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  1. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial

    DEFF Research Database (Denmark)

    Kelbaek, H.; Klovgaard, L.; Helqvist, S.

    2008-01-01

    OBJECTIVES: Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions. BACKGROUND: Although the use of SES has proved to be effective in patients with simple coronary artery lesions, there are limited...... data of the long-term outcome of patients with complex coronary artery lesions. METHODS: We randomly assigned 322 patients with total coronary occlusions or lesions located in bifurcations, ostial, or angulated segments of the coronary arteries to have SES or BMS implanted. RESULTS: At 3 years, major...

  2. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions

    DEFF Research Database (Denmark)

    Kelbaek, Henning; Kløvgaard, Lene; Helqvist, Steffen

    2008-01-01

    OBJECTIVES: Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions. BACKGROUND: Although the use of SES has proved to be effective in patients with simple coronary artery lesions, there are limited...... benefit was observed up to 3 years after implantation of SES in patients with complex coronary artery lesions. The rate of late adverse events was similar in the 2 groups, and stent thromboses occurred rarely after 1 year. (Sirolimus Eluting Stents in Complex Coronary Lesions [SCANDSTENT]; NCT00151658)...

  3. Biocompatibility of Coronary Stents

    Directory of Open Access Journals (Sweden)

    Thamarasee M. Jeewandara

    2014-01-01

    Full Text Available Cardiovascular disease is the dominant cause of mortality in developed countries, with coronary artery disease (CAD a predominant contributor. The development of stents to treat CAD was a significant innovation, facilitating effective percutaneous coronary revascularization. Coronary stents have evolved from bare metal compositions, to incorporate advances in pharmacological therapy in what are now known as drug eluting stents (DES. Deployment of a stent overcomes some limitations of balloon angioplasty alone, but provides an acute stimulus for thrombus formation and promotes neointimal hyperplasia. First generation DES effectively reduced in-stent restenosis, but profoundly delay healing and are susceptible to late stent thrombosis, leading to significant clinical complications in the long term. This review characterizes the development of coronary stents, detailing the incremental improvements, which aim to attenuate the major clinical complications of thrombosis and restenosis. Despite these enhancements, coronary stents remain fundamentally incompatible with the vasculature, an issue which has largely gone unaddressed. We highlight the latest modifications and research directions that promise to more holistically design coronary implants that are truly biocompatible.

  4. Auxetic coronary stent endoprosthesis

    DEFF Research Database (Denmark)

    Amin, Faisal; Ali, Murtaza Najabat; Ansari, Umar

    2014-01-01

    was obtained via laser cutting, and surface treatment was performed with acid pickling and electropolishing, followed by an annealing process. In vitro mechanical analysis was performed to analyze the mechanical performance of the auxetic coronary stent. Scanning electronic microscopy (SEM) was used...

  5. Coronary artery stent (image)

    Science.gov (United States)

    ... blocked. The stent is inserted along with a balloon catheter and expands when the balloon is inflated. The stent is ... blocked. The stent is inserted along with a balloon catheter and expands when the balloon is inflated. The stent is ...

  6. Percutaneous coronary angioscopy and stents

    Science.gov (United States)

    Heuser, Richard R.

    1994-05-01

    With the expanding array of therapies available for coronary intervention, the invasive cardiologist has many choices for treating a specific lesion in an individual patient. Certain types of lesions might respond more effectively with stents, particularly the rigid Palmax- Schatz device. Thrombus and dissection immediately following stent placement are associated with early occlusion, and the interventionist must be able to assess their presence pre- and post-stenting. Angiography is deficient in quantifying minimal disease and in defining lesion architecture and composition, as well as the plaque rupture and thrombosis associated with unstable angina. It is also imprecise in detecting dissection and thrombus. Intravascular ultrasound (IVUS) provides high-resolution images that delineate irregularities and other structures inside the lumen and within the vessel wall and surrounding tissues. Like angiography, IVUS has limited specificity for thrombus differentiation. Angioscopy is superior to angiography and IVUS in detecting thrombus and dissection. Angioscopy allows the clinician to assess the appearance of stent struts after deployment and at follow-up. This may aid in reducing acute complications as well as restenosis. Follow-up angioscopy of stents to detect thrombus or exposed struts may guide therapy in a patient who has clinical symptoms of restenosis.

  7. Incidence and predictors of coronary stent thrombosis

    DEFF Research Database (Denmark)

    D'Ascenzo, Fabrizio; Bollati, Mario; Clementi, Fabrizio

    2013-01-01

    Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent thrombo...

  8. The risk and prognostic impact of definite stent thrombosis or in-stent restenosis after coronary stent implantation

    DEFF Research Database (Denmark)

    Thayssen, Per; Jensen, Lisette Okkels; Lassen, Jens Flensted

    2012-01-01

    Aims: Data are limited on the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with coronary stents. We examined the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with percutaneous coronary intervention (PCI). Methods and result...

  9. Hemodynamics in Idealized Stented Coronary Arteries: Important Stent Design Considerations.

    Science.gov (United States)

    Beier, Susann; Ormiston, John; Webster, Mark; Cater, John; Norris, Stuart; Medrano-Gracia, Pau; Young, Alistair; Cowan, Brett

    2016-02-01

    Stent induced hemodynamic changes in the coronary arteries are associated with higher risk of adverse clinical outcome. The purpose of this study was to evaluate the impact of stent design on wall shear stress (WSS), time average WSS, and WSS gradient (WSSG), in idealized stent geometries using computational fluid dynamics. Strut spacing, thickness, luminal protrusion, and malapposition were systematically investigated and a comparison made between two commercially available stents (Omega and Biomatrix). Narrower strut spacing led to larger areas of adverse low WSS and high WSSG but these effects were mitigated when strut size was reduced, particularly for WSSG. Local hemodynamics worsened with luminal protrusion of the stent and with stent malapposition, adverse high WSS and WSSG were identified around peak flow and throughout the cardiac cycle respectively. For the Biomatrix stent, the adverse effect of thicker struts was mitigated by greater strut spacing, radial cell offset and flow-aligned struts. In conclusion, adverse hemodynamic effects of specific design features (such as strut size and narrow spacing) can be mitigated when combined with other hemodynamically beneficial design features but increased luminal protrusion can worsen the stent's hemodynamic profile significantly.

  10. Transient coronary aneurysm formation after Nevo™ stent implantation versus persistent coronary aneurysm after Cypher Select™ stent implantation

    DEFF Research Database (Denmark)

    Christiansen, Evald Høj; Lassen, Jens Flensted; Jensen, Lisette Okkels

    2011-01-01

    We implanted a Cypher Select™ coronary stent and two months later a Nevo™ sirolimus-eluting coronary stent in another vessel. At a prescheduled angiographic follow-up, coronary aneurysms were seen in the two stented segments, 6 and 8 months after stent implantation, respectively. Six months later......, the aneurysm had healed in the Nevo, but was still present in the Cypher stented segment. We hypothesize that aneurysm formation was induced by sirolimus and the polymer of the implanted stents, and that subsequent healing was possible in the Nevo stent after degradation of the polymer....

  11. Circadian Variation in Coronary Stent Thrombosis

    NARCIS (Netherlands)

    Mahmoud, Karim D.; Lennon, Ryan J.; Ting, Henry H.; Rihal, Charanjit S.; Holmes, David R.

    Objectives We sought to determine the circadian, weekly, and seasonal variation of coronary stent thrombosis. Background Other adverse cardiovascular events such as acute myocardial infarction are known to have higher incidences during the early morning hours, Mondays, and winter months. Methods The

  12. Design Optimisation of Coronary Artery Stent Systems.

    Science.gov (United States)

    Bressloff, Neil W; Ragkousis, Giorgos; Curzen, Nick

    2016-02-01

    In recent years, advances in computing power and computational methods have made it possible to perform detailed simulations of the coronary artery stenting procedure and of related virtual tests of performance (including fatigue resistance, corrosion and haemodynamic disturbance). Simultaneously, there has been a growth in systematic computational optimisation studies, largely exploiting the suitability of surrogate modelling methods to time-consuming simulations. To date, systematic optimisation has focussed on stent shape optimisation and has re-affirmed the complexity of the multi-disciplinary, multi-objective problem at hand. Also, surrogate modelling has predominantly involved the method of Kriging. Interestingly, though, optimisation tools, particularly those associated with Kriging, haven't been used as efficiently as they could have been. This has especially been the case with the way that Kriging predictor functions have been updated during the search for optimal designs. Nonetheless, the potential for future, carefully posed, optimisation strategies has been suitably demonstrated, as described in this review.

  13. The conical stent in coronary artery improves hemodynamics compared with the traditional cylindrical stent.

    Science.gov (United States)

    Yu, Yi; Zhou, Yujie; Ma, Qian; Jia, Shuo; Wu, Sijing; Sun, Yan; Liu, Xiaoli; Zhao, Yingxin; Liu, Yuyang; Shi, Dongmei

    2017-01-15

    This study sought to explore the efficacy of the conical stent implantation in the coronary artery by comparing the effects of cylindrical and conical stents on wall shear stress (WSS) and velocity of flow and fractional flow reserve (FFR). The traditional cylindrical stent currently used in the percutaneous coronary intervention (PCI) has a consistent diameter, which does not match the physiological change of the coronary artery. On the contrary, as a new patent, the conical stent with tapering lumen is consistent with the physiological change of vascular diameter. However, the effect of the conical stent implantation on the coronary hemodynamics remains unclear. The coronary artery, artery stenosis and two stent models were established by Solidworks software. All models were imported into the computational fluid dynamics (CFD) software ANSYS ICEM-CFD to establish the fluid model. After the boundary conditions were set, CFD analysis was proceeded to compare the effects of two stent implantation on the change of WSS, velocity of flow and FFR. Hemodynamic indexes including FFR, blood flow velocity distribution (BVD) and WSS were improved by either the cylindrical or the conical stent implantation. However, after the conical stent implantation, the change of FFR seemed to be slower and more homogenous; the blood flow velocity was more appropriate without any obvious blood stagnation and direction changes; the WSS after the conical stent implantation was uniform from the proximal to distal side of the stent. Compared with the cylindrical stent, the conical stent implantation in the coronary artery can make the changes of vascular hemodynamic more closer to the physiological condition, which can reduce the incidence of intra-stent restenosis and thrombosis, thus making it more suitable for PCI therapy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  14. The MGuard coronary stent: safety, efficacy, and clinical utility

    Directory of Open Access Journals (Sweden)

    Gracida M

    2015-09-01

    Full Text Available Montserrat Gracida, Rafael Romaguera, Francisco Jacobi, Joan A Gómez-Hospital, Angel Cequier Heart Diseases Institute, Hospital Universitari de Bellvitge – IDIBELL, University of Barcelona, Barcelona, Spain Abstract: Atheromatous and thrombotic embolization during percutaneous coronary revascularization is a feared complication that may cause impaired myocardial reperfusion even with a patent epicardial vessel. The MGuard stent is a cobalt chromium bare metal stent with a porous net attached to its outer surface that has been designed to prevent thrombus fragmentation and distal embolization during stent implantation. This review summarizes the available evidence supporting the use of the MGuard stent in different scenarios such as lesions with high thrombus burden, saphenous vein graft interventions, coronary perforations, or carotid lesions. Keywords: Coronary artery disease, myocardial infarction, coronary stent, complication, thrombus, no-reflow phenomenon

  15. Design and modeling balloon-expandable coronary stent for manufacturability

    Science.gov (United States)

    Suryawan, D.; Suyitno

    2017-02-01

    Coronary artery disease (CAD) is a disease that caused by narrowing of the coronary artery. The narrowing coronary artery is usually caused by cholesterol-containing deposit (plaque) which can cause a heart attack. CAD is the most common cause mortality in Indonesia. The commonly CAD treatment use the stent to opens or alleviate the narrowing coronary artery. In this study, the stent design is optimized for the manufacturability. Modeling is used to determine the free stent expansion due to applied pressure in the inner surface of the stent. The stress distribution, outer diameter change, and dogboning phenomena are investigated in the simulation. The result of modeling and simulating was analyzed and used to optimize the stent design before it is manufactured using EDM (Electric Discharge Machine) in the next research.

  16. Coronary Stents: The Impact of Technological Advances on Clinical Outcomes.

    Science.gov (United States)

    Mennuni, Marco G; Pagnotta, Paolo A; Stefanini, Giulio G

    2016-02-01

    Percutaneous coronary interventions (PCI) were proposed in the late 1970s as an alternative to surgical coronary artery bypass grafting for the treatment of coronary artery disease. Important technological progress has been made since. Balloon angioplasty was replaced by bare metal stents, which allowed to permanently scaffold the coronary vessel avoiding acute recoil and abrupt occlusion. Thereafter, the introduction of early generation drug-eluting stents (DES) has significantly improved clinical outcomes, primarily by markedly reducing the risk of restenosis. New generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new limus antiproliferative agents, have further improved upon the safety and efficacy profile of early generation DES. The present article aims to review the impact of technological advances on clinical outcomes in the field of PCI with coronary stents, and to provide a brief overview on clinical margins of improvement and unmet needs of available DES.

  17. The nature and pattern of coronary stent recalls.

    Science.gov (United States)

    Kumar, Sanjay; Innasimuthu, Antony L; Marmur, Jonathan D

    2014-09-01

    Each year, over 1 million percutaneous coronary interventions (PCIs) are performed in the United States. Coronary stents have been shown to reduce restenosis or abrupt vessel closure and therefore have improved the success of PCI. Rarely, manufacturers recall stents due to unanticipated problems. We sought to study the extent and pattern of stent recall. To determine the number and rate of stent recall and safety alerts, to identify trends in the rates, and to identify the nature of stent recalls. The Food and Drug Administration (FDA; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm) and Healthcare Recall Management websites (RASMAS; https://alerts.rasmas.noblis.org/rasmas/c/selectViewAlertList.do) were searched. The search terms for recall were, "coronary stent" or "stent." Dates were searched between November 2002 and June 2013. There were 17 coronary stent recalls involving almost 500,000 units; 12 recalls (71%) were before 2006 and 5 recalls (29%) were after. Thirteen recalls (76%) consisted of class II recalls (moderate hazard); the remaining 4 were equally split between class I (severe hazard) and class III (mild hazard; 12% each). The common reasons for recall were concerns with sterility (29%) followed by wrong labeling/packaging (23%) and impaired delivery of stent (18%). In terms of units involved with recalls, 98% (472,189/481,131) were related to wrong labeling/ packaging or misbranding, while 0.1% (542/481,131) were related to potential for broken struts or crack in inflation port hub or sterility. However, approximately 2% of units were related to the potentially lethal problem of impaired balloon inflation. Recalls involved multiple manufacturers with various stent types. The overall incidence of coronary stent recall is low and has declined over the years. The majority of stent recalls are of moderate hazard. However, due to the possibility of serious injury, clinicians should be aware of recalls.

  18. Coronary stent on coronary CT angiography: Assessment with model-based iterative reconstruction technique

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Eun Chae; Kim, Yeo Koon; Chun, Eun Ju; Choi, Sang IL [Dept. of of Radiology, Seoul National University Bundang Hospital, Seongnam (Korea, Republic of)

    2016-05-15

    To assess the performance of model-based iterative reconstruction (MBIR) technique for evaluation of coronary artery stents on coronary CT angiography (CCTA). Twenty-two patients with coronary stent implantation who underwent CCTA were retrospectively enrolled for comparison of image quality between filtered back projection (FBP), adaptive statistical iterative reconstruction (ASIR) and MBIR. In each data set, image noise was measured as the standard deviation of the measured attenuation units within circular regions of interest in the ascending aorta (AA) and left main coronary artery (LM). To objectively assess the noise and blooming artifacts in coronary stent, we additionally measured the standard deviation of the measured attenuation and intra-luminal stent diameters of total 35 stents with dedicated software. All image noise measured in the AA (all p < 0.001), LM (p < 0.001, p = 0.001) and coronary stent (all p < 0.001) were significantly lower with MBIR in comparison to those with FBP or ASIR. Intraluminal stent diameter was significantly higher with MBIR, as compared with ASIR or FBP (p < 0.001, p = 0.001). MBIR can reduce image noise and blooming artifact from the stent, leading to better in-stent assessment in patients with coronary artery stent.

  19. Biocompatibility of coronary stent materials: effect of electrochemical polishing

    Energy Technology Data Exchange (ETDEWEB)

    Scheerder, I. de [University Hospital Leuven (Belgium). Dept. of Cardiology; Sohier, J.; Froyen, L.; Humbeeck, J. van [Louvain Univ. (Belgium). Dept. of Metallurgy and Materials Engineering; Verbeken, E. [University Hospital Leuven (Belgium). Dept. of Pathology

    2001-02-01

    Percutaneous Transluminal Coronary Revascularization (PTCR) is now a widely accepted treatment modality for atherosclerotic coronary artery disease. Current multicenter randomized trials comparing PTCR with the more invasive Coronary Artery Bypass Grafting could not show long-term significant survival differences. During the last two decades progress has been made to further optimize PTCR. The most logic approach to treat atherosclerotic coronary narrowings is to remove the atherosclerotic material using especially developed devices. Several trials, however, could not show a significant beneficial outcome after use of these devices compared to plain old balloon angioplasty. Another approach was to implant a coronary prothesis (stent), scaffolding the diseased coronary artery after PTCA. This approach resulted in a decreased restenosis rate at follow-up. The beneficial effects of stenting, however, was not found to be related to the inhibition of the neointimal cellular proliferation after vascular injury, but simply to be the mechanical result of overstretching of the treated vessel segment. The most important remaining clinical problem after stenting remains the neointimal hyperplasia within the stent, resulting in a significant stent narrowing in 13 to 30% of patients. Further efforts to improve the clinical results of coronary stenting should focus on the reduction of this neointimal hyperplasia. Neointimal hyperplasia after stent implantation results from (1) a healting response to the injury caused by the stent implantation and (2) a foreign body response to the stent itself. Factors that seem to influence the neointimal hyperplastic response are genetic, local disease related, stent delivery related and stent related factors. Biocompatibilisation of coronary stents by looking for more biocompatible metal alloys, optimized surface characteristics and optimized stent designs should result in a better late patency. Furthermore drug eluting and radioactive stents

  20. Coronary bifurcation lesions treated with simple or complex stenting

    DEFF Research Database (Denmark)

    Behan, Miles W; Holm, Niels R; de Belder, Adam J

    2016-01-01

    AIMS: Randomized trials of coronary bifurcation stenting have shown better outcomes from a simple (provisional) strategy rather than a complex (planned two-stent) strategy in terms of short-term efficacy and safety. Here, we report the 5-year all-cause mortality based on pooled patient-level data...

  1. Late thrombosis of coronary bare-metal stent: Case report

    Directory of Open Access Journals (Sweden)

    Apostolović Svetlana

    2006-01-01

    Full Text Available Stent thrombosis remains the primary cause of death after percutaneous coronary interventions (PCI. Despite modern concepts of PCI, stent thrombosis occurs in 0.5% -2% of elective procedures and even 6% of patients with the acute coronary syndrome (ACS. Stent thrombosis most often develops within the first 48 hours after the PCI, and rarely after a week of stent implantation. Angiographically documented late (>6 months thrombosis of coronary bare-metal stent (BMS is rare, because the stent endothelialization is considered to be completed after four weeks of the intervention. Our patient is a 41 year old male and he had BMS thrombosis 345 days after the implantation, which was clinically manifested as an acute myocardial infarction in the inferoposterolateral localization. Stent Clinical Centre of Serbia, Belgrade thrombosis occurred despite a long term dual antiplatelet therapy and control of known risk factors. Thrombolytic therapy (Streptokinase in a dose of 1 500 000 IU was not successful in reopening the occluded vessel, so the flow through the coronary artery was achieved by rescue balloon angioplasty, followed by implantation of drug eluting stent in order to prevent restenosis.

  2. [Coronary stent evaluation with cardiac CT: Literature review].

    Science.gov (United States)

    Pesenti-Rossi, D; Allouch, P; Gibault-Genty, G; Baron, N; Augusto, S; Convers-Domart, R; Almeida, S; Aubert, S; Squara, P; Livarek, B

    2015-11-01

    Since the introduction of the 64-generation scanners, the accuracy and robustness of the diagnosis of coronary artery disease has progressed. The main advantage of cardiac CT is the exclusion of coronary artery disease by its excellent negative predictive value. Currently, cardiac CT applications extend thanks to innovations both in terms of technological development systems scanner or stents implanted. This is a literature review of stent evaluation with cardiac CT. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  3. Repair of an Atherosclerotic Coronary Artery Aneurysm by Implantation of a Coronary Covered Stent

    Directory of Open Access Journals (Sweden)

    Antenor Portela

    2002-05-01

    Full Text Available An atherosclerotic aneurysm of the right coronary artery complicated by a recent myocardial infarction was successfully treated with coronary artery stenting, using a device consisting of 2 stents with a layer of expandable polytetrafluorethylene (PTFE placed between them. A follow-up angiograph 5 months after the procedure showed sustained initial results.

  4. Repair of an Atherosclerotic Coronary Artery Aneurysm by Implantation of a Coronary Covered Stent

    OpenAIRE

    Portela, Antenor; Bastos, Raldir; Costa, Itamar; Paiva, Jayro

    2002-01-01

    An atherosclerotic aneurysm of the right coronary artery complicated by a recent myocardial infarction was successfully treated with coronary artery stenting, using a device consisting of 2 stents with a layer of expandable polytetrafluorethylene (PTFE) placed between them. A follow-up angiograph 5 months after the procedure showed sustained initial results.

  5. Pulsatile flow in coronary bifurcations for different stenting techniques

    OpenAIRE

    García García, Javier; Manuel Martín, Fernando Jaime; Doce Carrasco, Y.; Castro Ruiz, F.; Crespo Martínez, Antonio; Goicolea Marin, P.; Fernandez Diaz, J.A.

    2012-01-01

    The objective of this work is to analyze the local hem odynamic changes caused in a coronary bifurcation by three different stenting techniques: simple stenting of the main vessel, simple stenting of the main vessel with kissing balloon in the side branch and culotte. To carry out this study an idealized geometry of a coronary bifurcation is used, and two bifurcation angles, 45º and 90º, are chosen as representative of the wide variety of re al configurations. In order to quantify th...

  6. Very late stent thrombosis of bare-metal coronary stent nine years after primary percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Đurić Predrag

    2016-01-01

    Full Text Available Introduction. Stent thrombosis (ST in clinical practice can be classified according to time of onset as early (0–30 days after stent implantation, which is further divided into acute ( 30 days and very late (> 12 months. Myocardial reinfaction due to very late ST in a patient receiving antithrombotic therapy is very rare, and potentially fatal. The procedure alone and related mechanical factors seem to be associated with acute/subacute ST. On the other hand, in-stent neoathero-sclerosis, inflammation, premature cessation of antiplatelet therapy, as well as stent fracture, stent malapposition, un-covered stent struts may play role in late/very late ST. Some findings implicate that the etiology of very late ST of bare-metal stent (BMS is quite different from those following drug-eluting stent (DES implantation. Case report. We presented a 56-year old male with acute inferoposterior ST segment elevation myocardial infarction (STEMI related to very late stent thrombosis, 9 years after BMS implantation, despite antithrombotic therapy. Thrombus aspiration was successfully performed followed by percutaneous coronary intervention (PCI with implantation of DES into the pre-viously implanted two stents to solve the in-stent restenosis. Conclusion. Very late stent thrombosis, although fortu-nately very rare, not completely understood, might cause myocardial reinfaction, but could be successfully treated with thrombus aspiration followed by primary PCI. Very late ST in the presented patient might be connected with neointimal plaque rupture, followed by thrombotic events.

  7. FORMATION OF SIX SIGMA INFRASTRUCTURE FOR THE CORONARY STENTING PROCESS

    Directory of Open Access Journals (Sweden)

    Mehmet Tolga Taner

    2013-10-01

    Full Text Available The purpose of this study is to show how a tertiary care center in Turkey operating mainly in cardiology initiated Six Sigma principles to reduce the number of complications occuring during coronary stent insertion process. A Six Sigma’s Define-Measure-Analyze-Improve-Control (DMAIC model for coronary stent insertion is suggested. Data were collected for 24-months. Twenty-two Critical-to-Quality (CTQ factors were identified for successful coronary stent insertion. The most frequent causes of complications in the process were found to be patients with previous bypass surgery or PCI, inexperience of staff members, highly damaged vessel structure, thin and/or long vessel diameter, inappropriate selection of stent type, inappropriate selection of balloon type and poor image quality.

  8. Spontaneous coronary artery dissection: complete angiographic resolution without stenting

    Directory of Open Access Journals (Sweden)

    Alexandre Abizaid

    2007-09-01

    Full Text Available A case of spontaneous coronary artery dissection in a 49-year-oldwoman is presented. She did not present the classical cardiovascular riskfactors. Etiology and treatment are discussed. She underwent primarypercutaneous coronary intervention of the left anterior descendingartery with no stenting and had complete angiographic resolution.

  9. Compliance of a cobalt chromium coronary stent alloy – the COVIS trial

    OpenAIRE

    Hagemeister, Jens; Baer, Frank M; Schwinger, Robert HG; Höpp, Hans W

    2005-01-01

    Abstract Background Cobalt chromium coronary stents are increasingly being used in percutaneous coronary interventions. There are, however, no reliable data about the characteristics of unfolding and visibility of this stent alloy in vivo. The aim of this study is to compare cobalt chromium coronary stents with conventional stainless steel stents using intracoronary ultrasound. Methods Twenty de novo native coronary stenoses ≤ 20 mm in length (target vessel reference diameter ≥ 2.5 and ≤ 4.0 ...

  10. Coronary artery stent mimicking intracardiac thrombus on cardiac magnetic resonance imaging due to signal loss

    DEFF Research Database (Denmark)

    Qayyum, Abbas Ali; Vejlstrup, Niels Grove; Ahtarovski, Kiril Aleksov

    2012-01-01

    Since the introduction of percutaneous coronary intervention for coronary artery disease, thousands of patients have been treated with the implantation of coronary stents. Moreover, several of the patients with coronary stent undergo cardiac magnetic resonance (CMR) imaging every year. This case ...... the signal loss on MRI associated with implanted metallic devices is known, we report a case where an implanted coronary stent in the left circumflex artery led to an intracardiac signal loss mimicking intracardiac thrombus/tumor....

  11. Randomized comparison of coronary bifurcation stenting with the crush versus the culotte technique using sirolimus eluting stents: the Nordic stent technique study

    DEFF Research Database (Denmark)

    Erglis, Andrejs; Kumsars, Indulis; Niemelä, Matti

    2009-01-01

    BACKGROUND: In a number of coronary bifurcation lesions, both the main vessel and the side branch need stent coverage. Using sirolimus eluting stents, we compared 2 dedicated bifurcation stent techniques, the crush and the culotte techniques in a randomized trial with separate clinical and angiog......BACKGROUND: In a number of coronary bifurcation lesions, both the main vessel and the side branch need stent coverage. Using sirolimus eluting stents, we compared 2 dedicated bifurcation stent techniques, the crush and the culotte techniques in a randomized trial with separate clinical...

  12. Surface Topographical Modification of Coronary Stent: A Review

    Science.gov (United States)

    Tan, C. H.; Muhamad, N.; Abdullah, M. M. A. B.

    2017-06-01

    Driven by the urge of mediating the inflammatory response from coronary stent implant to improve patency rates of the current coronary stent, concern has been focusing on reducing the risk of in-stent restenosis and thrombosis for long-term safety. Surface modification approach has been found to carry great potential due to the surface is the vital parts that act as a buffer layer between the biomaterial and the organic material like blood and vessel tissues. Nevertheless, manipulating cell response in situ using physical patterning is very complex as the exact mechanism were yet elucidated. Thus, the aim of this review is to summarise the recent efforts on modifying the surface topography of coronary stent at the micro- and nanometer scale with the purpose of inducing rapid in situ endothelialization to regenerate a healthy endothelium layer on biomaterial surface. In particular, a discussion on the surface patterns that have been investigated on cell selective behaviour together with the methods used to generate them are presented. Furthermore, the probable future work involving the surface modification of coronary stent were indicated.

  13. Clinical utility of platinum chromium bare-metal stents in coronary heart disease

    OpenAIRE

    Jorge C; Dubois C.

    2015-01-01

    Claudia Jorge,1 Christophe Dubois1,2 1Department of Cardiovascular Medicine, University Hospitals Leuven, 2Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium Abstract: Coronary stents represent a key development for the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. While drug-eluting stents gained wide acceptance in contemporary percutaneous coronary intervention practice, further development...

  14. In vivo assessment of stent recoil of biodegradable polymer-coated cobalt-chromium sirolimus-eluting coronary stent system.

    Science.gov (United States)

    Abhyankar, Atul D; Thakkar, Ashok S

    2012-01-01

    Immediate and acute stent recoil has been observed following balloon deflation in normal and diseased coronary arteries, and the degree varies by stent design. A total of 19 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: all patients treated with the biodegradable polymer-coated sirolimus-eluting cobalt-chromium coronary stent system (Supralimus-Core(®)). The immediate, acute and cumulative stent recoil was assessed by quantitative coronary angiography. The cumulative stent recoil was measured at 24 h of stent implantation. The absolute late loss due to recoil was found 0.08 ± 0.19 mm for Immediate Stent Recoil (ISR), 0.05 ± 0.21 mm for Acute Stent Recoil (ASR) and 0.11 ± 0.25 mm for Cumulative Stent Recoil (CSR) respectively. In vivo acute stent recoil of the Supralimus-Core(®) has higher radial strength compared to other available standard drug-eluting stents. Copyright © 2012 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  15. Clinical and economic studies of eptifibatide in coronary stenting

    OpenAIRE

    Pasala T; Sattayaprasert P; Bhat PK; Athappan G; Gandhi S

    2014-01-01

    Tilak Pasala, Prasongchai Sattayaprasert, Pradeep K Bhat, Ganesh Athappan, Sanjay Gandhi The Heart and Vascular Center, Case Western Reserve University/MetroHealth, Cleveland, OH, USA Abstract: Platelet adhesion and aggregation at the site of coronary stenting can have catastrophic clinical and economic consequences. Therefore, effective platelet inhibition is vital during and after percutaneous coronary intervention. Eptifibatide is an intravenous antiplatelet agent that blocks the final co...

  16. Developed pulsatile flow in a deployed coronary stent.

    Science.gov (United States)

    Banerjee, Rupak K; Devarakonda, Surendra B; Rajamohan, Divakar; Back, Lloyd H

    2007-01-01

    The patho-physiologic process of restenosis and tissue growth may not be completely eliminated and is the primary concern of clinicians performing angioplasty and stent implantation procedures. Recent evidence suggests that the restenosis process is influenced by several factors: (1) geometry and size of vessel; (2) stent design; and (3) it's location that alter hemodynamic parameters, including local wall shear stress (WSS) distributions. The present three-dimensional (3D) analysis of pulsatile flow in a deployed coronary stent: (1) shows complex 3D variation of hemodynamic parameters; and (2) quantifies the changes in local WSS distributions for developed flow and compares with recently published WSS data for developing flow. Higher order of magnitude of WSS of 290 dyn/cm(2) is observed on the surface of cross-link intersections at the entrance of the stent for developed flow, which is about half of that for developing flow. Low WSS of 0.8 dyn/cm(2) and negative WSS of -8 dyn/cm(2) are seen at the immediate upstream and downstream regions of strut intersections. Persistent recirculation is observed at the downstream region of each strut cross-link and the regions of low and negative WSS may lead to patho-physiologic conditions near the stented region. The key finding of this study is that the location of stent in the coronary artery determines the developing or developed nature of the flow, which in turn, results in varied level of WSS.

  17. Safety of spinal anaesthesia in patients with recent coronary stents ...

    African Journals Online (AJOL)

    We report on a patient with a known history of chronic obstructive airway disease with respiratory tract infection who presented for emergency pseudoaneurysm repair. He underwent recent coronary stent implantation and was treated with clopidogrel and aspirin. Despite dual antiplatelet therapy, spinal anaesthesia was ...

  18. Coated stents to prevent restenosis in coronary heart disease

    Directory of Open Access Journals (Sweden)

    Hagen, Anja

    2005-11-01

    Full Text Available Background: In-stent-restenosis (ISR is considered to be an essential limiting factor of stenting in coronary heart disease (CHD. The development of coated stents has raised expectations on substantial lowering restenosis after stenting with decreasing the rate of restenosis and a reduction in the rate of clinical events. Objectives: The present analysis addresses the questions on medical effectiveness and cost-effectiveness of the use of various coated stent types in CHD. Methods: The literature was searched in December 2004 in the most relevant medical and economic databases. The medical evaluation was conducted on the basis of published RCT. The data from the studies regarding various angiographic, sonographic and clinical endpoints were checked for methodical quality and summarised in meta-analyses. Within the scope of economic evaluation the primary studies were analysed and modelling was performed, applying clinical effect estimates from the meta-analyses of the medical evaluation and current estimates of German costs. Results: Medical evaluation: Ten different stenttypes were used in the included 26 RCT. The results for heparin, silicon-carbide, carbon and PTFE coated stenttypes could not reveal any significant differences between the medical effectiveness of coated and uncoated stents. The application of sirolimus, paclitaxel, everolimus and 7-hexanoyltaxol eluting stents showed a significant lower restenosis at 6-9 months with decrease in the rate of restenosis for polymer-based sirolimus, paclitaxel and 7-hexanoyltaxol eluting stents. In contrast, the use of gold-coated and actinomycin-D eluting stents was associated with a significantly higher restenosis. The polymer-based sirolimus and paclitaxel eluting stents also showed a significant and considerable reduction in the rate of repeated percutaneous revascularisations at 6-12 months (3.5% vs. 19.7%; p<0.0001, RR=0.19 [95%CI: 0.11; 0.33] and 3.5% vs. 12.2%; p<0.0001, RR=0.30 [95%CI: 0

  19. Clinical utility of platinum chromium bare-metal stents in coronary heart disease

    Directory of Open Access Journals (Sweden)

    Jorge C

    2015-08-01

    Full Text Available Claudia Jorge,1 Christophe Dubois1,2 1Department of Cardiovascular Medicine, University Hospitals Leuven, 2Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium Abstract: Coronary stents represent a key development for the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. While drug-eluting stents gained wide acceptance in contemporary percutaneous coronary intervention practice, further developments in bare-metal stents remain crucial for patients who are not candidates for drug-eluting stents, or to improve metallic platforms for drug elution. Initially, stent platforms used biologically inert stainless steel, restricting stent performance due to limitations in flexibility and strut thickness. Later, cobalt chromium stent alloys outperformed steel as the material of choice for stents, allowing latest generation stents to be designed with significantly thinner struts, while maintaining corrosion resistance and radial strength. Most recently, the introduction of the platinum chromium alloy refined stent architecture with thin struts, high radial strength, conformability, and improved radiopacity. This review will provide an overview of the novel platinum chromium bare-metal stent platforms available for coronary intervention. Mechanical properties, clinical utility, and device limitations will be summarized and put into perspective. Keywords: bare metal stent, coronary stent alloys, coronary artery disease

  20. Saphenous vein covered stenting for right coronary artery lesion containing thrombus.

    Science.gov (United States)

    Joseph, D; Bashi, V V; Guhathakurtha, S; Harilal, H; Jacob, A; George, T; Suguna, S

    1997-12-01

    Vein covered stenting to close coronary pseudoaneurysm and perforation and in the setting of acute myocardial infarction have been described. This case report describes saphenous vein covered stenting to exclude a large thrombus in a right coronary artery lesion. Vein covered stenting may be considered as an option when dealing with a thrombus containing lesion.

  1. Biomimicry, vascular restenosis and coronary stents.

    Science.gov (United States)

    Schwartz, R S; van der Giessen, W J; Holmes, D R

    1998-01-01

    Biomimicry is in its earliest stages and is being considered in the realm of tissue engineering. If arterial implants are to limit neointimal thickening, purely passive structures cannot succeed. Bioactivity must be present, either by pharmacologic intervention or by fabricating a 'living stent' that contains active cellular material. As tissue engineering evolves, useful solutions will emerge from applying this knowledge directly to vascular biologic problems resulting from angioplasty, stenting, and vascular prosthesis research.

  2. Stents versus coronary-artery bypass grafting for left main coronary artery disease.

    Science.gov (United States)

    Seung, Ki Bae; Park, Duk-Woo; Kim, Young-Hak; Lee, Seung-Whan; Lee, Cheol Whan; Hong, Myeong-Ki; Park, Seong-Wook; Yun, Sung-Cheol; Gwon, Hyeon-Cheol; Jeong, Myung-Ho; Jang, Yangsoo; Kim, Hyo-Soo; Kim, Pum Joon; Seong, In-Whan; Park, Hun Sik; Ahn, Taehoon; Chae, In-Ho; Tahk, Seung-Jea; Chung, Wook-Sung; Park, Seung-Jung

    2008-04-24

    Several studies have compared the treatment effects of coronary stenting and coronary-artery bypass grafting (CABG). However, there are limited data regarding the long-term outcomes of these two interventions for patients with unprotected left main coronary artery disease. We evaluated 1102 patients with unprotected left main coronary artery disease who underwent stent implantation and 1138 patients who underwent CABG in Korea between January 2000 and June 2006. We compared adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction, or stroke; and target-vessel revascularization) with the use of propensity-score matching in the overall cohort and in separate subgroups according to type of stent. In the overall matched cohort, there was no significant difference between the stenting and CABG groups in the risk of death (hazard ratio for the stenting group, 1.18; 95% confidence interval [CI], 0.77 to 1.80) or the risk of the composite outcome (hazard ratio for the stenting group, 1.10; 95% CI, 0.75 to 1.62). The rates of target-vessel revascularization were significantly higher in the group that received stents than in the group that underwent CABG (hazard ratio, 4.76; 95% CI, 2.80 to 8.11). Comparisons of the group that received bare-metal stents with the group that underwent CABG and of the group that received drug-eluting stents with the group that underwent CABG produced similar results, although there was a trend toward higher rates of death and the composite end point in the group that received drug-eluting stents. In a cohort of patients with unprotected left main coronary artery disease, we found no significant difference in rates of death or of the composite end point of death, Q-wave myocardial infarction, or stroke between patients receiving stents and those undergoing CABG. However, stenting, even with drug-eluting stents, was associated with higher rates of target-vessel revascularization than was CABG. Copyright 2008

  3. In vitro evaluation of 56 coronary artery stents by 256-slice multi-detector coronary CT

    Energy Technology Data Exchange (ETDEWEB)

    Steen, Henning, E-mail: henning.steen@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Andre, Florian, E-mail: Florian.Andre@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Korosoglou, Grigorios, E-mail: Grigorios.Korosoglou@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Mueller, Dirk, E-mail: Dirk.Mueller@philips.com [Philips GmbH Healthcare Division, Luebeckertordamm 5, Hamburg 20099 (Germany); Hosch, Waldemar, E-mail: Waldemar.Hosch@med.uni-heidelberg.de [University of Heidelberg, Department of Diagnostic and Interventional Radiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Kauczor, Hans-Ulrich, E-mail: Hans-Ulrich.Kauczor@med.uni-heidelberg.de [University of Heidelberg, Department of Diagnostic and Interventional Radiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Giannitsis, Evangelos, E-mail: Evangelos.Giannitsis@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Katus, Hugo A., E-mail: Hugo.Katus@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany)

    2011-10-15

    Objective: We sought to investigate stent lumen visibility of 56 coronary stents with the newest 256-multi-slice-CT (256-MDCT) technology for different reconstruction algorithms in an in vitro model. Background: Early identification of in-stent restenosis (ISR) is important to avoid recurrent ischemia and prevent acute myocardial infarction (AMI). Since angiography has the disadvantage of high costs and its invasiveness, MDCT could be a convenient and safe non-invasive alternative for detection of ISR. Material and methods: Percentages of in-stent lumen diameter and in-stent signal attenuation (measured as contrast-to-noise ratio (CNR)) of 56 coronary stents (group A {<=}2.5 mm; group B = 2.75-3.0 mm; group C = 3.5-4.0 mm) were evaluated in a coronary vessel in vitro phantom (iodine-filled plastic tubes) employing four different reconstruction algorithms (XCD, CC, CD, XCB) on a novel 256-MDCT (Philips-iCT, collimation = 128 mm x 0.625 mm; rotation time = 270 ms; tube current = 800 mA s with 120 kV). Analysis was conducted with the semi-automatical full-width-at-half-maximum (FWHM) method. P-values <0.05 were regarded statistically significant. Results: In-stent lumen diameter >60% for group C stents was significantly larger and CNR was significantly lower (both p < 0.05) for sharp kernels (CD; XCD) when compared to groups A/B. The FWHM-method showed significantly smaller in-stent lumen diameter (p < 0.05) when compared to the manual method. Conclusion: 256-MDCT could potentially be employed for clinical assessment of stent patency in stents >3.0 mm when analysed with cardio-dedicated sharp kernels, although clinical studies corroborating this claim should be performed. However, stents {<=}3.0 mm reconstructed by soft kernels revealed insufficient in-stent lumen visualisation and should not be used in clinical practice. Further improvements in spatial and temporal image resolution as well as reductions of radiation exposure and image noise have to be accomplished

  4. Influence of metal alloy and the profile of coronary stents in patients with multivessel coronary disease

    Science.gov (United States)

    Maurício de Abreu Filho, Luciano; da Cruz Forte, Antonio Artur; Kiyoshi Sumita, Marcos; Favarato, Desidério; César Ximenes Meireles, George

    2011-01-01

    BACKGROUND: In Brazil, despite the recommendations of the Brazilian Society of Hemodynamics and Interventional Cardiology, the National Health System has not yet approved the use of drug-eluting stents. In percutaneous coronary interventions performed in the public and part of the private health care system, bare metal stents are used as the only option. Therefore, new information on bare metal stents is of great importance. The primary endpoint was to evaluate the influence of the alloy and the profile of coronary stents on late loss and restenosis rates 6 months after implantation in patients with multivessel coronary disease. METHODS: Single center, randomized and prospective study comparison of cobalt–chromium versus stainless steel stent implantation in 187 patients with multivessel coronary disease. At least one cobalt–chromium and one stainless steel stent were implanted per patient. RESULTS: Mean age of patients was 59.5±10.1 years with a prevalence of males (66.3%) and patients with acute coronary syndrome (56%). Baseline clinical characteristics were similar with hypertension in 146 (78%), dyslipidemia in 85 (45.5%) and diabetes in 68 (36.4%). Two hundred and twenty-nine cobalt–chromium and 284 stainless steel stents were implanted. Angiographic variables showed no statistically significant difference. Angiographic follow-up to 6 months after implantation showed similar late loss and restenosis rates. CONCLUSION: The use of two different alloys, stainless steel and cobalt–chrome stents, in the same patient and in the same vessel produced similar 6-month restenosis and late loss rates. PMID:21808863

  5. Influence of metal alloy and the profile of coronary stents in patients with multivessel coronary disease

    Directory of Open Access Journals (Sweden)

    Luciano Maurício de Abreu Filho

    2011-01-01

    Full Text Available BACKGROUND: In Brazil, despite the recommendations of the Brazilian Society of Hemodynamics and Interventional Cardiology, the National Health System has not yet approved the use of drug-eluting stents. In percutaneous coronary interventions performed in the public and part of the private health care system, bare metal stents are used as the only option. Therefore, new information on bare metal stents is of great importance. The primary endpoint was to evaluate the influence of the alloy and the profile of coronary stents on late loss and restenosis rates 6 months after implantation in patients with multivessel coronary disease. METHODS: Single center, randomized and prospective study comparison of cobalt-chromium versus stainless steel stent implantation in 187 patients with multivessel coronary disease. At least one cobalt-chromium and one stainless steel stent were implanted per patient. RESULTS: Mean age of patients was 59.5 + 10.1 years with a prevalence of males (66.3% and patients with acute coronary syndrome (56%. Baseline clinical characteristics were similar with hypertension in 146 (78%, dyslipidemia in 85 (45.5% and diabetes in 68 (36.4%. Two hundred and twenty-nine cobalt-chromium and 284 stainless steel stents were implanted. Angiographic variables showed no statistically significant difference. Angiographic follow-up to 6 months after implantation showed similar late loss and restenosis rates. CONCLUSION: The use of two different alloys, stainless steel and cobalt-chrome stents, in the same patient and in the same vessel produced similar 6-month restenosis and late loss rates.

  6. Incidence of definite stent thrombosis or in-stent restenosis after drug-eluting stent implantation for treatment of coronary in-stent restenosis. From western denmark heart registry

    DEFF Research Database (Denmark)

    Jensen, Jesper; Jensen, Lisette Okkels; Terkelsen, Christian Juhl

    2012-01-01

    There are limited data on the optimal management of in-stent restenosis after percutaneous coronary intervention (PCI) with bare metal stent (BMS) or drug-eluting stent (DES) implantations. We assessed the clinical presentation, the incidence, and prognosis of definite stent thrombosis...

  7. Sensor to detect endothelialization on an active coronary stent

    Directory of Open Access Journals (Sweden)

    Coffey Arthur C

    2010-11-01

    Full Text Available Abstract Background A serious complication with drug-eluting coronary stents is late thrombosis, caused by exposed stent struts not covered by endothelial cells in the healing process. Real-time detection of this healing process could guide physicians for more individualized anti-platelet therapy. Here we present work towards developing a sensor to detect this healing process. Sensors on several stent struts could give information about the heterogeneity of healing across the stent. Methods A piezoelectric microcantilever was insulated with parylene and demonstrated as an endothelialization detector for incorporation within an active coronary stent. After initial characterization, endothelial cells were plated onto the cantilever surface. After they attached to the surface, they caused an increase in mass, and thus a decrease in the resonant frequencies of the cantilever. This shift was then detected electrically with an LCR meter. The self-sensing, self-actuating cantilever does not require an external, optical detection system, thus allowing for implanted applications. Results A cell density of 1300 cells/mm2 on the cantilever surface is detected. Conclusions We have developed a self-actuating, self-sensing device for detecting the presence of endothelial cells on a surface. The device is biocompatible and functions reliably in ionic liquids, making it appropriate for implantable applications. This sensor can be placed along the struts of a coronary stent to detect when the struts have been covered with a layer of endothelial cells and are no longer available surfaces for clot formation. Anti-platelet therapy can be adjusted in real-time with respect to a patient's level of healing and hemorrhaging risks.

  8. Fourth update on CT angiography of coronary stents: in vitro evaluation of 24 novel stent types.

    Science.gov (United States)

    Hickethier, Tilman; Wenning, Justus; Doerner, Jonas; Maintz, David; Michels, Guido; Bunck, Alexander C

    2017-01-01

    Background Non-invasive evaluation of coronary stent patency by coronary computed tomography angiography (cCTA) remains challenging. Multiple studies showed that CT technology but also individual stent design strongly influence the assessability of coronary stents by cCTA. Purpose To expand the available data on cCTA characteristics of coronary stents by 24 novel types to help interpreting examinations of patients after stent placement and selecting which stents are suitable for assessment by cCTA. Material and Methods Twenty-four novel coronary stents (17 cobalt-chromium, six stainless-steel, one platinum-chromium) were examined in a coronary phantom. Standard cCTA parameters with stent-specific algorithms were used. Image quality was quantified for each stent using established parameters (in-stent attenuation alteration and visible lumen diameter). Results Most stents (n = 14) showed lumen visibilities of 45-55%. No severe restriction of lumen visibility (>60%) was found. The majority of stents (n = 13) caused only small intraluminal attenuation deviations and no severe alterations (>20%) were found. When grouped by manufacturing material, no significant differences were found between cobalt-chromium and stainless-steel with identical mean visible diameters (1.52 ± 0.17 mm vs. 1.52 ± 0.13 mm) and comparable attenuation alterations (35.04 ± 16.56 HU vs. 21.25 ± 14.60 HU). The only platinum-chromium stent showed a smaller visible diameter (1.23 mm) and higher attenuation alteration (41.70 HU), but was also deemed to be assessable by cCTA. Conclusion All 24 novel evaluated stents are eligible for non-invasive evaluation by cCTA without significant differences between cobalt-chromium and stainless-steel stents. This updated catalogue of CT appearances of current coronary stents may serve as reference when taking care of patients with stents in need of coronary imaging.

  9. Update on multidetector coronary CT angiography of coronary stents: in vitro evaluation of 29 different stent types with dual-source CT

    Energy Technology Data Exchange (ETDEWEB)

    Maintz, David; Burg, Matthias C.; Seifarth, Harald; Bunck, Alexander C.; Oezguen, Murat; Juergens, Kai Uwe; Heindel, Walter [University of Muenster, Department of Clinical Radiology, Muenster (Germany); Fischbach, Roman [University of Muenster, Department of Clinical Radiology, Muenster (Germany); Asklepios Klinikum Altona, Department of Radiology and Nuclear Medicine, Hamburg (Germany)

    2009-01-15

    The aim of this study was to test a large sample of the latest coronary artery stents using four image reconstruction approaches with respect to lumen visualization, lumen attenuation, and image noise in dual-source multidetector row CT (DSCT) in vitro and to provide a CT catalogue of currently used coronary artery stents. Twenty-nine different coronary artery stents (19 steel, 6 cobalt-chromium, 2 tantalum, 1 iron, 1 magnesium) were examined in a coronary artery phantom (vessel diameter 3 mm, intravascular attenuation 250 HU, extravascular density -70 HU). Stents were imaged in axial orientation with standard parameters: 32 x 0.6 collimation, pitch 0.24, 400 mAs, 120 kV, rotation time 0.33 s. Image reconstructions were obtained with four different convolution kernels (soft, medium-soft, standard high-resolution, stent-dedicated). To evaluate visualization characteristics of the stent, the lumen diameter, intraluminal density, and noise were measured. The stent-dedicated kernel offered best average lumen visualization (54{+-}8.3%) and most realistic lumen attenuation (222{+-}44 HU) at the expense of increased noise (23.9{+-}1.9 HU) compared with standard CTA protocols (p<0.001 for all). The magnesium stent showed the least artifacts with a lumen visibility of 90%. The majority of stents (79%) exhibited a lumen visibility of 50-59%. Less than half of the stent lumen was visible in only six stents. Stent lumen visibility largely varies depending on the stent type. Magnesium is by far more favorable a stent material with regard to CT imaging when compared with the more common materials steel, cobalt-chromium, or tantalum. The magnesium stent exhibits a lumen visibility of 90%, whereas the majority of the other stents exhibit a lumen visibility of 50-59%. (orig.)

  10. Outcomes after coronary stent implantation in patients with metal allergy.

    Science.gov (United States)

    Romero-Brufau, Santiago; Best, Patricia J M; Holmes, David R; Mathew, Verghese; Davis, Mark D P; Sandhu, Gurpreet S; Lennon, Ryan J; Rihal, Charanjit S; Gulati, Rajiv

    2012-04-01

    Clinical outcomes after stent placement in patients with a history of metal allergy remain incompletely understood. We performed a single-center retrospective study to evaluate such outcomes. Twenty-nine allergic patients who underwent coronary stent implantation were compared with a nonallergic group (n=250) matched for demographics and a propensity score for allergy to metal. Hypersensitivity to nickel was reported in 26 of 29 and chromium in 9 of 29. Patch testing performed in 11 of 29 patients was positive in all. Comparing allergy versus control subjects, there were no differences in number of segments treated (1.4±0.7 versus 1.5±0.7), stents placed (1.7±1.1 versus 1.6±0.9), and frequency of drug-eluting stent usage (52% versus 60%). In-hospital death (0% versus 0%), myocardial infarction (MI, 4% versus 3%, P=0.27), and 30-day death (3% versus 0%, P=0.53) and MI (3% versus 4%, P=0.71) were statistically similar. There were no differences in 4-year death (12% versus 13%), target lesion revascularization (TLR, 13 versus 17%, P=0.54), or death/MI/TLR (24% versus 34%, P=0.20). Clinically driven repeat angiography in 12 of 29 allergy patients revealed binary restenosis rates of 27% in bare metal stents and 0% in drug-eluting stents, with mean diameter in-stent restenosis of 36% and 8%, respectively. There was no change in circulating eosinophil and lymphocyte counts after stenting in the allergy group (0.19-0.20, P=0.67, and 1.90-1.79, P=0.59, respectively). A history of metal allergy was not associated with adverse early or late outcomes in this single-center study.

  11. Stent thrombosis after coronary stent implantation: a protective effect of high-dose statin therapy?

    Science.gov (United States)

    Jeger, Raban V; Brunner-La Rocca, Hans Peter; Bertel, Osmund; Kiowski, Wolfgang; Pfisterer, Matthias E; Kaiser, Christoph A

    2013-01-01

    To assess independent predictors of stent thrombosis (ST) in an all-comer trial. This is an observational case-control study based on a retrospective analysis of the Basel Stent Kosten Effektivitäts Trial (BASKET) (n = 826). Patients with ST were compared to controls with regard to baseline parameters. Multivariate models were performed to identify independent predictors of ST. At 36 months, there were 53 (6.4%) patients with ST, 17 (32%) of whom had early ST and 36 (68%) of whom had late/very late ST. Patients with ST were at a higher cardiovascular risk but received lower doses of statins than the controls (n = 212). Stents in ST patients were longer, had more overlap and were not as well expanded, with significantly more remaining stenoses than the stents in the controls. Multivariable analysis revealed interventions in saphenous vein grafts, malapposed stents, an overlap >3 mm, complex coronary anatomy and treatment with low-dose/no statins as risk factors for ST, while interventions in saphenous vein grafts, underexpanded or malapposed stents, a history of myocardial infarction and treatment with low-dose/no statins were risk factors for late ST. The use of statins might have a protective effect against ST. This observation is new, hypothesis-generating and should be evaluated in an adequately powered randomized trial. Copyright © 2013 S. Karger AG, Basel.

  12. Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V®

    Directory of Open Access Journals (Sweden)

    Imad Sheiban

    2008-02-01

    Full Text Available Imad Sheiban1, Gianluca Villata1, Mario Bollati1, Dario Sillano1, Marzia Lotrionte2, Giuseppe Biondi-Zoccai11Interventional Cardiology, Division of Cardiology, University of Turin, Turin, Italy; 2Institute of Cardiology, Catholic University, Rome, ItalyAbstract: Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES, such as sirolimus-eluting (Cypher® and paclitaxel-eluting stents (Taxus®, have further improved results of percutaneous coronary intervention (PCI by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor® and everolimus-eluting stents (Xience V®, have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent.Keywords: coronary artery disease, everolimus, percutaneous

  13. Degradable, drug-eluting stents: a new frontier for the treatment of coronary artery disease.

    Science.gov (United States)

    Kohn, Joachim; Zeltinger, Joan

    2005-11-01

    This article reviews the clinical use of stents in the treatment of coronary artery disease and the rationale for the use of degradable, drug-eluting polymer stents. The authors note the challenges of using off-the-shelf polymers for the development of degradable stents, as well as the interplay between polymer properties and a functional stent design. Drug-eluting metal stents are the most significant advancement in the treatment of coronary artery disease, and have significantly reduced the occurrence of in-stent restenosis after placement. Some regard drug-eluting metal stents as the final technologic advancement in the treatment of coronary artery disease, others consider the future development of degradable, drug-eluting stents as the next logical step.

  14. Zotarolimus-eluting vs. sirolimus-eluting coronary stents in patients with and without acute coronary syndromes

    DEFF Research Database (Denmark)

    Thim, Troels; Maeng, Michael; Kaltoft, Anne Kjer

    2012-01-01

    To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial.......To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial....

  15. Nickel-free stainless steel avoids neointima formation following coronary stent implantation

    Science.gov (United States)

    Fujiu, Katsuhito; Manabe, Ichiro; Sasaki, Makoto; Inoue, Motoki; Iwata, Hiroshi; Hasumi, Eriko; Komuro, Issei; Katada, Yasuyuki; Taguchi, Tetsushi; Nagai, Ryozo

    2012-12-01

    SUS316L stainless steel and cobalt-chromium and platinum-chromium alloys are widely used platforms for coronary stents. These alloys also contain nickel (Ni), which reportedly induces allergic reactions in some subjects and is known to have various cellular effects. The effects of Ni on neointima formation after stent implantation remain unknown, however. We developed coronary stents made of Ni-free high-nitrogen austenitic stainless steel prepared using a N2-gas pressurized electroslag remelting (P-ESR) process. Neointima formation and inflammatory responses following stent implantation in porcine coronary arteries were then compared between the Ni-free and SUS316L stainless steel stents. We found significantly less neointima formation and inflammation in arteries implanted with Ni-free stents, as compared to SUS316L stents. Notably, Ni2+ was eluted into the medium from SUS316L but not from Ni-free stainless steel. Mechanistically, Ni2+ increased levels of hypoxia inducible factor protein-1α (HIF-1α) and its target genes in cultured smooth muscle cells. HIF-1α and their target gene levels were also increased in the vascular wall at SUS316L stent sites but not at Ni-free stent sites. The Ni-free stainless steel coronary stent reduces neointima formation, in part by avoiding activation of inflammatory processes via the Ni-HIF pathway. The Ni-free-stainless steel stent is a promising new coronary stent platform.

  16. Nickel-free stainless steel avoids neointima formation following coronary stent implantation

    Science.gov (United States)

    Fujiu, Katsuhito; Manabe, Ichiro; Sasaki, Makoto; Inoue, Motoki; Iwata, Hiroshi; Hasumi, Eriko; Komuro, Issei; Katada, Yasuyuki; Taguchi, Tetsushi; Nagai, Ryozo

    2012-01-01

    SUS316L stainless steel and cobalt–chromium and platinum–chromium alloys are widely used platforms for coronary stents. These alloys also contain nickel (Ni), which reportedly induces allergic reactions in some subjects and is known to have various cellular effects. The effects of Ni on neointima formation after stent implantation remain unknown, however. We developed coronary stents made of Ni-free high-nitrogen austenitic stainless steel prepared using a N2-gas pressurized electroslag remelting (P-ESR) process. Neointima formation and inflammatory responses following stent implantation in porcine coronary arteries were then compared between the Ni-free and SUS316L stainless steel stents. We found significantly less neointima formation and inflammation in arteries implanted with Ni-free stents, as compared to SUS316L stents. Notably, Ni2+ was eluted into the medium from SUS316L but not from Ni-free stainless steel. Mechanistically, Ni2+ increased levels of hypoxia inducible factor protein-1α (HIF-1α) and its target genes in cultured smooth muscle cells. HIF-1α and their target gene levels were also increased in the vascular wall at SUS316L stent sites but not at Ni-free stent sites. The Ni-free stainless steel coronary stent reduces neointima formation, in part by avoiding activation of inflammatory processes via the Ni-HIF pathway. The Ni-free-stainless steel stent is a promising new coronary stent platform. PMID:27877545

  17. Long-term results of young patients with acute coronary syndrome undergoing coronary stent implantation.

    Science.gov (United States)

    Yao, Yuan; Zhang, Yao

    2016-09-01

    Long-term follow-up studies on young patients with acute coronary syndrome (ACS) undergoing coronary stent implantation are relatively scarce. This study was applied to review the long-term results of young ACS patients who had undergone coronary stenting in our hospital. One hundred and two young patients with ACS underwent coronary stent implantation in our hospital. In this study, inpatient records and long-term data of the 102 patients were comprehensively collected for analysis. Major gender of the young patients was men. Most of the patients had smoking, and each patient had at least one risk factor. During hospitalization, no patient died. At last follow-up, all patients were alive and the occurrence rate of major adverse cardio/cerebrovascular accidents was 4.9%. In summary, long-term follow-ups revealed extremely satisfactory outcomes in young ACS patients after coronary stent implantation. Smoking and traditional ACS risk factors are the leading causes of ACS in young population.

  18. Coronary stent occlusion: reverse attenuation gradient sign observed at computed tomography angiography improves diagnostic performance

    Energy Technology Data Exchange (ETDEWEB)

    Li, Minghua; Zhang, Jiayin [Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, Department of Radiology, Shanghai (China); Zhang, Qingyong; Pan, Jingwei; Lu, Zhigang; Wei, Meng [Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, Department of Cardiology, Shanghai (China)

    2014-09-26

    To evaluate the incidence and diagnostic performance of reverse attenuation gradient (RAG) sign in patients with coronary stent occlusion. We retrospectively included patients with suspected restenosis who underwent both coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA) within 2 weeks. Stent occlusion at CCTA was defined as (1) complete contrast filling defect of large calibre stents (at least 3 mm), or (2) presence of RAG sign in patients with small calibre stents (less than 3 mm) or (3) presence of RAG sign in patients with non-diagnostic image quality of stents. The diagnostic performance of RAG sign was further assessed by comparison to ICA results. A total of 162 patients with 231 implanted stents were included. ICA confirmed stent occlusion in 59 patients (99 stents). RAG sign was present in 59.3 % (35/59) of all stent occlusions. As shown by patient-based analysis, the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of our diagnostic criteria for detection of stent occlusion were 79.7 % (47/59), 100 % (103/103), 100 % (47/47) and 89.6 % (103/115) respectively. Superior diagnostic performance was confirmed by receiver operating characteristic (ROC) analysis with an area under the curve of 0.898. RAG sign observed at CCTA in patients with coronary stenting represents reverse collateral flow distal to stents and is highly specific to indicate stent occlusion. (orig.)

  19. Coronary Stenting With the Genous(TM) Bio-Engineered R Stent(TM) in Elderly Patients

    NARCIS (Netherlands)

    Damman, P.; Iñiguez, A.; Klomp, M.; Beijk, M.; Woudstra, P.; Silber, S.; Ribeiro, E.E.; Suryapranata, H.; Sim, K.H.; Tijssen, J.G.P.; de Winter, R.J.

    2011-01-01

    Background: We evaluated the Genous(TM) Bio-engineered R stent(TM) in elderly patients undergoing non-urgent percutaneous coronary intervention. The elderly have an increased risk of (temporary) discontinuation of clopidogrel, which is associated with a higher risk of developing stent thrombosis

  20. Compliance of a cobalt chromium coronary stent alloy – the COVIS trial

    Directory of Open Access Journals (Sweden)

    Schwinger Robert HG

    2005-10-01

    Full Text Available Abstract Background Cobalt chromium coronary stents are increasingly being used in percutaneous coronary interventions. There are, however, no reliable data about the characteristics of unfolding and visibility of this stent alloy in vivo. The aim of this study is to compare cobalt chromium coronary stents with conventional stainless steel stents using intracoronary ultrasound. Methods Twenty de novo native coronary stenoses ≤ 20 mm in length (target vessel reference diameter ≥ 2.5 and ≤ 4.0 mm received under sequential intracoronary ultrasound either a cobalt chromium stent (Multi-Link Vision®; n = 10 or a stainless steel stent (Multi-Link Zeta®; n = 10. Results For optimal unfolding, the cobalt chromium stent requires a higher balloon deployment pressure (13.90 ± 2.03 atm than the stainless steel stent (11.50 ± 2.12 atm. Furthermore, the achieved target vessel diameter of the cobalt chromium stent (Visibility-Index QCA/IVUS Multi-Link Vision®1.13 / Multi-Link Zeta® 1.04 is more easily overrated by Quantitative Coronary Analysis. Conclusion These data indicate that stent material-specific recommendations for optimal implantation pressure and different stent material with an equal design should both be considered in interpreting QCA-analysis.

  1. Clinical utility of platinum chromium bare-metal stents in coronary heart disease

    Science.gov (United States)

    Jorge, Claudia; Dubois, Christophe

    2015-01-01

    Coronary stents represent a key development for the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. While drug-eluting stents gained wide acceptance in contemporary percutaneous coronary intervention practice, further developments in bare-metal stents remain crucial for patients who are not candidates for drug-eluting stents, or to improve metallic platforms for drug elution. Initially, stent platforms used biologically inert stainless steel, restricting stent performance due to limitations in flexibility and strut thickness. Later, cobalt chromium stent alloys outperformed steel as the material of choice for stents, allowing latest generation stents to be designed with significantly thinner struts, while maintaining corrosion resistance and radial strength. Most recently, the introduction of the platinum chromium alloy refined stent architecture with thin struts, high radial strength, conformability, and improved radiopacity. This review will provide an overview of the novel platinum chromium bare-metal stent platforms available for coronary intervention. Mechanical properties, clinical utility, and device limitations will be summarized and put into perspective. PMID:26345228

  2. Silicon-carbide coated coronary stents have low platelet and leukocyte adhesion during platelet activation

    NARCIS (Netherlands)

    Monnink, SHJ; van Boven, AJ; Tigchelaar, [No Value; de Kam, PJ; Crijns, HJGM; van Oeveren, W

    Background: Stent thrombosis and restenosis are of great clinical significance. We constructed a closed loop in vitro heparinized whole human blood circulation model for testing hemocompatibility of coronary stents, This model allows evaluation of human blood activation by blood-stent interaction in

  3. Hemodynamics of Stent Implantation Procedures in Coronary Bifurcations: an in vitro study

    CERN Document Server

    Brindise, Melissa C; Burzotta, Francesco; Migliavacca, Francesco; Vlachos, Pavlos P

    2016-01-01

    Stent implantation in coronary bifurcations presents unique challenges and currently there is no universally accepted stent deployment approach. Despite clinical and computational studies, to date, the effect of each stent implantation method on the coronary artery hemodynamics is not well understood. In this study the hemodynamics of stented coronary bifurcations under pulsatile flow conditions were investigated experimentally. Three implantation methods, provisional side branch (PSB), culotte (CUL), and crush (CRU), were investigated using time-resolved particle image velocimetry (PIV) to measure the velocity fields. Subsequently, hemodynamic parameters including wall shear stress (WSS), oscillatory shear index (OSI), and relative residence time (RRT) were calculated and the pressure field through the vessel was non-invasively quantified. The effects of each stented case were evaluated and compared against an un-stented case. CRU provided the lowest compliance mismatch, but demonstrated detrimental stent in...

  4. Coronary artery stents: influence of adaptive statistical iterative reconstruction on image quality using 64-HDCT.

    Science.gov (United States)

    Gebhard, Cathérine; Fiechter, Michael; Fuchs, Tobias A; Stehli, Julia; Müller, Ennio; Stähli, Barbara E; Gebhard, Caroline E; Ghadri, Jelena R; Klaeser, Bernd; Gaemperli, Oliver; Kaufmann, Philipp A

    2013-10-01

    The assessment of coronary stents with present-generation 64-detector row computed tomography (HDCT) scanners is limited by image noise and blooming artefacts. We evaluated the performance of adaptive statistical iterative reconstruction (ASIR) for noise reduction in coronary stent imaging with HDCT. In 50 stents of 28 patients (mean age 64 ± 10 years) undergoing coronary CT angiography (CCTA) on an HDCT scanner the mean in-stent luminal diameter, stent length, image quality, in-stent contrast attenuation, and image noise were assessed. Studies were reconstructed using filtered back projection (FBP) and ASIR-FBP composites. ASIR resulted in reduced image noise vs. FBP (P ASIR with significantly larger luminal area visualization compared with FBP (+42.1 ± 5.4% with 100% ASIR vs. FBP alone; P Reconstruction of CCTA from HDCT using 40 and 60% ASIR incrementally improves intra-stent luminal area, diameter visualization, and image quality compared with FBP reconstruction.

  5. Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials

    DEFF Research Database (Denmark)

    Tanimoto, Shuzou; Serruys, Patrick W; Thuesen, Leif

    2007-01-01

    artery lesions, were enrolled: 27 patients treated with the BVS and 27 patients treated with the everolimus-eluting cobalt chromium stent (EES). Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon......OBJECTIVES: This study sought to evaluate and compare in vivo acute stent recoil of a novel bioabsorbable stent and a metallic stent. BACKGROUND: The bioabsorbable everolimus-eluting coronary stent (BVS) is composed of a poly-L-lactic acid backbone, coated with a bioabsorbable polymer containing...... the antiproliferative drug, everolimus, and expected to be totally metabolized and absorbed in the human body. Because the BVS is made from polymer, it may have more acute recoil than metallic stents in vivo. METHODS: A total of 54 patients, who underwent elective stent implantation for single de novo native coronary...

  6. Patient-rated health status predicts prognosis following percutaneous coronary intervention with drug-eluting stenting

    DEFF Research Database (Denmark)

    Pedersen, Susanne S.; Versteeg, Henneke; Denollet, Johan

    2011-01-01

    In patients treated with percutaneous coronary intervention (PCI) with the paclitaxel-eluting stent, we examined whether patient-rated health status predicts adverse clinical events.......In patients treated with percutaneous coronary intervention (PCI) with the paclitaxel-eluting stent, we examined whether patient-rated health status predicts adverse clinical events....

  7. Development and Validation of a Stent Thrombosis Risk Score in Patients With Acute Coronary Syndromes

    NARCIS (Netherlands)

    Dangas, George D.; Claessen, Bimmer E.; Mehran, Roxana; Xu, Ke; Fahy, Martin; Parise, Helen; Henriques, José P. S.; Ohman, E. Magnus; White, Harvey D.; Stone, Gregg W.

    2012-01-01

    Objectives This study sought to develop a practical risk score to predict the risk of stent thrombosis (ST) after percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS). Background ST is a rare, yet feared complication after PCI with stent implantation. A risk score for ST after

  8. Current status of the Xience V® everolimus-eluting coronary stent system

    NARCIS (Netherlands)

    Claessen, Bimmer E.; Caixeta, Adriano; Henriques, José P. S.; Piek, Jan J.

