measures. During a 12±8 month follow-up a mild peri-device flow and a thrombus adhering to the device, resolved under with enoxaparin therapy, were identified. The rate of transient ischemic attack (TIA)/stroke was lower than expected according to the CHADS2 score (0 vs. 6.7±2.2%). In our initial experience, this procedure proved to be a feasible, safe and effective alternative for atrial fibrillation patients in whom oral anticoagulation is not an option. Only relatively minor complications were observed, with a lower than expected TIA/stroke rate. Copyright © 2012 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

  15. Lupus anticoagulants and antiphospholipid antibodies

    Science.gov (United States)

    Blood clots - lupus anticoagulants; DVT - anticoagulants ... Most often, lupus anticoagulants and aPL are found in people with diseases such as systemic lupus erythematosus (SLE). Lupus anticoagulants and ...

  16. Management of direct oral anticoagulants in patients undergoing elective surgeries and invasive procedures: Updated guidelines from the French Working Group on Perioperative Hemostasis (GIHP) - September 2015.

    Science.gov (United States)

    Albaladejo, Pierre; Bonhomme, Fanny; Blais, Normand; Collet, Jean-Philippe; Faraoni, David; Fontana, Pierre; Godier, Anne; Llau, Juan; Longrois, Dan; Marret, Emmanuel; Mismetti, Patrick; Rosencher, Nadia; Roullet, Stéphanie; Samama, Charles-Marc; Schved, Jean-François; Sié, Pierre; Steib, Annick; Susen, Sophie

    2017-02-01

    Since 2011, data on patients exposed to direct oral anticoagulants (DOAs) while undergoing invasive procedures have accumulated. At the same time, an increased hemorrhagic risk during perioperative bridging anticoagulation without thrombotic risk reduction has been demonstrated. This has led the GIHP to update their guidelines published in 2011. For scheduled procedures at low bleeding risk, it is suggested that patients interrupt DOAs the night before irrespective of type of drug and to resume therapy six hours or more after the end of the invasive procedure. For invasive procedures at high bleeding risk, it is suggested to interrupt rivaroxaban, apixaban and edoxaban three days before. Dabigatran should be interrupted according to the renal function, four days and five days if creatinine clearance is higher than 50mL/min and between 30 and 50mL/min, respectively. For invasive procedures at very high bleeding risk such as intracranial neurosurgery or neuraxial anesthesia, longer interruption times are suggested. Finally, bridging with parenteral anticoagulation and measurement of DOA concentrations can no longer routinely be used. Copyright © 2016 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

  17. [Prevalence of oral anticoagulation and quality of its management in primary healthcare: A study by the Health Sentinel Network of the Region of Valencia (Spain)].

    Science.gov (United States)

    Boned-Ombuena, Ana; Pérez-Panadés, Jordi; López-Maside, Aurora; Miralles-Espí, Maite; Guardiola Vilarroig, Sandra; Adam Ruiz, Desamparados; Zurriaga, Oscar

    2017-11-01

    To estimate the prevalence of patients with oral anticoagulant therapy (OAT) in the Region of Valencia and to evaluate the quality of management of OAT with vitaminK antagonists (VKA) carried out in primary healthcare. Observational cross-sectional study conducted through the Health Sentinel Network of the Region of Valencia, which includes a survey and the retrospective analysis of OAT monitoring. Primary healthcare, Region of Valencia, Spain. All patients aged 18years or older on OAT who consulted during the year 2014. The population covered by the 59 doctors of the Health Sentinel Network constitutes 2.2% of the adult population of the Region of Valencia, and it is representative of it. Demographic, socioeconomic and health data as well as information concerning OAT. Quality of OAT management with VKA was assessed by means of the percentage of time in therapeutic range (TTR), computed using the Rosendaal method. A total of 1,144 patients were recorded (mean age 74.5±11 years; 49.7% women). Prevalence of OAT in the Region of Valencia is 1.3 cases per 100 population. The characteristic profile of these patients is an old person, with several comorbidities and a low level of education, who lives accompanied. Atrial fibrillation is the most common indication. 82.8% of patients on OAT with VKA were monitored in primary healthcare. The average TTR was 65.0%, and 53.9% of patients had a TTR ≥65%. Among inadequately controlled patients, 74.4% were perceived as well-controlled by their primary care doctor. Prevalence of OAT is high, and it is expected to increase. The degree of control achieved meets the generally accepted quality standard (mean TTR ≥65%), and it is comparable to that observed in other national and international studies. However, there is wide scope for improvement. It is crucial to optimize the management of this therapy in the most effective and cost-effective way. Among other measures, access of physicians to their patients' clinical information

  18. Practice nursed-based, individual and video-assisted patient education in oral anticoagulation - Protocol of a cluster-randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Background Managing oral anticoagulant treatment (OAT) is a challenge for patients and primary care providers. It requires a high level of patient knowledge and adherence. Studies have shown that insufficient adherence and a low level of patient knowledge about OAT are primary causes for complications. This trial is the first to evaluate the long-term effects of a complex practice nurse-based patient education program in comparison to a patient brochure only. Methods and design This trial will be a cluster-randomized controlled trial in 22 general practices (GPs) recruiting 360 patients with OAT. GPs will be randomized into an intervention group or a control group. A baseline questionnaire will assess pre-existing knowledge about OAT. The patients in the intervention group will be educated by a complex education program which consists of a video, a brochure and individual training by a practice nurse. The video gives information about OAT, nutrition, and instructions about how to manage critical situations. The brochure repeats the content of the video. After 4 to 6 weeks, the intervention will be recapitulated. The control group will receive the brochure only. After 6 months, questionnaires will be used in both groups to assess patient knowledge about OAT as well as patients' subjective feelings of safety. Separately, we will evaluate patient records, looking for documented complications and the time spent in the therapeutic range. Discussion This trial will start in January 2011. This trial will evaluate the long-term effectiveness of a video-assisted education program on patients with OAT in comparison to a patient information brochure. Most previous studies have evaluated knowledge directly after an educational intervention. Our trial will look for long-term differences in basic knowledge of OAT. We expect that our complex patient education program effectively increases long-term basic knowledge about OAT. Although the population of our study is too small to

  19. Practice nursed-based, individual and video-assisted patient education in oral anticoagulation - Protocol of a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Friede Tim

    2011-04-01

    Full Text Available Abstract Background Managing oral anticoagulant treatment (OAT is a challenge for patients and primary care providers. It requires a high level of patient knowledge and adherence. Studies have shown that insufficient adherence and a low level of patient knowledge about OAT are primary causes for complications. This trial is the first to evaluate the long-term effects of a complex practice nurse-based patient education program in comparison to a patient brochure only. Methods and design This trial will be a cluster-randomized controlled trial in 22 general practices (GPs recruiting 360 patients with OAT. GPs will be randomized into an intervention group or a control group. A baseline questionnaire will assess pre-existing knowledge about OAT. The patients in the intervention group will be educated by a complex education program which consists of a video, a brochure and individual training by a practice nurse. The video gives information about OAT, nutrition, and instructions about how to manage critical situations. The brochure repeats the content of the video. After 4 to 6 weeks, the intervention will be recapitulated. The control group will receive the brochure only. After 6 months, questionnaires will be used in both groups to assess patient knowledge about OAT as well as patients' subjective feelings of safety. Separately, we will evaluate patient records, looking for documented complications and the time spent in the therapeutic range. Discussion This trial will start in January 2011. This trial will evaluate the long-term effectiveness of a video-assisted education program on patients with OAT in comparison to a patient information brochure. Most previous studies have evaluated knowledge directly after an educational intervention. Our trial will look for long-term differences in basic knowledge of OAT. We expect that our complex patient education program effectively increases long-term basic knowledge about OAT. Although the population of

  20. Practice nursed-based, individual and video-assisted patient education in oral anticoagulation--protocol of a cluster-randomized controlled trial.

    Science.gov (United States)

    Hua, Thanh Duc; Vormfelde, Stefan Viktor; Abu Abed, Manar; Schneider-Rudt, Hannelore; Sobotta, Petra; Friede, Tim; Chenot, Jean-François

    2011-04-10

    Managing oral anticoagulant treatment (OAT) is a challenge for patients and primary care providers. It requires a high level of patient knowledge and adherence. Studies have shown that insufficient adherence and a low level of patient knowledge about OAT are primary causes for complications. This trial is the first to evaluate the long-term effects of a complex practice nurse-based patient education program in comparison to a patient brochure only. This trial will be a cluster-randomized controlled trial in 22 general practices (GPs) recruiting 360 patients with OAT. GPs will be randomized into an intervention group or a control group. A baseline questionnaire will assess pre-existing knowledge about OAT. The patients in the intervention group will be educated by a complex education program which consists of a video, a brochure and individual training by a practice nurse. The video gives information about OAT, nutrition, and instructions about how to manage critical situations. The brochure repeats the content of the video. After 4 to 6 weeks, the intervention will be recapitulated. The control group will receive the brochure only. After 6 months, questionnaires will be used in both groups to assess patient knowledge about OAT as well as patients' subjective feelings of safety. Separately, we will evaluate patient records, looking for documented complications and the time spent in the therapeutic range. This trial will start in January 2011. This trial will evaluate the long-term effectiveness of a video-assisted education program on patients with OAT in comparison to a patient information brochure. Most previous studies have evaluated knowledge directly after an educational intervention. Our trial will look for long-term differences in basic knowledge of OAT. We expect that our complex patient education program effectively increases long-term basic knowledge about OAT. Although the population of our study is too small to observe differences in adverse effects, we

  1. Imaginary Worlds: The Status of Modeled Quality Adjusted Life Year Claims for New Oral Anticoagulants in Atrial Fibrillation Published Between January 2012 and February 2016

    Directory of Open Access Journals (Sweden)

    Paul C Langley

    2016-09-01

    Full Text Available The purpose of this commentary is to evaluate modeled quality adjusted life year claims (QALYs for new oral anticoagulants (NOACs published in the period from January 2012 to February 2016. The focus of this commentary is to assess whether or not the modeled claims meet the standards of normal science in supporting falsification and replication. A systematic and consensus review by the authors identified a total of 23 cost-utility NOACs evaluations along with four single technology appraisals undertaken by the National Institute for Health and Care Excellence (NICE in the UK. Each study was evaluated in terms of four criteria: (i did the study generate evaluable claims (ii id the authors attempt to generate evaluable claims (iii did the authors suggest how the claims might be evaluated and (iv did the authors caution readers as to the implications of generating non-evaluable projections or claims for credibility in health system decision making? None of the 23 studies assessed or the four NICE single technology appraisals met any of the four assessment criteria. None of the studies presented projections or claims in a form suitable for empirical evaluation. None could support falsification or replication. They failed the standards associated with the scientific method. Failure to meet the standards of normal science meant that the studies, from a formulary assessment perspective, are not credible. The claims made were either impossible to verify, or if potentially verifiable, were not presented in a testable form. There was no basis for assessing whether the claims were right or even if they were wrong. This lack of scientific credibility is a major concern. In particular, the choice of a lifetime cost-utility framework for assessing the NOACs against warfarin and against each other effectively precludes any experimental assessment. If medical economics is to advance through the formulation and testing of hypotheses, then editors of journals

  2. Non-vitamin K antagonist oral anticoagulants compared with warfarin at different levels of INR control in atrial fibrillation: A meta-analysis of randomized trials.

    Science.gov (United States)

    Carmo, João; Ferreira, Jorge; Costa, Francisco; Carmo, Pedro; Cavaco, Diogo; Carvalho, Salomé; Morgado, Francisco; Adragão, Pedro; Mendes, Miguel

    2017-10-01

    The efficacy and safety of warfarin for stroke prevention in atrial fibrillation (AF) depend on the time in the therapeutic range (TTR) with an international normalised ratio (INR) of 2.0-3.0. This meta-analysis focused the relative efficacy and safety of non-VKA oral anticoagulants (NOAC) compared with warfarin at different thresholds of centre's TTR (cTTR). We searched PubMed, Embase, CENTRAL and websites of regulatory agencies, limiting searches to randomized phase 3 trials. Primary outcomes were stroke or systemic embolism (SSE) and major or non-major clinically relevant (NMCR) bleeding. We used a random-effects model to pool effect on outcomes according to different thresholds of cTTR. Four TTR sub-studies with a total of 71,222 patients were included. The benefit of NOAC in reducing SSE compared with warfarin was significantly higher in patients at cTTR<60% (HR 0.79, 95% CI 0.68-0.90) and at 60% to <70% (0.82, 0.71-0.95) but not at ≥70% (1.00, 0.82-1.23) with a significant interaction for cTTR<70% or ≥70% (p=0.042). The risk of major or NMCR bleeding was significantly lower with NOAC as compared with warfarin in patients at all sub-groups (0.67, 0.54-0.83 for patients at cTTR<60% and 0.75, 0.63-0.89 at 60% to <70%) except for cTTR≥70% (HR 0.84, 0.64-1.11), but the interaction for cTTR<70% or ≥70% was not statistically significant (p=0.271). The superiority in efficacy of NOAC compared with warfarin for stroke prevention is lost above a cTTR threshold of approximately 70%, but the relative safety appears to be less modified by the centre-based quality of INR control. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. New anticoagulants for venous thromboembolism and atrial fibrillation

    DEFF Research Database (Denmark)

    Dimitropoulos, Gerasimos; Rahim, S M Zubair; Moss, Alexandra Sophie

    2018-01-01

    INTRODUCTION: The field of anticoagulation has seen impressive progress over the last decade. The introduction of the Non Vitamin K Oral Anticoagulants (NOACs) has revolutionized practice surrounding thromboprophylaxis, treatment of thromboembolic disease and stroke prevention in atrial fibrillat...... on well-established targets such factor Xa and thrombin remains the mainstay, attention has also shifted to other factors in the coagulation cascade. The evidence emerging from clinical research is growing, generating exciting possibilities in the field of anticoagulation....

  4. Laser Vaporization of the Prostate With the 180-W XPS-Greenlight Laser in Patients With Ongoing Platelet Aggregation Inhibition and Oral Anticoagulation.

    Science.gov (United States)

    Lee, Daniel J; Rieken, Malte; Halpern, Joshua; Zhao, Fujun; Pueschel, Heike; Chughtai, Bilal; Kaplan, Steven A; Lee, Richard K; Bachmann, Alexander; Te, Alexis E

    2016-05-01

    To characterize the safety and efficacy of the 180-W XPS-Greenlight laser in patients on systemic anticoagulation. A retrospective analysis of 384 patients who underwent photoselective vaporization of the prostate with the 180-W XPS-laser between 2010 and 2013 at two centers in the United States and Switzerland was performed. The primary outcome was the intraoperative and postoperative complication rates for those on anticoagulation undergoing photoselective vaporization of the prostate. The secondary outcome was International Prostate Symptom Scores, postvoid residual, maximum flow rate, and prostate-specific antigen levels. Of 384 patients, aspirin, clopidogrel, and warfarin were used in 146 (38%), 34 (8.9%), and 57 (14.8%) patients, respectively. Single-drug, two-drug, and three-drug combinations were used in 142 (35.5%), 37 (9.3%), and 7 (1.7%) of the cases. Median lasing time (39 min vs 36 min; P = .99) and number of fibers used (1.0 vs 1.0; P = .63) were comparable between patients on vs off systemic anticoagulation. Postoperatively, urinary symptoms (International Prostate Symptom Score, quality of life) and objective voiding parameters (maximum flow rate, postvoid residual) improved in both groups of patients. During a maximum follow-up of 2 years, patients on vs off systemic anticoagulation did not show any significant differences in the rate of postoperative urinary tract infection (3.8% vs 5.1%; P = .71), retention (5.1% vs 5.9%; P = .71), urethral stricture (1.5% vs none, P = .05), and reoperation (2.2% vs 1.5%; P = .49). The primary limitation is the retrospective nature of the study. Photovaporization of the prostate with the 180-W XPS-laser is a safe and effective minimal-invasive treatment option for patients on systemic anticoagulation. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Electroconvulsive therapy and anticoagulation after pulmonary embolism: a case report

    Directory of Open Access Journals (Sweden)

    Julio Cesar Lazaro

    2014-07-01

    Full Text Available Introduction Electroconvulsive therapy (ECT is considered the most effective treatment for catatonia regardless its underlying condition. The rigid fixed posture and immobility observed in catatonia may lead to several clinical complications, of which, pulmonary embolism (PE is one of the most severe. The rapid improvement of the psychiatric condition in catatonia-related PE is essential, since immobility favors the occurrence of new thromboembolic events and further complications. In that scenario, ECT should be considered, based on a risk-benefit analysis, aiming at the faster resolution of the catatonia. Methods Case report and literature review. Results A 66-years-old woman admitted to the psychiatric ward with catatonia due to a depressive episode presented bilateral PE. Clinically stable, but still severely depressed after a trial of antidepressants, she was treated with ECT in the course of full anticoagulation with enoxaparin. After five ECT sessions, her mood was significantly better and she was walking and eating spontaneously. She did not present complications related either to PE or to anticoagulation. After the eighth ECT session, she evolved with hypomania, which was managed with oral medication adjustments. The patient was completely euthymic at discharge. Conclusion The case we presented provides further evidence to the anecdotal case reports on the safety of ECT in the course of concomitant full anticoagulant therapy after PE, and illustrates how, with the proper precautions, the benefits of ECT in such condition might outweigh its risks.

