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Sample records for elective stenting trial

  1. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction

    NARCIS (Netherlands)

    Davids, P. H.; Groen, A. K.; Rauws, E. A.; Tytgat, G. N.; Huibregtse, K.

    1992-01-01

    Self-expanding metal stents are claimed to prolong biliary-stent patency, although no formal comparative trial between plastic and expandable stents has been done. In a prospective randomised trial, we assigned 105 patients with irresectable distal bile-duct malignancy to receive either a metal

  2. Emergency and elective implantation of covered stent systems in iatrogenic arterial injuries

    Energy Technology Data Exchange (ETDEWEB)

    Goltz, J.P.; Kickuth, R. [Universitaetsklinikum Wuerzburg (Germany). Inst. fuer Roentgendiagnostik; Bastuerk, P.; Hoppe, H.; Triller, J. [Universitaetsspital Bern (Switzerland). Inst. fuer Diagnostische, Interventionelle und Paediatrische Radiologie

    2011-07-15

    Purpose: To evaluate the effectiveness and safety of covered stents for the management of iatrogenic arterial injury. Materials and Methods: Between 03/1998 and 12/2009, 31 patients underwent selective covered stent implantation after iatrogenic arterial injury. 12/31 of these patients (38.7 %) were hemodynamically unstable. Six different endovascular covered stent types were utilized. The primary endpoints of this study were technical and clinical success and rates of minor and major complications. Results: Initial angiograms demonstrated active extravasation in 19 (61.3 %) patients and pseudoaneurysms in 12 (38.7 %) patients. The following sites of bleeding origin were detected: axillary artery, subclavian artery, common iliac artery, external iliac artery, internal iliac artery, common femoral artery, superficial femoral artery, popliteal and fibular artery, femoro-popliteal and popliteo-crural bypasses, common hepatic artery, aberrant hepatic artery, cystic and gastroduodenal artery. In all patients bleeding was effectively controlled by covered stent implantation resulting in an immediate technical success of 100 %. Clinical success attributed to covered stent implantation was documented in 30 of the 31 patients (96.8 %). Major complications included death in four patients (11.1 %), acute thrombosis with arm ischemia in one patient (2.8 %) and stent fracture with associated pseudoaneurysm in another patient (2.8 %). In 2/31 patients (6.5 %) covered stent failure was detected and successfully treated by implantation of a second covered stent. Conclusion: Emergency and elective implantation of covered stents may be used for minimally invasive and effective management of iatrogenic arterial injury. (orig.)

  3. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.

    Science.gov (United States)

    Kandzari, David E; Mauri, Laura; Koolen, Jacques J; Massaro, Joseph M; Doros, Gheorghe; Garcia-Garcia, Hector M; Bennett, Johan; Roguin, Ariel; Gharib, Elie G; Cutlip, Donald E; Waksman, Ron

    2017-10-21

    The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of

  4. Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study

    Directory of Open Access Journals (Sweden)

    Scholten Pieter

    2007-07-01

    Full Text Available Abstract Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS. Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures

  5. Acute Thrombosis after Elective Direct Intracoronary Stenting in Primary Antiphospholipid Syndrome: A Case Report

    Directory of Open Access Journals (Sweden)

    Ho-Ming Su

    2003-04-01

    Full Text Available Antiphospholipid syndrome (APS is an uncommon prothrombotic disorder that has been increasingly recognized in recent years. The diagnosis of APS must be associated with venous or arterial thrombosis or both. Patients with APS usually present with recurrent deep vein thrombosis, pulmonary thromboembolism, thromboembolic stroke, or myocardial infarction. Here, we report a case of a 61-year-old female who presented with a 3-month history of increasingly frequent retrosternal chest tightness. After treadmill test and thallium-201 myocardial perfusion scan, she was admitted and underwent elective coronary angiography but developed acute thrombosis after direct intracoronary stenting. She was successfully rescued with repeat percutaneous transluminal coronary angioplasty and prolonged heparin and glycoprotein IIb/IIIa antagonist use. Laboratory data showed prolongation of partial thromboplastin time and positive anti-cardiolipin antibody. These findings satisfied the criteria for APS; the patient was diagnosed with primary APS because she had neither typical symptoms nor signs of systemic lupus erythematosus or other immunologic disorders. Thereafter, long-term oral anticoagulant appeared to be effective. To our knowledge, this is the first report of acute stent thrombosis in a patient with primary APS.

  6. Early and long-term outcome of elective stenting of the infarct-related artery in patients with viability in the infarct-area: Rationale and design of the Viability-guided Angioplasty after acute Myocardial Infarction-trial (The VIAMI-trial

    Directory of Open Access Journals (Sweden)

    Visser Cees A

    2004-11-01

    Full Text Available Abstract Background Although percutaneous coronary intervention (PCI is becoming the standard therapy in ST-segment elevation myocardial infarction (STEMI, to date most patients, even in developed countries, are reperfused with intravenous thrombolysis or do not receive a reperfusion therapy at all. In the post-lysis period these patients are at high risk for recurrent ischemic events. Early identification of these patients is mandatory as this subgroup could possibly benefit from an angioplasty of the infarct-related artery. Since viability seems to be related to ischemic adverse events, we initiated a clinical trial to investigate the benefits of PCI with stenting of the infarct-related artery in patients with viability detected early after acute myocardial infarction. Methods The VIAMI-study is designed as a prospective, multicenter, randomized, controlled clinical trial. Patients who are hospitalized with an acute myocardial infarction and who did not have primary or rescue PCI, undergo viability testing by low-dose dobutamine echocardiography (LDDE within 3 days of admission. Consequently, patients with demonstrated viability are randomized to an invasive or conservative strategy. In the invasive strategy patients undergo coronary angiography with the intention to perform PCI with stenting of the infarct-related coronary artery and concomitant use of abciximab. In the conservative group an ischemia-guided approach is adopted (standard optimal care. The primary end point is the composite of death from any cause, reinfarction and unstable angina during a follow-up period of three years. Conclusion The primary objective of the VIAMI-trial is to demonstrate that angioplasty of the infarct-related coronary artery with stenting and concomitant use of abciximab results in a clinically important risk reduction of future cardiac events in patients with viability in the infarct-area, detected early after myocardial infarction.

  7. Stent

    Science.gov (United States)

    ... Drugs & Supplements Videos & Tools Español You Are Here: Home → Medical Encyclopedia → Stent URL of this page: //medlineplus.gov/ency/article/002303.htm Stent To use the sharing features on this page, please enable JavaScript. A stent is a tiny tube placed into a hollow structure in your ...

  8. Carotid Artery Stenting Trials: Conduct, Results, Critique, and Current Recommendations

    International Nuclear Information System (INIS)

    Macdonald, Sumaira

    2012-01-01

    The carotid stenting trialists have demonstrated persistence and determination in comparing an evolving technique, carotid artery stenting (CAS), against a mature and exacting standard for carotid revascularisation, carotid endarterectomy (CEA). This review focuses on their endeavours. A total of 12 1-on-1 randomised trials comparing CAS and CEA have been reported; 6 of these can be considered major, and 5 of these reflect (in part) current CAS standards of practice and form the basis of this review. At least 18 meta-analyses seeking to compare CAS and CEA exist. These are limited by the quality and heterogeneity of the data informing them (e.g., five trials were stopped prematurely such that they collectively failed to reach recruitment target by >4000 patients). The Carotid Stenting Trialists’ Collaboration Publication represents a prespecified meta-analysis of European trials that were sufficiently similar to allow valid conclusions to be drawn; these trials and conclusions will be explored. When the rate of myocardial infarction (MI) is rigorously assessed, CAS and CEA are equivalent for the composite end point of stroke/death and MI, with more minor strokes for CAS and more MIs for CEA. These outcomes have a discrepant impact on quality of life and subsequent mortality. The all-stroke death outcomes for patients <70 years old are equivalent, with more minor strokes occurring in the elderly during CAS than CEA. There are significantly more severe haematomas and cranial nerve injuries after CEA. The influence of experience on outcome cannot be underestimated.

  9. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    NARCIS (Netherlands)

    Ederle, J.; Dobson, J.; Featherstone, R.L.; Bonati, L.H.; Worp, H.B. van der; Borst, G.J. de; Lo, T.H.; Gaines, P.; Dorman, P.J.; Macdonald, S.; Lyrer, P.A.; Hendriks, J.M.; McCollum, C.; Nederkoorn, P.J.; Brown, M.M.; Blankensteijn, J.D.; Leeuw, F.E. de; Schultze Kool, L.J.; Vliet, J.A. van der; et al.,

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  10. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Jörg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molyneux, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Brooks, M.; Chambers, B.; Chan, A.; Chu, P.; Clark, D.; Dewey, H.; Donnan, G.; Fell, G.; Hoare, M.; Molan, M.; Roberts, A.; Roberts, N.; Beiles, B.; Bladin, C.; Clifford, C.; Grigg, M.; New, G.; Bell, R.; Bower, S.; Chong, W.; Holt, M.; Saunder, A.; Than, P. G.; Gett, S.; Leggett, D.; McGahan, T.; Quinn, J.; Ray, M.; Wong, A.; Woodruff, P.; Foreman, R.; Schultz, D.; Scroop, R.; Stanley, B.; Allard, B.; Atkinson, N.; Cambell, W.; Davies, S.; Field, P.; Milne, P.; Mitchell, P.; Tress, B.; Yan, B.; Beasley, A.; Dunbabin, D.; Stary, D.; Walker, S.; Cras, P.; d'Archambeau, O.; Hendriks, J. M. H.; van Schil, P.; St Blasius, A. Z.; Bosiers, M.; Deloose, K.; van Buggenhout, E.; de Letter, J.; Devos, V.; Ghekiere, J.; Vanhooren, G.; Astarci, P.; Hammer, F.; Lacroix, V.; Peeters, A.; Verbist, J.; Blair, J.-F.; Caron, J. L.; Daneault, N.; Giroux, M.-F.; Guilbert, F.; Lanthier, S.; Lebrun, L.-H.; Oliva, V.; Raymond, J.; Roy, D.; Soulez, G.; Weill, A.; Hill, M.; Hu, W.; Hudion, M.; Morrish, W.; Sutherland, G.; Wong, J.; Albäck, A.; Harno, H.; Ijäs, P.; Kaste, M.; Lepäntalo, M.; Mustanoja, S.; Paananen, T.; Porras, M.; Putaala, J.; Railo, M.; Sairanen, T.; Soinne, L.; Vehmas, A.; Vikatmaa, P.; Goertler, M.; Halloul, Z.; Skalej, M.; Brennan, P.; Kelly, C.; Leahy, A.; Moroney, J.; Thornton, J.; Koelemay, M. J. W.; Reekers, J. A. A.; Roos, Y. B. W. E. M.; Hendriks, J. M.; Koudstaal, P. J.; Pattynama, P. M. T.; van der Lugt, A.; van Dijk, L. C.; van Sambeek, M. R. H. M.; van Urk, H.; Verhagen, H. J. M.; Bruijninckx, C. M. A.; de Bruijn, S. F.; Keunen, R.; Knippenberg, B.; Mosch, A.; Treurniet, F.; van Dijk, L.; van Overhagen, H.; Wever, J.; de Beer, F. C.; van den Berg, J. S. P.; van Hasselt, B. A. A. M.; Zeilstra, D. J.; Boiten, J.; van Otterloo, J. C. A. de Mol; de Vries, A. C.; Lycklama a Nijeholt, G. J.; van der Kallen, B. F. W.; Blankensteijn, J. D.; de Leeuw, F. E.; Kool, L. J. Schultze; van der Vliet, J. A.; de Borst, G. J.; de Kort, G. A. P.; Kapelle, L. J.; Lo, T. H.; Mali, W. P. Th M.; Moll, F.; van der Worp, H. B.; Verhagen, H.; Barber, P. A.; Bourchier, R.; Hill, A.; Holden, A.; Stewart, J.; Bakke, S. J.; Krohg-Sørensen, K.; Skjelland, M.; Tennøe, B.; Bialek, P.; Biejat, Z.; Czepiel, W.; Czlonkowska, A.; Dowzenko, A.; Jedrzejewska, J.; Kobayashi, A.; Lelek, M.; Polanski, J.; Kirbis, J.; Milosevic, Z.; Zvan, B.; Blasco, J.; Chamorro, A.; Macho, J.; Obach, V.; Riambau, V.; San Roman, L.; Branera, J.; Canovas, D.; Estela, Jordi; Gaibar, A. Gimenez; Perendreu, J.; Björses, K.; Gottsater, A.; Ivancev, K.; Maetzsch, T.; Sonesson, B.; Berg, B.; Delle, M.; Formgren, J.; Gillgren, P.; Kall, T.-B.; Konrad, P.; Nyman, N.; Takolander, R.; Andersson, T.; Malmstedt, J.; Soderman, M.; Wahlgren, C.; Wahlgren, N.; Binaghi, S.; Hirt, L.; Michel, P.; Ruchat, P.; Engelter, S. T.; Fluri, F.; Guerke, L.; Jacob, A. L.; Kirsch, E.; Lyrer, P. A.; Radue, E.-W.; Stierli, P.; Wasner, M.; Wetzel, S.; Bonvin, C.; Kalangos, A.; Lovblad, K.; Murith, M.; Ruefenacht, D.; Sztajzel, R.; Higgins, N.; Kirkpatrick, P. J.; Martin, P.; Varty, K.; Adam, D.; Bell, J.; Crowe, P.; Gannon, M.; Henderson, M. J.; Sandler, D.; Shinton, R. A.; Scriven, J. M.; Wilmink, T.; D'Souza, S.; Egun, A.; Guta, R.; Punekar, S.; Seriki, D. M.; Thomson, G.; Brennan, J. A.; Enevoldson, T. P.; Gilling-Smith, G.; Gould, D. A.; Harris, P. L.; McWilliams, R. G.; Nasser, H.-C.; White, R.; Prakash, K. G.; Serracino-Inglott, F.; Subramanian, G.; Symth, J. V.; Walker, M. G.; Clarke, M.; Davis, M.; Dixit, S. A.; Dorman, P.; Dyker, A.; Ford, G.; Golkar, A.; Jackson, R.; Jayakrishnan, V.; Lambert, D.; Lees, T.; Louw, S.; Macdonald, S.; Mendelow, A. D.; Rodgers, H.; Rose, J.; Stansby, G.; Wyatt, M.; Baker, T.; Baldwin, N.; Jones, L.; Mitchell, D.; Munro, E.; Thornton, M.; Baker, D.; Davis, N.; Hamilton, G.; McCabe, D.; Platts, A.; Tibballs, J.; Cleveland, T.; Dodd, D.; Lonsdale, R.; Nair, R.; Nassef, A.; Nawaz, S.; Venables, G.; Belli, A.; Cloud, G.; Halliday, A.; Markus, H.; McFarland, R.; Morgan, R.; Pereira, A.; Thompson, A.; Chataway, J.; Cheshire, N.; Gibbs, R.; Hammady, M.; Jenkins, M.; Malik, I.; Wolfe, J.; Adiseshiah, M.; Bishop, C.; Brew, S.; Brookes, J.; Jäger, R.; Kitchen, N.; Ashleigh, R.; Butterfield, S.; Gamble, G. E.; McCollum, C.; Nasim, A.; O'Neill, P.; Edwards, R. D.; Lees, K. R.; MacKay, A. J.; Moss, J.

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  11. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study) : an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Joerg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Hacke, W.; Halliday, A.; Malik, I.; Mas, J. L.; McGuire, A. J.; Sidhu, P.; Venables, G.; Bradbury, A.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molynewc, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Hendriks, J. M. H.; Hendriks, J. M.

    2010-01-01

    Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid

  12. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    LENUS (Irish Health Repository)

    Ederle, Jörg

    2010-03-20

    Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.

  13. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial

    DEFF Research Database (Denmark)

    Galløe, Anders M; Thuesen, Leif; Kelbaek, Henning

    2008-01-01

    Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients.......Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients....

  14. Pooled analysis of two randomized trials comparing titanium-nitride-oxide-coated stent versus drug-eluting stent in STEMI.

    Science.gov (United States)

    Tuomainen, Petri O; Sia, Jussi; Nammas, Wail; Niemelä, Matti; Airaksinen, Juhani K E; Biancari, Fausto; Karjalainen, Pasi P

    2014-07-01

    We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P=.49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P=.51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P=.04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P=.30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  15. Stent Thrombosis With Drug-Eluting Stents and Bioresorbable Scaffolds: Evidence From a Network Meta-Analysis of 147 Trials.

    Science.gov (United States)

    Kang, Si-Hyuck; Chae, In-Ho; Park, Jin-Joo; Lee, Hak Seung; Kang, Do-Yoon; Hwang, Seung-Sik; Youn, Tae-Jin; Kim, Hyo-Soo

    2016-06-27

    This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS. To improve outcomes of patients undergoing percutaneous coronary revascularization, there have been advances in the design of drug-eluting stents (DES), including the development of drug-eluting bioresorbable vascular scaffolds (BVS). Prospective, randomized, controlled trials comparing bare-metal stents (BMS), paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), Endeavor zotarolimus-eluting stents (E-ZES), cobalt-chromium (CoCr) everolimus-eluting stents (EES), platinum-chromium (PtCr)-EES, biodegradable polymer (BP)-EES, Resolute zotarolimus-eluting stents (R-ZES), BP biolimus-eluting stents (BP-BES), hybrid sirolimus-eluting stents (H [Orsiro]-SES), polymer-free sirolimus- and probucol-eluting stents, or BVS were searched in online databases. The primary endpoint was definite or probable stent thrombosis at 1 year. A total of 147 trials including 126,526 patients were analyzed in this study. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. CoCr-EES, PtCr-EES, and H-SES were associated with significantly lower risk than BVS. CoCr-EES and H-SES were superior to SES and BP-BES. The risk of myocardial infarction was significantly lower with H-SES than with BVS. There were no significant differences regarding all-cause or cardiac mortality. Contemporary devices including BVS showed comparably low risks of repeat revascularization. Contemporary DES, including biocompatible DP-DES, BP-DES, and polymer-free DES, showed a low risk of definite or probable stent thrombosis at 1 year. BVS had an increased risk of device thrombosis compared with CoCr-EES, PtCr-EES, and H-SES. Data from extended follow-up are warranted to confirm the long-term safety of contemporary coronary devices. Copyright © 2016 American College of Cardiology Foundation. Published by

  16. 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

    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...

  17. Carotid artery stenting vs carotid endarterectomy: meta-analysis and diversity-adjusted trial sequential analysis of randomized trials

    DEFF Research Database (Denmark)

    Bangalore, Sripal; Kumar, Sunil; Wetterslev, Jørn

    2011-01-01

    The role of carotid artery stenting (CAS) when compared with carotid endarterectomy (CEA) is controversial, with recent trials showing an increased risk of harm with CAS.......The role of carotid artery stenting (CAS) when compared with carotid endarterectomy (CEA) is controversial, with recent trials showing an increased risk of harm with CAS....

  18. 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 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...... 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...

  19. Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial

    NARCIS (Netherlands)

    Jeurnink, Suzanne M.; Steyerberg, Ewout W.; van Hooft, Jeanin E.; van Eijck, Casper H. J.; Schwartz, Matthijs P.; Vleggaar, Frank P.; Kuipers, Ernst J.; Siersema, Peter D.; Jeurnink, S. M.; Kuipers, E. J.; Siersema, P. D.; Steyerberg, E. W.; Polinder, S.; Borsboom, G.; van Eijck, C. H. J.; Fockens, P.; Gouma, D. J.; Schwartz, M. P.; Vermeijden, J. R.; van Ooijen, B.; Vleggaar, F. P.; Borel Rinkes, I. H. M.; Grubben, M.; van Laarhoven, C. H. J. M.; Peters, F. T. M.; Porte, R. J.; Plukker, J. Th M.; van Spreeuwel, J. P.; Jakimowicz, J. J.; Boot, H.; Cats, A.; van Coevorden, F. V.; Klaase, J. M.; van der Waaij, L. A.; Baas, P.; van der Schaar, P.; Sosef, M. N.; Timmer, R.; van Ramshorts, B.; Nicolai, J. J.; Houben, M. H. M. G.; Steup, W. H.; Pahlplatz, P. V. M.; Brouwers, M. A. M.; Meijssen, M. A. C.; Marinelli, A.; van der Linde, K.; Manusama, E.; ter Borg, F.; Eeftinck Schattenkerk, M.; Witteman, B.; Kruyt, F.; ten Hove, R.; Schmitz, R. F.; Lesterhuis, W.; Oostenbroek, R.; Veenendaal, R.; Hartgrink, H. H.; Tollenaar, R. A. E. M.; Wahab, P.; Spillenaar Bilgen, E. J.

    2010-01-01

    BACKGROUND: Both gastrojejunostomy (GJJ) and stent placement are commonly used palliative treatments of obstructive symptoms caused by malignant gastric outlet obstruction (GOO). OBJECTIVE: Compare GJJ and stent placement. DESIGN: Multicenter, randomized trial. SETTING: Twenty-one centers in The

  20. Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

    Science.gov (United States)

    Lemos, Pedro A; Abizaid, Alexandre A C; Meireles, George C; Sarmento-Leite, Rogério; Prudente, Mauricio; Cantarelli, Marcelo; Dourado, Adriano D; Mariani, Jose; Perin, Marco A; Costantini, Costantino; Costa, Ricardo A; Costa, José Ribamar; Chamie, Daniel; Campos, Carlos A; Ribeiro, Expedito

    2015-12-01

    To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent. © 2015 John Wiley & Sons Ltd.

  1. Renal artery stenting with noninvasive duplex ultrasound follow-up: 3-year results from the RENAISSANCE renal stent trial.