    2010-01-01

    The introduction of drug-eluting stents has led to a marked reduction of restenosis, which is a major limitation of percutaneous coronary intervention for coronary artery disease. The next-generation Xience V® (Abbott Vascular, CA, USA) everolimus-eluting stent was designed to address the

  9. Clinical and economic studies of eptifibatide in coronary stenting

    Directory of Open Access Journals (Sweden)

    Pasala T

    2014-08-01

    Full Text Available Tilak Pasala, Prasongchai Sattayaprasert, Pradeep K Bhat, Ganesh Athappan, Sanjay Gandhi The Heart and Vascular Center, Case Western Reserve University/MetroHealth, Cleveland, OH, USA Abstract: Platelet adhesion and aggregation at the site of coronary stenting can have catastrophic clinical and economic consequences. Therefore, effective platelet inhibition is vital during and after percutaneous coronary intervention. Eptifibatide is an intravenous antiplatelet agent that blocks the final common pathway of platelet aggregation and thrombus formation by binding to glycoprotein IIb/IIIa receptors on the surface of platelets. In clinical studies, eptifibatide was associated with a significant reduction of mortality, myocardial infarction, or target vessel revascularization in patients with acute coronary syndrome undergoing percutaneous coronary intervention. However, recent trials conducted in the era of dual antiplatelet therapy and newer anticoagulants failed to demonstrate similar results. The previously seen favorable benefit of eptifibatide was mainly offset by the increased risk of bleeding. Current American College of Cardiology/American Heart Association guidelines recommend its use as an adjunct in high-risk patients who are undergoing percutaneous coronary intervention with traditional anticoagulants (heparin or enoxaparin, who are not otherwise at high risk of bleeding. In patients receiving bivalirudin (a newer safer anticoagulant, routine use of eptifibatide is discouraged except in select situations (eg, angiographic complications. Although older pharmacoeconomic studies favor eptifibatide, in the current era of P2Y12 inhibitors and newer safer anticoagulants, the increased costs associated with bleeding make the routine use of eptifibatide an economically nonviable option. The cost-effectiveness of eptifibatide with the use of strategies that decrease the bleeding risk (eg, transradial access is unknown. This review provides an

  10. Multiple coronary micro-aneurysm formation after drug-eluting stent implantation

    Directory of Open Access Journals (Sweden)

    Apostolos H. Christou

    2016-05-01

    Full Text Available Although there are limited data regarding the formation of coronary artery aneurysms (CAAs after drug-eluting stent (DES implantation, CAAs appear to be a rare complication of coronary stenting. The exact mechanism of CAA formation is unknown, but several hypotheses have been proposed. As the use of DES increases, the clinical significance of these findings will become clearer. We report on a patient who developed multiple CAAs in 2 different locations after sirolimus-eluting stent implantation.

  11. CT virtual endoscopy and 3D stereoscopic visualisation in the evaluation of coronary stenting

    Science.gov (United States)

    Sun, Z; Lawrence-Brown

    2009-01-01

    The aim of this case report is to present the additional value provided by CT virtual endoscopy and 3D stereoscopic visualisation when compared with 2D visualisations in the assessment of coronary stenting. A 64-year old patient was treated with left coronary stenting 8 years ago and recently followed up with multidetector row CT angiography. An in-stent restenosis of the left coronary artery was suspected based on 2D axial and multiplanar reformatted images. 3D virtual endoscopy was generated to demonstrate the smooth intraluminal surface of coronary artery wall, and there was no evidence of restenosis or intraluminal irregularity. Virtual fly-through of the coronary artery was produced to examine the entire length of the coronary artery with the aim of demonstrating the intraluminal changes following placement of the coronary stent. In addition, stereoscopic views were generated to show the relationship between coronary artery branches and the coronary stent. In comparison with traditional 2D visualisations, virtual endoscopy was useful for assessment of the intraluminal appearance of the coronary artery wall following coronary stent implantation, while stereoscopic visualisation improved observers’ understanding of the complex cardiac structures. Thus, both methods could be used as a complementary tool in cardiac imaging. PMID:21610990

  12. Patient with Recent Coronary Artery Stent Requiring Major Non Cardiac Surgery

    OpenAIRE

    Usha Kiran; Neeti Makhija

    2009-01-01

    Summary Anaesthesiologists are increasingly confronted with patients who had a recent coronary artery stent implantation and are on dual anti-platelet medication. Non cardiac surgery and most invasive procedures increase the risk of stent thrombosis especially when procedure is performed early after stent implantation. Anaesthesiologist faces the dilemma of stopping the antiplatelet therapy before surgery to avoid bleeding versus perioperative stent thrombosis. Individualized approach should ...

  13. Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V).

    Science.gov (United States)

    Sheiban, Imad; Villata, Gianluca; Bollati, Mario; Sillano, Dario; Lotrionte, Marzia; Biondi-Zoccai, Giuseppe

    2008-01-01

    Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES), such as sirolimus-eluting (Cypher) and paclitaxel-eluting stents (Taxus), have further improved results of percutaneous coronary intervention (PCI) by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor) and everolimus-eluting stents (Xience V), have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent.

  14. Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V®)

    Science.gov (United States)

    Sheiban, Imad; Villata, Gianluca; Bollati, Mario; Sillano, Dario; Lotrionte, Marzia; Biondi-Zoccai, Giuseppe

    2008-01-01

    Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES), such as sirolimus-eluting (Cypher®) and paclitaxel-eluting stents (Taxus®), have further improved results of percutaneous coronary intervention (PCI) by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor®) and everolimus-eluting stents (Xience V®), have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent. PMID:18629361

  15. Off-pump coronary artery bypass grafting or percutaneous transluminal coronary angioplasty with stenting for proximal left anterior descending coronary artery disease?

    NARCIS (Netherlands)

    Drenth, Derk Jan

    2005-01-01

    This thesis describes and discusses the results of a prospective randomized controlled clinical trial comparing percutaneous coronary angioplasty with stenting (stenting) and off-pump coronary artery bypass grafting with a left internal mammary artery (surgery) in patients with a high-grade stenosis

  16. A novel antithrombotic coronary stent: lysine-poly(HEMA)-modified cobalt-chromium stent with fibrinolytic activity.

    Science.gov (United States)

    Wang, Shasha; Li, Dan; Chen, Hong; Wu, Zhaoqiang; Xu, Yajun; Brash, John L

    2013-01-01

    Prevention of coagulation appears not to be possible when a foreign surface is in contact with blood; the alternative concept of a clot lysing surface has therefore been suggested. In this work, a mimic of the fibrinolytic system was constructed on L605 cobalt-chromium coronary stents. Lysine which, immobilized on a surface, has been shown previously to adsorb plasminogen in contact with blood was attached to the stent using poly(2-hydroxyethyl methacrylate) (poly(HEMA)) as a spacer. The lysine-poly(HEMA) modified stent was shown to have low nonspecific protein adsorption and to bind plasminogen in high quantity from plasma. Following exposure to plasma and treatment with tissue plasminogen activator, the lysine-modified stents showed clot-lysing properties in vitro while the unmodified L605 stents did not. It was shown that the modified stents retained their clot lysing properties after 24 h exposure to plasma.

  17. Mechanical and Histopathological Comparison between Commercialized and Newly Designed Coronary Bare Metal Stents in a Porcine Coronary Restenosis Model

    Science.gov (United States)

    Lim, Kyung Seob; Bae, In Ho; Kim, Jung Ha; Park, Dae Sung; Kim, Jong Min; Kim, Jung Hyun; Sim, Doo Sun; Hong, Young Joon

    2013-01-01

    The aim of this study was to compare the stent designed by Chonnam National University Hospital (designated as CNUH) with commercial cobalt-chromium coronary stent in a porcine coronary overstretch restenosis model. CNUH stent was subjected to mechanical performance tests. Pigs were randomized into two groups in which the coronary arteries (10 pigs, 10 coronaries in each group) had either CNUH stent or control commercial bare metal stent. Histopathologic analysis was assessed at 28 days after stenting. In mechanical performance tests, CNUH stent showed 2.65N, 35.1N, 0.52N, 1.94%, 4.29% in the flat plate radial compression, radial force, 3 point bending, Foreshortening and recoil test, respectively. There was no significant difference in the injury score, internal elastic lamina (IEL), lumen area, neointima area, percent area stenosis, inflammation score and fibrin score between the two groups (1.2±0.35, 4.1±0.41 mm2, 2.7±0.56 mm2, 1.6±0.47 mm2, 36.7±11.2%, 1.2±0.62, 0.2±0.34 in CNUH stent group vs. 1.2±0.38, 3.7±0.64 mm2, 2.5±0.49 mm2, 1.5±0.61 mm2, 36.3±12.17%, 1.1±0.12, 0.4±0.46 in commercial stent group, respectively). In the mechanical performance test, CNUH stent showed the moderated performance under the guideline of FDA. CNUH stent demonstrated similar histological reactions compared with commercial cobalt-chromium stent in a porcine coronary overstretch restenosis model. PMID:23678471

  18. Drug-eluting stents vs bare metal stents for the treatment of large coronary vessels.

    Science.gov (United States)

    Quizhpe, Arturo R; Feres, Fausto; de Ribamar Costa, José; Abizaid, Alexandre; Maldonado, Galo; Costa, Ricardo; Abizaid, Andrea; Cano, Manuel; Moreira, Adriana C; Staico, Rodolfo; Mattos, Luiz Alberto; Tanajura, Luiz Fernando; Chaves, Aurea; Centemero, Marinella; Sousa, Amanda M R; Sousa, J Eduardo M R

    2007-08-01

    Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (> 3.0 mm) has yet to be established. We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels. This study assessed the long-term outcomes (cardiac death, acute myocardial infarction, and need for repeat intervention in the treated vessel) of patients treated with either a DES (Cypher and Taxus) or a BMS of > or = 3.5 mm in diameter. A total of 250 consecutive patients who underwent DES implantation were clinically followed for 1 year and compared to 250 patients who were treated with BMS. Interventions in the setting of acute ST elevation myocardial infarction and treatment of bypass grafts were excluded. Cypher was the DES deployed in 70.8% of cases. Most of the enrolled patients were men (78%) with single vessel disease (65.6%). The left anterior descending artery was the culprit vessel in 34.2% of cases. Bare metal stent and DES cohorts had equivalent interpolated reference vessel diameter (3.19 +/- 0.3 mm for BMS vs 3.18 +/- 0.2 for DES; P = .1). Lesion was significantly longer in the group treated with DES (13.4 +/- 5.1 mm for BMS group vs 14.3 +/- 3.5 for DES; P = .0018). After 1 year of clinical follow-up, 95.2% of patients treated with DES and 91.2% of the patients who received BMS were free of major events (P = .2). A trend toward higher target-lesion revascularization was noticed in the group treated with BMS (4.8% vs 1.6%; P = .07). Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type of stent used.

  19. Flow disturbances in stent-related coronary evaginations

    DEFF Research Database (Denmark)

    Radu, Maria D; Pfenniger, Aloïs; Räber, Lorenz

    2014-01-01

    non-diseased coronary arteries. The change in flow with varying evagination sizes was assessed using a particle tracing test where the particle transit time within the segment with evagination was compared with that of a control vessel. The presence of the evagination caused a delayed particle transit......-dynamic (CFD) simulations, whether OCT-detected coronary evaginations can induce local changes in blood flow. Methods and results: OCT-detected evaginations are defined as outward bulges in the luminal vessel contour between struts, with the depth of the bulge exceeding the actual strut thickness. Evaginations...... can be characterised cross ectionally by depth and along the stented segment by total length. Assuming an ellipsoid shape, we modelled 3-D evaginations with different sizes by varying the depth from 0.2-1.0 mm, and the length from 1-9 mm. For the flow simulation we used average flow velocity data from...

  20. Good visibility of TITAN-2 coronary stents demonstrable on cardiac computer tomographic angiography: a report of 2 cases.

    Science.gov (United States)

    Ong, Paul Jau; Jau, Ong Paul; Ho, Hee Hwa; Hwa, Ho Hee; Jafary, Fahim Haider; Haider, Jafary Fahim; Loh, Kwok Kong; Kong, Loh Kwok; Ooi, Yau Wei; Wei, Ooi Yau; Wong, Chun Pong; Pong, Wong Chun; Foo, David; David, Foo

    2011-09-01

    Numerous studies have sought to assess stent patency by cardiac computer tomographic angiography (CCTA) in comparison with invasive coronary angiography in patients who had undergone percutaneous coronary stenting. Even with newer generation scanners, CCTA has been of limited value in the assessment of the revascularized patient. The main reason being blooming artifact from metallic stents often obscures stent luminal dimension, making the stented segment unassessable. We report on a novel finding of good visibility of TITAN-2 coronary stents demonstrable on CCTA for 2 patients and discuss the possible mechanism and potential implications of this observation.

  1. Clinical and economic studies of eptifibatide in coronary stenting.

    Science.gov (United States)

    Pasala, Tilak; Sattayaprasert, Prasongchai; Bhat, Pradeep K; Athappan, Ganesh; Gandhi, Sanjay

    2014-01-01

    Platelet adhesion and aggregation at the site of coronary stenting can have catastrophic clinical and economic consequences. Therefore, effective platelet inhibition is vital during and after percutaneous coronary intervention. Eptifibatide is an intravenous antiplatelet agent that blocks the final common pathway of platelet aggregation and thrombus formation by binding to glycoprotein IIb/IIIa receptors on the surface of platelets. In clinical studies, eptifibatide was associated with a significant reduction of mortality, myocardial infarction, or target vessel revascularization in patients with acute coronary syndrome undergoing percutaneous coronary intervention. However, recent trials conducted in the era of dual antiplatelet therapy and newer anticoagulants failed to demonstrate similar results. The previously seen favorable benefit of eptifibatide was mainly offset by the increased risk of bleeding. Current American College of Cardiology/American Heart Association guidelines recommend its use as an adjunct in high-risk patients who are undergoing percutaneous coronary intervention with traditional anticoagulants (heparin or enoxaparin), who are not otherwise at high risk of bleeding. In patients receiving bivalirudin (a newer safer anticoagulant), routine use of eptifibatide is discouraged except in select situations (eg, angiographic complications). Although older pharmacoeconomic studies favor eptifibatide, in the current era of P2Y12 inhibitors and newer safer anticoagulants, the increased costs associated with bleeding make the routine use of eptifibatide an economically nonviable option. The cost-effectiveness of eptifibatide with the use of strategies that decrease the bleeding risk (eg, transradial access) is unknown. This review provides an overview of key clinical and economic studies of eptifibatide well into the current era of potent antiplatelet agents, novel safer anticoagulants, and contemporary percutaneous coronary intervention.

  2. Neoatherosclerosis: Coronary stents seal atherosclerotic lesions but result in making a new problem of atherosclerosis.

    Science.gov (United States)

    Komiyama, Hidenori; Takano, Masamichi; Hata, Noritake; Seino, Yoshihiko; Shimizu, Wataru; Mizuno, Kyoichi

    2015-11-26

    Chronic inflammation of the native vessel wall with infiltration of lipid-laden foamy macrophages through impaired endothelium results in atherosclerosis. Percutaneous coronary intervention, including metallic stent implantation, is now widely utilized for the treatment of atherosclerotic lesions of the coronary artery. Bare-metal stents and the subsequently developed drug-eluting stents seal the atherosclerosis and resolve lumen stenosis or obstruction of the epicardial coronary artery and myocardial ischemia. After stent implantation, neointima proliferates within the stented segment. Chronic inflammation caused by a foreign body reaction to the implanted stent and subsequent neovascularization, which is characterized by the continuous recruitment of macrophages into the vessel, result in the transformation of the usual neointima into an atheromatous neointima. Neointima with an atherosclerotic appearance, such as that caused by thin-cap fibroatheromas, is now recognized as neoatherosclerosis, which can sometimes cause in-stent restenosis and acute thrombotic occlusion originating from the stent segment following disruption of the atheroma. Neoatherosclerosis is emerging as a new coronary stent-associated problem that has not yet been resolved. In this review article, we will discuss possible mechanisms, clinical challenges, and the future outlook of neoatherosclerosis.

  3. Computational fluid dynamics study of commercially available stents inside an idealised curved coronary artery

    Science.gov (United States)

    Chen, Winson Xiao; Ooi, Andrew; Hutchins, Nicholas; Poon, Eric; Thondapu, Vikas; Barlis, Peter

    2015-11-01

    Stent placement restores blood flow in diseased coronary arteries and is the standard treatment for obstructive coronary atherosclerosis. Analysis of the hemodynamic characteristics of stented arteries is essential for better understanding of the relationship between key fluid dynamic variables and stent designs. Previous computational studies have been limited to idealised stents in curved arterial segments or more realistic stents in straight segments. In clinical practice, however, it is often necessary to place stents in geometrically complex arterial curvatures. Thus, numerical simulations of the incompressible Navier-Stokes equations are carried out to investigate the effects of curvature on hemodynamics using detailed, commercially available coronary stents. The computational domain is a 3mm curved coronary artery model and simulations are conducted using a physiologically realistic inlet condition. The averaged flow rate is about 80 mL/min, similar to the normal human resting condition. The examination of hemodynamic parameters will assess the performance of several commercially available stents in curved arteries and identify regions that may be at risk for restenosis. It is anticipated that this information will lead to improvements in future stent design and deployment.

  4. Development and characterization of a coronary polylactic acid stent prototype generated by selective laser melting.

    Science.gov (United States)

    Flege, Christian; Vogt, Felix; Höges, Simon; Jauer, Lucas; Borinski, Mauricio; Schulte, Vera A; Hoffmann, Rainer; Poprawe, Reinhart; Meiners, Wilhelm; Jobmann, Monika; Wissenbach, Konrad; Blindt, Rüdiger

    2013-01-01

    In-stent restenosis is still an important issue and stent thrombosis is an unresolved risk after coronary intervention. Biodegradable stents would provide initial scaffolding of the stenosed segment and disappear subsequently. The additive manufacturing technology Selective Laser Melting (SLM) enables rapid, parallel, and raw material saving generation of complex 3- dimensional structures with extensive geometric freedom and is currently in use in orthopedic or dental applications. Here, SLM process parameters were adapted for poly-L-lactid acid (PLLA) and PLLA-co-poly-ε-caprolactone (PCL) powders to generate degradable coronary stent prototypes. Biocompatibility of both polymers was evidenced by assessment of cell morphology and of metabolic and adhesive activity at direct and indirect contact with human coronary artery smooth muscle cells, umbilical vein endothelial cells, and endothelial progenitor cells. γ-sterilization was demonstrated to guarantee safety of SLM-processed parts. From PLLA and PCL, stent prototypes were successfully generated and post-processing by spray- and dip-coating proved to thoroughly smoothen stent surfaces. In conclusion, for the first time, biodegradable polymers and the SLM technique were combined for the manufacturing of customized biodegradable coronary artery stent prototypes. SLM is advocated for the development of biodegradable coronary PLLA and PCL stents, potentially optimized for future bifurcation applications.

  5. A novel platinum chromium everolimus-eluting stent for the treatment of coronary artery disease

    Directory of Open Access Journals (Sweden)

    Bennett J

    2013-06-01

    Full Text Available Johan Bennett, Christophe DuboisDepartment of Cardiovascular Diseases, University Hospitals Leuven, Leuven, BelgiumAbstract: The development of coronary stents represents a major step forward in the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. The initial enthusiasm for bare metal stents was, however, tempered by a significant incidence of in-stent restenosis, the manifestation of excessive neointima hyperplasia within the stented vessel segment, ultimately leading to target vessel revascularization. Later, drug-eluting stents, with controlled local release of antiproliferative agents, consistently reduced this need for repeat revascularization. In turn, the long-term safety of first-generation drug-eluting stents was brought into question with the observation of an increased incidence of late stent thrombosis, often presenting as myocardial infarction or sudden death. Since then, new drugs, polymers, and platforms for drug elution have been developed to improve stent safety and preserve efficacy. Development of a novel platinum chromium alloy with high radial strength and high radiopacity has enabled the design of a new, thin-strut, flexible, and highly trackable stent platform, while simultaneously improving stent visibility. Significant advances in polymer coating, serving as a drug carrier on the stent surface, and in antiproliferative agent technology have further improved the safety and clinical performance of newer-generation drug-eluting stents. This review will provide an overview of the novel platinum chromium everolimus-eluting stents that are currently available. The clinical data from major clinical trials with these devices will be summarized and put into perspective.Keywords: drug-eluting stent, restenosis, Promus Element, Synergy

  6. The benefits of drug-eluting stents in the treatment of coronary artery disease

    Directory of Open Access Journals (Sweden)

    Kiramijyan S

    2016-03-01

    Full Text Available Sarkis Kiramijyan,1 Ming W Liu2 1Division of Cardiology, Department of Medicine, Harbor-UCLA Medical Center, Torrance, CA, USA; 2Heart and Vascular Care Center, White Memorial Medical Center, Los Angeles, CA, USA Abstract: The advent of coronary stents has been a landmark development in the treatment of coronary artery disease with percutaneous coronary intervention. Initial percutaneous treatment using balloon angioplasty alone had limited clinical efficacy due to immediate vascular elastic recoil and dissection, in addition to late negative vascular remodeling and neointimal hyperplasia. With the introduction of coronary stents, initially bare-metal stents (BMS, the problems of dissection and negative remodeling due to injury in addition to vascular elastic recoil were eliminated; however, neointimal hyperplasia remained an ongoing obstacle in the long-term efficacy of stents. Neointimal hyperplasia resulted in in-stent restenosis in 20%–30% of cases after intervention with BMS, which led to high rates of target lesion revascularization. Subsequently, drug-eluting stents (DES were introduced, which had the added advantage of releasing an anti-proliferative drug from the stent to reduce the neointimal proliferation, thus resulting in the reduction of the rates of in-stent restenosis. Although the first-generation DES had significantly improved outcomes over its predecessor, the BMS, several challenges including stent thrombosis and delayed endothelialization of the stent remained. The second-generation DES have been significantly improved over their first-generation predecessors in regard to efficacy and safety, ie, improved long-term outcomes and significant reductions in stent thrombosis. The duration of dual antiplatelet therapy after DES has also been studied extensively in multiple large trials. A newer generation of stents, including those with bioresorbable polymers, polymer-free, and fully bioresorbable scaffolds is still in the early

  7. In vivo assessment of stent recoil of biodegradable polymer-coated cobalt–chromium sirolimus-eluting coronary stent system☆

    Science.gov (United States)

    Abhyankar, Atul D.; Thakkar, Ashok S.

    2012-01-01

    Introduction Immediate and acute stent recoil has been observed following balloon deflation in normal and diseased coronary arteries, and the degree varies by stent design. Methods A total of 19 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: all patients treated with the biodegradable polymer-coated sirolimus-eluting cobalt–chromium coronary stent system (Supralimus-Core®). The immediate, acute and cumulative stent recoil was assessed by quantitative coronary angiography. The cumulative stent recoil was measured at 24 h of stent implantation. Results The absolute late loss due to recoil was found 0.08 ± 0.19 mm for Immediate Stent Recoil (ISR), 0.05 ± 0.21 mm for Acute Stent Recoil (ASR) and 0.11 ± 0.25 mm for Cumulative Stent Recoil (CSR) respectively. Conclusions In vivo acute stent recoil of the Supralimus-Core® has higher radial strength compared to other available standard drug-eluting stents. PMID:23253404

  8. Safety and efficacy of angioplasty with intracoronary stenting in patients with unstable coronary syndromes. Comparison with stable coronary syndromes

    Directory of Open Access Journals (Sweden)

    Luís C. L. Correia

    2000-06-01

    Full Text Available OBJECTIVE: To assess safety and efficacy of coronary angioplasty with stent implantation in unstable coronary syndromes. METHODS: Retrospective analysis of in-hospital and late evolution of 74 patients with unstable coronary syndromes (unstable angina or infarction without elevation of the ST segment undergoing coronary angioplasty with stent placement. These 74 patients were compared with 31 patients with stable coronary syndromes (stable angina or stable silent ischemia undergoing the same procedure. RESULTS: No death and no need for revascularization of the culprit artery occurred in the in-hospital phase. The incidences of acute non-Q-wave myocardial infarction were 1.4% and 3.2% (p=0.6 in the unstable and stable coronary syndrome groups, respectively. In the late follow-up (11.2±7.5 months, the incidences of these events combined were 5.7% in the unstable coronary syndrome group and 6.9% (p=0.8 in the stable coronary syndrome group. In the multivariate analysis, the only variable with a tendency to significance as an event predictor was diabetes mellitus (p=0.07; OR=5.2; 95% CI=0.9-29.9. CONCLUSION: The in-hospital and late evolutions of patients with unstable coronary syndrome undergoing angioplasty with intracoronary stent implantation are similar to those of the stable coronary syndrome group, suggesting that this procedure is safe and efficacious when performed in unstable coronary syndrome patients.

  9. Usefulness of Drug Eluting Stent in Percutaneous Coronary Intervention—A Single Center Experience in Taiwan

    Directory of Open Access Journals (Sweden)

    Juey-Jen Hwang

    2007-08-01

    Conclusion: The use of DES in the Taiwanese population yielded comparable results as those in large clinical trials. Subacute stent thrombosis rate was higher in acute coronary syndrome. The safety of DES in these situations should be further clarified.

  10. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Serruys, Patrick W; Silber, Sigmund; Garg, Scot

    2010-01-01

    New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed...

  11. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent

    DEFF Research Database (Denmark)

    Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T

    2011-01-01

    We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI)....

  12. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

    DEFF Research Database (Denmark)

    Urban, Philip; Meredith, Ian T; Abizaid, Alexandre

    2015-01-01

    BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9),...... therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.)....

  13. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents

    NARCIS (Netherlands)

    P.W.J.C. Serruys (Patrick); S. Silber (Sigmund); S.A. Garg (Scot); R.J.M. van Geuns (Robert Jan); G. Richard (Gert); P. Buszman (Pawel); H. Kelbaek (Henning); A.J. van Boven (Ad); S.H. Hofma (Sjoerd); A. Linke (Axel); V. Klauss (Volker); W. Wijns (William); C.M. Miguel (Carlos); P. Garot (Phillipe); C. DiMario (Carlo); G. Manoharan (Ganesh); R. Kornowski (Ran); T. Ischinger (Thomas); A. Bartorelli (Antonio); J. Ronden (Jacintha)

    2010-01-01

    textabstractBACKGROUND: New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end

  14. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Serruys, Patrick W; Silber, Sigmund; Garg, Scot

    2010-01-01

    New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the ...

  15. Comparison of zotarolimus-eluting and sirolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Maeng, Michael; Jensen, Lisette O; Kaltoft, Anne

    2012-01-01

    ABSTRACT: BACKGROUND: We evaluated the effectiveness and safety of a zotarolimus-eluting (ZES) versus a sirolimus-eluting (SES) coronary stent in a large cohort of patients treated with one of these stents in Western Denmark. METHODS: A total of 6,122 patients treated with ZES (n = 2,282) or SES (n...

  16. Patient with Recent Coronary Artery Stent Requiring Major Non Cardiac Surgery

    Directory of Open Access Journals (Sweden)

    Usha Kiran

    2009-01-01

    Full Text Available Anaesthesiologists are increasingly confronted with patients who had a recent coronary artery stent implanta-tion and are on dual anti-platelet medication. Non cardiac surgery and most invasive procedures increase the risk of stent thrombosis especially when procedure is performed early after stent implantation. Anaesthesiologist faces the dilemma of stopping the antiplatelet therapy before surgery to avoid bleeding versus perioperative stent thrombosis. Individualized approach should be adopted with following precautions. i In a surgical patient with a history of percu-taneous coronary intervention (PCI and coronary stent, determine the date of the procedure, the kind of the stent inserted and the possibility of complications during the procedure. ii Consider all patents with a recent stent implan-tation (e.g. less than three months for bare metal stents and less than one year for brachytherapy or drug eluting stents as high risk and consult an interventional cardiologist. iii Any decision to postpone surgery, continue, modify or discontinue antiplatelet regimes must involve the cardiologist, anaesthesiologist, surgeon, haematologist and the intensivist to balance the risk and benefit of each decision.

  17. Correlates and Impact of Coronary Artery Calcifications in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents

    DEFF Research Database (Denmark)

    Giustino, Gennaro; Mastoris, Ioannis; Baber, Usman

    2016-01-01

    OBJECTIVES: The aim of this study was to investigate the clinical correlates and prognostic impact of coronary artery calcification (CAC) in women undergoing percutaneous coronary intervention with drug-eluting stents (DES). BACKGROUND: The clinical correlates and the prognostic significance of C...

  18. Snare removal of a deformed coronary stent via radial artery during percutaneous intervention for acute myocardial infarction.

    Science.gov (United States)

    Hanson, Ivan; Trivax, Justin; Hanzel, George

    2014-01-01

    A 49-year-old man underwent emergent coronary angiography for acute inferior myocardial infarction (MI). After balloon angioplasty of culprit right coronary artery (RCA) occlusion, a Promus Element stent would not advance to the target lesion. The proximal end of the stent became compressed against the tip of the guiding catheter, such that the stent could neither be advanced nor withdrawn. This case illustrates the technical aspects of snare removal of a severely deformed stent via the radial artery.

  19. Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.

    Science.gov (United States)

    Kesselheim, Aaron S; Xu, Shuai; Avorn, Jerry

    2014-01-01

    Medical device innovation remains poorly understood, and policymakers disagree over how to incentivize early development. We sought to elucidate the components of transformative health care innovation by conducting an in-depth case study of development of a key medical device: coronary artery stents. We conducted semi-structured interviews with the innovators whose work contributed to the development of coronary artery stents who we identified based on a review of the regulatory, patent, and medical literature. Semi-structured interviews with each participant covered the interviewee's personal involvement in coronary artery stent development, the roles of institutions and other individuals in the development process, the interplay of funding and intellectual property in the interviewee's contribution, and finally reflections on lessons arising from the experience. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis. We found that the first coronary artery stents emerged from three teams: Julio Palmaz and Richard Schatz, Cesare Gianturco and Gary Roubin, and Ulrich Sigwart. First, these individual physician-inventors saw the need for coronary artery stents in their clinical practice. In response, they developed prototypes with the support of academic medical centers leading to early validation studies. Larger companies entered afterwards with engineering support. Patents became paramount once the technology diffused. The case of coronary stents suggests that innovation policy should focus on supporting early physician-inventors at academic centers.

  20. Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.

    Directory of Open Access Journals (Sweden)

    Aaron S Kesselheim

    Full Text Available Medical device innovation remains poorly understood, and policymakers disagree over how to incentivize early development. We sought to elucidate the components of transformative health care innovation by conducting an in-depth case study of development of a key medical device: coronary artery stents.We conducted semi-structured interviews with the innovators whose work contributed to the development of coronary artery stents who we identified based on a review of the regulatory, patent, and medical literature. Semi-structured interviews with each participant covered the interviewee's personal involvement in coronary artery stent development, the roles of institutions and other individuals in the development process, the interplay of funding and intellectual property in the interviewee's contribution, and finally reflections on lessons arising from the experience. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis.We found that the first coronary artery stents emerged from three teams: Julio Palmaz and Richard Schatz, Cesare Gianturco and Gary Roubin, and Ulrich Sigwart. First, these individual physician-inventors saw the need for coronary artery stents in their clinical practice. In response, they developed prototypes with the support of academic medical centers leading to early validation studies. Larger companies entered afterwards with engineering support. Patents became paramount once the technology diffused. The case of coronary stents suggests that innovation policy should focus on supporting early physician-inventors at academic centers.

  1. Titanium-nitride-oxide-coated coronary stents: insights from the available evidence.

    Science.gov (United States)

    Karjalainen, Pasi P; Nammas, Wail

    2017-06-01

    Coating of stent surface with a biocompatible material is suggested to improve stent safety profile. A proprietary process was developed to coat titanium-nitride-oxide on the stent surface, based on plasma technology that uses the nano-synthesis of gas and metal. Preclinical in vitro and in vivo investigation confirmed blood compatibility of titanium (nitride-) oxide films. Titanium-nitride-oxide-coated stents demonstrated a better angiographic outcome, compared with bare-metal stents at mid-term follow-up; however, they failed to achieve non-inferiority for angiographic outcome versus second-generation drug-eluting stents. Observational studies showed adequate clinical outcome at mid-term follow-up. Non-randomized studies showed an outcome of titanium-nitride-oxide-coated stents comparable to - or better than - first-generation drug-eluting stents at long-term follow-up. Two randomized controlled trials demonstrated comparable efficacy outcome, and a better safety outcome of titanium-nitride-oxide-coated stents versus drug-eluting stents at long-term follow-up. Evaluation by optical coherence tomography at mid-term follow-up revealed better neointimal strut coverage associated with titanium-nitride-oxide-coated stents versus drug-eluting stents; yet, neointimal hyperplasia thickness was greater. Key messages Stents coated with titanium-nitride-oxide demonstrated biocompatibility in preclinical studies: they inhibit platelet and fibrin deposition, and reduce neointimal growth. In observational and non-randomized studies, titanium-nitride-oxide-coated stents were associated with adequate safety and efficacy outcome. In randomized trials of patients with acute coronary syndrome, titanium-nitride-oxide-coated stents were associated with a better safety outcome, compared with drug-eluting stents; efficacy outcome was comparable.

  2. The effects of intravascular stents on vasomotion in porcine coronary arteries.

    Science.gov (United States)

    Jenkins, J S; Webel, R; Laughlin, M H; Rowland, S M; Yoklavich, M F; Branson, K; Parker, J L; Myers, P R

    1995-09-01

    Intravascular stents are being increasingly utilized in the treatment of atherosclerotic coronary artery disease, however little is known about the effects of stents on coronary vasomotion. The purpose of the present study was to compare the effects of a heparin treated tantalum stent and balloon injury on coronary artery vasorelaxation and vasoconstriction. Male miniswine underwent cardiac catheterization and oversized balloon injury to the right and left circumflex coronary arteries. After two weeks, one artery was either balloon-injured again, or underwent implantation of a stent. Four weeks later, the coronary arteries were prepared for in vitro isometric ring studies. Vasodilator responses to bradykinin and A23187 calcium ionophore were significantly impaired in balloon-injured vessels. The bradykinin and A23187 responses in stented vessels showed significantly less vasorelaxation, compared to both balloon-injured and normal vessels. There were no significant differences between any of the groups in their vasodilator response to nitroprusside. Vasoconstrictor responses to acetylcholine were significantly greater in balloon-injured vessels, compared to normal vessels. Stented vessels, however, showed markedly less vasoconstriction to acetylcholine compared to both balloon-injured and normal vessels. The maximal KCI vasoconstrictor responses in balloon injured vessels and normal controls were not significantly different. However, the maximal KCI responses in stented vessels showed significantly less constriction compared to both balloon injured and normal vessels. In conclusion, the data demonstrated that coronary arteries implanted with a heparin treated tantalum stent were capable of vasomotor activity. Both conventional balloon angioplasty and stents resulted in impaired endothelium-dependent vasorelaxation. Endothelium-independent vasorelaxation, however, was not impaired.(ABSTRACT TRUNCATED AT 250 WORDS)

  3. The CID Chrono cobalt-chromium alloy carbofilm-coated coronary stent system.

    Science.gov (United States)

    Visconti, Gabriella; Focaccio, Amelia; Tavano, Davide; Airoldi, Flavio; Briguori, Carlo

    2011-06-02

    In an attempt to improve the stent's safety, development of bare metal stents (BMS) continues, with new materials and geometry. Chrono (CID, Italy) is a thin strut cobalt-chromium (Co-Cr) stent combining the clinical benefits of the bio- and haemo-compatible Carbofilm coating. We assessed the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Chrono stent in patients undergoing elective PCI for de novo lesions in native coronary vessels. The patients were followed for 12 months for the occurrence of major cardiac events (MACE, defined as death, myocardial infarction, repeat PCI and bypass surgery). Patients with complex (B2/C) lesions were compared to those with non-complex lesions (A/B1). A total of 340 consecutive patients were analysed: 155 patients with complex lesions (Complex group) and 185 patients with non-complex lesions (Non-complex group). Dual antiplatelet therapy was maintained >1 month in 21% of patients in both Complex and Non-complex group. Stent length was longer in the Complex group (25 ± 10 mm versus 17 ± 6 mm; pStent diameter stent thrombosis (ARC criteria) was 1.29% in the Complex group and 1.08% in the Non-complex group (p=1.0). Implantation of the Co-Cr Chrono stent results in a good safety and efficacy for both complex and non-complex de-novo coronary artery lesions. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  4. Advantages of novel BioMimeTM Sirolimus Eluting Coronary Stent system. Moving towards biomimicry.

    Science.gov (United States)

    Upendra, K; Sanjeev, B

    2012-02-01

    Since the first reported use of percutaneous transluminal coronary angioplasty (PTCA), advancements in interventional cardiology arena have been fast paced. Within the last ten years, these developments have been exponential. Developers & clinicians are fast adapting from the learning curve awarded by the time course of DES evolution. In that light BioMimeTM Sirolimus Eluting Coronary Stent comes as a fresh thought in taking stents towards a biomimicry concept. The stent is built on an ultra-low strut thickness (65 µm) cobalt chromium stent platform, using an intelligent hybrid of close and open cells allowing for morphology mediated expansion, employs a well known anti-proliferative - Sirolimus that elutes from a biodegradable co-polymer formulation in 30 days and ensures high coating integrity and low coating thickness of 2 µm. The resultant stent demonstrates almost 100% endothelialization at 30 days in preclinical model and zero percent MACE >18 months in the primary efficacy and safety clinical study.

  5. Eosinophilic responses to stent implantation and the risk of Kounis hypersensitivity associated coronary syndrome.

    Science.gov (United States)

    Kounis, Nicholas G; Giannopoulos, Sotiris; Tsigkas, Grigorios G; Goudevenos, John

    2012-04-19

    The use of drug eluting stents constitutes a major breakthrough in current interventional cardiology because it is more than halves the need of repeat interventions. It is incontrovertible that coronary stents, in general, have been beneficial for the vast majority of patients. A small increase in thrombosis, following DES implantation, is offset by a diminished risk of complications associated with repeat vascularization. However, late and, especially, very late stent thrombosis is a much feared complication because it is associated with myocardial infarction with increased mortality. Despite that stent thrombosis is thought to be multifactorial, so far clinical reports and reported pathology findings in patients died from coronary stent thrombosis as well as animal studies and experiments, point toward a hypersensitivity inflammation. The stented and thrombotic areas are infiltrated by interacting, via bidirectional stimuli inflammatory cells including eosinophils, macrophages, T-cells and mast cells. Stented regions constitute an ideal surrounding for endothelial damage and dysfunction, together with hemorheologic changes and turbulence as well as platelet dysfunction, coagulation and fibrinolytic disturbances. Drug eluting stent components include the metal strut which contains nickel, chromium, manganese, titanium, molybdenum, the polymer coating and the impregnated drugs which for the first generation stents are: the antimicrotubule antineoplastic agent paclitaxel and the anti-inflammatory, immunosuppressive and antiproliferative agent sirolimus. The newer stents which are called cobalt-chromiun stents and elute the sirolimus analogs everolimus and zotarolimus both contain nickel and other metals. All these components constitute an antigenic complex inside the coronary arteries which apply chronic, continuous, repetitive and persistent inflammatory action capable to induced Kounis syndrome and stent thrombosis. Allergic inflammation goes through three phases

  6. Coronary artery bypass surgery or coronary stenting in diabetic patients: too soon to make a statement?

    Energy Technology Data Exchange (ETDEWEB)

    Rodriguez, Alfredo E., E-mail: arodriguez@centroceci.com.ar

    2014-11-15

    Diabetic patients have been associated with poor procedural and long term outcome if they were treated either with percutaneous coronary interventions or coronary artery bypass surgery. Recently several randomized clinical trials (RCT) in this subset of patients have been published showing a greater incidence of major adverse cardiovascular events, death/myocardial infarction/stroke, if they were treated with first generation drug eluting stents (DES) which was not observed previously in the bare metal stent era. However, almost simultaneously with this data, several RCT demonstrated better safety profile with new generation DES including biocompatible polymers, biodegradable polymers and lately complete absorbable DES, all of them showed reduction in adverse cardiac events compared to 1st generation DES in patients with diabetes. In this editorial we review the old and new randomized data in diabetic patients and conclude that there are many unresolved issues to make a definitive statement regarding which is the best revascularization preference in diabetic patients and the measured final efficacy of PCI and CABG will not be reached until the arrival of RCT using next generation DES, including complete absorbable scaffolds. - Highlights: • Diabetic patients have been associated with poor procedural and long term outcome if they were treated either with percutaneous coronary interventions or coronary artery bypass surgery. Recently several randomized clinical trials (RCT) in this subset of patients have been published showing a greater incidence of major adverse cardiovascular events, death/myocardial infarction/stroke, if they were treated with first generation drug eluting stents (DES) which was not observed previously in the bare metal stent era. • In recent years, several RCT demonstrated better safety profile with new generation DES including biocompatible polymers, biodegradable polymers and lately complete absorbable DES, all of them showed reduction in

  7. High-Definition Computed Tomography for Coronary Artery Stent Imaging: a Phantom Study

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Wen Jie; Chen, Ke Min; Pang, Li Fang; Zhang, Huang; Pan, Zi Lai [Rui Jin Hospital, Medical School, Shanghai Jiao Tong University, Shangha (China); Guo, Ying; Li, Jian Ying [Beijing Economic and Technology Development Area, Beijing (China)

    2012-01-15

    To assess the performance of a high-definition CT (HDCT) for imaging small caliber coronary stents ({<=} 3 mm) by comparing different scan modes of a conventional 64-row standard-definition CT (SDCT). A cardiac phantom with twelve stents (2.5 mm and 3.0 mm in diameter) was scanned by HDCT and SDCT. The scan modes were retrospective electrocardiography (ECG)-gated helical and prospective ECG-triggered axial with tube voltages of 120 kVp and 100 kVp, respectively. The inner stent diameters (ISD) and the in-stent attenuation value (AVin-stent) and the in-vessel extra-stent attenuation value (AVin-vessel) were measured by two observers. The artificial lumen narrowing (ALN = [ISD - ISDmeasured]/ISD) and artificial attenuation increase between in-stent and in-vessel (AAI = AVin-stent - AVin-vessel) were calculated. All data was analyzed by intraclass correlation and ANOVA-test. The correlation coefficient of ISD, AVin-vessel and AVin-stent between the two observers was good. The ALNs of HDCT were statistically lower than that of SDCT (30 {+-} 5.7% versus 35 {+-} 5.4%, p < 0.05). HDCT had statistically lower AAI values than SDCT (15.7 {+-} 81.4 HU versus 71.4 {+-} 90.5 HU, p < 0.05). The prospective axial dataset demonstrated smaller ALN than the retrospective helical dataset on both HDCT and SDCT (p < 0.05). Additionally, there were no differences in ALN between the 120 kVp and 100 kVp tube voltages on HDCT (p = 0.05). High-definition CT helps improve measurement accuracy for imaging coronary stents compared to SDCT. HDCT with 100 kVp and the prospective ECG-triggered axial technique, with a lower radiation dose than 120 kVp application, may be advantageous in evaluating coronary stents with smaller calibers ({<=} 3 mm).

  8. Aspirin and clopidogrel hyporesponsiveness and nonresponsiveness in patients with coronary artery stenting

    Directory of Open Access Journals (Sweden)

    Rakesh K Sharma

    2009-11-01

    Full Text Available Rakesh K Sharma1, Hanumanth K Reddy1, Vibhuti N Singh2, Rohit Sharma1, Donald J Voelker1, Girish Bhatt11Medical Center of South Arkansas, El Dorado, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 2Bayfront Medical Center, St. Petersburg, University of South Florida, Tampa, FL, USAAbstract: Patients undergoing coronary artery stenting receive an antiplatelet regimen to reduce the risk of antithrombotic complications. Current guidelines recommend the use of acetyl salicylic acid (aspirin and clopidogrel as evidenced by large clinical trials. There has been a concern about variable responses of patients to aspirin and clopidogrel which may predispose them to subacute stent thrombosis or late stent thrombosis. Up to 25% of patients with acute myocardial infarction (AMI undergoing percutaneous coronary intervention (PCI were found to have hyporesponsiveness or resistance to clopidogrel which may predispose them to recurrent events. Dual antiplatelet regimen is a standard therapy in these patients and there is always a concern about variable responses to aspirin and clopidogrel predisposing them to acute coronary syndrome (ACS. Prevalence of this hyporesponsiveness or resistance may be due to noncompliance, genetic mutations, co-morbid situations and concomitant use of other drugs. This issue is of considerable importance in the era of coronary drug eluting stents when a long-term dual antiplatelet regimen is needed. This paper is a review for clinicians taking care of such patients with hyporesponsiveness or nonresponsiveness to dual antiplatelet regimen.Keywords: aspirin, clopidogrel, acute coronary syndrome, coronary artery stenting

  9. Comparative clinical-angiographic evaluation of long-term results of coronary stenting in patients with coronary artery disease using drug-sents a different cover

    Directory of Open Access Journals (Sweden)

    А. Г. Осиев

    2015-10-01

    Full Text Available The formation of restenosis after coronary stent implantation remains a major challenge for endovascular treatment of patients with coronary atherosclerosis. In the course of the study were analyzed in a comparative perspective, the frequency and nature of developing the long-term restenosis after implantation of coronary stents in the Cypher coated with sirolimus (Cordis, Johnson & Johnson (U.S. and eucaTAX double coated - artificial glycocalyx (artificial endothelium and paclitaxel (eucatech AG, Germany in patients with chronic coronary artery disease. The advantages of stent Cypher, in reducing the incidence of restenosis and repeated endovascular interventions in the late postoperative period in patients with coronary artery disease.

  10. Periprocedural (30-day) risk of myocardial infarction after drug-eluting coronary stent implantation: a meta-analysis comparing cobalt-chromium and stainless steel drug-eluting coronary stents.

    Science.gov (United States)

    Moreno, Raul; Jimenez-Valero, Santiago; Sanchez-Recalde, Angel; Galeote, Guillermo; Calvo, Luis; Martin-Reyes, Roberto; Sabate, Manuel; Plaza, Ignacio; Macaya, Carlos; Lopez-Sendon, Jose-Luis

    2011-03-01

    Because of the reduction in the rate events related with in-stent restenosis, most events after drug-eluting stent implantation occur shortly after coronary stenting. Cobalt-chromium alloys allow to reduce strut thickness and improve flexibility and deliverability of coronary stent platforms, and thus could be associated with lower short-term events after stenting. The aim of this study was to test the hypothesis that drug-eluting coronary stents with a cobalt-chromium platform reduce the incidence of periprocedural (30-day) myocardial infarction in comparison with stainless steel drug-eluting coronary stents. A meta-analysis from nine randomised trials comparing cobalt-chromium and stainless steel drug-eluting coronary stents that overall included 11,313 patients was performed. The incidence of myocardial infarction, stent thrombosis, and cardiac death at 30 days was compared between both types of stents. At 30 days, the incidence of acute myocardial infarction was significantly lower in patients allocated to cobalt-chromium drug-eluting stents (2.3% vs. 3.9%, respectively; p=0.006; odds ratio 0.72, 95% confidence interval 0.58-0.91), due to a significant reduction in the rate of non-Q-wave myocardial infarction (odds ratio 0.67, 95% confidence interval 0.51-0.88). The incidence of stent thrombosis was similar between both groups of patients, (0.5% vs. 0.5%, p=0.76; odds ratio 1.09, 95% confidence interval 0.63-1.89). Drug-eluting coronary stents that use cobalt-chromium stent platforms have a better safety profile at 30 days in comparison with stainless steel drug-eluting stents, due to a significant reduction in the rate of myocardial infarction.

  11. Clinical outcomes after heterogeneous overlap stenting with drug-eluting stents and bare-metal stents for de novo coronary artery narrowings.

    Science.gov (United States)

    Aoki, Jiro; Kirtane, Ajay J; Dangas, George D; Lansky, Alexandra J; Morales, Andy; Kimura, Masashi; Kim, Young-Hak; Moussa, Issam; Weisz, Giora; Kreps, Edward M; Collins, Michael; Frankin-Bond, Theresa; Stone, Gregg W; Moses, Jeffrey W; Leon, Martin B; Mehran, Roxana

    2008-01-01

    When it is difficult to deliver multiple drug-eluting stents (DES) or when size constraints limit DES implantation, bare-metal stents (BMS) may be implanted contiguous to DES. However, the clinical outcomes after overlapping DES and BMS implantation are not known. From September 2004 to June 2006, 4,872 consecutive patients who underwent percutaneous coronary intervention consented to be enrolled in a prospective registry. Of these patients, 44 (0.9%) with de novo lesions were treated with DES and BMS overlap stenting. All patients were followed to 12 months for the assessment of clinical outcomes. The average implanted stent diameter was 2.68 +/- 0.30 mm for DES and 2.35 +/- 0.38 mm for BMS. Overlapping BMS were implanted distal to DES in all but 1 case. One patient (2.3%) experienced acute stent thrombosis and died 2 days after the procedure. No other patient died or had a myocardial infarction during 12 months. The target vessel revascularization rate at 12 months, however, was 31.8%, mainly driven by diffuse in-stent restenosis in the BMS segments. In conclusion, the incidence of DES and BMS overlap stenting is rare in daily practice, but this procedure is associated with a high rate of target vessel revascularization.

  12. 64-slice multidetector coronary CT angiography: in vitro evaluation of 68 different stents

    Energy Technology Data Exchange (ETDEWEB)

    Maintz, David; Seifarth, Harald; Rink, Michael; Oezguen, Murat; Heindel, Walter; Fischbach, Roman [University of Muenster, Department of Clinical Radiology, Muenster (Germany); Raupach, Rainer; Flohr, Thomas [Siemens Medical Solutions, Forchheim (Germany); Sommer, Torsten [University of Bonn, Department of Radiology, Bonn (Germany)

    2006-04-15

    The purpose of this study was to test a large sample of different coronary artery stents using four image reconstruction approaches with respect to lumen visualization, lumen attenuation, and image noise in 64-slice multidetector-row computed tomography (MDCT) in vitro and to provide a catalogue of currently used coronary artery stents when imaged with state-of the-art MDCT. We examined 68 different coronary artery stents (57 stainless steel, four cobalt-chromium, one cobalt-alloy, two nitinol, four tantalum) in a coronary artery phantom (vessel diameter 3 mm, intravascular attenuation 250 HU, extravascular density -70). Stents were imaged in axial orientation with standard parameters: 32x0.6 collimation, pitch 0.24, 680 mAs, 120 kV, rotation time 0.37 s. Four different image reconstructions were obtained with varying convolution kernels and section thicknesses: (1) soft, 0.6 mm, (2) soft, 0.75, (3) medium soft, 0.6, and (4) stent-optimized sharp, 0.6. To evaluate visualization characteristics of of the stent, the lumen diameter, intraluminal density and noise were measured. The high-resolution kernel offered significantly better average lumen visualization (57% {+-}10%) and more realistic lumen attenuation (222 HU {+-}66 HU) at the expense of increased noise (15.3 HU {+-}3.7 HU) compared with the soft and medium-soft CT angiography (CTA) protocol (p<0.001 for all). Stents with a lumen visibility of more than 66% were: Arthos pico, Driver, Flex, Nexus2, S7, Tenax complete, Vision (all 67%), Symbiot, Teneo (70%), and Radius (73%). Only ten stents showed a lumen visibility of less than 50%. Stent lumen visibility largely varies depending on the stent type. Even with the improved spatial resolution of 64-slice CT, a stent-optimized kernel remains beneficial for stent visualization when compared with the standard medium-soft CTA protocol. Using 64-slice CT and high-resolution kernel, the majority of stent products show a lumen visibility of more than 50% of the stent

  13. Optimal kissing balloon inflation after single-stent deployment in a coronary bifurcation model.

    Science.gov (United States)

    Murasato, Yoshinobu; Iwasaki, Kiyotaka; Yamamoto, Tadashi; Yagi, Takanobu; Hikichi, Yutaka; Suematsu, Yasunori; Yamamoto, Tomohiko

    2014-12-01

    To define the optimal kissing balloon inflation (KBI) after single-stent deployment in a coronary bifurcation model. We deployed stents in main vessels (MV) followed by KBI in various conditions and compared the stent configurations. A) KBI at the operator's discretion vs. under the guidelines of minimal balloon overlapping (MBO). Various stent configurations were observed after the former option, whereas similar maximal dilation points were observed under the MBO guidelines. B) Long balloon overlapping (LBO) vs. MBO with proximal MV dilated by a large balloon. The proximal MV was dilated to an ideal round shape with MBO versus an oval shape with LBO. C) Two-link vs. 3-link stents. Although the 2-link stent was advantageous to open the side branch, it incurred a risk of overdilatation of the proximal struts, whereas the 3-link stent preserved its structure. Computed simulations of coronary flow were analysed in the following left main coronary models: circle with a diameter of 4 and 5.5 mm, ellipse with longitudinal direction and tilt position. They revealed that the overdilated side was exposed to low shear stress regardless of its shape. Optimal KBI can be achieved with MBO and proximal dilatation by an optimally sized balloon.

  14. Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI)

    DEFF Research Database (Denmark)

    Raungaard, Bent; Jensen, Lisette Okkels; Tilsted, Hans-Henrik

    2015-01-01

    BACKGROUND: New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety...... patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable......-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat...

  15. A third generation ultra-thin strut cobalt chromium stent: histopathological evaluation in porcine coronary arteries.

    Science.gov (United States)

    Jabara, Refat; Geva, Sarah; Ribeiro, Henrique B; Chen, Jack P; Hou, Dongming; Li, Jinsheng; King, Spencer B; Chronos, Nicolas; Robinson, Keith A

    2009-11-01

    The present study was designed to evaluate a novel third generation bare-metal stent (BMS) comprised of an ultra-thin-strut, cobalt-chromium platform with fixed geometry, uniform cell size, and superior surface finish in a porcine coronary artery model. A total of 47 BMS of two types were implanted in pig coronary arteries using QCA to optimise stent apposition: a commercially available cobalt alloy thin-strut stent (91 microm) as control (Driver; n=17), and an ultra-thin-strut (65 microm) cobalt-chromium stent (Protea; n=18). Animals underwent angiographic restudy and termination one week and one month post-implant for coronary artery histology. In addition, 12 overlapping Protea stents were analysed at one month. At one week, comparable thin neointima and mild inflammation were observed in both groups. At one month, Protea demonstrated significantly lower angiographic % stenosis (2+/-1% vs. 17+/-5%, p=0.006), intimal thickness (0.11+/-0.01 mm vs. 0.23+/-0.03 mm, p=0.003), and histologic % area stenosis (19+/-2% vs. 32+/-3%, p=0.003). Mean stent strut injury scores were low and similar between groups. Angiographic % stenosis, intimal thickness, and histologic % area stenosis of overlapping Protea stents were 3+/-1%, 0.13+/-0.01 mm, and 22+/-2%, respectively, and similar to the single Protea group. Stable fibrocellular neointimal incorporation, with complete endothelialisation and minimal inflammation, were observed at one month in all stents, including overlapped Protea segments. When compared to a commercially available cobalt alloy BMS, the new third generation Protea stent demonstrated favourable coronary arterial response with significant reduction of neointimal formation in the porcine model. Our results showed how seemingly trivial improvements to the BMS technology can result in substantial biological responses. Future, long-term investigations are needed to ascertain the clinical applicability and implications of these findings.

  16. Elevated blood viscosity and micro-recirculation linked to coronary stent malapposition.

    Science.gov (United States)

    Poon, Eric; Thondapu, Vikas; Hayat, Umair; Barlis, Peter; Yap, Chooi; Kuo, Po; Wang, Qisen; Ma, Jiawei; Zhu, Shuang; Moore, Stephen; Ooi, Andrew

    2018-02-14

    One particular complexity of coronary artery is the natural tapering of the vessel with proximal segments having larger caliber and distal tapering as the vessel get smaller. The natural tapering of a coronary artery often leads to proximal incomplete stent apposition (ISA). ISA alters coronary hemodynamics and creates pathological path to develop complications such as in-stent restenosis, and more worryingly, stent thrombosis. By employing state-of-the-art computer-aided design software, generic stent hoops were virtually deployed in an idealized tapered coronary artery with decreasing malapposition distance. Pulsatile blood flow simulations were carried out using computational fluid dynamics (CFD) on these computer-aided design models. CFD results reveal unprecedented details in both spatial and temporal development of micro-recirculation environments throughout the cardiac cycle. Arterial tapering also introduces secondary micro-recirculation. These primary and secondary micro-recirculations provoke significant fluctuations in arterial wall shear stress (WSS). There has been a direct correlation with changes in WSS and the development of atherosclerosis. Further, the presence of these micro-recirculations influence strongly on the local levels of blood viscosity in the vicinity of the malapposed stent struts. The observation of secondary micro-recirculations and changes in blood rheology is believed to complement the wall (-based) shear stress, perhaps providing additional physical explanations for tissue accumulation near ISA detected from high resolution optical coherence tomography. This work may aid in helping to optimize future stent properties and designs that will translate to innovations that directly impact clinical outcomes.

  17. The use of coronary stent in hepatic artery stenosis after orthotopic liver transplantation

    Energy Technology Data Exchange (ETDEWEB)

    Huang Mingsheng [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Shan Hong [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China)]. E-mail: gzshsums@public.guangzhou.gd.cn; Jiang Zaibo [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Li Zhengran [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Zhu Kangshun [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Guan Shouhai [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Qian Jiesheng [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Chen Guihua [Transplantation Center, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Lu Minqiang [Transplantation Center, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Yang Yang [Transplantation Center, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China)

    2006-12-15

    Purpose: This retrospective study was undertaken to evaluate the effectiveness of coronary stent placement in hepatic artery stenosis after orthotopic liver transplantation (OLT). Materials and methods: Of 430 consecutive adult orthotopic liver transplant recipients between November 2003 and September 2005, 17 had hepatic artery stenosis (HAS). Fourteen of them underwent coronary stent placement in the HAS. The technical results, complications, hepatic artery patency and clinical outcome were reviewed. Results: Technical and immediate success was 100%. After a mean follow-up of 159.4 days (range, 9-375 days), all patients obtained patent hepatic arteries except 2 patients occurred hepatic artery restenoses at 26 and 45 days after stent placement, respectively. Kaplan-Meier curve of patency showed cumulated stent patency at 3, 6, and 12 months of 78%, 58% and 45%, respectively. During the follow-up, 8 patients survived, 5 died of septic multiple-organ failure, 1 received retransplantation because of refractory biliary infection. Hepatic artery dissection induced by a guiding catheter occurred in one patient and was successfully treated with a coronary stent. Conclusion: Hepatic artery stenosis after OLT can be successfully treated with coronary stent placement with low complication rate and an acceptable 1-year hepatic artery patency rate.

  18. High-definition computed tomography for coronary artery stents imaging: Initial evaluation of the optimal reconstruction algorithm

    Energy Technology Data Exchange (ETDEWEB)

    Cui, Xiaoming, E-mail: mmayzy2008@126.com; Li, Tao, E-mail: litaofeivip@163.com; Li, Xin, E-mail: lx0803@sina.com.cn; Zhou, Weihua, E-mail: wangxue0606@gmail.com

    2015-05-15

    Highlights: • High-resolution scan mode is appropriate for imaging coronary stent. • HD-detail reconstruction algorithm is stent-dedicated kernel. • The intrastent lumen visibility also depends on stent diameter and material. - Abstract: Objective: The aim of this study was to evaluate the in vivo performance of four image reconstruction algorithms in a high-definition CT (HDCT) scanner with improved spatial resolution for the evaluation of coronary artery stents and intrastent lumina. Materials and methods: Thirty-nine consecutive patients with a total of 71 implanted coronary stents underwent coronary CT angiography (CCTA) on a HDCT (Discovery CT 750 HD; GE Healthcare) with the high-resolution scanning mode. Four different reconstruction algorithms (HD-stand, HD-detail; HD-stand-plus; HD-detail-plus) were applied to reconstruct the stented coronary arteries. Image quality for stent characterization was assessed. Image noise and intrastent luminal diameter were measured. The relationship between the measurement of inner stent diameter (ISD) and the true stent diameter (TSD) and stent type were analysed. Results: The stent-dedicated kernel (HD-detail) offered the highest percentage (53.5%) of good image quality for stent characterization and the highest ratio (68.0 ± 8.4%) of visible stent lumen/true stent lumen for luminal diameter measurement at the expense of an increased overall image noise. The Pearson correlation coefficient between the ISD and TSD measurement and spearman correlation coefficient between the ISD measurement and stent type were 0.83 and 0.48, respectively. Conclusions: Compared with standard reconstruction algorithms, high-definition CT imaging technique with dedicated high-resolution reconstruction algorithm provides more accurate stent characterization and intrastent luminal diameter measurement.

  19. Spectral Analysis Related to Bare-Metal and Drug-Eluting Coronary Stent Implantation

    Directory of Open Access Journals (Sweden)

    Rose Mary Ferreira Lisboa da Silva

    2014-08-01

    Full Text Available Background: The autonomic nervous system plays a central role in cardiovascular regulation; sympathetic activation occurs during myocardial ischemia. Objective: To assess the spectral analysis of heart rate variability during stent implantation, comparing the types of stent. Methods: This study assessed 61 patients (mean age, 64.0 years; 35 men with ischemic heart disease and indication for stenting. Stent implantation was performed under Holter monitoring to record the spectral analysis of heart rate variability (Fourier transform, measuring the low-frequency (LF and high-frequency (HF components, and the LF/HF ratio before and during the procedure. Results: Bare-metal stent was implanted in 34 patients, while the others received drug-eluting stents. The right coronary artery was approached in 21 patients, the left anterior descending, in 28, and the circumflex, in 9. As compared with the pre-stenting period, all patients showed an increase in LF and HF during stent implantation (658 versus 185 ms2, p = 0.00; 322 versus 121, p = 0.00, respectively, with no change in LF/HF. During stent implantation, LF was 864 ms2 in patients with bare-metal stents, and 398 ms2 in those with drug-eluting stents (p = 0.00. The spectral analysis of heart rate variability showed no association with diabetes mellitus, family history, clinical presentation, beta-blockers, age, and vessel or its segment. Conclusions: Stent implantation resulted in concomitant sympathetic and vagal activations. Diabetes mellitus, use of beta-blockers, and the vessel approached showed no influence on the spectral analysis of heart rate variability. Sympathetic activation was lower during the implantation of drug-eluting stents.

  20. Spectral Analysis Related to Bare-Metal and Drug-Eluting Coronary Stent Implantation

    Energy Technology Data Exchange (ETDEWEB)

    Silva, Rose Mary Ferreira Lisboa da, E-mail: roselisboa@cardiol.br [Faculdade de Medicina da UFMG, Divinópolis, MG (Brazil); Silva, Carlos Augusto Bueno [Faculdade de Medicina da UFMG, Divinópolis, MG (Brazil); Belo Horizonte, Hospital São João de Deus, Divinópolis, MG (Brazil); Greco, Otaviano José [Belo Horizonte, Hospital São João de Deus, Divinópolis, MG (Brazil); Moreira, Maria da Consolação Vieira [Faculdade de Medicina da UFMG, Divinópolis, MG (Brazil)

    2014-08-15

    The autonomic nervous system plays a central role in cardiovascular regulation; sympathetic activation occurs during myocardial ischemia. To assess the spectral analysis of heart rate variability during stent implantation, comparing the types of stent. This study assessed 61 patients (mean age, 64.0 years; 35 men) with ischemic heart disease and indication for stenting. Stent implantation was performed under Holter monitoring to record the spectral analysis of heart rate variability (Fourier transform), measuring the low-frequency (LF) and high-frequency (HF) components, and the LF/HF ratio before and during the procedure. Bare-metal stent was implanted in 34 patients, while the others received drug-eluting stents. The right coronary artery was approached in 21 patients, the left anterior descending, in 28, and the circumflex, in 9. As compared with the pre-stenting period, all patients showed an increase in LF and HF during stent implantation (658 versus 185 ms2, p = 0.00; 322 versus 121, p = 0.00, respectively), with no change in LF/HF. During stent implantation, LF was 864 ms2 in patients with bare-metal stents, and 398 ms2 in those with drug-eluting stents (p = 0.00). The spectral analysis of heart rate variability showed no association with diabetes mellitus, family history, clinical presentation, beta-blockers, age, and vessel or its segment. Stent implantation resulted in concomitant sympathetic and vagal activations. Diabetes mellitus, use of beta-blockers, and the vessel approached showed no influence on the spectral analysis of heart rate variability. Sympathetic activation was lower during the implantation of drug-eluting stents.

  1. Optimal duration of dual antiplatelet therapy after coronary stent implantation.

    Science.gov (United States)

    Witberg, Guy; Lev, Eli; Kornowski, Ran

    2015-11-15

    Dual antiplatelet pharmacotherapy reduces ischemic events at the cost of excess bleeding in patients who underwent coronary stenting. The currently recommended treatment period is based on trials held some 20 years ago and not relevant to current clinical practice. In recent years, numerous clinical trials have tried to answer the question of what is the optimal duration of therapy to maximize clinical benefit. These trials showed 2 seemingly conflicting answers-on one hand, shorter treatment duration seems to be safer in reducing bleeding while not increasing ischemic events, and on the other hand, longer duration is superior in terms of preventing ischemic events albeit at the cost of increased bleeding rates. In this review, we summarize the evidence favoring each approach, highlight the limitations of the various pivotal clinical trials in this field, review future directions of research and changes in practice that may influence the duration of antiplatelet therapy, and attempt to propose a personalized approach to achieve maximal benefit for the individual patient. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Fibrin clot formation and fibrinolysis in patients with a history of coronary stent thrombosis.

    Science.gov (United States)

    Godschalk, Thea C; Konings, Joke; Govers-Riemslag, José W; Ten Berg, Jurriën M; Hackeng, Christian M; Ten Cate, Hugo

    2016-07-01

    Coronary stent thrombosis is a devastating complication of percutaneous coronary intervention (PCI). Multiple factors underlie the pathophysiological mechanisms of stent thrombosis. Previous studies demonstrated that patients with stent thrombosis, compared to control PCI patients, formed denser fibrin clots in vitro which were more resistant to fibrinolysis, suggesting that altered fibrin clot properties may contribute to the pathophysiology of stent thrombosis. We assessed the plasma fibrin clot formation and fibrinolysis of patients with and without stent thrombosis. Cases (patients with stent thrombosis) and matched controls (patients without stent thrombosis) were included for a matched case-control study. Matching was performed on indication and time of the index PCI (initial stent implantation) from the cases. Fibrin clot formation and fibrinolysis were assessed in vitro by turbidimetric assays, with human thrombin to initiate fibrin polymerization and tissue type plasminogen activator to initiate fibrinolysis. Lag time, maximal absorbance and clot lysis time were determined by these assays. In total, 27 cases and 27 controls were included. No significant differences were observed between cases and controls in lag time (173 vs. 162s, p=0.18), maximal absorbance (0.78 vs. 0.83, p=0.36), and clot lysis time (69 vs. 71min, p=0.78). Fibrin clot formation and fibrinolysis were not associated with stent thrombosis. Plasma fibrin clot formation and fibrinolysis were not significantly different between patients with stent thrombosis and matched control patients, suggesting that fibrin clot formation and fibrinolysis play no significant role in the pathophysiology of stent thrombosis. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Two hour ambulation after coronary angioplasty and stenting with 6 F guiding catheters and low dose heparin

    NARCIS (Netherlands)

    Koch, K. T.; Piek, J. J.; de Winter, R. J.; Mulder, K.; Schotborgh, C. E.; Tijssen, J. G.; Lie, K. I.

    1999-01-01

    OBJECTIVE: To evaluate the feasibility and safety of ambulation of patients two hours after elective coronary angioplasty or stenting, or both. METHODS: Coronary angioplasty and stenting were performed using 6 F guiding catheters by the femoral approach and a standard dose of heparin 5000 IU. There

  4. New-generation stents compared with coronary bypass surgery for unprotected left main disease: A word of caution.

    Science.gov (United States)

    Benedetto, Umberto; Taggart, David P; Sousa-Uva, Miguel; Biondi-Zoccai, Giuseppe; Di Franco, Antonino; Ohmes, Lucas B; Rahouma, Mohamed; Kamel, Mohamed; Caputo, Massimo; Girardi, Leonard N; Angelini, Gianni D; Gaudino, Mario

    2018-01-12

    With the advent of bare metal stents and drug-eluting stents, percutaneous coronary intervention has emerged as an alternative to coronary artery bypass grafting surgery for unprotected left main disease. However, whether the evolution of stents technology has translated into better results after percutaneous coronary intervention remains unclear. We aimed to compare coronary artery bypass grafting with stents of different generations for left main disease by performing a Bayesian network meta-analysis of available randomized controlled trials. All randomized controlled trials with at least 1 arm randomized to percutaneous coronary intervention with stents or coronary artery bypass grafting for left main disease were included. Bare metal stents and drug-eluting stents of first- and second-generation were compared with coronary artery bypass grafting. Poisson methods and Bayesian framework were used to compute the head-to-head incidence rate ratio and 95% credible intervals. Primary end points were the composite of death/myocardial infarction/stroke and repeat revascularization. Nine randomized controlled trials were included in the final analysis. Six trials compared percutaneous coronary intervention with coronary artery bypass grafting (n = 4654), and 3 trials compared different types of stents (n = 1360). Follow-up ranged from 6 months to 5 years. Second-generation drug-eluting stents (incidence rate ratio, 1.3; 95% credible interval, 1.1-1.6), but not bare metal stents (incidence rate ratio, 0.63; 95% credible interval, 0.27-1.4), and first-generation drug-eluting stents (incidence rate ratio, 0.85; 95% credible interval, 0.65-1.1) were associated with a significantly increased risk of death/myocardial infarction/stroke when compared with coronary artery bypass grafting. When compared with coronary artery bypass grafting, the highest risk of repeat revascularization was observed for bare metal stents (hazard ratio, 5.1; 95% confidence interval, 2

  5. Modeling smooth muscle cell proliferation of coronary artery expanded with a drug eluting stent

    Science.gov (United States)

    Lyu, Suping

    2010-03-01

    The drug eluting coronary stent is for the treatment of narrowed coronary artery. A high strength balloon is used to open the narrowed vessel and leave behind a tiny metal mesh, or stent, to mechanically prevent the vessel from re-narrowing and biologically slow down proliferation of the smooth muscle cells. However, the drug eluting stents that had better performance also more seriously prevented the healing processes of the vessels, which could cause serious thrombotic reactions. In this study, we assume the healing process is controlled by proper proliferation of smooth cells. We also assume that the inflammation reactions and mechanical traction drive the smooth muscle cells to proliferate while the drug loaded in the stents drives the processes at the opposite direction. Numerical calculation was applied to the system. The drug distribution and elution durations, inflammation reactions and mechanical traction were discussed.