  6. Rare adverse events associated with oral poliovirus vaccine in Brazil

    Directory of Open Access Journals (Sweden)

    Friedrich F.

    1997-01-01

    Full Text Available Oral poliovirus vaccine (OPV developed by A. Sabin has been effectively used to control poliomyelitis in Brazil, and the last case with the isolation of a wild poliovirus strain occurred in March 1989. Although the vaccine controlled the circulation of wild strains and poliomyelitis cases associated with these strains were not detected during the last eight years, rare cases classified as vaccine-associated paralytic poliomyelitis (VAPP have been detected. Molecular characterization studies of poliovirus strains isolated from VAPP cases and from healthy contacts have confirmed that the isolates are derived from the Sabin vaccine strains and also detected genomic modifications known or suspected to increase neurovirulence such as mutations and recombination. The molecular characterization of polioviruses isolated during the last eight years from paralysis cases classified as Guillain-Barré (GBS syndrome and transverse myelitits (TM, and from facial paralysis (FP cases also confirmed the vaccine origin of the strains and demonstrated mutations known to increase neurovirulence. Analysis of the epidemiologic data of these GBS, TM and FP cases demonstrated that in most of them the last OPV dose was given months or years before the onset of the disease and the isolation of the polioviruses. The temporal association between the isolation of these strains and the GBS, TM and FP suggested that the Sabin vaccine-derived poliovirus strains could also rarely trigger the diseases.

  7. Current perspectives on dental patients receiving coumarin anticoagulant therapy.

    Science.gov (United States)

    Herman, W W; Konzelman, J L; Sutley, S H

    1997-03-01

    Despite approximately 40 years of experience with oral anticoagulant drugs, controversy still exists about the safety of dental treatment in a patient receiving this therapy. The authors review the topic in depth and offer detailed recommendations for the dental management of patients receiving coumarin anticoagulant therapy.

  8. Optical profiling of anticoagulation status (Conference Presentation)

    Science.gov (United States)

    Tshikudi, Diane M.; Tripathi, Markandey M.; Hajjarian, Zeinab; Nadkarni, Seemantini K.

    2016-02-01

    Defective blood coagulation resulting from excessive procoagulant activity often leads to thrombotic disorders such as stroke and myocardial infarction. A variety of oral and injectable anticoagulant drugs are prescribed to prevent or treat life-threatening thrombosis. However, due to bleeding complications often associated with anticoagulant treatment, routine monitoring and accurate dosing of anticoagulant therapy is imperative. We have developed Optical thromboelastography (OTEG), a non-contact approach that utilizes a drop of whole blood to measure blood coagulation status in patients. Here, we demonstrate the capability of OTEG for rapidly monitoring anticoagulation in whole blood samples. OTEG monitors coagulation status by assessing changes in blood viscosity from temporal intensity fluctuations of laser speckle patterns during clotting. In OTEG a blood drop is illuminated with coherent light and the blood viscosity is measured from the speckle intensity autocorrelation curve, g2 (t). The metrics, clotting time (R+k), clot progression (angle) and maximum clot stiffness (MA) are then extracted. The aim of the current study was to evaluate the accuracy of OTEG in assessing anticoagulation status of common anticoagulants including heparin, argatroban and rivaroxaban status. A dose-dependent prolongation of R+k was observed in anticoagulated blood, which closely corresponded with standard-reference Thromboelastography (TEG) (r 0.87-0.99, P>0.01 for all cases). OTEG angle was unaltered by anticoagulation whereas TEG angle presented a dose-dependent diminution probably linked to clot rupture. In both OTEG and TEG, MA was unaffected by heparin, argatroban or rivaroxaban. We conclude that OTEG can accurately monitor anticoagulation status following treatment, potentially providing a powerful tool for routine monitoring of patients in the doctor's office or in the home setting.

  9. Results of an open-label, prospective study of anticoagulant therapy for atrial fibrillation in an outpatient anticoagulation clinic.

    Science.gov (United States)

    Abdelhafiz, Ahmed H; Wheeldon, Nigel M

    2004-09-01

    The goal of this study was to investigate the complications and control of warfarin treatment in patients with nonvalvular atrial fibrillation (NVAF) newly referred to an outpatient anticoagulation clinic. This study included new patients with NVAF who were referred to an anticoagulation clinic for warfarin therapy over a recruitment period of 21 months. To reflect real-world clinical practice, patient selection for anticoagulation and patient management were left to the referring physicians, who were blinded to their patients' participation in the study. Patients were interviewed in person at the first clinic visit and then by telephone every 4 to 6 weeks. They were questioned about any bleeding or thromboembolic events. A total of 402 patients were included (100% of all new referrals over 21 months). The mean (SD) age was 72.3 (10.3) years, and 224 (56%) patients were men. The mean (SD) international normalized ratio (INR) was 2.4 (0.31). Patients were followed up for a mean (SD) of 19 (8.1) months (range, 1.0-31.0 months). They spent a mean (SD) 66% (18.3) of time in the target range of INR (ie, 2.0-3.0). Annual event rates were 1.7% (95% CI, 0.4%-3.0%) for major bleeding, 16.6% (95% CI, 13.0%-20.2%) for minor bleeding, 1.2% (95% CI, 0.1%-2.3%) for ischemic stroke, and 0.3% (95% CI, 0.2%-0.8%) for transient ischemic attacks. There were no cases of hemorrhagic stroke or fatal bleeding. Variability of INR and number of medications were identified as risk factors for bleeding (P = 0.03 and P = 0.001, respectively). There was no significant association between age and bleeding. Based on this analysis, the risks of long-term oral anticoagulation therapy in an outpatient anticoagulation clinic appear to reflect the results of clinical trials. Rates of ischemic stroke, major bleeding, and anticoagulation control were comparable. There was no age-related risk of complications.

  10. MANAGEMENT OF PATIENTS ON ANTICOAGULANT THERAPY UNDERGOING DENTAL SURGICAL PROCEDURES. Review Article.

    Directory of Open Access Journals (Sweden)

    Atanaska Dinkova

    2013-07-01

    Full Text Available Dental treatment performed in patients receiving oral anticoagulant drug therapy is becoming increasingly common in dental offices.The aim of oral anticoagulant therapy is to reduce blood coagulability to an optimal therapeutic range within which the patient is provided some degree of protection from thromboembolic events. This is achieved at the cost of a minor risk of haemorrhage. Frequently raised questions concern the safety and efficacy of the various anticoagulation regimens and their accompanying thromboembolic and bleeding risks relative to invasive dental procedures.The aim of this literature review is to evaluate the available evidence on the impact of anticoagulant medications on dental treatment and highlight certain patient management issues closely interrelated to various aspects of dental treatment. For that purpose literature search in the electronic database of Medscape, Pubmed-Medline, Science Direct, and EBSCO host, in the data base of Medical University Plovdiv and specialised published books in general medicine and dentistry was made.A total of 33 publications between 1995 and 2013 were identified: 12 review articles, 11 randomized controlled and non-randomised studies, 6 guidelines and practical guides, 1 meta-analysis and 3 specialised books.

  11. The perioperative management of treatment with anticoagulants and platelet aggregation inhibitors.

    Science.gov (United States)

    Schlitt, Axel; Jámbor, Csilla; Spannagl, Michael; Gogarten, Wiebke; Schilling, Tom; Zwissler, Bernhard

    2013-08-01

    When giving anticoagulants and inhibitors of platelet aggregation either prophylactically or therapeutically, physicians face the challenge of protecting patients from thromboembolic events without inducing harmful bleeding. Especially in the perioperative period, the use of these drugs requires a carefully balanced evaluation of their risks and benefits. Moreover, the choice of drug is difficult, because many different substances have been approved for clinical use. We selectively searched for relevant publications that appeared from 2003 to February 2013, with particular consideration of the guidelines of the European Society of Cardiology, the Association of Scientific Medical Societies in Germany (AWMF), the American College of Cardiology, and the American Heart Association. Vitamin K antagonists (VKA), low molecular weight heparins, and fondaparinux are the established anticoagulants. The past few years have seen the introduction of orally administered selective inhibitors of the clotting factors IIa (dabigatran) and Xa (rivaroxaban, apixaban). The timing of perioperative interruption of anticoagulation is based on pharmacokinetic considerations rather than on evidence from clinical trials. Recent studies have shown that substituting short-acting anticoagulants for VKA before a procedure increases the risk of bleeding without lowering the risk of periprocedural thromboembolic events. The therapeutic spectrum of acetylsalicylic acid and clopidogrel has been broadened by the newer platelet aggregation inhibitors prasugrel and ticagrelor. Patients with drug eluting stents should be treated with dual platelet inhibition for 12 months because of the risk of in-stent thrombosis. Anticoagulants and platelet aggregation inhibitors are commonly used drugs, but the evidence for their perioperative management is limited. The risks of thrombosis and of hemorrhage must be balanced against each other in the individual case. Anticoagulation need not be stopped for minor

  12. Long-term anticoagulation in patients with coronary disease, and future developments.

    NARCIS (Netherlands)

    Verheugt, F.W.A.

    2008-01-01

    PURPOSE OF REVIEW: As anticoagulant therapy is a cornerstone in the early management of acute coronary syndrome, the question remains whether long-term anticoagulation after discharge will further improve outcome. RECENT FINDINGS: Major trials demonstrated benefit from routine oral anticoagulation

  13. [Dental surgery in patients receiving anticoagulant therapy].

    Science.gov (United States)

    Mutzbauer, Till S; Imfeld, Thomas

    2008-02-01

    It has long been a standard procedure to replace coumarin by heparin if a patient using this oral anticoagulant had to undergo dental surgery. The Quick-Value had then to exceed a certain limit before surgery could be safely performed. Today this procedure has changed in that a switch to heparin is only made for invasive and large area surgery. Simple dental extractions, small biopsies and periodontal treatments are performed under continuous oral anticoagulation and local hemostyptic measures are applied. It has been shown that the likelihood of postoperative bleeding complications after adequate local hemostasis during dental surgery is much lower than is the risk of thrombosis or embolic complication following cessation of anticoagulant medication before surgery.

  14. Anticoagulation Therapy and NOACs in Heart Failure.

    Science.gov (United States)

    Thomas, Isac; EncisoSilva, Jorge; Schlueter, Michelle; Greenberg, Barry

    2017-01-01

    Current evidence indicates that heart failure (HF) confers a hyper-coagulable state that is associated with adverse events including stroke, systemic embolism, and mortality. This may be due to the elevated levels of pro-thrombotic and pro-inflammatory cytokines that are seen in patients with acute and chronic HF. Left ventricular wall motion abnormalities in patients with systolic dysfunction predispose to local thrombosis due to blood stasis as does atrial fibrillation (AF) which leads to blood stasis in regions of the atria. The high risk of thromboemboli in HF patients with AF has resulted in the use anticoagulation therapy to prevent the occurrence of catastrophic events. There is evidence, however, that the pro-inflammatory, pro-thrombotic state that exists in HF puts patients who are in sinus rhythm at risk. The novel oral anticoagulants (NOACs) have been shown in RCT to have at least equivalent efficacy in reducing stroke as warfarin while exposing patients to a lower risk of bleeding. The fact that the NOACs don't require routine monitoring to assure that patients remain within the therapeutic range and have relatively simple dosing requirements and a safer risk profile makes them attractive substitutes to warfarin in HF patients with atrial fibrillation and other conditions (e.g. deep venous thrombosis). Post hoc analyses from a subset of HF patients from the RCTs in AF patients have demonstrated similar findings as were reported in the entire populations that were included in the trials. As a result, NOACS are commonly used now in HF patients with AF. For HF patients with reduced ejection fraction in sinus rhythm, the use of warfarin in randomized clinical trials (RCT) to reduce stroke has been disappointing and associated with increase bleeding risk when compared to aspirin. The advantages of the NOACs over warfarin, however, raise the question of whether they might improve outcomes in HF patients who are in sinus rhythm. The currently ongoing COMMANDER

  15. [Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors. Proposals of the Working Group on Perioperative Haemostasis (GIHP) - March 2013].

    Science.gov (United States)

    Pernod, G; Albaladejo, P; Godier, A; Samama, C M; Susen, S; Gruel, Y; Blais, N; Fontana, P; Cohen, A; Llau, J V; Rosencher, N; Schved, J F; de Maistre, E; Samama, M M; Mismetti, P; Sié, P

    2013-10-01

    New direct oral anticoagulants (NOAC), inhibitors of factor IIa or Xa, are expected to be widely used for the treatment of venous thromboembolic disease, or in case of atrial fibrillation. Such anticoagulant treatments are known to be associated with haemorrhagic complications. Moreover, it is likely that such patients on long-term treatment with NOAC will be exposed to emergency surgery or invasive procedures. Due to the present lack of experience in such conditions, we cannot make recommendations, but only propose management for optimal safety as regards the risk of bleeding in such emergency conditions. In this article, only dabigatran and rivaroxaban were discussed. For emergency surgery at risk of bleeding, we propose to dose the plasmatic concentration of drug. Levels inferior or equal to 30ng/mL for both dabigatran and rivaroxaban, should enable the realization of a high bleeding risk surgery. For higher concentration, it was proposed to postpone surgery by monitoring the evolution of the drug concentration. Action is then defined by the kind of NOAC and its concentration. If the dosage of the drug is not immediately available, proposals only based on the usual tests, PT and aPTT, also are presented. However, these tests do not really assess drug concentration or bleeding risk. In case of severe haemorrhage in a critical organ, it is proposed to reduce the effect of anticoagulant therapy using a nonspecific procoagulant drug (activated prothrombin concentrate, FEIBA, 30-50U/kg, or non-activated 4-factors prothrombin concentrates 50U/kg). For any other type of severe haemorrhage, the administration of such a procoagulant drug, potentially thrombogenic in these patients, will be discussed regarding concentration of NACO and possibilities for mechanical haemostasis. Copyright © 2013 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.

  16. Anticoagulation in the Elderly

    Directory of Open Access Journals (Sweden)

    Helia Robert-Ebadi

    2010-12-01

    Full Text Available Management of anticoagulation in elderly patients represents a particularly challenging issue. Indeed, this patient population is at high thromboembolic risk, but also at high hemorrhagic risk. Assessment of the benefit-risk balance of anticoagulation is the key point when decisions are made about introducing and/or continuing such treatments in the individual elderly patient. In order to maximise the safety of anticoagulation in the elderly, some specific considerations need to be taken into account, including renal insufficiency, modified pharmacodynamics of anticoagulants, especially vitamin K antagonists, and the presence of multiple comorbidities and concomitant medications. New anticoagulants could greatly simplify and possibly increase the safety of anticoagulation in the elderly in the near future.

  17. Anticoagulation in acute ischemic stroke: A systematic search

    Directory of Open Access Journals (Sweden)

    Nayara L. Froio

    Full Text Available Summary Introduction: Stroke is one of the most important diseases worldwide. Several clinical scenarios demand full dose of anticoagulants primary to stroke etiology or to the treatment of comorbidity. However, controversy exists over many issues regarding anticoagulation treatment in stroke such as time for initiation, efficacy according to stroke etiology, the ideal dose of anticoagulants, and whether novel anticoagulants should be used. Method: Computerized search for clinical trials and randomized controlled clinical trials was done to the present date at Medline, Scielo, Embase, PsychInfo, and Cochrane Library using MeSH terms and the keywords stroke, ischemic stroke, anticoagulation, anticoagulants, heparin, low-molecular-weight heparin, warfarin, dabigatran, rivaroxaban, apixaban. The PRISMA statement was used to evaluate clinical trials. Results: Fourteen clinical trials were selected based on inclusion criteria. No evidence was found supporting the early use of heparin, heparinoids or low-molecular-weight heparin (LMWH early after stroke. No consistent evidence for the use of warfarin and the newer oral anticoagulants were found. Argatroban was the only anticoagulant with significant positive results early after large-artery ischemic stroke. Conclusion: The ideal time for initiating anticoagulation remains undefined, requiring further investigation. Early anticoagulation for ischemic stroke is not recommended, with few exceptions, such as that of argatroban.

  18. The Effects of Indirect- and Direct-Acting Anticoagulants on Lupus Anticoagulant Assays: A Large, Retrospective Study at a Coagulation Reference Laboratory.