    Science.gov (United States)

    Rocha-Singh, Krishna; Jaff, Michael R; Lynne Kelley, E

    2008-11-15

    The multicenter, single-arm RENAISSANCE trial evaluated outcomes in patients with progressive atherosclerotic renal artery stenosis (ARAS) treated with the Express Renal Premounted Stent System (Boston Scientific, Natick, MA). Renal artery stenting may prevent the morbidity and mortality of surgical revascularization and high restenosis rates of percutaneous renal angioplasty (PTRA). Renal artery duplex ultrasonography (DUS) offers an alternative to traditional invasive poststenting angiographic surveillance, though concordance with angiography for in-stent restenosis has yet to be validated independently. RENAISSANCE enrolled 100 patients (117 lesions) with de novo or restenotic ostial atherosclerotic lesions or=4.0 and or=70%. The primary endpoint, 9-month binary restenosis, was compared to an objective performance criterion (OPC) of 40% for published PTRA results. Follow-up was conducted through 3 years. Technical and procedural success was both 99%. Follow-up angiography, triggered clinically or by ultrasonography, revealed 21.3% binary restenosis at 9 months, which was superior to the OPC (P RENAISSANCE demonstrates that renal artery stenting is superior to the prespecified OPC at 9 months, and also shows that DUS can accurately identify in-stent restenosis. (c) 2008 Wiley-Liss, Inc.

  2. Dual role of circulating endothelial progenitor cells in stent struts endothelialisation and neointimal regrowth: A substudy of the IN-PACT CORO trial

    Energy Technology Data Exchange (ETDEWEB)

    De Maria, Giovanni Luigi [Institute of Cardiology, Catholic University of the Sacred Heart, Rome (Italy); Porto, Italo, E-mail: italo.porto@gmail.com [Institute of Cardiology, Catholic University of the Sacred Heart, Rome (Italy); Interventional Cardiology Unit, San Donato Hospital, Arezzo (Italy); Burzotta, Francesco; Brancati, Marta Francesca; Trani, Carlo; Pirozzolo, Giancarlo; Leone, Antonio Maria; Niccoli, Giampaolo [Institute of Cardiology, Catholic University of the Sacred Heart, Rome (Italy); Prati, Francesco [Department of Interventional Cardiology, San Giovanni Hospital, Rome (Italy); Crea, Filippo [Institute of Cardiology, Catholic University of the Sacred Heart, Rome (Italy)

    2015-01-15

    Background: Endothelialisation is a crucial event after percutaneous coronary intervention (PCI). Endothelial progenitor cells (EPCs) are bone marrow derived elements with reparative properties. We aimed to assess the relationship between circulating EPC levels and stent neointimal hyperplasia (NIH) using frequency domain optical coherence tomography (FD-OCT). Methods: Patients undergoing elective PCI to native vessels and randomised to bare metal stent (BMS) alone versus BMS plus drug coated balloon (DCB) were included. At six months, angiographic follow-up and FD-OCT were performed to measure percentage neointimal hyperplasia volume obstruction (%NIHV), and percentage of uncovered stent struts (%US). Venous blood samples were obtained before the procedure and at six months to detect CD34+CD45dimKDR + EPC levels. Results: Twenty patients were enrolled. A significant relationship was observed between baseline EPC levels and %NIHV (R: 0.63, p: 0.03) and %US (R: − 0.56, p: 0.01) at follow-up. Both EPC levels and DCB use were independently related to %NIHV (β: 0.55; p < 0.001 and β: − 0.51; p: 0.001, respectively), while only EPC levels were independently associated to %US (β: − 0.52; p: 0.01). Higher %NIHV (p: 0.004) and lower %US (p: 0.005) were observed in patients with stable or increasing EPC level. Conclusion: Our study shows a relationship between EPC levels and stent strut coverage, supporting a dual role for these cells in favouring stent endothelialisation but also NIH growth. - Highlights: • Substudy of IN-PACT CORO trial comparing, by adoption of optical coherence tomography, the amount of neointimal growth and stent struts coverage at six months of follow up, in elective patients randomised to conventional PCI with bare metal stent implantation (BMS group) or to stent implantation with pre or postdilation with a drug coated balloon (BMS + DCB group) • Lower neointimal regrowth observed in BMS + DCB group • First in vivo demonstration that

  3. Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

    Science.gov (United States)

    Philip, Femi; Stewart, Susan; Southard, Jeffrey A

    2016-07-01

    The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared. Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years. Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  4. Culotte stenting vs. TAP stenting for treatment of de-novo coronary bifurcation lesions with the need for side-branch stenting: the Bifurcations Bad Krozingen (BBK) II angiographic trial.

    Science.gov (United States)

    Ferenc, Miroslaw; Gick, Michael; Comberg, Thomas; Rothe, Jürgen; Valina, Christian; Toma, Aurel; Löffelhardt, Nikolaus; Hochholzer, Willibald; Riede, Florian; Kienzle, Rolf-Peter; Achtari, Amar; Neumann, Franz-Josef

    2016-12-01

    In percutaneous coronary intervention for de-novo coronary bifurcation lesions, the optimal technique for provisional side-branch stenting is still a matter of debate. We tested whether in this setting culotte stenting reduces the incidence of restenosis as compared with T-and-protrusion (TAP) stenting. This trial included 300 patients with a coronary bifurcation lesion requiring a side-branch stent. Patients were randomly assigned to culotte stenting or TAP stenting using drug-eluting stents in a 1:1 fashion. Primary endpoint was maximal per cent diameter stenosis of the bifurcation lesion at 9-month angiographic follow-up. As clinical endpoints we assessed target lesion re-intervention (TLR) and target lesion failure (composite of cardiac death, target vessel myocardial infarction, and TLR).Angiographic follow-up was available in 91% of the patients. After culotte stenting, the maximum per cent diameter stenosis in the treated bifurcation lesion was 21 ± 20% as compared with 27 ± 25% after TAP stenting (P = 0.038). The respective corresponding binary restenosis rates were 6.5 and 17% (P = 0.006). The 1-year incidence of TLR was 6.0% after culotte stenting vs. 12.0% after T-stenting (P = 0.069). Target lesion failure occurred in 6.7% of the culotte group and in 12.0% of the TAP group (P = 0.11). Only one patient of the culotte group incurred a definite stent thrombosis during 1-year follow-up. Compared with the TAP stenting, culotte stenting was associated with a significantly lower incidence of angiographic restenosis. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For Permissions, please email: journals.permissions@oup.com.

  5. Biodegradable polymer stents vs second generation drug eluting stents: A meta-analysis and systematic review of randomized controlled trials.

    Science.gov (United States)

    Pandya, Bhavi; Gaddam, Sainath; Raza, Muhammad; Asti, Deepak; Nalluri, Nikhil; Vazzana, Thomas; Kandov, Ruben; Lafferty, James

    2016-02-26

    To evaluate the premise, that biodegradable polymer drug eluting stents (BD-DES) could improve clinical outcomes compared to second generation permanent polymer drug eluting stents (PP-DES), we pooled the data from all the available randomized control trials (RCT) comparing the clinical performance of both these stents. A systematic literature search of PubMed, Cochrane, Google scholar databases, EMBASE, MEDLINE and SCOPUS was performed during time period of January 2001 to April 2015 for RCT and comparing safety and efficacy of BD-DES vs second generation PP-DES. The primary outcomes of interest were definite stent thrombosis, target lesion revascularization, myocardial infarction, cardiac deaths and total deaths during the study period. A total of 11 RCT's with a total of 12644 patients were included in the meta-analysis, with 6598 patients in BD-DES vs 6046 patients in second generation PP-DES. The mean follow up period was 16 mo. Pooled analysis showed non-inferiority of BD-DES, comparing events of stent thrombosis (OR = 1.42, 95%CI: 0.79-2.52, P = 0.24), target lesion revascularization (OR = 0.99, 95%CI: 0.84-1.17, P = 0.92), myocardial infarction (OR = 1.06, 95%CI: 0.86-1.29, P = 0.92), cardiac deaths (OR = 1.07, 95%CI 0.82-1.41, P = 0.94) and total deaths (OR = 0.96, 95%CI: 0.80-1.17, P = 0.71). BD-DES, when compared to second generation PP-DES, showed no significant advantage and the outcomes were comparable between both the groups.

  6. Impact of polymer formulations on neointimal proliferation after zotarolimus-eluting stent with different polymers: insights from the RESOLUTE trial.

    Science.gov (United States)

    Waseda, Katsuhisa; Ako, Junya; Yamasaki, Masao; Koizumi, Tomomi; Sakurai, Ryota; Hongo, Yoichiro; Koo, Bon-Kwon; Ormiston, John; Worthley, Stephen G; Whitbourn, Robert J; Walters, Darren L; Meredith, Ian T; Fitzgerald, Peter J; Honda, Yasuhiro

    2011-06-01

    Polymer formulation may affect the efficacy of drug-eluting stents. Resolute, Endeavor, and ZoMaxx are zotarolimus-eluting stents with different stent platforms and different polymer coatings and have been tested in clinical trials. The aim of this analysis was to compare the efficacy of zotarolimus-eluting stents with different polymers. Data were obtained from the first-in man trial or first randomized trials of each stent, The Clinical RESpOnse EvaLUation of the MedTronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (RESOLUTE), 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 (ENDEAVOR II), and ZoMaxx I trials. Follow-up intravascular ultrasound analyses (8 to 9 months of follow-up) were possible in 353 patients (Resolute: 88, Endeavor: 98, ZoMaxx: 82, Driver: 85). Volume index (volume/stent length) was obtained for vessel, stent, lumen, peristent plaque, and neointima. Cross-sectional narrowing was defined as neointimal area divided by stent area (%). Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. At baseline, vessel, lumen, and peristent plaque volume index were not significantly different among the 4 stent groups. At follow-up, percent neointimal obstruction was significantly lower in Resolute compared with Endeavor, ZoMaxx, and Driver (Resolute: 3.7±4.0, Endeavor: 17.5±10.1, ZoMaxx: 14.6±8.1, Driver: 29.4±17.2%; Ppolymer used in Resolute independently correlated with neointimal suppression among 3 zotarolimus-eluting stents. The different polymer formulations significantly affect the relative amount of neointima for zotarolimus-eluting stents. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00248079.

  7. Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR trial.

    Science.gov (United States)

    Lammer, Johannes; Zeller, Thomas; Hausegger, Klaus A; Schaefer, Philipp J; Gschwendtner, Manfred; Mueller-Huelsbeck, Stefan; Rand, Thomas; Funovics, Martin; Wolf, Florian; Rastan, Aljoscha; Gschwandtner, Michael; Puchner, Stefan; Beschorner, Ulrich; Ristl, Robin; Schoder, Maria

    2015-02-01

    The hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only. A prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN(®) Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN(®) versus 17.3 ± 6.6 cm in the BMS group. The 24-month primary patency rates in the VIABAHN(®) and BMS group were: intention-to-treat 63.1 (95 % CI 0.52-0.76) versus 41.2 % (95 % CI 0.29-0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58-0.83) versus 40.0 % (95 % CI 0.28-0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70-0.90) versus 73.0 % (95 % CI 0.63-0.85) for VIABAHN(®) versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50-0.85) versus 26.7 % (95 % CI 0.12-0.59; log rank p = 0.004) for VIABAHN(®) versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68-0.94) versus 61.9 % (95 % CI 0.44-0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN(®) versus the BMS group, respectively. At 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244).

  8. Timing of elective cesarean section and neonatal morbidity: A randomized controlled trial

    DEFF Research Database (Denmark)

    Glavind, Julie; Kindberg, Sara Fevre; Uldbjerg, Niels

    2012-01-01

    Objective Neonatal complications related to timing of elective cesarean section (ECS) have never been studied in randomized trials. We designed the first randomized trial of timing of ECS and hypothesized a decrease in neonatal admission rate if ECS was scheduled after 39 completed weeks of gesta......Objective Neonatal complications related to timing of elective cesarean section (ECS) have never been studied in randomized trials. We designed the first randomized trial of timing of ECS and hypothesized a decrease in neonatal admission rate if ECS was scheduled after 39 completed weeks...

  9. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial.

    Science.gov (United States)

    de Winter, Robbert J; Katagiri, Yuki; Asano, Taku; Milewski, Krzysztof P; Lurz, Philipp; Buszman, Pawel; Jessurun, Gillian A J; Koch, Karel T; Troquay, Roland P T; Hamer, Bas J B; Ophuis, Ton Oude; Wöhrle, Jochen; Wyderka, Rafał; Cayla, Guillaume; Hofma, Sjoerd H; Levesque, Sébastien; Żurakowski, Aleksander; Fischer, Dieter; Kośmider, Maciej; Goube, Pascal; Arkenbout, E Karin; Noutsias, Michel; Ferrari, Markus W; Onuma, Yoshinobu; Wijns, William; Serruys, Patrick W

    2018-02-03

    MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45

  10. Trial of self-expandable metallic stents in the palliation of tracheo ...

    African Journals Online (AJOL)

    Trial of self-expandable metallic stents in the palliation of tracheo-oesophageal fistula in carcinoma of the oesophagus. ... Over half of the patients in the TOF group had concomitant pneumonia at presentation with decreased survival (p = 0.010) and a hazard ratio of 10.86. Two patients died, on days 4 and 7 respectively.

  11. The Bolton Treovance abdominal stent-graft: European clinical trial design.

    Science.gov (United States)

    Chiesa, R; Riambau, V; Coppi, G; Zipfel, B; Llagostera, S; Marone, E M; Kahlberg, A

    2012-10-01

    Endovascular aortic repair (EVAR) has emerged as a promising, less invasive alternative to conventional open surgery for the treatment of infrarenal abdominal aortic aneurysms (AAAs). In the last 20 years, the application rate of EVAR and its clinical results have significantly improved thanks to the evolution of stent-grafts and endovascular delivery systems. However, further development is still needed to reduce the incidence of complications and secondary re-interventions. The Treovance abdominal aortic stent-graft (Bolton Medical, Barcelona, Spain) is a new-generation endovascular device, developed to increase flexibility, lower profile, improve deployment and sealing mechanisms. In particular, it is provided with some innovative features as a double layer of proximal barbs (suprarenal and infrarenal) for supplemental fixation, dull barbs between modules to avoid potential leg disconnections, detachable outer sheath provided with a new-design hemostatic valve, and a double improved mechanism (slow motion and "pin and pull") for precise stent-graft deployment. A European prospective, non-randomized, multi-institutional, "first-in-human" trial (the ADVANCE trial) was conducted from March to December 2011 to assess the safety and performance of the Treovance stent-graft system before commercialization. Thirty patients with anatomically suitable non-ruptured AAAs were enrolled at five clinical sites in Italy, Spain, and Germany. EVAR was completed successfully in all patients. The stent-graft was delivered and deployed safely even in heavily angulated or calcified anatomies. No 30-day device-related complications nor deaths were observed. Preliminary experience with the Treovance abdominal stent-graft within the ADVANCE trial was satisfactory with regard to technical success and perioperative clinical results. Follow-up data are needed to assess mid- and long-term clinical outcomes, along with durability of this new-generation endovascular device.

  12. 2-year outcome after biodegradable polymer sirolimus- and biolimus- eluting coronary stents.From the randomized SORT OUT VII trial

    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...

  13. Single-dose brachytherapy versus metal stent placement for the palliation of dysphagia from oesophageal cancer: multicentre randomised trial

    NARCIS (Netherlands)

    Homs, Marjolein Y. V.; Steyerberg, Ewout W.; Eijkenboom, Wilhelmina M. H.; Tilanus, Hugo W.; Stalpers, Lukas J. A.; Bartelsman, Joep F. W. M.; van Lanschot, Jan J. B.; Wijrdeman, Harm K.; Mulder, Chris J. J.; Reinders, Janny G.; Boot, Henk; Aleman, Berthe M. P.; Kuipers, Ernst J.; Siersema, Peter D.

    2004-01-01

    Background Both single-dose brachytherapy and self-expanding metal stent placement are commonly used for palliation of oesophageal obstruction due to inoperable cancer, but their relative merits are unknown. We under-took a randomised trial to compare the outcomes of brachytherapy and stent

  14. Provisional versus elective two-stent strategy for unprotected true left main bifurcation lesions: Insights from a FAILS-2 sub-study.

    Science.gov (United States)

    Kawamoto, Hiroyoshi; Chieffo, Alaide; D'Ascenzo, Fabrizio; Jabbour, Richard J; Naganuma, Toru; Cerrato, Enrico; Ugo, Fabrizio; Pavani, Marco; Varbella, Ferdinando; Boccuzzi, Giacomo; Pennone, Mauro; Garbo, Roberto; Conrotto, Federico; Biondi-Zoccai, Giuseppe; D'Amico, Maurizio; Moretti, Claudio; Escaned, Javier; Gaita, Fiorenzo; Nakamura, Sunao; Colombo, Antonio

    2018-01-01

    This study sought to investigate the optimal percutaneous coronary intervention (PCI) strategy for true unprotected left main coronary artery (ULMCA) bifurcations. The FAILS-2 was a retrospective multi-center study including patients with ULMCA disease treated with second-generation drug-eluting stents. Of these, we compared clinical outcomes of a provisional strategy (PS; n=216) versus an elective two-stent strategy (E2S; n=161) for true ULMCA bifurcations. The primary endpoint was the incidence of major adverse cardiac events (MACEs) at 3-years. We further performed propensity-score adjustment for clinical outcomes. There were no significant differences between the groups in terms of patient and lesion characteristics. 9.7% of patients in the PS group crossed over to a provisional two-stent strategy. MACEs were not significantly different between groups (MACE at 3-year; PS 28.1% vs. E2S 28.9%, adjusted p=0.99). The rates of target lesion revascularization (TLR) on the circumflex artery (LCX) were numerically high in the E2S group (LCX-TLR at 3-years; PS 11.8% vs. E2S 16.6%, adjusted p=0.51). E2S was associated with a comparable MACE rate to PS for true ULMCA bifurcations. The rates of LCX-TLR tended to be higher in the E2S group although there was no statistical significance. This study sought to compare the clinical outcomes of a provisional strategy (PS) with an elective two-stent strategy (E2S) for the treatment of true unprotected left main coronary artery bifurcations. 377 Patients (PS 216 vs. E2S 161 patients) were evaluated, and 9.7% in the PS group crossed over to a two-stent strategy. E2S was associated with a similar major adverse cardiac event rate at 3-years when compared to the PS strategy (PS 28.1% vs. E2S 28.9%, p=0.99). However, the left circumflex artery TLR rate at 3-year tended to be higher in the E2S group (PS 11.8% vs. E2S 16.6%, p=0.51). Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial

    DEFF Research Database (Denmark)

    Maeng, Michael; Jensen, Lisette Okkels; Galloe, Anders Michael

    2008-01-01

    The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients...... stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel...

  16. A randomized controlled trial comparing alpha blocker (tamsulosin) and anticholinergic (solifenacin) in treatment of ureteral stent-related symptoms.

    Science.gov (United States)

    El-Nahas, Ahmed R; Tharwat, Mohamed; Elsaadany, Mohamed; Mosbah, Ahmed; Gaballah, Mohamed A

    2016-07-01

    To compare the effectiveness of tamsulosin and solifenacin in relieving ureteral stents related symptoms. A randomized controlled trial was conducted between January 2013 and July 2014. Inclusion criteria were patients aged 20-50 years who underwent temporary unilateral ureteral stent for drainage of calcular upper tract obstruction or after ureteroscopic lithotripsy. Patients with history of lower urinary tract symptoms before stent placement, stents that were fixed after open or laparoscopic procedures, and those who developed complications related to the primary procedure were not included. Eligible patients were randomly assigned to 1 of 3 groups using computer-generated random tables. Patients in group 1 received placebo, patients in group 2 received tamsulosin 0.4 mg once daily, and those in group 3 received solifenacin 5 mg once daily. Ureteral Stent Symptom Questionnaire (USSQ) was answered by all patients 1-2 weeks after stent placement. The primary outcome was the comparison of total score of USSQ between all groups. The study included 131 patients. All baseline characteristics (age, sex, side, indication, length, and duration of stent) were comparable for all groups. Total USSQ score was 61 in solifenacin group, 76 in tamsulosin group, and 83 in control group (P tamsulosin group (P tamsulosin alone or solifenacin alone in patients with ureteral stents can improve the quality of life by decreasing ureteral stent-related symptoms. Solifenacin was better than tamsulosin. CLINICALTRIAL. NCT01880619.

  17. Effect of pioglitazone on in-stent restenosis after coronary drug-eluting stent implantation: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Ming-duo Zhang

    Full Text Available In-stent restenosis (ISR remains a common life-threatening complication and some studies have shown that pioglitazone can reduce the incidence of ISR in patients with drug-eluting stents (DES implantation. We conducted a meta-analysis to assess the effect of pioglitazone in preventing ISR after DES implantation.Randomized controlled trials (RCTs investigating the effects of pioglitazone for ISR after DES implantation were identified by systematic searches of multiple online databases and manual searches of related reference lists of identified trials through May 2014. The primary endpoint was the rate of ISR. Secondary endpoints included minimum lumen diameter, percentage stenosis of stented vessels, late loss, in-stent neointimal volume, target vessel revascularization (TVR, target lesion revascularization, myocardial infarction, stent thrombosis and death.Five studies, comprising 255 pioglitazone-treated patients and 245 controls, were identified in the current meta-analysis. Pioglitazone did not significantly reduce the rate of ISR (P = 0.20 with low heterogeneity (I2 = 13.3%, P = 0.32. For the secondary outcomes, pioglitazone did not substantially affect the pooled estimates of these endpoints except late loss (P = 0.01 and TVR (P = 0.04.The limited evidence indicates that pioglitazone does not demonstrate markedly beneficial effect in patients subjected to coronary DES implantation. However, the results should be interpreted with care given the small sample size. Further large-scale RCTs are needed.

  18. Three-Year Outcomes After Revascularization With Everolimus- and Sirolimus-Eluting Stents From the SORT OUT IV Trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Maeng, Michael

    2014-01-01

    OBJECTIVES: The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up. BACKGROUND: In the SORT OUT IV (SORT OUT IV Trial), comparing the EES...

  19. 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

  20. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Ravaud Philippe

    2009-05-01

    Full Text Available Abstract Background The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Methods The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected. A standardized abstraction form was used to extract data. Results 132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke were reported as primary or secondary outcomes in 107 reports (81%. However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22% and a definition of expected adverse events was provided in 47 (36%. The length of follow-up was reported in 95 reports (72%. Assessment of adverse events by an adjudication committee was described in 46 reports (35%, and adverse events were described as being followed up for 6 months in 24% of reports (n = 32, between 7 to 12 months in 42% (n = 55 and for more than 1 year in 4% (n = 5. In 115 reports (87%, numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%. The causality of adverse events was reported in only 4 articles. Conclusion Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials Registration Trials manuscript: 5534201182098351 (T80802P

  1. The Role of Vascular Imaging in Guiding Routine Percutaneous Coronary Interventions: A Meta-Analysis of Bare Metal Stent and Drug-Eluting Stent Trials.