  6. Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design

    DEFF Research Database (Denmark)

    Pfisterer, M.; Bertel, O.; Bonetti, P.O.

    2008-01-01

    Background Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitats Trial (BASKET) outcome data, we hypothesized that very late (>12 months) stent thrombosis occurs predominantly after drug-eluting stent implantation in large native coronary vessel stenting. Methods To prove or r...... to cobalt-chromium bare-metal stents in this relevant, low-risk group of everyday patients. In addition, a comparison with similar BASKET patients will allow to estimate the impact of 12-versus 6-month dual antiplatelet therapy on these outcomes Udgivelsesdato: 2008/4......Background Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitats Trial (BASKET) outcome data, we hypothesized that very late (>12 months) stent thrombosis occurs predominantly after drug-eluting stent implantation in large native coronary vessel stenting. Methods To prove...... or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with >= 3.0-mm stents only, randomized to receive Cypher (Johnson & Johnson, Miami Lakes, FL), Vision (Abbott Vascular, Abbott Laboratories, IL), or Xience stents (Abbott Vascular). Only...

  7. Evaluation Of Cobalt and Chromium Levels Following Implantation of Cobalt Chromium Coronary Stents: A Pilot Study.

    Science.gov (United States)

    Di Santo, Pietro; Motazedian, Pouya; Jung, Richard G; Simard, Trevor; Ramirez, F Daniel; Chong, Aun-Yeong; Glover, Christopher; Hibbert, Benjamin; Dwivedi, Girish

    2017-12-14

    Large increases in myocardial trace elements may adversely affect metabolism and become detrimental to cardiac function. Percutaneous coronary intervention (PCI) allows for the revascularisation of obstructive coronary artery disease using drug-eluting stents. These stents are comprised of a metallic stent backbone covered in an engineered polymer which delivers a drug over a prescribed period to the vessel wall. Given the potential implications of trace metal accumulation within the myocardium, our goal is to determine if metallic coronary stents are able to cause detectable elevations in serum cobalt and/or chromium levels. This study was a single centre, observational, pilot study with 20 patients who underwent planned PCI with implantation of a cobalt chromium drug eluting stent. Serum blood samples were drawn at baseline prior to PCI, 4hours post-stent deployment and at the time of routine follow-up after PCI. All blood samples were analysed for cobalt and chromium concentrations. The primary outcome of this study was the difference in serum cobalt and chromium levels at routine clinical follow-up. The mean follow up was 64.1±17.3 days. There was no difference in serum cobalt levels when comparing baseline and routine clinical follow up (3.32±2.14nmol/L vs. 3.14±1.00nmol/L, p=0.99) nor in chromium levels (4.24±2.31nmol/L vs. 2.82±1.22 nmol/L, p=0.11). There was also no difference between baseline and 4hours post-PCI serum concentrations. Percutaneous coronary intervention with cobalt chromium coronary stents does not appear to cause an elevation in these trace element serum concentrations. Copyright © 2017 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). All rights reserved.

  8. Coronary artery rupture during high-pressure post-dilatation of coronary stent in a heavily calcified lesion of an ectatic right coronary artery

    Directory of Open Access Journals (Sweden)

    Sina Ali

    2016-06-01

    Full Text Available Coronary artery perforation (CAP is a rare but feared complication of percutaneous coronary intervention. With the use of novel instruments, including hydrophilic and ultrarigid guidewires, rotablator devices, and cutting balloons, the success rate of intervention for coronary artery chronic total occlusion (CTOs and calcified lesions has increased. Along with these changes, the risk of CAP has also increased. In this case report, we present a tip III CAP due to high-pressure postdilatation of coronary stent in a heavily calcified lesion of an ectatic right coronary artery.

  9. [Percutaneous approach for the treatment of unprotected left main coronary stenosis. New perspectives with the use of coronary stents].

    Science.gov (United States)

    Pessanha, A V; Rodrigues, C; Fuks, V; Murad, H; Murad, M

    1997-03-01

    We describe a case of coronary stenosis located in an unprotected left main coronary artery, treated primarily and electively with the placement of a coronary stent. As a function of the large mass of myocardium involved, this patient would be considered a classical candidate for direct surgery, because the inherent risk involved with conventional balloon angioplasty, mainly due to the eventual occurrence of acute closure during the procedure. Since the previsibility of the immediate results with the use of coronary stents was significantly improved, we propose this new therapeutic approach for this traditionally surgical case, that has been performed with success and without any complication. This strategy for the treatment of unprotected left main lesions with the elective placement of Palmaz-Schatz stents, has not yet been proposed or applied in our country, and may represent a new universe of indication of percutaneous treatment of coronary artery disease, no longer approaching the left main stem only in special or emergency situations, usually a result of complications of left main manipulation during angioplasty of the coronary system. The patient involved in this case did not show any contraindication for the treatment with conventional open heart surgery.

  10. Selective endothelin A-receptor blockade attenuates coronary microvascular dysfunction after coronary stenting in patients with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Nikolaos Östlund Papadogeorgos

    2009-10-01

    Full Text Available Nikolaos Östlund Papadogeorgos, Mattias Bengtsson, Majid KalaniKarolinska Institute, Department of Clinical Sciences, Department of Cardiology, Danderyd Hospital, Stockholm, SwedenBackground: Endothelin-1 may be involved in the development of diabetic microangiopathy. We studied the effect of endothelin-1 blockade on myocardial microcirculation during coronary stenting.Patients and methods: Patients with type 2 diabetes and stable coronary artery disease undergoing elective percutaneous coronary intervention (PCI were randomized to bolus dose of 500 mg bosentan (n = 4, a dual endothelin receptor blocker, or intracoronary administration of 0.03 mmol BQ123 (n = 6, a selective endothelin A-receptor blocker, or placebo (n = 5, respectively. Coronary flow reserve (CFR was measured immediately post-PCI. CFR was also measured in five nondiabetic controls post-coronary stenting.Results: Patients in the placebo group had (P < 0.05 lower values of CFR (2.3 ± 1.2 as compared to those who received endothelin blockade (n = 10; 3.1 ± 0.7 and nondiabetic controls (4.9 ± 2.3. Patients who received BQ123 showed significantly higher CFR (3.3 ± 0.5; P < 0.05 as compared to those on placebo. Nondiabetic patients had significantly higher CFR as compared to patients with diabetes (4.9 ± 2.3 and 2.8 ± 1.0, respectively; P < 0.05. Conclusion: Coronary microvascular dysfunction is present during coronary stenting in patients with type 2 diabetes and may be reversed by selective endothelin A-receptor blockade. Targeting endothelin system may be of importance in protecting the myocardium against ischemic events during elective PCI in type 2 diabetic patients.Keywords: coronary flow reserve, diabetes, endothelin-1, coronary artery disease, coronary angioplasty

  11. Twelve-month outcomes after coronary stenting with the Genous bio-engineered R Stent in diabetic patients from the e-HEALING registry

    NARCIS (Netherlands)

    Damman, P.; Klomp, M.; Beijk, M.A.; Silber, S.; Grisold, M.; Ribeiro, E.E.; Suryapranata, H.; Wojcik, J.; Sim, K.H.; Tijssen, J.G.P.; Winter, R.J. de

    2011-01-01

    OBJECTIVES: We compared 12-month outcomes, regarding ischemic events, repeat intervention, and ST, between diabetic and nondiabetic patients treated with the Genous EPC capturing R stent during routine nonurgent percutaneous coronary intervention (PCI) using data from the multicenter, prospective

  12. Safety and Technical Success of Percutaneous Left Main Coronary Artery Stenting

    Science.gov (United States)

    Ali, Liaqat; Malik, Shahid Nawaz; Khalid, Abdullah Bin; Sultan, Mehboob; Sadiq, Nadeem

    2014-01-01

    Objective: Critical stenosis of left main coronary artery (LMCA) has always remained a challenge for interventional cardiologists. Conventionally Coronary Artery Bypass Grafting (CABG) is done for these patients but recently Percutaneous Coronary Intervention (PCI) is also being tried more frequently, but data of PCI is scarce in this regard. Our objective was to determine the safety and technical success rate of percutaneous left main coronary artery stenting. Methods: This was 12 month follow up study conducted at Pakistan Institute of Medical Sciences (PIMS), Islamabad from 11th Jan 2012 to 11th Jan 2013. All symptomatic patients who underwent coronary angiogram at PIMS and were found to have either isolated LMCA disease or coexisting osteal Left Anterior Descending (LAD) artery disease were potentially eligible for the study. Patients who had previous surgical treatment for coronary artery disease and those with renal dysfunction requiring dialysis were excluded. Patients were counselled in detail regarding the pros and cons of PCI versus CABG.Those who opted for PCI were included in the study. All these patients were treated with percutaneous left main coronary artery stenting with or without osteal LAD stenting. Results: Seventy two patients had LMCA disease during angiogram. Fifteen patients opted for CABG. Four patients did not meet the inclusion criteria, whereas 53 patients were finally enrolled. Mean age of patients were 55.45±10.275 years. Twenty nine patients were with acute coronary syndrome and 22 presented with unstable angina.PCI with stenting was technically successful in all patients. One patient died three months after PCI, there was no other mortality. Conclusion: Our study showed that Percutaneous Coronary Intervention (PCI) to LMS has good technical success rate; the safety of the procedure is also acceptable. PMID:25097507

  13. Diagnostic accuracy of 64 multislice CT angiography in the assessment of coronary in-stent restenosis: A meta-analysis

    Energy Technology Data Exchange (ETDEWEB)

    Sun Zhonghua [Discipline of Medical Imaging, Department of Imaging and Applied Physics, Curtin University of Technology, Perth, WA (Australia)], E-mail: z.sun@curtin.edu.au; Almutairi, Abdulrahman Marzouq D. [Discipline of Medical Imaging, Department of Imaging and Applied Physics, Curtin University of Technology, Perth, WA (Australia)

    2010-02-15

    Purpose: The aim of this study was to perform a meta-analysis of the diagnostic accuracy of 64-slice CT angiography for the detection of coronary in-stent restenosis in patients treated with coronary stents when compared to conventional coronary angiography. Materials and methods: A search of PUBMED/MEDLINE, ProQuest and Cochrane library databases for English literature was performed. Only studies comparing 64-slice CT angiography with conventional coronary angiography for the detection of coronary in-stent restenosis (more than 50% stenosis) were included for analysis. Sensitivity and specificity estimates pooled across studies were tested using a fixed effects model. Results: Fourteen studies met selection criteria for inclusion in the analysis. The mean value of assessable stents was 89%. Prevalence of in-stent restenosis following coronary stenting was 20% among these studies. Pooled estimates of the sensitivity and specificity of overall 64-slice CT angiography for the detection of coronary in-stent restenosis was 90% (95% CI: 86%, 94%) and 91% (95% CI: 90%, 93%), respectively, based on the evaluation of assessable stents. Diagnostic value of 64-slice CT angiography was found to decrease significantly when the analysis was performed with inclusion of nonassessable segments in five studies, with pooled sensitivity and specificity being 79% (95% CI: 68%, 88%) and 81% (95% CI: 77%, 84%). Stent diameter is the main factor affecting the diagnostic value of 64-slice CT angiography. Conclusion: Our results showed that 64-slice CT angiography has high diagnostic value (both sensitivity and specificity) for detection of coronary in-stent restenosis based on assessable segments when compared to conventional coronary angiography.

  14. In-Vitro Evaluation of Coronary Stents and 64-Detector-Row Computed Tomography Using a Newly Developed Model of Coronary Artery Stenosis

    Energy Technology Data Exchange (ETDEWEB)

    Schlosser, T.; Scheuermann, T.; Ulzheimer, S.; Mohrs, O.K.; Kuehling, M.; Albrecht, P.E.; Voigtlaender, T.; Barkhausen, J.; Schmermund, A. (Cardiovascular Center Bethanien (CCB), Frankfurt (DE))

    2008-02-15

    Background: Stent implantation is the predominant therapy for non-surgical myocardial revascularization in patients with coronary artery disease. However, despite substantial advances in multidetector computed tomography (MDCT) coronary imaging, a reliable detection of coronary in-stent restenosis is currently not possible. Purpose: To examine the ability of 64-detector-row CT to detect and to grade in-stent stenosis in coronary stents using a newly developed ex-vivo vessel phantom with a realistic CT density pattern, artificial stenosis, and a thorax phantom. Material and Methods: Four different stents (Liberte and Lunar ROX, Boston Scientific; Driver, Medtronic; Multi-Link Vision, Guidant) were examined. The stents were placed on a polymer tube with a diameter of 2.5, 3.0, 3.5, or 4.0 mm. Different degrees of stenosis (0%, 30%, 50%, 70-80%) were created inside the tube. For quantitative analysis, attenuation values were measured in the non-stenotic vessel outside the stent, in the non-stenotic vessel inside the stent, and in the stenotic area inside the stent. The grade of stenosis was visually assessed by two observers. Results: All stents led to artificial reduction of attenuation, the least degree of which was found in the Liberte stent (11.3+-10.2 HU) and the Multi-Link Vision stent (17.6+-17.9 HU; P 0.25). Overall, the non-stenotic vessel was correctly diagnosed in 55.5%, the low-grade stenosis in 58.3%, the intermediate stenosis in 63.8%, and the high-grade stenosis in 80.5%. In the 3.0-, 3.5-, and 4.0-mm vessels, in none of the cases was a non-stenotic or low-grade stenotic vessel misdiagnosed as intermediate or high-grade stenosis. The average deviation from the real grade of stenosis was 0.40 for the Liberte stent, 0.46 for the Lunar ROX stent, 0.45 for the Driver stent, and 0.58 for the Multi-Link Vision stent. Conclusion: Our ex-vivo data show that non-stenotic stents and low-grade in-stent stenosis can be reliably differentiated from intermediate and

  15. Reduction of late in-stent stenosis in a porcine coronary artery model by cobalt chromium stents with a nanocoat of polyphosphazene (Polyzene-F).

    Science.gov (United States)

    Stampfl, Ulrike; Sommer, Christof-Matthias; Thierjung, Heidi; Stampfl, Sibylle; Lopez-Benitez, Ruben; Radeleff, Boris; Berger, Irina; Richter, Goetz M

    2008-01-01

    The purpose of this study was to investigate the potential of nanoscale coating with the highly biocompatible polymer Polyzene-F (PZF), in combination with cobalt chromium and stainless steel stents, to reduce in-stent stenosis, thrombogenicity, and vessel wall injury and inflammation. One bare cobalt chromium, PZF-nanocoated stainless steel or PZF-nanocoated cobalt chromium stent was implanted in right coronary artery of 30 mini-pigs (4- or 12-week follow-up). Primary study end points were in-stent stenosis and thrombogenicity. Secondary study end points were vessel wall injury and inflammation as evaluated by microscopy and a new immunoreactivity score applying C-reactive protein (CRP), tumor-necrosis factor alpha (TNFalpha), and TGFbeta. At 12 weeks, angiography showed a significantly lower average loss in lumen diameter (2.1% +/- 3.05%) in PZF-nanocoated cobalt chromium stents compared with stents in the other groups (9.73% +/- 4.93% for bare cobalt chromium stents and 9.71% +/- 7% for PZF-nanocoated stainless steel stents; p = 0.04), which was confirmed at microscopy (neointima 40.7 +/- 16 lm in PZF-nanocoated cobalt chromium stents, 74.7 +/- 57.6 lm in bare cobalt chromium stents, and 141.5 +/- 109 lm in PZF-nanocoated stainless steel stents; p = 0.04). Injury and inflammation scores were low in all stents and were without significant differences. PZF-nanocoated cobalt chromium stents provided the highest efficacy in reducing in-stent stenosis at long-term follow-up. The PZF nanocoat proved to be biocompatible with respect to thromboresistance and inflammation. Our data suggest that its combination with cobalt chromium stents might provide an interesting passive stent platform.

  16. Long-term clinical effects of magnetic resonance imaging in patients with coronary artery stent implantation.

    Science.gov (United States)

    Kaya, Mehmet Gungor; Okyay, Kaan; Yazici, Huseyin; Sen, Nihat; Tavil, Yusuf; Turkoglu, Sedat; Timurkaynak, Timur; Ozdemir, Murat; Cemri, Mustafa; Yalcin, Ridvan; Cengel, Atiye

    2009-03-01

    We sought to investigate the early and late effects of magnetic resonance imaging (MRI) on stent thrombosis and major adverse coronary events after coronary artery stent (CAS) implantation at a long-term follow-up period. Forty-three patients (28 men, mean age 63+/-10 years) who underwent CAS implantation before MRI examination were included. MRI was performed on a 1.5-T MR-system with a phased array multicoil. An average of 1.3 stents per patient were implanted (1-4 stents). More than one MRI was performed for two patients. Patients who underwent MRI within 8 weeks after the procedure were included in the early-term group (17 patients), and those who underwent MRI after 8 weeks were included in the late-term group (26 patients). Mean follow-up period was 36+/-15 months. There was no acute or subacute stent thrombosis. Late stent thrombosis that resulted in acute myocardial infarction was observed in a patient from the early group after an operation for prostate hyperplasia 5 months after MRI, and the patient underwent percutaneous coronary artery angioplasty. De-nova lesion was observed in four patients in the early group and two patients in the late group (P=0.14). In-stent restenosis was recorded in two patients in the early group and three patients in the late group (P=0.98). Composite major adverse cardiac events (acute coronary syndrome, myocardial infarction, death, and cerebrovascular event) were observed in seven of the early-group patients (41%), and in six of the late-group patients (23%) (P=0.20). MRI can be safely performed in patients with CAS implantation both in the early and late course, and is not associated with an increased risk of major adverse clinical cardiac events at long-term follow-up.

  17. Detailing radio frequency heating induced by coronary stents: a 7.0 Tesla magnetic resonance study.

    Directory of Open Access Journals (Sweden)

    Davide Santoro

    Full Text Available The sensitivity gain of ultrahigh field Magnetic Resonance (UHF-MR holds the promise to enhance spatial and temporal resolution. Such improvements could be beneficial for cardiovascular MR. However, intracoronary stents used for treatment of coronary artery disease are currently considered to be contra-indications for UHF-MR. The antenna effect induced by a stent together with RF wavelength shortening could increase local radiofrequency (RF power deposition at 7.0 T and bears the potential to induce local heating, which might cause tissue damage. Realizing these constraints, this work examines RF heating effects of stents using electro-magnetic field (EMF simulations and phantoms with properties that mimic myocardium. For this purpose, RF power deposition that exceeds the clinical limits was induced by a dedicated birdcage coil. Fiber optic probes and MR thermometry were applied for temperature monitoring using agarose phantoms containing copper tubes or coronary stents. The results demonstrate an agreement between RF heating induced temperature changes derived from EMF simulations versus MR thermometry. The birdcage coil tailored for RF heating was capable of irradiating power exceeding the specific-absorption rate (SAR limits defined by the IEC guidelines by a factor of three. This setup afforded RF induced temperature changes up to +27 K in a reference phantom. The maximum extra temperature increase, induced by a copper tube or a coronary stent was less than 3 K. The coronary stents examined showed an RF heating behavior similar to a copper tube. Our results suggest that, if IEC guidelines for local/global SAR are followed, the extra RF heating induced in myocardial tissue by stents may not be significant versus the baseline heating induced by the energy deposited by a tailored cardiac transmit RF coil at 7.0 T, and may be smaller if not insignificant than the extra RF heating observed under the circumstances used in this study.

  18. Stent Thrombosis is the Primary Cause of ST-Segment Elevation Myocardial Infarction following Coronary Stent Implantation: A Five Year Follow-Up of the SORT OUT II Study

    DEFF Research Database (Denmark)

    Kristensen, S. L.; Galloe, A. M.; Thuesen, L.

    2014-01-01

    stent implantation, use of statins, initial PCI urgency (STEMI [primary PCI], NSTEMI/unstable angina [subacute PCI] or stable angina [elective PCI]), and glucose-lowering agents did not seem to influence risk of stent thrombosis. Conclusion: In a contemporary cohort of coronary stented patients, stent...

  19. Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis).

    Science.gov (United States)

    Kandzari, David E; Smits, Pieter C; Love, Michael P; Ben-Yehuda, Ori; Banai, Shmuel; Robinson, Simon D; Jonas, Michael; Kornowski, Ran; Bagur, Rodrigo; Iniguez, Andres; Danenberg, Haim; Feldman, Robert; Jauhar, Rajiv; Chandna, Harish; Parikh, Manish; Perlman, Gidon Y; Balcells, Mercedes; Markham, Peter; Ozan, Melek Ozgu; Genereux, Philippe; Edelman, Elazer R; Leon, Martin B; Stone, Gregg W

    2017-10-03

    The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01). In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. URL: http

  20. Successful Coronary Stent Retrieval from the Saphenous Vein Graft to Right Coronary Artery

    Directory of Open Access Journals (Sweden)

    Mustafa Aydin

    2009-01-01

    Full Text Available Stent dislodgement and migration is a rare but serious complication of stent usage. For extraction of unexpanded stents different techniques have been described previously. We describe a case which used small baloon catheter for retrieval of a stent from the SVG-RCA.

  1. Microstructure and Deformation of Coronary Stents from CoCr-Alloys with Different Designs

    Directory of Open Access Journals (Sweden)

    Sabine Weiss

    2015-05-01

    Full Text Available Coronary heart disease is still one of the most common sources for death in western industrial countries. Since 1986, a metal vessel scaffold (stent has been inserted to prevent the vessel wall from collapsing. Most of these coronary stents are made from CrNiMo­steel (316L. Due to its austenitic structure, the material shows a good combination of strength, ductility, corrosion resistance, and biocompatibility. However, this material has some disadvantages like its non-MRI compatibility and its poor fluoroscopic visibility. Other typically used materials are the Co­Base alloys L-605 and F-562 which are MRI compatible as well as radiopaque. Another interesting fact is their excellent radial strength and therefore the ability to produce extra thin struts with increased strength. However, because of a strut diameter much less than 100 μm, the cross section consists of about 5 to 10 crystal grains (oligo­crystalline. Thus, very few or even just one grain can be responsible for the success or failure of the whole stent. To investigate the relation between microstructure, mechanical factors and stent design, commercially available Cobalt-Chromium stents were investigated with focus on distinct inhomogeneous plastic deformation due to crimping and dilation. A characteristic, material related deformation behavior with predominantly primary slip was identified to be responsible for the special properties of CoCr stents.

  2. Shrinking the Supply Chain for Implantable Coronary Stent Devices.

    Science.gov (United States)

    Moore, Sean S; O'Sullivan, Kevin J; Verdecchia, Francesco

    2016-02-01

    Stenting treatments for the management of disease in the heart, arterial and venous systems, biliary ducts, urethras, ureters, oesophageal tract and prostate have made enormous technical advances since their introduction into clinical use. The progression from metallic to polymer based bio-absorbable stents, coupled with the advances in additive manufacturing techniques, present a unique opportunity to completely re-envision the design, manufacture, and supply chain of stents. This paper looks at current stenting trends and proposes a future where the stent supply chain is condensed from ~150 days to ~20 min. The Cardiologist therefore has the opportunity to become a designer, manufacturer and user with patients receiving custom stents specific to their unique pathology that will be generated, delivered and deployed in the Cath-lab. The paper will outline this potentially revolutionary development and consider the technical challenges that will need to be overcome in order to achieve these ambitious goals. A high level overview of the generating eluting stents in situ program-GENESIS-is outlined including some early experimental work.

  3. Coronary Artery Bypass Surgery Versus Drug-Eluting Stent Implantation for Left Main or Multivessel Coronary Artery Disease A Meta-Analysis of Individual Patient Data

    NARCIS (Netherlands)

    Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Suwannasom, Pannipa; Tenekecioglu, Erhan; Yun, Sung-Cheol; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Serruys, Patrick W.; Park, Seung-Jung

    2016-01-01

    OBJECTIVES The authors undertook a patient-level meta-analysis to compare long-term outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,280 patients with left main or multivessel coronary artery disease (CAD).

  4. Coronary artery aneurysm formation following implantation of a bioresorbable vascular scaffold for in-stent restenosis.

    Science.gov (United States)

    García-Guimaraes, Marcos; Cuesta, Javier; Alvarado, Teresa; Rivero, Fernando; Bastante, Teresa; Benedicto, Amparo; Alfonso, Fernando

    2017-06-01

    Coronary artery aneurysm (CAA) formation is a rare complication of coronary intervention that may develop after implantation of bare-metal or drug-eluting stents. The etiology of this entity appears to be multifactorial and its prognosis is poorly understood, but it has been associated with an increased risk of stent thrombosis. To date few cases of CAAs related to bioresorbable vascular scaffold (BVS) implantation have been reported, and the development of CAA after BVS implantation for the treatment of in-stent restenosis (ISR) has not been previously described. Here we present two cases of CAA formation after BVS, which represent the first demonstration of CAA formation after the use of BVS for ISR. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  5. Similar five-year outcome with paclitaxel- and sirolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Bligaard, Niels; Thuesen, Leif; Saunamäki, Kari

    2014-01-01

    OBJECTIVE: Millions of patients were treated with the sirolimus-eluting Cypher™ and the paclitaxel-eluting Taxus™ coronary stents with potential late-occurring increase in event rates. Therefore, the long-term outcome follow-up is of major clinical interest. DESIGN: In total, 2.098 unselected...

  6. Automatic detection of bioabsorbable coronary stents in IVUS images using a cascade of classifiers.

    Science.gov (United States)

    Rotger, David; Radeva, Petia; Bruining, Nico

    2010-03-01

    Bioabsorbable drug-eluting coronary stents present a very promising improvement to the common metallic ones solving some of the most important problems of stent implantation: the late restenosis. These stents made of poly-L-lactic acid cause a very subtle acoustic shadow (compared to the metallic ones) making difficult the automatic detection and measurements in images. In this paper, we propose a novel approach based on a cascade of GentleBoost classifiers to detect the stent struts using structural features to code the information of the different subregions of the struts. A stochastic gradient descent method is applied to optimize the overall performance of the detector. Validation results of struts detection are very encouraging with an average F-measure of 81%.

  7. Bioresorbable vascular scaffold for coronary in-stent restenosis: A novel concept

    Directory of Open Access Journals (Sweden)

    Surender Deora

    2014-07-01

    Full Text Available The management of patients with significant in-stent restenosis (ISR with drug-eluting stent is still not well defined. Various treatment modalities include plain old balloon angioplasty (POBA, metallic stent, cutting or scoring balloon and drug-eluting balloon (DEB. Bioresorbable vascular scaffold (BVS is the latest technology for the treatment of de novo coronary artery lesions. The use of BVS in ISR is based on the rationale of local drug delivery as achieved by DEB without the permanent bi-layer of metal and also stabilizes dissection flaps and prevents acute recoil as provided by metallic stent. To the best of our knowledge this is the first case report of the use of BVS in patient with ISR.

  8. Association of Coronary Perivascular Adipose Tissue Inflammation and Drug-Eluting Stent-Induced Coronary Hyperconstricting Responses in Pigs:18F-Fluorodeoxyglucose Positron Emission Tomography Imaging Study.

    Science.gov (United States)

    Ohyama, Kazuma; Matsumoto, Yasuharu; Amamizu, Hirokazu; Uzuka, Hironori; Nishimiya, Kensuke; Morosawa, Susumu; Hirano, Michinori; Watabe, Hiroshi; Funaki, Yoshihito; Miyata, Satoshi; Takahashi, Jun; Ito, Kenta; Shimokawa, Hiroaki

    2017-09-01

    Although coronary perivascular adipose tissue (PVAT) may play important roles as a source of inflammation, the association of coronary PVAT inflammation and coronary hyperconstricting responses remains to be examined. We addressed this important issue in a porcine model of coronary hyperconstricting responses after drug-eluting stent implantation with 18 F-fluorodeoxyglucose ( 18 F-FDG) positron emission tomographic imaging. An everolimus-eluting stent (EES) was randomly implanted in pigs into the left anterior descending or the left circumflex coronary artery while nonstented coronary artery was used as a control. After 1 month, coronary vasoconstricting responses to intracoronary serotonin (10 and 100 μg/kg) were examined by coronary angiography in vivo, followed by in vivo and ex vivo 18 F-FDG positron emission tomographic/computed tomographic imaging. Coronary vasoconstricting responses to serotonin were significantly enhanced at the EES edges compared with the control site ( P inflammation. © 2017 American Heart Association, Inc.

  9. Prospective registry evaluating safety and efficacy of cobalt-chromium stent implantation in patients with de novo coronary lesions.

    Science.gov (United States)

    Buszman, Paweł; Trznadel, Stanisław; Zurakowski, Aleksander; Milewski, Krzysztof; Kinasz, Leszek; Król, Marek; Kondys, Marek

    2007-09-01

    Cobalt-chromium (Co-Cr) stents are a new type of endovascular prostheses characterised by better mechanical properties than traditional stainless steel stents. To assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Kos stent (Balton, Poland). A total of 59 patients with coronary artery diseases (76% men, aged 60+/-9 years, diabetes - 16.9%, smoking - 62.7%, 11.8% - acute myocardial infarction) underwent PCI for de novo lesions in native coronary vessels. The patients were followed for 6 months for the occurrence of cardiac events. Quantitative coronary angiography was performed at baseline and after 6 months. In total, we implanted 62 stents in 59 coronary arteries. The mean diameter of the stents was 3.18+/-0.18 mm, and length - 14.62+/-2.12 mm. During a one-month follow-up period no cardiac events were noted. During a 6-month follow-up no death or new myocardial infarction were recorded. Control angiography was done in 55 (92%) subjects. Repeated target vessel revascularisation due to recurrent angina or in-stent restenosis was required in 10 (17%) patients; however, off-line core evaluation found significant re-narrowing in implanted stents (>50% diameter stenosis) only in 6 cases (10.9%). The mean late vessel lumen loss was 0.55+/-0.6 mm and stenosis 25.2+/-17.9%. Implantation of the new Co-Cr Kos stent during PCI is safe and effective.

  10. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial

    DEFF Research Database (Denmark)

    Rasmussen, Klaus; Maeng, Michael; Kaltoft, Anne

    2010-01-01

    In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery disease who were...

  11. Microvascular Coronary Flow Comparison in Acute Myocardial Infarction Angioplasty treated with a mesh covered stent (MGUARD Stent) versus Bare Metal Stent

    Energy Technology Data Exchange (ETDEWEB)

    Lindefjeld, Dante S., E-mail: dslindef@puc.cl [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Hospital Dr. Sótero del Río, Santiago-Chile (Chile); Guarda, Eduardo [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Méndez, Manuel [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Hospital Dr. Sótero del Río, Santiago-Chile (Chile); Martínez, Alejandro [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Pérez, Osvaldo [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Hospital Dr. Sótero del Río, Santiago-Chile (Chile); Fajuri, Alejandro; Marchant, Eugenio [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Aninat, Mauricio; Torres, Humberto [Hospital Dr. Gustavo Fricke, Viña del Mar-Chile (Chile); Dussaillant, Gastón [Hospital Clínico Universidad de Chile, Santiago-Chile (Chile)

    2013-01-15

    Background: Distal embolization of thrombus/platelet aggregates decreases myocardial reperfusion during primary percutaneous coronary intervention (PCI), and is associated with worse immediate and long-term prognosis of patients with ST-elevation myocardial infarction (STEMI). Objective: Assess the efficacy of a mesh covered stent (MGuard™ stent, MGS) in preventing distal embolization and microvascular reperfusion impairment during primary PCI, compared with a bare metal stent (BMS). Methods: Forty patients with STEMI referred for primary PCI were randomized for stenting the culprit lesion with the MGS (n = 20) or a BMS (n = 20). Blinded experts performed off-line measurements of angiographic epicardial and microvascular reperfusion criteria: TIMI flow grade, myocardial blush, corrected TIMI frame count (cTFC). Results: At baseline clinical, angiographic and procedural variables were not different between groups. Post PCI TIMI flow grade was similar in both groups. We observed better myocardial Blush grade in group MGS compared to BMS (median value 3.0 vs 2.5, 2p = 0.006) and cTFC (mean cTFC: MGS 19.65 ± 4.07 vs BMS 27.35 ± 7.15, 2p < 0.001, cTFC mean difference MGS-BMS: 7.7, CI 95%: 3.94 to 11.46). MGS stent group had a higher percentage of successful angioplasty (cTFC ≤ 23: MGS 85% vs BMS 30%, 2p < 0.001). We had two cases of acute stent thrombosis (one for each group) at 30 days follow up, but no clinical events at 6 months follow up. Conclusions: In this exploratory study, MGS significantly improved microvascular reperfusion criteria compared with a BMS in primary PCI. However its safety and impact on clinical outcomes should be verified in larger randomized clinical trials.

  12. A Review of Stent Thrombosis Following Percutaneous Coronary Intervention at Tripler Army Medical Center: 2002–2012

    Science.gov (United States)

    Fentanes, Emilio; Wisenbaugh, Thomas

    2013-01-01

    Background Stent thrombosis is a leading cause of death after percutaneous coronary intervention (PCI). Over the past decade, 929 PCI procedures were performed. We have found that half of the 18 deaths occurring within 30-days were related to stent thrombosis, and that of 32 patients who had definite or probable stent thrombosis at up to 26 months after PCI, more than half (17) died. To reduce the incidence of this often-fatal outcome, we need to identify and avoid repeating mistakes. Methods We reviewed records and angiograms of 12 patients with definite stent thrombosis. Results Technical factors possibly relevant to stent thrombosis: only half the patients were treated with drug-eluting rather than bare metal stents. Intravascular ultrasound (IVUS) was used to confirm adequate deployment in only 2 cases. Only 1 stent was 10% compared to proximal or distal reference vessel diameter. An untreated edge dissection was identified in only one case. In 5 cases multiple stents were used in bifurcation stenoses including one case of culotte stenting, a well-known risk factor for stent thrombosis. Patient factors possibly relevant to stent thrombosis: Four patients were still smoking at the time of stent thrombosis. One patient had discontinued clopidogrel 10 months after receiving a bare metal stent, and had thrombosis 4 months later. Two years after receiving a drug-eluting stent, 1 patient had stent thrombosis 16 days after discontinuing clopidogrel for a prostate biopsy. In two cases of subsequent, sub-acute stent thrombosis, the stents had been deployed emergently for, respectively, STEMI in the setting of hip surgery and coronary bypass surgery for myocardial infarction associated with 3-vessel disease. Discussion To reduce the incidence of the often-fatal complication of stent thrombosis, we need to try harder to get our patients to quit smoking and to continue diligently following their compliance with clopidogrel. Patient selection is important: those with

  13. The EBC TWO Study (European Bifurcation Coronary TWO): A Randomized Comparison of Provisional T-Stenting Versus a Systematic 2 Stent Culotte Strategy in Large Caliber True Bifurcations.

    Science.gov (United States)

    Hildick-Smith, David; Behan, Miles W; Lassen, Jens F; Chieffo, Alaide; Lefèvre, Thierry; Stankovic, Goran; Burzotta, Francesco; Pan, Manuel; Ferenc, Miroslaw; Bennett, Lorraine; Hovasse, Thomas; Spence, Mark J; Oldroyd, Keith; Brunel, Philippe; Carrie, Didier; Baumbach, Andreas; Maeng, Michael; Skipper, Nicola; Louvard, Yves

    2016-09-01

    For the treatment of coronary bifurcation lesions, a provisional strategy is superior to systematic 2-stent techniques for the most bifurcation lesions. However, complex anatomies with large side branches (SBs) with significant ostial disease length are considered by expert consensus to warrant a 2-stent technique upfront. This consensus view has not been scientifically assessed. Symptomatic patients with large caliber true bifurcation lesions (SB diameter ≥2.5 mm) and significant ostial disease length (≥5 mm) were randomized to either a provisional T-stent strategy or a dual stent culotte technique. Two hundred patients aged 64±10 years, 82% male, were randomized in 20 European centers. The clinical presentations were stable coronary disease (69%) and acute coronary syndromes (31%). SB stent diameter (2.67±0.27 mm) and length (20.30±5.89 mm) confirmed the extent of SB disease. Procedural success (provisional 97%, culotte 94%) and kissing balloon inflation (provisional 95%, culotte 98%) were high. Sixteen percent of patients in the provisional group underwent T-stenting. The primary end point (a composite of death, myocardial infarction, and target vessel revascularization at 12 months) occurred in 7.7% of the provisional T-stent group versus 10.3% of the culotte group (hazard ratio, 1.02; 95% confidence interval, 0.78-1.34; P=0.53). Procedure time, x-ray dose, and cost all favored the simpler procedure. When treating complex coronary bifurcation lesions with large stenosed SBs, there is no difference between a provisional T-stent strategy and a systematic 2-stent culotte strategy in a composite end point of death, myocardial infarction, and target vessel revascularization at 12 months. URL: http://www.clinicaltrials.gov. Unique identifier: NCT 01560455. © 2016 American Heart Association, Inc.

  14. Efectos biológicos de los stents medicados en la circulación coronaria Biological effects of drug-eluting stents in the coronary circulation

    Directory of Open Access Journals (Sweden)

    Darío Echeverri

    2010-04-01

    Full Text Available Los stents medicados ofrecen la mejor alternativa disponible no quirúrgica para el tratamiento de la enfermedad coronaria gracias a su demostrada eficacia. Sin embargo, estos excelentes resultados han sido opacados en términos de seguridad, principalmente por la presencia de trombosis de stents de manera tardía o muy tardía. La comprensión de los efectos biológicos que ejercen a nivel de la arteria coronaria luego de su implante, se debe al efecto de la plataforma utilizada, el polímero y la droga que liberan. Los trastornos de reparación vascular inducidos favorecen la trombosis de stents y sus consecuencias clínicas. Se hace una revisión de los diferentes efectos biológicos de los stents medicados en las arterias coronarias, que permite comprender como han surgido rápidamente nuevas versiones en materiales, diseños, polímeros y medicamentos que reducen los efectos adversos a nivel coronario, mejorando su eficacia y seguridad.Drug-eluting stents offer the best available non-surgical alternative for the treatment of coronary disease, thanks to its demonstrated efficacy. However, in terms of security, these excellent results have been overshadowed by the late or very late appearance of stent thromboses.The biological effects they have in the coronary artery after its implantation are due to the effect of the platform used, the polymer and the medication released. The vascular healing disorders induced by drug-eluting stents favor stent thrombosis and its clinical consequences. This is a review of the different biological effects of drug-eluting stents in coronary arteries that allows to understand how the rapid onset of new versions of materials, designs, polymers and medications diminish adverse coronary effects and improve its efficacy and safety.

  15. A Novel Stent Coated with Antibodies to Endoglin Inhibits Neointimal Formation of Porcine Coronary Arteries

    Directory of Open Access Journals (Sweden)

    Song Cui

    2014-01-01

    Full Text Available Endoglin/CD105 is an accessory protein of the transforming growth factor-β receptor system that plays a critical role in proliferation of endothelial cells and neovasculature. Here, we aimed to assess the effect of novel stents coated with antibodies to endoglin (ENDs on coronary neointima formation. Thirty ENDs, thirty sirolimus-eluting stents (SESs, and thirty bare metal stents (BMSs were randomly assigned and placed in the coronary arteries in 30 juvenile pigs. Histomorphometric analysis and scanning electron microscopy were performed after stent implantation. Our results showed that after 7 days, there was no difference in the neointimal area and percent area stenosis in ENDs compared with SMSs or BMSs. After 14 days, the neointima area and percent area stenosis in ENDs were markedly decreased than those in BMSs or SESs (P<0.05. Moreover, the percentage of reendothelialization was significantly higher in ENDs than that in SESs or BMSs (P<0.01 at 7 and 14 days. The artery injury and the inflammation scores were similar in all groups at 7 and 14 days. In conclusion, our results demonstrated for the first time to our knowledge that endoglin antibody-coated stents can markedly reduce restenosis by enhancing reendothelialization in the porcine model and potentially offer a new approach to prevent restenosis.

  16. Flow disturbances in stent-related coronary evaginations: a computational fluid-dynamic simulation study.

    Science.gov (United States)

    Radu, Maria D; Pfenniger, Aloïs; Räber, Lorenz; de Marchi, Stefano F; Obrist, Dominik; Kelbæk, Henning; Windecker, Stephan; Serruys, Patrick W; Vogel, Rolf

    2014-05-01

    Angiographic ectasias and aneurysms in stented segments have been associated with late stent thrombosis. Using optical coherence tomography (OCT), some stented segments show coronary evaginations reminiscent of ectasias. The purpose of this study was to explore, using computational fluid-dynamic (CFD) simulations, whether OCT-detected coronary evaginations can induce local changes in blood flow. OCT-detected evaginations are defined as outward bulges in the luminal vessel contour between struts, with the depth of the bulge exceeding the actual strut thickness. Evaginations can be characterised cross-sectionally by depth and along the stented segment by total length. Assuming an ellipsoid shape, we modelled 3-D evaginations with different sizes by varying the depth from 0.2-1.0 mm, and the length from 1-9 mm. For the flow simulation we used average flow velocity data from non-diseased coronary arteries. The change in flow with varying evagination sizes was assessed using a particle tracing test where the particle transit time within the segment with evagination was compared with that of a control vessel. The presence of the evagination caused a delayed particle transit time which increased with the evagination size. The change in flow consisted locally of recirculation within the evagination, as well as flow deceleration due to a larger lumen - seen as a deflection of flow towards the evagination. CFD simulation of 3-D evaginations and blood flow suggests that evaginations affect flow locally, with a flow disturbance that increases with increasing evagination size.

  17. Role of red blood cell distribution in predicting drug-eluting stent restenosis in patients with stable angina pectoris after coronary stenting.

    Science.gov (United States)

    Zhao, Kai; Li, Yong-Jian; Gao, Sheng

    2015-05-01

    It has been reported that increased red blood cell distribution width (RDW) predicts adverse events in cardiovascular disease and in patients undergoing percutaneous coronary intervention. However, the role of serum RDW levels in drug-eluting stent (DES) restenosis remains unclear. We aimed to investigate the relationship between serum RDW levels and in-stent restenosis (ISR) after coronary stenting with DES in stable angina pectoris (SAP) patients. A total of 293 consecutive chronic SAP patients with coronary DES implantation were enrolled in this study. The ISR was analyzed by coronary angiography analysis at a mean follow-up of 8 months. According to whether ISR was detected, patients were divided into two groups: the ISR group (n=45) and the non-ISR group (n=247). Serum RDW was assessed both at admission and at the 8-month follow-up in all patients. Standard medication was continued throughout the investigation period. Baseline characteristics of the two groups were similar. Patients in the ISR group had significantly higher RDW levels compared with patients in the non-ISR group both at admission and at follow-up (Psmoking, RDW levels, C-reactive protein levels, stent length, and stent diameter were associated independently with ISR. Serum RDW level may independently predict ISR at both admission and follow-up in SAP patients with coronary DES implantation, which indicates that a chronic inflammatory response might be involved in the pathogenesis of ISR.

  18. Treatment of high risk symptomatic intracranial atherosclerosis with balloon mounted coronary stents and Wingspan stents: single center experience over a 10 year period.

    Science.gov (United States)

    Tarlov, Nicholas; Jahan, Reza; Saver, Jeffrey L; Sayre, James W; Ali, Latisha K; Kim, Doojin; Duckwiler, Gary R; Tateshima, Satoshi; Viñuela, Fernando; Liebeskind, David S

    2012-01-01

    Stenting of symptomatic intracranial atherosclerosis remains under investigation, yet this option to potentially avert subsequent stroke has been offered at select centers under humanitarian device exemption and off-label use for several years. Retrospective case series of consecutive patients undergoing stenting with Wingspan and balloon mounted coronary stents for symptomatic intracranial atherosclerosis at a single institution. Recurrent symptomatic ischemia in the territory of the stented artery was ascertained. Rates of recurrent ischemic stroke were calculated per patient-year of follow-up and were compared with medically treated patients in the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial. During the 10 year study period, 41 cases of intracranial stenting were identified. Stenoses were severe (>70%) in 88% of patients. Stenting procedures occurred a median of 14 days from the most recent symptomatic event. 19 Wingspan stents and 22 balloon mounted coronary stents were deployed. Four strokes occurred within 24 h of stenting, seven within 1 month and eight within 3 months. By 3 months after stenting, no further strokes occurred during up to 2 years of follow-up. Patients had 0.194 ischemic strokes per person-year of follow-up, compared with 0.083 ischemic strokes per person-year of follow-up in the aspirin arm of WASID and 0.065 ischemic strokes per person-year of follow-up in the warfarin arm of WASID. Stenting of symptomatic intracranial atherosclerosis in a high risk subset of cases with advanced degree of luminal stenosis may be associated with an increased early risk of recurrent ischemic stroke.

  19. Outcomes after revascularisation with everolimus- and sirolimus-eluting stents in patients with acute coronary syndromes and stable angina pectoris

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Thayssen, Per; Hansen, Henrik S

    2014-01-01

    Aims: The aim of this substudy of the SORT OUT IV trial was to compare clinical outcomes among patients with acute coronary syndromes (ACS) and stable angina pectoris (SAP) treated with everolimus-eluting stents (EES) or sirolimus-eluting stents (SES). Methods and results: We performed a post hoc...

  20. Modelling Drug Release from Polymer-Free Coronary Stents with Microporous Surfaces.

    Science.gov (United States)

    Vo, Tuoi T N; Morgan, Sarah; McCormick, Christopher; McGinty, Sean; McKee, Sean; Meere, Martin

    2017-12-08

    Traditional coronary drug-eluting stents (DES) are made from metal and are coated with a permanent polymer film containing an anti-proliferative drug. Subsequent to stent deployment in a diseased coronary artery, the drug releases into the artery wall and helps prevent restenosis by inhibiting the proliferation of smooth muscle cells. Although this technology has proven to be remarkably successful, there are ongoing concerns that the presence of a polymer in the artery can lead to deleterious medical complications, such as late stent thrombosis. Polymer-free DES may help overcome such shortcomings. However, the absence of a rate-controlling polymer layer makes optimisation of the drug release profile a particular challenge. The use of microporous stent surfaces to modulate the drug release rate is an approach that has recently shown particularly promising clinical results. In this study, we develop a mathematical model to describe drug release from such stents. In particular, we develop a mathematical model to describe drug release from microporous surfaces. The model predicts a two-stage release profile, with a relatively rapid initial release of most of the drug, followed by a slower release of the remaining drug. In the model, the slow release phase is accounted for by an adsorption/desorption mechanism close to the stent surface. The theoretical predictions are compared with experimental release data obtained in our laboratory, and good agreement is found. The valuable insights provided by our model will serve as a useful guide for designing the enhanced polymer-free stents of the future. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

  1. Synergy between direct coronary stenting technique and use of the novel thin strut cobalt chromium Skylor™ stent: the MACE in follow up patients treated with Skylor stent [MILES Study].

    Science.gov (United States)

    Giordano, Arturo; Polimeno, Michele; Corcione, Nicola; Fattore, Luciano; Di Lorenzo, Luigi; Biondi-Zoccai, Giuseppe; Ferraro, Paolo; Romano, Maria Fiammetta

    2012-02-01

    Despite significant improvements in stent platform, currently available bare-metal stents (BMS) are still associated with restenosis. Thin-strut design cobalt-chromium alloys hold the promise of improving results of BMS, especially when implanted with direct technique. We performed an observational study to appraise outcomes of the novel Skylor™ stent, stratifying outcomes according to stenting technique. We included all consecutive patients undergoing coronary stenting with Skylor™ at 2 centers between 2006 and 2009. The primary end-point was the long-term rate of major adverse cardiac events (MACE, i.e. death, myocardial infarction (MI), coronary artery bypass grafting (CABG) or target vessel revascularization (TVR)). As pre-specified analysis, we compared patients undergoing direct stenting versus those stent implantation following predilation. A total of 1020 patients were included (1292 Skylor™ stents), with procedural success obtained in 99%. Comparing patients undergoing direct stenting (66%) versus pre-dilation (34%) at 16±7 months of follow-up, MACE had occurred in, respectively, 8% versus 14% (p=0.001), with death in 1% versus 2= (p=0.380), MI in 1% versus 2% (p=0.032), CABG in 0.2% versus 2% (p=0.012), and TVR in 6% versus 9% [p=0.071]. Even at multivariable analysis with propensity adjustment, direct stenting was associated with significantly fewer MACE [hazard ratio 0.60 [0.38-0.93], p=0.024]. This observational study suggests the presence of a beneficial synergy between direct coronary stenting technique and use of the novel thin-strut cobalt-chromium Skylor™ stent in real-world patients undergoing PCI.

  2. In vivo evaluation of a biolimus eluting nickel titanium self expanding stent with overlapping balloon expandable drug eluting and bare metal stents in a porcine coronary model.

    Science.gov (United States)

    Cilingiroglu, Mehmet; Elliott, James; Sangi, Pramod; Matthews, Holly; Tio, Fermin; Trauthen, Brett; Elicker, John; Bailey, Steven R

    2009-01-01

    Long lesions and complex vessel anatomy frequently require the use of overlapping stents to treat a lesion. The purpose of this study was to evaluate the long-term effects of overlapping the Axxess Biolimus A9 eluting stent (BES) with two of the most commonly used, commercially available drug eluting stents. These stents were compared to BxVelocity bare metal (BMS) stents in a porcine coronary stent-injury model. Nineteen juvenile farm swine, 25-35 kg in weight, 3-6 months in age were utilised. Each animal received an Axxess stent to their coronary artery as permitted by the individual animal's anatomy. A second stent, either a Cypher, sirolimus eluting stent (SES) or, a Taxus, paclitaxel eluting stent (PES), or a BxVelocity bare metal stent (BMS) were implanted in an overlapped fashion. The animals were then followed for either 28 or 180 days as specified by a randomisation scheme. At the end of each follow-up period, they were euthenised, and the vessels containing the overlapping stents were harvested, processed into histological sections, and analysed. Compared to bare metal stents, overlapped segments using DES exhibited delayed vascular healing compared to both the proximal and distal non-overlap sites at each of the follow-up time point. Overall, in the non-overlap stent segments, SES induced significantly more inflammation and neointimal hyperplasia compared to PES and BMS. In this study of BMS and two different types of DES overlapped with the Axxess Biolimus A9 eluting stent, we found that while there was a delay in the degree of vascular healing with DES compared to BMS, the specific type of DES that was overlapped with BES did not affect the behaviour of the overlap zone in terms of most of the histomorphometric measures at 28 or 180 days. This was true whether the stent was drug eluting or bare metal. More inflammation with delayed healing was seen in the SES compared to PES and BMS.

  3. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries.

    Science.gov (United States)

    Popma, Jeffrey J; Leon, Martin B; Moses, Jeffrey W; Holmes, David R; Cox, Nicholas; Fitzpatrick, Michelle; Douglas, John; Lambert, Charles; Mooney, Michael; Yakubov, Steven; Kuntz, Richard E

    2004-12-21

    Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis. Angiographic follow-up at 240 days was obtained in 701 patients with long (15- to 25-mm) lesions in small-diameter (2.5- to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (>50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; P<0.001) and within the stent (3.2% versus 35.4% with the BMS; P<0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges (all P<0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups. Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.

  4. Improved two-year outcomes after drug-eluting versus bare-metal stent implantation in women and men with large coronary arteries

    DEFF Research Database (Denmark)

    Hansen, K W; Kaiser, C; Hvelplund, A

    2013-01-01

    To investigate the importance of vessel size on outcome differences by comparing the effects of drug-eluting stents (DES) versus bare-metal stents (BMS) in women and men with large coronary vessels.......To investigate the importance of vessel size on outcome differences by comparing the effects of drug-eluting stents (DES) versus bare-metal stents (BMS) in women and men with large coronary vessels....

  5. Multi-objective optimization of coronary stent using Kriging surrogate model.

    Science.gov (United States)

    Li, Hongxia; Gu, Junfeng; Wang, Minjie; Zhao, Danyang; Li, Zheng; Qiao, Aike; Zhu, Bao

    2016-12-28

    In stent design optimization, the functional relationship between design parameters and design goals is nonlinear, complex, and implicit and the multi-objective design of stents involves a number of potentially conflicting performance criteria. Therefore it is hard and time-consuming to find the optimal design of stent either by experiment or clinic test. Fortunately, computational methods have been developed to the point whereby optimization and simulation tools can be used to systematically design devices in a realistic time-scale. The aim of the present study is to propose an adaptive optimization method of stent design to improve its expansion performance. Multi-objective optimization method based on Kriging surrogate model was proposed to decrease the dogboning effect and the radial elastic recoil of stents to improve stent expansion properties and thus reduce the risk of vascular in-stent restenosis injury. Integrating design of experiment methods and Kriging surrogate model were employed to construct the relationship between measures of stent dilation performance and geometric design parameters. Expected improvement, an infilling sampling criterion, was employed to balance local and global search with the aim of finding the global optimal design. A typical diamond-shaped coronary stent-balloon system was taken as an example to test the effectiveness of the optimization method. Finite element method was used to analyze the stent expansion of each design. 27 iterations were needed to obtain the optimal solution. The absolute values of the dogboning ratio at 32 and 42 ms were reduced by 94.21 and 89.43%, respectively. The dogboning effect was almost eliminated after optimization. The average of elastic recoil was reduced by 15.17%. This article presents FEM based multi-objective optimization method combining with the Kriging surrogate model to decrease both the dogboning effect and radial elastic recoil of stents. The numerical results prove that the proposed

  6. A randomized multicenter comparison of hybrid sirolimus-eluting stents with bioresorbable polymer versus everolimus-eluting stents with durable polymer in total coronary occlusion: rationale and design of the Primary Stenting of Occluded Native Coronary Arteries IV study

    Directory of Open Access Journals (Sweden)

    Teeuwen Koen

    2012-12-01

    Full Text Available Abstract Background Percutaneous recanalization of total coronary occlusion (TCO was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST with drug-eluting stents (DES for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO. Methods/Design The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence

  7. Sequential structural and fluid dynamic numerical simulations of a stented bifurcated coronary artery.

    Science.gov (United States)

    Morlacchi, Stefano; Chiastra, Claudio; Gastaldi, Dario; Pennati, Giancarlo; Dubini, Gabriele; Migliavacca, Francesco

    2011-12-01

    Despite their success, stenting procedures are still associated to some clinical problems like sub-acute thrombosis and in-stent restenosis. Several clinical studies associate these phenomena to a combination of both structural and hemodynamic alterations caused by stent implantation. Recently, numerical models have been widely used in the literature to investigate stenting procedures but always from either a purely structural or fluid dynamic point of view. The aim of this work is the implementation of sequential structural and fluid dynamic numerical models to provide a better understanding of stenting procedures in coronary bifurcations. In particular, the realistic geometrical configurations obtained with structural simulations were used to create the fluid domains employed within transient fluid dynamic analyses. This sequential approach was applied to investigate the final kissing balloon (FKB) inflation during the provisional side branch technique. Mechanical stresses in the arterial wall and the stent as well as wall shear stresses along the arterial wall were examined before and after the FKB deployment. FKB provoked average mechanical stresses in the arterial wall almost 2.5 times higher with respect to those induced by inflation of the stent in the main branch only. Results also enlightened FKB benefits in terms of improved local blood flow pattern for the side branch access. As a drawback, the FKB generates a larger region of low wall shear stress. In particular, after FKB the percentage of area characterized by wall shear stresses lower than 0.5 Pa was 79.0%, while before the FKB it was 62.3%. For these reasons, a new tapered balloon dedicated to bifurcations was proposed. The inclusion of the modified balloon has reduced the mechanical stresses in the proximal arterial vessel to 40% and the low wall shear stress coverage area to 71.3%. In conclusion, these results show the relevance of the adopted sequential approach to study the wall mechanics and

  8. Coronary stenting approaches in the treatment of chronic total occlusion: contemporary registry-based experience.

    Science.gov (United States)

    Vaduganathan, Muthiah; Kornowski, Ran; Vaknin-Assa, Hana; Greenberg, Gabriel; Bental, Tamir; Lev, Eli I; Assali, Abid R

    2016-09-01

    This 'real-world' investigation attempted to determine the long-term prognoses of patients who have undergone successful revascularization of chronic total occlusion (CTO) lesions. All consecutive unselected patients from January 2006 to June 2011, undergoing stenting for CTO (n = 272), were retrospectively identified through an institutional registry. Procedural failure was defined as final diameter stenosis greater than 30% or postdilatation thrombolysis in myocardial infarction flow less than 3. Outcomes were assessed based on stenting type [bare metal stent (BMS), drug-eluting stent (DES), or mixed] in the successful procedural cohort. Multiple logistic regression analyses were used to account for known baseline cardiovascular risk imbalances. The primary endpoint was 2-year target vessel revascularization. Overall procedural failure occurred in 55 (20.2%) patients presenting with CTO lesions. Failed revascularization was independently associated with multivessel disease, lesion lengths greater than 15 mm, tortuous segments, and presence of calcifications. Major complications included coronary dissection (10%) and perforation (2%). Of the successful procedures, 141 (64%) underwent pure DES, 46 (21%) pure BMS, and 34 (15%) mixed stenting. At 2-year follow-up, fewer patients in the DES group required repeat revascularization compared to the mixed stenting group (6 vs. 26%; P = 0.002). Mixed stenting was an independent predictor of long-term target vessel revascularization (adjusted odds ratio 2.1, 95% confidence interval 1.1-4.1, P = 0.02) compared to DES. Failed revascularization of CTO lesions occurs in a fifth of patients and appears to be associated with complex vessel anatomy. Our data suggest that DES use in this setting are associated with improved 2-year clinical endpoints compared with pure BMS or mixed stenting approaches.

  9. Coronary stenting as an adjunct to balloon angioplasty

    NARCIS (Netherlands)

    B.H. Strauss (Bradley)

    1991-01-01

    textabstractAndreas Gruentzig initiated the era of interventional cardiology in 19n with the introduction of percutaneous transluminal coronary angioplasty (PTCA) (1). The acceptance of coronary angioplasty is obvious by the widespread use of the procedure (>300,000 cases in the United States in

  10. Drug eluting stent induced coronary artery aneurysm repair by exclusion. Where are we headed?

    Science.gov (United States)

    Subramaniam, Krishnan Ganapathy; Akhunji, Zakir

    2009-07-01

    We present a case of left anterior descending (LAD) coronary artery aneurysm at the site of previous stent placement 3 years previously. The patient presented with recent worsening of angina. Angiography and 64 slice CT angiography confirmed the presence of 6mm aneurysm of LAD at the site of previous stent involving the origin of diagonal, with thrombus proximal and distal to the stent. This patient was successfully managed by taking the posterior wall of the anterior descending artery while suturing the heel of the left internal mammary artery (LIMA)-LAD anastomosis. The idea was to create severe stenosis upstream to prevent distal embolisation from the site of aneurysm. The diagonal was grafted with a saphenous venous graft. Follow-up angiogram at 3 months demonstrated successful exclusion of the aneurysm and unobstructed flow through the grafts.

  11. [Progress in genetic and epigenetic research on in-stent restenosis after percutaneous coronary interventions].

    Science.gov (United States)

    Kang, Yan-hong; Lao, Hai-yan; Yu, Xi-yong; Chen, Ji-yan; Zhong, Shi-long

    2012-02-01

    Coronary heart disease is one of the most important causes of death in human, and consumes vast medical resources. Percutaneous coronary intervention (PCI) has been a significant breakthrough for its treatment. However, clinical application has been hampered by in-stent restenosis (ISR). Although drug eluting stent (DES) has reduced the occurrence of restenosis, incidence of ISR is still about 5% to 10%. The main reasons for restenosis after PCI are hyperplasia of vascular endothelial cells and smooth muscle cell migration. The exact mechanism of personalized differences in restenosis is not clear yet, but there may be a variety of risk factors. In addition to aging, smoking and diabetes, an increasing number of studies have found that genetic and epigenetic factors play an important role in ISR. In this article, authors have reviewed genetic and epigenetic factors on the progression of ISR, which may help to determine the genetic risk factors in patients with ISR after PCI.

  12. Novel nanostructured biomaterials: implications for coronary stent thrombosis

    Science.gov (United States)

    Karagkiozaki, Varvara; Karagiannidis, Panagiotis G; Kalfagiannis, Nikolaos; Kavatzikidou, Paraskevi; Patsalas, Panagiotis; Georgiou, Despoina; Logothetidis, Stergios

    2012-01-01

    Background Nanomedicine has the potential to revolutionize medicine and help clinicians to treat cardiovascular disease through the improvement of stents. Advanced nanomaterials and tools for monitoring cell–material interactions will aid in inhibiting stent thrombosis. Although titanium boron nitride (TiBN), titanium diboride, and carbon nanotube (CNT) thin films are emerging materials in the biomaterial field, the effect of their surface properties on platelet adhesion is relatively unexplored. Objective and methods In this study, novel nanomaterials made of amorphous carbon, CNTs, titanium diboride, and TiBN were grown by vacuum deposition techniques to assess their role as potential stent coatings. Platelet response towards the nanostructured surfaces of the samples was analyzed in line with their physicochemical properties. As the stent skeleton is formed mainly of stainless steel, this material was used as reference material. Platelet adhesion studies were carried out by atomic force microscopy and scanning electron microscopy observations. A cell viability study was performed to assess the cytocompatibility of all thin film groups for 24 hours with a standard immortalized cell line. Results The nanotopographic features of material surface, stoichiometry, and wetting properties were found to be significant factors in dictating platelet behavior and cell viability. The TiBN films with higher nitrogen contents were less thrombogenic compared with the biased carbon films and control. The carbon hybridization in carbon films and hydrophilicity, which were strongly dependent on the deposition process and its parameters, affected the thrombogenicity potential. The hydrophobic CNT materials with high nanoroughness exhibited less hemocompatibility in comparison with the other classes of materials. All the thin film groups exhibited good cytocompatibility, with the surface roughness and surface free energy influencing the viability of cells. PMID:23269867

  13. Optical Coherence Tomography Findings in Patients With Coronary Stent Thrombosis: A Report of the PRESTIGE Consortium (Prevention of Late Stent Thrombosis by an Interdisciplinary Global European Effort).

    Science.gov (United States)

    Adriaenssens, Tom; Joner, Michael; Godschalk, Thea C; Malik, Nikesh; Alfonso, Fernando; Xhepa, Erion; De Cock, Dries; Komukai, Kenichi; Tada, Tomohisa; Cuesta, Javier; Sirbu, Vasile; Feldman, Laurent J; Neumann, Franz-Josef; Goodall, Alison H; Heestermans, Ton; Buysschaert, Ian; Hlinomaz, Ota; Belmans, Ann; Desmet, Walter; Ten Berg, Jurrien M; Gershlick, Anthony H; Massberg, Steffen; Kastrati, Adnan; Guagliumi, Giulio; Byrne, Robert A

    2017-09-12

    Stent thrombosis (ST) is a serious complication following coronary stenting. Intravascular optical coherence tomography (OCT) may provide insights into mechanistic processes leading to ST. We performed a prospective, multicenter study to evaluate OCT findings in patients with ST. Consecutive patients presenting with ST were prospectively enrolled in a registry by using a centralized telephone registration system. After angiographic confirmation of ST, OCT imaging of the culprit vessel was performed with frequency domain OCT. Clinical data were collected according to a standardized protocol. OCT acquisitions were analyzed at a core laboratory. Dominant and contributing findings were adjudicated by an imaging adjudication committee. Two hundred thirty-one patients presenting with ST underwent OCT imaging; 14 (6.1%) had image quality precluding further analysis. Of the remaining patients, 62 (28.6%) and 155 (71.4%) presented with early and late/very late ST, respectively. The underlying stent type was a new-generation drug-eluting stent in 50.3%. Mean reference vessel diameter was 2.9±0.6 mm and mean reference vessel area was 6.8±2.6 mm2. Stent underexpansion (stent expansion index presenting very late ST, uncovered stent struts were a common dominant finding in drug-eluting stents, and neoatherosclerosis was a common dominant finding in bare metal stents. In patients with ST, uncovered and malapposed struts were frequently observed with the incidence of both decreasing with longer time intervals between stent implantation and presentation. The most frequent dominant observation varied according to time intervals from index stenting: uncovered struts and underexpansion in acute/subacute ST and neoatherosclerosis and uncovered struts in late/very late ST. © 2017 The Authors.

  14. Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial.

    Science.gov (United States)

    Steg, P Gabriel; Harrington, Robert A; Emanuelsson, Håkan; Katus, Hugo A; Mahaffey, Kenneth W; Meier, Bernhard; Storey, Robert F; Wojdyla, Daniel M; Lewis, Basil S; Maurer, Gerald; Wallentin, Lars; James, Stefan K

    2013-09-03

    We aimed to describe the effects of ticagrelor versus clopidogrel on stent thrombosis in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Of 18 624 patients hospitalized for acute coronary syndromes, 11 289 (61%) had at least 1 intracoronary stent. Ticagrelor reduced stent thrombosis compared with clopidogrel across all definitions: definite, 1.37% (n=71) versus 1.93% (n=105; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.50-0.90; P=0.0091); definite or probable, 2.21% (n=118) versus 2.87% (n=157; HR, 0.75; 95% CI, 0.59-0.95; P=0.017); and definite, probable, and possible, 2.94% (n=154) versus 3.77 (n=201; HR, 0.77; 95% CI, 0.62-0.95). The reduction in definite stent thrombosis was consistent regardless of acute coronary syndrome type, presence of diabetes mellitus, stent type (drug-eluting or bare metal stent), CYP2C19 genetic status, loading dose of aspirin, dose of clopidogrel before randomization, and use of glycoprotein IIb/IIIa inhibitors at randomization. The reduction in stent thrombosis with ticagrelor was numerically greater for late (>30 days; HR, 0.48; 95% CI, 0.24-0.96) and subacute (4 hours-30 days; HR, 0.60; 95% CI, 0.39-0.93) compared with acute (<24 hours; HR, 0.94; 95% CI, 0.43-2.05) stent thrombosis or for patients compliant to therapy (ie, taking blinded study treatment ≥80% of the time) compared with less compliant patients. Randomization to ticagrelor was a strong independent inverse predictor of definite stent thrombosis (HR, 0.65; 95% CI, 0.48-0.88). Ticagrelor compared with clopidogrel reduces the incidence of stent thrombosis in patients with acute coronary syndromes, with consistent benefit across a broad range of patient, stent, and treatment characteristics.

  15. Long-term endothelial dysfunction is more pronounced after stenting than after balloon angioplasty in porcine coronary arteries

    NARCIS (Netherlands)

    Beusekom, H.M.M. van; Whelan, D.M.; Hofma, S.H.; Krabbendam, S.C.; Hinsbergh, V.W.M. van; Verdouw, P.D.; Giessen, W.J. van der

    1998-01-01

    Objectives. To compare percutaneous transluminal coronary angioplasty (PTCA) and stent implantation with respect to the long-term changes they induce in the newly formed endothelium in porcine coronary arteries by studying both morphological and functional parameters of the endothelium at 2 weeks

  16. Caracterización de la restenosis de stents coronarios convencionales y liberadores de medicamentos en pacientes incluidos en el registro DRug Eluting STent (DREST Characterization of conventional coronary stents restenosis and drug eluting stents in patients included in the Drug Eluting Stent Registry (DREST

    Directory of Open Access Journals (Sweden)

    Jorge A Arroyave C

    2012-06-01

    risk factor associated with stent restenosis of drug-eluting stents (p <0.002. We found smaller diameter of the vessel involved as well as smaller diameter of the implanted stent mainly in the drug-eluting stents associated with stent restenosis (p = 0.000. The focal pattern of stent restenosis was higher with drug eluting stents, while the diffuse pattern with standard stents (p = 0.000. The one-year survival was higher in patients with drug-eluting stent. Conclusions: The rates of stent restenosis and the related characteristics found are similar to those currently published. Dyslipidemia appears as a significant associated factor. The stent restenosis manifested as acute coronary syndrome in 60% of cases; it can not be regarded as a benign condition in this population.

  17. Successful technical and clinical outcome using a second generation balloon expandable coronary stent for transplant renal artery stenosis: Our experience

    Science.gov (United States)

    Salsamendi, Jason; Pereira, Keith; Baker, Reginald; Bhatia, Shivank S; Narayanan, Govindarajan

    2015-01-01

    Transplant renal artery stenosis (TRAS) is a vascular complication frequently seen because of increase in the number of renal transplantations. Early diagnosis and management is essential to optimize a proper graft function. Currently, the endovascular treatment of TRAS using angioplasty and/or stenting is considered the treatment of choice with the advantage that it does not preclude subsequent surgical correction. Treatment of TRAS with the use of stents, particularly in tortuous transplant renal anatomy presents a unique challenge to an interventional radiologist. In this study, we present three cases from our practice highlighting the use of a balloon-expandable Multi-Link RX Ultra coronary stent system (Abbott Laboratories, Abbott Park, Illinois, USA) for treating high grade focal stenosis along very tortuous renal arterial segments. Cobalt–Chromium alloy stent scaffold provides excellent radial force, whereas the flexible stent design conforms to the vessel course allowing for optimal stent alignment. PMID:26629289

  18. Successful technical and clinical outcome using a second generation balloon expandable coronary stent for transplant renal artery stenosis: Our experience.