    Science.gov (United States)

    Seheult, Jansen N; Meyer, Michael P; Bontempo, Franklin A; Chibisov, Irina

    2017-06-01

    To investigate the effects of indirect- and direct-acting anticoagulants on the interpretation of lupus anticoagulant (LAC) assays. A retrospective database review was performed to identify all LAC panels from November 2012 to November 2015. The positivity rates for three LAC tests were compared among various anticoagulant medications. This analysis included 7,721 LAC panels. Direct oral anticoagulants, warfarin, and unfractionated heparin (UFH) were associated with higher LAC positivity rates compared with patients not receiving documented anticoagulation (83% for argatroban, 58% for dabigatran, 72% for rivaroxaban, 53% for apixaban, 56% for warfarin, and 36% for UFH vs 29% for no anticoagulation, P LAC testing performed while patients are receiving anticoagulant therapies should be interpreted with caution to avoid misdiagnosing patients with the antiphospholipid syndrome and potentially committing them to long-term anticoagulation therapy.

  19. Effects of low dose aspirin (50 mg/day), low dose aspirin plus dipyridamole, and oral anticoagulant agents after internal mammary artery bypass grafting: patency and clinical outcome at 1 year. CABADAS Research Group of the Interuniversity Cardiology Institute of The Netherlands. Prevention of Coronary Artery Bypass Graft Occlusion by Aspirin, Dipyridamole and Acenocoumarol/Phenprocoumon Study

    NARCIS (Netherlands)

    van der Meer, J.; Brutel de la Rivière, A.; van Gilst, W. H.; Hillege, H. L.; Pfisterer, M.; Kootstra, G. J.; Dunselman, P. H.; Mulder, B. J.; Lie, K. I.

    1994-01-01

    This study was performed to compare the efficacy and safety of aspirin, aspirin plus dipyridamole, and oral anticoagulant agents in the prevention of internal mammary artery graft occlusion. Antithrombotic drugs increase vein graft patency after coronary artery bypass surgery. Their benefit after

  20. Prevention of one-year vein-graft occlusion after aortocoronary-bypass surgery: a comparison of low-dose aspirin, low-dose aspirin plus dipyridamole, and oral anticoagulants. The CABADAS Research Group of the Interuniversity Cardiology Institute of The Netherlands

    NARCIS (Netherlands)

    van der Meer, J.; Hillege, H. L.; Kootstra, G. J.; Ascoop, C. A.; Mulder, B. J.; Pfisterer, M.; van Gilst, W. H.; Lie, K. I.

    1993-01-01

    Aspirin, alone or in combination with dipyridamole, is known to prevent occlusion of aortocoronary vein grafts. The benefit of dipyridamole in addition to aspirin remains controversial, and the efficacy and safety of oral anticoagulants for prevention of vein-graft occlusion have not been

  1. Quality of oral anticoagulation with phenprocoumon in regular medical care and its potential for improvement in a telemedicine-based coagulation service--results from the prospective, multi-center, observational cohort study thrombEVAL.

    Science.gov (United States)

    Prochaska, Jürgen H; Göbel, Sebastian; Keller, Karsten; Coldewey, Meike; Ullmann, Alexander; Lamparter, Heidrun; Jünger, Claus; Al-Bayati, Zaid; Baer, Christina; Walter, Ulrich; Bickel, Christoph; ten Cate, Hugo; Münzel, Thomas; Wild, Philipp S

    2015-01-23

    The majority of studies on quality of oral anticoagulation (OAC) therapy with vitamin K-antagonists are performed with short-acting warfarin. Data on long-acting phenprocoumon, which is frequently used in Europe for OAC therapy and is considered to enable more stable therapy adjustment, are scarce. In this study, we aimed to assess quality of OAC therapy with phenprocoumon in regular medical care and to evaluate its potential for optimization in a telemedicine-based coagulation service. In the prospective observational cohort study program thrombEVAL we investigated 2,011 patients from regular medical care in a multi-center cohort study and 760 patients from a telemedicine-based coagulation service in a single-center cohort study. Data were obtained from self-reported data, computer-assisted personal interviews, and laboratory measurements according to standard operating procedures with detailed quality control. Time in therapeutic range (TTR) was calculated by linear interpolation method to assess quality of OAC therapy. Study monitoring was carried out by an independent institution. Overall, 15,377 treatment years and 48,955 international normalized ratio (INR) measurements were analyzed. Quality of anticoagulation, as measured by median TTR, was 66.3% (interquartile range (IQR) 47.8/81.9) in regular medical care and 75.5% (IQR 64.2/84.4) in the coagulation service (P service with TTR at 76.2% [(IQR 65.6/84.7); P = 0.001)]. Prospective follow-up of coagulation service patients with pretreatment in regular medical care showed an improvement of the TTR from 66.2% (IQR 49.0/83.6) to 74.5% (IQR 62.9/84.2; P service. Treatment in the coagulation service contributed to an optimization of the profile of time outside therapeutic range, a 2.2-fold increase of stabile INR adjustment and a significant decrease in TTR variability by 36% (P Quality of anticoagulation with phenprocoumon was comparably high in this real-world sample of regular medical care. Treatment in a

  2. Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP) - March 2013.

    Science.gov (United States)

    Pernod, Gilles; Albaladejo, Pierre; Godier, Anne; Samama, Charles M; Susen, Sophie; Gruel, Yves; Blais, Normand; Fontana, Pierre; Cohen, Ariel; Llau, Juan V; Rosencher, Nadia; Schved, Jean-François; de Maistre, Emmanuel; Samama, Meyer M; Mismetti, Patrick; Sié, Pierre

    2013-01-01

    Direct new oral anticoagulants (NOACs) - inhibitors of thrombin or factor Xa - are intended to be used largely in the treatment of venous thromboembolic disease or the prevention of systematic embolism in atrial fibrillation, instead of vitamin K antagonists. Like any anticoagulant treatment, they are associated with spontaneous or provoked haemorrhagic risk. Furthermore, a significant proportion of treated patients are likely to be exposed to emergency surgery or invasive procedures. Given the absence of a specific antidote, the action to be taken in these situations must be defined. The lack of data means that it is only possible to issue proposals rather than recommendations, which will evolve according to accumulated experience. The proposals presented here apply to dabigatran (Pradaxa(®)) and rivaroxaban (Xarelto(®)); data for apixaban and edoxaban are still scarce. For urgent surgery with haemorrhagic risk, the drug plasma concentration should be less or equal to 30ng/mL for dabigatran and rivaroxaban should enable surgery associated with a high bleeding risk. Beyond that, if possible, the intervention should be postponed by monitoring the drug concentration. The course to follow is then defined according to the NOAC and its concentration. If the anticoagulant dosage is not immediately available, worse propositions, based on the usual tests (prothrombin time and activated partial thromboplastin time), are presented. However, these tests do not really assess drug concentration or the risk of bleeding that depends on it. In case of serious bleeding in a critical organ, the effect of anticoagulant therapy should be reduced using a non-specific procoagulant drug as a first-line approach: activated prothrombin complex concentrate (aPCC) (FEIBA(®) 30-50U/kg) or non-activated PCC (50U/kg). In addition, for any other type of severe haemorrhage, the administration of a procoagulant drug, which is potentially thrombogenic in these patients, is discussed according

  3. Effects of anticoagulant and antiplatelet drugs on the risk for hospital admission for traumatic injuries: a case-control and population-based study.

    Science.gov (United States)

    Di Bartolomeo, Stefano; Marino, Massimiliano; Valent, Francesca; De Palma, Rossana

    2014-02-01

    The current cardiovascular literature advocates an overall beneficial balance between the advantages of oral anticoagulants and antiplatelet drugs in preventing and treating thromboembolic events and their disadvantages in promoting hemorrhage. However, traumatic injuries have usually received little attention despite several studies from the surgical literature showing worse outcomes in anticoagulated trauma registry patients. To quantify at population level too this seemingly deleterious impact, we investigated the effects of anticoagulants and antiplatelet use on the risk for hospital admission for acute traumatic causes. A population-based, case-control study in an Italian region with 4.5 million inhabitants was conducted. Cases were all the 59,348 adult residents admitted to the hospital for traumatic injuries in the years 2010 and 2011. Controls were age- and sex-matched residents selected by incidence density sampling. By conditional logistic regression adjusted for comorbidities, we estimated the risk for traumatic hospital admission while on anticoagulant, antiplatelet, and combined medications. The odds ratios (ORs) for anticoagulation and combined medications were 1.21 (95% confidence interval [CI], 1.15-1.28) and 1.39 (95% CI, 1.21-1.62). These effects were generally consistent across subgroups of demographic and clinical characteristics and particularly important in the head injured (e.g., OR for anticoagulation, 2.00; 95% CI, 1.77-12.27). Antiplatelets alone had no overall effect (OR, 1.02; 95% CI, 0.99-1.05). The number-needed-to-harm of anticoagulation was 595. Oral anticoagulation increased the population risk for traumatic hospital admission, with a further increase in case of concurrent antiplatelet use. Because this effect is most likely to derive from the prohemorrhagic properties of these drugs, injured patients should be included in the future evaluations of the cost-benefit profiles of these medications. Epidemiologic/prognostic study, level

  4. Pre-admission warfarin use in patients with acute ischemic stroke and atrial fibrillation: The appropriate use and barriers to oral anticoagulant therapy.

    Science.gov (United States)

    Partington, Sara L; Abid, Simona; Teo, Koon; Oczkowski, Wesley; O'Donnell, Martin J

    2007-01-01

    Warfarin reduces the risk of stroke in patients with atrial fibrillation. Despite strong guideline recommendations, studies continue to demonstrate the under-use of warfarin in clinical practice. To determine the prevalence and predictors of warfarin use in patients presenting with atrial fibrillation and acute ischemic stroke who do not have a documented contraindication to anticoagulants. We conducted a retrospective chart review of all patients admitted to the Hamilton General Hospital with a primary diagnosis of ischemic stroke and a coded diagnosis of atrial fibrillation between 1999 and 2004. Using a standardized data abstraction form, the following variables were recorded: baseline demographics, past medical history including risk factors for stroke and major bleeding and known predictors of warfarin under-use. In cases where warfarin was not prescribed, charts were also reviewed for documented contraindications to warfarin use. The following were considered valid contraindications to warfarin: patient refusal, non-compliance with INR monitoring, bleeding diathesis, history of major bleeding or significant alcohol consumption. In total, 196 patients with ischemic stroke and atrial fibrillation were identified. Of these patients, 106 were considered to be appropriate candidates for anticoagulation after excluding patients with no known diagnosis of atrial fibrillation prior to admission (N=59), a valid contraindication to warfarin use (N=18), a CHADS2 score heart failure (OR 3.2; 95% CI 1.1-9.0) were associated with an increased odds of warfarin use in patients without a contraindication to warfarin. While 75% of patients 85 years were prescribed warfarin on admission to hospital. early half of all patients presenting with atrial fibrillation and acute ischemic stroke who were suitable candidates for anticoagulation were not prescribed warfarin. In patients not prescribed warfarin, very few had a documented contraindication. Advanced age appears to be the

  5. The Patterns of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Use in Patients with Atrial Fibrillation in Seven Balkan Countries: a Report from the BALKAN-AF Survey.

    Science.gov (United States)

    Potpara, Tatjana S; Trendafilova, Elina; Dan, Gheorghe-Andrei; Goda, Artan; Kusljugic, Zumreta; Manola, Sime; Music, Ljilja; Gjini, Viktor; Pojskic, Belma; Popescu, Mircea Ioakim; Georgescu, Catalina Arsenescu; Dimitrova, Elena S; Kamenova, Delyana; Ekmeciu, Uliks; Mrsic, Denis; Nenezic, Ana; Brusich, Sandro; Milanov, Srdjan; Zeljkovic, Ivan; Lip, Gregory Y H

    2017-08-09

    Data on management of atrial fibrillation (AF) in the Balkan Region are scarce. To capture the patterns in AF management in contemporary clinical practice in the Balkan countries a prospective survey was conducted between December 2014 and February 2015, and we report results pertinent to the use of non-vitamin K antagonist oral anticoagulants (NOACs). A 14-week prospective, multicenter survey of consecutive AF patients seen by cardiologists or internal medicine specialists was conducted in Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Montenegro, Romania, and Serbia (a total of about 50 million inhabitants). Of 2712 enrolled patients, 2663 (98.2%) had complete data relevant to oral anticoagulant (OAC) use (mean age 69.1 ± 10.9 years, female 44.6%). Overall, OAC was used in 1960 patients (73.6%) of whom 338 (17.2%) received NOACs. Malignancy [odds ratio (OR), 95% confidence interval (CI) 2.06, 1.20-3.56], rhythm control (OR 1.64, 1.25-2.16), and treatment by cardiologists were independent predictors of NOAC use (OR 2.32, 1.51-3.54) [all p < 0.01)], whilst heart failure and valvular disease were negatively associated with NOAC use (both p < 0.01). Individual stroke and bleeding risk were not significantly associated with NOAC use on multivariate analysis. NOACs are increasingly used in AF patients in the Balkan Region, but NOAC use is predominantly guided by factors other than evidence-based decision-making (e.g., drug availability on the market or reimbursement policy). Efforts are needed to establish an evidence-based approach to OAC selection and to facilitate the optimal use of OAC, thus improving the outcomes in AF patients in this large region.

  6. Quality Control Approach to Anticoagulants and Transfusion.

    Science.gov (United States)

    McKean, Erin

    2016-06-01

    Quality can be defined by processes of care and by the characteristics of the care and its outcomes. In terms of blood loss and transfusion, otolaryngologists should be aware of available guidelines, standards for use of blood products, devices and hemostatic agents, outcomes metrics relevant to patients, and tools for implementing quality improvements. This article reviews the definition of health care quality, and discusses the data regarding anticoagulant medications (particularly new oral anticoagulants) and guidelines for blood product transfusion. A brief outline of quality tools is provided to help otolaryngologists create quality plans for themselves and their institutions/systems. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Anticoagulation therapy for the prevention of hemodialysis tunneled cuffed catheters (TCC) thrombosis.

    Science.gov (United States)

    Colì, L; Donati, G; Cianciolo, G; Raimondi, C; Comai, G; Panicali, L; Nastasi, V; Cannarile, D C; Gozzetti, F; Piccari, M; Stefoni, S

    2006-01-01

    Chronic oral anticoagulation is currently used to avoid thrombosis and the malfunction of tunneled cuffed catheters (TCCs) for hemodialysis (HD). The aim of the study was to assess the efficacy of early warfarin administration, after TCC placement, in comparison to its administration after the first thrombosis or malfunction event of the TCC. One hundred and forty-four chronic dialysis patients, who underwent TCC placement between June 2001 and June 2005, were randomized into two groups: 81 patients, group A, started oral anticoagulation 12 hr after the TCC placement (target international normalized ratio (INR) 1.8-2.5), in association with ticlopidine 250 mg/die; 63 patients, group B, started warfarin after the first thrombosis/malfunction episode (target INR 1.8-2.5) in association with ticlopidine 250 mg/die. The efficacy of oral anticoagulation therapy in preventing TCC thrombotic complications was evaluated in a 12-month follow-up period, after TCC placement, in terms of: a) the number of patients with thrombotic-malfunction events; b) the number of thrombotic-malfunction events with urokinase infusion (events/patient/year); c) intradialytic blood flow rate (BFR, ml/min); d) negative blood pressure (BP) from the arterial line of the TCC (AP, mmHg); e) positive BP, in the extracorporeal circuit from the venous line (VP, mmHg); and f) bleeding complications. Ten patients (12%) in group A showed TCC thrombosis/malfunction vs. 33 patients (52%) in group B (p TCC thrombotic complications and an improvement in both arterial and venous fluxes in comparison with the same therapy administered after the first TCC thrombotic/malfunction event. This therapy did not induce any bleeding complications in the patients included in the study.