    Science.gov (United States)

    Alsidawi, Said; Effat, Mohamed; Rahman, Shahid; Abdallah, Mouhamad; Leesar, Massoud

    2015-12-01

    The routine use of vascular imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in guiding percutaneous coronary interventions (PCI) is still controversial especially when using drug-eluting stents. A meta-analysis of trials using bare metal stents was previously published. We conducted a meta-analysis of available published trials that compared imaging-guided PCI and angiography-guided PCI in patients undergoing routine PCI only. Trials that enrolled patients with acute coronary syndrome were excluded to decrease heterogeneity. We aimed to study both drug-eluting stents (DES) as well as bare metal stents (BMS). We identified seven randomized controlled trials on IVUS-guided bare metal stents. We also identified three randomized controlled trials on IVUS-guided drug-eluting stents. To improve the power of the drug-eluting stent data, we identified, and included, nine registries that compared IVUS-guided PCI to angiography-guided PCI in the drug-eluting stent era. Nonrandomized registries that included BMS only were excluded as there are multiple previous meta-analyses that studied these patients. Finally, we identified one registry that compared OCT-guided PCI to angiography-guided PCI using either a BMS or a DES. A total of 14,197 patients were studied overall. The meta-analysis was conducted using a random effect model. Imaging guidance was associated with a significantly larger postintervention minimal luminal diameter (SMD: 0.289. 95% CI: 0.213-0.365. P DES patients (odds ratio: 0.810. 95% CI: 0.719-0.912. P DES and BMS patients (odds ratio: 0.782. 95% CI: 0.686-0.890. P DES patients (odds ratio: 0.654. 95% CI: 0.468-0.916. P DES and BMS patients (odds ratio: 0.727. 95% CI: 0.540-0.980. P DES patients (odds ratio: 0.551. 95% CI: 0.363-0.837. P DES and BMS patients (odds ratio: 0.589. 95% CI: 0.425-0.816. P DES patients (odds ratio: 0.651. 95% CI: 0.499-0.850. P DES and BMS patients (odds ratio: 0.665. 95% CI: 0.513-0.862. P

  2. Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial – The NeuroMorfeo trial

    Directory of Open Access Journals (Sweden)

    Guzzetti Stefano

    2009-04-01

    Full Text Available Abstract Background Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA with volatile-based neuroanaesthesia (VA has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intravenous anaesthetics in addition to narcotics. Actually the choice of the anaestesiological strategy depends only on the anaesthetists' preferences or institutional policies. This trial, named NeuroMorfeo, aims to assess the equivalence between volatile and intravenous anaesthetics for neurosurgical procedures. Methods/Design NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state (ASA I-III and Glasgow Coma Scale (GCS equal to 15, are randomly assigned to one of three anaesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil. The equivalence between intravenous and volatile-based neuroanaesthesia will be evaluated by comparing the intervals required to reach, after anaesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point. Two statistical comparisons have been planned: 1 sevoflurane + fentanyl vs. propofol + remifentanil; 2 sevoflurane + remifentanil vs. propofol + remifentanil. Secondary end-points include: an assessment of neurovegetative stress based on (a measurement of urinary catecholamines and plasma and urinary cortisol and (b estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded

  3. 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.

  4. Zotarolimus- and paclitaxel-eluting stents in an all-comer population in China: the RESOLUTE China randomized controlled trial.

    Science.gov (United States)

    Xu, Bo; Yang, Yuejin; Yuan, Zuyi; Du, Zhimin; Wong, S Chiu; Généreux, Philippe; Lu, Shuzheng

    2013-07-01

    This study sought to compare clinical outcomes and angiographic findings using the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Santa Rosa, California) versus the Taxus Liberte paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in an all-comer Chinese population. Concerns regarding restenosis risk led to new-generation drug-eluting stents (DES) designed for use in patients with complex clinical or lesion characteristics. In-stent late lumen loss (LLL) is a measure of restenosis risk. Patients with an indication for treatment with a DES were randomized in a 1:1 ratio to placement of at least 1 R-ZES or PES with minimal exclusions. The primary endpoint was angiographic in-stent LLL at 9 months post-procedure. Clinical endpoints at 12 months are compared between the 2 stents. A total of 198 patients received a R-ZES, and 202 patients received a PES. Most patients were male; 25.8% and 29.2% of R-ZES and PES patients, respectively, had diabetes. Over 70% of lesions in both cohorts were American College of Cardiology/American Heart Association lesion classification Type B2 and C (B2/C). In-stent LLL was 0.16 ± 0.38 mm for R-ZES and 0.33 ± 0.52 mm for PES at 9 months (p comers Chinese population, 9-month in-stent LLL was significantly less with R-ZES compared with PES, which was reflected in lower revascularization rates at 12 months for the R-ZES patients. Results are consistent with previous clinical trials of the R-ZES in all-comer populations. (Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in China [R-China RCT]; NCT01334268). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. Effect of white-matter lesions on the risk of periprocedural stroke after carotid artery stenting versus endarterectomy in the International Carotid Stenting Study (ICSS): a prespecified analysis of data from a randomised trial

    NARCIS (Netherlands)

    Ederle, J.; Davagnanam, I.; Worp, H.B. van der; Venables, G.S.; Lyrer, P.A.; Featherstone, R.L.; Brown, M.M.; Jager, H.R.; Leeuw, F.E. de; Schultze Kool, L.J.; Vliet, J.A. van der; et al.,

    2013-01-01

    BACKGROUND: Findings from randomised trials have shown a higher early risk of stroke after carotid artery stenting than after carotid endarterectomy. We assessed whether white-matter lesions affect the perioperative risk of stroke in patients treated with carotid artery stenting versus carotid

  6. Effect of white-matter lesions on the risk of periprocedural stroke after carotid artery stenting versus endarterectomy in the International Carotid Stenting Study (ICSS): a prespecified analysis of data from a randomised trial

    NARCIS (Netherlands)

    Ederle, Jörg; Davagnanam, Indran; van der Worp, H. Bart; Venables, Graham S.; Lyrer, Philippe A.; Featherstone, Roland L.; Brown, Martin M.; Jäger, H. Rolf; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Hacke, W.; Halliday, A.; Malik, I.; Mas, J. L.; McGuire, A. J.; Sidhu, P.; Venables, G.; Bradbury, A.; Collins, R.; Molyneux, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Brooks, M.; Chambers, B.; Chan, A.; Chu, P.; Clark, D.; Dewey, H.; Donnan, G.; Fell, G.; Hoare, M.; Molan, M.; Roberts, A.; Roberts, N.; Beiles, B.; Bladin, C.; Clifford, C.; Grigg, M.; New, G.; Bell, R.; Bower, S.; Chong, W.; Holt, M.; Saunder, A.; Than, P. G.; Gett, S.; Leggett, D.; McGahan, T.; Quinn, J.; Ray, M.; Wong, A.; Woodruff, P.; Foreman, R.; Schultz, D.; Scroop, R.; Stanley, B.; Allard, B.; Atkinson, N.; Cambell, W.; Davies, S.; Field, P.; Milne, P.; Mitchell, P.; Tress, B.; Yan, B.; Beasley, A.; Dunbabin, D.; Stary, D.; Walker, S.; Cras, P.; d'Archambeau, O.; Hendriks, J. M. H.; van Schil, P.; Bosiers, M.; Deloose, K.; van Buggenhout, E.; de Letter, J.; Devos, V.; Ghekiere, J.; Vanhooren, G.; Astarci, P.; Hammer, F.; Lacroix, V.; Peeters, A.; Verhelst, R.; DeJaegher, L.; Verbist, J.; Blair, J.-F.; Caron, J. L.; Daneault, N.; Giroux, M.-F.; Guilbert, F.; Lanthier, S.; Lebrun, L.-H.; Oliva, V.; Raymond, J.; Roy, D.; Soulez, G.; Weill, A.; Hill, M.; Hu, W.; Hudion, M.; Morrish, W.; Sutherland, G.; Wong, J.; Albäck, A.; Harno, H.; Ijäs, P.; Kaste, M.; Lepäntalo, M.; Mustanoja, S.; Paananen, T.; Porras, M.; Putaala, J.; Railo, M.; Sairanen, T.; Soinne, L.; Vehmas, A.; Vikatmaa, P.; Goertler, M.; Halloul, Z.; Skalej, M.; Brennan, P.; Kelly, C.; Leahy, A.; Moroney, J.; Thornton, J.; Koelemay, M. J. W.; Nederkoorn, P. J.; Reekers, J. A. A.; Roos, Y. B. W. E. M.; Hendriks, J. M.; Koudstaal, P. J.; Pattynama, P. M. T.; van der Lugt, A.; van Dijk, L. C.; van Sambeek, M. R. H. M.; van Urk, H.; Verhagen, H. J. M.; Bruijninckx, C. M. A.; de Bruijn, S. F.; Keunen, R.; Knippenberg, B.; Mosch, A.; Treurniet, F.; van Dijk, L.; van Overhagen, H.; Wever, J.; de Beer, F. C.; van den Berg, J. S. P.; van Hasselt, B. A. A. M.; Zeilstra, D. J.; Boiten, J.; de Mol van Otterloo, J. C. A.; de Vries, A. C.; Lycklama a Nijeholt, G. J.; van der Kallen, B. F. W.; Blankensteijn, J. D.; de Leeuw, F. E.; Schultze Kool, L. J.; van der Vliet, J. A.; de Borst, G. J.; de Kort, G. A. P.; Kapelle, L. J.; Lo, T. H.; Mali, W. P. Th M.; Moll, F.; van der Worp, H. B.; Verhagen, H.; Barber, P. A.; Bourchier, R.; Hill, A.; Holden, A.; Stewart, J.; Bakke, S. J.; Krohg-Sørensen, K.; Skjelland, M.; Tennøe, B.; Bialek, P.; Biejat, Z.; Czepiel, W.; Czlonkowska, A.; Dowzenko, A.; Jedrzejewska, J.; Kobayashi, A.; Lelek, M.; Polanski, J.; Kirbis, J.; Milosevic, Z.; Zvan, B.; Blasco, J.; Chamorro, A.; Macho, J.; Obach, V.; Riambau, V.; San Roman, L.; Branera, J.; Canovas, D.; Estela, Jordi; Gimenez Gaibar, A.; Perendreu, J.; Björses, K.; Gottsater, A.; Ivancev, K.; Maetzsch, T.; Sonesson, B.; Berg, B.; Delle, M.; Formgren, J.; Gillgren, P.; Kall, T.-B.; Konrad, P.; Nyman, N.; Takolander, R.; Andersson, T.; Malmstedt, J.; Soderman, M.; Wahlgren, C.; Wahlgren, N.; Binaghi, S.; Hirt, L.; Michel, P.; Ruchat, P.; Engelter, S. T.; Fluri, F.; Guerke, L.; Jacob, A. L.; Kirsch, E.; Lyrer, P. A.; Radue, E.-W.; Stierli, P.; Wasner, M.; Wetzel, S.; Bonvin, C.; Kalangos, A.; Lovblad, K.; Murith, N.; Ruefenacht, D.; Sztajzel, R.; Higgins, N.; Kirkpatrick, P. J.; Martin, P.; Varty, K.; Adam, D.; Bell, J.; Crowe, P.; Gannon, M.; Henderson, M. J.; Sandler, D.; Shinton, R. A.; Scriven, J. M.; Wilmink, T.; D'Souza, S.; Egun, A.; Guta, R.; Punekar, S.; Seriki, D. M.; Thomson, G.; Brennan, J. A.; Enevoldson, T. P.; Gilling-Smith, G.; Gould, D. A.; Harris, P. L.; McWilliams, R. G.; Nasser, H.-C.; White, R.; Prakash, K. G.; Serracino-Inglott, F.; Subramanian, G.; Symth, J. V.; Walker, M. G.; Clarke, M.; Davis, M.; Dixit, S. A.; Dorman, P.; Dyker, A.; Ford, G.; Golkar, A.; Jackson, R.; Jayakrishnan, V.; Lambert, D.; Lees, T.; Louw, S.; Macdonald, S.; Mendelow, A. D.; Rodgers, H.; Rose, J.; Stansby, G.; Wyatt, M.; Baker, T.; Baldwin, N.; Jones, L.; Mitchell, D.; Munro, E.; Thornton, M.; Baker, D.; Davis, N.; Hamilton, G.; McCabe, D.; Platts, A.; Tibballs, J.; Cleveland, T.; Dodd, D.; Lonsdale, R.; Nair, R.; Nassef, A.; Nawaz, S.; Belli, A.; Cloud, G.; Markus, H.; McFarland, R.; Morgan, R.; Pereira, A.; Thompson, A.; Chataway, J.; Cheshire, N.; Gibbs, R.; Hammady, M.; Jenkins, M.; Wolfe, J.; Adiseshiah, M.; Bishop, C.; Brew, S.; Brookes, J.; Jäger, R.; Kitchen, N.; Ashleigh, R.; Butterfield, S.; Gamble, G. E.; McCollum, C.; Nasim, A.; O'Neill, P.; Edwards, R. D.; Lees, K. R.; MacKay, A. J.; Moss, J.; Rogers, P.

    2013-01-01

    Findings from randomised trials have shown a higher early risk of stroke after carotid artery stenting than after carotid endarterectomy. We assessed whether white-matter lesions affect the perioperative risk of stroke in patients treated with carotid artery stenting versus carotid endarterectomy.

  7. Effectiveness of tranexamic acid on blood loss in patients undergoing elective cesarean section: randomized clinical trial.

    Science.gov (United States)

    Abdel-Aleem, H; Alhusaini, T K; Abdel-Aleem, M A; Menoufy, M; Gülmezoglu, A M

    2013-11-01

    Cesarean section is associated with more blood loss than vaginal delivery. This could increase the risk of morbidity and mortality especially among anemic women. The objective of the trial is to assess the possible effect of tranexamic acid on blood loss during and after elective cesarean section. We conducted a randomized controlled trial at Women's Health Hospital, Assiut University, Assiut, Egypt. All pregnant women with singleton fetus planned to have elective cesarean section at ≥37 wks gestation were randomized to receive 1 g tranexamic acid slowly intravenously over 10 min before elective cesarean section group or not. Blood loss was measured during and for two hours after operation. Any side effects, complications, medications, changes in vital signs and duration of hospital stay were recorded. This study is registered, number ACTRN12612000313831. Seven hundred and forty women were randomized (373 in study group and 367 in control group). Mean total blood loss was 241.6 (SE 6.77) ml in the tranexamic acid group versus 510 (SE 7.72) ml in the control group. The mean drop in hematocrit and hemoglobin levels were statistically significantly lower in the tranexamic acid group than in the control group. There were no statistically or clinically significant differences in other outcomes. Pre-operative use of tranexamic acid is associated with reduced blood loss during and after elective cesarean section. This could be of benefit for anemic women or those who refuse blood transfusion.

  8. A comparison of the ultrathin Orsiro Hybrid sirolimus-eluting stent with contemporary drug-eluting stents: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Lipinski, Michael J; Forrestal, Brian J; Iantorno, Micaela; Torguson, Rebecca; Waksman, Ron

    2018-01-01

    Recent studies suggest the Orsiro sirolimus-eluting stent (O-SES), which has ultrathin struts with a biodegradable sirolimus-eluting polymer coating, performed better than contemporary drug-eluting stents (DES). We performed a meta-analysis to compare clinical outcomes for all randomized controlled trials (RCTs) of O-SES vs contemporary DES. PubMed, Cochrane CENTRAL, and meeting abstracts were searched for all RCTs comparing O-SES with contemporary DES. Pooled estimates of longest available clinical outcomes at a minimum of one-year follow-up, presented as odds ratios (OR) [95% confidence intervals], were generated with random-effect models. We included 8 RCTs with a total of 11,176 patients (5444 O-SES and 5732 contemporary DES [3537 EES, 1295 ZES, and 1264 BP-BES) with a mean age of 65±11, 74% were male, 40% underwent PCI for stable angina, and 56% for ACS. We assessed outcomes comparing O-SES vs. everolimus-eluting stents, vs. permanent-polymer DES, and vs. all DES including biodegradable-polymer DES. Orsiro performed comparably in all categories with a trend toward a reduction in myocardial infarction (0.83 [0.68, 1.02], p=0.07) and stent thrombosis (0.75 [0.54, 1.04], p=0.08). Overall, the Orsiro SES had similar clinical outcomes to contemporary DES with a trend toward reduction in myocardial infarction and stent thrombosis. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Meta-Analysis of Randomized Clinical Trials Comparing Biodegradable Polymer Drug-Eluting Stent to Second-Generation Durable Polymer Drug-Eluting Stents.

    Science.gov (United States)

    El-Hayek, Georges; Bangalore, Sripal; Casso Dominguez, Abel; Devireddy, Chandan; Jaber, Wissam; Kumar, Gautam; Mavromatis, Kreton; Tamis-Holland, Jacqueline; Samady, Habib

    2017-03-13

    The authors sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to second-generation durable polymer drug-eluting stents (DP-DES). Prior meta-analyses have established the superiority of BP-DES over bare-metal stents and first-generation DP-DES; however, their advantage compared with second-generation DP-DES remains controversial. The authors searched PubMed and Scopus databases for RCTs comparing BP-DES to the second-generation DP-DES. Outcomes included target vessel revascularization (TVR) as efficacy outcome and cardiac death, myocardial infarction (MI), and definite or probable stent thrombosis (ST) as safety outcomes. In addition, we performed landmark analysis for endpoints beyond 1 year of follow-up and a subgroup analysis based on the stent characteristics. The authors included 16 RCTs comprising 19,886 patients in the meta-analysis. At the longest available follow-up (mean duration 26 months), we observed no significant differences in TVR (p = 0.62), cardiac death (p = 0.46), MI (p = 0.98), or ST (risk ratio: 0.83, 95% confidence interval: 0.64 to 1.09; p = 0.19). Our landmark analysis showed that BP-DES were not associated with a reduction in the risk of very late ST (risk ratio: 0.87, 95% confidence interval: 0.49 to 1.53; p = 0.62). Similar outcomes were seen regardless of the eluting drug (biolimus vs. sirolimus), the stent platform (stainless steel vs. alloy), the kinetics of polymer degradation or drug release (6 months), the strut thickness of the BP-DES (thin 100 μm), or the DAPT duration (≥6 months vs. ≥12 months). BP-DES have similar safety and efficacy profiles to second-generation DP-DES. Published by Elsevier Inc.

  10. Efficacy and safety of everolimus and zotarolimus-eluting stents versus first-generation drug-eluting stents in patients with diabetes: A meta-analysis of randomized trials.

    Science.gov (United States)

    Bavishi, Chirag; Baber, Usman; Panwar, Sadik; Pirrotta, Stefania; Dangas, George D; Moreno, Pedro; Tamis-Holland, Jacqueline; Kini, Annapoorna S; Sharma, Samin K

    2017-03-01

    Patients with diabetes and coronary artery disease remain at high risk for adverse cardiovascular events after percutaneous coronary intervention. The efficacy and safety of the various drug-eluting stents (DES) in patients with diabetes is unclear. Randomized controlled trials comparing first-generation DES [paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES)] with everolimus-eluting stents (EES) and zotarolimus-eluting stents (ZES) in diabetic patients were systematically searched. Efficacy [target vessel revascularization (TVR) and target lesion revascularization (TLR)] and safety [major adverse cardiac events (MACE), all-cause and cardiac mortality, myocardial infarction, stent thrombosis] outcomes were evaluated. Eighteen randomized controlled trials comprising of 8095 patients (17,000 patient-years of follow-up) were included. Compared to first-generation DES, EES significantly decreased MACE by 18% (relative risk [RR]: 0.82, 95% confidence interval [CI]: 0.70-0.96), myocardial infarction by 43% (RR: 0.57, 95% CI: 0.39-0.84) and stent thrombosis by 46% (RR: 0.54, 95% CI: 0.35-0.82) in patients with diabetes. Moreover EES showed a trend towards reduction in rates of TLR and TVR (p=0.05). ZES was associated with 89% increased risk for TLR (RR: 1.89, 95% CI: 1.10-3.22) compared to first-generation DES. Furthermore, meta-regression analysis showed a greater magnitude of benefit of EES over first-generation DES for MACE (p=0.037) and stent thrombosis (p=0.036) in diabetic patients requiring Insulin. In patients with diabetes and coronary artery disease undergoing stenting, EES is the most efficacious and safe DES. The outcomes data for ZES in diabetes patients were limited and further trials are needed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  11. Stent thrombosis with second-generation drug-eluting stents compared with bare-metal stents: network meta-analysis of primary percutaneous coronary intervention trials in ST-segment–elevation myocardial infarction [corrected].

    Science.gov (United States)

    Philip, Femi; Agarwal, Shikhar; Bunte, Matthew C; Bunte, Matthew; Goel, Sachin S; Tuzcu, E Murat; Ellis, Stephen; Kapadia, Samir R

    2014-02-01

    The relative safety of drug-eluting stents (DESs) and bare-metal stents (BMSs) with respect to stent thrombosis (ST) continues to be debated. There are limited data comparing safety and efficacy of second-generation DES to BMS. We compared the clinical outcomes between second-generation DES and BMS for primary percutaneous coronary intervention using network meta-analysis. Randomized controlled trials comparing stent types (first-generation DES, second-generation DES or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of the international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second-generation DES to BMS) and indirect evidence (first-generation DES with BMS and second-generation DES) from the randomized trials. Twenty-one trials comparing all stents types, including 12 866 patients randomly assigned to treatment groups, were analyzed. A significantly lower incidence of ST was noted with the use of second-generation DES as early as 30 days (odds ratio [OR], 0.36; 95% confidence interval [CI], 0.15-0.82) and between 31 days and 1 year (OR, 0.49; 95% CI, 0.30-0.79) when compared with BMS. Second-generation DES was associated with significantly lower incidence of definite ST at 1 year (OR, 0.3; 95% CI, 0.11-0.83) and myocardial infarction (OR, 0.3; 95% CI, 0.17-0.54) and target vessel revascularization at 1 year (OR, 0.54; 95% CI, 0.80-0.98) when compared with BMS. There was no difference in mortality at 30 days (OR, 0.84; 95% CI, 0.45-1.59) or 1 year (OR, 0.80; 95% CI, 0.56-1.14) with the use of second-generation DES versus BMS. The small number of events may influence the precision of the analysis. Network meta-analysis of randomized trials of primary percutaneous coronary intervention demonstrated lower incidence of ST, myocardial infarction, and target vessel revascularization

  12. 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....