    Science.gov (United States)

    Salsamendi, Jason; Pereira, Keith; Baker, Reginald; Bhatia, Shivank S; Narayanan, Govindarajan

    2015-10-01

    Transplant renal artery stenosis (TRAS) is a vascular complication frequently seen because of increase in the number of renal transplantations. Early diagnosis and management is essential to optimize a proper graft function. Currently, the endovascular treatment of TRAS using angioplasty and/or stenting is considered the treatment of choice with the advantage that it does not preclude subsequent surgical correction. Treatment of TRAS with the use of stents, particularly in tortuous transplant renal anatomy presents a unique challenge to an interventional radiologist. In this study, we present three cases from our practice highlighting the use of a balloon-expandable Multi-Link RX Ultra coronary stent system (Abbott Laboratories, Abbott Park, Illinois, USA) for treating high grade focal stenosis along very tortuous renal arterial segments. Cobalt-Chromium alloy stent scaffold provides excellent radial force, whereas the flexible stent design conforms to the vessel course allowing for optimal stent alignment.

  19. Drug-eluting stents versus bare-metal stents for acute coronary syndrome

    DEFF Research Database (Denmark)

    Feinberg, Joshua; Nielsen, Emil Eik; Greenhalgh, Janette

    2017-01-01

    -EXPANDED, and BIOSIS from their inception to January 2017. We also searched two clinical trials registers, the European Medicines Agency and the US Food and Drug Administration databases, and pharmaceutical company websites. In addition, we searched the reference lists of review articles and relevant trials. SELECTION...... recommendations of Cochrane. Two review authors independently extracted data. We assessed the risks of systematic error by bias domains. We conducted Trial Sequential Analyses to control the risks of random errors. Our primary outcomes were all-cause mortality, major cardiovascular events, serious adverse events...... and myocardial infarction.No trials reported results on quality of life or angina. AUTHORS' CONCLUSIONS: The current evidence suggests that drug-eluting stents may lead to fewer serious adverse events compared with bare-metal stents without increasing the risk of all-cause mortality or major cardiovascular...

  20. Drug-eluting stents for acute coronary syndrome: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Lishan Wang

    Full Text Available Drug-eluting stents (DES are increasingly used for treatment of acute coronary syndrome (ACS. However, clinical efficacy and safety of various types of DES is not well established in these subjects. We therefore evaluated clinical utility of second-generation and first-generation DES in patients with ACS by conducting a meta-analysis.A search of Medline, Embase, the Cochrane databases, and Web of Science was made. Randomized controlled trials (RCTs which compared second-generation DES (everolimus-eluting stents [EES] or zotarolimus-eluting stents [ZES] versus first-generation DES (sirolimus-eluting stents [SES] or paclitaxe-eluting stents [PES] in patients with ACS and provided data on clinical efficacy or safety endpoints were included. Pooled estimates were calculated using random-effects model.A total of 2,757 participants with ACS in 6 RCTs were included. Compared with first-generation one, second-generation DES trended to be associated with the decreased incidence of definite or probable stent thrombosis in ACS patients (risk ratio [RR]  = 0.60, 95% confidence intervals [CI] 0.33 to 1.07, p = 0.09. However, the rate of target lesion revascularization (TLR significantly increased in second-generation DES (RR = 2.08, 95%CI 1.25 to 3.47, p = 0.005. There were no significant differences in the incidence of major adverse cardiac events (MACEs, all-cause death, cardiac death, and recurrent myocardial infarction between the two arms (all p>0.10. The second-generation EES showed a tendency towards lower risk of MACEs (p = 0.06 and a beneficial effect on reducing stent thrombosis episodes (p = 0.009, while the second-generation ZES presented an increased occurrence of MACEs (p = 0.02 and TLR (p = 0.003.Second-generation DES, especially EES, appeared to present a lower risk of stent thrombosis, whereas second-generation ZES might increase the need for repeat revascularization in ACS patients. During coronary

  1. Comparison of stenting and surgical revascularization strategy in non-ST elevation acute coronary syndromes and complex coronary artery disease (from the Milestone Registry).

    Science.gov (United States)

    Buszman, Pawel E; Buszman, Piotr P; Bochenek, Andrzej; Gierlotka, Marek; Gąsior, Mariusz; Milewski, Krzysztof; Orlik, Bartłomiej; Janas, Adam; Wojakowski, Wojciech; Kiesz, R Stefan; Zembala, Marian; Poloński, Lech

    2014-10-01

    The optimal revascularization strategy in patients with complex coronary artery disease and non-ST-segment elevation acute coronary syndromes is undetermined. In this multicenter, prospective registry, 4,566 patients with non-ST-segment elevation myocardial infarctions, unstable angina, and multivessel coronary disease, including left main disease, were enrolled. After angiography, 3,033 patients were selected for stenting (10.3% received drug-eluting stents) and 1,533 for coronary artery bypass grafting. Propensity scores were used for baseline characteristic matching and result adjustment. Patients selected for percutaneous coronary intervention (PCI) were younger (mean age 64.4±10 vs 65.2±9 years, p=0.03) and more frequently presented with non-ST-segment elevation myocardial infarctions (32.0% vs 14.5%, p=0.01), cardiogenic shock (1.5% vs 0.7%, p65 years, women, patients with unstable angina, those with European System for Cardiac Operative Risk Evaluation scores>5, those with Thrombolysis In Myocardial Infarction (TIMI) risk scores >4, those receiving drug-eluting stents, and those with 2-vessel disease. In conclusion, in patients presenting with non-ST-segment elevation acute coronary syndromes and complex coronary artery disease, immediate stenting was associated with lower mortality risk in the long term compared with surgical revascularization, especially in subgroups at high clinical risk. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Levels of circulating CD34+/KDR+ cells do not predict coronary in-stent restenosis.

    Science.gov (United States)

    Haine, Steven E; Van Craenenbroeck, Emeline M; Hoymans, Vicky Y; Miljoen, Hielko P; Vandendriessche, Tom R; Claeys, Marc J; Frederix, Geert; Conraads, Viviane M; Bosmans, Johan M; Vrints, Christiaan J

    2014-01-01

    Angiographic and clinical parameters are poor predictors of in-stent restenosis. Bone marrow-derived CD34(+) cells that coexpress a receptor for vascular endothelial growth factor (kinase insert domain receptor [KDR]) are committed to endothelial lineage. Mobilization and infusion of CD34(+)/KDR(+) cells accelerates re-endothelialization and reduces neointimal thickness in vascular injury models. Bioengineered stents capturing CD34(+) cells also show expedited re-endothelialization. We examined whether circulating CD34(+)/KDR(+) cell counts can be used to predict restenosis in a bare-metal stent (BMS). CD34(+)/KDR(+) cells were counted by flow cytometry in 124 nondiabetic patients before BMS implantation and the relation to in-stent late luminal loss (LLL) was examined by angiography at 6 months (primary end point). Neointima was also quantified as the maximum percentage area stenosis (M%AS) and percentage volume intima hyperplasia (%VIH) on intravascular ultrasonography (secondary end points). Multiple linear regression analysis, taking into account implanted stent length and diameter, revealed no relation between CD34(+)/KDR(+) cell counts and LLL (partial regression coefficient b = 0.11; 95% confidence interval [CI], -0.19-0.42; P = 0.46). Similarly, no relation between CD34(+)/KDR(+) cell counts and M%AS or %VIH could be demonstrated. Moreover, the increase in CD34(+)/KDR(+) cell counts over 6 months was unrelated to LLL (b = -0.15; 95% CI, -0.42-0.12; P = 0.28), M%AS, and %VIH. Although our study does not exclude a pathophysiologic role for CD34(+)/KDR(+) cells in the formation of neointima, cell counts before percutaneous coronary intervention proved to be unrelated to LLL or intravascular ultrasonographically derived restenosis parameters in coronary BMSs at 6 months. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  3. Long-term outcome following percutaneous coronary intervention with drug-eluting stents compared with bare-metal stents in saphenous vein graft lesions

    DEFF Research Database (Denmark)

    Hougaard, Mikkel; Thayssen, Per; Kaltoft, Anne

    2014-01-01

    reduced the risk of restenosis in native coronary artery lesions. In saphenous vein grafts (SVG) the outcome after DES compared with BMS is insufficiently described. METHODS: From January 1, 2002 to December 31, 2010 all patients with PCI of SVG lesions were identified among 3.0 million inhabitants. Stent...

  4. Effect of a Dual Drug-Coated Stent With Abciximab and Alpha-Lipoic Acid in a Porcine Coronary Restenosis Model

    Science.gov (United States)

    Lim, Kyung Seob; Hong, Young Joon; Hachinohe, Daisuke; Ahmed, Khurshid; Kim, Jung Ha; Sim, Doo Sun; Lee, Min Goo; Park, Keun-Ho; Kim, Ju Han; Ahn, Youngkeun; Cho, Jeong Gwan; Park, Jong Chun; Song, Sun-Jung; Jung, Kyoung Woon; Cho, Dong Lyun; Kang, Jung Chaee

    2011-01-01

    Background and Objectives The aim of this study was to examine the anti-proliferative and anti-inflammatory effects of a stent coated with abciximab and alpha-lipoic acid (ALA) in a porcine coronary overstretch restenosis model. Materials and Methods A total of 10 pigs were randomized into two groups (10 pigs, 10 coronaries in each group) in which the coronary arteries were stented with a dual-coated stent and a bare metal stent (control) by randomization. Stents were deployed with oversizing (stent/artery ratio 1.3 : 1) in the porcine coronary arteries, and histopathology was assessed 28 days after stenting. Results There was no significant difference in the injury score between the two groups. In the neointima, the lymphohistiocyte count was significantly lower in dual-coat stent group compared with the control stent group (120±85 cells vs. 159±80 cells, p=0.048). There was no significant difference in the fibrin score between the two groups (0.16±0.34 in the dual-coated stent group vs. 0.25±0.48 in the control stent group, p=0.446). The neointima area was not significantly different between both groups (1.55±0.8 mm2 in dual-coated stent group vs. 1.40±0.86 mm2 in the control stent group, p=0.447). Conclusion Although the dual-coated stent with abciximab and ALA showed no significant difference in inhibition of neointimal hyperplasia when compared with the bare metal stent, it was associated with a reduced inflammatory reaction when compared with the control stent in a porcine coronary restenosis model. PMID:21731564

  5. Corrosion resistance improvement for 316L stainless steel coronary artery stents by trimethylsilane plasma nanocoatings.

    Science.gov (United States)

    Eric Jones, John; Chen, Meng; Yu, Qingsong

    2014-10-01

    To improve their corrosion resistance and thus long-term biocompatibility, 316L stainless steel coronary artery stents were coated with trimethylsilane (TMS) plasma coatings of 20-25 nm in thickness. Both direct current (DC) and radio-frequency (RF) glow discharges were utilized for TMS plasma coatings and additional NH₃/O₂ plasma treatment to tailor the surface properties. X-ray photoelectron spectroscopy (XPS) was used to characterize the coating surface chemistry. It was found that both DC and RF TMS plasma coatings had Si- and C-rich composition, and the O- and N-contents on the surfaces were substantially increased after NH₃/O₂ plasma treatment. Surface contact angle measurements showed that DC TMS plasma nanocoating with NH₃/O₂ plasma treatment generated very hydrophilic surface. The corrosion resistance of TMS plasma coated stents was evaluated through potentiodynamic polarization and electrochemical impedance spectroscopy (EIS) techniques. The potentiodynamic polarization demonstrated that the TMS plasma coated stents imparted higher corrosion potential and pitting potential, as well as lower corrosion current densities as compared with uncoated controls. The surface morphology of stents before and after potentiodynamic polarization testing was analyzed with scanning electron microscopy, which indicated less corrosion on coated stents than uncoated controls. It was also noted that, from EIS data, the hydrophobic TMS plasma nanocoatings showed stable impedance modulus at 0.1 Hz after 21 day immersion in an electrolyte solution. These results suggest improved corrosion resistance of the 316L stainless steel stents by TMS plasma nanocoatings and great promise in reducing and blocking metallic ions releasing into the bloodstream. © 2014 Wiley Periodicals, Inc.

  6. Corrosion resistance improvement for 316L stainless steel coronary artery stents by trimethylsilane plasma nanocoatings

    Science.gov (United States)

    Jones, John Eric; Chen, Meng; Yu, Qingsong

    2015-01-01

    To improve their corrosion resistance and thus long-term biocompatibility, 316L stainless steel coronary artery stents were coated with trimethylsilane (TMS) plasma coatings of 20–25 nm in thickness. Both direct current (DC) and radio-frequency (RF) glow discharges were utilized for TMS plasma coatings and additional NH3/O2 plasma treatment to tailor the surface properties. X-ray photoelectron spectroscopy (XPS) was used to characterize the coating surface chemistry. It was found that both DC and RF TMS plasma coatings had Si- and C-rich composition, and the O-and N-contents on the surfaces were substantially increased after NH3/O2 plasma treatment. Surface contact angle measurements showed that DC TMS plasma nanocoating with NH3/O2 plasma treatment generated very hydrophilic surface. The corrosion resistance of TMS plasma coated stents was evaluated through potentiodynamic polarization and electro-chemical impedance spectroscopy (EIS) techniques. The potentiodynamic polarization demonstrated that the TMS plasma coated stents imparted higher corrosion potential and pitting potential, as well as lower corrosion current densities as compared with uncoated controls. The surface morphology of stents before and after potentiodynamic polarization testing was analyzed with scanning electron microscopy, which indicated less corrosion on coated stents than uncoated controls. It was also noted that, from EIS data, the hydrophobic TMS plasma nanocoatings showed stable impedance modulus at 0.1 Hz after 21 day immersion in an electrolyte solution. These results suggest improved corrosion resistance of the 316L stainless steel stents by TMS plasma nanocoatings and great promise in reducing and blocking metallic ions releasing into the bloodstream. PMID:24500866

  7. Effect of oral sirolimus therapy on inflammatory biomarkers following coronary stenting

    Directory of Open Access Journals (Sweden)

    W.C.M. Rosa

    2010-08-01

    Full Text Available We studied the effect of oral sirolimus, administered to prevent and treat in-stent restenosis (ISR, on the variation of serum levels of inflammatory markers following coronary stenting with bare metal stents. The mean age of the patients was 56 ± 13 years, 65% were males and all had clinically manifested ischemia. Serum levels of high sensitivity C-reactive protein (hs-CRP concentration were determined by chemiluminescence and serum levels of all other biomarkers by ELISA. One group of patients at high risk for ISR received a loading oral dose of 15 mg sirolimus and 5 mg daily thereafter for 28 days after stenting (SIR-G. A control group (CONT-G was submitted to stenting without sirolimus therapy. The increase in hs-CRP concentration was highest at 24 h after stenting in both groups. A significant difference between SIR-G and CONT-G was observed at 4 weeks (-1.50 ± 5.0 vs -0.19 ± 0.4, P = 0.008 and lost significance 1 month after sirolimus discontinuation (-1.73 ± 4.3 vs -0.01 ± 0.7, P = 0.0975. A continuous fall in MMP-9 concentration was observed in SIR-G, with the greatest reduction at 4 weeks (-352.9 ± 455 vs +395.2 ± 377, P = 0.0004, while a positive variation was noted 4 weeks after sirolimus discontinuation (227 ± 708 vs 406.2 ± 472.1, P = 0.0958. SIR-G exhibited a higher increase in P-selectin after sirolimus discontinuation at week 8 (46.1 ± 67.9 vs 5.8 ± 23.7, P = 0.0025. These findings suggest that the anti-restenotic actions of systemic sirolimus include anti-proliferative effects and modulation of the inflammatory response with inhibition of adhesion molecule expression.

  8. Long-term safety and effectiveness of unprotected left main coronary stenting with drug-eluting stents compared with bare-metal stents.

    Science.gov (United States)

    Kim, Young-Hak; Park, Duk-Woo; Lee, Seung-Whan; Yun, Sung-Cheol; Lee, Cheol Whan; Hong, Myeong-Ki; Park, Seong-Wook; Seung, Ki Bae; Gwon, Hyeon-Cheol; Jeong, Myung-Ho; Jang, Yangsoo; Kim, Hyo-Soo; Seong, In-Whan; Park, Hun Sik; Ahn, Taehoon; Chae, In-Ho; Tahk, Seung-Jea; Chung, Wook-Sung; Park, Seung-Jung

    2009-08-04

    Limited information is available on long-term outcomes for patients with unprotected left main coronary artery disease who received drug-eluting stents (DES). In the multicenter registry evaluating outcomes among patients with unprotected left main coronary artery stenosis undergoing stenting with either bare metal stents (BMS) or DES, 1217 consecutive patients were divided into 2 groups: 353 who received only BMS and 864 who received at least 1 DES. The 3-year outcomes were compared by use of the adjustment of inverse-probability-of-treatment-weighted method. Patients receiving DES were older and had a higher prevalence of diabetes mellitus, hypertension, hyperlipidemia, and multivessel disease. In the overall population, with the use of DES, the 3-year adjusted risk of death (8.0% versus 9.5%; hazard ratio, 0.71; 95% confidence interval, 0.36 to 1.40; P=0.976) or death or myocardial infarction (14.3% versus 14.9%; hazard ratio, 0.83; 95% confidence interval, 0.49 to 1.40; P=0.479) was similar compared with BMS. However, the risk of target lesion revascularization was significantly lower with the use of DES than BMS (5.4% versus 12.1%; hazard ratio, 0.40; 95% confidence interval, 0.22 to 0.73; P=0.003). When patients were classified according to lesion location, DES was still associated with lower risk of target lesion revascularization in patients with bifurcation (6.9% versus 16.3%; hazard ratio, 0.38; 95% confidence interval, 0.18 to 0.78; P=0.009) or nonbifurcation (3.4% versus 10.3%; hazard ratio, 0.39; 95% confidence interval, 0.17 to 0.88; P=0.024) lesions with a comparable risk of death or myocardial infarction. Compared with BMS, DES was associated with a reduction in the need for repeat revascularization without increasing the risk of death or myocardial infarction for patients with unprotected left main coronary artery stenosis.

  9. Feasibility of coronary calcium and stent image subtraction using 320-detector row CT angiography

    DEFF Research Database (Denmark)

    Fuchs, Andreas; Kühl, J Tobias; Chen, Marcus Y

    2015-01-01

    . The use of coronary calcium image subtraction improved the reader confidence in 66% of these segments. In target segments, specificity (86% vs 65%; P positive predictive value (71% vs 51%, P = .03) were improved using CCTAsub compared to CCTAconv without loss in negative predictive value....... We defined target segments on CCTAconv as motion-free coronary segments with calcification or stent and low reader confidence. The effect of CCTAsub was assessed. No approval from the ethics committee was required according to Danish law. RESULTS: A total of 76 target segments were identified...... severity leading to false-positive results. In a pilot study, we tested the feasibility of a new coronary calcium image subtraction algorithm in relation to reader confidence and diagnostic accuracy. METHODS: Forty-three patients underwent clinically indicated ICA and CCTA using a 320-detector row CT...

  10. Results of genotype-guided antiplatelet therapy in patients who undergone percutaneous coronary intervention with stent.

    Science.gov (United States)

    Sánchez-Ramos, Jesús; Dávila-Fajardo, Cristina Lucía; Toledo Frías, Pablo; Díaz Villamarín, Xando; Martínez-González, Luis Javier; Martínez Huertas, Susana; Burillo Gómez, Francisco; Caballero Borrego, Juan; Bautista Pavés, Alicia; Marín Guzmán, Mª Carmen; Ramirez Hernández, José Antonio; Correa Vilches, Concepción; Cabeza Barrera, Jose

    2016-12-15

    Clopidogrel has provided beneficial effects in acute coronary syndrome and percutaneous coronary intervention. Different polymorphisms have been associated with differences in clopidogrel response. The aim of this study was to check if CYP2C19/ABCB1-genotype-guided strategy reduces the rates of cardiovascular events and bleeding. This experimental study included patients undergoing percutaneous coronary intervention with stent. The prospective genotype-guided strategy (intervention group) was compared against a retrospective non-tailored strategy (control group). Primary efficacy endpoint was the composite of cardiovascular death, acute coronary syndrome or stroke during 12months after intervention. Secondary endpoint was to compare the efficacy of the different antiplatelet therapies used in genotyping conditions. The study included 719 patients undergone stent, more than 86% with acute coronary syndrome. The primary endpoint occurred in 32 patients (10.1%) in the genotyping group and in 59 patients (14.1%) in the control group (HR 0.63, 95% CI (0.41-0.97), p =0.037). There was no difference in The Thrombolysis in Myocardial Infarction major and minor bleeding criteria between the two groups (4.1% vs. 4.7%, HR=0.80, 95% CI (0.39-1.63), p=0.55). In intervention group, there was no difference in the rate of events in patients treated with clopidogrel versus patients treated with other antiplatelet treatments (9.1% vs 11.5% p=0.44), or bleeding (3.7% vs 4.6%, p=0.69). The genotype-guided strategy could reduce the rates of composite of cardiovascular events and bleeding during 12months after percutaneous coronary intervention compared to a non-genotype-guide strategy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  11. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial

    DEFF Research Database (Denmark)

    Rasmussen, Klaus; Maeng, Michael; Kaltoft, Anne

    2010-01-01

    BACKGROUND: In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery...... percutaneous coronary intervention centres between January, 2006, and August, 2007. Computer-generated block randomisation and a telephone allocation service were used to randomly assign patients to receive the zotarolimus-eluting or the sirolimus-eluting stent. Data for follow-up were obtained from national...... is registered with ClinicalTrials.gov, number NCT00660478. FINDINGS: 1162 patients (1619 lesions) were assigned to receive the zotarolimus-eluting stent, and 1170 patients (1611 lesions) to receive the sirolimus-eluting stent. 67 patients (72 lesions) had stent failure, and six patients were lost to follow...

  12. Prospective rAndomized, single-blind, mulTicenter control clinical study of sirolimus-eluting coRonary stent “Calypso” vs everolimus-elutIng cOronary stenT “Xience Prime”: design and rationale for “PATRIOT” trial

    Directory of Open Access Journals (Sweden)

    А. А. Прохорихин

    2016-12-01

    Full Text Available Aim. This study is aimed at evaluating the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease. Methods. This is a prospective, randomized, single-blind multicenter clinical trial in patients undergoing coronary revascularization with coronary stenting. Seven clinical sites in Russia will enroll 610 patients with coronary artery disease. Patients suitable for coronary stenting will be randomized in group 1 (n=406 to receive coronary stent “Calypso” (“Angioline”, and group 2 (n=204 to receive coronary stent Xience Prime (Abbott. Clinical follow-up will continue for 1 year. By the end of follow-up, a quantitative coronary angiography will be performed in 122 patients (20 %. Conclusion. A randomized trial “PATRIOT” is designed to prove the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease.Received 5 October 2016. Accepted 6 December 2016.Funding: This study was funded by “Angioline Interventional Devices”, 630090, 18 Inzhenernaya Street, Novosibirsk, Russian Federation. Conflict of interest: The authors declare no conflict of interest.

  13. Update on the everolimus-eluting coronary stent system: results and implications from the SPIRIT clinical trial program

    Directory of Open Access Journals (Sweden)

    R Michael Kirchner

    2009-12-01

    Full Text Available R Michael Kirchner, J Dawn AbbottDepartment of Cardiology, Rhode Island Hospital, Brown Medical School, Providence, RI, USAAbstract: Drug-eluting stents (DES have had a major impact in interventional cardiology. Compared to bare metal stents, they significantly reduce restenosis and the need for target vessel revascularization. Four DES are available in the US, the first-generation sirolimuseluting (Cypher® and paclitaxel-eluting (Taxus® stents and later approved second-generation everolimus-eluting (Xience V® and zotarolimus-eluting (Endeavor® stents. The Xience V stent was approved on the basis of clinical efficacy and safety data from 3 studies in the SPIRIT clinical trial program. Within this trial series, the Xience V was superior to its bare metal stent counterpart, the Vision® stent, and noninferior to the paclitaxel-eluting stent for target vessel failure at 9 months. This review provides a comprehensive assessment of the data derived from both the pre- and post-approval randomized controlled trials and registry studies of Xience V that comprise the SPIRIT clinical trial program including recently published mid-term outcomes. The implications of the results in terms of interventional practice will be discussed.Keywords: cobalt-chromium, drug-eluting stent, everolimus, percutaneous coronary intervention, Xience V

  14. Safety and efficacy of everolimus-eluting stents compared with first-generation drug-eluting stents in patients undergoing primary percutaneous coronary intervention

    Energy Technology Data Exchange (ETDEWEB)

    Escárcega, Ricardo O.; Baker, Nevin C.; Magalhaes, Marco A.; Lipinski, Michael J.; Minha, Sa’ar; Torguson, Rebecca; Satler, Lowell F.; Pichard, Augusto D.; Suddath, William O.; Waksman, Ron, E-mail: ron.waksman@medstar.net

    2014-09-15

    Objective: To assess the safety and efficacy everolimus-eluting stents (EES) compared with first-generation drug-eluting stents (DES) in patients with acute myocardial infarction (MI) undergoing primary percutaneous coronary intervention (PCI). Background: EES have been associated with improved clinical outcomes compared to paclitaxel-eluting stents (PES) and with similar outcomes compared to sirolimus-eluting stents (SES). Methods: A total of 520 patients who presented with ST-elevation myocardial infarction (STEMI) from 2003 to 2013, who underwent primary PCI with DES, were retrospectively analyzed. Of these, 247 received SES, 136 PES, and 137 EES. Patients were followed up to 2 years for major adverse cardiac events (MACE). Univariate and multivariate models detected correlates to outcome. Results: EES implantation, compared with PES and SES, resulted in comparable rates of MACE (8.8% vs. 16.2%, p = 0.06 and 8.8% vs. 12.6%, respectively, p = 0.26), stent thrombosis, MI, and target lesion revascularization. Patients who received EES had lower rates of all-cause mortality (3.7% vs. 12.6% vs. 9.4%, p = 0.03) at 1-year follow up. However, in the univariate and multivariate analyses, stent type was not independently associated with the primary outcome or with all-cause mortality. Diabetes mellitus and number of stents implanted were independently associated with the primary outcome. Conclusion: While EES seem to be associated with better outcome when compared to PES, the main correlates of STEMI patients are the presence of diabetes and number of stents implanted, and not the type of stent used for intervention.

  15. Diagnostic accuracy of in-stent coronary restenosis detection with multislice spiral computed tomography: a meta-analysis

    Energy Technology Data Exchange (ETDEWEB)

    Hamon, Michele [University Hospital of Caen, Department of Radiology, 14033 Caen Cedex, Normandy (France); Champ-Rigot, Laure; Riddell, John W. [University Hospital of Caen, Department of Cardiology, 14033 Caen Cedex, Normandy (France); Morello, Remy [University Hospital of Caen, Department of Statistics, 14033 Caen Cedex, Normandy (France); Hamon, Martial [University Hospital of Caen, Department of Cardiology, 14033 Caen Cedex, Normandy (France); Institut Pasteur de Lille, INSERM 744, Lille (France); Centre Hospitalier Universitaire de Caen, Service des Maladies du Coeur et des Vaisseaux, 14033 Caen Cedex, Normandy (France)

    2008-02-15

    This study was designed to define the current role of multislice spiral computed tomography (MSCT) for the diagnosis of coronary in-stent restenosis using a meta-analytic process. Restenosis remains a limitation after coronary stent implantation and contributes to a substantial number of coronary re-assessments by conventional invasive coronary angiography (CA). We identified 15 studies (807 patients) evaluating in-stent restenosis by means of both MSCT ({>=}16 slices) and conventional CA until February 2007. After data extraction the analysis was performed according to a random-effects model. The analysis pooled the results from 15 studies with a total of 1,175 stents. A substantial number of unassessable stents (13%) were excluded from the analysis underscoring the shortcomings of MSCT. With this major limitation the diagnostic performance of MSCT for in-stent restenosis detection can be summarized as follows: the sensitivity and specificity were 84% [95% confidence interval (CI) 77-89%] and 91% (95% CI 89-93%), respectively, with positive and negative likelihood ratios of 12.2 (95% CI 6.6-22.6) and 0.23 (95% CI 0.17-0.31), respectively, and with a diagnostic odds ratio of 67.9 (95% CI 34.4-134.1). MSCT has shortcomings difficult to overcome in daily practice for in-stent restenosis detection and continues to have moderately high sensitivity and specificity. The diagnostic role of this emerging technology as an alternative to CA for in-stent restenosis detection remains limited. (orig.)

  16. Prospective study one-year clinical outcomes of the Calypso coronary stent in patients presenting with acute coronary syndrome

    Directory of Open Access Journals (Sweden)

    В. Л. Воробьев

    2017-04-01

    Full Text Available Aim. To evaluate the effectiveness of the stent use Calypso Angiolain Russia with primary percutaneous transluminal coronary angioplasty (PTCA.Methods. The study prospectively included 150 patients who underwent PTCA in acute coronary syndrome (ACS for the period from January to December 2015. During the one-year follow-up period were evaluated indicators insolvency target lesion (cardiac death, myocardial infarction in the pool target artery, target lesion revascularization when clinically indicated, major adverse cardiac events (death from any cause, myocardial infarction, repeat revascularization as clinically indicated. Results. In one year, the incidence of target lesion failure was 6.66% for cardiac death rate of 1.33%, myocardial infarction in the target artery 3.33% and target lesion revascularization at 5.3%. The frequency of cardiac major adverse cardiac events was 12% at mortality 2.66%, myocardial infarction 4% and revascularization when clinically indicated 8.66%. Conclusion. The use of stents in primary PTCA Calypso is possible, the percentage of cardiovascular complications is comparable with the data of clinical trials.Received 31 January 2017. Accepted 17 March 2017.Financing: The study did not have sponsorship.Conflict of interest: The authors declare no conflict of interest.

  17. Triple antithrombotic therapy in patients with atrial fibrillation undergoing coronary artery stenting: hovering among bleeding risk, thromboembolic events, and stent thrombosis

    Directory of Open Access Journals (Sweden)

    Menozzi Mila

    2012-10-01

    Full Text Available Abstract Dual antiplatelet treatment with aspirin and clopidogrel is the antithrombotic treatment recommended after an acute coronary syndrome and/or coronary artery stenting. The evidence for optimal antiplatelet therapy for patients, in whom long-term treatment oral anticoagulation is mandatory, is however scarce. To evaluate the safety and efficacy of the various antithrombotic strategies adopted in this population, we reviewed the available evidence on the management of patients receiving oral anticoagulation, such as a vitamin-k-antagonists, referred for coronary artery stenting. Atrial fibrillation is the most frequent indication for oral anticoagulation. The need of starting antiplatelet therapy in this clinical scenario raises concerns about the combination to choose: triple therapy with warfarin, aspirin, and a thienopyridine being the most frequent and advised. The safety of this regimen appeared suboptimal because of an increased risk in hemorrhagic complications. On the other hand, the combination of oral anticoagulation and an antiplatelet agent is suboptimal in preventing thromboembolic events and stent thrombosis; dual antiplatelet therapy may be considered only when a high hemorrhagic risk and low thromboembolic risk are perceived. Indeed, the need for prolonged multiple-drug antithrombotic therapy increases the bleeding risks when drug eluting stents are used. Since current evidence derives mainly from small, single-center and retrospective studies, large-scale prospective multicenter studies are urgently needed.

  18. Clinical Coronary In-Stent Restenosis Follow-Up after Treatment and Analyses of Clinical Outcomes

    Directory of Open Access Journals (Sweden)

    Barbara Campos Abreu Marino

    2015-05-01

    Full Text Available Background: Clinical in-stent restenosis (CISR is the main limitation of coronary angioplasty with stent implantation. Objective: Describe the clinical and angiographic characteristics of CISR and the outcomes over a minimum follow-up of 12 months after its diagnosis and treatment. Methods: We analyzed in 110 consecutive patients with CISR the clinical presentation, angiographic characteristics, treatment and combined primary outcomes (cardiovascular death, nonfatal acute myocardial infarction [AMI] and combined secondary (unstable angina with hospitalization, target vessel revascularization and target lesion revascularization during a minimal follow-up of one year. Results: Mean age was 61 ± 11 years (68.2% males. Clinical presentations included acute coronary syndrome (ACS in 62.7% and proliferative ISR in 34.5%. CISR was treated with implantation of drug-eluting stents (DES in 36.4%, Bare Metal Stent (BMS in 23.6%, myocardial revascularization surgery in 18.2%, balloon angioplasty in 15.5% and clinical treatment in 6.4%. During a median follow-up of 19.7 months, the primary outcome occurred in 18 patients, including 6 (5.5% deaths and 13 (11.8% AMI events. Twenty-four patients presented a secondary outcome. Predictors of the primary outcome were CISR with DES (HR = 4.36 [1.44–12.85]; p = 0.009 and clinical treatment for CISR (HR = 10.66 [2.53–44.87]; p = 0.001. Treatment of CISR with BMS (HR = 4.08 [1.75–9.48]; p = 0.001 and clinical therapy (HR = 6.29 [1.35–29.38]; p = 0.019 emerged as predictors of a secondary outcome. Conclusion: Patients with CISR present in most cases with ACS and with a high frequency of adverse events during a medium-term follow-up.

  19. Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: rationale and design of the BIOSCIENCE trial.

    Science.gov (United States)

    Pilgrim, Thomas; Roffi, Marco; Tüller, David; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Heg, Dik; Jüni, Peter; Windecker, Stephan

    2014-09-01

    Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population. The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with biodegradable polymer sirolimus-eluting stents (SES) or durable polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non-ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the biodegradable polymer SES compared with the durable polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years. The BIOSCIENCE trial will determine whether the biodegradable polymer SES is noninferior to the durable polymer EES with respect to TLF. Copyright © 2014 Mosby, Inc. All rights reserved.

  20. DK mini-culotte stenting in the treatment of true coronary bifurcation lesions: a propensity score matching comparison with T-provisional stenting.

    Science.gov (United States)

    Fan, Lin; Chen, Lianglong; Luo, Yukun; Zhang, Linlin; Zhong, Wenliang; Lin, Chaogui; Chen, Zhaoyang; Peng, Yafei; Zhen, Xingchun; Dong, Xianfeng

    2016-03-01

    The conventional culotte technique remains not to be widely used for the treatment of coronary bifurcation lesions due to its inherent drawbacks. Here, we developed a double kissing mini-culotte stenting (DK mini-culotte) and assessed its efficacy and safety by a propensity score matching comparison (PSM) with T-provisional stenting. From June 2010 to June 2012, a total of 223 consecutive patients with true coronary bifurcation lesions (TCBLs) were treated with DK mini-culotte (91 patients with 92 lesions) or T-provisional stenting (132 patients with 135 lesions). We performed a PSM to correct the confounders from clinical and lesion's characteristics. The primary endpoint was cumulative major adverse cardiac event (MACE) at 1 year including cardiac death, myocardial infarction, and target vessel revascularization or target lesion revascularization (TVR/TLR). The secondary endpoint was the rate of side branch (SB) restenosis at 12 months. After a PSM, there were 66 patients in each group. Additional SB stenting in the T-provisional group was performed in 10 (15.2 %) lesions. The incidence of 1-year cumulative MACE was 4.55 % for the DK mini-culotte versus 13.6 % for T-provisional stenting (P = 0.127), the rate of TVR/TLR was 1.52 % for DK mini-culotte versus 12.12 % for T-provisional stenting (P = 0.033). The SB binary restenosis rate was 5.6 % in the DK mini-culotte group and 22.4 % in the T-provisional group (P = 0.014). In summary, despite that there is no difference in MACE between groups, DK mini-culotte significantly reduce TVR/TLR and SB restenosis in the treatment of true coronary bifurcation lesions.

  1. Development and validation of a stent thrombosis risk score in patients with acute coronary syndromes.

    Science.gov (United States)

    Dangas, George D; Claessen, Bimmer E; Mehran, Roxana; Xu, Ke; Fahy, Martin; Parise, Helen; Henriques, José P S; Ohman, E Magnus; White, Harvey D; Stone, Gregg W

    2012-11-01

    This study sought to develop a practical risk score to predict the risk of stent thrombosis (ST) after percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS). ST is a rare, yet feared complication after PCI with stent implantation. A risk score for ST after PCI in ACS can be a helpful tool to personalize risk assessment. This study represents a patient-level pooled analysis of 6,139 patients undergoing PCI with stent implantation for ACS in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trials who were randomized to treatment with bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor. The cohort was randomly divided into a risk score development cohort (n = 4,093) and a validation cohort (n = 2,046). Cox regression methods were used to identify clinical, angiographic, and procedural characteristics associated with Academic Research Consortium-defined definite/probable ST at 1 year. Each covariate in this model was assigned an integer score based on the regression coefficients. Variables included in the risk score were type of ACS (ST-segment elevation myocardial infarction, non-ST-segment elevation ACS with ST deviation, or non-ST-segment elevation ACS without ST changes), current smoking, insulin-dependent diabetes mellitus, prior PCI, baseline platelet count, absence of early (pre-PCI) anticoagulant therapy, aneurysmal/ulcerated lesion, baseline TIMI (Thrombolysis In Myocardial Infarction) flow grade 0/1, final TIMI flow grade development cohort (p for trend validation cohort (p for trend = 0.006). The C-statistic for this risk score was over 0.65 in both cohorts. The individual risk of ST can be predicted using a simple risk score based on clinical, angiographic, and procedural variables. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT

  2. A randomized, controlled, multicenter trial to evaluate the safety and efficacy of Zotarolimus- vs. Paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries

    DEFF Research Database (Denmark)

    Chevalier, Bernard; Dimario, Carlo; Neumann, Franz-Josef

    2013-01-01

    The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the pr......The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis...... at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years....

  3. Direct coronary stenting versus stenting with balloon pre-dilation: incidence of enzyme release and follow-up results of a multicentre, prospective, randomized study. The CK and Troponin I Estimation in direct STenting (CK TEST) trial.

    Science.gov (United States)

    Balducelli, M; Varani, E; Vecchi, G; Paloscia, L; Manari, A; Santarelli, A; Cappi, B; Shoeib, A; Valenti, S; Maresta, A

    2007-06-01

    The aim of this study was to assess the safety of direct coronary stenting, its influence on costs, duration of the procedure, radiation exposure, clinical outcome and the incidence of periprocedural myocardial damage as assessed by enzyme release determination. We randomized 103 patients (109 lesions) to direct stent implant or stent implant following balloon predilatation. Patients with heavily calcified lesions, bifurcations, total occlusions, left main lesions and very tortuous vessels were excluded. Three samples of blood were drawn; before, 12 and 24 h after the procedure and total CK, CK MB mass and troponin I determination was carried out in a single centralized laboratory. Direct stenting was successful in 62/62 lesions (100%). No single loss or embolization of the stent occurred. All stents in the group with predilatation were effectively deployed. The immediate post procedure angiographic results were similar with both techniques. Contrast media consumption and procedural time were significantly lower in direct stenting (150+/-82 cc and 30+/-13 min) than in pre-dilated stenting (184+/-85 cc and 36+/-14 min) (P=0.04 and P=0.036 respectively) while fluoroscopy time was similar (9.1+/-12 vs 9.19+/-15 min, P=0.97). The incidence of enzyme release was similar in the groups with only three non Q MI all in the pre-dilated group (P=0.149). Any elevation of CK MB and troponin I occurred in 7% of direct stent vs 12% of pre-dilated group (P=0.66), isolated troponin I elevation in 21% of both groups. Major adverse cardiac events during hospitalization were 0 in direct and 3 in pre-dilated stenting (P=0.66), but there were no significant differences at follow-up at 1, 6 and 12 months between the 2 groups (target lesion revascularization at 12 months 11 vs 14% in the 2 groups respectively). Direct stenting is as safe as pre-dilated stenting in selected coronary lesions. Acute results and myocardial damage as assessed by enzyme release determination are similar, but

  4. Clopidogrel discontinuation and platelet reactivity following coronary stenting

    LENUS (Irish Health Repository)

    2011-01-01

    Summary. Aims: Antiplatelet therapy with aspirin and clopidogrel is recommended for 1 year after drug-eluting stent (DES) implantation or myocardial infarction. However, the discontinuation of antiplatelet therapy has become an important issue as recent studies have suggested a clustering of ischemic events within 90 days of clopidogrel withdrawal. The objective of this investigation was to explore the hypothesis that there is a transient ‘rebound’ increase in platelet reactivity within 3 months of clopidogrel discontinuation. Methods and Results: In this prospective study, platelet function was assessed in patients taking aspirin and clopidogrel for at least 1 year following DES implantation. Platelet aggregation was measured using a modification of light transmission aggregometry in response to multiple concentrations of adenosine diphosphate (ADP), epinephrine, arachidonic acid, thrombin receptor activating peptide and collagen. Clopidogrel was stopped and platelet function was reassessed 1 week, 1 month and 3 months later. Thirty-two patients on dual antiplatelet therapy were recruited. Discontinuation of clopidogrel increased platelet aggregation to all agonists, except arachidonic acid. Platelet aggregation in response to ADP (2.5, 5, 10, and 20 μm) and epinephrine (5 and 20 μm) was significantly increased at 1 month compared with 3 months following clopidogrel withdrawal. Thus, a transient period of increased platelet reactivity to both ADP and epinephrine was observed 1 month after clopidogrel discontinuation. Conclusions: This study demonstrates a transient increase in platelet reactivity 1 month after clopidogrel withdrawal. This phenomenon may, in part, explain the known clustering of thrombotic events observed after clopidogrel discontinuation. This observation requires confirmation in larger populations.

  5. Coronary stent implantation is superior to balloon angioplasty for chronic coronary occlusions: six-year clinical follow-up of the GISSOC trial.

    Science.gov (United States)

    Rubartelli, Paolo; Verna, Edoardo; Niccoli, Luigi; Giachero, Corinna; Zimarino, Marco; Bernardi, Guglielmo; Vassanelli, Corrado; Campolo, Luigi; Martuscelli, Eugenio

    2003-05-07

    We investigated whether the benefits of stent implantation over balloon percutaneous transluminal coronary angioplasty (PTCA) for treatment of chronic total coronary occlusions (CTO) are maintained in the long term. Several randomized trials have shown that in CTO, stent implantation confers clinical and angiographic mid-term outcomes superior to those observed after PTCA. However, limited information on the long-term results of either technique is available. Six-year clinical follow-up of patients enrolled in the Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche (GISSOC) trial was performed by direct visit or telephone interview. Major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, target lesion revascularization (TLR), and anginal status, were recorded. Freedom from MACE at six years was 76.1% in the stent group, compared with 60.4% in the PTCA group (p = 0.0555). This difference was due mainly to TLR-free survival rates (85.1% vs. 65.5% for the stent and PTCA groups, respectively; p = 0.0165). Eleven patients underwent TLR after the nine-month follow-up visit (stent group: n = 5; PTCA group: n = 6); however, in most cases, restenosis of the study occlusion was evident at nine-month angiography. This study represents the longest reported clinical follow-up of patients after percutaneous recanalization of CTO and demonstrates that the superiority of stent implantation over balloon PTCA is maintained in the long term. Stent and PTCA results appear to remain stable after nine-month angiographic follow-up. Stent implantation in CTO that can be recanalized percutaneously is therefore a valuable long-term therapeutic option.

  6. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis.

    Science.gov (United States)

    Bangalore, Sripal; Toklu, Bora; Amoroso, Nicholas; Fusaro, Mario; Kumar, Sunil; Hannan, Edward L; Faxon, David P; Feit, Frederick

    2013-11-08

    To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents. Mixed treatment comparison meta-analysis of 258,544 patient years of follow-up from randomized trials. PubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents. Long term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents. From 126 randomized trials and 258,544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1

  7. CT evaluation of coronary artery stents with iterative image reconstruction: improvements in image quality and potential for radiation dose reduction.

    Science.gov (United States)

    Ebersberger, Ullrich; Tricarico, Francesco; Schoepf, U Joseph; Blanke, Philipp; Spears, J Reid; Rowe, Garrett W; Halligan, William T; Henzler, Thomas; Bamberg, Fabian; Leber, Alexander W; Hoffmann, Ellen; Apfaltrer, Paul

    2013-01-01

    Comparison of coronary artery stent assessment with cardiac CT angiography (cCTA) using traditional filtered back projection (FBP) and sinogram affirmed iterative reconstruction (SAFIRE), in both full- and half-radiation dose image data. Dual-source cCTA studies of 37 implanted stents were reconstructed at full- and half-radiation dose with FBP and SAFIRE. Half-dose data were based on projections from one DSCT detector. In-stent noise, signal-to-noise ratio (SNR), and stent-lumen attenuation increase ratio (SAIR) were measured and image quality graded. Stent volumes were measured to gauge severity of beam hardening artefacts. Full-dose SAFIRE reconstructions were superior to full-dose FBP vis-à-vis in-stent noise (21.2 ± 6.6 vs. 35.7 ± 17.5; P  0.05). Comparing half-dose SAFIRE with full-dose FBP, in-stent noise (26.7 ± 13.0 vs. 35.7 ± 17.5; P  0.05), stent volume (129.6 ± 57.3 vs. 129.8 ± 65.0 mm(3); P > 0.05), and image quality (3.5 ± 1.0 vs. 3.7 ± 1.1; P > 0.05) did not differ. Radiation dose decreased from 8.7 ± 5.2 to 4.3 ± 2.6 mSv. Iterative reconstruction significantly improves imaging of coronary artery stents by CT compared with FBP, even with half-radiation-dose data.

  8. Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Kaltoft, Anne

    2007-01-01

    OBJECTIVES: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS). BACKGROUND: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death. METHODS: From January 2002...

  9. Percutaneous Stent Implantation for Treating Multivessel Coronary Disease in Patients with and without Involvement of the Proximal Segment of the Anterior Descending Coronary Artery

    Directory of Open Access Journals (Sweden)

    Salgueiro Sandro

    2002-01-01

    Full Text Available OBJECTIVE: To assess coronary stent placement in patients with multivessel coronary disease and involvement of the proximal portion of the anterior descending coronary artery. METHODS: We retrospectively analyzed the in-hospital and late evolution of 189 patients with multivessel coronary disease, who underwent percutaneous coronary stent placement. These patients were divided into 2 groups as follows: group I (GI - 59 patients with involvement of the proximal segment of the anterior descending coronary artery; and group II (GII - 130 patients without involvement of the proximal segment of the anterior descending coronary artery. RESULTS: No significant difference was observed in the success rate of the procedure (91.5% versus 97.6%, p=0.86, nor in the occurrence of major adverse cardiac events (5.1% versus 1.5%, p=0.38, nor in the occurrence of major vascular complications (1.7% versus 0%, p=0.69 in the in-hospital phase. In the late follow-up, the incidence of major adverse cardiac events (15.4% versus 13.7%, p=0.73 and the need for new revascularization (13.5% versus 10.3%, p=0.71 were similar for both groups. CONCLUSION: The in-hospital and late evolution of patients with multivessel coronary disease with and without involvement of the proximal segment of the anterior descending coronary artery treated with coronary stent placement did not differ. This suggests that this revascularization method is an effective procedure and a valuable option for treating these types of patients.

  10. Coronary Angiography

    Science.gov (United States)

    ... is used to diagnose coronary heart disease and coronary microvascular disease after chest pain, sudden cardiac arrest, or abnormal ... Cardiac CT Scan Clinical Trials Coronary Heart Disease Coronary Microvascular Disease Electrocardiogram Heart Attack Percutaneous Coronary Intervention Stents Stress ...

  11. JAK2 mutation and acute coronary syndrome complicated with stent thrombosis.

    Science.gov (United States)

    Inami, Toru; Okabe, Masahiro; Matsushita, Masato; Kobayashi, Nobuaki; Inokuchi, Koiti; Hata, Noritake; Seino, Yoshihiko; Shimizu, Wataru

    2016-10-01

    Acute coronary syndrome (ACS) could be a precious opportunity for patients to reveal concealed diseases other than conventional risk factors for ACS, such as hypertension, dyslipidemia, diabetes mellitus, etc. In the setting of ACS, the intracoronary and systemic prothrombotic environment has led to an increase in the risk of stent thrombosis of which mortality was higher among patients with ACS, especially with the highest mortality in patients with ST elevation myocardial infarction. The some specific conditions which were concealed beyond the cardiovascular pathophysiology except well-known risk factors for ACS and stent thrombosis might involve the onset of ACS. We describe a case of a 64-year-old man who was admitted to intensive care unit for chest pain. This case found the possibility that polycythemia vera with Janus kinase 2 (JAK2) V617F mutation might be a underlying disease of ACS with stent thrombosis, and highlighted the importance of recognizing polycythemia vera with JAK2 V617F mutation as concealed disease for cardiologists. We would like to report and review the relationship between ACS and polycythemia vera with JAK2 V617F mutation.

  12. Plasma big endothelin-1 and stent thrombosis: An observational study in patients undergoing percutaneous coronary intervention in China.

    Science.gov (United States)

    Chen, Yan; Li, Jian-Xin; Song, Ying; Xu, Jing-Jing; Tang, Xiao-Fang; Jiang, Lin; Jiang, Ping; Liu, Ru; Wang, Huan-Huan; Zhao, Xue-Yan; Chen, Jue; Gao, Zhan; Qiao, Shu-Bin; Gao, Run-Lin; Yang, Yue-Jin; Xu, Bo; Yuan, Jin-Qing

    2017-11-01

    Stent thrombosis (ST) is a rare but catastrophic complication of percutaneous coronary intervention, leading to poor prognosis. Endothelin-1 (ET-1) plays an important role in endothelial dysfunction and thrombogenesis. However, the impact of big ET-1 level on ST in patients with coronary stenting is unknown. We aimed to evaluate big ET-1 level as a potential predictor of ST in patients undergoing percutaneous coronary intervention. From January 2013 to December 2013, 8106 consecutive patients underwent successful coronary stent implantation and were prospectively enrolled in this study. Patients were stratified into three groups based on plasma big ET-1 level at admission. The incidence of definite and probable ST at 2years postoperatively was 0.84%; ST incidence was lowest in the low big ET-1 group (0.56%), highest in the high big ET-1 group (1.48%), and intermediate in the medium big ET-1 group (0.74%, log-rank p=0.001). Compared with the low big ET-1 group, the multivariate-adjusted hazard ratio (HR) for ST in the high big ET-1 group was 2.06 (95% confidence interval (CI) 1.14-3.73, p=0.017). In subgroup analyses, high big ET-1 level was independently associated with ST in patients with acute coronary syndrome (HR 2.29, 95% CI 1.03-5.06, p=0.041), but not in those with stable coronary artery disease (p=0.331), and tended to be associated with older age. Plasma big ET-1 level is a valuable independent predictor of ST in patients with coronary stents, especially in the acute coronary syndrome population. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Comparing the use of cobalt chromium stents to stainless steel stents in primary percutaneous coronary intervention for acute myocardial infarction: a prospective registry.

    Science.gov (United States)

    Koh, Angela S; Choi, L M; Sim, L L; Tan, Jack W; Khin, L W; Chua, Terrance S J; Koh, T H; Chia, Stanley

    2011-12-01

    To determine clinical outcome and rates of target vessel revascularization (TVR) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI who were treated with cobalt-chromium stents compared to stainless steel bare metal stents (BMS). The newer generation cobalt chromium stents were reported to achieve lower rates of TVR compared with conventional BMS. Consecutive STEMI cases admitted within 12 h of symptom onset and undergoing primary angioplasty and bare metal stent implantation 1 January 2002 and 31 December 2008 were identified. Primary outcomes were rates of clinically-driven TVR at six months as well as occurrence of major adverse cardiovascular events (MACE) either of all-cause death, repeat myocardial infarction or TVR at six months. 1030 cases with 1175 lesions (84% males) and median age of 58 years underwent primary PCI for STEMI in our registry. Overall procedural success rate was 98%. Stainless steel stents were inserted in 65% of the culprit lesions (stainless steel, n = 766 versus cobalt chromium, n = 264). Primary outcomes of TVR (3.5% in the stainless steel group and 3.4% in the cobalt chromium group, P = 0.93) and MACE (8.4% in the stainless steel group and 5.3% in the cobalt chromium group, P = 0.11) after six months were no different between the two groups. However, there were more deaths at 30 days in the stainless steel group compared to the cobalt chromium group (3.5% versus 0.4%, HR 4.04 (1.03-3.88), P = 0.04). Both cobalt-chromium and stainless steel coronary stents were associated with similar and low risk of clinically-driven TVR.

  14. ANGIOPLASTIA PERCUTÁNEA CON STENT EN EL TRONCO PRINCIPAL DE LA ARTERIA CORONARIA IZQUIERDA / Percutaneous angioplasty with stent in the left main coronary artery

    Directory of Open Access Journals (Sweden)

    Javier Almeida Gómez

    2012-10-01

    Full Text Available ResumenIntroducción y objetivos: La afectación significativa del tronco común izquierdo, es la más letal de las presentaciones de la enfermedad arterial coronaria. El tratamiento de elección, es la cirugía de derivación aorto-coronaria. En varios estudios multicéntricos, se sugiere la posibilidad de tratar la enfermedad de tronco mediante el intervencionismo coronario percutáneo con implantación de prótesis endoluminal o stent. El objetivo de esta investigación fue caracterizar la angioplastia percutánea con stent en el tronco principal de la arteria coronaria izquierda. Método: Se realizó un estudio observacional, descriptivo y transversal en 21 pacientes con angioplastia percutánea con stent en el tronco principal de la arteria coronaria izquierda, realizadas en el laboratorio de Hemodinámica y Cardiología Intervencionista del Hospital "Hermanos Ameijeiras", entre enero 2010 y julio 2011. Resultados: No existió diferencia significativa en el sexo. Predominó el grupo de edad entre 50-64 años (47,6 % y el color de la piel blanca (76,19 %. El factor de riesgo cardiovascular más encontrado fue la HTA (85,71 %, seguido de dislipidemia (47,61 %. El diagnóstico más observado fue la angina de esfuerzo estable, 14 casos (66,66 %. La lesión en el cuerpo del tronco (12 pacientes, 57,1 %, fue la más encontrada, seguida de la ostial (8 casos. El tipo de stent más utilizado fue el liberador de fármacos (61,9 %, y solamente 4 pacientes presentaban troncos protegidos quirúrgicamente. Conclusiones: La mayor cantidad de casos fueron electivos, con predominio de los troncos no protegidos. El factor de riesgo coronario más encontrado fue la HTA. Se encontró asociación significativa entre la diabetes mellitus y la localización ostial de la lesión tratada. / AbstractIntroduction and Objectives: Significant impairment of the left main coronary artery is the most lethal presentation of coronary artery disease. The treatment of choice

  15. Covered stent implantation through a single 8-french guide catheter for the management of a distal coronary perforation.

    Science.gov (United States)

    Sandoval, Yader; Lobo, Angie S; Brilakis, Emmanouil S

    2017-10-01

    Distal coronary perforation can cause early or late tamponade and is usually treated with fat or coil embolization. An alternative treatment strategy is occlusion of the ostium of the perforated vessel via implantation of a covered stent in the main vessel, which is typically achieved using the ping-pong guide catheter technique. In this technique, a balloon is inflated over one guide catheter to stop pericardial bleeding and a covered stent is delivered through a second guide catheter due to inability to fit both a balloon and a covered stent through a single guide catheter. With development of lower profile rapid exchange covered stents, a single guide catheter can be used to both occlude the target vessel and deliver the covered stent. We describe a case of distal vessel perforation in which a balloon was inflated to stop pericardial bleeding, followed by delivery of a covered stent (Graftmaster, Abbott Vascular) through a single 8-Fr guide catheter. This "block and deliver" technique represents a novel paradigm for treating coronary perforations through a single guide catheter, obviating the need for the ping-pong guide catheter technique. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  16. Safety and efficacy of a non-polymeric paclitaxel-eluting microporous stent in real-world percutaneous coronary intervention

    Science.gov (United States)

    WANG, SHAO-PENG; HUANG, RONG-CHONG; ZHU, HAO; ZHANG, BO; ZHENG, ZHEN-GUO; YIN, DA; WANG, JUN-JIE; ZHOU, XU-CHEN

    2013-01-01

    At present, there is an increasing focus on stents that have a biodegradable polymer coating, rather than a permanent polymer coating. This is due to the fact that following the implantation of a drug-eluting stent (DES) with a permanent polymer coating, the continued existence of the coating may result in a foreign body reaction and delayed re-endothelialization. The aim of the present study was to evaluate the safety and efficacy of a non-polymeric paclitaxel-eluting microporous (YINYI™) stent in real-life percutaneous coronary intervention (PCI) for patients with coronary artery disease (CAD). A total of 686 YINYI™ stents were implanted in 404 patients with CAD in a PCI procedure and outpatient follow-ups were performed 1, 6, 12 and 15 months subsequent to the PCI, respectively. The observation endpoints were major adverse cardiac events (MACEs), including cardiac death, non-fatal myocardial infarction (MI), restenosis, target lesion revascularization, stent thrombosis and recurrence of angina pectoris. The average follow-up time was 15 months. The results revealed that the cumulative incidences of MACEs were as follows: mortality, 0.99%; non-fatal MI, 0.74%; restenosis, 4.0%; and target lesion revascularization, 2.7%. The results at the short- and long-term clinical follow-ups indicated that YINYI™ stents are effective and safe for use in PCI for patients with CAD. PMID:24137271

  17. Aspirin challenge/desensitisation before coronary stenting in subjects with history of hypersensitivity. A pragmatic approach.

    Science.gov (United States)

    Cortellini, G; Testi, S; Severino, M; Chechi, T; Iorno, M L; Santucci, A; Corvetta, A; Piovaccari, G; Santarelli, A; Franco, N; Canonica, G W; Passalacqua, G

    2012-08-01

    Aspirin hypersensitivity may represent a major problem in patients with ischemic coronary disease who need a stenting procedure. In those patients, clinically unsettled reasonably quick desensitisation procedures are needed. In our study we attempted to select the most suitable procedure on the basis of characteristics and severity of ASA hypersensitivity. Thirty patients with a history of mild reactions to anti-inflammatory doses of aspirin (> 325 mg) were considered at low risk and underwent a tolerance test in 5 steps. Thirty-one patients, with a history of severe reactions to anti-platelet doses of aspirin 0 mg) underwent a slow desensitisation in 12 steps, reaching a cumulative dose of 150 mg ASA in 220 minutes. In the first group, 29 patients tolerated the challenge. One developed urticaria, thus underwent challenge/desensitisation and achieved tolerance. In the second group, 3 patients did not tolerate the procedure and had to discontinue. CONCLUSION. Our approach to aspirin hypersensitivity in patients needing coronary stenting, based on a severity stratification, allowed to achieve an effective tolerance to aspirin in the majority of subject in a reasonable short time.

  18. Zotarolimus-eluting stent utilization in small-vessel coronary artery disease (ZEUS).

    Science.gov (United States)

    Jim, Man-Hong; Yiu, Kai-Hang; Fung, Raymond Chi-Yan; Ho, Hee-Hwa; Ng, Andrew Kei-Yan; Siu, Chung-Wah; Chow, Wing-Hing

    2014-01-01

    The role of the second-generation zotarolimus-eluting stent RESOLUTE in small-vessel coronary artery disease is unclear. The aim of this study was examine the angiographic results of RESOLUTE in de novo coronary lesions of ≥50 % diameter stenosis in target vessels ≤2.5 mm. From August 2008 to April 2010, 142 symptomatic patients with 159 lesions who fitted the inclusion criteria were treated with RESOLUTE. The mean age of patients was 66 ± 10 years, with male predominance (66 %). Diabetes mellitus was found in 62 (43.7 %) patients, whereas multivessel disease was observed in 105 (73.9 %). The mean stent size and length used were 2.33 ± 0.13 and 22 ± 8 mm, respectively. Follow-up angiography was performed on 143 (89.9 %) lesions in 127 (89.4 %) patients at a mean of 10.3 ± 3.6 months. Angiographic restenosis was found in 9 (6.3 %) lesions; the late loss was 0.26 ± 0.34 mm. At 1-year follow-up there were four cardiovascular deaths, two nonfatal myocardial infarctions, and six repeated revascularizations. The resultant major adverse cardiac event rate was 8.5 %. The use of RESOLUTE to treat small-vessel disease is associated with good clinical and angiographic outcomes at 1 year.

  19. Long-term clinical and economic analysis of the Endeavor drug-eluting stent versus the Driver bare-metal stent: 4-year results from the ENDEAVOR II trial (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions).

    Science.gov (United States)

    Eisenstein, Eric L; Wijns, William; Fajadet, Jean; Mauri, Laura; Edwards, Rex; Cowper, Patricia A; Kong, David F; Anstrom, Kevin J

    2009-12-01

    This study was designed to evaluate long-term clinical and economic outcomes for subjects receiving Endeavor drug-eluting versus Driver bare-metal stents (both Medtronic CardioVascular, Santa Rosa, California). Early studies found that the drug-eluting stent (DES) was a clinically and economically attractive alternative to the bare-metal stent; however, associations between DES and very late stent thrombosis suggest that longer follow-up is required. We used clinical, resource use and follow-up data from 1,197 subjects randomized to receive Endeavor (n = 598) versus Driver (n = 599) stents in ENDEAVOR II (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions) study with Medicare cost weights and quality of life adjustments applied from secondary sources. We compared differences through 4-year follow-up (1,440 days). Patients in both treatment groups had similar baseline characteristics. The use of Endeavor versus Driver reduced 4-year target vessel revascularization rates per 100 subjects (10.4 vs. 21.5; difference: -11.1; 95% confidence interval [CI]: -16.0 to -6.1; p AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions [ENDEAVOR II]; NCT00614848).

  20. Comparison between ticlopidine and clopidogrel in patients with ST-segment elevation myocardial infarction treated with coronary stenting

    NARCIS (Netherlands)

    De Luca, G.; Suryapranata, H.; van't Hof, A.W.J.; Ottervanger, J.P.; Hoorntje, J.C.A.; Gosselink, A.T.M.; Damibrink, J.H.E.; Zijlstra, F.; Boer, M.J.C.

    Controversy still surrounds the question, which antiplatelet drug should be added to aspirin in patients undergoing coronary stent implantation. The aim of the current study was to compare ticlopidine and clopidogrel in a consecutive series of patients with ST-segment elevation myocardial infarction

  1. '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

  2. Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction

    DEFF Research Database (Denmark)

    Dangas, George D; Schoos, Mikkel M.; Steg, Philippe Gabriel

    2016-01-01

    BACKGROUND: Early stent thrombosis (ST) within 30 days after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction is a serious event. We sought to determine the predictors of and risk of mortality after early ST according to procedural antithrombotic therapy. M...

  3. Improved outcomes of elderly patients treated with drug-eluting versus bare metal stents in large coronary arteries

    DEFF Research Database (Denmark)

    Kurz, David J; Bernheim, Alain M; Tüller, David

    2015-01-01

    recruited to the "BASKET-PROVE" trial, in which 2,314 patients undergoing percutaneous coronary intervention for large (≥3.0 mm) native vessel disease were randomized 2:1 to DES (everolimus- vs sirolimus-eluting stents 1:1) versus BMS. All patients received 12 months of dual antiplatelet therapy...

  4. Evaluation of the MiStent sustained sirolimus eluting biodegradable polymer coated stent for the treatment of coronary artery disease: does uniform sustained abluminal drug release result in earlier strut coverage and better safety profile?

    NARCIS (Netherlands)

    Tijssen, Ruben Y. G.; Kraak, Robin P.; Lu, Huangling; Mifek, Jeffrey G.; Carlyle, Wenda C.; Donohoe, Dennis J.; de Winter, Robbert J.; Koch, Karel T.; Wykrzykowska, Joanna J.

    2017-01-01

    Treatment of coronary artery disease has made strides over the last decades. Development of drug eluting stents (DES), coated with a polymer layer and an anti-proliferative drug to reduce neointimal hyperplasia, has reduced the incidence of in-stent-restenosis relative to treatment with bare metal

  5. One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions: an analysis from the RAVEL trial

    NARCIS (Netherlands)

    B.A. van Hout (Ben); P.A. Lemos Neto (Pedro); G.A. van Es (Gerrit Anne); W.K. Lindeboom (Wietze); M-C. Morice (Marie-Claude); M.J.B.M. van den Brand (Marcel); P.W.J.C. Serruys (Patrick)

    2005-01-01

    textabstractOBJECTIVE: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo

  6. One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions : an analysis from the RAVEL trial

    NARCIS (Netherlands)

    van Hout, BA; Serruys, PW; Lemos, PA; van den Brand, MJBM; van Es, GA; Lindeboom, WK; Morice, MC

    Objective: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL ( randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native

  7. Trial of everolimus-eluting stents or bypass surgery for coronary disease.

    Science.gov (United States)

    Park, Seung-Jung; Ahn, Jung-Min; Kim, Young-Hak; Park, Duk-Woo; Yun, Sung-Cheol; Lee, Jong-Young; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Choo, Suk Jung; Chung, Cheol Hyun; Lee, Jae Won; Cohen, David J; Yeung, Alan C; Hur, Seung Ho; Seung, Ki Bae; Ahn, Tae Hoon; Kwon, Hyuck Moon; Lim, Do-Sun; Rha, Seung-Woon; Jeong, Myung-Ho; Lee, Bong-Ki; Tresukosol, Damras; Fu, Guo Sheng; Ong, Tiong Kiam

    2015-03-26

    Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents. We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups. After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG. Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).

  8. Successful treatment of cardiogenic shock by stenting of the left main coronary artery in acute myocardial infarction

    Directory of Open Access Journals (Sweden)

    Knežević Božidarka

    2008-01-01

    Full Text Available Introduction. Patients with non-ST elevation acute coronary syndromes (NSTE-ACS are sometimes severely hemodynamicly compromised. Urgent coronary angiography should be performed in these patients in percutaneous coronary intervention (PCI centers according to the ESC NSTE-ACS guidelines to determine suitabilty for percutaneous or surgical revascularization. Case report. We reported a 62-year-old male with chest pain admitted to the Coronary Care Unit. ST segment depression of 2 mm in leads I, L and V4-6 was revealed at electrocardiogram. After following 6 hours the patient had chest pain and signs of cardiogenic shock despite of the therapy. Chest x-ray showed pulmonary edema. Echocardiographic examination showed dyskinetic medium and apical segments of septum. The patient underwent coronary angiography immediately which revealed 75% stenosis of the left main coronary artery with thrombus. The use of a GPIIb/III inhibitor-tirofiban and stent implantation resulted in TIMI III flow. After that the patient had no chest pain and acute heart failure subsided in the following days Echocardiography done at the fourth day from PCI showed only hypokinesis medium and apical segment of septum. The patient was discharged at day 11 from admission in a stable condition. Conclusion. Stenting of left main coronary artery stenosis in patients with cardiogenic shock and non- ST segment elevation acute coronary syndromes may be a life saving procedure.

  9. Predictors of long-term outcomes after bypass grafting versus drug-eluting stent implantation for left main or multivessel coronary artery disease

    NARCIS (Netherlands)

    Chang, Mineok; Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Han, Minkyu; Park, Seong-Wook; Serruys, Patrick W.; Park, Seung-Jung

    2017-01-01

    Background: We assessed predictors of long-term outcomes after coronary artery bypass grafting (CABG) versus those after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,230 patients with left main or multivessel coronary artery disease (CAD). Methods and Results: Data

  10. Coronary stent thrombosis with vorapaxar versus placebo: results from the TRA 2° P-TIMI 50 trial.

    Science.gov (United States)

    Bonaca, Marc P; Scirica, Benjamin M; Braunwald, Eugene; Wiviott, Stephen D; O'Donoghue, Michelle L; Murphy, Sabina A; Morrow, David A

    2014-12-09

    Vorapaxar, a novel thrombin receptor antagonist, reduces cardiovascular death and recurrent thrombotic events when added to standard antiplatelet therapy in patients with stable atherosclerotic vascular disease. The goal of this study was to test the hypothesis that treatment with vorapaxar reduces the rate of coronary stent thrombosis (ST) in stable patients with a history of coronary stenting. TRA 2° P-TIMI 50 (Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Patients With Atherosclerosis-Thrombolysis In Myocardial Infarction 50) was a multinational, randomized, double-blind, placebo-controlled trial of vorapaxar in stable patients with prior myocardial infarction, peripheral arterial disease, or stroke. We evaluated the rates of definite ST as adjudicated by a central events committee using Academic Research Consortium (ARC) criteria. A total of 26,449 patients were randomized, with 14,042 (53%) having a history of a coronary stent implantation before randomization, and an additional 449 patients receiving a coronary stent during the trial (total 14,491). During follow-up (median 2.5 years), there were 152 definite ST events, with the majority (92%) occurring late or very late. Vorapaxar reduced ARC definite ST (1.1% vs. 1.4%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.51 to 0.98; p = 0.037). The reduction was consistent, regardless of time from percutaneous coronary intervention, history of diabetes, use of drug-eluting stents, and use of dual antiplatelet therapy (DAPT) at randomization. Vorapaxar increased GUSTO moderate/severe bleeding (HR: 1.57, 95% CI: 1.26 to 1.94; p TRA 2° P-TIMI 50] [P04737]; NCT00526474). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial

    Science.gov (United States)

    Saito, Shigeru; Valdes-Chavarri, Mariano; Richardt, Gert; Moreno, Raul; Iniguez Romo, Andrés; Barbato, Emanuele; Carrie, Didier; Ando, Kenji; Merkely, Bela; Kornowski, Ran; Eltchaninoff, Hélène; James, Stefan; Wijns, William

    2014-01-01

    Aim The aim of this study was to establish safety and efficacy of a new sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES). Sirolimus-eluting stent with bioresorbable polymer was compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in the frame of a CENTURY II clinical trial designed to make global clinical data compliant with regulatory requirements in Europe and Japan. Methods and results The CENTURY II is a prospective, multicentre, randomized (1 : 1), single blind, controlled, non-inferiority clinical trial conducted at 58 study sites in Japan, Europe, and Korea. A total of 1123 patients requiring a percutaneous coronary intervention (PCI) procedure, with implantation of drug-eluting stent (DES), were enrolled [total population (TP)]. Randomization of patients was stratified for the subset of patients matching requirements for DES in Japan (Cohort JR, n = 722). Baseline patient demographic and angiographic characteristics were similar in both study arms, with minimal differences between the TP and Cohort JR. The primary endpoint, freedom from target lesion failure (TLF) at 9 months—TLF [composite of cardiac death, target-vessel-related myocardial infarction (MI) and target lesion revascularization]—was 95.6% with BP-SES and 95.1% with PP-EES (Pnon-inferiority<0.0001). Composite of cardiac death and MI rate was 2.9 and 3.8% (P = 0.40) and target vessel revascularization was 4.5% with BP-SES and 4.2% with PP-EES (P = 0.77). The stent thrombosis rate was 0.9% in both arms. In Cohort JR, freedom from TLF was 95.9 and 94.6% (Pnon-inferiority < 0.0005) with BP-SES and PP-EES, respectively. Conclusion The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting stent at 9-month follow-up. Study registration number UMIN000006940. PMID:24847155

  12. Safety and efficacy of the cobalt chromium PRO-Kinetik coronary stent system: results of the MULTIBENE study.

    Science.gov (United States)

    Vermeersch, Paul; Appelman, Yolande; Horstkotte, Dieter; Richardt, Gert; Boland, Jean; Lalmand, Jacques; Coussement, Patrick; Castadot, Marc; Janssens, Luc; Agostoni, Pierfrancesco; Buysschaert, Ian; Suttorp, Maarten J

    2012-01-01

    The aim of this MULTIBENE study was to evaluate the safety and efficacy of the silicon carbide coated cobalt chromium PRO-Kinetik coronary stent system in patients with single de novo coronary lesions. This prospective international multicenter study included 202 patients at 10 European sites. Analysis was performed on the per protocol population of 197 patients. Patients were followed until 12 months, a subset of patients (n=72) underwent additional coronary angiography at 6 months. Primary endpoint was 6-months rate of target vessel failure (TVF), defined as a composite of cardiac death, myocardial infarction and target vessel revascularization (TVR). At 6 months, rate of TVF was 10.9% and rate of major adverse cardiac events, a composite of cardiac death, MI, target lesion revascularization (TLR) and coronary artery bypass graft, was 11.4%, both being mainly attributed to TVR respective TLR. No cardiac death or stent thrombosis occurred. In-segment late lumen loss was 0.66±0.61mm and binary restenosis was 20.8%, as determined by core laboratory in the angiographic subgroup. Based on these data, the PRO-Kinetik coronary stent system was found to be safe and effective. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. Relationship between the total length of the stents and patients' quality of life after percutaneous coronary intervention.