  8. Anticoagulant and Antiplatelet Therapy in Patients with Atrial Fibrillation and Coronary Artery Disease

    Science.gov (United States)

    Mischke, Karl; Knackstedt, Christian; Marx, Nikolaus

    2012-01-01

    Anticoagulation represents the mainstay of therapy for most patients with atrial fibrillation. Patients on oral anticoagulation often require concomitant antiplatelet therapy, mostly because of coronary artery disease. After coronary stent implantation, dual antiplatelet therapy is necessary. However, the combination of oral anticoagulation and antiplatelet therapy increases the bleeding risk. Risk scores such as the CHA2DS2-Vasc score and the HAS-BLED score help to identify both bleeding and stroke risk in individual patients. The guidelines of the European Society of Cardiology provide a rather detailed recommendation for patients on oral anticoagulation after coronary stent implantation. However, robust evidence is lacking for some of the recommendations, and especially for new oral anticoagulants and new antiplatelets few or no data are available. This review addresses some of the critical points of the guidelines and discusses potential advantages of new anticoagulants in patients with atrial fibrillation after stent implantation. PMID:22577538

  9. Current anticoagulant safety.

    Science.gov (United States)

    Denas, Gentian; Pengo, Vittorio

    2012-05-01

    Currently used anticoagulants such as unfractionated heparin, low-molecular-weight heparin and vitamin K antagonists, have several drawbacks, mostly related to safety. In this review, we will briefly discuss and compare the safety of anticoagulation therapy with 'old' and new agents. Safety issues with anticoagulation therapy are mostly related to bleeding. The intensity of anticoagulation is related to the risk of bleeding and thus, for the efficacy not to be affected, must be maintained at the lower effective intensity. Several improvements have been made in the management of anticoagulation therapy; these include monitoring, pathology-based treatment schemes taking into account patient characteristics, patient education and the introduction of anticoagulation centers. Safety of novel anticoagulants is encouraging. Novel agents have the potential to compete with existing therapy for thromboprophylaxis, treatment and stroke prevention in atrial fibrillation. Promising results have emerged from trials comparing them with existing treatment. Not long from now we will see these new agents in the armamentarium of antithrombotic drugs.

  10. Pulmonary Embolism Rates Following Total Hip Arthroplasty With Prophylactic Anticoagulation: Some Pulmonary Emboli Cannot Be Avoided.

    Science.gov (United States)

    Lieberman, Jay R; Cheng, Vincent; Cote, Mark P

    2017-03-01

    A symptomatic pulmonary embolism (PE) after total joint arthroplasty has been described as a "never event." Despite potent anticoagulants and improvements in patient care, PE continues to occur following total hip arthroplasty (THA). This study evaluates symptomatic PE rates over time in THA patients enrolled in multicenter randomized clinical trials (RCTs) assessing the efficacy of venous thromboembolism prophylaxis regimens. The MEDLINE and Cochrane Central Register of Controlled Trials were searched to identify clinical trials assessing prophylactic anticoagulation in patients undergoing THA between January 1995 and December 2015. Inclusion criteria consisted of RCTs evaluating prophylactic anticoagulation in patients undergoing THA. A random effect model was used to combine PE rates across studies. A total of 21 studies (34,764 patients) were included. Patients were administered low molecular weight heparin (13,590 patients), oral factor Xa inhibitors (6609 patients), oral direct thrombin inhibitors (5965 patients), indirect factors Xa/IIa inhibitors (3444 patients), aspirin (2427 patients), and warfarin (489 patients). Mobile compression was used in 199 patients, and placebo was used in 2041 patients. Across all included studies, the estimated PE rate was 0.21% (95% confidence interval: 0.13%, 0.32%). Between 1997 and 2013, the proportion of PEs did not change in regression analysis. Although the PE rate was low, it was consistent throughout the 17 years spanning these RCTs, which excluded patients with significant morbidity. These results suggest that even healthy THA patients receiving aggressive anticoagulation still have a risk for PE, and the "never event" designation requires reassessment. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Estimation of the impact of warfarin's time-in-therapeutic range on stroke and major bleeding rates and its influence on the medical cost avoidance associated with novel oral anticoagulant use-learnings from ARISTOTLE, ROCKET-AF, and RE-LY trials.

    Science.gov (United States)

    Amin, Alpesh; Deitelzweig, Steve; Jing, Yonghua; Makenbaeva, Dinara; Wiederkehr, Daniel; Lin, Jay; Graham, John

    2014-01-01

    Warfarin's time-in-therapeutic range (TTR) is highly variable among patients with nonvalvular atrial fibrillation (NVAF). The objective of this study was to estimate the impact of variations in wafarin's TTR on rates of stroke/systemic embolism (SSE) and major bleedings among NVAF patients in the ARISTOTLE, ROCKET-AF, and RE-LY trials. Additionally, differences in medical costs for clinical endpoints when novel oral anticoagulants (NOACs) were used instead of warfarin at different TTR values were estimated. Quartile ranges of TTR values and corresponding event rates (%/patient - year = %/py) of SSE and major bleedings among NVAF patients treated with warfarin were estimated from published literature and FDA documents. The associations of SSE and major bleeding rates with TTR values were evaluated by regression analysis and then the calculated regression coefficients were used in analysis of medical cost differences associated with use of each NOAC versus warfarin (2010 costs; US payer perspective) at different TTRs. Each 10 % increase in warfarin's TTR correlated with a -0.32%/py decrease in SSE rate (R(2) = 0.61; p estimated medical cost decreased from -$902 to -$83 for apixaban, from -$506 to +$314 for rivaroxaban, and from -$596 to +$223 for dabigatran. Among NVAF patients there is a significant negative correlation between warfarin's TTR and SSE rate, but not major bleedings. The variations in warfarin's TTR impacted the economic comparison of use of individual NOACs versus warfarin.

  12. Four-factor prothrombin complex concentrates: effectiveness in the reversal of anticoagulation

    Directory of Open Access Journals (Sweden)

    Gavva C

    2017-04-01

    Full Text Available Chakri Gavva, Manasa Reddy, Ravi Sarode Division of Transfusion Medicine and Hemostasis, Department of Pathology, University of Texas Southwestern Medical Center, Dallas, TX, USA Abstract: Vitamin K antagonists (VKAs continue to be the most commonly prescribed class of oral anticoagulants worldwide for the treatment and prevention of venous or arterial thromboembolic events (TEEs. While VKAs are effective at reducing the incidence of TEEs, the risk of major bleeding remains significant. In patients taking VKAs and presenting with clinically significant bleeding or undergoing an emergent procedure, a rapid, effective, and safe reversal agent is required. Available options for the reversal of VKAs include plasma, vitamin K, 3-factor prothrombin complex concentrate (3F-PCC, or 4-factor prothrombin complex concentrate (4F-PCC. Herein, we review the growing evidence that supports using 4F-PCC over both plasma and 3F-PCC for emergent VKA reversal. We also discuss the various dosing options and safety profile of 4F-PCC. In addition, we summarize the limited data available for 4F-PCC in reversing the effects of direct oral anticoagulants and the management of other coagulopathic bleeding. Keywords: anticoagulants, prothrombin complex concentrate, vitamin k antagonist, warfarin

  13. Single dose oral analgesics for postoperative pain have few adverse events.

    Science.gov (United States)

    Wong, Yin J

    2016-09-01

    Data sourcesThe Cochrane Database of Systematic Reviews on the Cochrane Library.Study selectionAll Cochrane reviews of RCTs between 1999 to 2015, conducted in adults examining the adverse events associated with single dose oral analgesics used for acute post-operative pain were considered.Data extraction and synthesisStudies were searched, reviewed and assessed independently by two reviewers and standard data items extracted. Methodological quality was assessed using criteria adapted from AMSTAR (Assessing the Methodological Quality of Systematic Reviews).ResultsData from 39 Cochrane reviews of 41 different analgesics or analgesic combinations involving a total of 350 studies involving 35,000 adults were included. Most analgesics were tested in a narrow dose range. For most NSAIDs, paracetamol (acetaminophen), and combinations not containing opioids, the rates of adverse events were similar to that of placebos (NSAID 3% - 44% vs 4 - 46%; paracetamol 7-18% vs 6-16%; combination 11-30% vs 6-48%). However, for higher dosages, like 1000 mg aspirin, 1000 mg diflunisal, and opioids or drug combinations containing opioids, there was a statistically significant difference in the incidence of adverse events reported (NNH 7.7(95%CI; 4.8 - 20) for 1000 mg aspirin; 7.5(95%CI; 4.8-17) for 1000 mg diflunisal; 3.5-8.6 for opioids and combinations). Serious adverse events were rare, occurring at about 1 in 3,200.ConclusionsDespite ongoing problems with the measurement, recording and reporting of adverse events in clinical trials and in systematic reviews, the large amount of information available for single oral doses of analgesics provides evidence that adverse events rates are generally similar with active drug and placebo in these circumstances, except at higher doses of some drugs, and in combinations including opioids.

  14. Role of novel anticoagulants for patients with mechanical heart valves.

    Science.gov (United States)

    Forsberg, Peter; DeSancho, Maria T

    2014-11-01

    The introduction of the target-specific oral anticoagulants (TSOACs) has led to a major shift in the management of patients at risk for thrombosis. The landscape continues to evolve as the evidence regarding their efficacy and safety in various clinical situations emerges. Antithrombotic therapy for thromboprophylaxis in patients with mechanical heart valves is challenging. To date, the RE-ALIGN trial comparing dabigatran etexilate to warfarin is the only randomized controlled study in this patient population. The higher risk of thromboembolic and bleeding events in the group of patients who received dabigatran compared with warfarin reinforced current guidelines recommending against the use of TSOACs in patients with mechanical heart valves. However, additional studies are needed to find suitable alternatives to vitamin K antagonists in this unique patient population.

  15. Is there a suitable method of anticoagulation in pregnant patients with mechanical prosthetic heart valves?

    Science.gov (United States)

    Malik, Humza T; Sepehripour, Amir H; Shipolini, Alex R; McCormack, David J

    2012-09-01

    A best evidence topic was written according to a structured protocol in order to identify the mode of anticoagulation that has the best safety profile for both the mother and the foetus in pregnant patients with mechanical prosthetic heart valves. A total of 281 papers were identified using the reported search, of which eight represented the best evidence to answer the clinical question. The authors, date, journal, study type, population, main outcome measures and results are tabulated. The reported measures were foetal mortality, maternal mortality, congenital abnormalities and embryopathy, and maternal thromboembolic and haemorrhagic complications. The medical orthodoxy has warned of the combination of oral anticoagulation and pregnancy due to the well-documented warfarin embryopathy. Yet only one of the reported papers identified a greater incidence of foetal aberrations among warfarin use, with the highest reported rate being 6.4% and two of the assessed papers reporting no embryopathy at all. Foetal mortality with oral anticoagulation use ranged from 1.52 to 76%. All reported publications demonstrated a superior maternal outcome with warfarin use, with a range of thromboembolic events from 0 to 10% in comparison with 4 to 48% where heparin was used. Thus, it is concluded that warfarin is a more durable anticoagulant with a better maternal outcome despite it carrying a greater foetal risk. Although, in contrast to previous teaching, the risks of embryopathy are not the major drawback of oral anticoagulation. Heparin is consistently less effective, but may be preferred for the superior foetal outcome. Heparin usage during the first trimester reduces the foetal risk but is still associated with an adverse maternal outcome. While the focus for clinicians looking after pregnant women with mechanical heart valves may be to prevent maternal thromboembolic complications, the overriding concern for many women is to avoid any harm to their unborn child, even when this

  16. Persisting thrombin activity in elderly patients with atrial fibrillation on oral anticoagulation is decreased by anti-inflammatory therapy with intensive cholesterol-lowering treatment.

    Science.gov (United States)

    van Kuilenburg, Janet; Lappegård, Knut Tore; Sexton, Joe; Plesiewicz, Izabela; Lap, Paul; Bouwels, Leon; Sprong, Tom; Mollnes, Tom Eirik; Verheugt, Freek; van Heerde, Waander L; Pop, Gheorghe A

    2011-01-01

    It has been demonstrated that the occurrence of ischemic stroke is more prevalent in AF patients, when increased levels of inflammatory markers are present. The aim of this study was to evaluate the effect of intensive cholesterol lowering therapy on inflammatory markers and evidence of thrombotic in elderly AF patients treated with OAC. 34 elderly patients (69-85 yrs) were randomized to double blind treatment with atorvastatin 40 mg plus ezetimibe 10 mg (n = 17) or double placebo (n = 17) for one year. All were anticoagulated with warfarin (target INR 2.5-3.5). Every 3 months inflammatory markers and parameters for evaluation of haemostatic and fibrinolytic activity were measured. Anti-inflammatory effects in the treatment arm were reflected by a significant decrease from baseline in hs-CRP, FGF, G-CSF, GM-CSF, IL-1ra, IL-9, IL-13, IL-17 and interferon-γ (P Intensive cholesterol lowering significantly reduced inflammation and was accompanied by reduced thrombin generation. Larger clinical studies should determine which inflammatory markers are most specific and sensitive for estimating the inflammatory burden in these patients and at which corresponding thrombin activity level it is beneficial and safe to add intensive cholesterol lowering therapy even if normal cholesterol levels are present. Copyright © 2011 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  17. Self-reported adherence to anticoagulation and its determinants using the Morisky medication adherence scale.

    Science.gov (United States)

    Castellucci, Lana A; Shaw, Joseph; van der Salm, Katrien; Erkens, Petra; Le Gal, Gregoire; Petrcich, William; Carrier, Marc

    2015-10-01

    Direct oral anticoagulants (DOACs) are used for treatment of venous thromboembolism (VTE) and stroke prevention in atrial fibrillation (AF). Given the shorter half-life and lack of laboratory monitoring compared to vitamin-K antagonists (VKAs), adequate adherence to DOACs is important. Reported anticoagulation adherence is unclear in clinical practice. To assess self-reported anticoagulation adherence in a tertiary center anticoagulation clinic. Cross-sectional study of patients on oral anticoagulants (VKAs, rivaroxaban, dabigatran and apixaban). Anticoagulation adherence was assessed using the 4-item Morisky score. Baseline characteristics were evaluated for association with adherence. Five hundred patients completed the survey; 74% were on VKAs and 26% on DOACs: rivaroxaban 102 (79%); dabigatran 26 (19%); apixaban 2 (2%). Main indications for anticoagulation were VTE (72%) and AF (18%). Self-reported anticoagulation adherence using the 4-item Morisky scale was 56.2% for patients on VKAs and 57.1% for patients on DOACs. Predictors of anticoagulation adherence were age (OR=1.02; 95% CI:1.01-1.03), female gender (OR=1.58; 95% CI:1.10-2.27), use of additional oral medications (OR=2.78; 95% CI:1.67-4.63), and retired employment status (OR=2.31; 95% CI:1.51-3.55). In backward selection multivariate analyses age, female gender and use of other oral medications remained significantly associated with anticoagulation adherence. Self-reported anticoagulation adherence was similar between VKAs and DOACs. Until laboratory assays are universally available to evaluate DOAC adherence, physicians should emphasize the importance of anticoagulation adherence at each patient encounter. The Morisky scale provides simple assessment of anticoagulation adherence; however it has not yet been validation for this purpose. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Anticoagulant effect of marine algae.

    Science.gov (United States)

    Kim, Se-Kwon; Wijesekara, Isuru

    2011-01-01

    Recently, a great deal of interest has been developed in the nutraceutical and pharmaceutical industries to isolate natural anticoagulant compounds from marine resources. Among marine resources, marine algae are valuable sources of novel bioactive compounds with anticoagulant effect. Phlorotannins and sulfated polysaccharides such as fucoidans in brown algae, carrageenans in red algae, and ulvans in green algae have been recognized as potential anticoagulant agents. Therefore, marine algae-derived phlorotannins and SPs have great potential for developing as anticoagulant drugs in nutraceutical and pharmaceutical areas. This chapter focuses on the potential anticoagulant agents in marine algae and presents an overview of their anticoagulant effect. Copyright © 2011 Elsevier Inc. All rights reserved.

  19. Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events: Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48).

    Science.gov (United States)

    Rost, Natalia S; Giugliano, Robert P; Ruff, Christian T; Murphy, Sabina A; Crompton, Andrea E; Norden, Andrew D; Silverman, Scott; Singhal, Aneesh B; Nicolau, José C; SomaRaju, Bhupathi; Mercuri, Michele F; Antman, Elliott M; Braunwald, Eugene

    2016-08-01

    Patients with atrial fibrillation and previous ischemic stroke (IS)/transient ischemic attack (TIA) are at high risk of recurrent cerebrovascular events despite anticoagulation. In this prespecified subgroup analysis, we compared warfarin with edoxaban in patients with versus without previous IS/TIA. ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a double-blind trial of 21 105 patients with atrial fibrillation randomized to warfarin (international normalized ratio, 2.0-3.0; median time-in-therapeutic range, 68.4%) versus once-daily edoxaban (higher-dose edoxaban regimen [HDER], 60/30 mg; lower-dose edoxaban regimen, 30/15 mg) with 2.8-year median follow-up. Primary end points included all stroke/systemic embolic events (efficacy) and major bleeding (safety). Because only HDER is approved, we focused on the comparison of HDER versus warfarin. Of 5973 (28.3%) patients with previous IS/TIA, 67% had CHADS2 (congestive heart failure, hypertension, age, diabetes, prior stroke/transient ischemic attack) >3 and 36% were ≥75 years. Compared with 15 132 without previous IS/TIA, patients with previous IS/TIA were at higher risk of both thromboembolism and bleeding (stroke/systemic embolic events 2.83% versus 1.42% per year; P<0.001; major bleeding 3.03% versus 2.64% per year; P<0.001; intracranial hemorrhage, 0.70% versus 0.40% per year; P<0.001). Among patients with previous IS/TIA, annualized intracranial hemorrhage rates were lower with HDER than with warfarin (0.62% versus 1.09%; absolute risk difference, 47 [8-85] per 10 000 patient-years; hazard ratio, 0.57; 95% confidence interval, 0.36-0.92; P=0.02). No treatment subgroup interactions were found for primary efficacy (P=0.86) or for intracranial hemorrhage (P=0.28). Patients with atrial fibrillation with previous IS/TIA are at high risk of recurrent thromboembolism and bleeding. HDER is at least as effective and is

  20. Anticoagulation service: improving the referral process

    OpenAIRE

    Davies, Thomas; Geleit, Ryan

    2014-01-01

    Oral anticoaguIants are extremely common, and it is estimated that there are between 500,000 and 1 million people prescribed them in the UK.[1] These drugs are the most frequently named medication in fatal errors and litigation claims [2] and they require the implementation of additional safety controls.[3] Warfarin is the most commonly prescribed anticoagulant and it requires regular international normalised ratio (INR) monitoring and dosage adjustment to achieve the desired therapeutic rang...