  13. Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes.

    Science.gov (United States)

    Hetts, S W; Turk, A; English, J D; Dowd, C F; Mocco, J; Prestigiacomo, C; Nesbit, G; Ge, S G; Jin, J N; Carroll, K; Murayama, Y; Gholkar, A; Barnwell, S; Lopes, D; Johnston, S C; McDougall, C

    2014-04-01

    Stent-assisted coiling may result in less aneurysm recanalization but more complications than coiling alone. We evaluated outcomes of coiling with and without stents in the multicenter Matrix and Platinum Science Trial. All patients in the Matrix and Platinum Science Trial with unruptured intracranial aneurysms treated per protocol were included. Baseline patient and aneurysm characteristics, procedural details, neurologic outcomes, angiographic outcomes, and safety data were analyzed. Overall, 137 of 361 (38%) patients were treated with a stent. Stent-coiled aneurysms had wider necks (≥4 mm in 62% with stents versus 33% without, P < .0001) and lower dome-to-neck ratios (1.3 versus 1.8, P < .0001). Periprocedural serious adverse events occurred infrequently in those treated with and without stents (6.6% versus 4.5%, P = .39). At 1 year, total significant adverse events, mortality, and worsening of mRS were similar in treatment groups, but ischemic strokes were more common in stent-coiled patients than in coiled patients (8.8% versus 2.2%, P = .005). However, multivariate analysis confirmed that at 2 years after treatment, prior cerebrovascular accident (OR, 4.7; P = .0089) and aneurysm neck width ≥4 mm (OR, 4.5; P = .02) were the only independent predictors of ischemic stroke. Stent use was not an independent predictor of ischemic stroke at 2 years (OR, 1.1; P = .94). Stent use did not predict target aneurysm recurrence at 2 years, but aneurysm dome size ≥10 mm (OR, 9.94; P < .0001) did predict target aneurysm recurrence. Stent-coiling had similar outcomes as coiling despite stented aneurysms having more difficult morphology than coiled aneurysms. Increased ischemic events in stent-coiled aneurysms were attributable to baseline risk factors and aneurysm morphology.

  14. 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).

  15. 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

    Chronic obstructive pulmonary disease (COPD) is associated with long-term all-cause death after percutaneous coronary intervention with bare-metal stents. Regarding other outcomes, previous studies have shown conflicting results and the impact of drug-eluting stent (DES) in this population...... 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.......001); all-cause death: 11.7% versus 2.4% (p 3.5% versus 1.9% (p = 0.045); definite/probable/possible stent thrombosis: 2.5% versus 0.9% (p = 0.01); and major bleeding: 4.2% versus 2.1% (p = 0.014). After adjusting for confounders...

  16. Newly developed biodegradable stents for benign gastrointestinal tract stenoses: a preliminary clinical trial.

    Science.gov (United States)

    Tanaka, Toyohiko; Takahashi, Masashi; Nitta, Norihisa; Furukawa, Akira; Andoh, Akira; Saito, Yasuharu; Fujiyama, Yoshihide; Murata, Kiyoshi

    2006-01-01

    We developed an Ultraflex-type stent by knitting polylactic acid monofilaments. The purpose of this study was to evaluate the stent's clinical usefulness for treating benign stenoses in the gastrointestinal tract. The radial force of the biodegradable stent was compared with those of commercially available metallic stents. The measured radial force of the new biodegradable stent was higher than that of commercially available metallic stents. The biodegradable stents were applied in 2 patients with benign gastrointestinal stenoses. The first patient was a 19-year-old female with esophageal stenosis, due to drinking of caustic potash in an attempt to commit suicide. The second patient was a 75-year-old male who had a stenosis at the anastomotic site after esophageal cancer resection. In both cases, the placement of the stent was performed successfully, and the patients' complaints improved immediately after stent placement. There were no complications during stent placement. The stenosis had not recurred at the six-month follow-up examination. In conclusion, the newly developed biodegradable stents were useful in treating benign stenoses of the alimentary tract. 2006 S. Karger AG, Basel

  17. Comparison of new-generation drug-eluting stents versus drug-coated balloon for in-stent restenosis: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Cai, Jin-Zan; Zhu, Yong-Xiang; Wang, Xin-Yu; Bourantas, Christos V; Iqbal, Javaid; Zhu, Hao; Cummins, Paul; Dong, Sheng-Jie; Mathur, Anthony; Zhang, Yao-Jun

    2018-02-22

    The study sought to compare angiographic and clinical outcomes of new-generation drug-eluting stents (DES) versus drug-coated balloon (DCB) in patients with coronary in-stent restenosis (ISR). Meta-analysis using data from randomised trial found by searches on PubMed, the Cochrane Library, ClinicalTrials.gov and websites of major cardiovascular congresses. Only randomised trials comparing DES with DCB were included. Patients with ISR in the included trials. New-generation DES versus DCB. The angiographic and clinical outcomes including cardiac death, all-cause death, myocardial infarction, target lesion revascularisation (TLR), target vessel revascularisation (TVR), major adverse cardiac events (MACE) and stent thrombosis were investigated. Five trials including 913 patients were eligible and included. Pooled analysis in angiographic results identified that new-generation DES were associated with higher acute luminal gain (-0.31 mm, 95% CI -0.42 to -0.20, PDES significantly reduced the risk of TLR (RR: 1.96, 95% CI 1.17 to 3.28, P=0.01) compared with DCB; however, there was no statistical differences for MACE (RR: 1.21, 95% CI 0.67 to 2.17, P=0.53), myocardial infarction (RR: 1.16, 95% CI 0.55 to 2.48, P=0.69) and cardiac death (RR: 1.80, 95% CI 0.60 to 5.39, P=0.29). Interventions with new-generation DES appear to be associated with significant reduction in per cent diameter stenosis and TLR at short-term follow-up, but had similar MACE, myocardial infarction and cardiac death for patients with coronary ISR compared with DCB. Appropriately powered studies with longer term follow-up are warranted to confirm these findings. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  18. 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

  19. Five year clinical effect of coronary stenting and coronary artery bypass grafting in renal insufficient patients with multivessel coronary artery disease: insights from ARTS trial.

    Science.gov (United States)

    Aoki, Jiro; Ong, Andrew T L; Hoye, Angela; van Herwerden, Lex A; Sousa, J Eduardo; Jatene, Adib; Bonnier, Johannes J R M; Schönberger, Jacques P M A; Buller, Nigel; Bonser, Robert; Lindeboom, Wietze; Unger, Felix; Serruys, Patrick W

    2005-08-01

    To compare coronary stent implantation and bypass surgery for multivessel coronary disease in patients with renal insufficiency. In the ARTS trial, 142 moderate renal insufficient patients (Ccr<60 mL/min) with multivessel coronary disease were randomly assigned to stent implantation (n=69) or CABG (n=73). At 5 years, there was no significant difference between the two groups in terms of mortality (14.5% in the stent group vs. 12.3% in the CABG group, P=0.81), or combined endpoint of death, cerebrovascular accident (CVA), or myocardial infarction (MI) (30.4% in the stent group vs. 23.3% in the CABG group, P=0.35). Among patients who survived without CVA or MI, 18.8% in the stent group underwent a second revascularization procedure when compared with 8.2% in the surgery group (P=0.08). The event-free survival at 5 years was 50.7% in the stent group and 68.5% in the surgery group (P=0.04). At 5 years, the differences in mortality and combined incidence of death, CVA, and MI between coronary stenting and surgery did not reach statistically significant level. However, the occurrence of MACCE in the stent group was higher than in the CABG group, mainly driven by the higher incidence of repeat revascularization in the stent group.

  20. A Multicenter Randomized Controlled Trial of Malignant Gastric Outlet Obstruction: Tailored Partially Covered Stents (Placed Fluoroscopically versus Standard Uncovered Stents (Placed Endoscopically

    Directory of Open Access Journals (Sweden)

    Ding Shi

    2014-01-01

    Full Text Available The aim of our study is to compare the efficacy and safety of “outlet-shape” tailored stents with standard stents for the management of distal gastric cancer causing gastric outlet obstructions (GOOs with varying gastric cavity shapes and sizes. To determine the shape and size of the GOOs, stomach opacifications were performed using contrast media before stenting. Two basic shapes of the residual cavity of the proximal GOO were observed: cup shaped or approximately cup shaped and funnel shaped or approximately funnel shaped. Other shapes were not found. In the GOO tailored group, the size and shape of the proximal ends of the tailored stent were suited for the residual cavity of the proximal GOO. The tailored stents included large cup-shaped stents and large funnel-shaped stents. GOO tailored covered stents led to less restenosis and reintervention rates compared to standard uncovered stents but with the same survival.

  1. One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study).

    Science.gov (United States)

    Ohki, Takao; Angle, John F; Yokoi, Hiroyoshi; Jaff, Michael R; Popma, Jeffrey; Piegari, Guy; Kanaoka, Yuji

    2016-02-01

    The purpose of this study was to assess the safety and efficacy of the Misago stent (Terumo Corp, Tokyo, Japan) in occlusive and stenotic superficial femoral artery (SFA) disease. The safety and efficacy of the Misago SFA stent were evaluated prospectively in this initial collaboration trial between Japan and the United States. Because this trial enrolled patients mainly from Japan and the United States and because there is a question as to whether a race difference exists in SFA stent performance, the race difference on outcome was also analyzed. In addition, results were compared with a prior SFA stent trial. The Misago stent was implanted in 261 subjects with TransAtlantic Inter-Society Consensus (TASC) type A and type B SFA lesions (201 subjects in the United States, 50 in Japan, 9 in Taiwan, 1 in South Korea). The mean age of the patients was 69.3 ± 10.0 years, and the mean lesion length was 83.8 ± 41.3 mm. The overall 12-month primary patency rate and clinically driven target lesion revascularization were 82.9% and 13.0%, respectively. Regional differences within the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) and outcomes between U.S. and Asian patients were similar, including primary patency (82.9% vs 83.0%; P = .889), clinically driven target lesion revascularization (13.4% vs 11.7%; P = .829), stent fracture rate (1.3% vs 0.0%; P = 1.000), and stent thrombosis rate (0.5% vs 0.0%; P = 1.000). OSPREY 12-month data showed satisfactory outcome of the Misago stent for the treatment of TASC type A and type B SFA lesions and appears to be comparable to recent stent trials. In addition, the lack of difference in outcome among races supports the value of international trials. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  2. Interventions to increase enrollment in a large multicenter phase 3 trial of carotid stenting vs. endarterectomy.

    Science.gov (United States)

    Longbottom, Mary E; Roberts, Jamie N; Tom, Meelee; Hughes, Susan E; Howard, Virginia J; Sheffet, Alice J; Meschia, James F; Brott, Thomas G

    2012-08-01

    Randomized clinical trials often encounter slow enrollment. Failing to meet sample size requirements has scientific, financial, and ethical implications. We report interventions used to accelerate recruitment in a large multicenter clinical trial that was not meeting prespecified enrollment commitments. The Carotid Revascularization Endarterectomy vs. Stenting Trial began randomization in December 2000. To accelerate enrollment, multiple recruitment tactics were initiated, which included expanding the number of sites, hiring a recruitment director (May 2003), broadening eligibility criteria (April 2005), branding with a study logo, Web site, and recruitment materials, increasing site visits by study leadership, sending e-mails to the site teams after every enrollment, distributing electronic newsletters, and implementing investigator and coordinator conferences. From December 2000 through May 2003, 14 sites became active (54 patients randomized), from June 2003 through April 2005, 44 sites were added (404 patients randomized), and from May 2005 through July 2008, 54 sites were added (2044 patients randomized). During these time intervals, the number of patients enrolled per site per year was 1·5, 3·6, and 5·6. For the single years 2004 to 2008, the mean monthly randomization rates per year were 19·7, 38·1, 56·4, 53·0, and 54·7 (annualized), respectively. Enrollment was highest after recruitment tactics were implemented: 677 patients in 2006, 636 in 2007, and 657 in 2008 (annualized). The prespecified sample size of 2502 patients, 47% asymptomatic, was accomplished on July 2008. Aggressive recruitment tactics and investment in a full-time recruitment director who can lead implementation may be effective in accelerating recruitment in multicenter trials. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

  3. Randomised trial of prevention of biliary stent occlusion by ursodeoxycholic acid plus norfloxacin.

    Science.gov (United States)

    Barrioz, T; Ingrand, P; Besson, I; de Ledinghen, V; Silvain, C; Beauchant, M

    1994-08-27

    Biliary stents are liable to clog. We investigated whether a choleretic plus an antibiotic could delay clogging. 20 consecutive patients with a malignant biliary stricture were randomised after endoscopic insertion of a polyethylene stent to receive ursodeoxycholic acid plus norfloxacin (13-15 mg/kg and 400 mg, daily) or conservative treatment. The drug combination was associated with: a longer median patency of first (49 vs 6 weeks) and all stents (38 vs 7 weeks); a prolonged median survival (67 vs 18 weeks); and a shorter mean hospital stay (0.2 vs 1.0 days per week of survival). Thus ursodeoxycholic acid plus norfloxacin may prevent stent clogging.

  4. Everolimus eluting stent vs first generation drug-eluting stent in primary angioplasty: A pooled patient-level meta-analysis of randomized trials.

    Science.gov (United States)

    De Luca, Giuseppe; Smits, Peter; Hofma, Sjoerd H; Di Lorenzo, Emilio; Vlachojannis, Georgios J; Van't Hof, Arnoud W J; van Boven, Ad J; Kedhi, Elvin; Stone, Gregg W; Suryapranata, Harry

    2017-10-01

    Several concerns have emerged about the higher risk of very late stent thrombosis (ST) with first generation drug-eluting stent (DES) especially among STEMI patients. Newer generation DES has demonstrated to reduce ST at mid-term follow-up. Therefore, the aim of the present study is to perform an individual patient's data meta-analysis of trials comparing 1st generation DES vs. 2nd generation DES (everolimus-eluting stent, EES) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. We performed a formal search of electronic databases (MEDLINE and CENTRAL) and scientific session presentations from January 2010 to June 2016. We included all completed randomized trials comparing 1st vs. EES for patient presenting with STEMI. Individual patients data were obtained from 3 trials, including a total of 1581 patients (686 or 43.4% randomized to 1st generation DES and 895 or 56.4% randomized to EES). At long-term follow-up (1584±588days), EES did not significantly reduce mortality (7.8.% vs 11.7%, HR [95%CI]=0.77 [0.52, 1.13], p=0.18, p heterogeneity =0.93), cardiac mortality (6.2% vs 7.6%, HR [95%CI]=0.90 [0.56, 1.44], p=0.65, p heterogeneity =0.85), and reinfarction (8.1% versus 11.2%, respectively; HR [95%CI]=0.74 [0.51, 1.07], p=0.11, p heterogeneity =0.52). However, EES significantly reduced the occurrence of ST (3.4% versus 6.1% respectively, HR [95%CI]=0.56 [0.32, 0.97], p=0.04, p heterogeneity =0.42) and target vessel revascularization (TVR) (14.2% versus 20.1%; HR [95%CI]=0.63 [0.42, 0.96], p=0.03, p heterogeneity =0.55). Landmark analysis showed more consistent benefits in ST with EES within 1year, whereas benefits in TVR were mostly observed later than 1year. The present pooled patient-level meta-analysis demonstrates that among STEMI patients undergoing primary PCI, EES as compared to 1st generation DES is associated with a significant reduction in ST and TVR at long-term follow-up. Copyright © 2017 Elsevier Ireland Ltd. All rights

  5. Chlorhexidine vaginal wipes prior to elective cesarean section: does it reduce infectious morbidity? A randomized trial.

    Science.gov (United States)

    Ahmed, Magdy R; Aref, Nisreen K; Sayed Ahmed, Waleed A; Arain, Farzana R

    2017-06-01

    To evaluate the efficacy of preoperative vaginal cleansing using chlorhexidine 0.25% antiseptic wipes on rates of postcesarean section (CS) infectious morbidities (endometritis, febrile morbidity and wound infection). This prospective randomized trial was conducted among 218 pregnant women scheduled for term elective CS. Patients were equally divided into two groups by simple randomization. After spinal anesthesia and catheterization under aseptic technique, the study group had preoperative vaginal cleansing using chlorhexidine 0.25% antiseptic wipes for about 1 min, while the control group did not. All cases received the prophylactic antibiotics and the usual abdominal scrub. All participants received the routine postoperative care without other interventions. Adverse postcesarean infectious morbidities such as endometritis, febrile morbidity and wound infection were observed at the time of hospital discharge and weekly for 6 weeks postpartum. Both groups were matched regarding the baseline patients' characteristics (age, gestational age, BMI, operative time and postoperative hospital stay). Overall, post-CS infectious morbidity were significantly reduced from 24.4% in the control group to 8.8% in the intervention group; p value chlorhexidine 0.25% wipes prior to elective CS appears to be effective in reducing rates of post-CS infectious morbidity mainly endometritis.

  6. A randomized placebo-controlled trial of preoperative tranexamic acid among women undergoing elective cesarean delivery.

    Science.gov (United States)

    Maged, Ahmed M; Helal, Omneya M; Elsherbini, Moutaz M; Eid, Marwa M; Elkomy, Rasha O; Dahab, Sherif; Elsissy, Maha H

    2015-12-01

    To study the efficacy and safety of preoperative intravenous tranexamic acid to reduce blood loss during and after elective lower-segment cesarean delivery. A single-blind, randomized placebo-controlled study was undertaken of women undergoing elective lower-segment cesarean delivery of a full-term singleton pregnancy at a center in Cairo, Egypt, between November 2013 and November 2014. Patients were randomly assigned (1:1) using computer-generated random numbers to receive either 1g tranexamic acid or 5% glucose 15 minutes before surgery. Preoperative and postoperative complete blood count, hematocrit values, and maternal weight were used to calculate the estimated blood loss (EBL) during cesarean, which was the primary outcome. Analyses included women who received their assigned treatment, whose surgery was 90 minutes or less, and who completed follow-up. Analyses included 100 women in each group. Mean EBL was significantly higher in the placebo group (700.3 ± 143.9 mL) than in the tranexamic acid group (459.4 ±7 5.4 mL; Pcesarean delivery. Australian New Zealand Clinical Trials Registry:ACTRN12615000312549. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  7. Mechanism of Procedural Stroke Following Carotid Endarterectomy or Carotid Artery Stenting Within the International Carotid Stenting Study (ICSS) Randomised Trial.

    Science.gov (United States)

    Huibers, A; Calvet, D; Kennedy, F; Czuriga-Kovács, K R; Featherstone, R L; Moll, F L; Brown, M M; Richards, T; de Borst, G J

    2015-09-01

    To decrease the procedural risk of carotid revascularisation it is crucial to understand the mechanisms of procedural stroke. This study analysed the features of procedural strokes associated with carotid artery stenting (CAS) and carotid endarterectomy (CEA) within the International Carotid Stenting Study (ICSS) to identify the underlying pathophysiological mechanism. Patients with recently symptomatic carotid stenosis (1,713) were randomly allocated to CAS or CEA. Procedural strokes were classified by type (ischaemic or haemorrhagic), time of onset (intraprocedural or after the procedure), side (ipsilateral or contralateral), severity (disabling or non-disabling), and patency of the treated artery. Only patients in whom the allocated treatment was initiated were included. The most likely pathophysiological mechanism was determined using the following classification system: (1) carotid-embolic, (2) haemodynamic, (3) thrombosis or occlusion of the revascularised carotid artery, (4) hyperperfusion, (5) cardio-embolic, (6) multiple, and (7) undetermined. Procedural stroke occurred within 30 days of revascularisation in 85 patients (CAS 58 out of 791 and CEA 27 out of 819). Strokes were predominately ischaemic (77; 56 CAS and 21 CEA), after the procedure (57; 37 CAS and 20 CEA), ipsilateral to the treated artery (77; 52 CAS and 25 CEA), and non-disabling (47; 36 CAS and 11 CEA). Mechanisms of stroke were carotid-embolic (14; 10 CAS and 4 CEA), haemodynamic (20; 15 CAS and 5 CEA), thrombosis or occlusion of the carotid artery (15; 11 CAS and 4 CEA), hyperperfusion (9; 3 CAS and 6 CEA), cardio-embolic (5; 2 CAS and 3 CEA) and multiple causes (3; 3 CAS). In 19 patients (14 CAS and 5 CEA) the cause of stroke remained undetermined. Although the mechanism of procedural stroke in both CAS and CEA is diverse, haemodynamic disturbance is an important mechanism. Careful attention to blood pressure control could lower the incidence of procedural stroke. Copyright © 2015

  8. A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial.

    Science.gov (United States)

    Gao, Run-Lin; Xu, Bo; Lansky, Alexandra J; Yang, Yue-Jin; Ma, Chang-Sheng; Han, Ya-Ling; Chen, Shao-Liang; Li, Hui; Zhang, Rui-Yan; Fu, Guo-Sheng; Yuan, Zu-Yi; Jiang, Hong; Huo, Yong; Li, Wei; Zhang, Yao-Jun; Leon, Martin B

    2013-05-20

    The study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) for treating patients with single de novo coronary lesions compared with the durable polymer everolimus-eluting stent (EES) XIENCE V. A total of 458 patients with single de novo native coronary lesions ≤24 mm in length and a coronary artery ≥2.25 to ≤4.0 mm in diameter were enrolled in the TARGET I study, a prospective, randomised, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), or ischaemia-driven target lesion revascularisation (iTLR). Patients were centrally randomised to treatment with either biodegradable polymer SES (n=227) or durable polymer EES (n=231). The nine-month in-stent LLL of the biodegradable polymer SES was comparable to the EES group (0.13 ± 0.24 mm vs. 0.13 ± 0.18 mm, p=0.94; difference and 95% confidence interval 0.00 [-0.04, 0.04] mm; p for non-inferiority 0.05). No definite/probable stent thrombosis was observed in both of these groups. In the multicentre TARGET I trial, the novel abluminal groove-filled biodegradable polymer SES FIREHAWK was non-inferior to the durable polymer EES XIENCE V with respect to the primary endpoint of in-stent LLL at nine months for treating patients with single de novo coronary lesions. The incidences of clinical endpoints were low in both of the stents at 12-month follow-up. (ClinicalTrials.gov identifier: NCT01196819).