    Science.gov (United States)

    Liu, Wei; Yang, Xuming; Dong, Pingshuan; Li, Zhijuan

    2015-01-01

    The aim of this study was to examine the relationship between the total length of the stents and the postoperative life quality of patients with multi-vessel coronary artery disease who undergo percutaneous coronary intervention (PCI). Using the short-form health survey (SF-36) items, we analyzed the data on the postoperative life quality of 166 patients with multi-vessel coronary artery disease who underwent percutaneous transluminal coronary intervention in the Department of Cardiology of the First Affiliated Hospital of Henan University of Science and Technology from September 2011 to September 2013. Follow-up was performed 6 months later. All of the dimensionalities, except general health and mental health, showed significantly higher scores after PCI. No significant relationships were observed between the total length of the stents and the postoperative life quality of patients with multi-vessel coronary artery disease who underwent PCI. PCI can effectively improve the postoperative life quality of patients; however, there was no significant relationship between the total length of the stents and postoperative life quality of patients.

  14. Impact of drug-eluting stent generation on patient- and stent-related adverse events of diabetic patients treated by percutaneous coronary intervention.

    Science.gov (United States)

    D'Amico, G; Fabris, T; Mojoli, M; Napodano, M; Frigo, A C; Buja, P; Hoxha, B; Lunardon, A; Zanetti, C; Isabella, G; Iliceto, S; Tarantini, G

    2014-02-01

    Aim of the present study was to assess stent- and patient-related outcomes of the first- vs. second-generation drug-eluting stents (DES) in diabetics, according to the insulin requirement status. Data were obtained from a prospective, single-center registry of 816 consecutive patients with diabetes mellitus (23% insulin-requiring) who underwent percutaneous coronary intervention (PCI) between April 2003 and May 2012 with first- (N.=534) or second-generation DES (N.=282) at our Institution, with at least 12 months of follow-up. We assessed the occurrence of stent-related outcome, including cardiac death, target vessel-related myocardial infarction and target lesion revascularization, versus patient-related outcome, including any cause death, any myocardial infarction and any coronary revascularization. Patients treated with second-generation DES were older and had more complex lesions than patients treated with first-generation DES. Both among patients treated with first-generation DES and those treated with second generation DES, patient-related events were almost double than stent-related events. No interactions were observed between the DES generation type and insulin requirement status. In this observational study, first- and second-generation DES were equally safe and efficacious in diabetic patients undergoing PCI, regardless of insulin requirements. The greater number of patient-related than stent-related events in patients with complex clinical and lesion characteristics emphasizes that the optimization of secondary prevention is at least as important as the selection of which new generation DES to implant in a specific lesion.

  15. Randomized trial of stents versus bypass surgery for left main coronary artery disease.

    Science.gov (United States)

    Park, Seung-Jung; Kim, Young-Hak; Park, Duk-Woo; Yun, Sung-Cheol; Ahn, Jung-Min; Song, Hae Geun; Lee, Jong-Young; Kim, Won-Jang; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Chung, Cheol-Hyun; Lee, Jae-Won; Lim, Do-Sun; Rha, Seung-Woon; Lee, Sang-Gon; Gwon, Hyeon-Cheol; Kim, Hyo-Soo; Chae, In-Ho; Jang, Yangsoo; Jeong, Myung-Ho; Tahk, Seung-Jea; Seung, Ki Bae

    2011-05-05

    Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice. We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups. The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P=0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P=0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P=0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P=0.02). In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered

  16. Early vascular healing after titanium-nitride-oxide-coated stent versus platinum-chromium everolimus-eluting stent implantation in patients with acute coronary syndrome.

    Science.gov (United States)

    Varho, Ville; Kiviniemi, Tuomas O; Nammas, Wail; Sia, Jussi; Romppanen, Hannu; Pietilä, Mikko; Airaksinen, Juhani K; Mikkelsson, Jussi; Tuomainen, Petri; Perälä, Anssi; Karjalainen, Pasi P

    2016-07-01

    Data on early vascular healing response of novel stent designs are scarce. In this randomized prospective trial, we sought to compare early neointimal coverage of cobalt-chromium-based titanium-nitride-oxide-coated bioactive stents (CoCr-BAS) versus platinum-chromium everolimus-eluting stents (PtCr-EES) at 2-month follow-up in patients with acute coronary syndrome (ACS). Forty patients with ACS were randomized to receive either CoCr-BAS (n = 19) or PtCr-EES (n = 21). Neointimal strut coverage and strut apposition were examined by optical coherence tomography; and coronary flow reserve (CFR), fractional flow reserve (FFR) and index of microcirculatory resistance (IMR) were assessed using a coronary pressure wire at 2 months. Two patients in the PtCr-EES underwent OCT out of the time frame of the study, and were excluded from analysis. At 63 ± 8 days, 302 cross-sections (3412 struts) were analysed in the CoCr-BAS group, and 324 cross-sections (3460 struts) in the PtCr-EES group. Median [IQR] neointimal thickness was 203 [108] µm and 42.2 [41] µm for CoCr-BAS and PtCr-EES, respectively (p  0.05 for all). CoCr-BAS showed earlier and more adequate neointimal coverage of struts at 2 months, compared with PtCr-EES, but with more neointimal hyperplasia. Functional healing as assessed by CFR, FFR, and IMR was similar between the two stent arms.

  17. Comparison of platinum chromium everolimus-eluting stent with cobalt chromium everolimus-eluting stent in unselected patients undergoing percutaneous coronary intervention.

    Science.gov (United States)

    Li, R-G; Lee, C-H; Low, A; Chan, M; Chan, K H; Richards, A M; Qu, X-K; Fang, W-Y; Tan, H C

    2015-06-01

    The recent PLATINUM trial has demonstrated that the use of the new generation platinum chromium everolimus-eluting stents (PtCr-EES) yield clinical outcomes similar to those obtained by the use of cobalt chromium everolimus-eluting stents (CoCr-EES) in selected patients with 1 or 2 de novo coronary artery lesions. This study aimed to compare the safety and efficacy of the PtCr-EES and CoCr-EES in unselected patients from a real-life single-center registry.   From July 2009 through November 2010, 788 consecutive patients in our institution with symptomatic coronary artery disease who were treated with the CoCr-EES (n = 410) or PtCr-EES (n = 378) were enrolled into this study. The primary endpoint of the study was target-lesion failure (TLF) at 12-month follow-up and the secondary endpoints were major adverse cardiovascular events and stent thrombosis. The prevalence of TLF in the PtCr-EES group (4.5%) was similar to that in the CoCr-EES group (3.9%). In addition, there were no significant differences in the 12-month rates of cardiac death (2.1% vs. 1.5%), myocardial infarction (2.4% vs. 3.9%), ischemia-driven target lesion revascularization (2.4% vs. 2.2%), and definite or probable stent thrombosis (0.5% vs. 1.5%, all p > 0.05). At 12-month follow-up, the PtCr-EES is comparable in safety and efficacy to the CoCr-EES in unselected patients with coronary artery diseases.

  18. Recurrent Myocardial Infarction After Primary Percutaneous Coronary Intervention in Multivessel Coronary Disease Is Primarily Related to Stent Failure: Post-Hoc Analysis of the PASSION Trial.

    Science.gov (United States)

    Vink, Maarten A; Vos, Nicola S; Dirksen, Maurits T; Suttorp, Maarten J; Slagboom, Ton; Patterson, Mark S; Kiemeneij, Ferdinand; Laarman, GertJan

    2015-12-01

    Our aim was to investigate the risk of events related to non-culprit lesions after primary percutaneous coronary intervention (PCI) in patients with multivessel coronary disease (MVD). In patients undergoing primary PCI for ST-elevation myocardial infarction (STEMI) who are diagnosed with MVD, the optimal treatment strategy is currently under debate. Although observational data exposed an increased risk of multivessel PCI in the acute phase of STEMI, 2 recently published randomized controlled trials showed a reduction of death or recurrent myocardial infarction (MI) after preventive PCI of non-culprit lesions when compared with culprit-lesion PCI only. We performed a post-hoc analysis of 279 patients with MVD included in the Paclitaxel-Eluting Stent versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation (PASSION) trial. We analyzed the incidence and cause of recurrent MI. Recurrent MI due to stent failure was assumed in the event of definite or probable stent thrombosis. After 5 years, 14 patients (5.7%) with MVD had a recurrent MI versus 17 (5.4%) patients with 1-vessel disease (HR 1.06, 95%CI 0.52-2.15, P = 0.87). The majority of events was attributable to stent failure, while of the remaining 6 events, only 1 was proven to originate from a lesion that was judged significant at enrolment. In this post-hoc analysis of the PASSION trial, recurrent MI in patients with MVD was mainly related to stent failure rather than a new event originating from a significant stenosis in a non-culprit coronary artery. © 2015, Wiley Periodicals, Inc.

  19. Multi-objective optimisation of stent dilation strategy in a patient-specific coronary artery via computational and surrogate modelling.

    Science.gov (United States)

    Ragkousis, Georgios E; Curzen, Nick; Bressloff, Neil W

    2016-01-25

    Although contemporary stents have been shown to improve short and long term clinical outcomes, the optimum dilation protocol is still uncertain in challenging cases characterised by long, highly calcified and tortuous anatomy. Recent clinical studies have revealed that in these cases, sub-optimal delivery can result in stent thrombosis (ST) and/or neointimal thickening as a result of stent malapposition (SM) and/or severe vessel trauma. One of the major contributors to vessel trauma is the damage caused by balloon dilation during stent deployment. In the present work, a Kriging based response surface modelling approach has been implemented to search for optimum stent deployment strategies in a clinically challenging, patient specific diseased coronary artery. In particular, the aims of this study were: (i) to understand the impact of the balloon pressure and unpressurised diameter on stent malapposition, drug distribution and wall stresses via computer simulations and (ii) obtain potentially optimal dilation protocols to simultaneously minimise stent malapposition and tissue wall stresses and maximise drug diffusion in the tissue. The results indicate that SM is inversely proportional to tissue stresses and drug deliverability. After analytical multi-objective optimisation, a set of "non-dominated" dilation scenarios was proposed as a post-optimisation methodology for protocol selection. Using this method, it has been shown that, for a given patient specific model, optimal stent expansion can be predicted. Such a framework could potentially be used by interventional cardiologists to minimise stent malapposition and tissue stresses whilst maximising drug deliverability in any patient-specific case. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Optical coherence tomography assessment of a coronary bare cobalt chromium stent deformed by the removal of an entrapped "jailed" guidewire.

    Science.gov (United States)

    Agostoni, Pierfrancesco; Van Belle, Eric; Stella, Pieter R

    2010-09-01

    A 64-year-old male with an ongoing acute coronary syndrome was treated percutaneously for a subtotal occlusion of a first diagonal branch. After predilatation of the diagonal, an important secondary branch was evident at the level of the subocclusion. A jailed wire was placed in this vessel, and stenting of the main diagonal branch was performed with a last-generation thin-strut bare cobalt-chromium stent. Conventional retrieval of the jailed wire was impossible, as the distal tip of the wire remained entrapped at the level of the stent. The strong pulling of the wire led only to a deep intubation of the guiding catheter with possible risk of dissection. Retrieval of the wire was finally possible with the support of an over-the-wire microcatheter. However, the stent, though still patent, appeared deformed. At a scheduled control angiogram 4 months later (while the patient was still asymptomatic), an optical coherence tomography (OCT) investigation of the stented segment confirmed the deformation of the stent. OCT showed a complete lack of stent struts on the side of origin of the secondary branch and an "overlap" or "accumulation" of several layers of stent struts on the other side. There were no signs of uncovered struts overall nor malapposition, and even the sites where multiple stent layers were visible were completely covered by neointimal hyperplasia. Despite the multiple layers of metal, the neointimal reaction was moderate and did not lead to a flow-limiting stenosis, thus the patient was further treated medically without the need for a new intervention.

  1. Percutaneous coronary intervention outcomes in a low-volume center: survival, stent thrombosis, and repeat revascularization.

    Science.gov (United States)

    Kenney, Kimberly M; Marzo, Mitchell C; Ondrasik, Nicholas R; Wisenbaugh, Thomas

    2009-11-01

    American College of Cardiology (ACC) guidelines state that percutaneous coronary interventions (PCI) be performed at centers and by operators with high-volume (>400 yearly/center) whose historical and current risk-adjusted outcomes statistics are comparable to those reported in large registries. Tripler Army Medical Center is a low-volume treatment facility but has a geographic need and special mission requirement for providing this service. We computed 30-day incidence of stent thrombosis, need for repeat revascularization, and all-cause mortality for all PCIs performed at Tripler from January 2002 through June 2008. The New York State Registry regression model was selected among 3 risk-adjustment models that we assessed in our patients. This model was used to compute expected mortality rate based on patient risk factors. The 30-day incidence of stent thrombosis and repeat revascularization was also determined, and the long-term incidence of these events was estimated with the Kaplan-Meier method as was survival. For all 546 PCI procedures, 30-day mortality was 1.47%, the incidence of stent thrombosis 2.1%, the incidence of any repeat revascularization 5.1%, and the combined event rate 5.9%. Based on risk factors used in the New York State Registry, our expected mortality was 1.93% and not significantly different from the observed rate. Although survival at 1 and 3 years appeared comparable with benchmarks at 94.6% and 89.3%, as did repeat revascularization rates at 13.0% and 21.4%, the incidence of stent thrombosis was regarded as high whether the definition included possible cases (3.2% and 3.9%) or only those regarded as definite or probable (2.7% and 3.1%). We did not identify any remediable risk factors for stent thrombosis, nor were we able to identify significant differences by year or by operator. However, visual inspection of a plot of deciles of New York State risk of death demonstrated 2 outlier cases among the 8 who died, who could have been considered

  2. Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.

    Science.gov (United States)

    Ando, Kenji; Ishii, Katsuhisa; Tada, Eiji; Kataoka, Kazuaki; Hirohata, Atsushi; Goto, Kenji; Kobayashi, Katsuyuki; Tsutsui, Hiroshi; Nakahama, Makoto; Nakashima, Hitoshi; Uchikawa, Shinichiroh; Kanda, Junji; Yasuda, Satoshi; Yajima, Junji; Kitabayashi, Hiroshi; Sakurai, Shumpei; Nakanishi, Keita; Inoue, Naoto; Noike, Hirofumi; Hasebe, Terumitsu; Sato, Tetsuya; Yamasaki, Masao; Kimura, Takeshi

    2017-07-01

    The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt-chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION®). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7-19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION® (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION®. All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.

  3. Approach to coronary bifurcation lesions using the everolimus-eluting stent: comparison between a simple strategy and a complex strategy with T-stenting.

    Science.gov (United States)

    Ruiz-Salmerón, Rafael J; Valenzuela, Luis F; Pérez, Inés; Fuentes, Marco; Rodríguez-Leiras, Sergio; Vizcaíno, Manuel; Carrascosa, César; Marcos, Francisco

    2013-08-01

    Coronary bifurcation lesions can be approached using a simple or a complex strategy. In clinical trials with first-generation drug-eluting stents, the complex strategy was not superior to the simple approach. However, to date, the best strategy when using second-generation drug-eluting stents has not been defined. We performed a prospective randomized study comparing a simple vs a complex strategy involving T-stenting for the percutaneous revascularization of bifurcation lesions using the everolimus-eluting stent. Angiographic and clinical follow-up were performed at 9 months. We included 70 lesions in 69 patients, who were randomized to the simple (34 lesions, 33 patients) or complex strategy (36 lesions and patients). In all, 85.6% of the lesions included were true bifurcations. The crossover rate was 17.1%. The binary restenosis rate was 12.1%, with no differences between the groups. Side branch restenosis tended to be higher with the simple strategy in the intention to treat analysis (10.7% vs 0%) but not in the per protocol analysis (5.9% vs 4.2%). The incidence of major adverse cardiac events (cardiac death, myocardial infarction, and target vessel revascularization) was 9.2%, with no differences between groups. There were no cases of stent thrombosis. According to the clinical and angiographic findings, the complex strategy was not significantly superior to the simple approach in the revascularization of bifurcation lesions with second-generation everolimus-drug eluting stents. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  4. [Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions].

    Science.gov (United States)

    Li, C J; Xu, B; Guan, C D; Gao, R L

    2017-11-24

    Objective: To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus eluting stent(Xience V stent) for the treatment of coronary de novo lesions. Methods: This prospective, multi-center, non-inferiority, randomized control trial(TARGETⅠ trial) was performed between August 2010 and April 2011, a total of 460 patients with primary, de novo, single vessel and single coronary lesion from 16 medical centers were enrolled. The diameter stenosis of target lesion was ≥70%, and lesion length was≤24 mm. The patients were randomly assigned to treatment with Firehawk stent (Firehawk stent group) or Xience V stent (Xience V stent group) groups by a web-based allocation system and was stratified by center. The late lumen loss after 9 months, target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction, or ischemia driven target lesion revascularization, patient-oriented composite endpoint (PoCE) which was a composite of all cause death, all cause myocardial infarction, or any revascularization, and stent thrombosis after 5 years were compared between the two groups. Results: (1) There were 2 patients without stent implantation dropped out of this trial. There were 227 patients in Firehawk stent group, and 231 patients in Xience V stent group. The baseline characteristics were similar between the two groups(all P>0.05). (2) The 9 months late lumen loss in Firehawk stent group was non-inferior to that in Xience V stent group ((0.13±0.24)mm vs. (0.13±0.18)mm, P=0.94). (3) A total of 442 (96.5%) patients completed 5 years clinical follow-up. There were no significant differences on 5-year TLF rate (6.0%(13/217) vs. 6.7% (15/225), P=0.77) and PoCE rate (12.0%(26/217) vs. 17.8% (40/225), P=0.09) between the Firehawk stent group and Xience V stent group. (4) Kaplan-Meier analysis showed that TLF rates between 1

  5. A higher volume of fibrotic tissue on virtual histology prior to coronary stent implantation predisposes to more pronounced neointima proliferation.

    Science.gov (United States)

    Haine, Steven; Wouters, Kristien; Miljoen, Hielko; Vandendriessche, Tom; Claeys, Marc; Bosmans, Johan; Vrints, Christiaan

    2017-08-11

    Since neointima smooth muscle cells (SMC) mainly originate from the vessel wall, we investigated whether atherosclerotic plaque composition influences subsequent in-stent neointima proliferation and restenosis. We performed intravascular ultrasound (IVUS) with virtual histology in 98 patients prior to elective bare-metal stent (BMS) implantation in de novo coronary artery lesions. Virtual histology variables pre-percutaneous coronary intervention (PCI) were related to in-stent neointima proliferation six months after implantation assessed as late luminal loss of 0.88 mm (interquartile range (IQR) 0.37-1.23 mm) on angiography and as maximal percentage area stenosis of 42% (IQR 33-59%) and percentage volume intima hyperplasia of 27% (IQR 20-36%) on IVUS. A ridge-trace based multiple linear regression model was constructed to account for multicollinearity of the virtual histology variables and was corrected for implanted stent length (18 mm, IQR 15-23 mm), stent diameter (3.0 mm, IQR 2.75-3.5 mm) and lesion volume (146 mm³, IQR 80-201 mm³) prior to PCI. Fibrous tissue volume prior to PCI (49 mm³, IQR 30-77 mm³) was significantly and independently related to late luminal loss (p = .038), maximal percentage area stenosis (p = .041) and percentage volume intima hyperplasia (p = .004). Neither absolute nor relative amounts of fibrofatty, calcified or necrotic core tissue appeared related to any of the restenosis parameters. Subgroup analysis after exclusion of acute coronary syndrome (ACS) patients yielded similar results. Lesions with more voluminous fibrotic tissue pre-PCI show more pronounced in-stent neointima proliferation, even after correction for lesion plaque volume.

  6. Frequency of Cardiac Death and Stent Thrombosis in Patients With Chronic Obstructive Pulmonary Disease Undergoing Percutaneous Coronary Intervention (from the BASKET-PROVE I and II Trials)

    DEFF Research Database (Denmark)

    Jatene, Tannas; Biering-Sørensen, Tor; Nochioka, Kotaro

    2017-01-01

    is not well known. We analyzed 4,605 patients who underwent percutaneous coronary intervention with bare-metal stents (33.1%) or DES (66.9%) from the Basel Stent Kosten-Effektivitats Trial-Prospective Validation Examination trials I and II. COPD patients (n = 283, 6.1%), were older and had more frequently...

  7. Eptifibatide and abciximab exhibit equivalent antiplatelet efficacy in an experimental model of stenting in both healthy volunteers and patients with coronary artery disease

    NARCIS (Netherlands)

    Amoroso, G; van Boven, AJ; van Veldhuisen, DJ; Tio, RA; Balje-Volkers, CP; Petronio, AS; van Oeveren, W

    2001-01-01

    Platelet deposition and aggregation are the major determinants of acute thrombosis in coronary stents. We aimed to compare the antiplatelet efficacy of different treatments-glycoprotein (Gp) IIb/IIIa inhibitors and conventional antiaggregants-in an experimental model for stenting. Blood samples were

  8. '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.).

  9. Randomized Comparisons Between Different Stenting Approaches for Bifurcation Coronary Lesions With or Without Side Branch Stenosis.

    Science.gov (United States)

    Kim, Young-Hak; Lee, Jae-Hwan; Roh, Jae-Hyung; Ahn, Jung-Min; Yoon, Sung-Han; Park, Duk-Woo; Lee, Jong-Young; Yun, Sung-Cheol; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Seung, Ki Bae; Shin, Won-Yong; Lee, Nae-Hee; Lee, Bong-Ki; Lee, Sang-Gon; Nam, Chang-Wook; Yoon, Junghan; Yang, Joo-Young; Hyon, Min-Su; Lee, Keun; Jang, Jae-Sik; Kim, Hyun-Sook; Park, Seong-Wook; Park, Seung-Jung

    2015-04-20

    This study sought to evaluate the optimal percutaneous coronary intervention techniques using drug-eluting stents for bifurcation coronary lesions. The optimal bifurcation stenting technique needs to be evaluated. The trial included 2 randomization studies separated by the presence of side branch (SB) stenosis for patients having non-left main bifurcation lesions. For 306 patients without SB stenosis, the routine final kissing balloon or leave-alone approaches were compared. Another randomization study compared the crush or single-stent approaches for 419 patients with SB stenosis. Between the routine final kissing balloon and leave-alone groups for nondiseased SB lesions, angiographic restenosis occurred in 17.9% versus 9.3% (p=0.064), comprising 15.1% versus 3.7% for the main branch (p=0.004) and 2.8% versus 5.6% for the SB (p=0.50) from 214 patients (69.9%) receiving 8-month angiographic follow-up. Incidence of major adverse cardiac events including death, myocardial infarction, or target vessel revascularization over 1 year was 14.0% versus 11.6% between the routine final kissing balloon and leave-alone groups (p=0.57). In another randomization study for diseased SB lesions, 28.2% in the single-stent group received SB stents. From 300 patients (71.6%) receiving angiographic follow-up, between the crush and single-stent groups, angiographic restenosis rate was 8.4% versus 11.0% (p=0.44), comprising 5.2% versus 4.8% for the main branch (p=0.90) and 3.9% versus 8.3% for the SB (p=0.12). One-year major adverse cardiac events rate between the crush and single-stent groups was 17.9% versus 18.5% (p=0.84). Angiographic and clinical outcomes were excellent after percutaneous coronary intervention using drug-eluting stents with any stent technique for non-left main bifurcation lesions once the procedure was performed successfully. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  10. Successful Implantation of a Coronary Stent Graft in a Peripheral Vessel

    Directory of Open Access Journals (Sweden)

    Alexander Hess

    2015-01-01

    Full Text Available Peripheral artery disease (PAD is a complex, often underdiagnosed illness with rising prevalence in western world countries. During the past decade there has been a rapid advance especially in the field of endovascular treatment of PAD. Here we present for the first time a case reporting on the placement of coronary stent graft in a peripheral vessel for the management of a peripheral side branch perforation. Interventional angiologists or radiologists may consider such an option for complication management after injury of smaller vessels during peripheral percutaneous interventions. Further specialization and novel options of complication management as described in our case may shift the treatment from surgical to even more endovascular treatment procedures in the future.

  11. Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents.

    Directory of Open Access Journals (Sweden)

    Kevin P Weinfurt

    2008-05-01

    Full Text Available Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006.We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests. Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%; specific disclosures vs no disclosure statements (34%; and specific disclosures vs declarations of no interests (2%. Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3% in which the organization was disclosed in every article the author wrote.In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors.

  12. Serotonin Antagonism Improves Platelet Inhibition in Clopidogrel Low-Responders after Coronary Stent Placement: An In Vitro Pilot Study

    Science.gov (United States)

    Duerschmied, Daniel; Ahrens, Ingo; Mauler, Maximilian; Brandt, Christoph; Weidner, Stefanie; Bode, Christoph; Moser, Martin

    2012-01-01

    Increased residual platelet reactivity remains a burden for coronary artery disease (CAD) patients who received a coronary stent and do not respond sufficiently to treatment with acetylsalicylic acid and clopidogrel. We hypothesized that serotonin antagonism reduces high on-treatment platelet reactivity. Whole blood impedance aggregometry was performed with arachidonic acid (AA, 0.5 mM) and adenosine diphosphate (ADP, 6.5 µM) in addition to different concentrations of serotonin (1–100 µM) in whole blood from 42 CAD patients after coronary stent placement and 10 healthy subjects. Serotonin increased aggregation dose-dependently in CAD patients who responded to clopidogrel treatment: After activation with ADP, aggregation increased from 33.7±1.3% to 40.9±2.0% in the presence of 50 µM serotonin (pclopidogrel low-responders (from 59.9±3.1% to 37.4±3.5, pclopidogrel responders. These results were confirmed with light transmission aggregometry in platelet-rich plasma in a subset of patients. Serotonin hence increased residual platelet reactivity in patients who respond to clopidogrel after coronary stent placement. In clopidogrel low-responders, serotonin receptor antagonism improved platelet inhibition, almost reaching responder levels. This may justify further investigation of triple antiplatelet therapy with anti-serotonergic agents. PMID:22384279

  13. CT evaluation of coronary artery stents with iterative image reconstruction: improvements in image quality and potential for radiation dose reduction

    Energy Technology Data Exchange (ETDEWEB)

    Ebersberger, Ullrich [Medical University of South Carolina, Department of Radiology and Radiological Science and Division of Cardiology, Department of Medicine, Charleston, SC (United States); Heart Centre Munich-Bogenhausen, Department of Cardiology and Intensive Care Medicine, Munich (Germany); Tricarico, Francesco [Catholic University of the Sacred Heart, ' ' A. Gemelli' ' Hospital, Department of Bioimaging and Radiological Sciences, Rome (Italy); Schoepf, U.J. [Medical University of South Carolina, Department of Radiology and Radiological Science and Division of Cardiology, Department of Medicine, Charleston, SC (United States); Medical University of South Carolina, Heart and Vascular Center, Charleston, SC (United States); Blanke, Philipp [Medical University of South Carolina, Department of Radiology and Radiological Science and Division of Cardiology, Department of Medicine, Charleston, SC (United States); University Hospital Freiburg, Department of Diagnostic Radiology, Freiburg (Germany); Spears, J.R.; Rowe, Garrett W.; Halligan, William T. [Medical University of South Carolina, Department of Radiology and Radiological Science and Division of Cardiology, Department of Medicine, Charleston, SC (United States); Henzler, Thomas; Apfaltrer, Paul [Medical University of South Carolina, Department of Radiology and Radiological Science and Division of Cardiology, Department of Medicine, Charleston, SC (United States); University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Institute of Clinical Radiology and Nuclear Medicine, Heidelberg (Germany); Bamberg, Fabian [University of Munich - Grosshadern Campus, Institute of Clinical Radiology, Munich (Germany); Leber, Alexander W. [University of Toronto, Institute for Cardiovascular Intervention and Imaging, Schulich Heart Center, Sunnybrook Health Science Centre, Toronto (Canada); Hoffmann, Ellen [Heart Centre Munich-Bogenhausen, Department of Cardiology and Intensive Care Medicine, Munich (Germany)

    2013-01-15

    Comparison of coronary artery stent assessment with cardiac CT angiography (cCTA) using traditional filtered back projection (FBP) and sinogram affirmed iterative reconstruction (SAFIRE), in both full- and half-radiation dose image data. Dual-source cCTA studies of 37 implanted stents were reconstructed at full- and half-radiation dose with FBP and SAFIRE. Half-dose data were based on projections from one DSCT detector. In-stent noise, signal-to-noise ratio (SNR), and stent-lumen attenuation increase ratio (SAIR) were measured and image quality graded. Stent volumes were measured to gauge severity of beam hardening artefacts. Full-dose SAFIRE reconstructions were superior to full-dose FBP vis-a-vis in-stent noise (21.2 {+-} 6.6 vs. 35.7 {+-} 17.5; P < 0.05), SNR (22.1 {+-} 8.6 vs. 14.3 {+-} 6.7; P < 0.05), SAIR (19.6 {+-} 17.6 vs. 33.4 {+-} 20.4%; P < 0.05), and image quality (4.2 {+-} 0.86 vs. 3.5 {+-} 1.0; P < 0.05). Stent volumes were lower measured with SAFIRE (119.9 {+-} 53.7 vs. 129.8 {+-} 65.0 mm{sup 3}; P > 0.05). Comparing half-dose SAFIRE with full-dose FBP, in-stent noise (26.7 {+-} 13.0 vs. 35.7 {+-} 17.5; P < 0.05) and SNR (18.2 {+-} 6.9 vs. 14.3 {+-} 6.7; P < 0.05) improved significantly. SAIR (31.6 {+-} 24.3 vs. 33.4 {+-} 20.4%; P > 0.05), stent volume (129.6 {+-} 57.3 vs. 129.8 {+-} 65.0 mm{sup 3}; P > 0.05), and image quality (3.5 {+-} 1.0 vs. 3.7 {+-} 1.1; P > 0.05) did not differ. Radiation dose decreased from 8.7 {+-} 5.2 to 4.3 {+-} 2.6 mSv. Iterative reconstruction significantly improves imaging of coronary artery stents by CT compared with FBP, even with half-radiation-dose data. (orig.)

  14. Preditores independentes de resultados intra-hospitalares pós-implante de stent coronariano Independent predictors of in-hospital outcomes following coronary stent implantation

    Directory of Open Access Journals (Sweden)

    Antônio José Neri-Souza

    2006-10-01

    Full Text Available OBJETIVO: Identificar preditores clínicos e angiográficos independentes, determinantes de resultados imediatos pós-implante de stent coronário. MÉTODOS: Novecentos e quarenta e seis pacientes com idade média de 61,04 ± 10,98 anos (31 a 91 anos, foram submetidos a implante de stents, sendo 580 do sexo masculino (61,3%. Sucesso do procedimento foi definido quando pelo menos um vaso era dilatado com sucesso, com estenose residual OBJECTIVE: To identify the clinical and angiographic predictors of early outcome following coronary stent implantation. METHODS: Nine hundred and forty-six patients (pt [61.04 ± 10.98 years old, range 31 to 91] underwent stent implantation; 580 male (61.3%. Procedural success was defined when a pt had at least one vessel successfully dilated with a residual stenosis < 20%. Clinical success occured when a pt had at least one vessel successfully dilated without a major complication (MC [death, myocardial infarction (MI, coronary artery bypass graft] during the hospital stay. Clinical and angiographic determinants of outcome were studied. All variables related to early outcome evaluated by univariate analysis were included in a multiple logistic regression analysis (MLR. RESULTS: Procedural success was achieved in 98.9%; clinical success in 95.7%; an unsuccessful uncomplicated outcome in 0.1% and major complications in 4.2%. By MLR, procedural success was related to restenotic lesion, calcification, and irregular contour. Clinical success was related to diabetes mellitus, cardiogenic shock, acute coronary syndromes, age, left ventricular dysfunction, calcification, and total occlusion. Major complications was predicted by diabetes mellitus, cardiogenic shock, acute coronary syndromes, age, multivessel disease, left ventricular dysfunction, calcification, long lesions, and total occlusions. Mortality was predicted by cardiogenic shock, acute coronary syndromes, age, arterial hypertension, and left ventricular

  15. Long-term safety and efficacy of percutaneous coronary intervention with stenting and coronary artery bypass surgery for multivessel coronary artery disease: A meta-analysis with 5-year patient-level data from the ARTS, ERACI-II, MASS-II, and SoS trials

    NARCIS (Netherlands)

    J. Daemen (Joost); H. Boersma (Eric); M. Flather (Marcus); J. Booth (Jean); R.H. Stables (Rodney); A. Rodriguez (Alfredo Chapin); G.A. Rodriguez-Granillo (Gaston); W.A. Hueb (Whady Armindo); P.A. Lemos Neto (Pedro); P.W.J.C. Serruys (Patrick)

    2008-01-01

    textabstractBackground - Randomized trials that studied clinical outcomes after percutaneous coronary intervention (PCI) with bare metal stenting versus coronary artery bypass grafting (CABG) are underpowered to properly assess safety end points like death, stroke, and myocardial infarction. Pooling

  16. Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial.

    Science.gov (United States)

    Zbinden, Rainer; Piccolo, Raffaele; Heg, Dik; Roffi, Marco; Kurz, David J; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Franzone, Anna; Eberli, Franz; Jüni, Peter; Windecker, Stephan; Pilgrim, Thomas

    2016-03-15

    No data are available on the long-term performance of ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES). We reported 2-year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP-SES with durable-polymer everolimus-eluting stents (DP-EES) in patients undergoing percutaneous coronary intervention. A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP-SES (n=1063) or DP-EES (n=1056). Follow-up at 2 years was available for 2048 patients (97%). The primary end point was target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. At 2 years, target-lesion failure occurred in 107 patients (10.5%) in the BP-SES arm and 107 patients (10.4%) in the DP-EES arm (risk ratio [RR] 1.00, 95% CI 0.77-1.31, P=0.979). There were no significant differences between BP-SES and DP-EES with respect to cardiac death (RR 1.01, 95% CI 0.62-1.63, P=0.984), target-vessel myocardial infarction (RR 0.91, 95% CI 0.60-1.39, P=0.669), target-lesion revascularization (RR 1.17, 95% CI 0.81-1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56-3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP-SES arm and 4 cases (0.4%) in the DP-EES arm (P=0.423). In the prespecified subgroup of patients with ST-segment elevation myocardial infarction, BP-SES was associated with a lower risk of target-lesion failure compared with DP-EES (RR 0.48, 95% CI 0.23-0.99, P=0.043, Pinteraction=0.026). Comparable safety and efficacy profiles of BP-SES and DP-EES were maintained throughout 2 years of follow-up. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by

  17. Combined paclitaxel-eluting balloon and Genous cobalt-chromium alloy stent utilization in de novo coronary stenoses (PEGASUS).

    Science.gov (United States)

    Jim, Man-Hong; Fung, Raymond Chi-Yan; Yiu, Kai-Hang; Ng, Andrew Kei-Yan; Siu, Chung-Wah; Fan, Katherine Yu-Yan

    2013-12-01

    The aim of this study was to examine the angiographic result and its outcome predictors using the combination of paclitaxel-eluting balloon (PEB) and Genous stent. This approach to treat coronary stenoses is a logical strategy to strike a balance between minimizing restenosis and stent thrombosis. From November 2010 to June 2012, 40 symptomatic patients with 44 de novo coronary lesions of diameter stenosis ≥ 50% were treated with the combination of PEB and Genous stents. Angiographic and clinical follow-up were intended at 6 and 9 months, respectively. The mean age of patients was 61 ± 11 years, with male predominance (83%). Diabetes mellitus and end-stage renal failure on peritoneal dialysis were found in 15 (38%) and 10 (25%) patients, respectively. Patients received dual antiplatelet therapy for 5.1 ± 1.5 months post procedure. The size and length of PEB used was larger than the stents (3.13 ± 0.46 mm and 28 ± 9 mm vs. 2.98 ± 0.36 mm and 23 ± 7 mm). Restudy angiography was performed on 41 (95%) lesions in 37 (93%) patients at 5.9 ± 1.7 months. Angiographic restenosis was seen in 5 (12%) lesions, and significantly associated with diabetes mellitus and dialysis dependency; the late lumen loss was 0.38 ± 0.37 mm. At 9-month follow-up, no stent thrombosis was observed. The use of PEB combined with Genous stent is associated with a reasonably low restenosis and late lumen loss, whereas diabetes mellitus and renal failure with dialysis are poor predictors of angiographic restenosis. © 2013, Wiley Periodicals, Inc.

  18. Long Term Outcomes of MGuard Stent Deployment in Saphenous Vein Grafts and Native Coronary Arteries: A Single Center Experience.

    Science.gov (United States)

    Vaknin-Assa, Hana; Assali, Abid; Lev, Eli I; Greenberg, Gabriel; Orvin, Katia; Valzer, Orna; Paul, Gideon; Levi, Amos; Kornowski, Ran

    2017-03-01

    The MGuard™ stent (InspireMD, Tel Aviv, Israel) is a bare metal mesh-covered stent, developed to prevent no-reflow phenomenon during percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) and acute myocardial infarction (MI), both associated with significant atherothrombotic lesions. To report on local experience with patients treated with the MGuard stent until follow-up at 1 year. We followed 163 consecutive patients who underwent MGuard stent deployment during the period 2009 to 2014 in a large tertiary cardiac center in central Israel. The MGuard stent was used in 67% of patients who underwent SVG-PCI while 33% were treated for native coronary artery disease, the majority during ST-elevation MI (STEMI). The mean age was 67 years and 83% were males. The clinical presentation was STEMI in 30% and non-STEMI/unstable angina in 60% of patients. Of the total number of patients, 47% had diabetes and 29% had chronic kidney disease. All patients had follow-up at 1 year. Mortality in the native group was 1.9% vs. 10% in the vein graft cohort. ST was 2% in both groups. The major adverse cardiac event (MACE) rates were 11% in the native artery and 29% in the vein graft group, mainly due to respective target lesion revascularization/target vessel revascularization rates of 6% and 7% in the native vessel group and 11% and 15% in the SVG group. In suitable patients undergoing SVG-PCI or native lesion intervention during acute MI, the MGuard stent is a viable treatment strategy. Its potential merits and limitations warrant further evaluation.

  19. Concomitant use of clopidogrel and statins and risk of major adverse cardiovascular events following coronary stent implantation

    DEFF Research Database (Denmark)

    Schmidt, Morten; Johansen, Martin B; Mæng, Michael

    2012-01-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The CYP3A4 inhibition by lipophilic statins may attenuate the effectiveness of clopidogrel. • No studies have measured drug exposure in a time-varying manner that detects discontinuation and restart of clopidogrel and statin therapy, allowing clinical...... quantification of the interaction effect. WHAT THIS STUDY ADDS • Clopidogrel and CYP3A4-metabolizing statin use were each associated with a substantially reduced rate of major adverse cardiovascular events within 12 months after coronary stent implantation. • Although we observed an interaction between use...... of clopidogrel and statins, statin use vs. non-use was not associated with an increased rate of major adverse cardiovascular events in patients using clopidogrel after coronary stent implantation. AIMS To examine whether CYP3A4-metabolizing statin use modified the association between clopidogrel use and major...

  20. Prevention of the renarrowing of coronary arteries using drug-eluting stents in the perioperative period: an update

    Directory of Open Access Journals (Sweden)

    Juan V Llau

    2010-09-01

    Full Text Available Juan V Llau1, Raquel Ferrandis1, Pilar Sierra2, Aurelio Gómez-Luque31Department of Anaesthesiology and Critical Care Medicine, Hospital Clínic Universitari, València, Spain; 2Department of Anaesthesiology, Fundació Puigvert, Barcelona, Spain; 3Department of Anaesthesiology and Critical Care Medicine, Hospital Clínico Universitario, Málaga, SpainAbstract: The management of patients scheduled for surgery with a coronary stent, and receiving 1 or more antiplatelet drugs, has many controversies. The premature discontinuation of antiplatelet drugs substantially increases the risk of stent thrombosis (ST, myocardial infarction, and cardiac death, and surgery under an altered platelet function could also lead to an increased risk of bleeding in the perioperative period. Because of the conflict in the recommendations, this article reviews the current antiplatelet protocols after positioning a coronary stent, the evidence of increased risk of ST associated with the withdrawal of antiplatelet drugs and increased bleeding risk associated with its maintenance, the different perioperative antiplatelet protocols when patients are scheduled for surgery or need an urgent operation, and the therapeutic options if excessive bleeding occurs.Keywords: stent thrombosis, antiplatelet agents, aspirin, clopidogrel, surgical bleeding, perioperative management

  1. Intravascular Ultrasound Predictors of Major Adverse Cardiovascular Events After Implantation of Everolimus-eluting Stents for Long Coronary Lesions.

    Science.gov (United States)

    Lee, Seung-Yul; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2017-02-01

    There are limited data on the usefulness of intravascular ultrasound (IVUS) for long coronary lesions treated with second-generation drug-eluting stents. We evaluated IVUS predictors of major adverse cardiovascular events (MACE) 12 months after implantation of everolimus-eluting stents for long coronary lesions. A total of 804 patients who underwent both postintervention IVUS examination and long everolimus-eluting stent (≥ 28mm in length) implantation were included from 2 randomized trials. MACE was defined as a composite of cardiac death, myocardial infarction, and target-lesion revascularization. MACE occurred in 24 patients (3.0%) over 12 months. On multivariable Cox regression analysis, independent IVUS predictors of MACE included the postintervention minimum lumen area (MLA) at the target lesion (HR = 0.623; 95%CI, 0.433-0.895; P=.010) and the ratio of MLA/distal reference segment lumen area (HR = 0.744; 95%CI, 0.572-0.969; P=.028). The MLA and MLA-to-distal reference segment lumen area ratio that best predicted patients with MACE from those without these events were 5.0 mm(2) and 1.0, respectively. Patients with MLAMLA of<5.0 mm(2) or a distal reference segment lumen area were at risk for MACE after long everolimus-eluting stent implantation. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  2. Multicenter assessment of the reproducibility of volumetric radiofrequency-based intravascular ultrasound measurements in coronary lesions that were consecutively stented

    DEFF Research Database (Denmark)

    Huisman, Jennifer; Egede, Rasmus; Rdzanek, Adam

    2012-01-01

    To assess in a multicenter design the between-center reproducibility of volumetric virtual histology intravascular ultrasound (VH-IVUS) measurements with a semi-automated, computer-assisted contour detection system in coronary lesions that were consecutively stented. To evaluate the reproducibility...... of volumetric VH-IVUS measurements, experienced analysts of 4 European IVUS centers performed independent analyses (in total 8,052 cross-sectional analyses) to obtain volumetric data of 40 coronary segments (length 20.0 ± 0.3 mm) from target lesions prior to percutaneous intervention that were performed...

  3. Concomitant use of clopidogrel and statins and risk of major adverse cardiovascular events following coronary stent implantation

    Science.gov (United States)

    Schmidt, Morten; Johansen, Martin B; Maeng, Michael; Kaltoft, Anne; Jensen, Lisette O; Tilsted, Hans-Henrik; Bøtker, Hans E; Baron, John A; Sørensen, Henrik Toft

    2012-01-01

    AIMS To examine whether CYP3A4-metabolizing statin use modified the association between clopidogrel use and major adverse cardiovascular events (MACE) after coronary stent implantation, using time-varying drug exposure ascertainment. METHODS We conducted this population-based cohort study in Western Denmark (population: 3 million) using medical databases. We identified all 13 001 patients with coronary stent implantation between 2002 and 2005 and their comorbidities. During 12 months of follow-up, we tracked the use of clopidogrel and CYP3A4-metabolizing statins and the rate of MACE. We used Cox regression to compute hazard ratios (HRs) controlling for potential confounders. RESULTS The rate of MACE per 1000 person years was 104 for concomitant clopidogrel and statin use, 130 for clopidogrel without statin use, 108 for statin without clopidogrel use and 446 for no use of either drug. The adjusted HR comparing clopidogrel use with non-use was 0.68 (95% confidence interval (CI) 0.58, 0.79) among statin users and 0.34 (95% CI 0.29, 0.40) among statin non-users, yielding an interaction effect (i.e. relative rate increase) of 1.97 (95% CI 1.59, 2.44). The adjusted HR for MACE comparing statin use with non-use was 0.97 (95% CI 0.83, 1.13) among clopidogrel users and 0.49 (95% CI 0.42, 0.57) among clopidogrel non-users. CONCLUSIONS Clopidogrel and CYP3A4-metabolizing statin use were each associated with a substantially reduced rate of MACE within 12 months after coronary stent implantation. Although we observed an interaction between use of clopidogrel and statins, statin use vs. non-use was not associated with an increased rate of MACE in patients using clopidogrel after coronary stent implantation. PMID:22243420

  4. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial.

    Science.gov (United States)

    Park, Duk-Woo; Kim, Young-Hak; Song, Hae-Geun; Ahn, Jung-Min; Kim, Won-Jang; Lee, Jong-Young; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Yun, Sung-Cheol; Seung, Ki-Bae; Yang, Tae-Hyun; Lee, Sang-Gon; Lee, Jae-Hwan; Seong, In-Whan; Cheong, Sang-Sig; Lee, Bong-Ki; Lee, Nae-Hee; Lee, Se-Whan; Lee, Seung-Wook; Lee, Keun; Kim, Hyun-Sook; Jeon, Doo-Soo; Kim, Min-Kyu; Nah, Deuk-Young; Tahk, Seung-Jea; Park, Seung-Jung

    2011-10-01

    This study compared everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) for long coronary lesions. Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments. This randomized, multicenter, prospective trial compared the use of long EES with SES in 450 patients with long (≥ 25 mm) native coronary lesions. The primary endpoint of the trial was in-segment late luminal loss at 9-month angiographic follow-up. The EES and SES groups had similar baseline characteristics. Lesion length was 34.0 ± 15.4 mm in the EES group and 34.3 ± 13.5 mm in the SES group (p = 0.85). Nine-month angiographic follow-up was performed in 80% of the EES group and 81% of the SES group (p = 0.69). In-segment late loss as the primary study endpoint was significantly larger in the EES group than in the SES group (0.17 ± 0.41 mm vs. 0.09 ± 0.30 mm, p for noninferiority = 0.96, p for superiority = 0.04). The in-segment binary restenosis rate was also higher in the EES group than in the SES group (7.3% vs. 2.7%, p = 0.046). However, in-stent late loss (0.22 ± 0.43 mm vs. 0.18 ± 0.28 mm, p = 0.29) and in-stent binary restenosis rate (3.9% vs. 2.7%, p = 0.53) were similar among the 2 groups. The incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes) was not statistically different between the 2 groups. For patients with long native coronary artery disease, EES implantation was associated with greater angiographic in-segment late loss and higher rates of in-segment restenosis compared with SES implantation. However, clinical outcomes were both excellent and not statistically different. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. The importance of tests applied to evaluate the effectiveness of antiplatelet therapy in patients with recurrent coronary stent thrombosis

    Directory of Open Access Journals (Sweden)

    Grdinić Aleksandra

    2009-01-01

    Full Text Available Background. Stent thrombosis is potentially lethal complication with huge economic burden. The role of insufficient response to antiplatelet therapy is still unclear reason for its occurrence. Case report. We presented 54-year-old man with recurrent stent thrombosis on the 4th, 9th and 12th day after the primary percutaneous coronary intervention in spite of double antiaggregation therapy (aspirin+ clopidogrel. All possible procedural causes were excluded and reimplantation of intracoronary stent was insufficient to resolve the problem, so four platelet tests were performed: flow cytometry, Platelet Function Analyzer-100 test, aggregometry, and determination of gene polymorphism for P2Y12 receptor (directly involved in the mechanism of thienopyridine, and GPIIbIIIa receptor (final receptor in aggregation. The patient was the carrier of the major haplotype H1H1 for P2Y12 receptor and minor A1A2 for GPIIbIIIa receptor. The results of all the performed tests showed insufficient antiplatelet effect of aspirin and sufficient response to thienopyridin (not to clopidogrel, but to ticlopidine. Conclusion. Performance of platelet function tests is necessary in the case of major adverse cardiac events especially stent thrombosis, after implantation of intracoronary stent.

  6. Carotid artery stenting in patients with acute coronary syndrome: a possible primary therapy for symptomatic carotid stenosis.

    Science.gov (United States)

    Casana, Renato; Halliday, Alison; Bianchi, Paolo; Fresa, Emanuele; Silani, Vincenzo; Parati, Gianfranco; Blengino, Simonetta; Cireni, Lea; Adobbati, Laura; Calvillo, Laura; Tolva, Valerio S

    2013-08-01

    To report the results of carotid artery stenting (CAS) in symptomatic patients (stroke/transient ischemic attack) after recent percutaneous transluminal coronary angioplasty (PTCA) for acute coronary syndrome (ACS). Between January 2009 and July 2011, 28 consecutive patients (18 women; mean age 66 years, range 42-82) underwent protected CAS for symptomatic carotid stenosis following recent PTCA that included bare or drug-eluting stents requiring uninterrupted dual antiplatelet therapy. Primary technical success, neurological complications, major adverse cardiovascular events, and death were evaluated at 30 days and over midterm follow-up. Technical success was 96%; 1 patient suffered a nonfatal major stroke (3.5% 30-day stroke rate) during the procedure. During a median 21.6-month follow-up, 4 (14%) patients died of myocardial infarction (all diabetic smokers with ejection fractions 34 kg/m(2). This preliminary experience demonstrated that CAS is a reasonable, safe, and effective treatment for patients with symptomatic carotid artery stenosis who were recently treated with coronary stents requiring uninterrupted dual antiplatelet therapy.

  7. Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: the INtegrilin plus STenting to Avoid myocardial Necrosis Trial.

    Science.gov (United States)

    Biondi-Zoccai, Giuseppe; Valgimigli, Marco; Margheri, Massimo; Marzocchi, Antonio; Lettieri, Corrado; Stabile, Amerigo; Petronio, A Sonia; Binetti, Giorgio; Bolognese, Leonardo; Bellone, Pietro; Sardella, Gennaro; Contarini, Marco; Sheiban, Imad; Marra, Sebastiano; Piscione, Federico; Romeo, Francesco; Colombo, Antonio; Sangiorgi, Giuseppe

    2012-05-01

    The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase-MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use. The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase-MB mass values in the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05). Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies. Copyright © 2012 Mosby, Inc. All rights reserved.

  8. Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention: observations from the ESPRIT trial.

    Science.gov (United States)

    Tolleson, Thaddeus R; O'Shea, J Conor; Bittl, John A; Hillegass, William B; Williams, Kathryn A; Levine, Glenn; Harrington, Robert A; Tcheng, James E

    2003-02-05

    We evaluated the relationship between the degree of heparin anticoagulation and clinical efficacy and bleeding in patients undergoing contemporary percutaneous coronary intervention (PCI) with stent implantation. Despite universal acceptance of heparin anticoagulation as a standard of care in PCI, considerable controversy still exists regarding the appropriate dosing of heparin. The study population (n = 2,064) comprised all patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. The index activated clotting time (ACT) was defined as the ACT measured after the last heparin dose and before first device activation and was correlated with outcome and bleeding events. No association was observed between decreasing ACT levels and the rate of ischemic events in the treatment or placebo arms. The incidence of the primary composite end point (death, myocardial infarction, urgent target vessel revascularization, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy at 48 h) was actually lowest in the lowest ACT tertile for both the placebo (10.0%) and treatment groups (6.1%). When analyzed by tertile, major bleeding rates did not increase in the lowest ACT tertile in patients given placebo (0.6%) versus those receiving eptifibatide (0.7%). Major bleeding rates increased as the ACT increased in the eptifibatide-treated patients. Ischemic end points in patients undergoing contemporary PCI with stent placement do not increase by decreasing ACT levels, at least to a level of 200 s. Bleeding events do increase with increasing ACT levels and are enhanced with eptifibatide treatment. An ACT of 200 to 250 s is reasonable in terms of efficacy and safety with the use of contemporary technology and pharmacotherapy.

  9. 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.

  10. Cobalt-chromium KAname™ coRonary stEnt system in the treatment of patients with coronary artery disease (KARE study).

    Science.gov (United States)

    Carrie, Didier; Schächinger, Volker; Danzi, Gian Battista; Macaya, Carlos; Zeymer, Uwe; Putnikovic, Biljana; Iniguez, Andres; Moreno, Raul; Mehmedbegovic, Zlatko; Beleslin, Branko

    2014-10-01

    To evaluate the safety and effectiveness of the Kaname™ cobalt-chromium (Co-Cr), thin strut, bare metal stent (BMS) system for the treatment of coronary artery lesions. Despite widespread use of drug-eluting stents, a certain percentage of patients with coronary artery disease are still treated with BMS. Therefore, it is essential to evaluate their clinical performance. Two hundred eighty-two patients were enrolled in this prospective, single-arm study including a predefined subset of 79 patients with small vessels. The primary end-point was freedom from target vessel failure (TVF) at 6 months. Key angiographic and intravascular ultrasound (IVUS) end-points were late loss, diameter stenosis, binary restenosis, and neointimal hyperplasia volume. Freedom from TVF at 6 months was 93.3% and at 1 year 90.8% in total population, and 92.4% and 87.3% in small vessels, respectively. Clinically driven target lesion revascularization (TLR) rates at 6 and 12 months were 4.3% and 6.4% in total population, and 3.8% and 7.6% in small vessels, respectively. At 6 months in-stent late loss was 0.75 ± 0.43 mm and binary restenosis rate was 16.9% in total population, and 0.64 ± 0.40 mm and 26.1% in small vessels, while IVUS assessed neointimal hyperplasia volume at 6 months was 128.9 ± 42.6 mm(3) for total population. There were no definite and probable stent thromboses up to 12 months. Results indicate good safety and effectiveness of the Kaname™ stent with clinically equivalent results in small and larger vessels, as such providing useful treatment option for patients with ischemic heart disease considered for BMS implantation. © 2014, Wiley Periodicals, Inc.

  11. TIDES-ACS Trial: comparison of titanium-nitride-oxide coated bio-active-stent to the drug (everolimus)-eluting stent in acute coronary syndrome. Study design and objectives.

    Science.gov (United States)

    Colkesen, E B; Eefting, F D; Rensing, B J; Suttorp, M J; Ten Berg, J M; Karjalainen, P P; Van Der Heyden, J A

    2015-02-01

    Drug-eluting stents (DES), delivering antiproliferative drugs from a durable polymer, have shown to reduce in-stent restenosis after percutaneous coronary intervention (PCI) compared to bare-metal stents (BMS). However, they have been associated with a hypersensitivity reaction, delayed healing, and incomplete endothelialization, which may contribute to an increased risk of late stent thrombosis. Consequently, a prolonged duration of dual antiplatelet therapy (DAPT) is needed, with an increased risk of bleeding complication. A number of stent technologies are being developed in an attempt to modify late thrombotic events and DAPT duration. The Optimax™ stent is such a novel, next generation bioactive stent (BAS), in which a thicker layer of titanium-nitride-oxide coating is inserted over the stent struts. The rationale of this is to obtain more efficient and rapid vascular healing at the site of the stent implantation. The aim of TIDES-ACS Trial is to compare clinical outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus Synergy™-EES. Second objective is to explore whether the Optimax™-BAS use is superior compared with Synergy™-EES use with respect of hard end points (cardiac death, myocardial infarction [MI] and major bleeding). A prospective, randomized, multicenter trial (ClinicalTrials.gov Identifier: NCT02049229), will be conducted in interventional centres in Finland (six centres), France (five centres) and Holland (two centres), including a total of 1800 patients.

  12. Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F nanocoated cobalt-chromium stents in the minipig coronary artery model.

    Science.gov (United States)

    Radeleff, Boris; Thierjung, Heidi; Stampfl, Ulrike; Stampfl, Sibylle; Lopez-Benitez, Ruben; Sommer, Christof; Berger, Irina; Richter, Goetz M

    2008-01-01

    To date no direct experimental comparison between the CYPHER-Select and TAXUS-Express stents is available. Therefore, we investigated late in-stent stenosis, thrombogenicity, and inflammation, comparing the CYPHER-Select, TAXUS-Express, and custom-made cobalt chromium Polyzene-F nanocoated stents (CCPS) in the minipig coronary artery model. The three stent types were implanted in the right coronary artery of 30 minipigs. The primary endpoint was in-stent stenosis assessed by quantitative angiography and microscopy. Secondary endpoints were inflammation and thrombogenicity evaluated by scores for inflammation and immunoreactivity (C-reactive protein and transforming growth factor beta). Follow-up was at 4 and 12 weeks. Stent placement was successful in all animals; no thrombus deposition occurred. Quantitative angiography did not depict statistically significant differences between the three stent types after 4 and 12 weeks. Quantitative microscopy at 4 weeks showed a statistically significant thicker neointima (p = 0.0431) for the CYPHER (105.034 +/- 62.52 microm) versus the TAXUS (74.864 +/- 66.03 microm) and versus the CCPS (63.542 +/- 39.57 microm). At 12 weeks there were no statistically significant differences. Inflammation scores at 4 weeks were significantly lower for the CCPS and CYPHER compared with the TAXUS stent (p = 0.0431). After 12 weeks statistical significance was only found for the CYPHER versus the TAXUS stent (p = 0.0431). The semiquantitative immunoreactivity scores for C-reactive protein and transforming growth factor beta showed no statistically significant differences between the three stent types after 4 and 12 weeks. The CCPS provided effective control of late in-stent stenosis and thrombogenicity in this porcine model compared with the two drug-eluting stents. Its low inflammation score underscores its noninflammatory potential and might explain its equivalence to the two DES.

  13. The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis

    NARCIS (Netherlands)

    Jaguszewski, Milosz; Aloysius, Romila; Wang, Wei; Bezerra, Hiram G.; Hill, Jonathan; de Winter, Robbert J.; Karjalainen, Pasi P.; Verheye, Stefan; Wijns, William; Lüscher, Thomas F.; Joner, Michael; Costa, Marco; Landmesser, Ulf

    2017-01-01

    The aim of the present study was to evaluate vascular healing of the bioengineered COMBO Dual Therapy Stent compared with a cobalt-chromium (CoCr) everolimus-eluting stent (EES) as assessed by optical coherence tomography in patients with acute coronary syndromes. CD34+ cells promote endothelial

  14. Coronary Artery Stent Evaluation Using a Vascular Model at 64-Detector Row CT: Comparison between Prospective and Retrospective ECG-Gated Axial Scans

    Energy Technology Data Exchange (ETDEWEB)

    Suzuki, Shigeru; Furui, Shigeru; Kaminaga, Tatsuro; Miyazawa, Akiyoshi; Ueno, Yasunari; Konno, Kumiko [Teikyo University School of Medicine, Tokyo (Japan); Kuwahara, Sadatoshi; Mehta, Dhruv [Philips Electronics Japan, Ltd. Medical Systems, Tokyo (Japan)

    2009-06-15

    We wanted to evaluate the performance of prospective electrocardiogram (ECG)-gated axial scans for assessing coronary stents as compared with retrospective ECG-gated helical scans. As for a vascular model of the coronary artery, a tube of approximately 2.5-mm inner diameter was adopted and as for stents, three (Bx-Velocity, Express2, and Micro Driver) different kinds of stents were inserted into the tube. Both patent and stenotic models of coronary artery were made by instillating different attenuation (396 vs. 79 Hounsfield unit [HU]) of contrast medium within the tube in tube model. The models were scanned with two types of scan methods with a simulated ECG of 60 beats per minute and using display field of views (FOVs) of 9 and 18 cm. We evaluated the in-stent stenosis visually, and we measured the attenuation values and the diameter of the patent stent lumen. The visualization of the stent lumen of the vascular models was improved with using the prospective ECG-gated axial scans and a 9-cm FOV. The inner diameters of the vascular models were underestimated with mean measurement errors of -1.10 to -1.36 mm. The measurement errors were smaller with using the prospective ECG-gated axial scans (Bx-Velocity and Express2, p < 0.0001; Micro Driver, p = 0.0004) and a 9-cm FOV (all stents: p < 0.0001), as compared with the other conditions, respectively. The luminal attenuation value was overestimated in each condition. For the luminal attenuation measurement, the use of prospective ECG-gated axial scans provided less measurement error compared with the retrospective ECG-gated helical scans (all stents: p < 0.0001), and the use of a 9-cm FOV tended to decrease the measurement error. The visualization of coronary stents is improved by the use of prospective ECG-gated axial scans and using a small FOV with reduced blooming artifacts and increased spatial resolution.

  15. Bioabsorbable drug-eluting vascular scaffold for the treatment of coronary in-stent restenosis: A two center registry

    Energy Technology Data Exchange (ETDEWEB)

    Moscarella, Elisabetta [Division of Cardiology, Seconda Università degli studi di Napoli, AO Dei cColli, PO Monaldi (Italy); Varricchio, Attilio [Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli “Federico II”, Napoli (Italy); Stabile, Eugenio, E-mail: geko50@hotmail.com [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); Franzone, Anna [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); Granata, Francesco [Division of Cardiology, Seconda Università degli studi di Napoli, AO Dei cColli, PO Monaldi (Italy); Rapacciuolo, Antonio; Galasso, Gennaro [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); Capozzolo, Claudia [Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli “Federico II”, Napoli (Italy); Cirillo, Plinio [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); and others

    2015-10-15

    Background/purpose: Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR. Methods/materials: Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months. Results: A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6 ± 15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%). Conclusions: Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial. - Highlights: • A safe therapeutic option for the treatment of diffuse ISR; • Technically feasible; • Associated to a low rate of restenosis recurrence at nine month.

  16. Aspirin desensitization in patients undergoing planned or urgent coronary stent implantation. A single-center experience

    NARCIS (Netherlands)

    Luca, G. De; Verdoia, M.; Binda, G.; Schaffer, A.; Suryapranata, H.; Marino, P.

    2013-01-01

    INTRODUCTION: Dual antiplatelet therapy (aspirin and ADP-antagonists) is mandatory after stent implantation in order to avoid stent thrombosis, especially in the era of DES. In fact, a delayed re-endothelization process may enlarge the window of occurrence of stent thrombosis beyond 1-year after

  17. Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial.

    Science.gov (United States)

    2000-12-16

    The platelet glycoprotein IIb/IIIa inhibitors, although effective in reducing ischaemic complications of percutaneous coronary intervention, are used in few coronary stent implantation procedures. ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy) is a randomised, placebo-controlled trial to assess whether a novel, double-bolus dose of eptifibatide could improve outcomes of patients undergoing coronary stenting. We recruited 2064 patients undergoing stent implantation in a native coronary artery. Immediately before percutaneous coronary intervention, patients were randomly allocated to receive eptifibatide, given as two 180 microg/kg boluses 10 min apart and a continuous infusion of 2.0 microg/kg/min for 18-24 h, or placebo, in addition to aspirin, heparin, and a thienopyridine. The primary endpoint was the composite of death, myocardial infarction, urgent target vessel revascularisation, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy within 48 h after randomisation. The key secondary endpoint was the composite of death, myocardial infarction, or urgent target vessel revascularisation at 30 days. The trial was terminated early for efficacy. The primary endpoint was reduced from 10.5% (108 of 1024 patients on placebo [95% CI 8.7-12.4%]) to 6.6% (69 of 1040 [5.1-8.1%]) with treatment (p=0.0015). The key 30 day secondary endpoint was also reduced, from 10.5% (107 of 1024 patients on placebo [8.6-12.3%]) to 6.8% (71 of 1040 [5.3-8.4%]; p=0.0034). There was consistency in reduction of events across all components of the composite endpoint and among the major subgroups. Major bleeding was infrequent but arose more often with eptifibatide than placebo (1.3%, 13 of 1040 [0.7-2.1%]) vs 0.4%, 4 of 1024 [0.1-1.0%]; p=0.027). Routine glycoprotein IIb/IIIa inhibitor pretreatment with eptifibatide substantially reduces ischaemic complications in coronary stent intervention and is better than a strategy of reserving treatment

  18. Percutaneous Coronary Intervention of Left Main Disease: Pre- and Post-EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) Era.

    Science.gov (United States)

    Park, Duk-Woo; Park, Seung-Jung

    2017-06-01

    For nearly half a century, coronary artery bypass grafting has been the standard treatment for patients with obstructive left main coronary artery (LMCA) disease. However, there has been considerable evolution in the field of percutaneous coronary intervention, and especially, percutaneous coronary intervention for LMCA disease has been rapidly expanded with adoption of drug-eluting stents. Some, but not all randomized trials, have shown that percutaneous coronary intervention with drug-eluting stents might be a suitable alternative for selected patients with LMCA disease instead of bypass surgery. However, none of previous trials involving early-generation drug-eluting stents was sufficiently powered and comparative trials using contemporary drug-eluting stents were limited. Recently, primary results of 2 new trials of EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) were reported. However, these trials showed conflicting results, which might pose uncertainty on the optimal revascularization strategy for LMCA disease. In this article, with the incorporation of a key review on evolution of LMCA treatment, we summarize the similarity or disparity of the EXCEL and NOBLE trials, focus on how they relate to previous trials in the field, and finally speculate on how the treatment strategy may be changed or recommended for LMCA treatment. © 2017 American Heart Association, Inc.

  19. Lung resection for non-small cell lung cancer after prophylactic coronary angioplasty and stenting: short- and long-term results.

    Science.gov (United States)

    Voltolini, L; Rapicetta, C; Luzzi, L; Paladini, P; Ghiribelli, C; Scolletta, S; Fineschi, M; Gotti, G

    2012-02-01

    Recent studies have reported a high incidence of perioperative in-stent trombosis with myocardial infarction (MI), in patients undergoing non-cardiac surgery, early after coronary angioplasty and stenting. The short and long-term results of surgery for non-small cell lung cancer (NSCLC) after prophylatic coronary angioplasty and stenting were analyzed. Prospective collected data were examined for postoperative complications and long-term survival in 16 consecutive patients who underwent mayor lung resection for NSCLC after prophylactic coronary angioplasty and stenting for significant coronary artery disease , from 2001 to 2008. One and two non-drug-eluting stents were placed in 75% or (25% of the patient, respectively. All patients had four weeks of dual antiplatelet therapy, that was discontinued 5 days prior to surgery and replaced by low molecular weight heparin. Patients were keep sedated and intubated overnight, according to our protocol. There were no postoperative deaths nor MI. A patient experienced pulmonary embolism with moderate troponin release and underwent coronary angiography that showed patency of the stent. Two patients developed postoperative bleeding complications haemothorax requiring a re-thoracotomy in 1, gastric bleeding requiring blood transfusion in 1. At the mean follow-up of 30 months (range 3-95), none of the patients showed evidence of myocardial ischemia, while 5 (31%) patients died, mostly (N.=4) due to distant metastasis. The five-year survival rate was 53%. In contrast to previous reports, lung resection after prophylactic coronary angioplasty and stenting is a safe and effective treatment for NSCLC and myocardial ischemia. The application of a refined protocol could be the key factor for improved results.