  1. Anticoagulant Treatment of Deep Vein Thrombosis and Pulmonary Embolism: The Present State of the Art.

    Science.gov (United States)

    Thaler, Johannes; Pabinger, Ingrid; Ay, Cihan

    2015-01-01

    Venous thromboembolism (VTE), a disease entity comprising deep vein thrombosis (DVT) and pulmonary embolism (PE), is a frequent and potentially life-threatening event. To date different agents are available for the effective treatment of acute VTE and the prevention of recurrence. For several years, the standard of care was the subcutaneous application of a low molecular weight heparin (LMWH) or fondaparinux, followed by a vitamin K antagonist (VKA). The so-called direct oral anticoagulants (DOAC) were introduced rather recently in clinical practice for the treatment of VTE. DOAC seem to have a favorable risk-benefit profile compared to VKA. Moreover, DOAC significantly simplify VTE treatment because they are administered in fixed doses and no routine monitoring is needed. Patients with objectively diagnosed DVT or PE should receive therapeutic anticoagulation for a minimum of 3 months. Whether a patient ought to receive extended treatment needs to be evaluated on an individual basis, depending mainly on risk factors determined by characteristics of the thrombotic event and patient-related factors. In specific patient groups (e.g., pregnant women, cancer patients, and elderly patients), treatment of VTE is more challenging than that in the general population and additional issues need to be considered in those patients. The aim of this review is to give an overview of the currently available treatment modalities of acute VTE and secondary prophylaxis. In particular, specific aspects regarding the initiation of VTE treatment, duration of anticoagulation, and specific patient groups will be discussed.

  2. Safety and efficacy of direct oral anticoagulants compared to warfarin for extended treatment of venous thromboembolism -a systematic review and meta-analysis

    DEFF Research Database (Denmark)

    Sindet-Pedersen, Caroline; Pallisgaard, Jannik Langtved; Olesen, Jonas Bjerring

    2015-01-01

    OBJECTIVE: To examine and compare the safety and efficacy of extended treatment with dabigatran, apixaban, rivaroxaban and warfarin in patients with unprovoked venous thromboembolism. METHODS: PubMed and Embase were searched for randomized clinical trials reporting on the use of direct oral...

  3. The role of prothrombin complex concentrates in reversal of target specific anticoagulants.

    Science.gov (United States)

    Babilonia, Katrina; Trujillo, Toby

    2014-01-01

    Over the past several years a new era for patients requiring anticoagulation has arrived. The approval of new target specific oral anticoagulants offers practitioners several advantages over traditionally used vitamin K antagonist agents including predictable pharmacokinetics, rapid onset of action, comparable efficacy and safety, all without the need for routine monitoring. Despite these benefits, hemorrhagic complicates are inevitable with any anticoagulation treatment. One of the major disadvantages of the new oral anticoagulants is lack of specific antidotes or reversal agents for patients with serious bleeding or need for urgent surgery. As use of the new target specific oral anticoagulants continues to increase, practitioners will need to understand both the pharmacodynamics and pharmacokinetic properties of the agents, as well as, the available literature with use of non-specific therapies to reverse anticoagulation. Four factor prothrombin complex concentrates have been available for several years in Europe, and recently became available in the United States with approval of Kcentra. These products have shown efficacy in reversing anticoagulation from vitamin K antagonists, however their usefulness with the new target specific oral anticoagulants is poorly understood. This article will review the properties of dabigatran, rivaroxaban and apixaban, as well as the limited literature available on the effectiveness of prothrombin complex concentrates in reversal of their anticoagulant effects. Additional studies are needed to more accurately define the role of prothrombin complex concentrates in patients with life threatening bleeding or who require emergent surgery, as current data is both limited and conflicting.

  4. Prevention of Venous Thromboembolism in Major Orthopedic Surgery: Bayesian Network Meta-Analysis of 21 Randomized Trials Evaluating Unfractionated Heparins, Low-Molecular Weight Heparins, and New Oral Anticoagulants

    Directory of Open Access Journals (Sweden)

    Andrea Messori

    2014-09-01

    Full Text Available Background: In major orthopedic surgery, prevention of venous thromboembolism has been based on Unfractionated Heparins (UFHs over the past decades, then on Low-Molecular Weight Heparins (LMWHs, and on New Oral Anticoagulants (NOACs more recently. To summarize the comparative effectiveness of UFHs, LMWHs, and NOACs in this clinical indication, we applied Bayesian network meta-analysis to the clinical material (randomized studies published in two previous reviews focused on this issue.. Objectives: Our end-point was a composite of venous thromboembolism and pulmonary embolism.. Materials and Methods: Our analysis was based on standard Bayesian network meta-analysis (random-effect model.. Results: The analysis included 21 randomized trials for a total of 21,805 patients. Our results showed that the degree of effectiveness did not differ among UFHs, LMWHs, and NOACs. Although some trends emerged from an in-depth analysis of these data (e.g. according to the histogram of rankings, no significant differences were found (P > 0.05. Moreover, two agents among LMWHs proved to be adequately supported by randomized trials (enoxaparin and dalteparin, while limited evidence was available for other agents of this class.. Conclusions: Our synthesis of the effectiveness data can be useful as an overall reference in this area and can also contribute to defining the place of further innovative treatments for this clinical indication..

  5. Patient outcome after aortic valve replacement with a mechanical or biological prosthesis: weighing lifetime anticoagulant-related event risk against reoperation risk.

    Science.gov (United States)

    van Geldorp, Martijn W A; Eric Jamieson, W R; Kappetein, A Pieter; Ye, Jian; Fradet, Guy J; Eijkemans, Marinus J C; Grunkemeier, Gary L; Bogers, Ad J J C; Takkenberg, Johanna J M

    2009-04-01

    Although the results of aortic valve replacement with different valve prostheses are well documented in terms of survival, the risks of (valve-related) events are less well explored. We used a dataset of 3934 patients who underwent aortic valve replacement with either a bioprosthesis (73%) or a mechanical prosthesis (27%) between 1982 and 2003 to simulate the outcome of patients after aortic valve replacement with either valve type. With the use of microsimulation, we compared total age and gender-specific life expectancy, event-free life expectancy, reoperation-free life expectancy, lifetime risks of reoperation, and valve-related events for both valve types. The total follow-up was 26,467 patient-years. The mean follow-up was 6.1 years in the biological arm and 8.5 years in the mechanical arm. The mean age at implantation was 70 and 58 years for biological and mechanical prostheses, respectively, and the percentage of concomitant coronary artery bypass grafting was 47% and 28%, respectively. For a 60-year-old man, simulated life expectancy in years for biological versus mechanical prostheses was 11.9 versus 12.2, event-free life expectancy was 9.8 versus 9.3, and reoperation-free life expectancy was 10.5 versus 11.9. Lifetime risk of reoperation was 25% versus 3%. Lifetime risk of bleeding was 12% versus 41%. Even for patients aged 60 years, event-free life expectancy is better with a bioprosthesis. Although the chance of reoperation is higher, the lifetime risk of bleeding is lower compared with a mechanical prosthesis. Comparing lifetime event risks between different types of valve prostheses provides more insight into patient outcome after aortic valve replacement and aids patient selection and counseling.

  6. Care transitions in anticoagulation management for patients with atrial fibrillation: an emphasis on safety.

    Science.gov (United States)

    Deitelzweig, Steven

    2013-01-01

    Thromboprophylaxis with oral anticoagulants is an important but underused element of atrial fibrillation (AF) treatment. Reduction of stroke risk by anticoagulants comes at the price of bleeding risk. Patients with AF receiving anticoagulants require heightened attention with transition from one care setting to another. This review of the literature focuses on issues specific to the anticoagulation treatment of patients with AF. Patients presenting for emergency care of anticoagulant-related bleeding should be triaged for the severity and source of the bleeding using appropriate measures, such as discontinuing the oral anticoagulant, administering vitamin K when appropriate to reverse warfarin-induced bleeding, or administering clotting factors for emergent bleeding. Reversal of oral anticoagulants in patients admitted to the hospital for surgery can be managed similarly to patients with bleeding, depending on the urgency of the surgical procedure. Patients with AF who are admitted for conditions unrelated to AF should be assessed for adequacy of stroke risk prophylaxis and bleeding risk. Newly diagnosed AF should be treated in nearly all patients with either warfarin or a newer anticoagulant. Patient education is critically important with all anticoagulants. Close adherence to the prescribed regimen, regular international normalized ratio testing for warfarin, and understanding the stroke risk conferred by AF and aging are goals for all patients receiving oral anticoagulants. Detailed handoff from the hospitalist to the patient's primary care physician is required for good continuity of care. Monitoring by an anticoagulation clinic is the best arrangement for most patients. The elderly, particularly frail or debilitated patients who are transferring to long-term care, need a detailed transfer of information between settings, education for the patient and family, and medication reconciliation. Communication and coordination of care among outpatient, emergency

  7. Perfil sócio demográfico e clínico de pacientes em uso de anticoagulantes orais El perfil socio demográficos y clínicas de los pacientes en uso de los anticoagulantes orales Socio-demographic and clinical profile of patients using oral anticoagulants

    Directory of Open Access Journals (Sweden)

    Flávia Martinelli Pelegrino

    2010-03-01

    Full Text Available Este estudo teve como objetivo investigar o perfil sócio-demográfico, clínico e laboratorial de indivíduos em seguimento ambulatorial devido ao uso de anticoagulantes orais. O estudo foi descritivo, transversal, realizado no ambulatório de anticoagulação oral de um hospital terciário do interior do estado de São Paulo. Os dados foram coletados por entrevistas e consultas aos prontuários dos pacientes. Participaram 180 sujeitos, a maioria do sexo feminino (65,6%, com idade média de 55 anos, em uso de varfarina (83,3% há mais de 6,9 anos, devido à presença de prótese cardíaca metálica (50%. Os resultados obtidos fornecem subsídios para os enfermeiros planejarem à assistencia aos usuários de anticoagulação oral com vistas a diminuição de possíveis complicações relacionadas à terapia e ao aumento da adesão ao tratamento.Este estudio tiene como objetivo investigar el perfil sócio-demográfico, clínico y de laboratorio, período de seguimiento, porque las personas en el uso de los anticoagulantes orales. El estudio fue descriptivo, transversal, realizado en la clínica de anticoagulación oral en un hospital terciario en el estado de São Paulo, Brasil. Los datos fueron obtenídos a través de entrevistas y consultas con los registros médicos de los pacientes. Participaron 180 sujetos, la mayoría de las mujeres (65,6% con edad media de 55 años, el uso de warfarina (83,3% a lo largo de 6,9 años, debido a la presencia de prótesis metálicas corazón (50%. Los resultados proveen información para que las enfermeras plan de asistencia a los usuarios de la anticoagulación oral con el fin de reducir las complicaciones asociadas a la terapia y aumento de la adherencia al tratamiento.The purpose of this study is to investigate the socio-demographic, clinical and laboratory profile of individuals in the follow-up period due to the use of oral anticoagulants. This is a descriptive study, cross performed in the clinic of oral

  8. lupus anticoagulants: pathophysiology, clinical

    African Journals Online (AJOL)

    2003-11-02

    Nov 2, 2003 ... report. East Afr. Med. J. 1998; 75:619-620. procainamide induced lupus anticoagulant. Acta Haematol. 13. Mateo, 1., Oliver, A., Borell, M. et al. Laboratory evaluation 1989; 82:50-52. and clinical characteristics of 2, 132 consecutive unselected 29. Rai, R., Cohen H., Dave M., and Regan, L. Randomised.

  9. Characterization of Morphological and Cellular Events Underlying Oral Regeneration in the Sea Anemone, Nematostella vectensis

    Directory of Open Access Journals (Sweden)

    Aldine R. Amiel

    2015-12-01

    Full Text Available Cnidarians, the extant sister group to bilateria, are well known for their impressive regenerative capacity. The sea anemone Nematostella vectensis is a well-established system for the study of development and evolution that is receiving increased attention for its regenerative capacity. Nematostella is able to regrow missing body parts within five to six days after its bisection, yet studies describing the morphological, cellular, and molecular events underlying this process are sparse and very heterogeneous in their experimental approaches. In this study, we lay down the basic framework to study oral regeneration in Nematostella vectensis. Using various imaging and staining techniques we characterize in detail the morphological, cellular, and global molecular events that define specific landmarks of this process. Furthermore, we describe in vivo assays to evaluate wound healing success and the initiation of pharynx reformation. Using our described landmarks for regeneration and in vivo assays, we analyze the effects of perturbing either transcription or cellular proliferation on the regenerative process. Interestingly, neither one of these experimental perturbations has major effects on wound closure, although they slightly delay or partially block it. We further show that while the inhibition of transcription blocks regeneration in a very early step, inhibiting cellular proliferation only affects later events such as pharynx reformation and tentacle elongation.

  10. Characterization of Morphological and Cellular Events Underlying Oral Regeneration in the Sea Anemone, Nematostella vectensis.

    Science.gov (United States)

    Amiel, Aldine R; Johnston, Hereroa T; Nedoncelle, Karine; Warner, Jacob F; Ferreira, Solène; Röttinger, Eric

    2015-12-01

    Cnidarians, the extant sister group to bilateria, are well known for their impressive regenerative capacity. The sea anemone Nematostella vectensis is a well-established system for the study of development and evolution that is receiving increased attention for its regenerative capacity. Nematostella is able to regrow missing body parts within five to six days after its bisection, yet studies describing the morphological, cellular, and molecular events underlying this process are sparse and very heterogeneous in their experimental approaches. In this study, we lay down the basic framework to study oral regeneration in Nematostella vectensis. Using various imaging and staining techniques we characterize in detail the morphological, cellular, and global molecular events that define specific landmarks of this process. Furthermore, we describe in vivo assays to evaluate wound healing success and the initiation of pharynx reformation. Using our described landmarks for regeneration and in vivo assays, we analyze the effects of perturbing either transcription or cellular proliferation on the regenerative process. Interestingly, neither one of these experimental perturbations has major effects on wound closure, although they slightly delay or partially block it. We further show that while the inhibition of transcription blocks regeneration in a very early step, inhibiting cellular proliferation only affects later events such as pharynx reformation and tentacle elongation.

  11. New anticoagulants for the prevention and treatment of venous thromboembolism

    Directory of Open Access Journals (Sweden)

    Simon J McRae

    2005-04-01

    Full Text Available Simon J McRae, Jeffrey S GinsbergDepartment of Medicine, McMaster University, Hamilton, ON, CanadaAbstract: Anticoagulant therapy is effective at preventing the development of venous thromboembolism in high-risk patients, and reduces morbidity and mortality in individuals with established thromboembolic disease. Vitamin K antagonists and heparins are currently the most commonly used anticoagulant drugs, but they have practical limitations. Therefore, new antithrombotic agents with predictable dose-responses (thereby decreasing the need for monitoring without compromising efficacy or safety, ideally available in an oral formulation and with a rapidly reversible anticoagulant effect, are needed. New drugs fulfilling some of the above criteria have been developed and have proven to be effective agents for the treatment and prevention of venous thromboembolism.Keywords: venous thromboembolism, anticoagulants, antithrombotic

  12. AREVA: multicenter randomized comparison of low-dose versus standard-dose anticoagulation in patients with mechanical prosthetic heart valves.