  9. Comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction (COMFORTABLE AMI trial): rationale and design

    NARCIS (Netherlands)

    Räber, L.; von Birgelen, Clemens

    2012-01-01

    Aims: Compared with bare metal stents (BMS), early generation drug-eluting stents (DES) reduce the risk of revascularisation in patients with ST-elevation myocardial infarction (STEMI) at the expense of an increased risk of very late stent thrombosis (ST). Durable polymer coatings for controlled

  10. Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at standard surgical risk: results from the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST).

    Science.gov (United States)

    Vilain, Katherine R; Magnuson, Elizabeth A; Li, Haiyan; Clark, Wayne M; Begg, Richard J; Sam, Albert D; Sternbergh, W Charles; Weaver, Fred A; Gray, William A; Voeks, Jenifer H; Brott, Thomas G; Cohen, David J

    2012-09-01

    The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) demonstrated similar rates of the primary composite end point between carotid artery stenting (CAS) and carotid endarterectomy (CEA), although the risk of stroke was higher with CAS, and the risk of myocardial infarction was higher with CEA. Given the large number of patients who are candidates for these procedures, an understanding of their relative cost and cost-effectiveness may have important implications for health care policy and treatment guidelines. We performed a formal economic evaluation alongside the CREST trial. Costs were estimated from all trial participants over the first year of follow-up using a combination of resource use data and hospital billing data. Patient-level health use scores were obtained using data from the SF-36. We then used a Markov disease-simulation model calibrated to the CREST results to project 10-year costs and quality-adjusted life expectancy for the 2 treatment groups. Although initial procedural costs were $1025/patient higher with CAS, postprocedure costs and physician costs were lower such that total costs for the index hospitalization were similar for the CAS and CEA groups ($15 055 versus $14 816; mean difference, $239/patient; 95% CI for difference, -$297 to $775). Neither follow-up costs after discharge nor total 1-year costs differed significantly. For the CREST population, model-based projections over a 10-year time horizon demonstrated that CAS would result in a mean incremental cost of $524/patient and a reduction in quality-adjusted life expectancy of 0.008 years compared with CEA. Probabilistic sensitivity analysis demonstrated that CEA was economically attractive at an incremental cost-effectiveness threshold of $50 000/quality-adjusted life-year gained in 54% of samples, whereas CAS was economically attractive in 46%. Despite slightly lower in-trial costs and lower rates of stroke with CEA compared with CAS, projected 10-year outcomes

  11. Sustained Benefit at 2 Years for Covered Stents Versus Bare-Metal Stents in Long SFA Lesions: The VIASTAR Trial

    Energy Technology Data Exchange (ETDEWEB)

    Lammer, Johannes, E-mail: jlammer@gmx.at, E-mail: johannes.lammer@meduniwien.ac.at [Medical University Vienna, The Department of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy (Austria); Zeller, Thomas, E-mail: thomas.zeller@universitaets-herzzentrum.de [Universitaets-Herzzentrum Freiburg-Bad Krozingen, Department of Angiology (Germany); Hausegger, Klaus A., E-mail: klaus.hausegger@lkh-klu.at [Klinikum Klagenfurt, The Department of Diagnostic and Interventional Radiology (Austria); Schaefer, Philipp J., E-mail: jp.schaefer@rad.uni-kiel.de [University Clinics Schleswig-Holstein, The Department of Radiology (Germany); Gschwendtner, Manfred, E-mail: manfred.gschwendtner@elisabethinen.or.at [Elisabethinen Hospital, The Department of Diagnostic and Interventional Radiology (Austria); Mueller-Huelsbeck, Stefan, E-mail: muehue@diako.de [Diakonissen Hospital, The Department of Diagnostic and Interventional Radiology (Germany); Rand, Thomas, E-mail: thomas.rand@wienkav.at [Hietzing Hospital, The Department of Radiology (Austria); Funovics, Martin, E-mail: martin.funovics@meduniwien.ac.at; Wolf, Florian, E-mail: florian.wolf@meduniwien.ac.at [Medical University Vienna, The Department of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy (Austria); Rastan, Aljoscha, E-mail: aljoscha.rastan@universitaets-herzzentrum.de [Universitaets-Herzzentrum Freiburg-Bad Krozingen, Department of Angiology (Germany); Gschwandtner, Michael, E-mail: michael.gschwandtner@meduniwien.ac.at [Medical University Vienna, The Department of Angiology (Austria); Puchner, Stefan, E-mail: stefan.puchner@meduniwien.ac.at [Medical University Vienna, The Department of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy (Austria); and others

    2015-02-15

    PurposeThe hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only.MethodsA prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN{sup ®} Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN{sup ®} versus 17.3 ± 6.6 cm in the BMS group.ResultsThe 24-month primary patency rates in the VIABAHN{sup ®} and BMS group were: intention-to-treat 63.1 (95 % CI 0.52–0.76) versus 41.2 % (95 % CI 0.29–0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58–0.83) versus 40.0 % (95 % CI 0.28–0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70–0.90) versus 73.0 % (95 % CI 0.63–0.85) for VIABAHN{sup ®} versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50–0.85) versus 26.7 % (95 % CI 0.12–0.59; log rank p = 0.004) for VIABAHN{sup ®} versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68–0.94) versus 61.9 % (95 % CI 0.44–0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN{sup ®} versus the BMS group, respectively.ConclusionAt 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244)

  12. Elective repeat cesarean delivery compared with trial of labor after a prior cesarean delivery: a propensity score analysis

    NARCIS (Netherlands)

    Kok, N.; Ruiter, L.; Lindeboom, R.; de Groot, C.; Pajkrt, E.; Mol, B. W.; Kazemier, B. M.

    2015-01-01

    To determine neonatal and short term maternal outcomes according to intentional mode of delivery following a cesarean delivery (CD). Women pregnant after CD between January 2000 and December 2007 were categorized according to whether they had an elective repeat CD (ERCD) or a Trial of Labor (TOL).

  13. Safety and efficacy of biodegradable drug-eluting vs. bare metal stents: a meta-analysis from randomized trials.

    Science.gov (United States)

    Yin, Yangguang; Zhang, Yao; Zhao, Xiaohui

    2014-01-01

    Biodegradable polymeric coatings have been proposed as a promising strategy to enhance biocompatibility and improve the delayed healing in the vessel. However, the efficacy and safety of biodegradable polymer drug-eluting stents (BP-DES) vs. bare metal stents (BMS) are unknown. The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) comparing the outcomes of BP-DES vs. BMS. PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials, until December 2013, that compared any of approved BP-DES and BMS. Efficacy endpoints were target-vessel revascularization (TVR), target-lesion revascularization (TLR) and in-stent late loss (ISLL). Safety endpoints were death, myocardial infarction (MI), definite stent thrombosis (DST). The meta-analysis included 7 RCTs with 2,409 patients. As compared with BMS, there was a significantly reduced TVR (OR [95% CI] = 0.37 [0.28-0.50]), ISLL (OR [95% CI] = -0.41 [-0.48-0.34]) and TLR (OR [95% CI] = 0.38 [0.27-0.52]) in BP-DES patients. However, there were no difference for safety outcomes between BP-DES and BMS. BP-DES is more effective in reducing ISLL, TVR and TLR, as safe as standard BMS with regard to death, ST and MI. Further large RCTs with long-term follow-up are warranted to better define the relative merits of BP-DES.

  14. Paclitaxel-eluting stents versus everolimus-eluting coronary stents in a diabetic population: two-year follow-up of the TUXEDO-India trial.

    Science.gov (United States)

    Kaul, Upendra; Bhagwat, Ajit; Pinto, Brian; Goel, Praveen K; Jagtap, Prashant; Sathe, Shireesh; Wander, Gurpreet S; Arambam, Priyadarshini; Bangalore, Sripal

    2017-11-20

    The aim of this study was to report whether the superiority of the everolimus-eluting stent (EES) vs. the paclitaxel-eluting stent (PES) at one-year follow-up in the Taxus Element versus Xience Prime in a Diabetic Population (TUXEDO)-India trial was sustained at longer-term follow-up. One thousand eight hundred and thirty (1,830) patients with diabetes mellitus and coronary artery disease were randomised to EES vs. PES. Follow-up data up to two years were available in 1,701 (92.9%) patients. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischaemia-driven target vessel revascularisation (TVR). Treatment with EES had a lower two-year rate of TVF (4.3% vs. 6.6%, p=0.03). Of the secondary endpoints, EES significantly reduced any MI (1.6% vs. 3.5%, p=0.01), TV-MI (0.7% vs. 3.1%, p=0.0001), ST (0.4% vs. 2.2%, p=0.001), cardiac death or target vessel MI (2.9% vs. 4.8%, p=0.04) and TLR (1.9% vs. 3.7%, p=0.02), compared with PES. Between one year and two years, no significant differences in the clinical outcomes were observed (pinteraction >0.05). In this adequately powered trial, the benefits of EES vs. PES in a diabetic population seen at one year were maintained at two years.

  15. Does Combination Therapy with Tamsulosin and Tolterodine Improve Ureteral Stent Discomfort Compared with Tamsulosin Alone? A Double-Blind, Randomized, Controlled Trial.

    Science.gov (United States)

    Sivalingam, Sri; Streeper, Necole M; Sehgal, Priyanka D; Sninsky, Brian C; Best, Sara L; Nakada, Stephen Y

    2016-02-01

    Ureteral stent discomfort is a significant postoperative problem for many patients. Despite the use of narcotics and α-blockers patients often experience bothersome lower urinary tract symptoms and pain, which impair daily activities. We compared combination therapy with an α-blocker and an anticholinergic to monotherapy with an α-blocker. A double-blind, randomized, controlled trial was performed from December 2012 to April 2014. A total of 80 patients were randomized, including 44 to the combination group (tamsulosin 0.4 mg and tolterodine early release 4 mg) and 36 to the monotherapy group (tamsulosin 0.4 mg and placebo). Patients with preexisting ureteral stent placement or current anticholinergic therapy were excluded from study. Patients completed USSQ (Urinary Stent Symptom Questionnaire) before stent placement on the day of surgery, the day after stent placement, the morning of stent removal and the day after stent removal. The questionnaire included questions regarding urinary symptoms, general health, body pain, and work and sexual history. A total of 80 patients (40 males and 40 females) were studied. Mean age was 51.5 vs 51.3 years (p = 0.95) and mean body mass index was 33.6 vs 31.9 kg/m(2) (p = 0.44) in monotherapy group 1 vs combination therapy group 2. Between the 2 groups there was no significant difference in urinary symptoms, body pain and activities of daily living from baseline to just before stent removal (p = 0.95, 0.40 and 0.95, respectively). Although there was no difference between the groups, both showed improvement in urinary symptoms from the time of initial stent insertion to just prior to stent removal (difference -0.50 for combination therapy and -0.40 for monotherapy). The mean stent indwelling time of 9.6 and 8.7 days in the combination and monotherapy groups, respectively, did not differ (p = 0.67). On ANOVA it had no significant impact on results (p = 0.64). Combination therapy with tamsulosin and tolterodine does not

  16. 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.

  17. First-in-man randomised comparison of the BuMA Supreme biodegradable polymer sirolimus-eluting stent versus a durable polymer zotarolimus-eluting coronary stent: the PIONEER trial.

    Science.gov (United States)

    von Birgelen, Clemens; Asano, Taku; Amoroso, Giovanni; Aminian, Adel; Brugaletta, Salvatore; Vrolix, Mathias; Hernandez-Antolín, Rosana; van de Harst, Pim; Iñiguez, Andres; Janssens, Luc; Smits, Pieter C; Wykrzykowska, Joanna J; Ribeiro, Vasco Gama; Pereira, Hélder; da Silva, Pedro Canas; Piek, Jan J; Onuma, Yoshinobu; Serruys, Patrick W; Sabaté, Manel

    2018-04-20

    A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device. This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

  18. Safety and efficacy of second-generation drug-eluting stents compared with bare-metal stents: An updated meta-analysis and regression of 9 randomized clinical trials.

    Science.gov (United States)

    Mahmoud, Ahmed N; Shah, Nikhil H; Elgendy, Islam Y; Agarwal, Nayan; Elgendy, Akram Y; Mentias, Amgad; Barakat, Amr F; Mahtta, Dhruv; David Anderson, R; Bavry, Anthony A

    2018-01-01

    The efficacy of second-generation drug-eluting stents (DES; eg, everolimus and zotarolimus) compared with bare-metal stents (BMS) in patients undergoing percutaneous coronary intervention was challenged recently by new evidence from large clinical trials. Thus, we aimed to conduct an updated systematic review and meta-analysis of randomized clinical trials (RCTs) evaluating the efficacy and safety of second-generation DES compared with BMS. Electronic databases were systematically searched for all RCTs comparing second-generation DES with BMS and reporting clinical outcomes. The primary efficacy outcome was major adverse cardiac events (MACE); the primary safety outcome was definite stent thrombosis. The DerSimonian and Laird method was used for estimation of summary risk ratios (RR). A total of 9 trials involving 17 682 patients were included in the final analysis. Compared with BMS, second-generation DES were associated with decreased incidence of MACE (RR: 0.78, 95% confidence interval [CI]: 0.69-0.88), driven by the decreased incidence of myocardial infarction (MI) (RR: 0.67, 95% CI: 0.48-0.95), target-lesion revascularization (RR: 0.47, 95% CI: 0.42-0.53), definite stent thrombosis (RR: 0.57, 95% CI: 0.41-0.78), and definite/probable stent thrombosis (RR: 0.54, 95% CI: 0.38-0.80). The incidence of all-cause mortality was similar between groups (RR: 0.94, 95% CI: 0.79-1.10). Meta-regression showed lower incidences of MI with DES implantation in elderly and diabetic patients (P = 0.026 and P DES appear to be associated with a lower incidence of MACE, mainly driven by lower rates of target-lesion revascularization, MI, and stent thrombosis. However, all-cause mortality appears similar between groups. © 2018 Wiley Periodicals, Inc.

  19. Impact of drug-eluting stents with different coating strategies on stent thrombosis: A meta-analysis of 19 randomized trials.

    Science.gov (United States)

    Niu, Xiaowei; Yang, Cuiling; Chen, De; He, Shengliang; Yan, Dong; Yao, Yali

    2014-01-01

    Whether drug-eluting stents with biodegradable polymers (BP-DES) improve safety, especially with respect to stent thrombosis (ST) compared with permanent polymers DES (PP-DES), remains uncertain. We aimed to compare the short- and long-term outcomes and the ST risk in patients treated with BP-DES vs. We searched Medline, Embase, Web of science, CENTRAL databases, and conferenceproceedings/abstracts for randomized controlled trials (RCTs) comparing BP-DES with PP-DES. The primary endpoint was to compare the risks of overall and different temporalc ategories of definite/probable ST. Other clinical outcomes were target lesion revascularization (TLR), myocardial infarction (MI), and all-cause death in short-term (≤ 1 year) and long-term follow-up. The meta-analyses were performed by computing odds ratios (ORs) with 95% confidence intervals (CIs) using a random-effects model. Nineteen RCTs including 20,229 patients were analyzed. Overall, BP-DES significantly decreased the risks of very late definite/probable ST (OR 0.33; 95% CI 0.16-0.70), and TLR in long-term follow-up (OR 0.70; 95% CI 0.52-0.95) compared with PP-DES. There were no significant differences between the groups regarding MI incidence and mortality during both short and long follow-up periods. In stratified analyses, the long-term superiority of BP-DES was maintained only by using first-generation DES as the comparators. The present meta-analysis indicated that BP-DES were more efficacious than PP-DES at reducing the risks of very late ST and long-term TLR, but it could vary by heterogeneities in the use of PP-DES comparators. Additional rigorous RCTs with longer follow-up periods are warranted to verify these very promising long-term endpoints.

  20. Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Adamson, Douglas; Blazeby, Jane; Nelson, Annmarie; Hurt, Chris; Nixon, Lisette; Fitzgibbon, Jim; Crosby, Tom; Staffurth, John; Evans, Mim; Kelly, Noreen Hopewell; Cohen, David; Griffiths, Gareth; Byrne, Anthony

    2014-10-22

    The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion. The study is a randomized multicenter phase III trial, with an internal pilot phase, comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer. Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia. Radiotherapy will be administered as 20 Gray (Gy) in five fractions over one week or 30 Gy in 10 fractions over two weeks, within four weeks of stent insertion. The internal pilot will assess rates and methods of recruitment; pre-agreed criteria will determine progression to the main trial. In total, 496 patients will be randomized in a 1:1 ratio with follow up until death. The primary outcome is time to progression of patient-reported dysphagia. Secondary outcomes include survival, toxicity, health resource utilization, and quality of life. An embedded qualitative study will explore the feasibility of patient recruitment by examining patients' motivations for involvement and their experiences of consent and recruitment, including reasons for not consenting. It will also explore patients' experiences of each trial arm. The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on

  1. Covered metallic stents with an anti-migration design vs. uncovered stents for the palliation of malignant gastric outlet obstruction: a multicenter, randomized trial.

    Science.gov (United States)

    Lee, Hyuk; Min, Byung-Hoon; Lee, Jeong Hoon; Shin, Cheol Min; Kim, Younjoo; Chung, Hyunsoo; Lee, Sang Hyub

    2015-10-01

    Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO. A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement. At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency. WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer.

  2. Five-year outcomes for first generation drug-eluting stents versus bare-metal stents in patients with ST-segment elevation myocardial infarction: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Zheng, Fei; Xing, Shanshan; Gong, Zushun; Xing, Qichong

    2014-06-01

    Drug-eluting stent (DES) implantation has been proved more effective compared with bare-metal stent (BMS) implantation for ST-segment elevation myocardial infarction (STEMI) within medium follow up. However, limited information is available on the long-term safety and efficacy of DES. We performed a meta-analysis of randomised controlled trials (RCT) comparing DES with BMS in patients with STEMI at long-term follow up, defined as five years or more. The clinical end points were target vessel revascularisation (TVR), death, recurrent myocardial infarction (MI), stent thrombosis and very late stent thrombosis. We calculated the pooled estimate based on a fixed-effects model using odds ratio (OR) for rare events. Four RCT were included, with a total of 1414 patients enrolled. Up to five years, DES showed a significant reduction in TVR (OR, 0.55; 95% confidence interval [CI], 0.55-0.77; P = 0.0005), but an increase in very late stent thrombosis (OR, 3.03; 95% CI, 1.28-7.18; P = 0.01), without increasing mortality (OR, 0.85; 95% CI, 0.59-1.20; P = 0.35), recurrent MI (OR, 1.05; 95% CI, 0.69-1.60; P = 0.80), and overall stent thrombosis (OR, 1.10; 95% CI, 0.66-1.82; P = 0.72). At long-term follow-up, primary percutaneous coronary intervention with DES improved efficacy, without reducing overall safety. However, a trade-off must be made between the reduction of reintervention with DES and an increase in very late stent thrombosis. Crown Copyright © 2014. Published by Elsevier B.V. All rights reserved.

  3. Gastric-Esophageal Stenting for Malignant Dysphagia: Results of Prospective Clinical Trial Evaluation of Long-Term Gastroesophageal Reflux and Quality of Life-Related Symptoms.

    Science.gov (United States)

    Philips, Prejesh; North, D Alan; Scoggins, Charles; Schlegel, Melissa; Martin, Robert C G

    2015-07-01

    Stenting across the gastroesophageal (GE) junction for adenocarcinoma has historically been contraindicated secondary to the concerns for severe GE reflux (GER) symptoms. The aim of this study was to assess reflux symptoms and quality of life (QOL) effects in patients undergoing esophageal stenting across the GE junction. We performed a prospective single arm QOL clinical trial evaluating patients with stage 2/3 GE junction adenocarcinoma, undergoing neoadjuvant therapy (from baseline to 10 weeks post-stenting) after stenting across the GE junction, for GER symptoms and QOL-GER assessments (EORTC-QLQ-O25 and Functional Assessment of Cancer Therapy-Esophageal [FACT-E]). Forty consecutive patients were enrolled in this clinical trial. The median age was 62 years (range 47 to 83 years); 84% were male and 19% were female patients. Median dysphagia score of 3 (only liquids tolerated) pre-stent was significantly improved to a score of 0 (ability to eat all foods) post-stent (p = 0.01). There was a significantly improved and sustained swallowing QOL from 2 weeks up to 10 weeks post-stent. The GER-QOL scores were similar 2 weeks post-stent, but were significantly improved throughout the rest of the study. Proton pump inhibitors were being used in 58% of patients pre-stent and in 85% of patients at 2- to 10-week follow-up. Planned chemotherapy and/or chemo-radiation therapy was completed in 95% of all patients. Stent migration (radiologic and/or complete) was seen in 63% of patients at some time during their therapy and corresponded to pathologic response in 85% of those patients. Esophageal stenting across the GE junction remains the optimal therapy for dysphagia relief in esophageal malignancies and does not adversely affect a patient's GER-QOL. Esophageal stenting across the GE junction is not contraindicated and should be the initial therapy in patient management. Copyright © 2015 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  4. Ureteral Stenting after Uncomplicated Ureteroscopy for Distal Ureteral Stones: A Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Y. El Harrech

    2014-01-01

    Full Text Available Objectives. We compared outcome and complications after uncomplicated ureteroscopic treatment of distal ureteral calculi with or without the use of ureteral stents. Materials and Methods. 117 patients, prospectively divided into three groups to receive a double j stent (group 1, 42 patients, ureteral stent (group 2, 37 patients, or no stent (group 3, 38 patients, underwent ureteroscopic treatment of distal ureteral calculi. Stone characteristics, operative time, postoperative pain, lower urinary tract symptoms (LUTS, analgesia need, rehospitalization, stone-free rate, and late postoperative complications were all studied. Results. There were no significant differences in preoperative data. There was no significant difference between the three groups regarding hematuria, fever, flank pain, urinary tract infection, and rehospitalisation. At 48 hours and 1 week, frequency/urgency and dysuria were significantly less in the nonstented group. When comparing group 1 and group 3, patients with double j stents had statistically significantly more bladder pain (P=0.003, frequency/urgency (P=0.002, dysuria (P=0.001, and need of analgesics (P=0.001. All patients who underwent imaging postoperatively were without evidence of obstruction or ureteral stricture. Conclusions. Uncomplicated ureteroscopy for distal ureteral calculi without intraoperative ureteral dilation can safely be performed without placement of a ureteral stent.