  20. Safety and efficacy of coronary stent implantation. Acute and six month outcomes of 1,126 consecutive patients treated in 1996 and 1997

    Directory of Open Access Journals (Sweden)

    Luiz Alberto Mattos

    1999-07-01

    Full Text Available PURPOSE: The authors analyzed the 30-day and 6-month outcomes of 1,126 consecutive patients who underwent coronary stent implantation in 1996 and 1997. METHODS: The 30-day results and 6-month angiographic follow-up were analyzed in patients treated with coronary stents in 1996 and 1997. All patients underwent coronary stenting with high-pressure implantation (>12 atm and antiplatelet drug regimen (aspirin plus ticlopidine. RESULTS: During the study period, 1,390 coronary stents were implanted in 1,200 vessels of 1,126 patients; 477 patients were treated in the year 1996 and 649 in 1997. The number of percutaneous procedures performed using stents increased significantly in 1997 compared to 1996 (64 % vs 48%, p=0.0001. The 30-day results were similar in both years; the success and stent thrombosis rates were equal (97% and 0.8%, respectively. The occurrence of new Q wave MI (1.3% vs 1.1%, 1996 vs 1997, p=NS, emergency coronary bypass surgery (1% vs 0.6%, 1996 vs 1997, p=NS and 30-day death rates (0.2% vs 0.5%, 1996 vs 1997, p=NS were similar. The 6-month restenosis rate was 25% in 1996 and 27% in 1997 (p= NS; the target vessel revascularization rate was 15% in 1996 and 16% in 1997 (p = NS. CONCLUSIONS: Intracoronary stenting showed a high success rate and a low incidence of 30-day occurrence of new major coronary events in both periods, despite the greater angiographic complexity of the patients treated with in 1997. These adverse variables did not have a negative influence at the 6-month clinical and angiographic follow-up, with similar rates of restenosis and ischemia-driven target lesion revascularization rates.

  1. A systematic review of outcomes in patients with staged carotid artery stenting and coronary artery bypass graft surgery.

    Science.gov (United States)

    Guzman, Luis A; Costa, Marco A; Angiolillo, Dominick J; Zenni, Martin; Wludyka, Peter; Silliman, Scott; Bass, Theodore A

    2008-02-01

    Although current guidelines state that carotid endarterectomy is probably recommended before or concomitant to coronary artery bypass grafting (CABG) in patients with carotid stenosis, significant controversies to this recommendation still persist. Carotid artery stenting has been recently introduced as an alternative revascularization modality in high-risk patients. The aim of this study was to define, based on the published information, if carotid artery stenting is beneficial in this setting. A search of MEDLINE and a manual search of the literature from selected articles were performed. A total of 6 studies with 277 patients reporting carotid stenting followed by staged CABG were available for this clinical outcome analysis. All were retrospective and single-center studies. The mean age was 69 years; 78% were males. Asymptomatic carotid stenosis was present in 76% of patients. The mean time to CABG was 32 days. The incidence of stroke and death associated with the stent procedure was 4.7%. Only 6 patients (2.2%) developed stroke associated with CABG. The overall combined 30-day event rate after CABG, including all events during carotid artery stenting, were as follows: minor stroke, 2.9%; major stroke, 3.2%; mortality, 7.6%; and combined death and any stroke, 12.3%. In this pooled analysis, the combined incidence of death and stroke in patients undergoing carotid artery stenting and staged CABG remains elevated. These results confirm that the presence of carotid stenosis is per se a marker of risk that might persists independent of its treatment. A systematic or randomized evaluation appears warranted.

  2. Effect of Bleeding Risk on Type of Stent Used in Patients Presenting With Acute Coronary Syndrome.

    Science.gov (United States)

    Alraies, M Chadi; Lee, Sang Yeub; Lipinski, Michael J; Buchanan, Kyle; Steinvil, Arie; Rogers, Toby; Koifman, Edward; Gai, Jiaxiang; Torguson, Rebecca; Ben-Dor, Itsik; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2017-10-15

    Patients at high bleeding risk (HBR) are at increased risk of bleeding following percutaneous coronary intervention (PCI) with drug-eluting stents (DES) due to the need for longer dual antiplatelet duration. We sought to evaluate the likelihood of receiving DES during PCI in HBR populations and to characterize DES utilization trends over time. Consecutive patients who underwent PCI from April 2003 to September 2015 were identified. HBR is defined as patients fulfilling 1 or more of the HBR criteria: age ≥75 years, anticoagulation use at discharge, history of stroke, cancer in previous 3 years, glucocorticoid use, hemoglobin (Hgb) HBR definition. When adjusting for known risk factors, HBR patients were less likely to receive a DES compared with non-HBR patients (odds ratio [OR] 0.58, 95% confidence interval [CI] 0.54 to 0.62, p HBR patients, having 3 or more HBR criteria versus HBR criteria had lower likelihood of receiving a DES (OR 0.50, 95% CI 0.44 to 0.57, p HBR has a significant impact upon the decision to use DES. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents.

    Science.gov (United States)

    Chevalier, Bernard; Moulichon, Robert; Teiger, Emmanuel; Brunel, Philippe; Metzger, Jean-Philippe; Pansieri, Michel; Carrie, Didier; Stoll, Hans-Peter; Wittebols, Kristel; Spaulding, Christian; Fajadet, Jean

    2012-12-01

     We compared the efficacy of the Cypher Select (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus or Taxus Liberté paclitaxel-eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES. Optimal treatment strategies have not been identified for drug-eluting stent (DES) ISR. Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months. 281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12-month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end-point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in-stent binary restenosis (11.1% vs. 14%, P = 0.59). Target-lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES. In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed abstract optimal treatment strategies have not been identified for sirolimus-(SES) or paclitaxel-eluting stent (PES) in-stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There

  4. Two-year outcome after biodegradable polymer sirolimus- and biolimus- eluting coronary stents

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Raungaard, Bent

    2018-01-01

    AIMS: The SORT OUT VII trial compared the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent with a slow polymer degradation and the thicker-strut stainless steel biolimus-eluting Nobori stent with a moderate-term polymer degradation in an all-comer patient population. METHODS AND RESULTS......: The 2-year pre-specified endpoint target lesion failure did not differ significantly between the sirolimus-eluting stent: 6.7% and the biolimus-eluting stent: 7.0% (rate ratio (RR) 0.94, 95% confidence interval (CI) 0.70-1.28). Definite stent thrombosis were numerically lower in the sirolimus...... in the two groups (0.4% versus 0.2%, RR 1.68, 95% CI 0.40-7.03). CONCLUSIONS: In an all-comer patient population, 2-year target lesions failure was similar for the sirolimus-eluting Orsiro stent and the biolimus-eluting Nobori stent....

  5. Corrosion Behavior of Platinum-Enhanced Radiopaque Stainless Steel (PERSS®) for Dilation-Baloon Expandable Coronary Stents

    Energy Technology Data Exchange (ETDEWEB)

    Covino, Jr., Bernard S.; Craig, Charles H.; Cramer, Stephen D.; Bullard, Sophie J.; Ziomek-Moroz, Margaret; Jablonski, Paul D.; Turner, Paul C.; Radisch, Jr., Herbert R.; Gokcen, Nev A.; Friend, Clifford M.; Edwards, Michael R.

    2002-05-01

    Dilation-balloon expandable coronary stents are commonly made of implant grade stainless steels conforming to ASTM F138/F139, e.g., Biodur? 316LS (UNS S31673). Typical of such stents is the Boston Scientific/Interventional Technologies? (BS/IVT) LP-StentTM. In 2000, BS/IVT determined that the addition of 5 to 6 wt % platinum to Biodur 316LS produced a stainless steel with enhanced radiopacity to make their stents more visible radiographically and thus more effective clinically. A goal of the program was to ensure platinum additions would not adversely affect the corrosion resistance of Biodur 316LS. The corrosion resistance of 5-6 wt % PERSS? alloys and Biodur 316LS was determined using electrochemical tests for general, pitting, crevice and intergranular corrosion. Experimental methods included ASTM A262E, F746, F2129, and potentiodynamic polarization. The 6 wt % PERSS? alloy (IVT 78) had a resistance to pitting, crevice and intergranular corrosion that was similar to the Biodur 316LS base material. IVT 78 was a single-phase austenitic alloy with no evidence of inclusions or precipitates. It was more resistant to pitting corrosion than 5 wt % PERSS? alloys. Performance of the PERSS? alloys was not a function of alloy oxygen content in the range 0.01 to 0.03 wt %.

  6. Expansion of the Multi-Link Frontier™ Coronary Bifurcation Stent: Micro-Computed Tomographic Assessment in Human Autopsy and Porcine Heart Samples

    Science.gov (United States)

    Kralev, Stefan; Haag, Benjamin; Spannenberger, Jens; Lang, Siegfried; Brockmann, Marc A.; Bartling, Soenke; Marx, Alexander; Haase, Karl-Konstantin; Borggrefe, Martin; Süselbeck, Tim

    2011-01-01

    Background Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML) Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection. Methodology/Principal Findings Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively), corresponding opening areas (PA, DA, SBA) and the mean stent length (L) were assessed by micro-computed tomography (micro-CT). PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm2 vs. 12.84±1.38 mm2, p = 0.034, respectively) and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014). L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32), and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015). Conclusions/Significance Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow-up) of dedicated

  7. Expansion of the Multi-Link Frontier™ coronary bifurcation stent: micro-computed tomographic assessment in human autopsy and porcine heart samples.

    Science.gov (United States)

    Kralev, Stefan; Haag, Benjamin; Spannenberger, Jens; Lang, Siegfried; Brockmann, Marc A; Bartling, Soenke; Marx, Alexander; Haase, Karl-Konstantin; Borggrefe, Martin; Süselbeck, Tim

    2011-01-01

    Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML) Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection. Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively), corresponding opening areas (PA, DA, SBA) and the mean stent length (L) were assessed by micro-computed tomography (micro-CT). PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm(2) vs. 12.84±1.38 mm(2), p = 0.034, respectively) and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014). L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32), and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015). Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow-up) of dedicated stent systems, considering final intravascular ultrasound or

  8. Expansion of the Multi-Link Frontier™ coronary bifurcation stent: micro-computed tomographic assessment in human autopsy and porcine heart samples.

    Directory of Open Access Journals (Sweden)

    Stefan Kralev

    Full Text Available BACKGROUND: Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection. METHODOLOGY/PRINCIPAL FINDINGS: Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively, corresponding opening areas (PA, DA, SBA and the mean stent length (L were assessed by micro-computed tomography (micro-CT. PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm(2 vs. 12.84±1.38 mm(2, p = 0.034, respectively and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014. L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32, and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015. CONCLUSIONS/SIGNIFICANCE: Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow

  9. Snuggle T and protrusion (S-TAP) technique for coronary bifurcation stenting: A step-by-step angiographic and illustration demonstration.

    Science.gov (United States)

    Dahdouh, Ziad; Fadel, Bahaa M; Roule, Vincent; Sarkis, Antoine; Grollier, Gilles

    2017-09-01

    T and small protrusion (TAP) is a stenting technique that is utilized for the management of coronary bifurcation lesions when using a two-stent strategy. This technique is also useful whenever stenting of a main vessel (MV) jeopardizes a side branch (SB) or when a sub-optimal result is encountered in a daughter vessel after starting with one-stent approach. The conversion from one-stent strategy to TAP could be achieved smoothly and often leads to good results. Technically, optimal positioning of the SB stent to achieve the required protrusion into the lumen of the MV remains a challenge. Toward that goal we propose an added step that involves inflating a balloon in the MV to serve as an anvil with simultaneous pullback of the SB stent, to be followed by stent deployment. We refer to this approach as the snuggle T and protrusion (S-TAP) technique owing to close contact between the SB stent and the MV balloon during simultaneous inflation. In this manuscript, we detail this interventional technique and provide a demonstrative case study. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. COmplex coronary Bifurcation lesions: RAndomized comparison of a strategy using a dedicated self-expanding biolimus-eluting stent versus a culotte strategy using everolimus-eluting stents: primary results of the COBRA trial.

    Science.gov (United States)

    Dubois, Christophe; Bennett, Johan; Dens, Joseph; De Cock, Dries; Desmet, Walter; Belmans, Ann; Ughi, Giovanni J; Sinnaeve, Peter; Vrolix, Mathias; D'hooge, Jan; Adriaenssens, Tom

    2016-04-20

    We aimed to compare healing responses with optical coherence tomography, and clinical and angiographic outcome after treatment of coronary bifurcation lesions with a dedicated stent versus a conventional culotte technique. Forty patients with true and complex coronary bifurcation lesions were randomly assigned to treatment with the Axxess™ bifurcation stent in the proximal main vessel (MV) and additional BioMatrix™ stents in the branches (Biosensors Europe SA, Morges, Switzerland), versus a culotte technique using XIENCE™ stents (Abbott Vascular, Santa Clara, CA, USA). The primary endpoint of percentage of uncovered struts at nine months was similar with the dedicated strategy vs. culotte in the proximal MV (median 17.8 [IQR 3.3-24.7] vs. 6.8 [2.0-20.5]; p=0.19), bifurcation core (9.5 [5.7-19.5] vs. 4.0 [0.7-17.6]; p=0.17), distal MV (2.6 [2.3-18] vs. 2.2 [0.5-6.0]; p=0.09) and side branch (5.7 [1.5-11.5] vs. 1.9 [0-5.8]; p=0.14). As compared with culotte, a strategy using Axxess resulted in a significantly larger lumen in the proximal MV both acutely (minimum lumen diameter 3.03±0.51 vs. 2.71±0.44 mm, p=0.04) and at follow-up (mean lumen area 10.0±2.1 vs. 7.1±1.8 mm2, pstrategies resulted in good clinical outcomes at one year, and no stent thromboses. As compared with a culotte strategy with XIENCE stents, complex bifurcation stenting using a dedicated strategy combining Axxess and BioMatrix stents results in similar stent strut coverage at nine-month follow-up, and a significantly larger lumen and lower angiographic late lumen loss in the proximal MV.

  11. Prospective versus retrospective ECG gating for dual source CT of the coronary stent: Comparison of image quality, accuracy, and radiation dose

    Energy Technology Data Exchange (ETDEWEB)

    Zhao Lei, E-mail: zhaolei219@sohu.com [Beijing Anzhen Hospital of the Capital University of Medical Sciences (China); Zhang Zhaoqi; Fan Zhanming; Yang Lin; Du Jing [Beijing Anzhen Hospital of the Capital University of Medical Sciences (China)

    2011-03-15

    Objective: To compare image quality, diagnostic accuracy and radiation dose of prospective and retrospective electrocardiogram (ECG) gated dual source computed tomography (DSCT) for the evaluation of the coronary stent, using conventional coronary angiography (CA) as a standard reference. Design, setting and patients: Sixty patients (heart rates {<=}70 bpm) with previous stent implantation who were scheduled for CA were divided in two groups, receiving either prospective or retrospective ECG gated DSCT separately. Two reviewers scored coronary stent image quality and evaluated stent lumen. Results: There was no significant difference in image quality between the two groups. In the prospective group, there were 86.4% (51/59) stents with interpretable images, in the retrospective group, there were 87.5% (49/56) stents with interpretable images. Image quality was not influenced by age, body mass index or heart rate in either group, but heart rate variability had a weak impact on the image quality of the prospective group. Image noise was higher in the prospective group, but this difference reached statistical significance only by using a smooth kernel reconstruction. Per-stent based sensitivity, specificity, and positive and negative predictive value were 100%, 84.1%, 68.2%, and 100%, respectively, in the prospective CT angiography group and 94.4%, 86.8%, 77.3%, and 97.1%, respectively, in the retrospective CT angiography group. There was a significant difference in the effective radiation dose between the two groups, mean effective dose in the prospective and retrospective group was 2.2 {+-} 0.5 mSv (1.5-3.2 mSv) and 14.6 {+-} 3.3 mSv (10.0-20.4 mSv) (p < .001) respectively. Conclusions: Compared with retrospective CT angiography, prospective CT angiography has a similar performance in assessing coronary stent patency, but a lower effective dose in selected patients with regular heart rates {<=}70 bpm.

  12. Impact of coronary artery calcification in percutaneous coronary intervention with paclitaxel-eluting stents: Two-year clinical outcomes of paclitaxel-eluting stents in patients from the ARRIVE program.

    Science.gov (United States)

    Lee, Michael S; Yang, Tae; Lasala, John; Cox, David

    2016-11-15

    The purpose of this study was to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with coronary artery calcification (CAC). Smaller studies have reported worse clinical outcomes in patients with CAC who undergo PCI. The impact of CAC in the drug-eluting stent era is unclear. Data from 7,492 patients treated by PCI with ≥1 TAXUS Express stent in the ARRIVE registry with no inclusion/exclusion criteria were stratified by the severity of CAC, as determined by the operator. Endpoints were independently adjudicated. All major adverse cardiac events were assessed at 2 years. Moderate/severe CAC was present in 19.6%. The nil/mild CAC group had higher rate of current smokers. The moderate/severe CAC group was older and had a higher prevalence of hypertension, kidney disease, prior coronary artery bypass grafting, congestive heart failure, and left main disease. After adjustment for imbalanced baseline variables, patients with moderate/severe CAC had higher 2 year rates of major adverse cardiac events (18.3% vs 13.5%, p = 0.01) and death (10.3% vs 5.6%, p = 0.02). Moderate/severe CAC was associated with increased clinical events in patients who underwent PCI with TAXUS stents. This may be explained in part due to differences important baseline characteristics including more patients with more comorbidities and more complex lesions. After adjustment for imbalanced baseline variables, the moderate/severe CAC group had a higher risk of major adverse cardiac events and death. Improvements in treatment strategies are needed for this high-risk group of patients who undergo PCI. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  13. Prasugrel vs. clopidogrel in contemporary Western European patients with acute coronary syndromes receiving drug-eluting stents

    DEFF Research Database (Denmark)

    Wein, Bastian; Coslovsky, Michael; Jabbari, Reza

    2017-01-01

    BACKGROUND: Clinical and cost-effectiveness of prasugrel vs. clopidogrel in acute coronary syndrome (ACS) was only evaluated using TRITON-TIMI 38 event rates. A comparative analysis of both drugs in contemporary European ACS patients is lacking. METHODS: To address this issue, cardiac and bleeding...... events of 2 "sister" multicenter stent trials, BASKET-PROVE (BP) I with clopidogrel and BPII with prasugrel (for 12months each) were used in a hybrid analysis. Medication costs were 2015 sales prices, event costs modelled for Denmark (DNK), Germany (GER) and Switzerland (SUI) and quality adjusted life...... years (QALY) by EQ-5D-3L questionnaire. RESULTS: In BPI and II, 1012 and 985 ACS-patients received drug eluting stents, respectively, followed-up for 2years. Compared to clopidogrel, prasugrel-treated patients had no more major cardiac events (5.2% vs. 6.4%, p=0.422) nor cardiac deaths (1.6% vs. 1.0%, p...

  14. Relationship between the Level of Circulating CD45+ Platelets and Development of Restenosis after Implantation of Drug-Eluting Stents to Patients with Coronary Heart Disease.

    Science.gov (United States)

    Gabbasov, Z A; Kozlov, S G; Byazrova, S V; Mel'nikov, I S; Saburova, O S

    2017-02-01

    The study was carried out in 126 patients with stable angina pectoris, who underwent elective coronary artery stenting with drug-eluting stents and follow-up angiography within 6-12 months thereafter. Five significant risk factors of restenosis were identified by binary comparisons of different variables. The logistic regression equation that included the level of CD45-positive platelets, diabetes, small vessel stenting, number of simultaneously implanted stents in one patient, and lesion length demonstrates the highest level of prediction of in-stent restenosis (OR=22.8; plogit model (area under ROC curve 0.87, p<0.001). The data suggest that a close relationship exists between the development of restenosis and the level of circulating CD45+ platelets.

  15. Effect of cold deformation on pitting corrosion of 00Cr18Mn15Mo2N0.86 stainless steel for coronary stent application.

    Science.gov (United States)

    Ren, Yibin; Zhao, Haochuan; Liu, Wenpeng; Yang, Ke

    2016-03-01

    The high nitrogen nickel-free stainless steel has offered an alternative to further improve the performance of the coronary stents, and simultaneously avoids the potential harms of nickel element. Both cold deformation and pitting corrosion are very important for coronary stents made of stainless steel. In this work, the effect of cold deformation on the pitting corrosion resistance of a high nitrogen nickel-free stainless steel (00Cr18Mn15Mo2N0.86) in 0.9% saline solution was investigated. The results showed that the pitting corrosion of the steel was nearly unchanged with increases of the cold deformation up to 50%, indicating that the higher nitrogen content can reduce the negative effect of cold deformation on the pitting corrosion resistance, which is beneficial for the long term service of coronary stents in blood vessel. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

    Directory of Open Access Journals (Sweden)

    Wehrenberg Scott

    2010-01-01

    Full Text Available Abstract Background Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods/Design The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1, single-blind, non-inferiority trial in subjects with lesion length ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length ≤20 mm and vessel diameter ≥2.25 mm to Discussion The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platform provide comparable safety and improved procedural performance compared to the previous generation Express stent. PERSEUS trial enrollment is complete and primary endpoint data are expected in 2010. PERSEUS Workhorse and Small Vessel are registered at http://www.clinicaltrials.gov, identification numbers NCT00484315 and NCT00489541.

  17. A randomized comparison of platinum chromium-based everolimus-eluting stents versus cobalt chromium-based Zotarolimus-Eluting stents in all-comers receiving percutaneous coronary intervention: HOST-ASSURE (harmonizing optimal strategy for treatment of coronary artery stenosis-safety & effectiveness of drug-eluting stents & anti-platelet regimen), a randomized, controlled, noninferiority trial.

    Science.gov (United States)

    Park, Kyung Woo; Kang, Si-Hyuck; Kang, Hyun-Jae; Koo, Bon-Kwon; Park, Byoung-Eun; Cha, Kwang Soo; Rhew, Jay Young; Jeon, Hui-Kyoung; Shin, Eun-Seok; Oh, Ju Hyeon; Jeong, Myung-Ho; Kim, Sanghyun; Hwang, Kyung-Kuk; Yoon, Jung-Han; Lee, Sung Yun; Park, Tae-Ho; Moon, Keon Woong; Kwon, Hyuck-Moon; Hur, Seung-Ho; Ryu, Jae-Kean; Lee, Bong-Ryul; Park, Yong Whi; Chae, In-Ho; Kim, Hyo-Soo

    2014-07-01

    This study sought to test whether the newly developed platinum chromium (PtCr)-based everolimus-eluting stent (EES) is noninferior to the cobalt chromium (CoCr)-based zotarolimus-eluting stent (ZES) in all-comers receiving percutaneous coronary intervention (PCI). PtCr provides improved radial strength, conformability, and visibility compared with the CoCr alloy, but PtCr-based stents have not been tested in a wide range of patients receiving PCI. Also, recent case series have raised the issue of longitudinal stent deformation (LSD) with newer drug-eluting stents. We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES. The primary outcome was target lesion failure (TLF) at 1-year post-PCI, defined as the composite of cardiac death, nonfatal target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization. Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD. At 1 year, TLF occurred in 2.9% and 2.9% of the population in the PtCr-EES and CoCr-ZES groups, respectively (superiority p = 0.98, noninferiority p = 0.0247). There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome. Of 5,010 stents analyzed, LSD occurred in 0.2% and 0% in the PtCr-EES and CoCr-ZES groups, respectively (p = 0.104). There was no significant difference in post-deployment stent length ratio between the 2 stents (p = 0.352). At 1 year, PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI. Although LSD was observed only in PtCr-EES, both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types, and PtCr-EES was not associated with adverse clinical outcomes. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734). Copyright © 2014 American College of Cardiology

  18. Six-month results of the NEVO Res-Elution I (NEVO RES-I) trial: a randomized, multicenter comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberté paclitaxel-eluting stent in de novo native coronary artery lesions.

    Science.gov (United States)

    Ormiston, John A; Abizaid, Alexandre; Spertus, John; Fajadet, Jean; Mauri, Laura; Schofer, Joachim; Verheye, Stefan; Dens, Joseph; Thuesen, Leif; Dubois, Christophe; Hoffmann, Rainer; Wijns, William; Fitzgerald, Peter J; Popma, Jeffrey J; Macours, Nathalie; Cebrian, Ana; Stoll, Hans-Peter; Rogers, Campbell; Spaulding, Christian

    2010-12-01

    Drug-eluting stents reduce restenosis and reintervention rates but are complicated by stent thrombosis, which may be related to polymer coating. The NEVO sirolimus-eluting coronary stent (NEVO SES) is designed to improve long-term percutaneous coronary intervention safety by combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. NEVO ResElution-I was a prospective randomized study in 394 patients with coronary artery disease comparing the NEVO SES with the TAXUS Liberté paclitaxel-eluting coronary stent (TAXUS Liberté PES) stent. The primary end point was in-stent angiographic late loss at 6 months. Six months after percutaneous coronary intervention (PCI), the primary end point favored NEVO SES (0.13±0.31 mm versus 0.36±0.48 mm, PNEVO SES versus TAXUS Liberté PES: death: 0.5 versus 1.6%, P=0.36; myocardial infarction: 2.0 versus 2.6%, P=0.75; target lesion revascularization: 1.5 versus 3.2%, P=0.33; major adverse cardiac events: 4.0 versus 7.4%, P=0.19. No stent thrombosis was observed with NEVO SES, whereas 2 cases occurred in TAXUS Liberté PES. Intravascular ultrasound showed lower percent volume obstruction for NEVO SES (5.5±11% versus 11.5±9.7%, P=0.016). This trial proved the superiority of NEVO SES over TAXUS Liberté PES for the primary angiographic end point of in-stent late loss. No stent thrombosis occurred in the NEVO SES group. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00606333.

  19. Comparison of zotarolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for coronary revascularization: the ZEST (comparison of the efficacy and safety of zotarolimus-eluting stent with sirolimus-eluting and paclitaxel-eluting stent for coronary lesions) randomized trial.

    Science.gov (United States)

    Park, Duk-Woo; Kim, Young-Hak; Yun, Sung-Cheol; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol-Whan; Park, Seong-Wook; Seong, In-Whan; Lee, Jae-Hwan; Tahk, Seung-Jea; Jeong, Myung-Ho; Jang, Yangsoo; Cheong, Sang-Sig; Yang, Joo-Young; Lim, Do-Sun; Seung, Ki-Bae; Chae, Jei-Keon; Hur, Seung-Ho; Lee, Sang-Gon; Yoon, Junghan; Lee, Nae-Hee; Choi, Young-Jin; Kim, Hyun-Sook; Kim, Kee-Sik; Kim, Hyo-Soo; Hong, Taeg-Jong; Park, Hun-Sik; Park, Seung-Jung

    2010-10-05

    The aim of this study was to evaluate the relative efficacy and safety of zotarolimus-eluting stents (ZES) in comparison with the established and widely used sirolimus- (SES) and paclitaxel-eluting stents (PES) in routine clinical practice. Whether ZES might provide similar clinical and angiographic outcomes in a broad spectrum of patients compared with SES or PES is undetermined. We performed a single-blind, multicenter, prospectively randomized trial to compare ZES with SES and PES in 2,645 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE) (death, myocardial infarction, and ischemia-driven target vessel revascularization) at 12 months. A noninferiority comparison (ZES vs. SES) and a superiority comparison (ZES vs. PES) were performed for the primary end point. Baseline clinical and angiographic characteristics were similar in the 3 groups. At 12 months, the ZES group showed noninferior rates of MACE compared with the SES group (10.2% vs. 8.3%, p for noninferiority = 0.01, p for superiority = 0.17) and significantly fewer MACE than the PES group (10.2% vs. 14.1%, p for superiority = 0.01). The incidence of death or myocardial infarction was similar among the groups (ZES vs. SES vs. PES, 5.8% vs. 6.9% vs. 7.6%, respectively, p = 0.31). The incidence of stent thrombosis was significantly lower in the SES group (ZES vs. SES vs. PES, 0.7% vs. 0% vs. 0.8%, respectively, p = 0.02). In this large-scale, practical randomized trial, the use of ZES resulted in similar rates of MACE compared with SES and in fewer MACE compared with PES at 12 months. (Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions; NCT00418067). Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  20. Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery Disease: 5-Year Outcomes of the PRECOMBAT Study.

    Science.gov (United States)

    Ahn, Jung-Min; Roh, Jae-Hyung; Kim, Young-Hak; Park, Duk-Woo; Yun, Sung-Cheol; Lee, Pil Hyung; Chang, Mineok; Park, Hyun Woo; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Choo, Suk Jung; Chung, CheolHyun; Lee, JaeWon; Lim, Do-Sun; Rha, Seung-Woon; Lee, Sang-Gon; Gwon, Hyeon-Cheol; Kim, Hyo-Soo; Chae, In-Ho; Jang, Yangsoo; Jeong, Myung-Ho; Tahk, Seung-Jea; Seung, Ki Bae; Park, Seung-Jung

    2015-05-26

    In a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year. This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis. We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent (n = 300) or CABG (n = 300). The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE: a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) and compared on an intention-to-treat basis. At 5 years, MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group (cumulative event rates of 17.5% and 14.3%, respectively; hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.84 to 1.90; p = 0.26). The 2 groups did not differ significantly in terms of death from any cause, myocardial infarction, or stroke as well as their composite (8.4% and 9.6%; HR, 0.89; 95% CI, 0.52 to 1.52; p = 0.66). Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group (11.4% and 5.5%, respectively; HR: 2.11; 95% CI: 1.16 to 3.84; p = 0.012). During 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. Prospective rAndomized, single-blind, mulTicenter study of sirolimus-eluting coRonary stent “Calypso” vs everolimus-eluting cOronary stenT “XiencePrime”: results of the PATRIOT trial

    Directory of Open Access Journals (Sweden)

    A. A. Prokhorikhin

    2017-11-01

    Full Text Available Aim. This trial was aimed at comparing the efficacy and safety of sirolimus-eluting coronary stent “Calypso” (Angioline and everolimus-eluting coronary stent “XiencePrime” (Abbott Vascular when used for treatment of ischemic heart disease patients.Methods. The trial included patients suitable for coronary revascularization with coronary stenting. They underwent a standard revascularization procedure and were randomized in 2:1 ratio to receive “Calypso” coronary stent (Angioline (n = 407 or “XiencePrime” coronary stent (AbbottVascular (n = 203. The follow-up period was 12 months. In order to detect restenosis (secondary endpoint, angiographic follow-up was performed in 20% of cases at 12 months. The trial protocol had no limitations regarding the length of lesions, number of target lesions and number of implanted stents. The main exclusion criterion was STEMI. The composite primary endpoint included one-year target lesion-related complications determined as cardiogenic death, target vessel myocardial infarction, clinically indicated target lesion revascularization. The primary endpoint data were evaluated by an independent committee.Results. In the trial, 55% of patients had acute coronary syndrome with ST elevation and type C lesions were detected in 46% of cases. In “Calypso” and “XiencePrime” groups, TLF occurred in 5.4% and 6.4% respectively (absolute risk difference in TLF accounted for 1%, 95% CI [---;2.1%]; p non-inferiority = 0.017. Thus, the hypothesis of non-inferiority of “Calypso” as compared to “XiencePrime” was confirmed. The incidence of stent thrombosis (definite and probable was relatively low and had no significant differences between “Calypso” and “XiencePrime” groups (0.73% and 0%; p>0.05. Definite stent thrombosis was noted in two cases in the “Calypso” group (0.49%, in one case the cause of thrombosis turned out to be incomplete stent expansion after implantation.Conclusion.

  2. Expression and function of calcium-activated potassium channels following in-stent restenosis in a porcine coronary artery model

    Directory of Open Access Journals (Sweden)

    Mais F. Absi

    2012-04-01

    Functional analysis using 1-EBIO and Bradykinin produced hyperpolarization of neointimal but not medial myocytes, which indicated the expression of functional endothelial SK3 and IKCa in the former and not in the latter. The expression of IKCa and SK3 within the neointimal layer suggested that some degree of recovery of both endothelial as well as smooth muscle regeneration had occurred. Future development of selective modulators of IKCa and SK3 channels may decrease the progression of ISR and improve coronary vascular function after stent placement, and is an area for future investigation.

  3. Successful stenting of catheter-induced unprotected left main coronary artery dissection

    NARCIS (Netherlands)

    G. Ertaş; E. Ural (E.); W.J. van der Giessen (Wim)

    2012-01-01

    textabstractCatheter-induced left main coronary artery (LMCA) dissection is a dramatic, although uncommon complication of diagnostic coronary angiography and requires prompt treatment. We describe a case of iatrogenic occlusive dissection of the LMCA during coronary angiography, treated by

  4. Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: methodology and external validation.

    Science.gov (United States)

    Vranckx, Pascal; McFadden, Eugene; Cutlip, Donald E; Mehran, Roxana; Swart, Michael; Kint, P P; Zijlstra, Felix; Silber, Sigmund; Windecker, Stephan; Serruys, Patrick W C J

    2013-01-01

    Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting. We performed a validation of the clinical event committee (CEC) adjudication process on 100 suspected events in the RESOLUTE All-comers trial (Resolute-AC). Two experienced Clinical Research Organisations (CRO) that had already extensive internal validation processes in place, participated in the study. After initial adjudication by the primary-CEC, events were cross-adjudicated by an external-CEC using the same definitions. Major discrepancies affecting the primary end point of target-lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically-indicated target-lesion revascularization (CI-TLR), were analysed by an independent oversight committee who provided recommendations for harmonization. Discordant adjudications were reconsidered by the primary CEC. Subsequently, the RAC database was interrogated for cases that based on these recommendations merited re-adjudication and these cases were also re-adjudicated by the primary CEC. Final discrepancies in adjudication of individual components of TLF occurred in 7 out of 100 events in 5 patients. Discrepancies for the (hierarchical) primary endpoint occurred in 5 events (2 cardiac deaths and 3 TV-MI). After application of harmonization recommendations to the overall RAC population (n=2292), the primary CEC adjudicated 3 additional clinical-TLRs and considered 1 TV-MI as no event. A harmonization process provided a high level of concordance for event adjudication and improved accuracy for final event reporting. These findings suggest it is feasible to pool clinical event outcome data across clinical trials even when different CECs are responsible for event adjudication. Copyright © 2012 Elsevier Inc. All rights reserved.

  5. Cost-effectiveness of adjunctive eptifibatide in patients undergoing coronary stenting in Germany.

    Science.gov (United States)

    Dewilde, Sarah; Brüggenjürgen, Bernd; Nienaber, Christoph; Senges, Jochen; Welte, Robert; Willich, Stefan N

    2012-08-01

    To determine the cost-effectiveness of adding eptifibatide to the standard treatment for selected high-risk patients undergoing coronary stenting in Germany. Furthermore, to investigate the impact of several extrapolation methods on the results. A Markov model was developed to reflect the clinical events in this specific patient population, including target vessel revascularization, myocardial infarction, and death. To extrapolate clinical data beyond 1 year, a linear, an exponential, and a Weibull survival curves were estimated. Patient characteristics and transition probabilities were derived from a high-risk subgroup of the ESPRIT trial; patient-level utility data came from a published Dutch study. Costs were calculated from a hospital and from a third-party payer perspective. For both perspectives, the additional treatment with eptifibatide is the considered dominant alternative. The incremental net benefit of its use exceeds €10,000 for both perspectives. Results proved stable in probabilistic sensitivity analysis as well as under the different extrapolation scenarios. Eptifibatide is likely to be dominant strategy with 77.7 and 96.7% of the simulations leading to QALYs gained and generating cost savings from both the hospital and the third-party payer perspective. Eptifibatide offsets its additional treatment costs by avoiding costly repeat procedures and leads to positive QALY gains by preventing cardiovascular events lending themselves to transient or permanent lower quality of life. The method used to extrapolate the short-term risks did not impact on results, mainly due to similar clinical risk profiles between the two treatment groups in the long term.

  6. A Chemical Stability Study of Trimethylsilane Plasma Nanocoatings for Coronary Stents

    Science.gov (United States)

    Jones, John Eric; Yu, Qingsong; Chen, Meng

    2016-01-01

    In this study, trimethylsilane (TMS) plasma nanocoatings were deposited onto 316L stainless steel coupons in direct current (DC) and radio frequency (RF) glow discharges and additional NH3/O2 plasma treatment to tailor the coating surface properties. The chemical stability of the plasma nanocoatings were evaluated after 12 week (~3 month) storage under dry condition (25 °C) and immersion in simulated body fluid (SBF) at 37 °C. It was found that nanocoatings did not impact surface roughness of underlying stainless steel substrates. X-ray photoelectron spectroscopy (XPS) and Fourier transform infrared spectroscopy (FTIR) were used to characterize surface chemistry and compositions. Both DC and RF TMS plasma nanocoatings had Si– and C– rich composition; and the O– and N– contents on the surfaces were substantially increased after NH3/O2 plasma treatment. Contact angle measurements showed that DC TMS nanocoating with NH3/O2 treatment generated very hydrophilic surfaces. DC TMS nanocoatings with NH3/O2 treatment showed minimal surface chemistry change after 12 week immersion in SBF. However, nitrogen functionalities on RF-TMS coating with NH3/O2 post treatment were not as stable as in DC case. Cell culture studies revealed that the surfaces with DC coating and NH3/O2 post treatment demonstrated substantially improved proliferation of endothelial cells over the 12 week storage period at both dry and wet conditions, as compared to other coated surfaces. Therefore, DC nanocoatings with NH3/O2 post treatment may be chemically stable for long-term properties, including shelf-life storage and exposure to the bloodstream for coronary stent applications. PMID:27712432

  7. Improved outcomes of elderly patients treated with drug-eluting versus bare metal stents in large coronary arteries: results from the BAsel Stent Kosten-Effektivitäts Trial PROspective Validation Examination randomized trial.

    Science.gov (United States)

    Kurz, David J; Bernheim, Alain M; Tüller, David; Zbinden, Rainer; Jeger, Raban; Kaiser, Christoph; Galatius, Soeren; Hansen, Kim W; Alber, Hannes; Pfisterer, Matthias; Eberli, Franz R

    2015-10-01

    Drug-eluting stents (DES) improve outcomes in elderly patients with small coronary artery disease compared with bare-metal stents (BMS), but randomized data in elderly patients in need of large coronary stents are not available. Planned secondary analysis of patients ≥75 years recruited to the "BASKET-PROVE" trial, in which 2,314 patients undergoing percutaneous coronary intervention for large (≥3.0 mm) native vessel disease were randomized 2:1 to DES (everolimus- vs sirolimus-eluting stents 1:1) versus BMS. All patients received 12 months of dual antiplatelet therapy. The primary end point was a composite of cardiac death or nonfatal myocardial infarction at 2 years. Comparison of DES versus BMS among 405 patients ≥75 years showed significantly lower rates of the primary end point for DES (5.0% vs 11.6%; hazard ration (HR) 0.64 [0.44-0.91]; P = .014). Rates of nonfatal myocardial infarction (1.2% vs 5.5%, hazard ration (HR) 0.44 [0.21-0.83]; P = .009), all-cause death (7.4% vs 14.4%; HR 0.7 [0.51-0.95]; P = .02), and target vessel revascularization (TVR) (2.3% vs 6.2%; HR 0.59 [0.34-0.99]; P = .046) were also lower, whereas stent thrombosis and bleeding rates were similar. In contrast, among patients <75 years (n = 1,909), the only significant benefit of DES was a reduced rate of TVR (4.0% vs 8.7%, HR 0.66 [0.55-0.80]; P < .0001). In patients ≥75 years requiring large (≥3.0 mm) coronary stents, use of DES was beneficial compared with BMS and reduced the rate of ischemic events, mortality, and TVR. These data suggest that DES should be preferred over BMS in elderly patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. What Are the Risks of Having a Stent?

    Science.gov (United States)

    ... What Are the Risks of Having a Stent? Risks Related to Percutaneous Coronary Intervention Percutaneous coronary intervention ( ... section of the tissue growth around the stent. Risks Related to Stents About 1–2 percent of ...

  9. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial.

    Science.gov (United States)

    Pilgrim, Thomas; Heg, Dik; Roffi, Marco; Tüller, David; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Fahrni, Therese; Moschovitis, Aris; Noble, Stéphane; Eberli, Franz R; Wenaweser, Peter; Jüni, Peter; Windecker, Stephan

    2014-12-13

    Refinements in stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-eluting stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-eluting stent. We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104. Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-eluting stents (1063 patients, 1594 lesions) or everolimus-eluting stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-eluting stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-eluting stents (70 cases; 6·6%) at 12 months (absolute risk difference -0·14%, upper limit of one

  10. Biodegradable polymer Biolimus-eluting stent (Nobori® for the treatment of coronary artery lesions: review of concept and clinical results

    Directory of Open Access Journals (Sweden)

    Schurtz G

    2014-02-01

    Full Text Available Guillaume Schurtz,1,2 Cédric Delhaye,1 Christopher Hurt,1,2 Henri Thieuleux,1,2 Gilles Lemesle1–3 1Centre Hémodynamique et Unité des Soins Intensifs de Cardiologie, Hôpital Cardiologique, Centre Hospitalier Régional et Universitaire de Lille, Lille, France; 2Faculté de Médecine de Lille, Lille, France; 3Unité INSERM UMR744, Institut Pasteur de Lille, Lille, France Abstract: First-generation drug-eluting stents have raised concerns regarding the risk of late and very late stent thrombosis compared with bare metal stents and require prolonged dual antiplatelet therapy. Despite extensive investigations, the physiopathology of these late events remains incompletely understood. Aside from patient- and lesion-related risk factors, stent polymer has been cited as one of the potential causes. In fact, the persistence of durable polymer after complete drug release has been shown to be responsible for local hypersensitivity and inflammatory reactions. Third-generation drug-eluting stents with more biocompatible or biodegradable polymers have subsequently been developed to address this problem. In this article, we evaluate and discuss the concept and clinical results (safety and efficacy of a third-generation drug-eluting stent with biodegradable polymer: the Nobori® stent. Keywords: percutaneous coronary intervention, stent thrombosis, antiplatelet therapy

  11. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V)

    DEFF Research Database (Denmark)

    Christiansen, Evald Høj; Jensen, Lisette Okkels; Thayssen, Per

    2013-01-01

    Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer...

  12. What Is a Stent?

    Science.gov (United States)

    ... surgery or a fabric stent is used to repair an aneurysm in the abdominal aorta. These problems ... with clinical research. More Information Related Health Topics Aneurysm Carotid Artery Disease Coronary Heart Disease Percutaneous Coronary Intervention Peripheral Artery Disease ...

  13. Multi-link Vision and MiniVision stent registry in Asian patients with coronary artery disease: a prospective, multi-center study.

    Science.gov (United States)

    Xu, Ya-Wei; Wei, Yi-Dong; Tang, Kai; Chen, Yan-Qing; Li, Wei-Ming; Yu, Xue-Jing; Qin, Yong-Wen; Qi, Guo-Xian; Qu, Peng; Hou, Yu-Qing; Jain, Ashok; Grant, Parvez; Ramesh, Gudapati; Ramesh, Basavappa; Piamsomboon, Chumpol; Kuanprasert, Srun; Gwon, Hyeon-Cheol; Cho, Yoon Haeng; Kamar, Haizal Haroon; Huang, Cong-Xin

    2007-06-20

    Recent studies have showed that the fine mesh stents are associated with a significant reduction in both clinical and angiographic re-stenosis of the coronary arteries. To maintain a very satisfactory radio-opacity using the stents, Guidant of the USA has designed a new type of bare metal stents (BMS)-Multi-link (ML) Vision/ML MiniVision stents. The clinical outcomes of Asian patients with coronary artery disease (CAD) after implanting the Multi-link Vision or MiniVision stent were investigated in this study. An observational, prospective, multi-center, non-randomized post marketing registry was conducted to demonstrate the efficacy of the BMS-ML Vision/ML MiniVision stents. The primary end point of the registry was clinical target lesion revascularization (TLR) at a 6-month follow-up. The major secondary end points included the rate of major adverse cardiac events (MACE) and serious adverse events (SAE) in hospital and at 6 months; and the rate of clinical TLR as a function of the type of angina. A total of 429 Asian people with 449 lesions from 14 centers were selected for this study. The average reference diameter of the lesions was (3.0 +/- 0.5) mm, and the mean length was (15.7 +/- 5.0) mm. The successful rate of the procedure was 99.3%. Twenty-five percent of the lesions were treated by direct stenting without pre-dilation. Eighty-six percent of the lesions were implanted with ML Vision stent. After the 6-month follow-up, the rate of clinical TLR was 1.4%. The MACE, SAE and target vessel revascularization (TVR) were 6.8%, 3.5% and 1.4% respectively. The current registry showed the excellent 6-month clinical outcomes of ML Vision/ML MiniVision stents in Asian patients with CAD.

  14. High-definition computed tomography for coronary artery stents: image quality and radiation doses for low voltage (100 kVp) and standard voltage (120 kVp) ECG-triggered scanning.

    Science.gov (United States)

    Lee, Ji Won; Kim, Chang Won; Lee, Han Cheol; Wu, Ming-Ting; Hwangbo, Lee; Choo, Ki Seok; Kim, June Hong; Lee, Ki-Nam; Kim, Jin You; Jeong, Yeon Joo

    2015-06-01

    The noninvasive assessment of coronary stents by coronary CT angiography (CCTA) is an attractive method. However, the radiation dose associated with CCTA remains a concern for patients. The purpose of this study is to compare the radiation doses and image qualities of CCTA performed using tube voltages of 100 or 120 kVp for the evaluation of coronary stents. After receiving institutional review board approval, 53 consecutive patients with previously implanted stents (101 stents) underwent 64-slice CCTA. Patients were divided into three different protocol groups, namely, prospective ECG triggering at 100 kVp, prospective ECG triggering at 120 kVp, or retrospective gating at 100 kVp. Two reviewers qualitatively scored the quality of the resulting images for coronary stents and determined levels of artificial lumen narrowing (ALN), stent lumen attenuation increase ratio (SAIR), image noise, and radiation dose parameters. No significant differences were found between the three protocol groups concerning qualitative image quality or SAIR. Coronary lumen attenuation and in-stent attenuation of 100 kVp prospective CCTA (P-CCTA) were higher than in the 120 kVp P-CCTA protocol (all Ps quality of 100 kVp R-CCTA and 120 kVp P-CCTA for the evaluation of coronary stents.

  15. Mechanisms of myocardial hypoperfusion during rotational atherectomy of de novo coronary artery lesions and stenosed coronary stents: insights from serial myocardial scintigraphy.

    Science.gov (United States)

    Koch, Karl-Christian; Radke, Peter W; Kleinhans, Eduard; Ninnemann, Susanne; Janssens, Uwe; Klues, Heinrich G; Buell, Udalrich; Hanrath, Peter; vom Dahl, Juergen

    2002-01-01

    Rotational atherectomy (rotablation) frequently results in transient myocardial hypoperfusion due to peripheral vessel obstruction. This study compares the incidence, extent, and severity of perfusion defects induced by rotablation of de novo coronary lesions with rotablation of in-stent restenosis. Twenty-five patients undergoing rotablation for restenosed stents (group A) were studied by technetium 99m sestamibi single photon emission computed scintigraphy at rest before rotablation, during rotablation, and 2 days after the procedure. For semiquantitative analysis, perfusion in 24 left ventricular regions was expressed as percentage of maximal sestamibi uptake. The results were compared with those of 25 patients treated for de novo coronary lesions (group B). Transient perfusion defects were observed in 22 (88%) of 25 patients in group A and, similarly, in 23 (92%) of 25 in group B. Perfusion was significantly reduced during rotablation in 3.1 +/- 2.6 (mean +/- SD) regions in group A and in 3.3 +/- 2.5 regions in group B. Perfusion in the region with maximal reduction during rotablation in groups A and B was 77% +/- 13% and 76% +/- 15% at baseline. Technetium uptake decreased to 59% +/- 19% and 54% +/- 14% during rotablation (P microcavitation or platelet aggregation.

  16. Thin strut chrome-cobalt stent implantation for treatment of de-novo lesions in small coronary vessels: results of the RISICO Italian Registry (Registro Italiano Mini VISION nei piccolo Vasi) utilizing the Mini VISION coronary stent platform.

    Science.gov (United States)

    Brambilla, Nedy; Morici, Nuccia; Bedogni, Francesco; De Benedictis, Mauro; Scrocca, Innocente; Naldi, Monica; Fiscella, Antonio; Prosperi, Franco; Dominici, Mauro; Rebuzzi, Antonio; Colombo, Antonio; Sangiorgi, Giuseppe M

    2009-11-01

    The Registro Italiano Mini VISION nei piccoli Vasi registry is a prospective, multicenter, observational study, aimed at assessing immediate and long-term angiographic and clinical outcomes of a small-vessel cobalt-chrome super alloy-dedicated stent (Multi-Link RX VISION) in de-novo and long lesions. Small artery size is an important determinant of poor outcomes in percutaneous coronary interventions. Patients with ischemic heart disease were included. The primary end point was procedural success. Secondary end points included clinical restenosis (need for target lesion revascularization ), incidence of major adverse cardiac events at 6 months, and cost-effectiveness analysis. Between September 2004 and October 2005, 143 patients (mean age 67 +/- 11 years; 22% diabetes) were enrolled; 6-month follow-up was completed in May 2006. Average lesion length, mean stent length and diameter were 16.8 +/- 7.1, 17.01 +/- 3.9 and 2.41 +/- 0.14 mm, respectively. Procedural success was 96%. At 6-month follow-up, the hierarchical major adverse cardiac event rate was 11.6%, 2.9% deaths, 2.9% myocardial infarction and 5.8% target lesion revascularization. Cost-effectiveness analysis will be reported in a further publication. Small-vessel disease treatment with Mini VISION stents permits an elevated procedural success rate with low incidence of clinical restenosis and major adverse cardiac events at mid-term follow-up. Such results require confirmation by means of a randomized controlled study against drug-eluting stents.

  17. Biomechanical impact of provisional stenting and balloon dilatation on coronary bifurcation: clinical implications.

    Science.gov (United States)

    Chen, Henry Y; Al-Saadon, Khalid; Louvard, Yves; Kassab, Ghassan S

    2017-07-01

    In-stent restenosis (ISR) and stent thrombosis remain clinically significant problems for bifurcations. Although the role of wall shear stress (WSS) has been well investigated, the role of circumferential wall stresses (CWS) has not been well studied in provisional stenting with and without final kissing balloon (FKB). We hypothesized that the perturbation of CWS at the SB in provisional stenting and balloon dilatation is an important factor in addition to WSS, and, hence, may affect restenosis rates (i.e., higher CWS correlates with higher restenosis). To test this hypothesis, we developed computational models of stent, FKB at bifurcation, and finite element simulations that considered both fluid and solid mechanics of the vessel wall. We computed the stress ratio (CWS/WSS) to show potential correlation with restenosis in clinical studies (i.e., higher stress ratio correlates with higher restenosis). Our simulation results show that stenting in the main branch (MB) increases the maximum CWS in the side branch (SB) and, hence, yields a higher stress ratio in the SB, as compared with the MB. FKB dilatation decreases the CWS and increases WSS, which collectively lowers the stress ratio in the SB. The changes of stress ratio were correlated positively with clinical data in provisional stenting and FKB. Both fluid and solid mechanics need to be evaluated when considering various stenting techniques at bifurcations, as solid stresses also play an important role in clinical outcome. An integrative index of bifurcation mechanics is the stress ratio that considers both CWS and WSS.NEW & NOTEWORTHY Although the role of wall shear stress (WSS) has been well investigated, the role of circumferential wall stresses (CWS) has not been well studied in provisional stenting with and without final kissing balloon. Both fluid and solid mechanics need to be evaluated when considering various stenting techniques at bifurcations. An integrative index of bifurcation mechanics is the

  18. Prevalence, correlation and clinical outcome of intra-procedural stent thrombosis in patients undergoing primary percutaneous coronary intervention for acute coronary syndrome.

    Science.gov (United States)

    Xu, Yingjia; Qu, Xinkai; Fang, Weiyi; Chen, Hui

    2013-06-01

    To assess the occurrence, correlation, and clinical outcome of intraprocedural stent thrombosis (IPST) in patients undergoing primary percutaneous coronary intervention (PCI) in the setting of acute coronary syndromes (ACSs). Stent thrombosis (ST), a rare complication of PCI, is more common in the setting of ACS. It is not known whether IPST carries the same prognosis as postprocedural ST. This retrospective study comprised a review of 1,901 consecutive ACS patients who received primary PCI in our center from January 2006 to January 2011. IPST was defined as new, reappearing or increased thrombus within the deployed stent before the index PCI procedure was completed. All angiograms were independently reviewed frame by frame for the incidence of IPST. Patients with and without IPST were compared with respect to clinical characteristics, angiographic parameters, and major adverse cardiac events (MACEs) at 30 days and 1-year follow-up. Overall, there were 23 cases of IPST detected, thus, the prevalence of IPST was 1.2%. There were no significant differences in baseline clinical characteristics between the 2 groups. Patients with compared to those without IPST had significantly more bifurcation lesions involved, and more thrombus burden at baseline. IPST group compared to no IPST group had more MACEs on 30 days (26.1% vs. 8.7%, P = 0.01) and 1-year follow-up (30.4% vs. 14.4%, P = 0.02). IPST was a rare complication of PCI in the setting of ACS. It correlated with lesion morphology, presence of thrombus at baseline and was more likely to cause MACEs in 30 days and 1-year follow-up. © 2013, Wiley Periodicals, Inc.

  19. Platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention: the ESPRIT trial: a randomized controlled trial.

    Science.gov (United States)

    O'Shea, J C; Hafley, G E; Greenberg, S; Hasselblad, V; Lorenz, T J; Kitt, M M; Strony, J; Tcheng, J E

    2001-05-16

    The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial showed the efficacy of adjunctive, double-bolus eptifibatide therapy in reducing ischemic complications of nonurgent coronary stent implantation at 48 hours and at 30 days. To determine whether the beneficial effects of eptifibatide persist at 6 months after treatment. Follow-up study of a randomized, double-blind, placebo-controlled, crossover-permitted trial conducted from June 1999 through February 2000. Ninety-two tertiary care centers in the United States and Canada. A total of 2064 patients scheduled to undergo nonurgent percutaneous coronary intervention with stent implantation. Patients were randomly assigned to receive placebo or eptifibatide (two 180-microg/kg boluses 10 minutes apart and continuous infusion of 2.0 microg/kg per minute), started immediately before stent implantation and continued for 18 to 24 hours. Complete follow-up data were available for 988 (95.0%) of 1040 patients given eptifibatide and 977 (95.4%) of 1024 patients given placebo. Composite rates of death or myocardial infarction (MI); death, MI, or target vessel revascularization; and their individual components 6 months after enrollment, compared between the 2 groups. By 6 months, the composite end point of death or MI had occurred in 7.5% of eptifibatide-treated patients and in 11.5% of placebo-treated patients (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.47-0.84; P =.002). The composite of death, MI, or target vessel revascularization was 14.2% in eptifibatide-treated patients vs 18.3% in placebo-treated patients (HR, 0.75; 95% CI, 0.60-0.93; P =.008). Most of this benefit accrued early (<48 hours after initiation of therapy) and was maintained through 6 months. Six-month mortality in the eptifibatide group was 0.8% vs 1.4% in the placebo group (HR, 0.56; 95% CI, 0.24-1.34; P =.19) and target vessel revascularization occurred in 8.6% of the eptifibatide group vs 9.4% of

  20. Randomized comparison between provisional and routine kissing-balloon technique after main vessel crossover stenting for coronary bifurcation lesions.

    Science.gov (United States)

    Yamawaki, Masahiro; Fujita, Masaki; Sasaki, Shinya; Tsurugida, Masanori; Nanasato, Mamoru; Araki, Motoharu; Hirano, Keisuke; Ito, Yoshiaki; Tsukahara, Reiko; Muramatsu, Toshiya

    2017-04-11

    We compared the myocardial ischemic burden of provisional and routine final kissing-balloon inflation (FKI) with the 1-stent strategy using a second-generation drug-eluting stent for coronary bifurcation lesions (CBL). There are no established guidelines for side branch (SB) intervention after main vessel stenting. In total, 113 CBL patients were randomized to receive different SB intervention strategies: provisional-FKI group (n = 57; FKI only when SB flow was TIMI stress myocardial perfusion scintigraphy with (99m)Tc was performed after 8 months. The regional summed-difference score (r-SDS) was calculated according to the coronary territory. The primary endpoint included target vessel ischemia (TVI; r-SDS ≥ 2) at 8 months, whereas the clinical primary endpoint was major adverse cardiovascular events (MACE) at 3 years. The percent (%) myocardial ischemia (100 × SDS/68) was also calculated. At 8 months, TVI was identified in 11 and 4% in the provisional-FKI and routine-FKI groups, respectively (p = 0.226). SB-binary restenosis (48 vs. 4%, p 10% myocardial ischemia) was not observed in the target vessel in either group. Long-term cumulative MACE were similar between the groups (9 vs. 14%; p = 0.358). Provisional-FKI according to TIMI-SB flow grade led to similar and acceptable myocardial ischemia, in comparison with routine-FKI, which may contribute to the identical long-term follow-up.

  1. Pharmacokinetic sub-study in the SPIRIT III Randomized and Controlled Trial of XIENCE V everolimus eluting coronary stent system.

    Science.gov (United States)

    Wang, Qing; Pierson, Wesley; Sood, Poornima; Bol, Cornelis; Cannon, Louis; Gordon, Paul; Saucedo, Jorge; Sudhir, Krishnankutty

    2010-02-01

    Drug-eluting stents (DES) are widely used for treatment of coronary artery disease with benefit of reduced restenosis compared to bare metal stents. The XIENCE VEverolimus Eluting Coronary Stent System is a second-generation DES system for better deliverability while maintaining safety and efficacy profiles. The present pharmacokinetic sub-study from the SPIRIT III Randomized and Controlled Trial (RCT) was to evaluate systemic exposure of patients to everolimus and to further demonstrate safety following implantation of XIENCE Vstents with everolimus doses ranging from 53 to 181 microg. Drug concentrations in whole blood were determined at multiple time points using a validated analytical method with a limit of quantification of 0.1 ng/mL. Individual C(max) ranged from 0.17 to 2.40 ng/mL and occurred between 0.07 and 1.88 hours across all dose levels. Both mean and individual C(max) values were below the trough blood concentrations of everolimus (Certican) for inhibition of organ transplant rejection. The last time point at which drug concentrations could be quantified ranged from 12 to 168 hours postimplantation in individual patients. In most cases, the blood levels dropped below the limit of quantification after 72 hours. This study confirms that the XIENCE Vstent causes a limited and systemic exposure to everolimus. The presumed localized and efficient delivery of everolimus to target vessels coupled with limited and transient systemic drug exposure contributes to the safety and effectiveness of the XIENCE VEECSS in patients of SPIRIT III RCT for longer than 2 years.

  2. Simultaneous dual vascular access site for the treatment of coronary artery bifurcation lesions by complex 2-stent technique.

    Science.gov (United States)

    Isaaz, Karl; Mayaud, Norbert; Lamaud, Michel; Raynaud, Amélie; Cerisier, Alexis; Sabry, Mohammed Hassan; Richard, Laure; Khamis, Hazem; Abd-Alaziz, Ahmad; DA Costa, Antoine

    2012-10-01

    To propose an original approach based on simultaneous dual vascular access site (DAS) using 2 small-size guiding catheters to easily perform complex 2-stent techniques for bifurcation coronary lesions (BL). Simultaneous kissing stenting and classic crush technique require large 7 or 8Fr guiding catheters leading to large amounts of contrast medium, vascular access site complications, and sometimes frictions or criss-cross of the 2-stent delivery systems. DAS was used in 30 patients with BL (11 radio-radial, 16 radio-femoral, and 3 femoro-femoral). Among 60 guiding catheters, the size was 5Fr in 28, 6Fr in 30, and 7Fr in 2 cases of double adjacent BL. When 2 different size catheters were used, contrast medium injections were done using the smallest size catheter. DAS patients were compared with a group of 30 BL patients treated using a single femoral vascular access site (SAS) with 7 or 8Fr catheters. Success rate was 100% in all patients. Contrast volume used was smaller in DAS than in SAS patients (277 ± 156 cc vs. 380 ± 165 cc,P = 0.01). No vascular access site complication occurred in the sub-group of the 11 DAS radio-radial patients. Postintervention hospitalization duration was shorter in DAS than in SAS (1.9 ± 2 vs. 2.8 ± 2 days,P = 0.048). DAS allows to successfully perform complex stenting technique of BL using small-size guiding catheters leading to decreased contrast medium volume, decreased vascular access site complications rates, and shortened hospitalization duration. ©2012, Wiley Periodicals, Inc.

  3. Percutaneous handling of coronary lesions >20mm through stents. Is there a first choice strategy?

    Directory of Open Access Journals (Sweden)

    Luiz Fernando L. Tanajura

    1999-10-01

    Full Text Available OBJECTIVE - This study compared the early and late results of the use of one single stent with those of the use of multiple stents in patients with lesions longer than 20mm. METHODS - Prospective assessment of patients electively treated with stents, with optimal stent deployment and followed-up for more than 3 months. From February '94 to January '98, 215 patients with lesions >20mm were treated. These patients were divided into 2 groups as follows: Group A - 105 patients (49% with one stent implanted; Group B - 110 patients (51% with multiple stents implanted. RESULTS - The mean length of the lesions was 26mm in group A (21-48mm versus 29mm in group B (21-52mm (p=0.01. Major complications occurred in one patient (0.9% in group A (subacute thrombosis, myocardial infarctionand death and in 2 patients (1.8% in group B (one emergency surgery and one myocardial infarction (p=NS. The results of the late follow-up period (>6 months were similar for both groups (group A = 82% vs group B = 76%; p=NS, and we observed an event-free survical in 89% of the patients in group A and in 91% of the patients in group B (p=NS. Angina (group A = 11% vs group B = 7% and lesion revascularization (group A = 5% vs group B = 6%; p=NS also occurred in a similar percentage. No infarction or death was observed in the late follow-up period; restenosis was identified in 33% and 29% of the patients in groups A and B, respectively (p=NS. CONCLUSION - The results obtained using one stent and using multiple stents were similar; the greater cost-effectiveness of one stent implantation, however, seems to make this strategy the first choice.

  4. Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: A Patient-Level Pooled Analysis of Randomized Controlled Trials

    NARCIS (Netherlands)

    Baber, Usman; Giustino, Gennaro; Sartori, Samantha; Aquino, Melissa; Stefanini, Giulio G.; Steg, Gabriel; Windecker, Stephan; Leon, Martin B.; Wijns, William; Serruys, Patrick W.; Valgimigli, Marco; Stone, Gregg W.; Dangas, George D.; Morice, Marie-Claude; Camenzind, Edoardo; Weisz, Giora; Smits, Pieter C.; Kandzari, David E.; von Birgelen, Clemens; Mastoris, Ioannis; Galatius, Soren; Jeger, Raban V.; Kimura, Takeshi; Mikhail, Ghada W.; Itchhaporia, Dipti; Mehta, Laxmi; Ortega, Rebecca; Kim, Hyo-Soo; Kastrati, Adnan; Chieffo, Alaide; Mehran, Roxana

    2016-01-01

    Objectives This study sought to evaluate: 1) the effect of impaired renal function on long-term clinical outcomes in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES); and 2) the safety and efficacy of new-generation compared with early-generation DES in women

  5. Functional comparison between BuMA Supreme biodegradable polymer sirolimus-eluting and durable polymer zotarolimus-eluting coronary stents using Quantitative Flow Ratio: PIONEER QFR substudy

    NARCIS (Netherlands)

    Asano, Taku; Katagiri, Yuki; Collet, Carlos; Tenekecioglu, Erhan; Miyazaki, Yosuke; Sotomi, Yohei; Amoroso, Giovanni; Aminian, Adel; Brugaletta, Salvatore; Vrolix, Mathias; Hernandez-Antolín, Rosana; van de Harst, Pim; Iñiguez, Andres; Janssens, Luc; Smits, Pieter; Wykrzykowska, Joanna J.; Ribeiro, Vasco Gama; Periera, Helder; da Silva, Pedro Canas; Piek, Jan J.; Reiber, Johan H. C.; von Birgelen, Clemens; Sabaté, Manel; Onuma, Yoshinobu; Serruys, Patrick W.

    2017-01-01

    Quantitative Flow Ratio (QFR) based on 3-dimensional quantitative coronary angiography (3D-QCA) is a novel method to assess the physiological functionality after treatment with stents. The current study aimed to evaluate the difference in physiological functionality 9 months after implantation of a

  6. Risk factors for impaired health status differ in women and men treated with percutaneous coronary intervention in the drug-eluting stent era

    DEFF Research Database (Denmark)

    Pedersen, Susanne S.; Ong, Andrew T L; Lemos, Pedro A

    2006-01-01

    In patients treated with percutaneous coronary intervention (PCI) in the drug-eluting stent era, we compared women's and men's health status 6 and 12 months post-PCI and investigated whether predictors of poor health status at 12 months are similar for women and men....

  7. Is quantitative coronary angiography reliable in assessing the late lumen loss of the everolimus-eluting bioresorbable polylactide scaffold in comparison with the cobalt-chromium metallic stent?

    NARCIS (Netherlands)

    Sotomi, Yohei; Onuma, Yoshinobu; Miyazaki, Yosuke; Asano, Taku; Katagiri, Yuki; Tenekecioglu, Erhan; Jonker, Hans; Dijkstra, Jouke; de Winter, Robbert J.; Wykrzykowska, Joanna J.; Stone, Gregg W.; Popma, Jeffrey J.; Kozuma, Ken; Tanabe, Kengo; Serruys, Patrick W.; Kimura, Takeshi

    2017-01-01

    Aims: Immediately after stent/scaffold implantation, quantitative coronary angiography (QCA) in comparison to optical coherence tomography (OCT) more severely underestimates the lumen diameter (LD) in Absorb than in XIENCE. This OCT-QCA discrepancy has not been evaluated at long-term follow-up. The

  8. Impact of Hemoglobin A1c Levels on Residual Platelet Reactivity and Outcomes After Insertion of Coronary Drug-Eluting Stents (from the ADAPT-DES Study)

    DEFF Research Database (Denmark)

    Schoos, Mikkel M.; Dangas, George D.; Mehran, Roxana

    2016-01-01

    An increasing hemoglobin A1c (HbA1c) level portends an adverse cardiovascular prognosis; however, the association between glycemic control, platelet reactivity, and outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is unknown. We sought to investigate whether ...

  9. Optical Coherence Tomography Guided Percutaneous Coronary Intervention With Nobori Stent Implantation in Patients With Non-ST-Segment-Elevation Myocardial Infarction (OCTACS) Trial

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Thayssen, Per; Maehara, Akiko

    2015-01-01

    BACKGROUND: Incomplete strut coverage has been documented an important histopathologic morphometric predictor for later thrombotic events. This study sought to investigate whether optical coherence tomography (OCT)-guided percutaneous coronary intervention with Nobori biolimus-eluting stent impla...... at 6-month follow-up in comparison with angiographic guidance alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02272283....

  10. Clinical Outcomes After Drug-Eluting Stents Versus Coronary Artery Bypass Surgery in High Surgical Risk Patients With Left Main or Three-Vessel Coronary Artery Disease

    Directory of Open Access Journals (Sweden)

    Tonga Nfor

    2015-08-01

    Full Text Available Purpose: Previous studies comparing percutaneous coronary intervention (PCI with coronary artery bypass graft surgery (CABG in patients with unprotected left main or three-vessel coronary artery disease (LM-3VD have excluded patients at high surgical risk. We compared clinical outcomes after PCI with drug-eluting stents to CABG in high surgical risk patients with LM-3VD. Methods: Patients with symptomatic LM-3VD who had Society of Thoracic Surgeons (STS-predicted operative mortality > 5% and were undergoing either PCI with drug-eluting stents or CABG at a tertiary care center from January 2009 to December 2010 were enrolled in this nonrandomized prospective study. Results: Mean STS score was 14.5 ± 5.8% for PCI (n=83 vs. 13.6 ± 7.1% for CABG (n=187 (P=0.31. After mean follow-up of 37 months, incidence of the composite primary endpoint (death, myocardial infarction or stroke was 42.2% for PCI and 39.6% for CABG (P=0.69, hazard ratio 1.3, 95% confidence interval 0.5-2.8. There were no differences in the individual components of the primary endpoint between PCI and CABG. Repeat revascularization was 30.1% for PCI vs. 9.6% for CABG (P=0.001. Major adverse cardiac and cerebrovascular event rates were similar between PCI and CABG, 50.6% vs. 42.2%, respectively (P=0.23. Patients in the PCI group were less likely than those in the CABG group to be discharged to a nursing home (12.1% vs. 47.1%, P 5%.

  11. Periprocedural quantitative coronary angiography after Palmaz-Schatz stent implantation predicts the restenosis rate at six months: results of a meta-analysis of the BElgian NEtherlands Stent study (BENESTENT) I, BENESTENT II Pilot, BENESTENT II and MUSIC trials. Multicenter Ultrasound Stent In Coronaries.