    Science.gov (United States)

    Acar, J; Iung, B; Boissel, J P; Samama, M M; Michel, P L; Teppe, J P; Pony, J C; Breton, H L; Thomas, D; Isnard, R; de Gevigney, G; Viguier, E; Sfihi, A; Hanania, G; Ghannem, M; Mirode, A; Nemoz, C

    1996-11-01

    Moderate anticoagulation may be proposed to reduce the risk of hemorrhage for certain patients with a mechanical prosthesis, but the consequences for risk of thromboembolism are debated. The purpose of the AREVA trial was to compare moderate oral anticoagulation (international normalized ratio [INR] of 2.0 to 3.0) with the usual regimen (INR of 3.0 to 4.5) after a single-valve replacement with a mechanical prosthesis, either Omnicarbon or St Jude. Patients included were between 18 and 75 years old, in sinus rhythm, and with a left atrial diameter < or = 50 mm on the time-motion echocardiogram. Patients were randomized for INR after surgery. From 1991 to 1994, 433 patients underwent valve replacement (aortic, 414; mitral, 19) with 353 St Jude and 80 Omnicarbon prostheses; 380 patients were randomized for INR: 188 for INR 2.0 to 3.0 and 192 for INR 3.0 to 4.5. Mean follow-up was 2.2 years (1 to 4 years). Analysis of 18001 INR samples showed that the mean of the median of INR was 2.74 +/- 0.35 in the 2.0 to 3.0 group and 3.21 +/- 0.33 in the 3.0 to 4.5 group (P < .0001). Thromboembolic events, as assessed from clinical data and CT brain scans, occurred in 10 patients in the 2.0 to 3.0 INR group and 9 patients in the 3.0 to 4.5 INR group (P = .78). Hemorrhagic events occurred in 34 patients in the 2.0 to 3.0 INR group and 56 patients in the 3.0 to 4.5 INR group (P < .01), with 13 and 19 major hemorrhagic events, respectively (P = .29). In selected patients with mechanical prostheses, moderate anticoagulation prevents thromboembolic events as effectively as conventional anticoagulation and reduces the incidence of hemorrhagic events.

  13. Anticoagulation service: improving the referral process.

    Science.gov (United States)

    Davies, Thomas; Geleit, Ryan

    2014-01-01

    Oral anticoaguIants are extremely common, and it is estimated that there are between 500,000 and 1 million people prescribed them in the UK.[1] These drugs are the most frequently named medication in fatal errors and litigation claims [2] and they require the implementation of additional safety controls.[3] Warfarin is the most commonly prescribed anticoagulant and it requires regular international normalised ratio (INR) monitoring and dosage adjustment to achieve the desired therapeutic range.[4] Under-anticoagulation can cause thrombosis and over-anticoagulation can lead to haemorrhage, both of which can be fatal.[5] At St. Peter's hospital there is an anticoagulation service providing regular international normalised ratio (INR) monitoring for patients on warfarin. However, the current referral system is paper-based and a baseline audit found that only 66% of patients were successfully referred to the service on discharge from hospital. This identifies a significant patient safety issue which could result in life-threatening consequences. An electronic referral form was developed within a pre-existing computer based ordering system with the aim of improving the referral rate. The electronic referral tool streamlined the referral process, making the form quicker and easier to fill out and removed the need for faxing lengthy paper forms. Key information on the form was made mandatory. After intervention a re-audit revealed that 84% of patients discharged on warfarin were referred to the clinic, which equates to an increase of 18%. The increased referral rate will improve patient safety and prevent unnecessary hospital admissions. There should be continued promotion of the importance of referring patients to the anticoagulation clinic. This can be delivered through inductions, teaching sessions, and re-audits. Future goals include an automated referral system triggered on patient discharge.

  14. Acupuncture safety in patients receiving anticoagulants: a systematic review.

    Science.gov (United States)

    Mcculloch, Michael; Nachat, Arian; Schwartz, Jonathan; Casella-Gordon, Vicki; Cook, Joseph

    2015-01-01

    Theoretically, acupuncture in anticoagulated patients could increase bleeding risk. However, precise estimates of bleeding complication rates from acupuncture in anticoagulated patients have not been systematically examined. To critically evaluate evidence for safety of acupuncture in anticoagulated patients. We searched PubMed, EMBASE, the Physiotherapy Evidence Database, and Google Scholar. Of 39 potentially relevant citations, 11 met inclusion criteria: 2 randomized trials, 4 case series, and 5 case reports. Seven provided reporting quality sufficient to assess acupuncture safety in 384 anticoagulated patients (3974 treatments). Minor-moderate bleeding related to acupuncture in an anticoagulated patient occurred in one case: a large hip hematoma, managed with vitamin K reversal and warfarin discontinuation following reevaluation of its medical justification. Blood-spot bleeding, typical for any needling/injection and controlled with pressure/cotton, occurred in 51 (14.6%) of 350 treatments among a case series of 229 patients. Bleeding deemed unrelated to acupuncture during anticoagulation, and more likely resulting from inappropriately deep needling damaging tissue or from complex anticoagulation regimens, occurred in 5 patients. No bleeding was reported in 2 studies (74 anticoagulated patients): 1 case report and 1 randomized trial prospectively monitoring acupuncture-associated bleeding as an explicit end point. Altogether, 1 moderate bleeding event occurred in 3974 treatments (0.003%). Acupuncture appears to be safe in anticoagulated patients, assuming appropriate needling location and depth. The observed 0.003% complication rate is lower than the previously reported 12.3% following hip/knee replacement in a randomized trial of 27,360 anticoagulated patients, and 6% following acupuncture in a prospective study of 229,230 all-type patients. Prospective trials would help confirm our findings.

  15. THE ROLE OF ANTICOAGULATION THERAPY IN PATIENTS WITH PROSTHETIC HEART VALVES

    Directory of Open Access Journals (Sweden)

    N. A. Shostak

    2016-01-01

    Full Text Available Cardiac surgery is the only radical method of treatment of valvular defects (congenital or acquired: valve preservation procedures or prosthetics operations. 250 000 – 280 000 valve prostheses are implanted every year worldwide, while the number of prosthetic valves operation increases by an average of 5–7 % per year (biological prostheses – 8–11 %, mechanical prostheses – 3–5 %. Selection of biological or mechanical types of prosthesis, its location, the presence of associated risk factors for embolic events, such as atrial fibrillation, previous embolism, left ventricular dysfunction, hypercoagulable states determine patient management tactics. Particularly high risk of prosthetic thrombosis and thromboembolic complications can be seen in case of mechanical prosthesis implantation. Numerous prospective and retrospective clinical studies have proven high effectiveness of anticoagulants for reduction the risk of cardioembolic complications. The degree of anticoagulation (optimal international normalized ratio (INR is determined by risk factors for prosthetic thrombosis and thromboembolic complications in a patient, as well as thrombogenicity of the prosthesis by itself; INR may range from 2.5 to 4.0. International recommendations take into account the presence/absence of additional risk factors for thromboembolism, and based on warfarin administration with the achievement of target INR values combined with low-dose aspirin. Administration of novel direct oral anticoagulation remedies in patients with prosthetic heart valves has not been studied sufficiently up to date and is contraindicated. Thus, warfarin currently is a drug of choice for the prevention of thromboembolic complications in patients with prosthetic heart valves.

  16. Adverse events and intravenous versus oral bisphosphonate use in patients with osteoporosis and cancer in the U.S.

    Science.gov (United States)

    Skrepnek, Grant H; Seal, Brian; Tangirala, Muralikrishna; Jeffcoat, Marjorie K; Watts, Nelson B; Hay, Joel W

    2010-01-01

    This observational study utilized a patient-level database of more than 55 million patients and 70 U.S.-based health plans compiled from 2000-2006. Patients diagnosed with osteoporosis or various cancers were categorized according to bisphosphonate use (via IV, oral, or none). Continuous enrollment for at least six months pre- and post-index diagnosis was required. Outcomes of adverse events were defined as inflammatory conditions of the jaw, including osteonecrosis; major jaw surgery for necrotic or inflammatory conditions; or jaw surgeries for malignancies. Propensity scores and multivariate regression analyses were used to determine adjusted odds ratios for adverse events based on IV or oral bisphosphonate use relative to no bisphosphonate use, controlling for patient demographics, co-morbidities, prior dental or oral surgery, physician likelihood of prescribing oral versus IV bisphosphonates, and antibiotic, hormonal treatment, or thalidomide use. Subgroup analyses-excluding patients using oral corticosteroids-were conducted. After controlling for numerous demographic, clinical, and instrumental variables, this study found significant relationships between IV bisphosphonate use and both inflammatory conditions of the jaw and major jaw surgery for necrotic or inflammatory conditions in patients with osteoporosis or various cancers. While no significant relationship was observed for oral bisphosphonates, continued research is warranted to assess the long-term use of the medications and adverse events in patients with osteoporosis.

  17. Anticoagulation in adults with congenital heart disease

    DEFF Research Database (Denmark)

    Jensen, A S; Idorn, L; Nørager, B

    2015-01-01

    Adults with congenital heart disease are a growing population. One of the major challenges in the care of these patients is to prevent thromboembolic episodes. Despite relative young age and no typical cardiovascular risk factors, this cohort has a high prevalence of thrombotic events....... It is difficult to use treatment algorithms from the general adult population with acquired heart disease in this heterogeneous population due to special conditions such as myocardial scarring after previous surgery, atypical atrial flutter, prothrombotic conditions and the presence of interatrial shunts....... Furthermore, there is a lack of scientific evidence regarding how to prevent thromboembolic events with anticoagulation in adults with congenital heart disease. The aim of this paper is to review the current literature pertaining to anticoagulation in adults with congenital heart disease and hence enable...

  18. Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population: a modelling analysis based on a nationwide cohort study.

    Science.gov (United States)

    Banerjee, Amitava; Lane, Deirdre A; Torp-Pedersen, Christian; Lip, Gregory Y H

    2012-03-01

    The concept of net clinical benefit has been used to quantify the balance between risk of ischaemic stroke (IS) and risk of intracranial haemorrhage (ICH) with the use oral anticoagulant therapy (OAC) in the setting of non-valvular atrial fibrillation (AF), and has shown that patients at highest risk of stroke and thromboembolism gain the greatest benefit from OAC with warfarin. There are no data for the new OACs, that is, dabigatran, rivaroxaban and apixaban, as yet. We calculated the net clinical benefit balancing IS against ICH using data from the Danish National Patient Registry on patients with non-valvular AF between 1997-2008, for dabigatran, rivaroxaban and apixaban on the basis of recent clinical trial outcome data for these new OACs. In patients with CHADS(2)=0 but at high bleeding risk, apixaban and dabigatran 110 mg bid had a positive net clinical benefit. At CHA(2)DS(2)-VASc=1, apixaban and both doses of dabigatran (110 mg and 150 mg bid) had a positive net clinical benefit. In patients with CHADS(2) score≥1 or CHA(2)DS(2)-VASc≥2, the three new OACs (dabigatran, rivaroxaban and apixaban) appear superior to warfarin for net clinical benefit, regardless of risk of bleeding. When risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit than warfarin. In the absence of head-to-head trials for these new OACs, our analysis may help inform decision making processes when all these new OACs become available to clinicians for stroke prevention in AF. Using 'real world' data, our modelling analysis has shown that when the risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit compared to warfarin.

  19. Discrepancies between the use of MDRD-4 IDMS and CKD-EPI equations, instead of the Cockcroft-Gault equation, in the determination of the dosage of direct oral anticoagulants in patients with non-valvular atrial fibrillation.

    Science.gov (United States)

    Pérez Cabeza, Alejandro Isidoro; Chinchurreta Capote, Pedro Antonio; González Correa, Jose Antonio; Ruiz Mateas, Francisco; Rosas Cervantes, Gabriel; Rivas Ruiz, Francisco; Valle Alberca, Almudena; Bravo Marqués, Rafael

    2017-07-21

    Direct oral anticoagulants (DOACs) require dose adjustment according to estimated clearance creatinine (eClCr) using the Cockcroft-Gault (CG) equation. There are discrepancies with the equations that estimate glomerular filtration rate (eGFR). We analyse how the use of the CKD-EPI and MDRD-4 IDMS equations affect the recommended dosage for ACODs. Retrospective study of patients with non-valvular atrial fibrillation seen at a cardiology clinic between November 2012 and August 2014. Patients were reclassified according to the recommended dosage for dabigatran, rivaroxaban, apixaban and edoxaban, based on the eGFR equation used. Other clinical factors are taken into account, according to the product label. We analysed the percentage of discordance. Four hundred and fifty-four patients, 53.3% men, with a mean age of 68.7±13.8 years were studied. The mean intra-individual differences recorded for the CG equation were 3.9ml/min/1.73m2 with MDRD-4 IDMS (95% CI 1.4-6.4, P=.003) and 11.3ml/min/1.73m2 with CKD-EPI (95% CI 8.9-13.7, PIDMS). Differences were limited to patients with eClCr<60ml/min and were more evident in≥75 years in which the eGFR equations overestimate renal function. In patients with non-valvular atrial fibrillation, especially with renal failure and in the elderly, eGFR equations tend to overestimate renal function relative to CG and therefore suggest an overdose of DOACs. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  20. Hematoma growth and outcome in treated neurocritical care patients with intracerebral hemorrhage related to oral anticoagulant therapy: comparison of acute treatment strategies using vitamin K, fresh frozen plasma, and prothrombin complex concentrates.

    Science.gov (United States)

    Huttner, Hagen B; Schellinger, Peter D; Hartmann, Marius; Köhrmann, Martin; Juettler, Eric; Wikner, Johannes; Mueller, Stephan; Meyding-Lamade, Uta; Strobl, Ralf; Mansmann, Ulrich; Schwab, Stefan; Steiner, Thorsten

    2006-06-01

    Intracerebral hemorrhage (ICH) is the most serious and potentially fatal complication of oral anticoagulant therapy (OAT). Still, there are no universally accepted treatment regimens for patients with OAT-ICH, and randomized controlled trials do not exist. The aim of the present study was to compare the acute treatment strategies of OAT-associated ICH using vitamin K (VAK), fresh frozen plasma (FFP), and prothrombin complex concentrates (PCCs) with regard to hematoma growth and outcome. In this retrospective study, a total of 55 treated patients were analyzed. Three groups were compared by reviewing the clinical, laboratory, and neuroradiological parameters: (1) patients who received PCCs alone or in combination with FFP or VAK (n=31), (2) patients treated with FFP alone or in combination with VAK (n=18), and (3) patients who received VAK as a monotherapy (n=6). The end points of early hematoma growth and outcome after 12 months were analyzed including multivariate analysis. Hematoma growth within 24 hours occurred in 27% of patients. Incidence and extent of hematoma growth were significantly lower in patients receiving PCCs (19%/44%) compared with FFP (33%/54%) and VAK (50%/59%). However, this effect was no longer seen between PCC- and FFP-treated patients if international normalized ratio (INR) was completely reversed within 2 hours after admission. The overall outcome was poor (modified Rankin scale 4 to 6 in 77%). Predictors for hematoma growth were an increased INR after 2 hours, whereas administration of PCCs was significantly protective in multivariate analyses. Predictors for a poor outcome were age, baseline hematoma volume, and occurrence of hematoma growth. Overall, PCC was associated with a reduced incidence and extent of hematoma growth compared with FFP and VAK. This effect seems to be related to a more rapid INR reversal. Randomized controlled trials are needed to identify the most effective acute treatment regimen for lasting INR reversal because

  1. Oral Cholera Vaccine Coverage, Barriers to Vaccination, and Adverse Events following Vaccination, Haiti, 2013.

    Science.gov (United States)

    Tohme, Rania A; François, Jeannot; Wannemuehler, Kathleen; Iyengar, Preetha; Dismer, Amber; Adrien, Paul; Hyde, Terri B; Marston, Barbara J; Date, Kashmira; Mintz, Eric; Katz, Mark A

    2015-06-01

    In 2013, the first government-led oral cholera vaccination (OCV) campaign in Haiti was implemented in Petite Anse and Cerca Carvajal. To evaluate vaccination coverage, barriers to vaccination, and adverse events following vaccination, we conducted a cluster survey. We enrolled 1,121 persons from Petite Anse and 809 persons from Cerca Carvajal, categorized by 3 age groups (1-4, 5-14, >15 years). Two-dose OCV coverage was 62.5% in Petite Anse and 76.8% in Cerca Carvajal. Two-dose coverage was lowest among persons >15 years of age. In Cerca Carvajal, coverage was significantly lower for male than female respondents (69% vs. 85%; p<0.001). No major adverse events were reported. The main reason for nonvaccination was absence during the campaign. Vaccination coverage after this campaign was acceptable and comparable to that resulting from campaigns implemented by nongovernmental organizations. Future campaigns should be tailored to reach adults who are not available during daytime hours.