  5. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Spiliopoulos, Stavros [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Diamantopoulos, Athanasios [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Karnabatidis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Sabharwal, Tarun [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Siablis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece)

    2013-06-15

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of {>=}50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall

  6. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    International Nuclear Information System (INIS)

    Katsanos, Konstantinos; Spiliopoulos, Stavros; Diamantopoulos, Athanasios; Karnabatidis, Dimitris; Sabharwal, Tarun; Siablis, Dimitris

    2013-01-01

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration’s tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford–Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel–Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18–1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford–Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002–1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28–0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02–1.62, p = 0.04; NNT = 5.9), and better

  7. Biodegradable polymer drug-eluting stents versus first-generation durable polymer drug-eluting stents: A systematic review and meta-analysis of 12 randomized controlled trials.

    Science.gov (United States)

    Bundhun, Pravesh Kumar; Pursun, Manish; Huang, Feng

    2017-11-01

    Even if drug-eluting stents (DES) showed beneficial effects in patients with coronary artery diseases (CADs), limitations have been observed with the first-generation durable polymer DES (DP-DES). Recently, biodegradable polymer DES (BP-DES) have been approved to be used as an alternative to DP-DES, with potential benefits. We aimed to systematically compare BP-DES with the first-generation DP-DES using a large number of randomized patients. Electronic databases were searched for randomized controlled trials (RCTs) comparing BP-DES with first-generation DP-DES. The main endpoints were the long-term (≥2 years) adverse clinical outcomes that were reported with these 2 types of DES. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) and the analysis was carried out by RevMan 5.3 software. Twelve trials with a total number of 13,480 patients (7730 and 5750 patients were treated by BP-DES and first-generation DP-DES, respectively) were included. During a long-term follow-up period of ≥2 years, mortality, myocardial infarction (MI), target lesion revascularization (TLR), and major adverse cardiac events (MACEs) were not significantly different between these 2 groups with OR: 0.84, 95% CI: 0.66-1.07; P = .16, I = 0%, OR: 1.01, 95% CI: 0.45-2.27; P = .98, I = 0%, OR: 0.91, 95% CI: 0.75-1.11; P = .37, I = 0% and OR: 0.86, 95% CI: 0.44-1.67; P = .65, I = 0%, respectively. Long-term total stent thrombosis (ST), definite ST, and probable ST were also not significantly different between BP-DES and the first-generation DP-DES with OR: 0.77, 95% CI: 0.50-1.18; P = .22, I = 0%, OR: 0.71, 95% CI: 0.43-1.18; P = .19, I = 0% and OR: 1.31, 95% CI: 0.56-3.08; P = .53, I = 6%, respectively. Long-term mortality, MI, TLR, MACEs, and ST were not significantly different between BP-DES and the first-generation DP-DES. However, the follow-up period was restricted to only 3 years in this analysis. Copyright © 2017

  8. Prospective randomized controlled trial to evaluate "fast-track" elective open infrarenal aneurysm repair.

    Science.gov (United States)

    Muehling, Bernd M; Halter, Gisela; Lang, Gunter; Schelzig, Hubert; Steffen, Peter; Wagner, Florian; Meierhenrich, Rainer; Sunder-Plassmann, Ludger; Orend, Karl-Heinz

    2008-05-01

    Fast-track programs have been introduced in many surgical fields to minimize postoperative morbidity and mortality. Morbidity after elective open infrarenal aneurysm repair is as high as 30%; mortality ranges up to 10%. In terms of open infrarenal aneurysm repair, no randomized controlled trials exist to introduce and evaluate such patient care programs. This study involved prospective randomization of 82 patients in a "traditional" and a "fast-track" treatment arm. Main differences consisted in preoperative bowel washout (none vs. 3 l cleaning solution) and analgesia (patient controlled analgesia vs. patient controlled epidural analgesia). Study endpoints were morbidity and mortality, need for postoperative mechanical ventilation, and length of stay (LOS) on intensive care unit (ICU). The need for assisted postoperative ventilation was significantly higher in the traditional group (33.3% vs. 5.4%; p = 0.011). Median LOS on ICU was shorter in the fast-track group, 41 vs. 20 h. The rate of postoperative medical complications was significantly lower in the fast-track group, 16.2% vs. 35.7% (p = 0.045). We introduced and evaluated an optimized patient care program for patients undergoing open infrarenal aortic aneurysm repair which showed a significant advantage for "fast-track" patients in terms of postoperative morbidity.

  9. A randomized clinical trial of preoperative versus postoperative misoprostol in elective cesarean delivery.

    Science.gov (United States)

    Ragab, Ahmed; Barakat, Rafik; Alsammani, Mohamed A

    2016-01-01

    To determine the optimum time for misoprostol administration to minimize blood loss during and after elective cesarean delivery. A randomized clinical trial was conducted at Mansoura University Hospital, Egypt, between January 1, 2013, and December 31, 2014. Eligible participants had full-term pregnancies, were scheduled to have a cesarean, and had normal fetal heart tracing. Patients were randomly allocated into two equal groups using computer-generated tables and sealed opaque envelopes. Misoprostol (400μg, given rectally) was given either before (group 1) or after (group 2) surgery. Patients, investigators, and data analysts were not masked to group assignment. The primary outcome was blood loss. A total of 348 women were included (174 in each group). Blood loss was significantly lower in group 1 than in group 2 (570±240 vs 844±270mL; Pcesarean delivery. The frequency of complications was not affected by time of administration. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  10. Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial

    NARCIS (Netherlands)

    Bonati, L.H.; Dobson, J.; Featherstone, R.L.; Ederle, J.; Worp, H.B. van der; Borst, G.J. de; Mali, W.P.; Beard, J.D.; Cleveland, T.; Engelter, S.T.; Lyrer, P.A.; Ford, G.A.; Dorman, P.J.; Brown, M.M.; Leeuw, F.E. de; et al.,

    2015-01-01

    BACKGROUND: Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments. METHODS: Patients with symptomatic carotid

  11. Everolimus eluting stent vs first generation drug-eluting stent in primary angioplasty: A pooled patient-level meta-analysis of randomized trials

    NARCIS (Netherlands)

    Luca, G. De; Smits, Peter; Hofma, S.H.; Lorenzo, E. Di; Vlachojannis, G.J.; Hof, A.W. van 't; Boven, A.J. van; Kedhi, E.; Stone, G.W.; Suryapranata, H.

    2017-01-01

    BACKGROUND: Several concerns have emerged about the higher risk of very late stent thrombosis (ST) with first generation drug-eluting stent (DES) especially among STEMI patients. Newer generation DES has demonstrated to reduce ST at mid-term follow-up. Therefore, the aim of the present study is to

  12. Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial

    NARCIS (Netherlands)

    Bonati, Leo H.; Dobson, Joanna; Featherstone, Roland L.; Ederle, Jörg; van der Worp, H. Bart; de Borst, Gert J.; Mali, Willem P. Th M.; Beard, Jonathan D.; Cleveland, Trevor; Engelter, Stefan T.; Lyrer, Philippe A.; Ford, Gary A.; Dorman, Paul J.; Brown, Martin M.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Hacke, W.; Halliday, A.; Malik, I.; Mas, J. L.; McGuire, A. J.; Sidhu, P.; Venables, G.; Clifton, A.; Gaines, P.; Collins, R.; Molyneux, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Coward, L.; Dobson, J.; Doig, D.; Ederle, J.; Featherstone, R. F.; Kennedy, F.; Tindall, H.; Turner, E.; McCabe, D. J. H.; Wallis, A.; Brooks, M.; Chambers, B.; Chan, A.; Dewey, H.; Donnan, G.; Fell, G.; Hoare, M.; Molan, M.; Roberts, A.; Roberts, N.; Beiles, B.; Bladin, C.; Clifford, C.; Grigg, M.; New, G.; Bell, R.; Bower, S.; Chong, W.; Holt, M.; Than, P. G.; Gett, S.; Quinn, J.; Ray, M.; Wong, A.; Woodruff, P.; Foreman, R.; Schultz, D.; Scroop, R.; Atkinson, N.; Cambell, W.; Davis, S.; Field, P.; Milne, P.; Mitchell, P.; Tress, B.; Yan, B.; Beasley, A.; Dunbabin, D.; Stary, D.; Walker, S.; Cras, P.; Hendriks, J. M. H.; van, P.; St, A. Z.; Bosiers, M.; Deloose, K.; Brugge-Oostende, A. Z. Sint Jan; Devos, V.; Ghekiere, J.; Vanhooren, G.; Astarci, P.; Hammer, F.; Lacroix, V.; Peeters, A.; Verhelst, R.; Ziekenhuis, Imelda; DeJaegher, L.; Daneault, N.; Lanthier, S.; Lebrun, L.-H.; Oliva, V.; Raymond, J.; Roy, D.; Soulez, G.; Hill, M.; Hu, W.; Hudion, M.; Wong, J.; Albäck, A.; Curtze, S.; Harno, H.; Ijäs, P.; Lappalainen, K.; Lepäntalo, M.; Meretoja, A.; Mustanoja, S.; Paananen, T.; Railo, M.; Sairanen, T.; Soinne, L.; Vehmas, A.; Vikatmaa, P.; Goertler, M.; Halloul, Z.; Brennan, P.; Kelly, C.; Leahy, A.; Moroney, J.; Thornton, J.; Koelemay, M. J. W.; Nederkoorn, P. J.; Reekers, J. A. A.; Roos, Y. B. W. E. M.; Pattynama, P. M. T.; van Dijk, L. C.; van Sambeek, H. M.; van Urk, H.; Verhagen, H. J. M.; de Bruijn, S. F.; Keunen, R.; Knippenberg, B.; Mosch, A.; Treurniet, F.; van Dijk, L.; van Overhagen, H.; Wever, J.; van Hasselt, A. A. M.; Zeilstra, D. J.; Boiten, J.; Lycklama, G. J.; Blankensteijn, J. D.; de Leeuw, F. E.; Schultze, L. J.; de Borst, G. J.; de Kort, G. A. P.; Kapelle, L. J.; Lo, T. H.; Mali, W. P. Th M.; Moll, F.; Barber, P. A.; Bourchier, R.; Hill, A.; Holden, A.; Bakke, S. J.; Krohg, K.; Skjelland, M.; Tennøe, B.; Bialek, P.; Biejat, Z.; Czepiel, W.; Czlonkowska, A.; Dowzenko, A.; Buczek, J.; Kobayashi, A.; Lelek, M.; Polanski, J.; Kirbis, J.; Milosevic, Z.; Zvan, B.; Blasco, J.; Chamorro, A.; Macho, J.; San, L.; Branera, J.; Canovas, D.; Perendreu, J.; Björses, K.; Gottsäter, A.; Mätzsch, T.; Sonesson, B.; Berg, B.; Delle, M.; Formgren, J.; Nyman, N.; Takolander, R.; Andersson, T.; Malmstedt, J.; Soderman, M.; Wahlgren, C.; Wahlgren, N.; Binaghi, S.; Hirt, L.; Michel, P.; Ruchat, P.; Bonati, L. H.; Engelter, S. T.; Jacob, A. L.; Kirsch, E.; Lyrer, P. A.; Bonvin, C.; Kalangos, A.; Lovblad, K.; Sztajzel, R.; Higgins, N.; Kirkpatrick, P. J.; Martin, P.; Varty, K.; Adam, D.; Bell, J.; Crowe, P.; Gannon, M.; Henderson, M. J.; Sandler, D.; Shinton, R. A.; Scriven, J. M.; Wilmink, T.; Egun, A.; Guta, R.; Punekar, S.; Seriki, D. M.; Thomson, G.; Brennan, J. A.; Enevoldson, T. P.; Gilling-Smith, G.; Gould, D. A.; Harris, P. L.; McWilliams, R. G.; White, R.; Prakash, K. G.; Serracino-Inglott, F.; Subramanian, G.; Walker, M. G.; Clarke, M.; Davis, M.; Dixit, S. A.; Dorman, P.; Dyker, A.; Ford, G.; Golkar, A.; Lambert, D.; Lees, T.; Louw, S.; Macdonald, S.; Mendelow, A. D.; Rodgers, H.; Stansby, G.; Wyatt, M.; Baker, T.; Jones, L.; Mitchell, D.; Munro, E.; Thornton, M.; Baker, D.; Davis, N.; Hamilton, G.; McCabe, D.; Platts, A.; Tibballs, J.; Cleveland, T.; Dodd, D.; Nair, R.; Nassef, A.; Nawaz, S.; Belli, A.; Markus, H.; McFarland, R.; Morgan, R.; Pereira, A.; Chataway, J.; Cheshire, N.; Gibbs, R.; Hammady, M.; Jenkins, M.; Wolfe, J.; Adiseshiah, M.; Bishop, C.; Brew, S.; Jäger, R.; Kitchen, N.; Ashleigh, R.; Butterfield, S.; Gamble, G. E.; McCollum, C.; Nasim, A.; O'Neill, P.; Edwards, R. D.; Lees, K. R.; MacKay, A. J.; Moss, J.; Rogers, P.

    2015-01-01

    Background Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments. Methods Patients with symptomatic carotid stenosis

  13. 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%, P noninferiority =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 ( P noninferiority =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 ( P noninferiority =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

  14. Planned vaginal birth or elective repeat caesarean: patient preference restricted cohort with nested randomised trial.

    Directory of Open Access Journals (Sweden)

    Caroline A Crowther

    Full Text Available BACKGROUND: Uncertainty exists about benefits and harms of a planned vaginal birth after caesarean (VBAC compared with elective repeat caesarean (ERC. We conducted a prospective restricted cohort study consisting of a patient preference cohort study, and a small nested randomised trial to compare benefits and risks of a planned ERC with planned VBAC. METHODS AND FINDINGS: 2,345 women with one prior caesarean, eligible for VBAC at term, were recruited from 14 Australian maternity hospitals. Women were assigned by patient preference (n = 2,323 or randomisation (n = 22 to planned VBAC (1,225 patient preference, 12 randomised or planned ERC (1,098 patient preference, ten randomised. The primary outcome was risk of fetal death or death of liveborn infant before discharge or serious infant outcome. Data were analysed for the 2,345 women (100% and infants enrolled. The risk of fetal death or liveborn infant death prior to discharge or serious infant outcome was significantly lower for infants born in the planned ERC group compared with infants in the planned VBAC group (0.9% versus 2.4%; relative risk [RR] 0.39; 95% CI 0.19-0.80; number needed to treat to benefit 66; 95% CI 40-200. Fewer women in the planned ERC group compared with women in the planned VBAC had a major haemorrhage (blood loss ≥ 1,500 ml and/or blood transfusion, (0.8% [9/1,108] versus 2.3% [29/1,237]; RR 0.37; 95% CI 0.17-0.80. CONCLUSIONS: Among women with one prior caesarean, planned ERC compared with planned VBAC was associated with a lower risk of fetal and infant death or serious infant outcome. The risk of major maternal haemorrhage was reduced with no increase in maternal or perinatal complications to time of hospital discharge. Women, clinicians, and policy makers can use this information to develop health advice and make decisions about care for women who have had a previous caesarean. TRIAL REGISTRATION: Current Controlled Trials ISRCTN53974531

  15. Complex bifurcation lesions: Randomized comparison of a fully bioresorbable modified t stenting strategy versus bifurcation reconstruction with a dedicated self-expanding stent in combination with bioresorbable scaffolds, an OCT study: Rationale and design of the COBRA II trial.

    Science.gov (United States)

    Bennett, J; Adriaenssens, T; Desmet, W; Dubois, C

    2016-11-15

    There is an ongoing controversy regarding the efficacy and safety of different percutaneous stenting techniques for coronary bifurcation lesions needing >1 stent. The promise of safe vessel restoration with bioresorbable scaffolds (BRS) may not be transferable to complex double BRS bifurcation techniques, and permanent metallic scaffolding of the bifurcation core may be needed. We identified modified-T stenting as the most promising fully bioresorbable 2-stent strategy in a preclinical setting. The objective of this study is to assess acute performance and compare long-term vessel healing with this strategy, versus an approach combining BRS with a dedicated metallic drug-eluting bifurcation stent. In a single center, 60 consecutive patients with true and complex coronary bifurcation lesions will be randomly assigned to treatment with the dedicated self-expanding Axxess ™ biolimus-eluting bifurcation stent in the proximal main vessel and additional Absorb ™ everolimus-eluting BRS in the branches versus a modified T technique using Absorb ™ only. Angiography and optical coherence tomography (OCT) will be performed immediately after implantation and at 30 months, and clinical follow-up is foreseen up to 5 years after implantation. The primary endpoint is the change in minimal luminal area assessed with OCT from baseline to 30 months in pre-specified bifurcation segments. To date the use of Absorb ™ BRS in complex coronary bifurcations has not been evaluated in a randomized clinical trial setting. The COBRA II study will examine the role and safety of a double BRS strategy in coronary bifurcations, alone or in combination with a metallic dedicated bifurcation device. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  16. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

    Directory of Open Access Journals (Sweden)

    Norrie John

    2010-04-01

    Full Text Available Abstract Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676

  17. Are postoperative intravenous fluids in patients undergoing elective laparoscopic cholecystectomy a necessity? A randomized clinical trial.

    Science.gov (United States)

    Henriques, Jessimara Ribeiro; Correia, Maria Isabel Toulson Davisson

    2018-04-01

    Intravenous (IV) fluid therapy should be individualized according to each patient's weight, disease, and comorbidities, as well as the type and duration of the operative procedure. Laparoscopic cholecystectomy represents one of the most common, short-duration operations; thus, the aim of this study was to assess the necessity of postoperative administration of IV fluids. A randomized clinical trial with patients undergoing elective laparoscopic cholecystectomy was performed. Patients were randomly assigned to control group (IV fluids at the surgeon's discretion) and study group (no IV fluids after the operation). Body weight and composition, total intravenous fluids, urinary output, creatinine levels, and the presence of thirst and hunger were assessed. Costs related to the administration of postoperative IV fluids were measured. The study and control groups were similar with regard to sex distribution, age, and general characteristics. There was a significant difference in the amount of infused IV fluids (1,600 mL vs 3,000 mL), directly related to the amount offered postoperatively to the control group. Weight, extracellular water, and urinary output (1,257 ± 736 mL vs 888 ± 392 mL; P fluids (r = 0.333). There were no differences in creatinine levels, thirst, hunger, and well-being features. An average of 10.7 minutes per patient of nursing time was required for IV administration. Cost related to IV fluids was increased in the control group. Postoperative intravenous fluids are not necessary in patients undergoing laparoscopic cholecystectomy, and their use is associated with increased nursing time and costs. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial.

    Science.gov (United States)

    Ormiston, John A; Serruys, Patrick W; Regar, Evelyn; Dudek, Dariusz; Thuesen, Leif; Webster, Mark W I; Onuma, Yoshinobu; Garcia-Garcia, Hector M; McGreevy, Robert; Veldhof, Susan

    2008-03-15

    A fully bioabsorbable drug-eluting coronary stent that scaffolds the vessel wall when needed and then disappears once the acute recoil and constrictive remodelling processes have subsided has theoretical advantages. The bioasorbable everolimus-eluting stent (BVS) has a backbone of poly-L-lactic acid that provides the support and a coating of poly-D,L-lactic acid that contains and controls the release of the antiproliferative agent everolimus. We assessed the feasibility and safety of this BVS stent. In this prospective, open-label study we enrolled 30 patients who had either stable, unstable, or silent ischaemia and a single de-novo lesion that was suitable for treatment with a single 3.0 x 12 mm or 3.0 x 18 mm stent. Patients were enrolled from four academic hospitals in Auckland, Rotterdam, Krakow, and Skejby. The composite endpoint was cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation. Angiographic endpoints were available for 26 patients and intravascular-ultrasound endpoints for 24 patients. Clinical endpoints were assessed in all 30 patients at 6 and 12 months. In a subset of 13 patients, optical coherence tomography was undertaken at baseline and follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00300131. Procedural success was 100% (30/30 patients), and device success 94% (29/31 attempts at implantation of the stent). At 1 year, the rate of major adverse cardiac events was 3.3%, with only one patient having a non-Q wave myocardial infarction and no target lesion revascularisations. No late stent thromboses were recorded. At 6-month follow-up, the angiographic in-stent late loss was 0.44 (0.35) mm and was mainly due to a mild reduction of the stent area (-11.8%) as measured by intravascular ultrasound. The neointimal area was small (0.30 [SD 0.44] mm2), with a minimal area obstruction of 5.5%. This study shows the feasibility of implantation of the bioabsorbable

  19. A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction

    NARCIS (Netherlands)

    van Berkel, A. M.; Boland, C.; Redekop, W. K.; Bergman, J. J.; Groen, A. K.; Tytgat, G. N.; Huibregtse, K.

    1998-01-01

    Clogging of biliary stents continues to be a major clinical problem. Different polymer materials may have different effects on clogging. In vitro studies have shown a direct relation between the frictional coefficient of a polymer and the amount of encrusted material. Teflon appeared to be the best

  20. Planned vaginal birth or elective repeat caesarean: patient preference restricted cohort with nested randomised trial.