    Science.gov (United States)

    Serruys, P W; Kay, I P; Disco, C; Deshpande, N V; de Feyter, P J

    1999-10-01

    We aimed to identify periprocedural quantitative coronary angiographic (QCA) variables that have predictive value on long-term angiographic results and to construct multivariate models using these variables for postprocedural prognosis. Coronary stent implantation has reduced the restenosis rate significantly as compared with balloon angioplasty in short de novo lesions in coronary arteries >3 mm in size. Although the postprocedural minimal luminal diameter (MLD) is known to have significant bearing on long-term angiographic results, no practically useful model exists for prediction of angiographic outcome based on the periprocedural QCA variables. The QCA data from patients who underwent Palmaz-Schatz stent implantation for short (3 mm and completed six months of angiographic follow-up in the four prospective clinical trials (BENESTENT I, BENESTENT II pilot, BENESTENT II and MUSIC) were pooled. Multiple models were constructed using multivariate analysis. The Hosmer-Lemeshow goodness-of-fit test was used to identify the model of best fit, and this model was used to construct a reference chart for prediction of angiographic outcome on the basis of periprocedural QCA variables. Univariate analysis performed using QCA variables revealed that vessel size, MLD before and after the procedure, reference area before and after the procedure, minimal luminal cross-sectional area before and after the procedure, diameter stenosis after the procedure, area of plaque after the procedure and area stenosis after the procedure were significant predictors of angiographic outcome. Using multivariate analysis, the Hosmer-Lemeshow goodness-of-fit test showed that the model containing percent diameter stenosis after the procedure and vessel size best fit the data. A reference chart was then developed to calculate the expected restenosis rate. Restenosis rate after stent implantation for short lesions can be predicted using the variables percent diameter stenosis after the procedure and

  12. Zotarolimus-eluting Resolute Integrity versus everolimus-eluting Xience Xpedition stents in the management of very long (>30 mm) de novo coronary artery stenosis

    Energy Technology Data Exchange (ETDEWEB)

    Patra, Soumya, E-mail: dr_soumyapatra@rediffmail.com; Chakraborty, Rabindra Nath; Pande, Arindam; Banerjee, Suvro; Jena, Manabhanjan; Mandal, Prakash Chandra; De, Swapan Kumar; Khan, Aftab; Das, Sankha Suvro; Ghosh, Debashish; Nag, Raja

    2017-04-15

    Background: Procedural and clinical outcomes in patients with very long (>30 mm) coronary lesions who underwent stent-based percutaneous coronary interventions are still unfavorable. Therefore, we compared the relative efficacy and safety of resolute zotarolimus-eluting stents (R-ZES) and Xpedition everolimus-eluting stents (X-EES) for patients with de novo very long coronary lesions. Methods: This comparative single-centre, retrospective study compared long R-ZES and X-EES in consecutive patients admitted with very long (≥30 mm) native ACC/AHA type C coronary lesions in 2014. All patients were followed up clinically at 1, 3, 6 and 12 months. In this study, only symptom-driven angiogram was advised. The study end point was to evaluate immediate procedural success and one-year rate of target lesion failure (TLF), which is a composite of cardiac death, target lesion myocardial infarction, or target lesion revascularization (TLR). Results: Total number of patients enrolled in this study was 185 (R-ZES = 107; X-EES = 78). The baseline characteristics and post procedural success rate were similar between R-ZES and X-EES groups, including the post stenting lesion lengths (36.6 ± 1.92 mm vs 40.71 ± 6.175 mm, P = 0.09). At 12-month follow-up, there were no significant between-group differences in the rate of adverse clinical events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes). Procedural success was achieved in 94% in R-ZES group and 93% in X-EES group (P = 0.24). The incidence of TLF was 5% in R-ZES and 4% in X-EES groups (HR-1.25; 95% CI-0.86-5.6; P = 0.19). Conclusion: Patients with de novo long coronary artery disease, R-ZES implantation showed similar clinical outcome as compared with X-EES implantation. - Highlights: • This is the first study comparing between R-ZES (Resolute Integrity) and X-EES (Xience Xpedition) used in PCI for long coronary artery disease. Here, single stent length of more than 30

  13. The pharmacokinetics of Biolimus A9 after elution from the BioMatrix II stent in patients with coronary artery disease: the Stealth PK Study.

    Science.gov (United States)

    Ostojic, Miodrag C; Perisic, Zoran; Sagic, Dragan; Jung, Robert; Zhang, Yan-Ling; Bendrick-Peart, Jamie; Betts, Ronald; Christians, Uwe

    2011-04-01

    This prospective, open-label multicenter study was conducted to assess the pharmacokinetics of Biolimus A9 after elution from BioMatrix II coronary stents. Recent clinical trials have demonstrated the efficacy and safety of Biolimus A9 eluted from different stent platforms. To date, the pharmacokinetics of Biolimus A9 in patients following the deployment of BioMatrix II stents has not yet been studied BioMatrix II stents were implanted into 27 patients with coronary artery disease. The primary endpoints of the study were the systemic concentrations of Biolimus A9 after 28 days and 6 months as measured using a sensitive validated liquid chromatography-tandem mass spectrometry assay. The highest measured blood concentration at any time point was 394 pg/mL. At 28 days and 6 months following stent placement, 51.8 and 100% of patients, respectively, had Biolimus A9 concentrations <10 pg/mL. After 9 months, 100% of the patients were free of major cardiac adverse events (MACE). There was no Biolimus A9 toxicity, no cardiac or non-cardiac deaths, no myocardial infarctions, nor target vessel or target lesion revascularizations during the 9 months of follow-up. No case of acute, subacute, or late stent thrombosis was detected. Compared to other drug-eluting stents, such as Cypher, BioMatrix II results in relatively low systemic exposure, which may be explained by the ablominal coating of the Biomatrix II stent in combination with Biolimus A9's high lipophilicity.

  14. Impact of Paclitaxel-Eluting Balloons Compared to Second-Generation Drug-Eluting Stents for of In-Stent Restenosis in a Primarily Acute Coronary Syndrome Population

    Directory of Open Access Journals (Sweden)

    Guillaume Marquis-Gravel

    2017-09-01

    Full Text Available Abstract Background: The place of drug-eluting balloons (DEB in the treatment of in-stent restenosis (ISR is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS. Objective: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES for the treatment of ISR in a real-world population with a high proportion of ACS. Methods: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization. Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. Results: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS. Median follow-up was 26 months. MACE occurred in 33 patients (36% in the DEB group, compared to 17 patients (19% in the DES group (p log-rank = 0.02. After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27. Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06. Conclusion: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings.

  15. Computational and experimental investigation into mechanical performances of Poly-L-Lactide Acid (PLLA) coronary stents.

    Science.gov (United States)

    Wang, Qian; Fang, Gang; Zhao, Yinghong; Wang, Guohui; Cai, Tao

    2017-01-01

    Poly-L-lactide Acid (PLLA), as a credible biodegradable polymer-based material, can provide a promising amount of degradation time for vessel remodeling. Served as a sort of reliable intravascular implants, PLLA stents are expected to provide sufficient scaffolding to the target arteries without generating too much recoil after deployment. Besides, the stress and strain distribution should be as homogeneous as possible, and the stent conformability in fitting to the nature curvature of the vessels needs to be guaranteed. In the present study, mechanical performances of a stent made of PLLA material were investigated based on 3-D finite element method (FEM) and experiment verification. Simulations contained several deformation steps: crimping, spring-back after crimping, expanding and spring-back after expanding. The stent's deformation and stress/strain distributions were analyzed. Several indexes including the radial recoil ratio after crimping and expanding to different sizes, the radial properties including radial strength, the radial stiffness and the collapse pressure were established. In vitro static loading experiments of the stent were conducted as the verification of the FEM results, and a good agreement between them was obtained. Moreover, simulation of three-point bending was performed to assess the bending flexibility of the stent, and bending stiffness was defined as a measurement of structure resistance to the bending deformation. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Drug-eluting coronary stents in clinical practice: lessons from the «BAsel Stent Kosten-Effektivitäts Trials» (BASKET). A review of the BASKET trials.

    Science.gov (United States)

    Pfisterer, Matthias; Nietlispach, Fabian; Jeger, Raban; Kaiser, Christoph

    2011-08-31

    In this review of the BAsel Stent Kosten-Effektivitäts Trial (BASKET) the trials and their impact on coronary stenting practice were examined, basing the clinical questions of each study on the findings of the previous study. Are the new drug-eluting stents (DES) cost-effective compared to standard bare-metal stents (BMS) if used in all patients? No. Are there specific subgroups of patients with a particular benefit? Yes. A "targeted stent use" was proposed for daily practice. What is the long-term safety of DES? Unexpected safety problems were observed. Was this a chance finding? No. However, with improved stenting techniques, newer stents and intensified antiplatelet regimens late problems were minimised as shown in the BASKET-PROspective Validation Examination (BASKET-PROVE). Further stent developments? Wait and see! - Many additional questions were raised and answered or are still under investigation. Obviously, answers were not always simple and needed a closer look and this is discussed. The BASKET trials proceeded not only from one question to the other, but also in size and methodology. From the restricted single-centre "local" BASKET study to multicentre international long-term trials, all prospective, randomized and investigator-driven. Their relevance was acknowledged by publications in major medical journals as well as by their impact on US and European practice guidelines and on DES research. These aspects are summarised in the present review, highlighting lessons learned from each study and commenting on the possibilities and difficulties of performing such clinical research in Switzerland.

  17. Intravascular ultrasound results from the NEVO ResElution-I trial: a randomized, blinded comparison of sirolimus-eluting NEVO stents with paclitaxel-eluting TAXUS Liberté stents in de novo native coronary artery lesions.

    Science.gov (United States)

    Otake, Hiromasa; Honda, Yasuhiro; Courtney, Brian K; Shimohama, Takao; Ako, Junya; Waseda, Katsuhisa; Macours, Nathalie; Rogers, Campbell; Popma, Jeffrey J; Abizaid, Alexandre; Ormiston, John A; Spaulding, Christian; Cohen, Sidney A; Fitzgerald, Peter J

    2011-04-01

    The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberté PES) in human native coronary lesions using intravascular ultrasound (IVUS). The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P=0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberté PES(0.04±0.04 mm versus 0.10±0.07 mm, PNEVO SES (Δvessel volume index: 1.30±1.36 mm(3)/mm versus 0.36±0.63 mm(3)/mm, respectively, P=0.003). The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberté PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00714883. © 2011 American Heart Association, Inc.

  18. Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: two-year results of the ENERGY Registry.

    Science.gov (United States)

    Erbel, Raimund; Eggebrecht, Holger; Roguin, Ariel; Schroeder, Erwin; Philipp, Sebastian; Heitzer, Thomas; Schwacke, Harald; Ayzenberg, Oded; Serra, Antonio; Delarche, Nicolas; Luchner, Andreas; Slagboom, Ton

    2014-01-01

    Novel bare metal stents with improved stent design may become a viable alternative to drug-eluting stents in certain patient groups, particularly, when long-term dual antiplatelet therapy should be avoided. The ENERGY registry aimed to assess the safety and benefits of a cobalt-chromium thin strut bare metal stent with a passive coating in a large series of patients under real-world conditions. This prospective registry recruited 1016 patients with 1074 lesions in 48 centers from April to November 2010. The primary endpoint was the rate of major adverse cardiac events (MACEs), a composite of cardiac death, myocardial infarction and clinically driven target lesion revascularization. More than half of the lesions (61.0%) were type A/B1 lesions, mean lesion length was 14.5±6.5mm and mean reference vessel diameter 3.2±0.5mm. MACE rates at 6, 12 and 24months were 4.9%, 8.1% and 9.4%, target lesion revascularization rates 2.8%, 4.9% and 5.4% and definite stent thrombosis rates 0.5%, 0.6% and 0.6%. Subgroups showed significant differences in baseline and procedural characteristics which did not translate into significantly different clinical outcomes. Specifically, MACE rates at 24months were 13.5% in diabetics, 8.6% in small stents and 9.6% in acute coronary syndrome patients. The population of ENERGY reflects real-world conditions with bare metal stents being mainly used in simple lesions. In this setting, percutaneous coronary intervention using a cobalt-chromium thin strut bare metal stent with a passive coating showed very good results up to 24months. (ClinicalTrials.gov:NCT01056120) SUMMARY FOR ANNOTATED TABLE OF CONTENTS: The ENERGY international registry evaluated the safety and benefits of a cobalt-chromium thin strut bare metal stent with passive coating in 1016 patients under real-world conditions until 2years. Results were encouraging with a low composite rate of cardiac death, myocardial infarction and clinically driven target lesion revascularization, even

  19. Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

    Energy Technology Data Exchange (ETDEWEB)

    Erbel, Raimund, E-mail: erbel@uk-essen.de [Department of Cardiology, University of Duisburg-Essen, Essen (Germany); Eggebrecht, Holger [Cardioangiological Center Bethanien (CCB), Frankfurt (Germany); Roguin, Ariel [Department of Cardiology, Rambam Medical Center, Haifa (Israel); Schroeder, Erwin [Division of Cardiovascular Medicine, Cliniques Universitaires de Mont-Godinne, Yvoir (Belgium); Philipp, Sebastian [Department Internal Medicine/Cardiology, Elbe Klinikum Stade, Stade (Germany); Heitzer, Thomas [Department of Cardiology, Heart Center Dortmund, Dortmund (Germany); Schwacke, Harald [Department of Internal Medicine, Diakonissen-Stiftungs- Krankenhaus Speyer (Germany); Ayzenberg, Oded [The Heart Institute, Kaplan Medical Center, Rehovot (Israel); Serra, Antonio [Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, España (Spain); Delarche, Nicolas [Cardiology unit, Pau General Hospital, Pau (France); Luchner, Andreas [Department of Internal Medicine/Cardiology, Universitätsklinikum Regensburg (Germany); Slagboom, Ton [Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam (Netherlands)

    2014-11-15

    Background: Novel bare metal stents with improved stent design may become a viable alternative to drug-eluting stents in certain patient groups, particularly, when long-term dual antiplatelet therapy should be avoided. Purpose: The ENERGY registry aimed to assess the safety and benefits of a cobalt–chromium thin strut bare metal stent with a passive coating in a large series of patients under real-world conditions. Methods and materials: This prospective registry recruited 1016 patients with 1074 lesions in 48 centers from April to November 2010. The primary endpoint was the rate of major adverse cardiac events (MACEs), a composite of cardiac death, myocardial infarction and clinically driven target lesion revascularization. Results: More than half of the lesions (61.0%) were type A/B1 lesions, mean lesion length was 14.5 ± 6.5 mm and mean reference vessel diameter 3.2 ± 0.5 mm. MACE rates at 6, 12 and 24 months were 4.9%, 8.1% and 9.4%, target lesion revascularization rates 2.8%, 4.9% and 5.4% and definite stent thrombosis rates 0.5%, 0.6% and 0.6%. Subgroups showed significant differences in baseline and procedural characteristics which did not translate into significantly different clinical outcomes. Specifically, MACE rates at 24 months were 13.5% in diabetics, 8.6% in small stents and 9.6% in acute coronary syndrome patients. Conclusion: The population of ENERGY reflects real-world conditions with bare metal stents being mainly used in simple lesions. In this setting, percutaneous coronary intervention using a cobalt–chromium thin strut bare metal stent with a passive coating showed very good results up to 24 months. (ClinicalTrials.gov:NCT01056120) Summary for annotated table of contents: The ENERGY international registry evaluated the safety and benefits of a cobalt–chromium thin strut bare metal stent with passive coating in 1016 patients under real-world conditions until 2 years. Results were encouraging with a low composite rate of cardiac death

  20. A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study

    Directory of Open Access Journals (Sweden)

    Jacek Legutko

    2013-07-01

    Conclusions: In this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up.

  1. The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis.

    Science.gov (United States)

    Jaguszewski, Milosz; Aloysius, Romila; Wang, Wei; Bezerra, Hiram G; Hill, Jonathan; De Winter, Robbert J; Karjalainen, Pasi P; Verheye, Stefan; Wijns, William; Lüscher, Thomas F; Joner, Michael; Costa, Marco; Landmesser, Ulf

    2017-03-13

    The aim of the present study was to evaluate vascular healing of the bioengineered COMBO Dual Therapy Stent compared with a cobalt-chromium (CoCr) everolimus-eluting stent (EES) as assessed by optical coherence tomography in patients with acute coronary syndromes. CD34+ cells promote endothelial repair after vascular injury. The bioengineered COMBO Dual Therapy Stent combines CD34+ cell-capturing technology with abluminal sirolimus release, but more data from clinical studies evaluating the vascular response are needed. In a prospective randomized multicenter clinical trial, 60 patients with acute coronary syndromes were randomized 1:1 to COMBO or CoCr EES implantation. The primary endpoint was the percentage of uncovered stent struts per stent. Stent assessment by optical coherence tomography was performed at baseline and at 60 days, followed by independent core laboratory analysis. The percentage of uncovered struts per stent was higher with the COMBO than the CoCr EES at 60 days (median 14.7% vs. 7.7%; p = 0.04). However, no significant difference in uncovered stent struts was observed in the strut level-based analysis at 60 days, which also accounted for clustering (COMBO vs. CoCr EES; 13.6% vs. 6.9%; p = 0.09; generalized linear mixed models-adjusted analysis). Neointimal thickness at 60 days was lower with the COMBO compared with the CoCr EES (median 30.17 vs. 50.26 μm; p = 0.02; stent-level analysis). There were no significant differences in the frequency of major adverse cardiac events and each component of major adverse cardiac events within the study population between the 2 groups at 30, 60, 180, 360, and 540 days post-procedure. No target vessel stent thrombosis has been documented within 540 days. The present multicenter, prospective clinical study for the first time compared the vascular response of the bioengineered COMBO Dual Therapy Stent with a CoCr EES in patients early after acute coronary syndrome by using intracoronary optical coherence

  2. Impact of an advanced image-based monoenergetic reconstruction algorithm on coronary stent visualization using third generation dual-source dual-energy CT: a phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Mangold, Stefanie [Medical University of South Carolina, Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Charleston, SC (United States); Eberhard-Karls University Tuebingen, Department of Diagnostic and Interventional Radiology, Tuebingen (Germany); Cannao, Paola M. [Medical University of South Carolina, Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Charleston, SC (United States); University of Milan, Scuola di Specializzazione in Radiodiagnostica, Milan (Italy); Schoepf, U.J. [Medical University of South Carolina, Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Charleston, SC (United States); Medical University of South Carolina, Division of Cardiology, Department of Medicine, Charleston, SC (United States); Wichmann, Julian L. [Medical University of South Carolina, Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Charleston, SC (United States); University Hospital Frankfurt, Department of Diagnostic and Interventional Radiology, Frankfurt (Germany); Canstein, Christian [Siemens Medical Solutions, Malvern, PA (United States); Fuller, Stephen R.; Varga-Szemes, Akos [Medical University of South Carolina, Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Charleston, SC (United States); Muscogiuri, Giuseppe; De Cecco, Carlo N. [Medical University of South Carolina, Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Charleston, SC (United States); University of Rome ' ' Sapienza' ' , Department of Radiological Sciences, Oncology and Pathology, Rome (Italy); Nikolaou, Konstantin [Eberhard-Karls University Tuebingen, Department of Diagnostic and Interventional Radiology, Tuebingen (Germany)

    2016-06-15

    To evaluate the impact of an advanced monoenergetic (ME) reconstruction algorithm on CT coronary stent imaging in a phantom model. Three stents with lumen diameters of 2.25, 3.0 and 3.5 mm were examined with a third-generation dual-source dual-energy CT (DECT). Tube potential was set at 90/Sn150 kV for DE and 70, 90 or 120 kV for single-energy (SE) acquisitions and advanced modelled iterative reconstruction was used. Overall, 23 reconstructions were evaluated for each stent including three SE acquisitions and ten advanced and standard ME images with virtual photon energies from 40 to 130 keV, respectively. In-stent luminal diameter was measured and compared to nominal lumen diameter to determine stent lumen visibility. Contrast-to-noise ratio was calculated. Advanced ME reconstructions substantially increased lumen visibility in comparison to SE for stents ≤3 mm. 130 keV images produced the best mean lumen visibility: 86 % for the 2.25 mm stent (82 % for standard ME and 64 % for SE) and 82 % for the 3.0 mm stent (77 % for standard ME and 69 % for SE). Mean DLP for SE 120 kV and DE acquisitions were 114.4 ± 9.8 and 58.9 ± 2.2 mGy x cm, respectively. DECT with advanced ME reconstructions improves the in-lumen visibility of small stents in comparison with standard ME and SE imaging. (orig.)

  3. Safety of hydrophilic guidewires used for side-branch protection during stenting and proximal optimization technique in coronary bifurcation lesions

    Energy Technology Data Exchange (ETDEWEB)

    Chatterjee, Arka [Division of Cardiology, University of Alabama-Birmingham (United States); Brott, Brigitta C. [Division of Cardiology, University of Alabama-Birmingham (United States); Department of Biomedical Engineering, University of Alabama-Birmingham (United States); Foley, Robin [Department of Material Science and Engineering, University of Alabama-Birmingham (United States); Alli, Oluseun; Sasse, Mark; Ahmed, Mustafa; Al Solaiman, Firas; Reddy, Gautam; Ather, Sameer [Division of Cardiology, University of Alabama-Birmingham (United States); Leesar, Massoud A., E-mail: mleesar@uab.edu [Division of Cardiology, University of Alabama-Birmingham (United States)

    2016-10-15

    Background and propose: In coronary bifurcation lesions (CBL), hydrophilic guidewires used for side-branch (SB) protection can be withdrawn from underneath the stent easier than other wires. However, the safety of which has not been investigated. Methods/materials: We performed scanning electron microscopic (SEM) examination of hydrophilic wires – the Whisper and Runthrough wires – used for SB protection during stenting and proximal optimization technique (POT) in 30 patients with CBL. The distal 15 cm of the wire was examined every 1 mm by SEM and 4500 segments were analyzed to investigate for wire fracture, polymer shearing (PS), and its correlations with post-stenting creatine kinase (CK)-MB release. Results: SEM examination showed no evidence for wire fracture. The total area of PS and the largest defect on the wire were significantly larger with the Whisper wire versus the Runthrough wire (0.15 ± 0.04 mm{sup 2} vs. 0.026 ± 0.01 mm{sup 2} and 0.04 ± 0.05 mm{sup 2} vs. 0.01 ± 0.01 mm{sup 2}; P < 0.05, respectively). The total length of PS and the longest defect on the wire were significantly longer with the Whisper wire vs. the Runthrough wire (12.1 ± 14.5 mm vs. 2.7 ± 3.0 mm and 2.9 ± 4.2 mm vs. 1.0 ± 1.2 mm; P < 0.05, respectively), but there were weak correlations between the extents of PS with CK-MB release. Conclusions: Hydrophilic guidewires may be safely used for SB protection during stenting and POT in CBLs. The extent of PS was significantly greater with the Whisper wire than with the Runthrough wire, but its correlation with post-stenting CK-MB release was weak. - Highlights: • There was no wire fracture by jailing hydrophilic wires. • There was no wire entrapment by jailing hydrophilic wires. • There were weak correlations between polymer shearing and creatine kinase-MB levels. • The impact of polymer shearing on myocardial infraction warrants future studies.

  4. Effect of PlA1/A2 glycoprotein IIIa gene polymorphism on the long-term outcome after successful coronary stenting

    Directory of Open Access Journals (Sweden)

    Riddell John

    2007-11-01

    Full Text Available Abstract Aim To prospectively determine the role of platelet glycoprotein IIIa (GP IIIa gene PlA1/PlA2 polymorphism on the long-term clinical outcome in patients with coronary artery disease undergoing coronary stenting. Design and setting Prospective observational study in the University Hospital of Caen (France. Patients and methods 1 111 symptomatic consecutive Caucasian patients treated with percutaneous coronary intervention including stent implantation underwent genotyping for GP IIIa PlA1/A2. Main outcome measures Long-term clinical outcome in terms of the rate of major adverse cardiac events (MACE, ie death from any cause, non-fatal Q wave or non Q wave myocardial infarction, and need for coronary revascularisation was obtained and subsequently stratified according to the GP IIIa PlA1/A2 polymorphism. Results Three groups of patients were determined according to the GP IIIa PlA1/A2 polymorphism (71.6% had the A1/A1, 25.8% had the A1/A2 and 2.6% had the A2/A2 genotype. These three groups were comparable for all clinical characteristics including sex ratio, mean age, vascular risk factors, previous coronary events, baseline angiographic exam, indication for the percutaneous coronary intervention and drug therapy. The incidence of MACE was similar in these 3 groups of patients during a mean follow-up period of 654+/-152 days. Independent risk factors for MACE were a left ventricular ejection fraction Conclusion The GP IIIa PlA1/A2 polymorphism does not influence the clinical long-term outcome in patients with symptomatic coronary disease undergoing percutaneous coronary intervention with stent implantation.

  5. Hemodynamic change in wall shear stress in patients with coronary bifurcation lesions treated by double kissing crush or single-stent technique.

    Science.gov (United States)

    Chen, Shao-Liang; Kan, Jing; Zhang, Jun-Jie; Hu, Zuo-Ying; Xu, Tian

    2012-05-01

    Fluid dynamic mechanisms attributed to coronary bifurcation lesions remain a subject of study. The present study aimed at investigating the hemodynamic change of wall shear stress (WSS) in patients with coronary bifurcation lesions treated by double kissing (DK) crush or one-stent with final kissing balloon inflation (FKBI). Eighty-one patients with bifurcation lesions treated by stenting who had 3-D model reconstruction were studied. The bifurcation vessels were divided into main vessel (MV), main branch (MB), side branch (SB), and polygon of confluence (POC). MB and SB were classified by internal- and lateral-subsegments, respectively. The baseline magnitude of WSS in proximal MV, POC-MV, POC-MB, POC-SB and MB-internal segments increased significantly, compared to MB-lateral, SB-internal and SB-lateral. DK crush had the potential of uniformly reducing WSS, turbulent index and the WSS gradient. The WSS value at the POC-SB and SB in the one-stent group remained higher. The turbulent index and WSS gradient between the POC-SB minus the SB-lateral had equal predictive values for in-stent restenosis (ISR). Fluid dynamic results favor the use of DK crush over the one-stent technique.

  6. Patient-specific computer modelling of coronary bifurcation stenting: the John Doe programme.

    Science.gov (United States)

    Mortier, Peter; Wentzel, Jolanda J; De Santis, Gianluca; Chiastra, Claudio; Migliavacca, Francesco; De Beule, Matthieu; Louvard, Yves; Dubini, Gabriele

    2015-01-01

    John Doe, an 81-year-old patient with a significant distal left main (LM) stenosis, was treated using a provisional stenting approach. As part of an European Bifurcation Club (EBC) project, the complete stenting procedure was repeated using computational modelling. First, a tailored three-dimensional (3D) reconstruction of the bifurcation anatomy was created by fusion of multislice computed tomography (CT) imaging and intravascular ultrasound. Second, finite element analysis was employed to deploy and post-dilate the stent virtually within the generated patient-specific anatomical bifurcation model. Finally, blood flow was modelled using computational fluid dynamics. This proof-of-concept study demonstrated the feasibility of such patient-specific simulations for bifurcation stenting and has provided unique insights into the bifurcation anatomy, the technical aspects of LM bifurcation stenting, and the positive impact of adequate post-dilatation on blood flow patterns. Potential clinical applications such as virtual trials and preoperative planning seem feasible but require a thorough clinical validation of the predictive power of these computer simulations.

  7. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial

    NARCIS (Netherlands)

    von Birgelen, Clemens; Sen, Hanim; Sen, Hanim; Lam, Ming Kai; Danse, Peter W.; Jessurun, Gillian A.J.; Hautvast, Raymond W.M.; van Houwelingen, Gert K.; Schramm, Alexander R.; Gin, R. Melvyn Tjon Joe; Louwerenburg, Johannes W.; de Man, Frits H.A.F.; Stoel, Martin G.; Löwik, Marije M.; Linssen, Gerard C.M.; Saïd, Salla A.M.; Nienhuis, Mark B.; Verhorst, Patrick M.J.; Basalus, Mounir W.Z.; Doggen, Catharina Jacoba Maria; Tandjung, K.; Tandjung, K.

    2014-01-01

    Background Third-generation, permanent-polymer-based drug-eluting stents with novel, flexible designs might be more easily delivered than previous generations of stents in complex coronary lesions, but might be less longitudinally stable. We aimed to assess the safety and efficacy in all-comer

  8. Predictors of restenosis after percutaneous coronary intervention using bare-metal stents: a comparison between patients with and without dysglycemia

    Directory of Open Access Journals (Sweden)

    M.O. Lima-Filho

    2010-06-01

    Full Text Available The objective of this study was to identify intravascular ultrasound (IVUS, angiographic and metabolic parameters related to restenosis in patients with dysglycemia. Seventy consecutive patients (77 lesions selected according to inclusion and exclusion criteria were evaluated by the oral glucose tolerance test and the determination of insulinemia after a successful percutaneous coronary intervention (PCI with a bare-metal stent. The degree of insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA-IR. Six-month IVUS and angiogram follow-up were performed. Thirty-nine patients (55.7% had dysglycemia. The restenosis rate in the dysglycemic group was 37.2 vs 23.5% in the euglycemic group (P = 0.299. The predictors of restenosis using bivariate analysis were reference vessel diameter (RVD: £2.93 mm (RR = 0.54; 95%CI = 0.05-0.78; P = 0.048, stent area (SA: 2.063 (RR = 0.44; 95%CI = 0.14-0.64; P = 0.027, and fasting plasma glucose (FPG: ≤108.8 mg/dL (RR = 0.53; 95%CI = 0.13-0.75; P = 0.046. SV was an independent predictor of restenosis by multivariable analysis. Dysglycemia is a common clinical condition in patients submitted to PCI. The degree of insulin resistance, FPG, RVD, SA, and SV were correlated with restenosis. SV was inversely correlated with an independent predictor of restenosis in patients treated with a bare-metal stent.

  9. Mortality after presentation with stent thrombosis is associated with time from index percutaneous coronary intervention: a report from the VA CART program.

    Science.gov (United States)

    Armstrong, Ehrin J; Maddox, Thomas M; Carey, Evan P; Grunwald, Gary K; Shunk, Kendrick A

    2014-10-01

    The risk of mortality for patients presenting to the cardiac catheterization laboratory with stent thrombosis (ST) may differ as a function of the timing from initial stent implantation. We hypothesized that the 30-day mortality would differ for angiographically defined early ST (EST), late ST (LST), and very late ST (VLST). All patients undergoing angiography for diagnosis and treatment of ST were identified by the Department of Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) Program from 2006 to 2012. Stent thrombosis occurring ≤30 days after stent implantation were defined as EST; 31 to 365 days as LST; and >365 days as VLST. Log-rank test and Cox proportional hazard regression modeling were used to describe unadjusted and adjusted differences in mortality between groups. A total of 656 patients were diagnosed with angiographic definite ST with known timing. This cohort consisted of 129 (20%), 138 (21%), and 389 (59%) patients with EST, LST, and VLST, respectively. Over three fourths (76%) of VLST cases occurred >2 years after stent implantation. Stent thrombosis timing was significantly associated with 30-day mortality risk in unadjusted (P presentation is associated with time from index percutaneous coronary intervention to ST. This relationship potentially reflects the differing mechanisms of ST that are postulated to predominate at different timeframes. Published by Elsevier Inc.

  10. Everolimus-eluting stent implantation for unprotected left main coronary artery stenosis. The PRECOMBAT-2 (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study.

    Science.gov (United States)

    Kim, Young-Hak; Park, Duk-Woo; Ahn, Jung-Min; Yun, Sung-Cheol; Song, Hae Geun; Lee, Jong-Young; Kim, Won-Jang; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Jang, Yangsoo; Jeong, Myung-Ho; Kim, Hyo-Soo; Hur, Seung-Ho; Rha, Seung-Woon; Lim, Do-Sun; Her, Sung-Ho; Seung, Ki Bae; Seong, In-Whan; Park, Seung-Jung

    2012-07-01

    This study sought to evaluate the safety and efficacy of second-generation drug-eluting stents (DES) for patients with unprotected left main coronary artery (ULMCA) stenosis. The clinical benefit of second-generation DES for ULMCA stenosis has not been determined. The authors assessed 334 consecutive patients who received everolimus-eluting stents (EES) for ULMCA stenosis between 2009 and 2010. The 18-month incidence rates of major adverse cardiac or cerebrovascular events (MACCE), including death, myocardial infarction (MI), stroke, or ischemia-driven target vessel revascularization (TVR), were compared with those of a randomized study comparing patients who received sirolimus-eluting stents (SES) (n = 327) or coronary artery bypass grafts (CABG) (n = 272). EES (8.9%) showed a comparable incidence of MACCE as SES (10.8%; adjusted hazard ratio [aHR] of EES: 0.84; 95% confidence interval [CI]: 0.51 to 1.40; p = 0.51) and CABG (6.7%, aHR of EES: 1.40; 95% CI: 0.78 to 2.54; p = 0.26). The composite incidence of death, MI, or stroke also did not differ among patients receiving EES (3.3%), SES (3.7%; aHR of EES: 0.63; 95% CI: 0.27 to 1.47; p = 0.29), and CABG (4.8%; aHR of EES: 0.67; 95% CI: 0.29 to 1.54; p = 0.34). However, the incidence of ischemia-driven TVR in the EES group (6.5%) was higher than in the CABG group (2.6%, aHR of EES: 2.77; 95% CI: 1.17 to 6.58; p = 0.02), but comparable to SES (8.2%, aHR of EES: 1.14; 95% CI: 0.64 to 2.06; p = 0.65). Angiographic restenosis rates were similar in the SES and EES groups (13.8% vs. 9.2%, p = 0.16). Second-generation EES had a similar 18-month risk of MACCE for ULMCA stenosis as first-generation SES or CABG. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. Clopidogrel discontinuation within the first year after coronary drug-eluting stent implantation

    DEFF Research Database (Denmark)

    Thim, Troels; Johansen, Martin Berg; Chisholm, Gro Egholm

    2014-01-01

    -eluting stents in Western Denmark for 1 year and obtained data on redeemed clopidogrel prescriptions and major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, or stent thrombosis) from medical databases. RESULTS: Discontinuation of clopidogrel within the first 3 months after...... associated with smaller, not statistically significant, increases in MACE rates. Among patients who discontinued clopidogrel, MACE rates were highest within the first 2 months after discontinuation. CONCLUSIONS: Discontinuation of clopidogrel was associated with an increased rate of MACE among patients...

  12. FACTORES DE RIESGO CARDIOVASCULAR Y CALIDAD DE VIDA EN MUJERES REVASCULARIZADAS CON STENT CORONARIOS / Cardiovascular risk factors and quality of life in women who under-went revascularization with coronary stenting

    Directory of Open Access Journals (Sweden)

    José C. Castillo Núñez

    2013-10-01

    Full Text Available Resumen Introducción: Los factores de riesgo cardiovascular son responsables directos de la elevada mortalidad por enfermedad coronaria aterosclerótica en la mujer. Objetivo: Describir dichos factores, la evolución clínica y la calidad de vida en las féminas tras realizarle angioplastia coronaria. Método: Estudio descriptivo, longitudinal y prospectivo en 62 mujeres revascularizadas con angioplastia e implante de stent en el período de enero a junio de 2011. Se realizó seguimiento clínico durante 180 días a través de las consultas médicas. Resultados: La edad media fue de 52,8 años y el factor de riesgo cardiovascular más frecuente, la hipertensión arterial (66,1 %, y la diabetes (24,2 %, el menos prevalente. La enfermedad coronaria aterosclerótica de un vaso fue la de mayor frecuencia (87,1 % y la de tres vasos (1,6 %, la menos representada. En 75,8 % de los pacientes se utilizó un stent, solo uno requirió de tres. El 83,9 % de ellos valoraron su calidad de vida como buena, 14,5 % la consideraron aceptable y uno la estimó como pobre. En 93,5 % de los pacientes no se evidenciaron acontecimientos cardiovasculares durante el seguimiento clínico. La diabetes y la categoría calidad de vida pobre, mostraron una asociación estadísticamente significativa con la extensión de la enfermedad coronaria aterosclerótica, el número de stents utilizados y los acontecimientos cardiovasculares. Conclusiones: Las mujeres con enfermedad coronaria aterosclerótica, revascularizadas con stents coronarios, tienen una elevada frecuencia de factores de riesgo, una evolución clínica favorable y un predominio de las percepciones positivas sobre su calidad de vida. / Abstract Introduction: Cardiovascular risk factors are directly responsible for the high mortality from atherosclerotic coronary artery disease in women. Objective: To describe these risk factors, the clinical course and quality of life in women after coronary angioplasty. Method: A

  13. Prognostic Value of Plasma Pentraxin-3 Levels in Patients with Stable Coronary Artery Disease after Drug-Eluting Stent Implantation

    Directory of Open Access Journals (Sweden)

    Liu Haibo

    2014-01-01

    Full Text Available Pentraxin-3 (PTX3 is an inflammatory marker thought to be more specific to cardiovascular inflammation than C-reactive protein (CRP. Our aim was to assess the prognostic value of PTX3 in patients with stable coronary artery disease (CAD after drug eluting stent (DES implantation. Plasma PTX3 levels were measured before percutaneous coronary intervention (PCI and at 24 h post-PCI in 596 consecutive patients with stable CAD. Patients were followed up for a median of 3 years (range 1–5 for major adverse cardiovascular events (MACEs. We found that the post-PCI plasma PTX3 levels were significantly higher at 24 h after PCI than pre-PCI, patients with MACEs had higher post-PCI PTX3 levels compared with MACEs-free patients, patients with higher post-PCI PTX3 levels (median > 4.384 ng/mL had a higher risk for MACEs than those with PTX3 < 4.384 ng/mL, and post-PCI PTX3, cTnI, multiple stents, and age but not high-sensitivity CRP (hsCRP were independently associated with the prevalence of MACEs after DES implantation. The present study shows that post-PCI PTX3 may be a more reliable inflammatory predictor of long-term MACEs in patients with stable CAD undergoing DES implantation than CRP. Measurement of post-PCI PTX3 levels could provide a rationale for risk stratification of patients with stable CAD after DES implantation.

  14. Nine-month Angiographic and Two-year Clinical Follow-up of Novel Biodegradable-polymer Arsenic Trioxide-eluting Stent Versus Durable-polymer Sirolimus-eluting Stent For Coronary Artery Disease

    Directory of Open Access Journals (Sweden)

    Li Shen

    2015-01-01

    Full Text Available Background: Despite great reduction of in-stent restenosis, first-generation drug-eluting stents (DESs have increased the risk of late stent thrombosis due to delayed endothelialization. Arsenic trioxide, a natural substance that could inhibit cell proliferation and induce cell apoptosis, seems to be a promising surrogate of sirolimus to improve DES performance. This randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent (AES, compared with traditional sirolimus-eluting stent (SES. Methods: Patients with symptoms of angina pectoris were enrolled and randomized to AES or SES group. The primary endpoint was target vessel failure (TVF, and the second endpoint includes rates of all-cause death, cardiac death or myocardial infarction, target lesion revascularization (TLR by telephone visit and late luminal loss (LLL at 9-month by angiographic follow-up. Results: From July 2007 to 2009, 212 patients were enrolled and randomized 1:1 to receive either AES or SES. At 2 years of follow-up, TVF rate was similar between AES and SES group (6.67% vs. 5.83%, P = 0.980. Frequency of all-cause death was significantly lower in AES group (0 vs. 4.85%, P = 0.028. There was no significant difference between AES and SES in frequency of TLR and in-stent restenosis, but greater in-stent LLL was observed for AES group (0.29 ± 0.52 mm vs. 0.10 ± 0.25 mm, P = 0.008. Conclusions: After 2 years of follow-up, AES demonstrated comparable efficacy and safety to SES for the treatment of de novo coronary artery lesions.

  15. Accounting for the mortality benefit of drug-eluting stents in percutaneous coronary intervention: a comparison of methods in a retrospective cohort study

    Directory of Open Access Journals (Sweden)

    McCulloch Charles E

    2011-06-01

    Full Text Available Abstract Background Drug-eluting stents (DES reduce rates of restenosis compared with bare metal stents (BMS. A number of observational studies have also found lower rates of mortality and non-fatal myocardial infarction with DES compared with BMS, findings not observed in randomized clinical trials. In order to explore reasons for this discrepancy, we compared outcomes after percutaneous coronary intervention (PCI with DES or BMS by multiple statistical methods. Methods We compared short-term rates of all-cause mortality and myocardial infarction for patients undergoing PCI with DES or BMS using propensity-score adjustment, propensity-score matching, and a stent-era comparison in a large, integrated health system between 1998 and 2007. For the propensity-score adjustment and stent era comparisons, we used multivariable logistic regression to assess the association of stent type with outcomes. We used McNemar's Chi-square test to compare outcomes for propensity-score matching. Results Between 1998 and 2007, 35,438 PCIs with stenting were performed among health plan members (53.9% DES and 46.1% BMS. After propensity-score adjustment, DES was associated with significantly lower rates of death at 30 days (OR 0.49, 95% CI 0.39 - 0.63, P P P Conclusions Although propensity-score methods suggested a mortality benefit with DES, consistent with prior observational studies, a stent era comparison failed to support this conclusion. Unobserved factors influencing stent selection in observational studies likely account for the observed mortality benefit of DES not seen in randomized clinical trials.

  16. 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),

  17. Improved predictive value of GRACE risk score combined with platelet reactivity for 1-year cardiovascular risk in patients with acute coronary syndrome who underwent coronary stent implantation.

    Science.gov (United States)

    Li, Shan; Liu, Hongbin; Liu, Jianfeng; Wang, Haijun

    2016-11-01

    Both high platelet reactivity (HPR) and Global Registry of Acute Coronary Events (GRACE) risk score have moderate predictive value for major adverse cardiovascular disease (CVD) events in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI), whereas the prognostic significance of GRACE risk score combined with platelet function testing remains unclear. A total of 596 patients with non-ST elevation ACS who underwent PCI were enrolled. The P2Y 12 reaction unit (PRU) value was measured by VerifyNow P2Y 12 assay and GRACE score was calculated by GRACE risk 2.0 calculator. Patients were stratified by a pre-specified cutoff value of PRU 230 and GRACE score 140 to assess 1-year risk of cardiovascular death, non-fatal myocardial infarction (MI), and stent thrombosis. Seventy-two (12.1%) patients developed CVD events during 1-year follow-up. Patients with CVD events had a higher PRU value (244.6 ± 50.9 vs. 203.7 ± 52.0, p risk independently. Compared to patients with normal platelet reactivity (NPR) and GRACE score risk (HR: 5.048; 95% CI: 2.268-11.237; p risk score yielded superior risk predictive capacity beyond GRACE score alone, which is shown by improved c-statistic value (0.871, p = 0.002) as well as net reclassification improvement (NRI 0.263, p risk of adverse CVD events. The combination of platelet function testing and GRACE score predicted 1-year CVD risk better.

  18. Evaluation of coronary in-stent restenosis by 64-slice computed tomography in patients with optimal heart rate control by systematic administration of beta-blocker drugs.

    Science.gov (United States)

    Martuscelli, Eugenio; Romagnoli, Andrea; D'eliseo, Alessia; Sperandio, Massimiliano; Di Luozzo, Marco; De Angelis, Barbara; Romeo, Francesco; Simonetti, Giovanni

    2010-06-01

    Imaging artifacts due to metallic stent struts can reduce the diagnostic accuracy of multislice computed tomography (MSCT) in the evaluation of in-stent restenosis (ISR). Our aim was to determine the accuracy of binary ISR exclusion using a 64-slice MSCT scanner and a systematic administration of beta-blockers having an aggressive heart rate (HR) control. We performed 64-slice MSCT in 218 consecutive patients revascularized by stenting. All patients were treated with oral/intravenous beta-blocker drugs in order to obtain a HR less than 65 beats/min in the prescan phase. Coronary stents were evaluated by two experienced observers in order to rule out the presence of significant (>50%) ISR. Quantitative conventional coronary angiography (CCA) served as a standard for reference. Five patients (2.3%) were excluded from the analysis; mean HR was 59 +/- 3 beats/min in the prescan phase and 62 +/- 5 beats/min during acquisition. In the 321 stented coronary segments, CCA found 27 significant ISRs. MSCT correctly diagnosed 26 significant ISRs, with two false-positive and one false-negative case. In a per-segment analysis, the sensitivity was 96%, specificity 99%, positive predictive value (PPV) 92.8%, and negative predictive value (NPV) 99%. In a per-patient analysis, the sensitivity was 100%, specificity 98.9%, PPV 92.8%, and NPV 100%. In our study, the evaluation of significant ISR by MSCT showed an excellent diagnostic accuracy with a PPV of 92.8% and a NPV of 99%. Selection criteria and radiation exposure can be considered a limitation of the method.

  19. First-in-Man Trial of SiO2Inert-Coated Bare Metal Stent System in Native Coronary Stenosis - The AXETIS FIM Trial.

    Science.gov (United States)

    Asano, Taku; Suwannasom, Pannipa; Katagiri, Yuki; Miyazaki, Yosuke; Sotomi, Yohei; Kraak, Robin P; Wykrzykowska, Joanna; Rensing, Benno J; Piek, Jan J; Gyöngyösi, Mariann; Serruys, Patrick W; Onuma, Yoshinobu

    2018-01-25

    A novel bare metal stent with an SiO 2 coating was developed to prevent excessive neointimal hyperplasia by inertization of the metallic stent surface. The efficacy of the device was demonstrated in a preclinical model. The aim of this first-in-man trial was to assess the safety and feasibility of the new device.Methods and Results:This prospective non-randomized single-arm trial was designed to enroll 35 patients with a de novo coronary lesion. Quantitative coronary angiography and optical coherence tomography (OCT) were performed at the baseline procedure and at the 6-month follow-up. Stent implantation was performed with OCT guidance according to optimal stent implantation criteria. The trial was terminated upon the advice of the data safety monitoring board after enrolling 14 patients due to the high incidence of re-intervention. Optimal OCT implantation criteria were achieved in only 8.3% of lesions. At 6 months, angiographic in-stent late lumen loss as the primary endpoint was 0.77±0.44 mm, and binary restenosis occurred in 33.3% of lesions. At the 6-month OCT, neointimal volume obstruction was 32.8±15.6% with a neointimal thickness of 237±117 µm. At 12 months, the device-oriented composite endpoint (defined as cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization rate) was 33.3%. In contrast with the preclinical study, the Axetis stent did not efficiently suppress neointimal hyperplasia in humans in this trial.

  20. Provisional T-stenting and kissing balloon in the treatment of coronary bifurcation lesions: results of the French multicenter "TULIPE" study.

    Science.gov (United States)

    Brunel, Philippe; Lefevre, Thierry; Darremont, Olivier; Louvard, Yves

    2006-07-01

    In previous prospective studies, a strategy of (a) stenting of the main branch, (b) provisional T-stenting of the side branch, and (c) final kissing balloon inflation, was associated with high success and low target lesion revascularization (TLR) rates on the long-term. To examine the performance of this strategy in a multicenter study. Consecutive patients were treated at 14 French medical centers for de novo coronary bifurcation lesions with the same technique used. Immediate results and clinically-driven TLR at 7 months were examined. The mean reference diameters of the main and side branches were 3.2 +/- 0.6 mm and 2.4 +/- 0.5 mm, respectively. The side branch was stented in 34% of patients. A wave and 5 non-Qwaves MI (0.54% and 2.7%). At 7 months of follow-up, 3 patients (1.76%) had died, 1 suffered a non-Q-wave MI (0.59%), and 28 (15.88%) underwent TLR. By multivariate analysis, a lower left ventricular ejection fraction (OR: 0.934), moderate calcifications (OR: 7.86), and non-use of the "jailed" wire technique (OR: 4.26) were associated with reinterventions during follow-up. A strategy of provisional T-stenting with a tubular stent and final kissing balloon angioplasty for the treatment of coronary bifurcation lesions was safe and associated with a low TLR rate at 7 months. This strategy should be applicable to the new era of drug eluting stents. Copyright 2006 Wiley-Liss, Inc.

  1. Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus.

    Science.gov (United States)

    Ali, Rosli Mohd; Degenhardt, Ralf; Zambahari, Robaayah; Tresukosol, Damras; Ahmad, Wan Azman Wan; Kamar, Haizal bin Haron; Kui-Hian, Sim; Ong, Tiong Kiam; bin Ismail, Omar; bin Elis, Safari; Udychalerm, Wasan; Ackermann, Hanns; Boxberger, Michael; Unverdorben, Martin

    2011-05-01

    Coronary lesions in diabetics (DM) are associated with a high recurrence following percutaneous coronary intervention (PCI), even after drug-eluting stent (DES) deployment. Encouraging clinical data of the drug-eluting balloon catheter (DEB) SeQuent Please warrant its investigation in these patients. Eighty-four diabetic patients (60.8 ± 9.1 years, 76.2% male) were randomised to either the DEB SeQuent Please or the DES Taxus Liberté to compare the 9-month clinical and angiographic outcome of PCI in native coronary arteries. Comparing the DEB vs. the DES the 9-month results (follow-up DEB 39/45 [86.7%], DES 36/39 [92.3%]) are statistically not different at the 0.05 level for the primary endpoint of in-segment (0.37 ± 0.59 mm vs. 0.35 ± 0.63 mm) and in-stent (0.51 ± 0.61 mm vs. 0.53 ± 0.67 mm) late lumen loss, overall and cardiac deaths (2/45 [4.4%] and 3/45 [6.7%] vs. 0), target lesion revascularisation (3/45 [8.9%] vs. 4/39 [10.3%]), the total MACE rate (6/45 [13.3%] vs. 6/39 [15.4%]), and the event free survival after 10.2 ± 3.8 months (Kaplan-Meier analysis, pcobalt chromium stent compared to the drug eluting Taxus stent are similar.

  2. Long-term safety and efficacy of stenting versus coronary artery bypass grafting for unprotected left main coronary artery disease: 5-year results from the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) registry.

    Science.gov (United States)

    Park, Duk-Woo; Seung, Ki Bae; Kim, Young-Hak; Lee, Jong-Young; Kim, Won-Jang; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Yun, Sung-Cheol; Gwon, Hyeon-Cheol; Jeong, Myung-Ho; Jang, Yang-Soo; Kim, Hyo-Soo; Kim, Pum Joon; Seong, In-Whan; Park, Hun Sik; Ahn, Taehoon; Chae, In-Ho; Tahk, Seung-Jea; Chung, Wook-Sung; Park, Seung-Jung

    2010-07-06

    We performed the long-term follow-up of a large cohort of patients in a multicenter study receiving left main coronary artery (LMCA) revascularization. Limited information is available on long-term outcomes for patients with unprotected LMCA disease who underwent coronary stent procedure or coronary artery bypass grafting (CABG). We evaluated 2,240 patients with unprotected LMCA disease who received coronary stents (n = 1,102; 318 with bare-metal stents and 784 with drug-eluting stents) or underwent CABG (n = 1,138) between 2000 and 2006 and for whom complete follow-up data were available for at least 3 to 9 years (median 5.2 years). The 5-year adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction [MI], or stroke; and target vessel revascularization [TVR]) were compared with the use of the inverse probability of treatment weighted method and propensity-score matching. After adjustment for differences in baseline risk factors with the inverse probability of treatment weighting, the 5-year risk of death (hazard ratio [HR]: 1.13; 95% confidence interval [CI]: 0.88 to 1.44, p = 0.35) and the combined risk of death, Q-wave MI, or stroke (HR: 1.07; 95% CI: 0.84 to 1.37, p = 0.59) were not significantly different for patients undergoing stenting versus CABG. The risk of TVR was significantly higher in the stenting group than in the CABG group (HR: 5.11; 95% CI: 3.52 to 7.42, p < 0.001). Similar results were obtained in comparisons of bare-metal stent with concurrent CABG and of drug-eluting stent with concurrent CABG. In further analysis with propensity-score matching, overall findings were consistent. During 5-year follow-up, stenting showed similar rates of mortality and of the composite of death, Q-wave MI, or stroke but higher rates of TVR as compared with CABG for patients with unprotected LMCA disease. Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. Nanotextured stainless steel for improved corrosion resistance and biological response in coronary stenting

    Science.gov (United States)

    Mohan, Chandini C.; Prabhath, Anupama; Cherian, Aleena Mary; Vadukumpully, Sajini; Nair, Shantikumar V.; Chennazhi, Krishnaprasad; Menon, Deepthy

    2014-12-01

    Nanosurface engineering of metallic substrates for improved cellular response is a persistent theme in biomaterials research. The need to improve the long term prognosis of commercially available stents has led us to adopt a `polymer-free' approach which is cost effective and industrially scalable. In this study, 316L stainless steel substrates were surface modified by hydrothermal treatment in alkaline pH, with and without the addition of a chromium precursor, to generate a well adherent uniform nanotopography. The modified surfaces showed improved hemocompatibility and augmented endothelialization, while hindering the proliferation of smooth muscle cells. Moreover, they also exhibited superior material properties like corrosion resistance, surface integrity and reduced metal ion leaching. The combination of improved corrosion resistance and selective vascular cell viability provided by nanomodification can be successfully utilized to offer a cell-friendly solution to the inherent limitations pertinent to bare metallic stents.

  4. Early results after synchronous carotid stent placement and coronary artery bypass graft in patients with asymptomatic carotid stenosis.

    Science.gov (United States)

    Barrera, Juan Guillermo; Rojas, Kristin E; Balestrini, Carlos; Espinel, Camilo; Figueredo, Antonio; Saaibi, Jose Federico; Machuca, Santiago; Murcia, Adriana

    2013-02-01

    The optimal management of patients with combined carotid and coronary artery disease requiring cardiac surgery is still unknown. Staged carotid endarterectomy and carotid artery stenting (CAS), each followed by coronary artery bypass graft (CABG), are options frequently employed. However, for patients with severe carotid artery disease in urgent need of open cardiac revascularization, staged operations may not be the most appropriate alternative. The aim of this study was to describe our experience using a synchronous CAS-CABG method with minimal interprocedural time. We used this synchronous combination of procedures in patients with combined carotid and coronary artery disease admitted for urgent CABG. Patients with concomitant severe carotid and coronary artery disease scheduled for synchronous CAS and urgent CABG between December 2006 and January 2010 were included in the study. All procedures were performed at a single center: the Cardiovascular Foundation of Colombia, in Floridablanca, Santander, Colombia. The study cohort was characterized according to demographic and clinical characteristics, which included degree of carotid stenosis, presence/absence of preoperative neurological symptoms, and cardiac operative risk profile. All patients underwent CAS under embolic protection devices and then CABG within the next 2 hours. Patients received aspirin pre- and postprocedure but were started on clopidogrel only after CABG. The primary end point of the study was the composite incidence rate of myocardial infarction, stroke, and death 30 days after CAS-CABG. Fifteen patients with concomitant severe carotid and coronary artery disease underwent synchronous CAS-CABG. Most patients (60%) were men, and mean (± standard deviation) age was 65.2 (± 8.4) years. Most patients (93%) were neurologically asymptomatic. The median (interquartile range) ejection fraction and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) for the cohort were 55% (36

  5. Clinical outcome after primary percutaneous coronary intervention with drug-eluting and bare metal stents in patients with ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Thayssen, Per

    2008-01-01

    BACKGROUND: The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is a matter of debate. Therefore, we examined the risk of target lesion revascularization (TLR), stent thrombosis...... Registry from January 2002 through June 2005, were followed up for 2 years. We used Cox regression analysis to control for confounding. The 2-year incidence of definite stent thrombosis was 1.9% in the DES group and 1.1% in the BMS group (adjusted relative risk [RR]=1.53; 95% CI=0.84 to 2.78; P=0.17). Very...... late definite stent thrombosis (> or =12 months) was seen in 0.4% in the DES group and 0.06% in the BMS group (adjusted RR=6.74; 95% CI=1.23 to 37.00; P=0.03). The 2-year incidence of myocardial infarction was similar in the 2 groups, 5.2% in the DES group versus 6.3% in the BMS group (P=0.28; adjusted...

  6. Impact of stent diameter and length on in-stent restenosis after DES vs BMS implantation in patients needing large coronary stents-A clinical and health-economic evaluation

    DEFF Research Database (Denmark)

    Zbinden, Rainer; von Felten, Stefanie; Wein, Bastian

    2017-01-01

    AIMS: The British National Institute of Clinical Excellence (NICE) guidelines recommend to use drug-eluting stents (DES) instead of bare-metal stents (BMS) only in lesions >15 mm in length or in vessels

  7. Comparison of clinical outcomes of coronary artery stent implantation in patients with end-stage chronic kidney disease including hemodialysis for three everolimus eluting (EES) stent designs: Bioresorbable polymer-EES, platinum chromium-EES, and cobalt chrome-EES.

    Science.gov (United States)

    Sato, Takao; Hatada, Katsuharu; Kishi, Syohei; Fuse, Koichi; Fujita, Satoshi; Ikeda, Yoshio; Takahashi, Minoru; Matsubara, Taku; Okabe, Masaaki; Aizawa, Yoshifusa

    2017-11-22

    New-generation bioresorbable polymer-everolimus eluting stents (BP-EES) are available. This study aimed to compare the clinical outcomes for BP-EES compared to more established stent designs, namely the platinum chromium-EES (PtCr-EES) and cobalt chrome-EES(CoCr-EES) in patients with the end-stage chronic kidney disease (CKD) including hemodialysis (HD). One-hundred-forty-one consecutive stents (BP-EES [n = 44], PtCr-EES [n = 45], and CoCr-EES [n = 52]) were implanted in 104 patients with CKD. All patients underwent a follow-up coronary angiography at 12 months after implantation. End-stage CKD was defined as an estimated glomerular filtration rate (eGFR) stent groups after implantation and the 12-month follow-up: target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac event (MACE). Minimal stent diameter (MSD) and %diameter-stenosis (%DS) were measured using quantitative coronary angiography. The overall rate of TLR and MACE was 14.6% and 30.8%, respectively, with no incidence of ST. Immediately after implantation, the MSD (P = 0.22) and %DS (P = 0.42) were equivalent among the three groups. However, at the 12-month follow-up, a tendency towards higher TLR was observed for the BP-EES group (22.7%) compared with the PtCr-EES (8.8%) and CoCr-EES (9.6%) groups (P = 0.07). Late loss in lumen diameter was also significantly greater for the BP-EES (0.51 ± 0.64 mm) group than either the PtCr-EES (0.20 ± 0.61 mm) and CoCr-EES (0.25 ± 0.70 mm) groups (P = 0.03). BP-EES might increase the risk of in-stent restenosis in patients with end-stage of CKD or the need for HD. © 2017, Wiley Periodicals, Inc.

  8. In vitro blood flow model with physiological wall shear stress for hemocompatibility testing-An example of coronary stent testing.

    Science.gov (United States)

    Engels, Gerwin Erik; Blok, Sjoerd Leendert Johannes; van Oeveren, Willem

    2016-09-18

    Hemocompatibility of blood contacting medical devices has to be evaluated before their intended application. To assess hemocompatibility, blood flow models are often used and can either consist of in vivo animal models or in vitro blood flow models. Given the disadvantages of animal models, in vitro blood flow models are an attractive alternative. The in vitro blood flow models available nowadays mostly focus on generating continuous flow instead of generating a pulsatile flow with certain wall shear stress, which has shown to be more relevant in maintaining hemostasis. To address this issue, the authors introduce a blood flow model that is able to generate a pulsatile flow and wall shear stress resembling the physiological situation, which the authors have coined the "Haemobile." The authors have validated the model by performing Doppler flow measurements to calculate velocity profiles and (wall) shear stress profiles. As an example, the authors evaluated the thrombogenicity of two drug eluting stents, one that was already on the market and one that was still under development. After identifying proper conditions resembling the wall shear stress in coronary arteries, the authors compared the stents with each other and often used reference materials. These experiments resulted in high contrast between hemocompatible and incompatible materials, showing the exceptional testing capabilities of the Haemobile. In conclusion, the authors have developed an in vitro blood flow model which is capable of mimicking physiological conditions of blood flow as close as possible. The model is convenient in use and is able to clearly discriminate between hemocompatible and incompatible materials, making it suitable for evaluating the hemocompatible properties of medical devices.

  9. Predictors and variability of drug-eluting vs bare-metal stent selection in contemporary percutaneous coronary intervention: Insights from the PRISM study.

    Science.gov (United States)

    Shafiq, Ali; Gosch, Kensey; Amin, Amit P; Ting, Henry H; Spertus, John A; Salisbury, Adam C

    2017-08-01

    Drug-eluting stents (DES) reduce risk of in-stent restenosis after percutaneous coronary intervention (PCI) but require dual antiplatelet therapy (DAPT) for a longer term than bare-metal stents (BMS). Few studies have examined clinical predictors of DES vs BMS, and variability in provider selection between DES and BMS in clinical practice has not been well described. These insights can inform our understanding of current practice and may identify opportunities to improve decision-making stent selection decinsion-making. In a multicenter registry, 3295 consecutive patients underwent PCI by 158 interventional cardiologists across 10 US sites. Eighty percent of patients with treated with DES. Using hierarchical regression, diabetes mellitus, multivessel disease, health insurance, and white race were independently associated with greater DES use, whereas increasing age, history of hypertension, anticipated surgery, use of warfarin, lower hemoglobin, prior history of bleeding, and treatment of right coronary and left circumflex artery lesions as compared with PCI of left anterior descending artery were associated with lower likelihood of receiving DES. Adjusted rates of DES use across providers varied from 52.3% to 94.6%, and adjusted median odds ratio for DES selection was 1.69. DES selection appeared to reflect physicians' attempts to balance benefits of DES against risks of prolonged DAPT. Nevertheless, marked residual variability in DES selection across providers persisted after adjusting for predictors of restenosis, bleeding, and other factors. Further studies are needed to better understand drivers of this variability and identify the impact of patient and provider preferences on stent selection at the time of PCI. © 2017 Wiley Periodicals, Inc.

  10. Blood level of CD45+ platelets and development of restenosis after drug-eluting stent implantation in patients with stable coronary artery disease.

    Science.gov (United States)

    Gabbasov, Zufar; Kozlov, Sergey; Byazrova, Svetlana; Saburova, Olga; Melnikov, Ivan; Caprnda, Martin; Curilla, Eduard; Gaspar, Ludovit; Kruzliak, Peter; Smirnov, Vladimir

    2016-12-01

    The aim of this study was to assess CD45-positive platelets (CD45+ platelets) involvement in restenosis development after drug-eluting stent (DES) implantation in patients with stable coronary artery disease (CAD). The study comprised 126 male and female patients with stable angina pectoris, who underwent elective coronary stenting with DES and follow-up angiography within 6-12 months. The patients were assigned to the group with restenosis (n = 53) or group without restenosis (n = 73) according to the follow-up angiograms. In both groups we compared the level in blood of CD45+ platelets, the clinical, laboratory and angiographic variables, which may affect the development of restenosis. We have also constructed a logit regression model for prognosis of restenosis occurrence after DES implantation. The blood count of CD45+ platelets was higher in patients with restenosis than in patients without: 0.82 % (0.58; 1.12) vs. 0.34 % (0.20; 0.68), p binary comparisons of more than 35 different clinical, laboratory and angiographic variables we identified 8 significant risk factors for the development of stent restenosis after DES. In order to define the risk of the development of restenosis, we have built a logit regression model. The resulting logit regression equation included the level of CD45+ platelets, the neutrophil to lymphocyte ratio (NLR), small diameter arteries stenting and the number of simultaneously implanted stents in one patient. Receiver operating characteristic (ROC) curve analysis has demonstrated the high prognostic value of the resulting logit regression equation with an area under the curve (AUC) of 0.91 % (p < 0.001). The acquired data indicate the presence of a close relationship between circulating CD45+ platelets and restenosis development after DES implantation in patients with stable CAD.

  11. Clinical Outcomes in Diabetic Patients Who Underwent Percutaneous Coronary Intervention during the Plain Old Balloon Angioplasty (POBA)-, Bare Metal Stents (BMS)- and Drug-eluting Stents (DES)-eras from 1984 to 2010

    Science.gov (United States)

    Naito, Ryo; Miyauchi, Katsumi; Konishi, Hirokazu; Tsuboi, Shuta; Ogita, Manabu; Dohi, Tomotaka; Kasai, Takatoshi; Tamura, Hiroshi; Okazaki, Shinya; Isoda, Kikuo; Daida, Hiroyuki

    2017-01-01

    Objective Diabetes is a negative predictor in coronary artery disease patients. Since the introduction of percutaneous coronary intervention (PCI), PCI has evolved through technological advances in devices, improvements in operators' techniques and the establishment of effective therapeutic protocols. The aim of this study is to examine the changes in the clinical outcomes following PCI in patients with diabetes. Methods We compared the clinical outcomes in patients with diabetes following PCI from 1984 to 2010 at Juntendo University over three eras (plain old balloon angioplasty (POBA)-, bare metal stents (BMS)- and drug-eluting stents (DES)-eras). The primary endpoint was a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and repeat revascularization within 3 years after the index PCI. Results A total of 1,584 patients were examined. The baseline characteristics became unfavorable over time with regard to age, prevalence of hypertension, presentation with acute coronary syndrome and a reduced left ventricular ejection fraction. The administration of aspirin, statins and β-blockers increased over time. The event-free survival rate for the 3-year cardiovascular events was lower in the DES-era. The adjusted relative risk reduction for 3-year cardiovascular events was 46 % in the DES-era compared with the POBA-era. Conclusion The incidence of 3-year cardiovascular events decreased from 1984 to 2010 in patients with diabetes following PCI, despite the higher risk profiles in the DES-era. PMID:28049984

  12. Restoration of myocardial blood flow following percutaneous coronary balloon dilatation and stent implantation: Assessment with qualitative and quantitative contrast-enhanced magnetic resonance imaging

    Energy Technology Data Exchange (ETDEWEB)

    Sensky, P.R.; Samani, N.J.; Horsfield, M.A.; Cherryman, G.R

    2002-07-01

    AIM: To examine the serial use of magnetic resonance imaging (MRI) to evaluate regional myocardial perfusion changes following percutaneous coronary angioplasty and stent implantation (PTCA). MATERIALS AND METHODS: Six patients with single vessel coronary artery disease (CAD) underwent contrast-enhanced first pass MRI immediately prior to (visit A) and within 7 days after (visit B) PTCA. Three sequential short axis slices were obtained after gadodiamide (Gd) bolus (0.025 mmol/kg{sup -1}) at rest and during adenosine. Each short axis was divided radially into eight regions of interest (ROIs). ROIs were anatomically assigned to a coronary artery territory (CAT). Stress and rest qualitative and quantitative (unidirectional extraction fraction constant (K{sub i}); index of myocardial perfusion reserve (MPRI) = stressK{sub i} / restK{sub i}) perfusion parameters were determined for ROI supplied by remote and stenosed/stented vessels for each visit. RESULTS: In stented ROIs the number of ROIs demonstrating normal perfusion, as opposed to reversible perfusion deficits, increased. Qualitative perfusion assessment in remote CATs was unchanged. MPRI in stenotic CATs was lower than in remote CATs at visit A (P < 0.001). Following PTCA, MPRI increased in stented CATs (P < 0.001) but was unchanged in remote CATs. CONCLUSION: Restoration of myocardial perfusion following PTCA can be delineated with qualitative and quantitative perfusion MRI. Although at present the investigation is technically complex and not perfectly sensitive or specific, MRI has the potential to be a valuable tool for patient follow-up and evaluation of revascularization strategy efficacy. Sensky, P.R. et al. (2002)

  13. Development of radiolabelled compound using reactor producted RI - Evaluation of Ho-166 endovascular therapy to prevent restenosis after PTCA or stenting for occlusive coronary artery disease

    Energy Technology Data Exchange (ETDEWEB)

    Park, Chan Hee; Choi, Byung Il; Kim, Han Soo [Ajou University, Suwon (Korea)

    2000-04-01

    Occlusive coronary artery disease is managed successfully by percutaneous transfemoral coronary angioplasty (PTCA) or stenting with 95% success rate. However, restenosis after PTCA is not uncommon and the reported incidence of reocclusion is about 30 {approx} 40%. Therefore, the objective of the research was to develop endovascular brachytherapy using liquid form of Ho-166 in order to inhibit neointimal hyperplasia responsible for restenosis following PTCA or stenting. Our research was carried out in 3 stages: First stage - The effectiveness of radiation was confirmed by using animal model. Following over-sized balloon injury to rat carotid artery and porcine coronary artery, various external radiation doses were delivered. Second stage - For radiation dose distribution within the coronary artery and its surrounding tissues, Gafchromic film was used. In vitro dose distribution of Ho-166 utilizing water phantom and Gafchromic film was measured. Third stage - None uniform dose distribution from Ho-166 within the balloon caused by small air bubbles was eliminated by negative suction method. More accurate dose distribution was also possible using newly developed micrometer by our physicist. Limited number of human trial was performed without adverse effect. 40 refs. (Author)

  14. Incidence and classification of neointimal proliferation and in-stent restenosis in post-stenting patients at 1-year interval: Findings from non-invasive coronary computed tomography angiography

    Energy Technology Data Exchange (ETDEWEB)

    Xu, Nan, E-mail: southmuch@hotmail.com [Department of Radiology, East Hospital, Tongji University School of Medicine, No. 150, Jimo Road, Shanghai 200120 (China); Zhang, Jiayin, E-mail: andrewssmu@msn.com [Department of Radiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, No. 600, Yishan Road, Shanghai 200233 (China); Li, Minghua, E-mail: drliminghua@gmail.com [Department of Radiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, No. 600, Yishan Road, Shanghai 200233 (China); Pan, Jingwei, E-mail: drpanjingwei@gmail.com [Department of Cardiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, No. 600, Yishan Road, Shanghai 200233 (China); Lu, Zhigang, E-mail: drluzhigang@gmail.com [Department of Cardiology, Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, No. 600, Yishan Road, Shanghai 200233 (China)

    2014-10-15

    Highlights: • The incidence of silent in-stent restenosis at 1-year as revealed by CT is 7.6%. • The incidence of neointimal proliferation at 1-year as revealed by CT is 12.6%. • Diabetes are associated with higher incidence of neointimal proliferation. - Abstract: Objectives: To evaluate the incidence of coronary in-stent restenosis (ISR) and neointimal proliferation by coronary CT angiography (CCTA) at 1-year follow-up in asymptomatic patients. Methods: 234 patients (mean age: 67 ± 10.2 years, range 39–88 years, 180 males and 54 females) with 379 stents were prospectively enrolled in this study. Binary ISR was classified by CCTA into 4 types using Mehran classification. Neointimal proliferation was similarly classified into focal and diffuse types. All patients with CCTA-revealed ISR or neointimal proliferation underwent further invasive coronary angiography (ICA) for validation. Fisher's exact test was used for comparison. Results: ICA revealed patent stents with neointimal proliferation in 39 patients (16.7%, 39/234) and binary ISR in 23 patients (9.8%, 23/234). Lesion-based analysis showed 12 type I ISR lesions, 4 type II ISR lesions, 1 type III ISR lesion and 7 type IV ISR lesions. Among cases with neointimal proliferation, 27 lesions were classified as focal type whereas 13 lesions were classified as diffuse type. Patients with diabetes mellitus were associated with higher incidence of CCTA-revealed neointimal proliferation (21/77 vs. 18/157, p = 0.002) as well as ISR (12/77 vs. 11/157, p = 0.038), compared to patients without diabetes. CCTA was found to have good diagnostic performance for neointimal proliferation and ISR detection as well as classification, with an overall accuracy of 84.4% (54/64). Conclusions: Silent ISR as well as neointimal proliferation is not uncommon findings in asymptomatic post-stenting patients at 1-year interval, as revealed by CCTA. Patients with diabetes are prone to have higher incidence of neointimal

  15. Cost-effectiveness of percutaneous coronary intervention with cobalt-chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta-analysis of randomized trials.