  2. Oral Cholera Vaccine Coverage, Barriers to Vaccination, and Adverse Events following Vaccination, Haiti, 20131

    Science.gov (United States)

    François, Jeannot; Wannemuehler, Kathleen; Iyengar, Preetha; Dismer, Amber; Adrien, Paul; Hyde, Terri B.; Marston, Barbara J.; Date, Kashmira; Mintz, Eric; Katz, Mark A.

    2015-01-01

    In 2013, the first government-led oral cholera vaccination (OCV) campaign in Haiti was implemented in Petite Anse and Cerca Carvajal. To evaluate vaccination coverage, barriers to vaccination, and adverse events following vaccination, we conducted a cluster survey. We enrolled 1,121 persons from Petite Anse and 809 persons from Cerca Carvajal, categorized by 3 age groups (1–4, 5–14, >15 years). Two-dose OCV coverage was 62.5% in Petite Anse and 76.8% in Cerca Carvajal. Two-dose coverage was lowest among persons >15 years of age. In Cerca Carvajal, coverage was significantly lower for male than female respondents (69% vs. 85%; p<0.001). No major adverse events were reported. The main reason for nonvaccination was absence during the campaign. Vaccination coverage after this campaign was acceptable and comparable to that resulting from campaigns implemented by nongovernmental organizations. Future campaigns should be tailored to reach adults who are not available during daytime hours. PMID:25988350

  3. Interactions between Host and Oral Commensal Microorganisms are Key Events in Health and Disease Status

    Directory of Open Access Journals (Sweden)

    Mahmoud Rouabhia

    2002-01-01

    Full Text Available The oral cavity has sometimes been described as a mirror that reflects a person's health. Systemic diseases such as diabetes or vitamin deficiency may be seen as alterations in the oral mucosa. A variety of external factors cause changes in the oral mucosa, thus altering mucosal structure and function, and promoting oral pathologies (most frequently bacterial, fungal and viral infections. Little is known, however, about immune surveillance mechanisms that involve the oral mucosa.

  4. Health related quality of life of patients undergoing oral anticoagulation therapy Calidad de vida relacionada a la salud de pacientes que usan anticoagulación oral Qualidade de vida relacionada à saúde de pacientes em uso de anticoagulação oral

    Directory of Open Access Journals (Sweden)

    Inaiara Scalçone Almeida Corbi

    2011-08-01

    Full Text Available This is a descriptive cross-sectional study, which aimed to analyze the health related quality of life (HRQoL and its relationship with gender, age, duration and indication for the use of oral anticoagulants. A total of 178 patients were interviewed and the HRQoL was assessed through eight domains of the SF-36. The descriptive statistics used were, the Student's t, ANOVA and Tukey's tests for the comparison of the means between the groups. The indication for use was predominantly the metallic prosthetic heart valve (50% with warfarin the most widely prescribed anticoagulant (83.3%. The means of the domains of the SF-36 ranged from 82 (Social aspects to 54.8 (Physical aspects. Women, elderly, patients diagnosed with atrial fibrillation and with less than one year of medication use, presented a worse HRQoL evaluation. The results obtained can guide nursing actions, in that they indicate possible associations between the HRQoL and the sociodemographic and clinical variables of the patients.Se trata de un estudio descriptivo, de tipo corte transversal, que tuvo como objetivo analizar la calidad de vida relacionada a la salud (CVRS y su relación con sexo, edad, tiempo e indicación de uso de anticoagulantes orales. Fueron entrevistados 178 pacientes y la CVRS fue evaluada por los ocho dominios del SF-36. Fue utilizada estadística descriptiva, las pruebas: t Student, ANOVA y Tukey, para comparación de los promedios entre los grupos. La indicación para el uso fue predominantemente la prótesis cardíaca metálica (50% y la warfarina el anticoagulante más prescrito (83,3%. Los promedios de los dominios del SF-36 variaron de 82 (Aspectos sociales a 54,8 (Aspectos físicos. Mujeres, ancianos, y pacientes con diagnóstico de fibrilación atrial y con menos de un año de uso del medicamento, presentaron peor evaluación de la CVRS. Los resultados obtenidos pueden orientar acciones de enfermería, en la medida en que indican posibles asociaciones entre

  5. Effect of Genotype-Guided Warfarin Dosing on Clinical Events and Anticoagulation Control Among Patients Undergoing Hip or Knee Arthroplasty: The GIFT Randomized Clinical Trial.

    Science.gov (United States)

    Gage, Brian F; Bass, Anne R; Lin, Hannah; Woller, Scott C; Stevens, Scott M; Al-Hammadi, Noor; Li, Juan; Rodríguez, Tomás; Miller, J Philip; McMillin, Gwendolyn A; Pendleton, Robert C; Jaffer, Amir K; King, Cristi R; Whipple, Brandi DeVore; Porche-Sorbet, Rhonda; Napoli, Lynnae; Merritt, Kerri; Thompson, Anna M; Hyun, Gina; Anderson, Jeffrey L; Hollomon, Wesley; Barrack, Robert L; Nunley, Ryan M; Moskowitz, Gerard; Dávila-Román, Victor; Eby, Charles S

    2017-09-26

    Warfarin use accounts for more medication-related emergency department visits among older patients than any other drug. Whether genotype-guided warfarin dosing can prevent these adverse events is unknown. To determine whether genotype-guided dosing improves the safety of warfarin initiation. The randomized clinical Genetic Informatics Trial (GIFT) of Warfarin to Prevent Deep Vein Thrombosis included patients aged 65 years or older initiating warfarin for elective hip or knee arthroplasty and was conducted at 6 US medical centers. Enrollment began in April 2011 and follow-up concluded in October 2016. Patients were genotyped for the following polymorphisms: VKORC1-1639G>A, CYP2C9*2, CYP2C9*3, and CYP4F2 V433M. In a 2 × 2 factorial design, patients were randomized to genotype-guided (n = 831) or clinically guided (n = 819) warfarin dosing on days 1 through 11 of therapy and to a target international normalized ratio (INR) of either 1.8 or 2.5. The recommended doses of warfarin were open label, but the patients and clinicians were blinded to study group assignment. The primary end point was the composite of major bleeding, INR of 4 or greater, venous thromboembolism, or death. Patients underwent a screening lower-extremity duplex ultrasound approximately 1 month after arthroplasty. Among 1650 randomized patients (mean age, 72.1 years [SD, 5.4 years]; 63.6% women; 91.0% white), 1597 (96.8%) received at least 1 dose of warfarin therapy and completed the trial (n = 808 in genotype-guided group vs n = 789 in clinically guided group). A total of 87 patients (10.8%) in the genotype-guided group vs 116 patients (14.7%) in the clinically guided warfarin dosing group met at least 1 of the end points (absolute difference, 3.9% [95% CI, 0.7%-7.2%], P = .02; relative rate [RR], 0.73 [95% CI, 0.56-0.95]). The numbers of individual events in the genotype-guided group vs the clinically guided group were 2 vs 8 for major bleeding (RR, 0.24; 95% CI, 0

  6. Effects of anticoagulant from Spirodela polyrhiza in rats.

    Science.gov (United States)

    Cho, Hong Rae; Choi, Hye-Seon

    2003-04-01

    A fibrinolytic protease was purified from an Oriental medicinal herb, Spirodela polyrhiza (Choi, H. S., et al., Biosci. Biotechnol. Biochem., 65, 781-786 (2001)). The protease hydrolyzed not only fibrin but also fibrinogen. The enzyme had an anticoagulant activity measured with activated partial thromboplastin time, thrombin time, and prothrombin time in rat plasma. It doubled all three at 69, 29, and 221 nM, respectively. The protein had anticoagulant activity when given intravenously and orally. The maximum delay in the activated partial thromboplastin time was at the dose of 0.52 and 4.2 mg/kg for intravenous and oral administration, respectively. This protein may be useful in clinical applications for anticoagulation.

  7. A post hoc analysis of dalteparin versus oral anticoagulant (VKA) therapy for the prevention of recurrent venous thromboembolism (rVTE) in patients with cancer and renal impairment.

    Science.gov (United States)

    Woodruff, Seth; Feugère, Guillaume; Abreu, Paula; Heissler, Joseph; Ruiz, Marcia T; Jen, Frank

    2016-11-01

    Venous thromboembolism (VTE) is a common and serious complication in patients with cancer; treatment guidelines recommend extended therapy of ≥6 months with low-molecular-weight heparin (LMWH) for treatment and prevention of recurrent VTE (rVTE) in this population. This post hoc analysis used data from the CLOT study-a phase III, randomized, open-label, controlled study (N = 676)-to compare the efficacy and safety of dalteparin, a LMWH, versus vitamin K antagonist (VKA) for prevention of rVTE in patients with cancer and renal impairment (creatinine clearance renal impairment at baseline. Patients received subcutaneous dalteparin 200 IU/kg once daily during month 1, followed by 150 IU/kg once daily for months 2-6; or VKA once daily for 6 months, with initial overlapping subcutaneous dalteparin 200 IU/kg once daily for ≥5 days until international normalized ratio was 2.0-3.0 for 2 consecutive days. Endpoints included the rates of rVTE (primary) and bleeding events. Overall, fewer dalteparin-treated patients (2/74 [2.7 %]) experienced ≥1 adjudicated symptomatic rVTE compared with VKA-treated patients (15/88 [17.0 %]; hazard ratio = 0.15 [95 % confidence interval 0.03-0.65]; p = 0.01). Bleeding event rates for both treatments were similar (p = 0.47). In summary, compared with VKA, dalteparin significantly reduced risk of rVTE in patients with cancer and renal impairment (p = 0.01) while exhibiting a comparable safety profile. This analysis supports dosing patients with renal impairment in accordance with patients with normal renal function; however, anti-Xa monitoring could be considered to further support safety in selected patients, particularly those with very severe renal impairment.

  8. The Italian START-Register on Anticoagulation with Focus on Atrial Fibrillation

    Science.gov (United States)

    2015-01-01

    START-Register – Survey on anTicoagulated pAtients RegisTer – is an independent, inception-cohort, observational, collaborative database aimed at recording prospectively the clinical history of adult patients starting anticoagulant treatment for any reason and using whatever drug. In this article we present the START-Register and give cross section baseline data focusing on non valvular atrial fibrillation (NVAF). Participants are asked to insert prospectively consecutive patients recorded as electronic file on the web-site of the registry. Required data are: demographic and clinical characteristics of patients, associated risk factors for stroke and bleeding, laboratory routine data, clinical indication for treatment, expected therapeutic range (in cases of treatment with vitamin K antagonists -VKAs). The follow-up is carried out to record: quality of treatment (for patients on VKAs), bleeding complications, thrombotic events, and the onset of any type of associated disease. To date 5252 patients have been enrolled; 97.6% were on VKAs because direct oral anticoagulants (DOAC) have been available in Italy only recently. The median age was 74 years [interquartile range (IQR) 64-80]; males 53.7%. This analysis is focused on the 3209 (61.1%) NVAF patients. Mean CHADS2 score was 2.1±1.1, CHADSVASc score was 3.1±1.3;median age was 76 years (IQR 70-81); 168 patients (5.3%) had severe renal failure [Creatinine clearance (CrCl) START-Register data shows that two-third of patients who started chronic anticoagulant treatment had NVAF, one-third of them was > 80 years with high prevalence of renal failure. PMID:26001109

  9. Adverse event management of oral mucositis in patients with breast cancer.

    Science.gov (United States)

    Seiler, Sabine; Kosse, Jens; Loibl, Sibylle; Jackisch, Christian

    2014-04-01

    Oral mucositis (OM) is a clinically important and frequent adverse event (AE) associated with cancer treatment with conventional chemotherapy as well as new targeted agents. Incidence and severity of OM vary from treatment to treatment and from patient to patient. The pathogenesis of chemotherapy-induced OM can be divided into 5 phases. OM induced by targeted therapies differs among other things in appearance, course, concomitant AEs and toxicity, and thus could be perceived as an entity distinct from chemotherapy-induced OM with an innate pathogenic mechanism. OM has a severe impact on a patient's quality of life (QoL) by causing complications such as pain and discomfort. Even more important are associated restrictions in nutrition and hydration. Thus, the efficacy of cancer therapy might be impaired due to the necessity of dose delays and dose reductions. Numerous preventive and therapeutic approaches have been evaluated, but currently no single agent has changed the standard of care in preventing and treating OM. Thus, the current management has evolved from clinical experience rather than clinical evidence. This article will review the AE 'OM' induced by breast cancer treatment with chemotherapy and targeted agents in order to provide practical guidance for management and prevention.

  10. Will NOACs become the new standard of care in anticoagulation therapy?

    Directory of Open Access Journals (Sweden)

    Ergene Oktay

    2015-06-01

    Full Text Available Atrial fibrillation is the most common cardiac arrhythmia in the general population, with a prevalence of 1–3%, which increases with age, reaching 15% in elderly people. Prophylaxis of ischemic stroke with warfarin was the gold standard of medical management for many years. On the other hand heparin and warfarin was the main pharmacologic agents for the prophylaxis/treatment of venous thromboembolism. In the last 5 years warfarin is getting replaced by non-vitamin K antagonist oral anticoagulants at least partly. In this article it is attempted to foresee whether new oral anticoagulants will become the new standard of care in anticoagulation therapy.

  11. Postoperative anticoagulation in patients with mechanical heart valves following surgical treatment of subdural hematomas.

    Science.gov (United States)

    Amin, Anubhav G; Ng, Julie; Hsu, Wesley; Pradilla, Gustavo; Raza, Shaan; Quinones-Hinojosa, Alfredo; Lim, Michael

    2013-08-01

    Thromboembolic events and anticoagulation-associated bleeding events represent frequent complications following cardiac mechanical valve replacement. Management guidelines regarding the timing for resuming anticoagulation therapy following a surgically treated subdural hematoma (SDH) in patients with mechanical valves remains to be determined. To determine optimal anticoagulation management in patients with mechanical heart valves following treatment of SDH. Outcomes were retrospectively reviewed for 12 patients on anticoagulation therapy for thromboembolic prophylaxis for mechanical cardiac valves who underwent surgical intervention for a SDH at the Johns Hopkins Hospital between 1995 and 2010. The mean age at admission was 71 years. All patients had St. Jude's mechanical heart valves and were receiving anticoagulation therapy. All patients had their anticoagulation reversed with vitamin K and fresh frozen plasma and underwent surgical evacuation. Anticoagulation was withheld for a mean of 14 days upon admission and a mean of 9 days postoperatively. The average length of stay was 19 days. No deaths or thromboembolic events occurred during the hospitalization. Average follow-up time was 50 months, during which two patients had a recurrent SDH. No other associated morbidities occurred during follow-up. Interruptions in anticoagulation therapy for up to 3 weeks pose minimal thromboembolic risk in patients with mechanical heart valves. Close follow-up after discharge is highly recommended, as recurrent hemorrhages can occur several weeks after the resumption of anticoagulation.

  12. Seguimento de 8 anos de prótese aórtica Medtronic-Hall: influência da anticoagulação oral na ocorrência de embolias Eight years follow-up of the Medtronic-Hall aortic prosthesis: influence of oral anti-coagulation on embolism incidence

    Directory of Open Access Journals (Sweden)

    Iseu Affonso da Costa

    1988-12-01

    were additionally 8 prosthetic dysfunctions, 8 acute infective endocarditis and 3 interventricular septal defects plus aortic insufficiency. One hundred and sixty three patients were followed (98.72, 9 of them being lost during the observation period. There were 45 late deaths, 59% SE 10.9% being the actuarial survival probality in 8 years. Twenty one patients suffered 26 embolic episodes, 69.8 SE 11.7% the probability of freedom from embolism and 39.7% SE 10.4% the chance of survival free from embolism. The rate of embolism episodes was 3,5% per patients/year in the entire series, 6 of them being lethal. In relation to the use of oral anticoagulation patients were divided into three sub-groups. Sub-group A included 144 patients, with a linearized incidence of 3.2% episodes per patients/year. Sub-group B included 21 patients who used anticoagulants after surgery, with an incidence of 1.9% per patients/year. Sub-group C comprised 9 patients who were put on anticoagulants after the occurence of an embolic episode. This sub-group presented 8.1 episodes per patients/year. It is concluded that it was not possible to doccument the influence of anticoagulation in the conditions prevailing during the observation of this series. After the occurence of one embolic episode the institution of oral anticoagulation was not effective in decreasing chance of its reccurence.

  13. Confidence in the Use of Direct Oral Anticoagulants in the Acute Phase of Nonvalvular Atrial Fibrillation-Related Ischemic Stroke Over the Years: A Real-World Single-Center Study.