    Science.gov (United States)

    Crowther, Caroline A; Dodd, Jodie M; Hiller, Janet E; Haslam, Ross R; Robinson, Jeffrey S

    2012-01-01

    Uncertainty exists about benefits and harms of a planned vaginal birth after caesarean (VBAC) compared with elective repeat caesarean (ERC). We conducted a prospective restricted cohort study consisting of a patient preference cohort study, and a small nested randomised trial to compare benefits and risks of a planned ERC with planned VBAC. 2,345 women with one prior caesarean, eligible for VBAC at term, were recruited from 14 Australian maternity hospitals. Women were assigned by patient preference (n = 2,323) or randomisation (n = 22) to planned VBAC (1,225 patient preference, 12 randomised) or planned ERC (1,098 patient preference, ten randomised). The primary outcome was risk of fetal death or death of liveborn infant before discharge or serious infant outcome. Data were analysed for the 2,345 women (100%) and infants enrolled. The risk of fetal death or liveborn infant death prior to discharge or serious infant outcome was significantly lower for infants born in the planned ERC group compared with infants in the planned VBAC group (0.9% versus 2.4%; relative risk [RR] 0.39; 95% CI 0.19-0.80; number needed to treat to benefit 66; 95% CI 40-200). Fewer women in the planned ERC group compared with women in the planned VBAC had a major haemorrhage (blood loss ≥ 1,500 ml and/or blood transfusion), (0.8% [9/1,108] versus 2.3% [29/1,237]; RR 0.37; 95% CI 0.17-0.80). Among women with one prior caesarean, planned ERC compared with planned VBAC was associated with a lower risk of fetal and infant death or serious infant outcome. The risk of major maternal haemorrhage was reduced with no increase in maternal or perinatal complications to time of hospital discharge. Women, clinicians, and policy makers can use this information to develop health advice and make decisions about care for women who have had a previous caesarean. Current Controlled Trials ISRCTN53974531

  1. Rationale and design of amphilimus sirolimus-eluting stents versus zotarolimus-eluting stents in all-comers requiring percutaneous coronary intervention (ReCre8): A multicenter randomized clinical trial.

    Science.gov (United States)

    Rozemeijer, Rik; Stein, Mèra; Frambach, Peter; Voskuil, Michiel; Kraaijeveld, Adriaan O; Rodríguez-Olivares, Ramón; Timmers, Leo; Pereira, Bruno; Rittersma, Saskia Z; Agostoni, Pierfrancesco; Doevendans, Pieter A; Stella, Pieter R

    2018-02-15

    Amphilimus sirolimus-eluting stents (A-SES) represent a novel elution technology in the current era of drug-eluting stents with promising results in patients with diabetes mellitus. At present no large trial has been designed to evaluate clinical outcomes of A-SES as compared to new-generation drug-eluting stents in unselected patients. Accordingly, we designed this trial to evaluate clinical noninferiority of A-SES as compared with zotarolimus-eluting stents (ZES) in a real-world, all-comers setting. ReCre8 is a prospective multicenter randomized clinical trial evaluating the clinical outcomes of A-SES as compared with ZES in all-comers requiring percutaneous coronary intervention. Patients are randomized 1:1 to receive either A-SES or ZES. On-site block-randomization is stratified by diabetes mellitus, and troponin status to perform prespecified subanalyses. Patients receive 1-month of dual antiplatelet therapy (DAPT) when troponin-negative, or 12-months of DAPT when troponin-positive. The primary endpoint is target-lesion failure at 1-year follow-up. A total of 1,532 patients will be enrolled to demonstrate clinical noninferiority of A-SES with at least 80% power, a noninferiority margin of 3.5% and a type-I-error of 0.05. ReCre8 (NCT02328898) is the first randomized multicenter trial with a head-to-head comparison of A-SES as compared with ZES to investigate the clinical safety and efficacy of these new-generation DES in a real-world, all-comers population. © 2017 Wiley Periodicals, Inc.

  2. Association between age and risk of stroke or death from carotid endarterectomy and carotid stenting : A meta-analysis of pooled patient data from four randomised trials

    NARCIS (Netherlands)

    Howard, George; Roubin, Gary S.; Jansen, Olav; Hendrikse, Jeroen; Halliday, Alison; Fraedrich, Gustav; Eckstein, Hans Henning; Calvet, David; Bulbulia, Richard; Bonati, Leo H.; Becquemin, Jean Pierre; Algra, Ale; Brown, Martin M.; Ringleb, Peter A.; Brott, Thomas G.; Mas, Jean Louis

    2016-01-01

    Background: Age was reported to be an effect-modifier in four randomised controlled trials comparing carotid artery stenting (CAS) and carotid endarterectomy (CEA), with better CEA outcomes than CAS outcomes noted in the more elderly patients. We aimed to describe the association of age with

  3. Meta-analysis of 14 trials comparing bypass grafting vs drug-eluting stents in diabetic patients with multivessel coronary artery disease

    NARCIS (Netherlands)

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

    2014-01-01

    BACKGROUND AND AIM: Clinical trials have reported lower mortality and repeated revascularization rate in diabetic patients treated with coronary artery bypass grafting (CABG) as compared to percutaneous revascularization. However, these studies were conducted in the era of bare-metal stents.

  4. Re-examining minimal luminal diameter relocation and quantitative coronary angiography - Intravascular ultrasound correlations in stented saphenous vein grafts: Methodological insights from the randomised RRISC trial

    NARCIS (Netherlands)

    O. Semeraro (Oscar); P. Agostoni (Pierfrancesco); S. Verheye (Stefan); G.J.J. van Langenhove (Glenn); P.A. van den Heuvel (Paul); C. Convens (Carl); F. van den Branden (Frank); N. Bruining (Nico); P. Vermeersch (Paul)

    2009-01-01

    textabstractAims: Angiographic parameters (such as late luminal loss) are common endpoints in drug-eluting stent trials, but their correlation with the neointimal process and their reliability in predicting restenosis are debated. Methods and results: Using quantitative coronary angiography (QCA)

  5. 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.

  6. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol.

    Science.gov (United States)

    Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Vale, Luke; Norrie, John; Kinsella, John; Cook, Jonathan; Brittenden, Julie; Grant, Adrian

    2010-04-16

    Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial registration number - ISRCTN32188676.

  7. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon- expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial

    NARCIS (Netherlands)

    J.M.R. Ligthart (Jürgen); M-C. Morice (Marie-Claude); P.J. de Feyter (Pim); M. Degertekin (Muzaffer); K. Tanabe (Kengo); J.E. Sousa (Eduardo); A. Colombo (Antonio); G. Guagliumi (Giulio); W. Wijns (William); W.K. Lindeboom (Wietze); P.W.J.C. Serruys (Patrick); A.C. Abizaid (Alexandre)

    2002-01-01

    textabstractBACKGROUND: The goal of this intravascular ultrasound investigation was to provide a more detailed morphological analysis of the local biological effects of the implantation of a sirolimus-eluting stent compared with an uncoated stent. METHODS AND RESULTS: In the RAVEL trial, 238

  8. 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.

  9. 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.

    Science.gov (United States)

    von Birgelen, Clemens; 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, Salah A M; Nienhuis, Mark B; Verhorst, Patrick M J; Basalus, Mounir W Z; Doggen, Carine J M; Tandjung, Kenneth

    2014-02-01

    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 patients of two third-generation stents that are often used clinically, but that have not yet been compared, and one of which has not previously been assessed in a randomised trial. In this investigator-initiated, single-blind, multicentre, randomised, two-arm, non-inferiority trial, patients aged 18 years and older who required a percutaneous coronary intervention with implantation of a drug-eluting stent were recruited from four study sites in the Netherlands. We randomly assigned patients by independently managed computer-generated allocation sequences in a 1:1 ratio to receive either cobalt-chromium-based zotarolimus-eluting stents (Resolute Integrity, Medtronic, Santa Rosa, CA, USA) or platinum-chromium-based everolimus-eluting stents (Promus Element, Boston Scientific, Natick, MA, USA). Patients and analysts were masked to the allocated stent, but treating clinicians were not. The primary endpoint of target-vessel failure was a composite of safety (cardiac death or target-vessel-related myocardial infarction) and efficacy (target-vessel revascularisation) at 12 months, analysed by intention to treat (with a non-inferiority margin of 3·6%). This trial is registered with ClinicalTrials.gov, number NCT01331707. Between Nov 25, 2010, and May 24, 2012, 1811 eligible all-comer patients, with 2371 target lesions, were enrolled in the study. 370 (20%) patients presented with ST-elevation myocardial infarction and 447 (25%) with non-ST-elevation myocardial infarction. 906 patients were assigned to receive zotarolimus-eluting stents and 905 to receive everolimus-eluting stents. Ease of stent delivery was shown by very low numbers of patients requiring treatment other than their assigned

  10. Sex-related Impact on Clinical Outcome of Everolimus-eluting Versus Bare-metal Stents in ST-segment Myocardial Infarction. Insights From the EXAMINATION Trial.

    Science.gov (United States)

    Regueiro, Ander; Fernández-Rodríguez, Diego; Brugaletta, Salvatore; Martín-Yuste, Victoria; Masotti, Monica; Freixa, Xavier; Cequier, Ángel; Íñiguez, Andrés; Serruys, Patrick W; Sabaté, Manel

    2015-05-01

    The use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events. We aimed to evaluate the impact of sex on the performance of everolimus-eluting stents vs bare-metal stents in ST-segment elevation myocardial infarction at 2-year follow-up. This is a sub-study of the EXAMINATION trial that randomized 1498 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention to everolimus-eluting or bare-metal stents. Primary end point was combined all-cause death, any recurrent myocardial infarction, and any revascularization. All end points were analyzed according to sex at 2-year follow-up. Of 1498 patients included in the trial, 254 (17.0%) were women. Women were older and had higher prevalence of hypertension and lower prevalence of smoking compared with men. In contrast with men, stent diameter was smaller in women. After multivariate analysis, the primary end point was similar between women and men (hazard ratio=0.95; 95% confidence interval, 0.66-1.37), and among women, between those treated with bare-metal vs everolimus-eluting stents (hazard ratio=2.48; 95% confidence interval, 0.95-6.46). Women showed a lower rate of repeat revascularization than men (hazard ratio=0.55; 95% confidence interval, 0.32-0.95) despite worse baseline characteristics. This difference was driven by better performance of the everolimus-eluting stent in women. Despite poorer baseline clinical characteristics, women with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention showed outcomes similar to men. The use of everolimus-eluting stents may represent an added value in women as it showed a reduced rate of repeated revascularization compared to men. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  11. At what price? A cost-effectiveness analysis comparing trial of labour after previous Caesarean versus elective repeat Caesarean delivery.

    LENUS (Irish Health Repository)

    Fawsitt, Christopher G

    2013-01-01

    Elective repeat caesarean delivery (ERCD) rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland.

  12. The efficacy of a smoking cessation programme in patients undergoing elective surgery - a randomised clinical trial

    DEFF Research Database (Denmark)

    Azodi, O. Sadr; Lindstrom, D.; Adami, J.

    2009-01-01

    It is known that smokers constitute an important risk group of patients undergoing surgery. It is unknown how smoking cessation intervention initiated 4 weeks prior to elective surgery affects the probability of permanent cessation. We randomly assigned 117 patients, scheduled to undergo elective...... orthopaedic and general surgery, to smoking cessation intervention and control group. The intervention group underwent a programme initiated, on average, 4 weeks prior to surgery with weekly meetings or telephone counselling and were provided with free nicotine replacement therapy (NRT). The control group...

  13. Clinical outcomes of second- versus first-generation drug-eluting stents in patients with acute myocardial infarction: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Wu, Guodong; Sun, Guoqiang; Zhao, Ruihong; Sun, Mingli

    2014-08-29

    It remains unclear whether the clinical outcomes of patients with acute myocardial infarction (AMI) receiving second- and first-generation drug-eluting stents (DES) are identical. The study aimed to investigate the differences in clinical utility between the two generations of DES in these specific subjects by a meta-analysis. We systemically searched PubMed and EMBASE databases and the Cochrane Library up until January 2013. Randomized trials, which compared clinical outcomes of second-generation DES (everolimus- (EES) or zotarolimus-eluting stents (ZES)) with first-generation DES (sirolimus- or paclitaxel-eluting stents) in patients with AMI were included. Five trials with 1720 AMI subjects were included in the meta-analysis. Pooled analysis demonstrated a trend toward lower incidence of stent thrombosis with the second-generation DES relative to the first-generation one (risk ratio (RR), 0.53; 95% confidence intervals (CI): 0.25-1.13; p = 0.10). However, the second-generation DES did not offer a significant advantage over the first-generation DES in reducing the incidence of target lesion revascularization (TLR) (RR = 1.73; 95% CI: 0.83-3.64; p = 0.15), major adverse cardiac events (MACEs) (RR = 0.97; p = 0.90), or all-cause death (RR = 1.00; p = 1.0). In addition, in elderly patients the second-generation DES seemed to reduce the occurrence of MACEs (RR = 0.65; p = 0.10) and stent thrombosis (RR = 0.40; p = 0.08), and the second-generation EES showed a potential benefit in lowering the MACE rate (RR = 0.55; p = 0.06). The second-generation DES appeared to lower the risk of stent thrombosis in AMI patients. There might be a lower incidence of MACEs associated with the second-generation EES.

  14. The cost effectiveness of elective laparoscopic sigmoid resection for symptomatic diverticular disease: financial outcome of the randomized control Sigma trial.

    Science.gov (United States)

    Klarenbeek, Bastiaan R; Coupé, Veerle M H; van der Peet, Donald L; Cuesta, Miguel A

    2011-03-01

    Direct healthcare costs of patients with symptomatic diverticular disease randomized for either laparoscopic or open elective sigmoid resection are compared. Cost-effectiveness analysis of the laparoscopic approach compared with open sigmoid resections is presented. An economic evaluation of the randomized control Sigma trial was conducted, comparing elective laparoscopic sigmoid resection (LSR) to open sigmoid resection (OSR) in patients with symptomatic diverticulitis. Prospective registration of detailed intervention units per patient resulted in actual resource use per individual patient. To avoid distributional assumptions, the nonparametric bootstrap was applied. For the cost-effectiveness analysis, differences in total cost between LSR and OSR were compared with the differences in VAS pain score, SF-36 values for general health, and complication rate. The difference in total healthcare costs between the group that received LSR (euro 9969) and the group that received OSR (euro 9366) was not statistically significant. The slight increase in total costs was determined mainly by the significantly higher operation costs of LSR (euro 6663 vs. euro 5306). Lower costs for hospitalization (euro 2983 vs. euro 3598), blood products (euro 87 vs. euro 240), paramedical services (euro 157 vs. euro 278), and emergency attendance (euro 72 vs. euro 115) in the LSR group partially compensated these increased operation costs. The incremental cost-effectiveness ratios (ICER) indicate that improvements in pain, quality of life, and complication rate could be achieved at limited costs. Total healthcare costs of laparoscopic and open elective sigmoid resections for symptomatic diverticular disease are similar. As the clinical outcomes are in favor of the LSR group, candidates for an elective sigmoid resection should preferably be approached laparoscopically.

  15. 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.

  16. Bile viscosity in patients with biliary drainage. Effect of co-trimoxazole and N-acetylcysteine and role in stent clogging

    NARCIS (Netherlands)

    Coene, P. P.; Groen, A. K.; Davids, P. H.; Hardeman, M.; Tytgat, G. N.; Huibregtse, K.

    1994-01-01

    The main disadvantage of endoscopic insertion of an endoprosthesis is the tendency of the stent to clog after a few months. In this study we determined the role of bile viscosity in stent clogging. Sixty patients were stented with 10 Fr 11-cm stents. The stents were electively removed after 2

  17. Renal PTA stenting

    International Nuclear Information System (INIS)

    Tsetis, D.

    2012-01-01

    Full text: Renal artery stenosis (RAS) is a common condition that may lead to hypertension, progressive renal dysfunction and cardiovascular morbidity. Catheter-based therapy for symptomatic, haemodynamically significant, RAS has become the preferred method of revascularization. Balloon angioplasty has been the traditional treatment of choice for fibromuscular dysplasia, however stents are increasingly used for the treatment of atheromatous lesions; in many cases-such as in ostial lesions-, direct stenting is strongly indicated. Despite the increased use of endovascular therapy for renal artery stenosis, there is still controversy regarding the optimal management and the net benefit of this treatment. Several randomized trials of balloon angioplasty or stenting for renal artery stenosis compared with medical therapy alone have been conducted, however these could not show definite advantage of endovascular therapy. Problems encountered with those trials include enrollment of small number of patients, frequent crossover from medical to interventional therapy compromising the intention-to-treat results, or selection of patients that are not expected to show clear benefit. The Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) is the most important of these trials; however, it,s study design was faulty and therefore did not provide conclusive evidence to answer the question of whether angioplasty and stenting or medical therapy is the best treatment for haemodynamically significant RAS. All expectations are now focused on the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial which was designed to answer the same question, and its methodologies took into consideration the weaknesses of the ASTRAL trial. Regarding stent device itself, it seems that the optimal design is probably a stainless steel, laser cut, open-cells stent mounted on a rapid exchange delivery balloon catheter compatible with 0.014-in and 0.018-in guidewire. As a future

  18. Randomized controlled trial comparing carbetocin, misoprostol, and oxytocin for the prevention of postpartum hemorrhage following an elective cesarean delivery.

    Science.gov (United States)

    Elbohoty, Ahmed E H; Mohammed, Walid E; Sweed, Mohamed; Bahaa Eldin, Ahmed M; Nabhan, Ashraf; Abd-El-Maeboud, Karim H I

    2016-09-01

    To compare the effectiveness and safety of carbetocin, misoprostol, and oxytocin for the prevention of postpartum hemorrhage following cesarean deliveries. A double-blind randomized controlled trial enrolled patients with a singleton pregnancy scheduled for an elective cesarean delivery at a maternity hospital in Cairo, Egypt, between October 1, 2012 and June 30, 2013. Participants were randomized using a computer-generated sequence to receive treatment with carbetocin, misoprostol, or oxytocin. The primary outcome was the occurrence of uterine atony necessitating additional uterotonics. Per-protocol analyses were performed. Patients, investigators, and data analysts were masked to treatment assignments. The present study enrolled 263 patients; data were analyzed from 88 patients treated with carbetocin, 89 treated with misoprostol, and 86 women treated with oxytocin. Further uterotonics were needed for the treatment of 5 (6%) patients who were treated with carbetocin, 20 (22%) patients treated with misoprostol, and 11 (13%) patients treated with oxytocin. In the prevention of uterine atony, carbetocin was comparable with oxytocin (RR 0.41, 95%CI 0.14-1.25) and superior to misoprostol (RR 0.21, 95%CI 0.07-0.58). Additional uterotonics were needed less frequently by patients treated with carbetocin. Carbetocin was comparable to oxytocin and superior to misoprostol in the prevention of uterine atony following an elective cesarean delivery. ClinicalTrials.gov: NCT02053922. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  19. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis)

    DEFF Research Database (Denmark)

    Verheye, Stefan; Vrolix, Mathias; Kumsars, Indulis

    2017-01-01

    centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. RESULTS Procedural success in the intention-to-treat population was 100 The primary safety endpoint was target lesion failure (TLF) (cardiac death...... and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. CONCLUSIONS This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes...

  20. Outcomes of patients treated with durable polymer platinum-chromium everolimus-eluting stents: a meta-analysis of randomised trials.

    Science.gov (United States)

    Cassese, Salvatore; Ndrepepa, Gjin; Byrne, Robert A; Kufner, Sebastian; Xhepa, Erion; de Waha, Antoinette; Rheude, Tobias; Colleran, Roisin; Giacoppo, Daniele; Harada, Yukinori; Laugwitz, Karl-Ludwig; Schunkert, Heribert; Fusaro, Massimiliano; Kastrati, Adnan

    2017-10-20

    The durable polymer platinum-chromium everolimus-eluting stent (PtCr-EES) is a new-generation drug-eluting stent (DES) with a platinum-enriched metallic platform developed to improve the percutaneous treatment of patients with coronary artery disease. We sought to investigate the performance of durable polymer PtCr-EES versus other new-generation DES. We undertook a meta-analysis of trials in which patients receiving percutaneous coronary intervention (PCI) were randomly assigned to durable polymer PtCr-EES versus other new-generation DES (other DES). Primary efficacy and safety outcomes were target lesion revascularisation (TLR) and definite/probable stent thrombosis (ST), respectively. Secondary outcomes were myocardial infarction (MI), target vessel revascularisation (TVR), death, cardiac death and longitudinal stent deformation (LSD). A total of 11,036 patients in seven trials received a PCI with either durable polymer PtCr-EES (n=6,613) or other DES (n=4,423). This latter group comprised patients treated with biolimus- (n=325), cobalt-chromium everolimus- (n=1,940) or zotarolimus-eluting stents (n=2,158). After a median follow-up of 12 months (interquartile range 12-24), durable polymer PtCr-EES displayed a risk of TLR (odds ratio 0.98, 95% confidence interval [CI]: 0.75-1.29; p=0.90) and definite/probable ST (0.89 [0.55-1.45]; p=0.63) comparable to that of other DES. However, the durable polymer PtCr-EES was associated with a higher risk of LSD (12.05 [1.60-90.71], p=0.02) compared to other DES. There was no significant difference with regard to other secondary outcomes nor was there heterogeneity across trials. At one-year follow-up, the durable polymer PtCr-EES displays a performance comparable to that of other new-generation DES platforms.

  1. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial.

    Science.gov (United States)

    Sabaté, Manel; Brugaletta, Salvatore; Cequier, Angel; Iñiguez, Andrés; Serra, Antonio; Jiménez-Quevedo, Pilar; Mainar, Vicente; Campo, Gianluca; Tespili, Maurizio; den Heijer, Peter; Bethencourt, Armando; Vazquez, Nicolás; van Es, Gerrit Anne; Backx, Bianca; Valgimigli, Marco; Serruys, Patrick W

    2016-01-23

    Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial. In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087. 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047). Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction. Spanish Heart Foundation. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Five-year outcome after implantation of zotarolimus- and everolimus-eluting stents in randomized trial participants and nonenrolled eligible patients : A secondary analysis of a randomized clinical trial

    NARCIS (Netherlands)

    Von Birgelen, Clemens; Van Der Heijden, Liefke C.; Basalus, Mounir Welson Zakhary; Kok, Marlies M.; Sen, Hanim; Louwerenburg, Hans W.; van Houwelingen, Gert K.; Stoel, Martin G.; de Man, Frits H.A.F.; Linssen, Gerard C.M.; Tandjung, Kenneth; Doggen, Carine J.M.; Van Der Palen, Job; Löwik, Marije M.