    Science.gov (United States)

    Ferko, Nicole; Ferrante, Giuseppe; Hasegawa, James T; Schikorr, Tanya; Soleas, Ireena M; Hernandez, John B; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Valgimigli, Marco

    2017-05-01

    Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI). To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI. A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis. The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

  16. Treatment effects of eptifibatide in planned coronary stent implantation in patients with chronic kidney disease (ESPRIT Trial).

    Science.gov (United States)

    Reddan, Donal N; O'Shea, John Conor; Sarembock, Ian J; Williams, Kathryn A; Pieper, Karen S; Santoian, Edward; Owen, William F; Kitt, Michael M; Tcheng, James E

    2003-01-01

    The role of platelet glycoprotein IIb/IIIa inhibitor therapy in patients with mild renal impairment is not well characterized. Our objective was to explore the associations of creatinine clearance (CrCl) with outcomes in a trial of eptifibatide therapy in patients who underwent percutaneous coronary intervention (PCI). We analyzed 48-hour and 30-day outcomes of patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. Patients were randomly assigned to placebo or eptifibatide as an adjunct to stent implantation (1,755 with CrCl > or =60 ml/min and 289 with CrCl <60 ml/min). CrCl was calculated using the Cockcroft and Gault formula, and the associations of CrCl with outcomes were evaluated using logistic regression models. Patients with CrCl <60 ml/min were more likely to be older, women, hypertensive, and have a history of coronary artery bypass surgery, stroke, or peripheral vascular disease. The interaction of eptifibatide with CrCl had borderline significance for the 30-day outcome (p = 0.109). Treatment effect trended toward a greater magnitude in patients with lower CrCl (60 ml/min) (odds ratio 0.53, confidence interval 0.34 to 0.83) compared with those with higher CrCl (90 ml/min) (odds ratio 0.68, confidence interval 0.49 to 0.94). An accompanying increase in bleeding risk also was not apparent with lower CrCl. The treatment effect of eptifibatide is realized regardless of renal function and trends toward being greater in patients with mild renal impairment.

  17. Peri-stent contrast staining, major evaginations and severe malapposition after biolimus-eluting stent implantation

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Thayssen, Per; Jensen, Lisette Okkels

    2014-01-01

    Peri-stent contrast staining and late acquired malapposition represent pathological vessel wall healing patterns following percutaneous coronary intervention with stent implantation. Earlier studies have described these abnormal vessel wall responses commonly present after implantation of first......-generation drug-eluting stents. These coronary vascular changes can cause flow disturbance and thereby dispose for later thrombotic events. This case report, based on coronary optical frequency domain imaging, describes peri-stent contrast staining, major evaginations and severe malapposition occurring 18months...

  18. Paclitaxel and sirolimus eluting stents versus bare metal stents: long-term risk of stent thrombosis and other outcomes. From the Western Denmark Heart Registry

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Tilsted, Hans Henrik; Thayssen, Per

    2010-01-01

    AIMS: Stent thrombosis is a serious complication of percutaneous coronary intervention (PCI). We examined the incidence of stent thrombosis and other outcomes in patients treated with PCI and paclitaxeleluting stents (PES), sirolimus-eluting stents (SES) or bare-metal stents (BMS). METHODS AND RE...

  19. Influence of a pressure gradient distal to implanted bare-metal stent on in-stent restenosis after percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Thuesen, Leif

    2007-01-01

    performed in the target vessel: (1) P(d)/P(a) as distal to the artery as possible (fractional flow reserve per definition); (2) P(d)/P(a) just distal to the stent; (3) P(d)/P(a) just proximal to the stent; and (4) P(d)/P(a) at the ostium. Residual abnormal P(d)/P(a) was defined as a pressure drop between P...

  20. Early vessel healing of the Avantgarde cobalt-chromium coronary stent: the ON-GARDE OCT study.

    Science.gov (United States)

    Prati, Francesco; Monaco, Sergio; Pawlosky, Tomasz; Mallus, Maria Teresa; Di Giorgio, Alessandro; Imola, Fabrizio; Ficarra, Eleonora; Ramazzotti, Vito; Biondi-Zoccai, Giuseppe; Albertucci, Mario

    2013-04-01

    Uncoverage and malapposition of stent struts at optical coherence tomography (OCT) have been associated with stent thrombosis. Stent uncoverage by OCT is being used as a surrogate to address the propensity of a stent to develop thrombosis. We aimed to appraise early vessel healing in patients with ST-elevation myocardial infarction (STEMI) treated with the novel Avantgarde stent. Patients with STEMI and multivessel disease were enrolled. The stent deployed on the infarct-related artery was imaged by frequency domain-OCT during deferred intervention (4-7 days apart). The primary end-point was the percentage of uncovered struts. Secondary end-points were the percentage of malapposed struts and struts covered with thrombus. Twenty patients (20 lesions) were enrolled, with 18 (18 stents) achieving a complete OCT pull-back and thus entering the final analysis (1497 cross-sections, 11 446 struts). Uncovered struts were 3.9%, whilst 8.0% of struts were malapposed and 2.6% were covered by thrombus. At per-stent analysis, all stents but two had a homogeneous distribution of strut coverage (i.e. % of uncovered struts ≥10). This study, originally exploiting OCT data early after stenting in STEMI patients, shows that the Avantgarde stent is associated with favourable vessel healing features.

  1. Primary angioplasty: Effect of deferred stenting on stent size.

    Science.gov (United States)

    Harbaoui, Brahim; Emsellem, Philippe; Cassar, Emmanuel; Besnard, Cyril; Dauphin, Raphael; Motreff, Pascal; Courand, Pierre-Yves; Lantelme, Pierre

    2017-04-01

    Primary angioplasty with immediate stenting (IS) is the gold standard for ST-segment elevation myocardial infarction (STEMI). Deferred stenting (DS) has been proposed to limit periprocedural complications, and may influence stent size because of thrombus and spasm alleviation. We sought to study the effect of DS on stent size. Over the study period, 258 patients underwent primary angioplasty for STEMI (DS, n=84; IS, n=174). An informative coronary angiogram run - i.e. allowing for proper lesion analysis - was selected and anonymized by an independent operator. Two experienced operators randomly analysed these runs, and proposed stent dimensions after having measured vessel diameter and lesion length by quantitative coronary analysis. The primary objective was the variation in stent size between the two coronary angiograms. The median delay between the two coronary angiograms was 2 days. Overall, the stent length was shorter (-1.64mm; P=0.030) and its diameter was larger (+0.13mm; P<0.001) during the second coronary angiogram, especially in the right coronary arteries. DS led to the implantation of a larger and shorter stent; this is probably because DS allows for more accurate assessment of the residual lesion after relief of spasm and thrombus, and may have clinical consequences in terms of stent thrombosis and restenosis. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  2. In vitro and in vivo degradation of rapamycin-eluting Mg-Nd-Zn-Zr alloy stents in porcine coronary arteries.

    Science.gov (United States)

    Shi, Yongjuan; Zhang, Lei; Chen, Jiahui; Zhang, Jian; Yuan, Feng; Shen, Li; Chen, Chenxin; Pei, Jia; Li, Zhonghua; Tan, Jinyun; Yuan, Guangyin

    2017-11-01

    In this work, rapamycin-eluting poly (d, l-lactic acid) coating (PDLLA/RAPA) was prepared on biodegradable Mg-Nd-Zn-Zr alloy (JDBM) for both in vitro and in vivo investigation of the degradation behaviors of the magnesium alloy stent platform. Electrochemical tests and hydrogen evolution test demonstrated significant in vitro protection of the polymeric coating against magnesium degradation both in short and long term. The 3-month in vivo study on the RAPA-eluting JDBM stent implanted into porcine coronary arteries confirmed its favorable safety, and in the meanwhile revealed similar neointima proliferation compared to the second generation DES Firebird 2 with no occurrence of adverse complications. Moreover, Micro-CT examination combined with IVUS and OCT detection indicated a remarkably lower degradation rate and prolonged radial supporting duration of the drug-eluting JDBM stent as compared to the bare, attributable to the protection of the coating in vivo. Hence, rapamycin-eluting JDBM stents exhibit great potential for clinical application. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Dose perturbation of a novel cobalt chromium coronary stent on 32P intravascular brachytherapy: a monte carlo study.

    Science.gov (United States)

    Mourtada, Firas; Horton, John L

    2005-01-01

    Intravascular brachytherapy has been adopted for the indication of in-stent restenosis on the basis of results of clinical trials using mainly stainless steel stents. Recently, a new stent made of cobalt-chromium L-605 alloy (CoCr, p=9.22 g/cm3) (MULTI-LINK VISION) was introduced as an alternative to the 316L stainless steel stent design (SS, p=7.87 g/cm3) (MULTI-LINK PENTA). In this work, we used the Monte Carlo code MCNPX to compare the dose distribution for the 32P GALILEO source in CoCr and SS 8 mm stent models. The dose perturbation factor (DPF), defined as the ratio of the dose in water with the presence of a stent to the dose without a stent, was used to compare results. Both stent designs were virtually expanded to diameters of 2.0, 3.0, and 4.0 mm using finite element models. The complicated strut shapes of both the CoCr and SS stents were simplified using circular rings with an effective width to yield a metal-to-tissue ratio identical to that of the actual stents. The mean DPF at a 1 mm tissue depth, over the entire stented length of 8 mm, was 0.935 for the CoCr stent and 0.911 for the SS stent. The mean DPF at the intima (0.05 mm radial distance from the strut outer surface), over the entire stented length of 8 mm, was 0.950 for CoCr, and 0.926 for SS. The maximum DPFs directly behind the CoCr and SS struts were 0.689 and 0.644, respectively. All DPF estimates have a standard deviation of +/-0.6%(k=2), approximating the 95% confidence interval. Although the CoCr stent has a higher effective atomic number and greater density than the SS stent, the DPFs for the two stents are similar, probably because the metal-to-tissue ratio and strut thickness of the CoCr stent are lower than those of the SS stent.

  4. Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial.

    Science.gov (United States)

    Kappetein, Arie Pieter; Serruys, Patrick W; Sabik, Joseph F; Leon, Martin B; Taggart, David P; Morice, Marie-Claude; Gersh, Bernard J; Pocock, Stuart J; Cohen, David J; Wallentin, Lars; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Simonton, Charles A; Stone, Gregg W

    2016-09-18

    Coronary artery bypass graft (CABG) surgery is the standard of care for revascularisation of patients with left main coronary artery disease (LMCAD). Recent studies have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may provide comparable outcomes in selected patients with LMCAD without extensive CAD. We therefore designed a trial to investigate whether PCI with XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) would result in non-inferior or superior clinical outcomes to CABG in selected patients with LMCAD. The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a prospective, open-label, multicentre, international study of 1,900 randomised subjects. Patients with significant LMCAD with a SYNTAX score ≤32 and local Heart Team consensus that the subject is appropriate for revascularisation by both PCI and CABG are consented and randomised 1:1 to undergo PCI using CoCr-EES or CABG. All patients undergo follow-up for five years. The primary endpoint is the three-year composite rate of death, stroke or myocardial infarction, assessed at a median follow-up of at least three years (with at least two-year follow-up in all patients), powered for sequential non-inferiority and superiority testing. The EXCEL study will define the contemporary roles of CABG and PCI using XIENCE CoCr-EES in patients with LMCAD disease with low and intermediate SYNTAX scores.

  5. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy

    Energy Technology Data Exchange (ETDEWEB)

    Jiménez, Victor A., E-mail: victor.alfonso.jimenez.diaz@sergas.es [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Iñiguez, Andrés; Baz, José A. [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Valdés, Mariano [Hospital Universitario V. Arrixaca, Murcia (Spain); Ortiz, Alberto [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Vuilliomenet, André [Kantonsspital Aarau, Aarau (Switzerland); Mainar, Vicente [Department of Cardiology, University General Hospital of Alicante, Alicante (Spain); Dudek, Dariusz [Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow (Poland); Banai, Shmuel [Tel Aviv Sourasky Medical Centre, Tel Aviv (Israel); Tüller, David [Department of Cardiology, Stadtspital Triemli, Zürich (Switzerland); Bonnet, Jean-Louis [Department of Cardiology, Hospital La Timone, Marseille (France); De Miguel, Antonio; Bastos, Guillermo [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Wijns, William [Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium); Saito, Shigeru [Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura (Japan)

    2016-09-15

    Background: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. Methods: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9 month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24 months. Results: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24 months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P = 0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P = 0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. Conclusions: BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up. - Highlights: • This study reported the 24-month clinical outcomes of new-generation BP-SES compared with PP-EES in ACS subgroup from CENTURY II study. • This is a pre-specified subgroup analysis of a large randomized, prospective, multicenter clinical trial. • The BP-SES showed good and comparable clinical performance as PP-EES at 24 months. • This substudy has a relatively small sample size and

  6. A Randomized Comparison between Everolimus-Eluting Stent and Cobalt Chromium Stent in Patients with Acute ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention Using Routine Intravenous Eptifibatide: The X-MAN (Xience vs. Multi-Link Stent in Acute Myocardial Infarction) Trial, A Pilot Study.

    Science.gov (United States)

    Dharma, Surya; Wardeh, Alexander J; Soerianata, Sunarya; Firdaus, Isman; Jukema, J Wouter

    2014-06-01

    The objective of this study is to determine the efficacy and safety of an everolimus-eluting stent (EES/Xience; Abbott Vascular, Santa Clara, CA) compared with a cobalt chromium stent (CoCr/Multi-Link Vision; Abbott Vascular) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) with routine administration of eptifibatide infusion. This is a prospective, single center, randomized trial comparing EES (n = 75) and CoCr stent (n = 75) implantation in patients with acute STEMI undergoing primary PCI. Intravenous eptifibatide administration was mandatory by protocol in this pilot study. The primary efficacy endpoint was major adverse cardiac events (MACE) at 30 days, defined as the composite of death, reinfarction, and target vessel revascularization. Secondary safety endpoints were stent thrombosis at 30 days and in-hospital bleeding event. Acute reperfusion parameters were also assessed. One-month MACE rate did not differ between EES and CoCr group (1.3 vs. 1.3%, p = 1.0). No stent thrombosis cases were observed in the EES group. The groups did not differ with respect to in-hospital bleeding events (5 vs. 9%, p = 0.37), achievement of final thrombolysis in myocardial infarction flow 2 or 3 (p = 0.21), achievement of myocardial blush grade 2 or 3 (p = 0.45), creatine kinase-MB level at 8 to 12 hours after stenting (p = 0.29), and left ventricular ejection fraction (p = 0.21). This pilot study demonstrates that after one-month follow-up, the use of EES is as safe and effective as the use of CoCr stents in patients with acute STEMI undergoing primary PCI with routine administration of intravenous eptifibatide.

  7. Treatment of a Coronary Bifurcation Lesion Using One Dedicated Sirolimus Eluting Bifurcation Stent in Combination with a Bioresorbable Vascular Scaffold: A Novel Option for Coronary Bifurcation Approach

    Directory of Open Access Journals (Sweden)

    Javier Benezet

    2016-01-01

    Full Text Available We present a complex bifurcation lesion treated with a new two-stent strategy combining a dedicated sirolimus eluting bifurcation stent, BiOSS Lim, with a bioresorbable vascular scaffold (BVS. The advantages of this strategy compared with the conventional two-stent approach are as follows: the dedicated stent protects the carina from being damaged, the large cell at the middle zone of the BiOSS Lim gives possibility to enter easily into the side branch (SB with any standard size conventional device, and, finally, the additional use of BVS in the SB could have a long-term benefit in terms of restenosis.

  8. Effect of obesity on coronary atherosclerosis and outcomes of percutaneous coronary intervention: grayscale and virtual histology intravascular ultrasound substudy of assessment of dual antiplatelet therapy with drug-eluting stents.

    Science.gov (United States)

    Kang, Soo-Jin; Mintz, Gary S; Witzenbichler, Bernhard; Metzger, D Christopher; Rinaldi, Michael J; Duffy, Peter L; Weisz, Giora; Stuckey, Thomas D; Brodie, Bruce R; Shimizu, Takehisa; Xu, Ke; Kirtane, Ajay J; Stone, Gregg W; Maehara, Akiko

    2015-01-01

    Obesity is a cardiovascular risk factor, but the obesity paradox in patients undergoing percutaneous coronary intervention is poorly understood. Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) was a prospective, multicenter study of patients undergoing drug-eluting stent implantation. Overall, 780 patients (916 culprit lesions) were evaluated by grayscale and virtual histology-intravascular ultrasound pre-percutaneous coronary intervention. Poststenting intravascular ultrasound was done in 780 patients (894 treated lesions). Patients were divided into body mass index (BMI) tertiles. The high-BMI group had more diabetes mellitus, hypertension, and hyperlipidemia and more frequent plaque ruptures compared with the low-BMI group. At the minimal lumen area site, the high-BMI group had a larger plaque area (11.7 [11.0-12.4] versus 9.8 [9.3-10.4] mm(2)) and a greater plaque burden (77.3% [76.1%-78.5%] versus 74.4% [73.1%-75.8%]) compared with the low-BMI group; however, a larger external elastic membrane area (14.6 [13.8-15.3] versus 12.7 [12.1-13.3] mm(2)) resulted in a similar minimal lumen area compared with the low-BMI group. Post stenting, the high-BMI group had a significantly larger stent area versus the lower-BMI group. At 1-year follow-up, the high-BMI group was associated with less clinically driven target lesion revascularization compared with the low-BMI group in both the overall and the propensity-matched cohorts. A high BMI was associated with a greater plaque burden; however, a larger external elastic membrane preserved lumen dimensions and was associated with a larger stent area during intravascular ultrasound-guided stent implantation. Thus, despite more comorbidities, greater plaque burden, and more plaque rupture, a high BMI was not associated with worse outcomes after drug-eluting stent implantation. http://www.clinicaltrials.gov. Unique identifier: NCT00638794. © 2014 American Heart Association, Inc.

  9. Late Silent Stent Abscess.

    Science.gov (United States)

    Zateyshchikov, Dmitry; Fattakhova, Elvira; Demchinsky, Vladimir; Baklanova, Tatiana; Serebruany, Victor

    2015-01-01

    Coronary stent infections in general and stent abscesses (SAs) in particular are rare but often deadly complications. Most SAs manifest with fever and chest pain within 30 days after intervention and require antibiotics and stent removal. A 45-year-old man with second ST elevated myocardial infarction and cardiogenic shock was admitted to a hospital that had no cardiac catheterization laboratory. The patient underwent fibrinolytic therapy with alteplase but died 1 h later. His medical history revealed posterior myocardial infarction 7 years before, which had been successfully treated with a bare metal stent of the right coronary artery. The post-discharge observation had been unremarkable with no evidence of ischaemia or infection but gross non-compliance. Autopsy revealed complete closure of the left main coronary artery and a surprise additional finding, namely SA; the stented portion of the artery was enveloped by an abscess, and purulent material completely occluded the stent, which was floating in pus. Impressions: Since coronary angioplasty is so common, the incidence of late silent SA is probably higher than expected, especially considering that there is often a lack of clinical manifestations. Clinicians should be cognizant of this complication. More attention may be required to assess the condition of existing stents during repeated interventions. Gross non-compliance and/or early withdrawal from dual anti-platelet therapy may be directly responsible for the development of silent delayed SA.

  10. Provisional T-drug-eluting stenting technique for the treatment of bifurcation lesions: clinical, myocardial scintigraphy and (late) coronary angiographic results.

    Science.gov (United States)

    Vigna, Carlo; Biondi-Zoccai, Giuseppe; Amico, Cesare M; Lanna, Pompeo; Stanislao, Mario; Santoro, Tiberio; Valle, Guido; Fanelli, Raffaele; Loperfido, Francesco

    2007-03-01

    Treatment of bifurcation stenoses (BS) by percutaneous coronary intervention (PCI) remains challenging, even with drug-eluting stents (DES). We aimed to appraise clinical, myocardial scintigraphy and late (>9 months) exploratory angiographic outcomes of provisional T-stenting in the management of BS. We enrolled 53 consecutive patients with BS in the proximity of a greater than or equal to 2 mm side branch (SB). The provisional T-technique was performed in all cases, with implantation of DES in the main branch (MB), SB balloon-only dilatation, and final kissing in the event of >50% SB stenosis. Provisional SB-stenting (using another DES) was reserved to cases with persisting >50% stenosis/dissection and reduced TIMI flow. Further kissing inflation was recommended in such patients. Stress/rest single-photon emission computed tomography (MIBI) and coronary angiography follow up were scheduled >6 and 9 months after PCI, respectively. Major adverse cardiac events at 14 +/- 3 months occurred in 5 patients (9.4% [95% confidence interval 0.1-17.4%]: 1 (1.9% [0.1-5.8%]) non-Q-wave myocardial infarction for subacute stent thrombosis, 2 (3.8% [0.1-9.0%]) target lesion revascularizations and 2 (3.8% [0.1-9.0%]) target vessel revascularizations. Six-month MIBI was performed in 51 patients (96.3%): 4 patients had positive results (7.8% [0.2-15.4%]). Angiography was performed in 4 of these patients and in another 27 patients, with clinical restenosis occurring overall in only 5 (16.1% [8.9-23.3%]), 1 case of clinical restenosis in the MB (3.2% [0.6-9.4%]), and 4 in the SB (12.9% [5.1-24.9%]). This study suggests the safety and efficacy of provisional T-drug-eluting stent implantation in bifurcation coronary lesions, and supports the use of follow-up myocardial scintigraphy, with angiography reserved for selected patients and lesions.

  11. Antiplatelet therapy discontinuation and the risk of serious cardiovascular events after coronary stenting: observations from the CREDO-Kyoto Registry Cohort-2.

    Directory of Open Access Journals (Sweden)

    Hirotoshi Watanabe

    Full Text Available Relation of antiplatelet therapy (APT discontinuation with the risk of serious cardiovascular events has not been fully addressed yet. This study is aimed to evaluate the risk of ischemic event after APT discontinuation based on long-term APT status of large cohort. In the CREDO-Kyoto Registry Cohort-2 enrolling 15939 consecutive patients undergoing first coronary revascularization, 10470 patients underwent percutaneous coronary intervention either with bare-metal stents (BMS only (N=5392 or sirolimus-eluting stents (SES only (N=5078. Proportions of patients taking dual-APT were 67.3% versus 33.4% at 1-year, and 48.7% versus 24.3% at 5-year in the SES and BMS strata, respectively. We evaluated daily APT status (dual-, single- and no-APT and linked the adverse events to the APT status just 1-day before the events. No-APT as compared with dual- or single-APT was associated with significantly higher risk for stent thrombosis (ST beyond 1-month after SES implantation (cumulative incidence rates beyond 1-month: 1.23 versus 0.15/0.29, P<0.001/P<0.001, while higher risk of no-APT for ST was evident only until 6-month after BMS implantation (incidence rates between 1- and 6-month: 8.43 versus 0.71/1.20, P<0.001/P<0.001, and cumulative incidence rates beyond 6-month: 0.31 versus 0.11/0.08, P=0.16/P=0.08. No-APT as compared with dual- or single-APT was also associated with significantly higher risk for spontaneous myocardial infarction (MI and stroke regardless of the types of stents implanted. Single-APT as compared with dual-APT was not associated with higher risk for serious adverse events, except for the marginally higher risk for ST in the SES stratum. In conclusion, discontinuation of both aspirin and thienopyridines was associated with increased risk for serious cardiovascular events including ST, spontaneous MI and stroke beyond 1-month after coronary stenting.

  12. Antiplatelet therapy discontinuation and the risk of serious cardiovascular events after coronary stenting: observations from the CREDO-Kyoto Registry Cohort-2.

    Science.gov (United States)

    Watanabe, Hirotoshi; Morimoto, Takeshi; Natsuaki, Masahiro; Furukawa, Yutaka; Nakagawa, Yoshihisa; Kadota, Kazushige; Yamaji, Kyohei; Ando, Kenji; Shizuta, Satoshi; Shiomi, Hiroki; Tada, Tomohisa; Tazaki, Junichi; Kato, Yoshihiro; Hayano, Mamoru; Abe, Mitsuru; Tamura, Takashi; Shirotani, Manabu; Miki, Shinji; Matsuda, Mitsuo; Takahashi, Mamoru; Ishii, Katsuhisa; Tanaka, Masaru; Aoyama, Takeshi; Doi, Osamu; Hattori, Ryuichi; Kato, Masayuki; Suwa, Satoru; Takizawa, Akinori; Takatsu, Yoshiki; Shinoda, Eiji; Eizawa, Hiroshi; Takeda, Teruki; Lee, Jong-Dae; Inoko, Moriaki; Ogawa, Hisao; Hamasaki, Shuichi; Horie, Minoru; Nohara, Ryuji; Kambara, Hirofumi; Fujiwara, Hisayoshi; Mitsudo, Kazuaki; Nobuyoshi, Masakiyo; Kita, Toru; Kastrati, Adnan; Kimura, Takeshi

    2015-01-01

    Relation of antiplatelet therapy (APT) discontinuation with the risk of serious cardiovascular events has not been fully addressed yet. This study is aimed to evaluate the risk of ischemic event after APT discontinuation based on long-term APT status of large cohort. In the CREDO-Kyoto Registry Cohort-2 enrolling 15939 consecutive patients undergoing first coronary revascularization, 10470 patients underwent percutaneous coronary intervention either with bare-metal stents (BMS) only (N=5392) or sirolimus-eluting stents (SES) only (N=5078). Proportions of patients taking dual-APT were 67.3% versus 33.4% at 1-year, and 48.7% versus 24.3% at 5-year in the SES and BMS strata, respectively. We evaluated daily APT status (dual-, single- and no-APT) and linked the adverse events to the APT status just 1-day before the events. No-APT as compared with dual- or single-APT was associated with significantly higher risk for stent thrombosis (ST) beyond 1-month after SES implantation (cumulative incidence rates beyond 1-month: 1.23 versus 0.15/0.29, P<0.001/P<0.001), while higher risk of no-APT for ST was evident only until 6-month after BMS implantation (incidence rates between 1- and 6-month: 8.43 versus 0.71/1.20, P<0.001/P<0.001, and cumulative incidence rates beyond 6-month: 0.31 versus 0.11/0.08, P=0.16/P=0.08). No-APT as compared with dual- or single-APT was also associated with significantly higher risk for spontaneous myocardial infarction (MI) and stroke regardless of the types of stents implanted. Single-APT as compared with dual-APT was not associated with higher risk for serious adverse events, except for the marginally higher risk for ST in the SES stratum. In conclusion, discontinuation of both aspirin and thienopyridines was associated with increased risk for serious cardiovascular events including ST, spontaneous MI and stroke beyond 1-month after coronary stenting.

  13. Cost‐effectiveness of percutaneous coronary intervention with cobalt‐chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta‐analysis of randomized trials

    Science.gov (United States)

    Ferrante, Giuseppe; Hasegawa, James T.; Schikorr, Tanya; Soleas, Ireena M.; Hernandez, John B.; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W.; Valgimigli, Marco

    2016-01-01

    Background Second‐generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first‐generation DES with improved cost‐effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt‐chromium everolimus eluting stent (Co‐Cr EES) compared with BMS in percutaneous coronary intervention (PCI). Objective To conduct a cost‐effectiveness analysis (CEA) of a cobalt‐chromium everolimus eluting stent (Co‐Cr EES) versus BMS in PCI. Methods A Markov state transition model with a 2‐year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co‐Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta‐analysis of 5 RCTs (n = 4,896). The base‐case analysis evaluated stent‐related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta‐analysis. Results The base‐case and secondary analyses reported an additional 0.018 and 0.013 quality‐adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co‐Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co‐Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. Conclusions Using data from a recent patient level meta‐analysis and contemporary cost data, this analysis found that PCI with Co‐Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. PMID:27527508

  14. 3-Year clinical outcomes in the randomized SORT OUT III superiority trial comparing zotarolimus- and sirolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Maeng, Michael; Tilsted, Hans-Henrik; Jensen, Lisette Okkels

    2012-01-01

    This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice.......This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice....

  15. Impact of inhospital stent thrombosis and cerebrovascular accidents on long-term prognosis after percutaneous coronary intervention.

    Science.gov (United States)

    Guerra, Elena; Ndrepepa, Gjin; Schulz, Stefanie; Byrne, Robert; Hoppmann, Petra; Kufner, Sebastian; Ibrahim, Tareq; Tada, Tomohisa; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan

    2014-12-01

    Inhospital stent thrombosis (ST) and cerebrovascular accidents (CVA) are rare but serious adverse events after percutaneous coronary intervention (PCI). The association of ST or CVA with long-term outcome after PCI remains poorly investigated. The study included 18,334 consecutive patients who underwent PCI. Patients were divided into 3 groups: the group with ST, the group with CVA, and the group without these events. The primary outcome was all-cause mortality at 3-year follow-up. Inhospital ST or CVA occurred in 59 patients (0.32%) and in 90 patients (0. 49%), respectively. There were 2,149 deaths (11.7%) during the follow-up: 26 deaths among patients with ST, 32 deaths among patients with CVA, and 2,091 deaths among patients without ST or CVA (Kaplan-Meier estimates of 3-year mortality 45.3%, 38.0%, and 12.9%, odds ratio 6.1, 95% CI 3.6-10.2, P < .001 for ST group vs the group without ST or CVA and odds ratio 4.2 [2.7-6.6], P < .001 for CVA group vs the group without ST or CVA). There was no significant difference in the 3-year mortality between CVA and ST groups (P = .29). The Cox proportional hazards model showed that ST (adjusted hazard ratio 4.97, 95% CI 2.58-9.56, P < .001) and CVA (adjusted hazard ratio 2.25 [1.25-4.04], P = .006) were independently associated with the increased risk of 3-year mortality. Inhospital ST and CVA after PCI are associated with the increased risk of 3-year mortality. Both events seem to have a similar impact on long-term survival. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Maeng, Michael

    2015-01-01

    -coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population. DESIGN: The multicenter SORT OUT VII trial (NCT01879358...

  17. 2-year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare-metal coronary stents: results from the WDHR (Western Denmark Heart Registry)

    DEFF Research Database (Denmark)

    Kaltoft, Anne; Jensen, Lisette Okkels; Maeng, Michael

    2009-01-01

    OBJECTIVES: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). BACKGROUND: Drug-eluting stents may increase the risk of stent thrombosis (ST...

  18. Biodegradable and bioabsorbable stents.

    Science.gov (United States)

    Waksman, Ron; Pakala, Rajbabu

    2010-01-01

    Angioplasty of the coronary arteries has made significant headway in the past 20 years as a treatment for atherosclerotic vascular disease. Though drug-eluting stents are effective, they appear to invoke a thrombogenic response. Biodegradable stents are a promising alternative to permanent stents and may eventually be used to solve the lingering problem of in-stent restenosis. Additionally, fully degradable stents have the ability to deliver more drugs to the target site than a thin coating of drug on metallic stents. A variety of degradable materials have been studied for stent design, including polyesters, polycarbonates, bacterial-derived polymers, and corrodible metals. The ideal biodegradable stent would be reliably deployable under fluoroscopic guidance and situate into the target lesion with minimal endovascular trauma. The stent should degrade into nontoxic byproducts and invoke a minimal degree of inflammation at the target site. Finally, the stent itself should disappear within months (to years) without significant displacement from the deployment site. Although initial data from clinical trials have been sufficient to bring biodegradable materials into the realm of feasibility, future research is undoubtedly necessary to resolve the critical issues of inflammation and mechanical stability.

  19. Evaluation of acrylate-based block copolymers prepared by atom transfer radical polymerization as matrices for paclitaxel delivery from coronary stents.

    Science.gov (United States)

    Richard, Robert E; Schwarz, Marlene; Ranade, Shrirang; Chan, A Ken; Matyjaszewski, Krzysztof; Sumerlin, Brent

    2005-01-01

    Acrylate-based block copolymers, synthesized by atom transfer radical polymerization (ATRP) processes, were evaluated as drug delivery matrices for the controlled release of paclitaxel from coronary stents. The polymers were multiblock copolymers consisting of poly(butyl acrylate) or poly(lauryl acrylate) soft blocks and hard blocks composed of poly(methyl methacrylate), poly(isobornyl acrylate), or poly(styrene) homo- or copolymers. Depending on the ratio of hard to soft blocks in the copolymers, coating formulations were produced that possessed variable elastomeric properties, resulting in stent coatings that maintained their integrity when assessed by scanning electron microscopy (SEM) imaging of overexpanded stents. In vitro paclitaxel release kinetics from coronary stents coated with these copolymers typically showed an early burst followed by sustained release behavior, which permitted the elution of the majority of the paclitaxel over a 10-day time period. It was determined that neither the nature of the polyacrylate (n-butyl or lauryl) nor that of the hard block appeared to affect the release kinetics of paclitaxel at a loading of 25% drug by weight, whereas some effects were observed at lower drug loading levels. Differential scanning calorimetry (DSC) analysis indicated that the paclitaxel was at least partially miscible with the poly(n-butyl acrylate) phase of those block copolymers. The copolymers were also evaluated for sterilization stability by exposing both the copolymer alone and copolymer/paclitaxel coated stents to e-beam radiation at doses of 1-3 times the nominal dose used for medical device sterilization (25 kGy). It was found that the copolymers containing blocks bearing quaternary carbons within the polymer backbone were less stable to the radiation and showed a decrease in molecular weight as determined by gel-permeation chromatography. Conversely, those without quaternary carbons showed no significant change in molecular weight when

  20. Biodegradable polymer-based, argatroban-eluting, cobalt-chromium stent (JF-04) for treatment of native coronary lesions: final results of the first-in-man study and lessons learned.

    Science.gov (United States)

    Morino, Yoshihiro; Tobaru, Tetsuya; Yasuda, Satoshi; Kataoka, Kazuaki; Tanabe, Kengo; Hirohata, Atsushi; Kozuma, Ken; Kimura, Takeshi

    2016-11-20

    The aim of the study was to investigate the six-month angiographic and nine-month clinical follow-up outcomes in a first-in-man study using the biodegradable polymer-based cobalt-chromium argatroban-eluting stent (JF-04) for treatment of native coronary atherosclerotic lesions. A total of 31 patients with either stable or unstable angina, or silent myocardial ischaemia, exhibiting de novo coronary lesions were enrolled at seven Japanese sites. The lesions were treated with the JF-04 stent after predilatation. The primary endpoint was angiographic in-stent late loss six months after implantation. The secondary endpoints included angiographic restenosis and in-stent volume obstruction by intravascular ultrasound at six months and target vessel failure (TVF) at nine months. Procedural success was achieved in 100% of cases. At six months, angiographic in-stent late loss was 1.01±0.48 mm and binary restenosis was observed in nine cases (29.0%). Among these restenotic cases, most (n=8) demonstrated advanced angiographic restenosis patterns, including diffuse/proliferative restenosis and total occlusion. At nine months, TVF was observed in four cases (12.9%), exclusively attributed to target vessel revascularisation. This argatroban-eluting stent failed to inhibit neointimal hyperplasia sufficiently, despite the theoretical benefits and promising clinical experience with local drug delivery.

  1. Acute thrombosis during left main stenting using tap technique in a patient presenting with non-ST-segment elevation acute coronary syndrome

    Energy Technology Data Exchange (ETDEWEB)

    Natarajan, Deepak, E-mail: deepaknatarajan@me.com

    2015-06-15

    This case reports the sudden development of large burden of thrombi in the left anterior descending coronary artery immediately following distal left main stenting using TAP technique in a middle aged man who presented with non ST-segment elevation acute coronary syndrome despite having been administered 7,500 units of unfractionated heparin and being given 325 mg of aspirin and 60 mg of prasugrel prior to the procedure. The thrombi were managed effectively by giving an intra-coronary high bolus dose of tirofiban (25 mcg/kg) without the need for catheter thrombus extraction. Tirofiban intra-venous infusion was maintained for 18 hours, and the patient was discharged in stable condition on the third day. Importantly there is no controlled study on upstream administration of glycoprotein IIb/IIIa inhibitors in addition to the newer more potent anti-platelet agents in patients with unprotected distal left main disease presenting with non ST-segment elevation acute coronary syndrome, nor is there any data on safety and efficacy of mandatory usage of injectable anti-platelet agents at the start of a procedure in a catheterization laboratory in such a setting.

  2. Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration.

    Science.gov (United States)

    Tcheng, James E; Crowley, Jay; Tomes, Madris; Reed, Terrie L; Dudas, Joseph M; Thompson, Kweli P; Garratt, Kirk N; Drozda, Joseph P

    2014-10-01

    Although electronic product identification in the consumer sector is ubiquitous, unique identification of medical devices is just being implemented in 2014. To evaluate unique device identifiers (UDIs) in health care, the US Food and Drug Administration (FDA) funded the Medical Device Epidemiology Network initiative, including a demonstration of the implementation of coronary stent UDI data in the information systems of a multihospital system (Mercy Health). This report describes the first phase of the demonstration. An expert panel of interventional cardiologists nominated by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions was convened with representatives of industry, health system members of the Healthcare Transformation Group, the American College of Cardiology National Cardiovascular Data Registry, and FDA to articulate concepts needed to best use UDI-associated data. The expert panel identified 3: (1) use cases for UDI-associated data (eg, research), (2) a supplemental data set of clinically relevant attributes (eg, stent dimensions), and (3) governance and administrative principles for the authoritative management of these data. Eighteen use cases were identified, encompassing clinical care, supply chain management, consumer information, research, regulatory, and surveillance domains. In addition to the attributes of the FDA Global Unique Device Identification Database, 9 additional coronary stent-specific attributes were required to address use case requirements. Recommendations regarding governance were elucidated as foundational principles for UDI-associated data management. This process for identifying requisite extensions to support the effective use of UDI-associated data should be generalizable. Implementation of a UDI system for medical devices must anticipate both global and device-specific information. Copyright © 2014 Mosby, Inc. All rights reserved.

  3. Coronary aneurysm formation after primary coronary angioplasty

    NARCIS (Netherlands)

    Pavlakis, Georgios P.; Stella, Pieter R.

    2008-01-01

    We describe the case of a man who underwent primary angioplasty with stenting for acute myocardial infarction and subsequently developed a coronary artery aneurysm at the site of stent deployment. The aneurysm grew rapidly in size over a few weeks and required treatment with a covered stent. The use

  4. Novel management strategy for coronary steal syndrome: case report of occlusion of a LIMA graft side branch with a combination of drug-eluting and covered-stent deployment.

    LENUS (Irish Health Repository)

    Hynes, Brian G

    2009-11-01

    We report a novel percutaneous therapeutic approach to the management of suspected coronary artery steal syndrome resulting from a large side branch of the left internal mammary artery bypass graft, using a combination of coated and drug-eluting stents. We demonstrate the feasibility and long-term efficacy of this strategy in a case report.

  5. Long-term forecasting and comparison of mortality in the Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial: Prospective validation of the SYNTAX Score II

    NARCIS (Netherlands)

    C.A.M. Campos (Carlos); D. van Klaveren (David); V. Farooq (Vasim); C. Simonton (Charles); A.P. Kappetein (Arie Pieter); J.F. Sabik (Joseph); E.W. Steyerberg (Ewout); G.W. Stone (Gregg); P.W.J.C. Serruys (Patrick)

    2015-01-01

    textabstractAims To prospectively validate the SYNTAX Score II and forecast the outcomes of the randomized Evaluation of the Xience Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) Trial. Methods and results Evaluation of the

  6. Procedural and early clinical outcomes of patients with de novo coronary bifurcation lesions treated with the novel Nile PAX dedicated bifurcation polymer-free paclitaxel coated stents: Results from the prospective, multicentre, non-randomised BIPAX clinical trial

    NARCIS (Netherlands)

    R.A. Costa (Ricardo); A.C. Abizaid (Alexandre); A.C. Abizaid (Alexandre); B.G. Del Blanco (Bruno Garcia); J. Berland (Jacques); I. Petrov (Ivo); P. Brenot (Philippe); R.J. van Guens; T. Royer (Thierry); M. Rubino (Maurizio); M. Lesiak (MacIej); J. Fajadet (Jean)

    2012-01-01

    textabstractAims: To demonstrate the acute and early outcomes of the novel Nile PAX dedicated polymer-free paclitaxel-coated stents (Minvasys SAS, Gennevilliers, France) in the treatment of de novo coronary bifurcation lesions. Methods and results: The Nile PAX device incorporates a cobalt-chromium

  7. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Kyung

    2012-03-01

    Full Text Available Abstract Background Second-generation drug-eluting stents (DES have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES. In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI. A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES and antiplatelet regimen (TAT vs DDAT. The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734.

  8. Clinical outcome of titanium-nitride-oxide-coated cobalt-chromium stents in patients with de novo coronary lesions: 12-month results of the OPTIMAX first-in-man study.

    Science.gov (United States)

    Karjalainen, Pasi P; Mikkelsson, Jussi; Paana, Tuomas; Nammas, Wail

    2016-03-01

    We explored the 12-month clinical outcome of the titanium-nitride-oxide-coated OPTIMAX stent based on cobalt-chromium platform. The OPTIMAX stent demonstrated a satisfactory 6-month clinical outcome in de novo coronary lesions. We enrolled 224 consecutive symptomatic patients with significant (50%) stenosis in de novo coronary lesions, who were treated with OPTIMAX stent implantation. The primary endpoint was major adverse cardiac events at 12-month follow-up, defined as a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Stent thrombosis was adjudicated according to the definition of the Academic Research Consortium. The mean age of the cohort was 67 ± 8 years (75% males). Patients presented with acute coronary syndrome in 62.1%. Radial access was used in 92%; complex (type B and C) lesions were treated in 79.9%. Both procedural and clinical success occurred in 100% of the cases. The mean follow-up period was 366 ± 22 days. At 12-month follow-up, the primary endpoint occurred in 14 (6.3%) patients. Cardiac death occurred in three (1.3%) patients, non-fatal MI in seven (3.1%) patients, and ischemia-driven TLR in seven (3.1%) patients. No definite stent thrombosis occurred. In the current prospective observational study, implantation of the OPTIMAX stent demonstrated an adequate 12-month clinical outcome, with a low rate of major adverse cardiac events, and no stent thrombosis. © 2015 Wiley Periodicals, Inc.

  9. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734. PMID:22463698

  10. Long-Term Survival and Repeat Coronary Revascularization in Dialysis Patients Following Surgical and Percutaneous Coronary Revascularization with Drug-Eluting and Bare Metal Stents in the United States

    Science.gov (United States)

    Shroff, Gautam R.; Solid, Craig A.; Herzog, Charles A.

    2013-01-01

    Background Few published data describe long-term survival of dialysis patients undergoing surgical versus percutaneous coronary revascularization in the era of drug-eluting stents (DES). Methods and Results Using United States Renal Data System data, we identified 23,033 dialysis patients who underwent coronary revascularization (6178 coronary artery bypass grafting [CABG], 5011 bare-metal stent [BMS], 11,844 DES), 2004–2009. Revascularization procedures decreased from 4347 in 2004 to 3344 in 2009. DES use decreased by 41% and BMS use increased by 85% 2006–2007. Long-term survival was estimated by the Kaplan-Meier method and independent predictors of mortality examined in a comorbidity-adjusted Cox model. In-hospital mortality for CABG patients was 8.2%; all-cause survival at 1, 2, and 5 years was 70%, 57%, and 28% respectively. In-hospital mortality for DES patients was 2.7%; 1, 2, and 5 year survival was 71%, 53%, and 24% respectively. Independent predictors of mortality were similar in both cohorts: age >65 years, white race, dialysis duration, peritoneal dialysis, and congestive heart failure, but not diabetes. Survival was significantly higher for CABG patients who received internal mammary grafts (IMG) (HR 0.83, Prevascularization accounting for the competing risk of death was 18% with BMS, 19% with DES, and 6% with CABG at 1 year. Conclusions Among dialysis patients undergoing coronary revascularization, in-hospital mortality was higher after CABG but long-term survival was superior with IMGs. In-hospital mortality was lower for DES patients, but probability of repeat revascularization was higher and comparable to BMS patients. Revascularization decisions for dialysis patients should be individualized. PMID:23572500

  11. 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents

    DEFF Research Database (Denmark)

    Galløe, Anders M.; Kelbæk, Henning; Thuesen, Leif

    2017-01-01

    . During the follow-up period, MACE occurred in 346 (32.5%) in the group receiving a sirolimus-eluting stent and in 342 (33.1%) in the group receiving a paclitaxel-eluting stent (hazard ratio: 0.96; 95% confidence interval: 0.83 to 1.11; p = 0.60), with a steady annual rate of 2.6% after the first year...

  12. Clinical characteristics predict benefits from eptifibatide therapy during coronary stenting: insights from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy (ESPRIT) trial.

    Science.gov (United States)

    Puma, Joseph A; Banko, Lesan T; Pieper, Karen S; Sacchi, Terrence J; O'Shea, J Conor; Dery, Jean Pierre; Tcheng, James E

    2006-02-21

    In order to determine a differential benefit from treatment, we compared the long-term outcome of high-risk versus low-risk patients and evaluated survival free from death or myocardial infarction at one year. Newer anticoagulant strategies during percutaneous coronary intervention have necessitated a reanalysis of the role of intravenous GP IIb/IIIa inhibitors. The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy trial randomized 2,064 patients undergoing nonurgent coronary stent implantation to eptifibatide or placebo. High-risk characteristics were defined as age >75 years, diabetes, elevated cardiac markers, ST-segment elevation myocardial infarction within 7 days, or unstable angina within 48 h of randomization. Age <5 years, absence of diabetes, and any other reason for admission were considered low risk characterstics. There were 1,018 patients in the high-risk group (50.8% eptifibatide, 49.2% placebo) and 1,045 patients in the low-risk group (50.0% eptifibatide, 50.0% placebo). Baseline demographics were similar in both groups except for more hypertension (63% vs. 55%, respectively), peripheral vascular disease (8.2% vs. 5.2%, respectively), prior stroke (5.5% vs. 3.2%, respectively), and female gender (33% vs. 22%, respectively) in the high-risk than the low-risk group. At one year, the composite end point of death or myocardial infarction occurred in 15.89% of placebo patients and 7.99% of eptifibatide patients in the high-risk group and 9.02% of the placebo and 8.11% of eptifibatide patients in the low-risk group. Although eptifibatide treatment improved outcomes for all patients, preprocedural clinical characteristics can define a subgroup of patients who may derive greatest benefit from its use during coronary stent placement.

  13. Long term outcomes of new generation drug eluting stents versus coronary artery bypass grafting for multivessel and/or left main coronary artery disease. A Bayesian network meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Mina, George S; Watti, Hussam; Soliman, Demiana; Shewale, Anand; Atkins, Jessica; Reddy, Pratap; Dominic, Paari

    2018-01-05

    Most data guiding revascularization of multivessel disease (MVD) and/or left main disease (LMD) favor coronary artery bypass grafting (CABG) over percutaneous coronary intervention (PCI). However, those data are based on trials comparing CABG to bare metal stents (BMS) or old generation drug eluting stents (OG-DES). Hence, it is essential to outcomes of CABG to those of new generation drug eluting stents (NG-DES). We searched PUBMED and Cochrane database for trials evaluating revascularization of MVD and/or LMD with CABG and/or PCI. A Bayesian network meta-analysis was performed to calculate odds ratios (OR) and 95% credible intervals (CrI). Primary outcome was major adverse cardiovascular events (MACE) at 3-5 years. Secondary outcomes were mortality, cerebrovascular accidents (CVA), myocardial infarction (MI) and repeat revascularization. We included 10 trials with a total of 9287 patients. CABG was associated with lower MACE when compared to BMS or OG-DES. However, MACE was not significantly different between CABG and NG-DES (OR 0.79, CrI 0.45-1.40). Moreover, there were no significant differences between CABG and NG-DES in mortality (OR 0.78, CrI 0.45-1.37), CVA (OR 0.93 CrI 0.35-2.2) or MI (OR 0.6, CrI 0.17-2.0). On the other hand, CABG was associated with lower repeat revascularization (OR 0.55, CrI 0.36-0.84). Our study suggests that NG-DES is an acceptable alternative to CABG in patients with MVD and/or LMD. However, repeat revascularization remains to be lower with CABG than with PCI. Copyright © 2018. Published by Elsevier Inc.

  14. A modern generation of drug-eluting stents. Focusing on a sirolimus-eluting stent Calypso

    Directory of Open Access Journals (Sweden)

    А. Н. Кудряшов

    2017-04-01

    Full Text Available The review deals with the evolution of interventional coronary procedures and development of the state-of-art coronary stent market. Emphasis in the review is placed on comprehensive analysis of technical characteristics of the world’s most popular coronary stents versus a Russian bioresorbable sirolimus-eluting stent “Calipso”.Received 13 January 2017. Accepted 17 March 2017.Conflict of interest: Kudryashov A.N., Trebushat D.V. are “Angioline” Company employees, the producer of “Kalipso” coronary stent. Kretov E.I. served as executive editor of “Endovascular surgery” section. All other authors declare no conflict of interest.

  15. Drug-eluting balloon versus bare-mental stent and drug-eluting stent for de novo coronary artery disease: A systematic review and meta-analysis of 14 randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Kongyong Cui

    Full Text Available Drug-eluting balloon (DEB has become an alternative option to drug-eluting stent (DES for the treatment of in-stent restenosis (ISR. However, the effect of drug-eluting balloon with regular bare-mental stent (BMS in de novo coronary artery disease (CAD is unclear. This meta-analysis aimed to evaluate the efficacy of DEB with regular BMS compared to BMS or DES in de novo CAD.Randomized controlled trials (RCTs assessing the efficacy of DEB+BMS in comparison with BMS or DES were obtained by searching the PubMed, EMBASE, and Cochrane Library databases through January 2016. Primary endpoints were major adverse cardiac events (MACEs and late lumen loss (LLL. Secondary endpoints included death, myocardial infarction (MI, target lesion revascularization (TLR, stent thrombosis (ST, binary restenosis, and minimum lumen diameter (MLD. Dichotomous and continuous data were presented as odds ratios (ORs and mean differences (MDs with 95% confidence intervals (CIs, respectively, and analyzed using a random-effects model.A total of 14 RCTs involving 2281 patients were included in this meta-analysis. DEB+BMS showed significantly less MACEs (OR: 0.67, 95%CI 0.45 to 0.99, P = 0.04 and reduced LLL (MD: -0.30 mm, 95%CI: -0.48 mm to -0.11 mm, P = 0.001 compared with BMS. Meanwhile, treatment with DEB+BMS had disadvantages over DES in terms of MACEs (OR: 1.94, 95%CI 1.24 to 3.05, P = 0.004, LLL (MD: 0.20 mm, 95%CI: 0.07 mm to 0.33 mm, P = 0.003, TLR (OR: 2.53, 95% CI 1.36 to 4.72, P = 0.003, and MLD (MD: -0.25 mm, 95%CI: -0.42 mm to -0.09 mm, P = 0.003.This limited evidence demonstrated that treatment with DEB+BMS appears to be effective in de novo CAD. In addition, DEB+ BMS clearly showed superiority to BMS, but is inferior to DES in the treatment of patients with de novo CAD. Hence, DES (especially new generation DES should be recommended for patients with de novo CAD.

  16. Contribution of quantitative coronary angiography in Palmaz-Schatz optimal stent liberation strategy for subacute occlusion control; Contribuicao da angiografia coronaria quantitativa na estrategia de liberacao otima da endoprotese de Palmaz-Schatz para o controle da oclusao subaguda

    Energy Technology Data Exchange (ETDEWEB)

    Sousa, Amanda Guerra de Moraes Rego

    1995-07-01

    This study examines whether a single method, quantitative coronary angiography with automated edge detection, could efficiently guide optimal stent liberation, assuring good clinical results and eliminating the need for anticoagulation therapy. This investigation includes 101 patients with optimal implantation of 104 Palmaz-stents. Their mean age was 58.62 years and 79.2% were male. Most of them presented unstable angina (61.39%) and had single vessel disease (85.15%) The treated vessel was the left anterior descending artery in 39.60%; the right coronary artery in 34.66%; the left circumflex artery in 7.92% and saphenous vein grafts in 17.82%. The mean reference diameter of the target vessel was 3.43 mm. Each implantation comprehended two phases: initial stent liberation and additional high pressure balloon inflation, guided by quantitative coronary angiography. Arterial quantification showed an important increase in the mean luminal diameter (p<0.001), characterized by an immediate gain of 2.37 mm [standard deviation (SD): 0.55 m]. Quantitative angiography permitted to identify a further gain in the luminal diameter following the high pressure balloon inflation, o.49 mm 9 SD:0.53 mm). Therefore, the total mean immediate gain was 2.85 mm (SD:0.64 mm). The mean diameter stenosis changed from 80.21% (SD:14.56%) to 11.81% (SD: 7.59% - p<0.001) after initial stent delivery; and to 0.16% (SD:3.45% - p<,0.001), after high pressure balloon inflation. Quantitative coronary angiography performed detailed measurements of the minimal caliber variations along the entire prosthesis due to the high pressure balloon inflations, similarly to the intracoronary ultrasound. This guided the optimal stent implantation and helped the clinical management of these cases. In this series, even maintained only under antiaggregant agents, no patient presented major ischemic complications and only one (0.99%) had a hemorrhage in the puncture site that required blood transfusion. The mean in

  17. MR stress perfusion for the detection of flow-limiting stenoses in symptomatic patients with known coronary artery disease and history of stent implantation; MR-Stressperfusion zur Vorhersage flusslimitierender Stenosen bei symptomatischen Patienten mit bekannter KHK nach Stentimplantation

    Energy Technology Data Exchange (ETDEWEB)

    Seeger, A.; Klumpp, B.; Kramer, U.; Fenchel, M.; Claussen, C.D.; Miller, S. [Universitaetsklinikum Tuebingen (Germany). Radiologische Diagnostik; Doesch, C.; Hoevelborn, T.; Gawaz, M.; May, A.E. [Universitaetsklinikum Tuebingen (Germany). Innere Medizin III

    2007-10-15

    Purpose: The aim of the present study was to determine the correlation of myocardial perfusion MR imaging (MPMRI) and coronary angiography for the detection of flow-limiting stenosis in symptomatic patients with known coronary artery disease and a history of intervention. Materials and Methods: MPMRI was performed in 51 symptomatic patients (44 male, 64.7 {+-} 9.5 years) with known coronary artery disease and a history of stent implantation (between 5 years and 2 weeks prior to MRI). Malperfused myocardial regions were correlated with findings of coronary angiography. A stenosis of > 70 % was regarded as hemodynamically significant. Results: In MPMRI 37 patients (73 %) showed a stress induced perfusion deficit. In 35 of these patients coronary angiography revealed a stenosis of > 70 %. A total of 38 patients (75 %) showed stenoses of > 70 %. MPMRI yielded a sensitivity of 92 % with a specificity of 85 %. The positive predictive value was 95 % and negative predictive value was 79 %. The assignment of malperfused segments to coronary artery territories was carried out according to the standardized myocardial model of the American Heart Association (sensitivity/specificity was 59/85 % for RCA, 79/81 % for LAD and 54/68 % for LCX). Conclusion: MPMRI is a suitable non-invasive method for detecting flow-limiting coronary artery stenoses in patients with a history of stent implantation. (orig.)

  18. ANALYSIS OF OUTPATIENT PHYSICIANS, PRESCRIPTION OF DISAGGREGANT THERAPY FOR PATIENTS AFTER ACUTE MYOCARDIAL INFARCTION AND/OR CORONARY ANGIOPLASTY WITH STENT IMPLANTATION WITHIN THE RECVAD REGISTRY

    Directory of Open Access Journals (Sweden)

    A. V. Zagrebelnyi

    2015-01-01

    Full Text Available Objective: to estimate the quality of antiaggregants therapy in patients with coronary heart disease in outpatient settings. Materials and methods. The data of the retrospective outpatient RECVAD registry (3690 patients who lived in Ryazan and its Region and had evidence in their outpatient medical records for one of the diagnoses, such as coronary heart disease, hypertension, chronic heart failure, atrial fibrillation, or their concurrence, were used. Forty­nine patients after acute myocardial infarction (AMI and/or percutaneous coro­ nary interventions (PCI with stenting ≤ 1 year before their inclusion in the registry, who were to undergo dual antiaggregant therapy (DAT according to current clinical guidelines (CG, were identified among 427 patients after AMI and/or PCI with coronary angioplasty. Contra­ indications to DAT were simultaneously revealed and a relationship of the use of therapy to their presence was compared. Results. Among the 49 patients who had indications for DAT that was used in 15 (30.6 % cases and that was not in 3 (6.1 % patients in the presence of contraindications, 25 (51.0 % did not receive DAT in the absence of contraindications and 6 (12.3 % patients received the therapy in the presence of contraindications. Conclusion. DAT prescribed by outpatient physicians does not always meet the current CG. There are cases of not using DAT in the presence of obvious indications for DAT and, on the contrary, those of its use in the presence of contraindications. 

  19. Negative vascular remodelling after implantation of bioabsorbable magnesium alloy stents in porcine coronary arteries: a randomised comparison with bare-metal and sirolimus-eluting stents

    DEFF Research Database (Denmark)

    Maeng, M; Jensen, Lisette Okkels; Falk, E

    2009-01-01

    randomly implanted in 31 porcine coronary arteries (n = 11 pigs). MAIN OUTCOME MEASURES: Neointima formation was measured by histomorphometry at 90 days. Vascular remodelling defined as change in external elastic membrane area from index intervention to follow-up was assessed by serial intravascular...

  20. Sirolimus-eluting versus bare-metal stent implantation in patients with ostial lesions

    DEFF Research Database (Denmark)

    Jørgensen, Erik; Kelbæk, Henning; Kløvgaard, Lene

    2010-01-01

    To investigate the efficacy of implantation of sirolimus-eluting stents (SES) in the ostium of coronary arteries.......To investigate the efficacy of implantation of sirolimus-eluting stents (SES) in the ostium of coronary arteries....

  1. Influence of initial acute myocardial infarction presentation on the outcome of surgical procedures after coronary stent implantation: a report from the CREDO-Kyoto PCI/CABG Registry Cohort-2.

    Science.gov (United States)

    Tokushige, Akihiro; Shiomi, Hiroki; Morimoto, Takeshi; Ono, Koh; Furukawa, Yutaka; Nakagawa, Yoshihisa; Kadota, Kazushige; Iwabuchi, Masashi; Shizuta, Satoshi; Tada, Tomohisa; Tazaki, Junichi; Kato, Yoshihiro; Hayano, Mamoru; Abe, Mitsuru; Hamasaki, Shuichi; Tei, Chuwa; Nakashima, Hitoshi; Mitsudo, Kazuaki; Nobuyoshi, Masakiyo; Kita, Toru; Kimura, Takeshi

    2013-01-01

    Several previous publications have consistently reported that surgical procedures performed early after coronary stenting were associated with significantly higher risk for ischemic events than those performed late. In the current post hoc analysis of the Coronary REvascularization Demonstrating Outcome Study in Kyoto PCI/coronary artery bypass grafting Registry Cohort-2, we compared the outcomes of early (within 42 days) versus late surgery (beyond 42 days) after coronary stenting stratified by the initial clinical presentations [acute myocardial infarction (AMI) [early N = 153, and late N = 586] and non-AMI (early N = 202, and late N = 1457)]. Cumulative incidence of death/myocardial infarction/stent thrombosis at 30 days after surgery was significantly higher in the early group than in the late group in the AMI stratum [18.4 vs. 2.6 %, P presentation and the timing of surgery (P interaction = 0.03). Deaths in patients with early surgery in the AMI stratum were mostly related to preoperative complications of AMI (76 %), but not related to perioperative stent-related complications (4.0 %). In conclusion, significantly higher risk of early versus late surgery for perioperative ischemic events was seen only in patients with initial AMI presentation, but not in patients with non-AMI presentation. Previous observations suggesting higher risk in early surgery might not be related to the timing after stent implantation per se, but related to more morbid preoperative conditions in patients who underwent early surgery.

  2. Clinical outcomes after final kissing balloon inflation compared with no final kissing balloon inflation in bifurcation lesions treated with a dedicated coronary bifurcation stent.

    Science.gov (United States)

    Grundeken, Maik J; Lesiak, Maciej; Asgedom, Solomon; Garcia, Eulogio; Bethencourt, Armando; Norell, Michael S; Damman, Peter; Woudstra, Pier; Koch, Karel T; Vis, M Marije; Henriques, Jose P; Tijssen, Jan G; Onuma, Yoshinobu; Foley, David P; Bartorelli, Antonio L; Stella, Pieter R; de Winter, Robbert J; Wykrzykowska, Joanna J

    2014-03-01

    We evaluated differences in clinical outcomes between patients who underwent final kissing balloon inflation (FKBI) and patients who did not undergo FKBI in bifurcation treatment using the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina, USA). Clinical outcomes were defined as target vessel failure (composite of cardiac death, any myocardial infarction and clinically indicated target vessel revascularisation), cardiac death, myocardial infarction (MI), clinically indicated target vessel revascularisation and stent thrombosis. Cumulative event rates were estimated using the Kaplan-Meier method. A multivariable logistic regression analysis was performed to evaluate which factors were potentially associated with FKBI performance. Follow-up data was available in 717 (96%) patients with a median follow-up of 190 days. Cardiac death at 1 year occurred more often in the no-FKBI group (1.7% vs 4.6%, respectively, p=0.017), although this difference was no longer observed after excluding patients presenting with ST segment elevation MI (1.6% vs 3.3%, p=0.133). No significant differences were observed concerning the other clinical outcomes. One-year target vessel failure rates were 10.1% in the no-FKBI group and 9.2% in the FKBI group (p=0.257). Multivariable logistic regression analysis identified renal dysfunction, ST segment elevation MI as percutaneous coronary intervention indication, narrow (<30°) bifurcation angle and certain stent platforms as being independently associated with unsuccessful FKBI. A lower cardiac death rate was observed in patients in whom FKBI was performed compared with a selection of patients in whom FKBI could not be performed, probably explained by an unbalance in the baseline risk profile of the patients. No differences were observed regarding the other clinical outcomes.

  3. One Versus 2-stent Strategy for the Treatment of Bifurcation Lesions in the Context of a Coronary Chronic Total Occlusion. A Multicenter Registry.

    Science.gov (United States)

    Ojeda, Soledad; Azzalini, Lorenzo; Chavarría, Jorge; Serra, Antonio; Hidalgo, Francisco; Benincasa, Susanna; Gheorghe, Livia L; Diletti, Roberto; Romero, Miguel; Bellini, Barbara; Gutiérrez, Alejandro; Suárez de Lezo, Javier; Mazuelos, Francisco; Segura, José; Carlino, Mauro; Colombo, Antonio; Pan, Manuel

    2017-11-08

    There is little evidence on the optimal strategy for bifurcation lesions in the context of a coronary chronic total occlusion (CTO). This study compared the procedural and mid-term outcomes of patients with bifurcation lesions in CTO treated with provisional stenting vs 2-stent techniques in a multicenter registry. Between January 2012 and June 2016, 922 CTO were recanalized at the 4 participating centers. Of these, 238 (25.8%) with a bifurcation lesion (side branch ≥ 2mm located proximally, distally, or within the occluded segment) were treated by a simple approach (n=201) or complex strategy (n=37). Propensity score matching was performed to account for selection bias between the 2 groups. Major adverse cardiac events (MACE) consisted of a composite of cardiac death, myocardial infarction, and clinically-driven target lesion revascularization. Angiographic and procedural success were similar in the simple and complex groups (94.5% vs 97.3%; P=.48 and 85.6% vs 81.1%; P=.49). However, contrast volume, radiation dose, and fluoroscopy time were lower with the simple approach. At follow-up (25 months), the MACE rate was 8% in the simple and 10.8% in the complex group (P=.58). There was a trend toward a lower MACE-free survival in the complex group (80.1% vs 69.8%; P=.08). After propensity analysis, there were no differences between the groups regarding immediate and follow-up results. Bifurcation lesions in CTO can be approached similarly to regular bifurcation lesions, for which provisional stenting is considered the technique of choice. After propensity score matching, there were no differences in procedural or mid-term clinical outcomes between the simple and complex strategies. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  4. Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial.

    Science.gov (United States)

    Ariotti, Sara; Adamo, Marianna; Costa, Francesco; Patialiakas, Athanasios; Briguori, Carlo; Thury, Attila; Colangelo, Salvatore; Campo, Gianluca; Tebaldi, Matteo; Ungi, Imre; Tondi, Stefano; Roffi, Marco; Menozzi, Alberto; de Cesare, Nicoletta; Garbo, Roberto; Meliga, Emanuele; Testa, Luca; Gabriel, Henrique Mesquita; Ferlini, Marco; Vranckx, Pascal; Valgimigli, Marco

    2016-03-14

    This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease. DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns. The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization. Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p ZEUS]; NCT01385319). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. The paclitaxel-eluting PTCA-balloon in combination with a cobalt-chromium stent in two different sequences to treat de novo coronary artery lesions: an angiographic follow up study.

    Science.gov (United States)

    Kaul, Upendra; Unverdorben, Martin; Degenhardt, Ralf; Seth, Ashok; Bahl, Vinay K; Hiremath, Shirish M S; Chandra, Praveen; Mullesari, Ajit S; Sandhu, P S; Rao, Seshagiri; George, Oommen; Ackermann, Hanns; Boxberger, Michael

    2013-01-01

    The paclitaxel-coated balloon catheter (DCB) based on the PACCOCATH(®) technology has yielded angiographic and clinical results superior to drug-eluting stents (DES) in situations like in-stent restenosis (ISR) and a trend towards superior results in small coronary vessels and side branches of coronary bifurcations. Using the DCB followed by cobalt-chromium stent (CoCr) deployment or with a reverse sequence may yield different outcomes in terms of late loss. 97 patients with de-novo coronary stenosis (55.6 ± 10.7 years, 79.4% male, ≥70%, length: ≤25 mm, vessel diameter: 2.5-4.0 mm) were randomly treated with the DCB (3 μg/mm²) followed by a CoCr-stent or stent first and DCB later. Six-month angiographic and one-year clinical follow-up intention-to-treat analyses were performed. Angiographic and demographic baseline data was comparable between the two groups. When comparing balloon first versus stent first technique, the primary outcome variables were not statistically different for mean in-segment (0.51 ± 0.56 mm vs. 0.36 ± 0.55 mm, p = 0.23) and in-stent (0.52 ± 0.55 mm vs. 0.46 ± 0.52 mm, p = 0.65) late lumen loss. The lesion related 12-month MACE rates were 5/49 (10.2%) and 2/48 (4.2%) (p = 0.44). Lesion related thrombotic events occurred in three patients in balloon first and in one patient in stent first group, two of which were associated with early discontinuation of continuous dual anti-platelet therapy, two with suboptimal PCI, and one each were performed in a thrombotic lesion and a bifurcation type 1.1.0. Drug-coated balloon first followed by cobalt chromium stent deployment versus a reverse sequence is not associated with statistically significantly different 6-month angiographic or 12-month clinical outcomes. Copyright © 2013 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  6. Randomized, double-blind, multicenter study of the polymer-based 17-beta estradiol-eluting stent for treatment of native coronary artery lesions: six-month results of the ETHOS I trial.

    Science.gov (United States)

    Abizaid, Alexandre; Chaves, Aurea J; Leon, Martin B; Hauptmann, Karl; Mehran, Roxana; Lansky, Alexandra J; Baumbach, William; Shankar, Hari; Muller, Ralf; Feres, Fausto; Sousa, Amanda G M R; Sousa, J Eduardo; Grube, Eberhard

    2007-11-01

    The ETHOS I trial was the first in-human experience evaluating the safety and efficacy of two different release formulations of the 17-beta estradiol-eluting R-Stent versus uncoated control stents for the treatment of patients with single de novo native coronary lesions. Estrogens were reported to inhibit neointimal proliferation and to accelerate endothelial regeneration after coronary angioplasty and thus could be an ideal compound to deliver on a stent for the purpose of reducing in-stent restenosis. Ninety-five patients were randomized to receive a slow-release (n = 32) or the moderate release (n = 31) formulations or the bare metal stent (n = 32). The primary end point was the 6-month percent in-stent volume obstruction by intravascular ultrasound (IVUS). Diabetes was present in 29.5% of patients; the mean reference vessel diameter was 2.90 mm; and the mean lesion length was 13.5 mm. Primary endpoint, 6-month percent in-stent volume obstruction by IVUS, did not differ significantly between the 3 groups (31% +/- 14%, 33% +/- 11%, and 31% +/- 14%, P = 0.83). Secondary endpoints also did not differ significantly between the groups including 6-month rates of in-lesion binary angiographic restenosis (13.3%, 14.3%, and 12.5%, P = 0.98), in-stent late loss (0.82 +/- 0.49 mm, 0.86 +/- 0.53 mm, and 0.84 +/- 0.46 mm, P = 0.97), target lesion revascularization (12.5%, 6.9%, and 6.5%, P = 0.64), and major adverse cardiac events (18.8%, 10.3%, and 6.5%, P = 0.31). In this first-in-man randomized trial, the 17-beta estradiol-eluting R-Stent, in either slow- or moderate-release formulations, was well-tolerated, but showed no benefit for treatment of coronary lesions when compared to controls. (c) 2007 Wiley-Liss, Inc.

  7. 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.

  8. Complementary effects of thienopyridine pretreatment and platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention; results from the ESPRIT trial.