    Science.gov (United States)

    Moroni, Federico; Masotti, Luca; Vannucchi, Vieri; Chiarelli, Raffaella; Seravalle, Cristiana; Pesci, Alessandra; Pallini, Francesca; Puliti, Silvia; Cimolato, Barbara; Fattorini, Lamberto; Scerra, Cornelia; Ristori, Francesca; Imbalzano, Maria Letizia; Spolveri, Stefano; Landini, Giancarlo; Grifoni, Elisa; Paciaroni, Maurizio

    2018-01-01

    The use of direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation (NVAF)-related acute ischemic stroke (AIS) is controversial. The aims of our study were to analyze physicians' confidence in prescribing DOACs in NVAF-related AIS, the characteristics of patients receiving DOACs, and their 90-day prognosis. Clinical records of consecutive patients admitted to our wards for NVAF-related AIS over the years 2014-2016 were reviewed. One hundred forty-seven patients, 72.7% females, mean age ± standard deviation 83.4 ± 8.8 years, were admitted to our ward for atrial fibrillation (AF)-related AIS (38 in 2014, 47 in 2015, 62 in 2016). Of these patients, 141 had NVAF-related AIS. Median length of hospital stay was 8 days (interquartile range [IQR], 6-11). In-hospital mortality was 10.8%. Ninety-eight patients (69.5%) received DOACs for secondary prevention, with increasing percentages from 2014 (62.5%) to 2016 (88%). In 88% of them, DOACs were started during hospital stay, whereas in 12% DOACs were started during ambulatory follow-up. The median time for starting DOACs was 5 days (IQR, 3-8). In patients receiving DOACs, the median National Institutes of Health Stroke Scale score was 6 (IQR, 3-12), and large ischemic lesions were present in 48%; the median modified Rankin Scale score at hospital discharge was 3 (IQR, 1-4), whereas the score at 90 days was 2 (IQR, 1-3). At the 90-day follow-up, in patients receiving DOACs, overall mortality was 3.0%, stroke recurrence was 1%, and no patients had major intracranial or extracranial bleedings. Our study suggests that physicians are becoming increasingly confident in the use of DOACs in NVAF-related AIS. The use of DOACs seems effective and safe even when started in the acute phase of stroke. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  14. Quality of life in patients with antiphospholipid syndrome is related to disease burden and anticoagulant therapy.

    Science.gov (United States)

    Hernández-Molina, Gabriela; González-Pérez, Itzel; Pacheco-Molina, Carlos; Cabral, Antonio R

    2017-06-01

    To evaluate health-related quality of life (HRQoL) in primary antiphospholipid syndrome (PAPS) and correlate it with a crude estimate of accrual organ damage, comorbidity (diabetes mellitus, hypertension and dyslipidemia) and treatment (oral anticoagulation, immunosuppressors and prednisone). We assessed HRQoL with the Short-Form 36 (SF-36) and the Lupus Quality of Life instrument (LupusQoL) and the disease burden with a modified Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR SDI). As controls we used SF-36 data from a Mexican general population within the same age range. We included 50 PAPS patients (86% women), mean age 47.6 ± 14.5 years, median disease duration 9.4 years, median SLICC/ACR score of 1 point and 80% had thrombotic events. PAPS patients had lower HRQoL than controls. We found a positive correlation between SF-36 and LupusQoL (r = 0.85, P < 0.0001). The SLICC/ACR SDI correlated negatively with both LupusQoL and SF-36, specifically the peripheral vascular domain (r = -0.29, P = 0.03, for both). Patients on oral anticoagulants (n = 37) had lower LupusQoL, physical functioning, intimate relationships, burden to others and pain scores as well as a lower SF-36 physical functioning score. We did not find differences in HRQoL regarding comorbidities and other treatments. HRQoL in PAPS was related to burden of the disease specifically at the vascular peripheral area and use of anticoagulants. © 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

  15. Adverse events associated with single dose oral analgesics for acute postoperative pain in adults - an overview of Cochrane reviews.

    Science.gov (United States)

    Moore, R Andrew; Derry, Sheena; Aldington, Dominic; Wiffen, Philip J

    2015-10-13

    This is an update of a Cochrane overview published in Issue 9, 2011; that overview considered both efficacy and adverse events. This overview considers adverse events, with efficacy dealt with in a separate overview.Thirty-nine Cochrane reviews of randomised trials have examined the adverse events associated with individual drug interventions in acute postoperative pain. This overview brings together the results of those individual reviews. To provide an overview of adverse event rates associated with single-dose oral analgesics, compared with placebo, for acute postoperative pain in adults. We identified systematic reviews in The Cochrane Database of Systematic Reviews on The Cochrane Library through a simple search strategy. All reviews were overseen by a single review group. We extracted information related to participants experiencing any adverse event, and reports of serious adverse events, and deaths from the individual reviews. Information was available from 39 Cochrane reviews for 41 different analgesics or analgesic combinations (51 drug/dose/formulations) tested in single oral doses in participants with moderate or severe postoperative pain. This involved around 350 unique studies involving about 35,000 participants. Most studies involved younger participants with pain following removal of molar teeth.For most nonsteroidal anti-inflammatory drugs (NSAIDs), paracetamol, and combinations not containing opioids, there were few examples where participants experienced significantly more or fewer adverse events than with placebo. For aspirin 1000 mg and diflunisal 1000 mg, opioids, or fixed-dose combination drugs containing opioids, participants typically experienced significantly more adverse events than with placebo. Studies of combinations of ibuprofen and paracetamol reported significantly fewer adverse events.Serious adverse events were rare, occurring a rate of about 1 in 3200 participants.Most reviews did not report specific adverse events. Despite

  16. Prevention of hemorrhagic complications after dental extractions into open heart surgery patients under anticoagulant therapy: the use of leukocyte- and platelet-rich fibrin.

    Science.gov (United States)

    Sammartino, Gilberto; Dohan Ehrenfest, David M; Carile, Francesco; Tia, Mariano; Bucci, Paolo

    2011-12-01

    Leukocyte- and platelet-rich fibrin (L-PRF) is a biomaterial commonly used in periodontology and implant dentistry to improve healing and tissue regeneration, particularly as filling material in alveolar sockets to regenerate bone for optimal dental implant placement. The objective of this work was to evaluate the use of L-PRF as a safe filling and hemostatic material after dental extractions (or avulsions) for the prevention of hemorrhagic complications in heart surgery patients without modification of the anticoagulant oral therapy. Fifty heart surgery patients under oral anticoagulant therapy who needed dental extractions were selected for the study. Patients were treated with L-PRF clots placed into 168 postextraction sockets without modification of anticoagulant therapy (mean international normalized ratio  =  3.16 ± 0.39). Only 2 patients reported hemorrhagic complications (4%), all of which resolved a few hours after the surgery by compression and hemostatic topical agents. Ten patients (20%) showed mild bleeding, which spontaneously resolved or was resolved by minimal compression less than 2 hours after surgery. No case of delayed bleeding was reported. The remaining 38 patients (76%) showed an adequate hemostasis after the dental extractions. In all cases, no alveolitis or painful events were reported, soft tissue healing was quick, and wound closure was always complete at the time of suture removal one week after surgery. The proposed protocol is a reliable therapeutic option to avoid significant bleeding after dental extractions without the suspension of the continuous oral anticoagulant therapy in heart surgery patients. Other applications of the hemostatic and healing properties of L-PRF should be investigated in oral implantology.

  17. Regulatory Impact on Thrombosis Treatment, Prevention, and Anticoagulant Use.

    Science.gov (United States)

    Dannemiller, Robert; Ward, Tucker; Fanikos, John

    2016-10-01

    Thromboembolism afflicts millions of patients annually in the United States and is associated with a significant cost burden. Oral anticoagulants provide clinicians with options for management of these diseases and their use continues to grow. Accordingly, regulatory, legislative, and nonprofit organizations have set performance standards with the goal of improving patient outcomes, ensuring patient safety, and reducing costs. Recent efforts in quality improvement have introduced changes surrounding regulatory requirements, surveillance, litigation, and oversight that clinicians should be familiar with. This article summarizes key updates related to the management of anticoagulant therapy as it relates to thrombosis prevention and treatment. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Monitoring Oral Anticoagulant Therapy: Measuring Coagulant Activity

    DEFF Research Database (Denmark)

    Attermann, Jorn

    is linear, such that the standardization by the INR system is feasible (substudy 2). • Based on a realistic statistical model, the statistical distribution of INR estimates, given a true INR value, can be adequately described to allow for good estimates of accuracy and precision (substudy 3). In the first...... central aspects of the INR system, such as the inaccuracy of INR estimates based on a given path of calibrations. The main result states that, under weak regularity conditions, log (log (estimated INR)) is approximately normally distributed with mean log (log (true INR)). The variance is a function....... Numerous reports on inconsistent or discrepant INR values suggest that the distributional properties of the INR system are not fully understood. The aim of this Ph.D. thesis was to investigate and describe the INR system in order to provide a basis for the evaluation and comparison of different forms...

  19. oral

    African Journals Online (AJOL)

    association between oral candidosis and. AIDS; the first documented patient with. AIDS had oral candidosis.3 A sub- stantial amount of data now emphasise its high prevalence in HIV-infected individuals. The manifestations of candidal infection in HIV-infected persons are restricted to superficial mucosal lesions of varying ...

  20. Nonoclusive thrombosis of mechanical mitral valve prosthesis caused by inadequate treatment of anticoagulant therapy resistance

    Directory of Open Access Journals (Sweden)

    Ivanović Branislava

    2008-01-01

    Full Text Available Background. Oral anticoagulants have been used in the prevention of thromboembolic complications for over six decades. A rare, but possible problem in the application of these medications could be resistance to them. Case report. We presented a patient with nonocclusive thrombosis of the mechanical mitral prosthesis due to inadequately treated resistance to peroral anticoagulant therapy. Resistance to oral anticoagulant medications was proven by an increased dosage of warfarin up to 20 mg and, after that, acenokumarol to 15 mg over ten days which did not lead to an increase in the international normalized ratio (INR value over 1.2. On the basis of information that she did not take food rich in vitamin K or medications which could reduce effects of oral anticoagulants, and that she did not have additional illnesses and conditions that could cause an inadequate response to anticoagulant therapy, it was circumstantially concluded that this was a hereditary form of resistance. Because of the existing mechanical prosthetics on the mitral position, low molecular heparin has been introduced into the therapy. The patient reduced it on her own initiative, leading to nonocclusive valvular thrombosis. Conclusion. When associated complications like absolute arrhithmia does not exist, the finding of resistance to oral anticoagulant agents is an indication for the replacement of a mechanical prosthetic with a biological one which has been done in this patients.

  1. Therapeutic strategies after coronary stenting in chronically anticoagulated patients: the MUSICA study.

    Science.gov (United States)

    Sambola, A; Ferreira-González, I; Angel, J; Alfonso, F; Maristany, J; Rodríguez, O; Bueno, H; López-Minguez, J R; Zueco, J; Fernández-Avilés, F; San Román, A; Prendergast, B; Mainar, V; García-Dorado, D; Tornos, P

    2009-09-01

    To identify the therapeutic regimens used at discharge in patients receiving oral anticoagulant therapy (OAT) who undergo stenting percutaneous coronary intervention and stent implantation (PCI-S), and to assess the safety and efficacy associated with different therapeutic regimens according to thromboembolic risk. A prospective multicentre registry. In hospital, after discharge and follow-up by telephone call. 405 patients (328 male/77 female; mean (SD) age 71 (9) years) receiving OAT who underwent PCI-S between November 2003 and June 2006 from nine catheterisation laboratories of tertiary care teaching hospitals in Spain and one in the United Kingdom were included. Three therapeutic regimens were identified at discharge: triple therapy (TT) -- that is, any anticoagulant (AC) plus double antiplatelet therapy (DAT; 278 patients (68.6%); AC and a single antiplatelet (AC+AT; 46 (11.4%)) and DAT only (81 (20%)). At 6 months, patients receiving TT showed the greatest rate of bleeding events. No patients receiving DAT at low thromboembolic risk presented a bleeding event (14.8% receiving TT, 11.8% receiving AC+AT and 0% receiving DAT, p = 0.033) or cardiovascular event (6.7% receiving TT, 0% receiving AC+AT and 0% receiving DAT, p = 0.126). The combination of AC+AT showed the worst rate of adverse events in the whole cohort, especially in patients at moderate-high thromboembolic risk. In patients receiving OAT, TT was the most commonly used regimen after PCI-S. DAT was associated with the lowest rate of bleeding events and a similar efficacy to TT in patients at low thromboembolic risk. TT should probably be restricted to patients at moderate-high thromboembolic risk.

  2. Dental extractions during anticoagulant therapy.

    Science.gov (United States)

    Anavi, Y; Sharon, A; Gutman, D; Laufer, D

    1981-04-01

    1. 15 patients, whose therapy with the anticoagulant Coumarin was not discontinued, were observed for bleeding following dental extractions. 2. There was no significant bleeding in these patients as compared to 15 others whose Coumarin therapy was temporarily interrupted. 3. Patients with prosthetic heart valves should preferably be hospitalized for dental extractions. but Coumarin/anticoagulant therapy need not be discontinued. The procedures can safely be done within a therapeutic range of 20-30% P.T.

  3. A comparison of sedation-related events for two multiagent oral sedation regimens in pediatric dental patients.

    Science.gov (United States)

    McCormack, Laura; Chen, Jung-Wei; Trapp, Larry; Job, Allen

    2014-01-01

    This study compared the incidence of adverse sedation-related events occurring with two different multiagent oral sedation regimens in pediatric dental patients. Forty healthy patients (three to six years old), received either a sedation regimen of chloral hydrate, meperidine, and hydroxyzine with nitrous oxide (CH/M/H/N2O; N=19) or a regimen of midazolam, meperidine, and hydroxyzine with nitrous oxide (MZ/M/H/N2O; N=21). The two treating dentists answered a questionnaire regarding the perioperative period. Parents received two phone interviews at eight and 24 hours after sedation. Statistical analysis included chi-square, Pearson correlation coefficient, and t-test (Phours after discharge. Children sedated with CH/M/H/N2O showed a significant increase in frequency of sleeping, talking less than normal after arriving home, and an increased need for postoperative pain medication. Different oral sedation regimens produce different adverse sedation-related events. The provider of pediatric oral sedation should select a sedative regimen with an adverse sedation-related profile that he/she believes is optimal for the patient being treated. Parents should be counseled as to possible postsedation effects anticipated based on the sedative regimen administered.

  4. Anticoagulation in pregnancy complications.

    Science.gov (United States)

    Middeldorp, Saskia

    2014-12-05

    Women with acquired and inherited thrombophilia are thought to be at increased risk for pregnancy complications, including recurrent pregnancy loss and, depending on the type of thrombophilia, severe preeclampsia. This review discusses the associations between the types of thrombophilia and types of complications, as well as the currently available clinical trial evidence regarding the use of aspirin and heparin to prevent these pregnancy complications. In women with antiphospholipid syndrome, guidelines recommend prescribing aspirin and heparin to women with recurrent miscarriage. The same regimen is suggested for late pregnancy complications by some, but not all, experts. Aspirin or low-molecular-weight heparin to improve pregnancy outcome in women with unexplained recurrent miscarriage has no benefit and should not be prescribed. Whether anticoagulant therapy prevents recurrent miscarriage in women with inherited thrombophilia or in women with severe pregnancy complications remains controversial because of inconsistent results from trials. Aspirin modestly decreases the risk of severe preeclampsia in women at high risk. © 2014 by The American Society of Hematology. All rights reserved.

  5. Lupus anticoagulant hypoprothrombinemia syndrome associated with severe thrombocytopenia in a child.

    Science.gov (United States)

    Foord, Aimee; Baca, Nicole; Buchbinder, David; Mahajerin, Arash

    2017-06-01

    Lupus anticoagulant hypoprothrombinemia syndrome (LAHPS) comprises lupus anticoagulant, acquired hypoprothrombinemia, and often mild thrombocytopenia or normal platelets. It is usually associated with autoimmunity or postviral illness. We describe a case of a 10-year-old boy with oral bleeding and severe thrombocytopenia initially suggestive of immune thrombocytopenia. Secondary to bleeding, evaluation demonstrated prolonged coagulation tests and subsequently revealed the presence of lupus anticoagulant and hypoprothrombinemia, along with marked autoimmunity, suggestive of LAHPS. He was treated with intravenous immunoglobulin and hydroxychloroquine. This case report and discussion highlight the diagnostic and therapeutic challenges associated with LAHPS and coincident severe thrombocytopenia. © 2016 Wiley Periodicals, Inc.

  6. Oral adverse events associated with tyrosine kinase and mammalian target of rapamycin inhibitors in renal cell carcinoma: a structured literature review

    NARCIS (Netherlands)

    Boers-Doets, Christine B.; Epstein, Joel B.; Raber-Durlacher, Judith E.; Ouwerkerk, Jan; Logan, Richard M.; Brakenhoff, Jan A.; Lacouture, Mario E.; Gelderblom, Hans

    2012-01-01

    Oral adverse events