    2017-01-01

    IMPORTANCE: Long-term follow-up after a clinical trial of 2 often-used, newer-generation drug-eluting stents (DESs) in a broad patient population is of interest. Comprehensive long-term outcome of eligible nonenrolled patients has never been reported. OBJECTIVE: To assess 5-year safety and efficacy

  3. Safety and efficacy of degradable vs. permanent polymer drug-eluting stents: a meta-analysis of 18,395 patients from randomized trials.

    Science.gov (United States)

    Wang, Yuqing; Liu, Shijian; Luo, Yuanlin; Wang, Fangjuan; Liu, Huanyun; Li, Lufeng; Zhao, Xiaohui; Huang, Lan

    2014-04-15

    Degradable polymer drug-eluting stents (DP-DES) represent a promising strategy to improve the delayed healing and hypersensitive reaction in the vessel. However, the efficacy and safety of DP-DES vs. permanent polymer drug-eluting stents (PP-DES) are less well defined. The aim of this meta-analysis was to compare the total, short (1 year) term outcomes of DP-DES vs. PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials to compare any of approved DP- and PP-DES. Efficacy endpoints were target-lesion revascularization (TLR) and in-stent late loss (ISLL). Safety endpoints were death, myocardial infarction (MI), and composite of definite and probable stent thrombosis (ST). The meta-analysis included 19 RCTs (n=18,395) with interesting results. As compared with DES, there was a significantly reduced very late ST (OR [95% CI]=0.42 [0.24-0.77], p=0.852) and ISLL (OR [95% CI]=-0.07 [-0.12-0.02], p=0.000) in DP-DES patients. However, there were no differences between DP-DES and PP-DES for other safety and efficiency outcomes, except that the stratified analysis showed a significant decreased TLR with DP-DES as compared to paclitaxel-eluting stent (OR [95% CI]=0.41 [0.20-0.81], p=0.457). DP-DES are more effective in reducing very late ST and ISLL, as well as comparable to PP-DES with regard to death, TLR and MI. Further large RCTs with long-term follow-up are warranted to better define the relative merits of DP-DES. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  4. 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....

  5. Bronchial stents

    Directory of Open Access Journals (Sweden)

    Ibrahim Emad

    2006-01-01

    Full Text Available Bronchial stents are mostly used as a Palliative relief of symptoms often caused by airway obstruction, It is also used for sealing of stump fistulas after pneumonectomy and dehiscence after bronchoplastic operations. Advances in airway prosthetics have provided a variety of silicone stents, expandable metal stents, and pneumatic dilators, enabling the correction of increasingly complex anatomical problems. Several series have been published describing the application and results of these techniques. This manuscript reviews the historical development of stents, types, indication, outcome, and complications. Alternative therapies for tracheobronchial stenting were also reviewed

  6. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial.

    Science.gov (United States)

    Walsh, Stewart R; Sadat, Umar; Boyle, Jonathan R; Tang, Tjun Y; Lapsley, Marta; Norden, Anthony G; Gaunt, Michael E

    2010-07-01

    We aimed to determine whether remote ischemic preconditioning (IP) reduces renal damage following elective open infrarenal abdominal aortic aneurysm (AAA) repair. Sequential common iliac clamping was used to induce remote IP in randomized patients. Urinary retinol binding protein (RBP) and albumin-creatinine ratio (ACR) were measured following induction and 3, 24, and 48 hours postoperatively. In controls (n = 22), median urinary RBP increased from 112 microg/mL (interquartile range [IQR] 96-173 microg/mL) preoperatively to 5919 microg/mL (IQR 283-17 788 microg/mL) at 3 hours. Preoperative urinary RBP in preconditioned patients was 96 microg/mL (IQR 50 to 229 microg/mL) preoperatively, rising to 1243 microg/mL (IQR 540 to 15400 microg/mL) at 3 hours. Although control patients' median urinary RBP level was 5 times greater at 3 hours, there were no statistically significant differences in renal outcome indices. This trial could not confirm that remote IP reduces renal injury following elective open aneurysm surgery.

  7. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial.

    Science.gov (United States)

    Barberan-Garcia, Anael; Ubré, Marta; Roca, Josep; Lacy, Antonio M; Burgos, Felip; Risco, Raquel; Momblán, Dulce; Balust, Jaume; Blanco, Isabel; Martínez-Pallí, Graciela

    2018-01-01

    The aim of this study was to assess the impact of personalized prehabilitation on postoperative complications in high-risk patients undergoing elective major abdominal surgery. Prehabilitation, including endurance exercise training and promotion of physical activity, in patients undergoing major abdominal surgery has been postulated as an effective preventive intervention to reduce postoperative complications. However, the existing studies provide controversial results and show a clear bias toward low-risk patients. This was a randomized blinded controlled trial. Eligible candidates accepting to participate were blindly randomized (1:1 ratio) to control (standard care) or intervention (standard care + prehabilitation) groups. Inclusion criteria were: i) age >70 years; and/or, ii) American Society of Anesthesiologists score III/IV. Prehabilitation covered 3 actions: i) motivational interview; ii) high-intensity endurance training; and promotion of physical activity. The main study outcome was the proportion of patients suffering postoperative complications. Secondary outcomes included the endurance time (ET) during cycle-ergometer exercise. We randomized 71 patients to the control arm and 73 to intervention. After excluding 19 patients because of changes in the surgical plan, 63 controls and 62 intervention patients were included in the intention-to-treat analysis. The intervention group enhanced aerobic capacity [ΔET 135 (218) %; P high-risk candidates for elective major abdominal surgery, which can be explained by the increased aerobic capacity.

  8. Antibiotic prophylaxis to prevent postoperative infectious morbidity in low-risk elective cesarean deliveries: a prospective randomized clinical trial.

    Science.gov (United States)

    Hong, Fanzhen; Zhang, Lei; Zhang, Yuan; Sun, Wenjuan; Hong, Haijie; Xu, Yongping

    2016-01-01

    To determine the effectiveness and cost of antibiotic chemoprophylaxis in reducing infectious morbidity in low-risk women undergoing elective cesarean delivery. A prospective randomized clinical trial was performed at a single tertiary care center in Jinan, China between November 2012 and December 2013. Women were randomized to receive either antibiotic prophylaxis or no antibiotics prior to elective cesarean delivery at term. The infectious morbidity (fever, surgical site infection - SSI, endometritis and urinary tract infection), routine blood tests and hospital costs were measured. Total of 414 women were enrolled into the study; and 202 women received antibiotic chemoprophylaxis and 212 women received no antibiotics. Demographic and clinical characteristics were similar between the two groups. Total of one case in the treatment group and four case in the non-treatment group developed endometritis, giving the postoperative infection rate of 1.2%, which was not statistically significant between the two groups (χ(2) = 1.679, p = 0.195). The secondary outcomes were also not different between the two groups, except the costs of hospitalization, which was significantly higher in the treatment group (p cesarean delivery at term, prophylactic antibiotics did not reduce the risk of postoperative infection, but significantly increased the cost of hospitalization.

  9. Efficacy of octreotide in the prevention of pancreatic fistula after elective pancreatic resections: a prospective, controlled, randomized clinical trial.

    Science.gov (United States)

    Montorsi, M; Zago, M; Mosca, F; Capussotti, L; Zotti, E; Ribotta, G; Fegiz, G; Fissi, S; Roviaro, G; Peracchia, A

    1995-01-01

    A prospective, randomized controlled clinical trial was conducted in 33 Italian surgical departments with the aim of evaluating the efficacy of octreotide in the prevention of pancreatic fistula after elective pancreatic resections. Between July 1990 and May 1992, 278 patients were enrolled in the study. Fifty-four dropped out because of unresectable disease and six were excluded because of protocol violation; the remaining 218 were randomly assigned to the octreotide group (n = 111) or to the placebo group (n = 107). There were 131 men and 87 women with a mean age of 58.2 +/- 11.7 yrs. Pancreaticoduodenectomy was the most common operation performed (n = 143), sixty-four percent of patients had a pancreatic or periampullary cancer; chronic pancreatitis accounted for 8.2% of cases. Mortality rate was 6.9%. A pancreatic fistula occurred in 31 patients (14.2%), 9% in the octreotide group and 19.6% in the placebo group (p < 0.05). Morbidity rate was significantly lower in the octreotide (21.6%) than in the placebo group (36.4%) (p < 0.05). When specific pancreatic complications were grouped together and evaluated, they occurred less frequently in the treated (15.3%) than in the placebo group (29.9%) (p < 0.05). Octreotide was able to reduce significantly the incidence of pancreatic fistula after elective pancreatic resections.

  10. Removal of retrievable self-expandable urethral stents: experience in 58 stents

    International Nuclear Information System (INIS)

    Shin, Ji Hoon; Song, Ho-Young; Kim, Jin Hyoung; Ko, Heung-Kyu; Kim, Yong Jae; Woo, Chul-Woong; Kim, Tae-Hyung; Ko, Gi-Young; Yoon, Hyun-Ki; Sung, Kyu-Bo; Park, Hyungkeun

    2006-01-01

    The purpose of this study was to retrospectively evaluate the safety and efficacy of removing retrievable self-expandable urethral stents using a retrieval hook wire. Under fluoroscopic guidance, the removal of 58 polyurethane or PTFE (polytetrafluoroethylene)-covered stents was attempted in 33 patients using a retrieval hook wire. Indications for removal were elective removal (n=21), stent migration (n=19), formation of tissue hyperplasia around or inside of the stent (n=14), stent deformity (n=3), and severe pain (n=1). The mean time the stents remained in place was 64.8±42.9 days (range, 1-177 days). Fifty-six (97%) of the 58 stents were successfully removed using the retrieval hook wire despite the following difficulties; hook wire disconnection (n=2), untied drawstrings (n=3), and polyurethane membrane disruption/separation (n=4). The removal procedure using a retrieval hook wire failed in two stents (3%) which had migrated into the urinary bladder. One of the two stents with migration into the urinary bladder was removed using a snare through the cystostomy route. The overall complication rate was 14% (seven hematuria cases and one urethral tear case), and all were minor and spontaneously resolved without further treatment. In conclusion, removal of retrievable urethral stents using a retrieval hook wire was safe and effective despite some technical difficulties. It is a useful method for allowing temporary stent placement and solving various complications of stent use. (orig.)

  11. Adverse cardiovascular events associated with biodegradable polymer drug-eluting stents and durable polymer everolimus-eluting stents: A systematic review and meta-analysis of 10 randomized controlled trials.

    Science.gov (United States)

    Bundhun, Pravesh Kumar; Janoo, Girish; Yanamala, Chandra Mouli; Huang, Feng

    2017-07-01

    Controversies have been observed among network meta-analyses comparing biodegradable polymer drug-eluting stents (BP-DES) with durable polymer drug-eluting stents (DP-DES). We aimed to compare the adverse cardiovascular events associated with BP-DES and durable polymer everolimus-eluting stents (DP-EES) using a large number of patients obtained from randomized controlled trials (RCTs). Electronic databases were searched for randomized trials comparing BP-DES with DP-EES. Adverse cardiovascular outcomes observed between 6 months and 3 years were considered as the clinical endpoints in this analysis. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated and the pooled analyses were performed with RevMan 5.3 software. All authors had full access to the data, and they have read and agreed to the manuscript as written. Ten trials involving a total number of 13,218 patients (7451 patients treated by BP-DES and 5767 patients treated by DP-EES) were included. No significant difference was observed when analyzing mortality and myocardial infarction between BP-DES and DP-EES with OR 1.08, 95% CI 0.87-1.34, P = .47 and OR 1.04, 95% CI 0.84-1.28, P = .72 respectively. Target vessel revascularization, target lesion revascularization, major adverse cardiac events, and stroke were also not significantly different with OR 1.11, 95% CI 0.92-1.33, P = .28; OR 1.11, 95% CI 0.94-1.33, P = .22; OR 1.12, 95% CI 0.99-1.27; P = .07; and OR 1.13, 95% CI 0.69-1.84; P = .62 respectively. In addition, total stent thrombosis (ST) was similarly reported between BP-DES and DP-EES with OR 0.85, 95% CI 0.59-1.21; P = .37. However, even if BP-DES were associated with a higher rate of definite ST with OR 1.69, 95% CI 0.92-3.08, P = .09 and DP-EES were associated with a higher rate of probable ST with OR 0.67, 95% CI 0.38-1.17, P = .16, these results were not statistically significant. Between 6 months and 3 years, BP-DES were similar in terms of

  12. A prospective randomized trial comparing traditional and fast-track patient care in elective open infrarenal aneurysm repair.

    Science.gov (United States)

    Muehling, Bernd; Schelzig, Hubert; Steffen, Peter; Meierhenrich, Rainer; Sunder-Plassmann, Ludger; Orend, Karl-Heinz

    2009-03-01

    Fast-track recovery programs have led to reduced patient morbidity and mortality after major surgery. In terms of elective open infrarenal aneurysm repair, no evidence is available about such programs. To address this issue, we have conducted a randomized prospective pilot study. The study involved prospective randomization of 101 patients with the indication for elective open aneurysm repair in a traditional and a fast-track treatment arm. The basic fast-track elements were no bowel preparation, reduced preoperative fasting, patient-controlled epidural analgesia (PCEA), enhanced postoperative feeding, and postoperative mobilization. Morbidity and mortality, need for postoperative mechanical ventilation, length of stay (LOS) in the intensive care unit (ICU) and total length of postoperative hospital stay were analyzed in terms of an intention to treat. Demographic data for the two groups were similar. In the fast-track group the need for postoperative ventilation was significantly lower (6.1% versus 32%; p = 0.002), the median LOS on ICU did not significantly differ (20 h versus 32 h; p = 0.183), full enteral feeding was achieved significantly earlier (5 versus 7 days; p < 0.0001), and the rate of postoperative medical complications-gastrointestinal, cardiac, pulmonary, renal, and infective-was significantly lower (16% versus 36%; p = 0.039). The postoperative hospital stay was significantly shorter in the fast-track group (10 days versus 11 days; p = 0.016); the mortality rate in both groups was 0%. An optimized patient care program in open infrarenal aortic aneurysm repair shows favorable results concerning need for postoperative assisted mechanical ventilation, time to full enteral feeding, and incidence of medical complications. Further ranomized multicentric trials are necessary to justify broad implementation (clinical trials. gov identifier NCT 00615888).

  13. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial.

    Science.gov (United States)

    Clair, Daniel G; Adams, Julie; Reen, Bernard; Feldman, Robert; Starr, Jean; Diaz-Cartelle, Juan; Dawkins, Keith D

    2014-04-01

    To report the 1-year results of a pivotal study for a new-generation nitinol stent for the treatment of iliac atherosclerotic lesions. The ORION trial (ClinicalTrials.gov identifier NCT00896337) was a single-arm, non-randomized, prospective, multicenter clinical trial that enrolled 125 patients (81 men; mean age 61.1±9.3 years) implanted with the EPIC self-expanding nitinol stent system in 166 de novo or restenotic iliac artery lesions ≤13 cm long. The primary endpoint was the 9-month major adverse event rate [i.e., device- or procedure-related death within 30 days, myocardial infarction during the index hospitalization, target vessel revascularization (TVR), or index limb amputation]. Follow-up occurred at hospital discharge and at 1, 9, and 12 months. An independent core laboratory evaluated ultrasound results at 1, 9, and 12 months. The primary endpoint met the prespecified performance goal, with only 3.4% (4/117) of patients experiencing a major adverse event by 9 months (p<0.0001). By 12 months, 6 (5.4%) of 111 patients had TVR; none had an index limb amputation. The ankle-brachial index, Walking Impairment Questionnaire, and Rutherford classifications all showed sustained improvements through 12 months. Primary patency was 94.4% with comparable results for lesions classified as complex (TASC II C/D 95.5%) or non-complex (TASC II A/B 95.0%). The EPIC stent system demonstrated safety and effectiveness through 12 months, including improvements for complex lesions. The EPIC stent is a viable alternative to surgery for patients with either complex or non-complex lesions.

  14. Drug-eluting versus bare metal stent in treatment of patients with saphenous vein graft disease: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Gao, Jing; Ren, Min; Liu, Yin; Gao, Mingdong; Sun, Bo

    2016-11-01

    Drug-eluting stent (DES) and bare metal stent (BMS) are effective treatments for preventing vascular disease, but whether using DES is associated with positive clinical outcomes compared with BMS in patients with saphenous vein graft disease (SVGD) has not been established. Three electronic databases including PubMed, EmBase, and the Cochrane Central Register of Controlled Trials were searched to identify potentially includible studies. We did a random-effects meta-analysis of randomized controlled trials (RCTs) to obtain summary effect estimates for the clinical outcomes with the use of relative risk calculated from the raw data of individual trial. Among 812 patients from 4 RCTs, DES was associated with lower risk of short-term major cardiovascular events (MACEs) when compared with BMS, whereas no significant effect on the risk of long-term MACEs. Furthermore, there was no significant difference between DES and BMS for short-term myocardial infarction (MI) and long-term MI. Similarly, DES was not associated with risk of short- and long-term mortality risk as compared with BMS. In addition, DES has no significant effect on the risk of cardiac death and stent thrombosis. Finally, DES therapy significantly reduced the risk of TLR, TVF, and TVR. SVGD patients received DES can minimize the risk of short-term MACEs, TLR, TVF, and TVR when compared with BMS. However, it does not effect on the incidence of long-term MACEs, MI, mortality, cardiac death, and stent thrombosis. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  15. Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction

    DEFF Research Database (Denmark)

    Räber, Lorenz; Kelbæk, Henning; Taniwaki, Masanori

    2014-01-01

    BACKGROUND: This study sought to determine whether the 1-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents (BMSs) in the COMFORTABLE trial (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal...

  16. 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.

  17. Outcome After Myocardial Infarction Treated With Resolute Integrity and Promus Element Stents: Insights From the DUTCH PEERS (TWENTE II) Randomized Trial.

    Science.gov (United States)

    van Houwelingen, K Gert; Lam, Ming Kai; Löwik, Marije M; Danse, Peter W; Tjon Joe Gin, R Melvyn; Jessurun, Gillian A; Anthonio, Rutger L; Sen, Hanim; Linssen, Gerard C M; IJzerman, Maarten J; Doggen, Carine J M; von Birgelen, Clemens

    2016-12-01

    In acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI. The prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non-ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization. Of all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF, 5.1% vs 4.9%; P = .81) and 447 patients with non-ST-segment elevation MI (TVF, 9.0% vs 7.5%; P = .56). Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  18. Short- versus long-term duration of dual antiplatelet therapy in patients treated for in-stent restenosis: a PRODIGY trial substudy (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia).

    Science.gov (United States)

    Campo, Gianluca; Tebaldi, Matteo; Vranckx, Pascal; Biscaglia, Simone; Tumscitz, Carlo; Ferrari, Roberto; Valgimigli, Marco

    2014-02-18

    This study sought to investigate the clinical outcome of patients treated with percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) randomized to short (6 months) versus long (24 months) dual antiplatelet therapy (DAPT) regimen. It is still unclear if patients treated for ISR may benefit from a long DAPT regimen. For the present purpose, we selected 224 patients undergoing the PCI procedure for ISR enrolled in the PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial and randomized to short (6 months) versus long (24 months) DAPT regimen. The primary objective was the cumulative incidence of death, nonfatal myocardial infarction (MI), or cerebrovascular accident at 24 months. Safety endpoints were moderate and major bleeding complications. Overall, 114 patients were allocated to short DAPT regimen, whereas 110 patients were allocated to long DAPT regimen. Twenty-seven patients reached the primary endpoint (19 in short DAPT regimen vs. 8 in long DAPT regimen; p = 0.02). The cumulative incidence of the primary endpoint at 24 months was 16.7% in the short DAPT regimen group compared with 7.3% in the long DAPT regimen group (p = 0.034). This is principally due to a lower occurrence of death and MI in the long DAPT regimen group as compared to the short DAPT regimen group (6.5% vs. 15.5%; p = 0.03). There was no difference in the occurrence of bleeding complications between long and short DAPT regimen. Our study offers preliminary evidence that patients receiving a new PCI procedure for ISR may benefit from long-term administration of aspirin plus clopidogrel. (Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention [PRODIGY]; NCT00611286). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  19. The effect of distant reiki on pain in women after elective Caesarean section: a double-blinded randomised controlled trial

    Science.gov (United States)

    vanderVaart, Sondra; Berger, Howard; Tam, Carolyn; Goh, Y Ingrid; Gijsen, Violette M G J; de Wildt, Saskia N; Taddio, Anna

    2011-01-01

    Introduction Approximately 25% of all babies in North America are delivered via Caesarean section (C-section). Though a common surgical procedure, C-section recovery can be painful. Opioids, specifically codeine, are commonly used to ease pain; however, its active metabolite, morphine, passes into breast milk, and may produce unwanted side effects in neonates; therefore, alternatives to opioids are being sought. Reiki is an ancient Japanese form of healing where practitioners transfer healing energy through light touch and positive healing intention. Although 1.2 million Americans use reiki to reduce pain or depression, there is a lack of strong evidence supporting its effectiveness. A recent systematic review showed existing studies to be of poor methodological quality, with the common limitation of lack of blinding. To overcome this issue, the authors used distant reiki to assess its effectiveness in reducing pain following an elective C-section. Methods In this randomised, double-blinded study, women who underwent an elective C-section were allocated to either usual care (control, n=40) or three distant reiki sessions in addition to usual care (n=40). Pain was assessed using a visual analogue scale (VAS). The primary endpoint was the Area Under the VAS-Time Curve (AUC) for days 1–3. Secondary measures included: the proportion of women who required opioid medications and dose consumed, rate of healing and vital signs. Results AUC for pain was not significantly different in the distant reiki and control groups (mean±SD; 212.1±104.7 vs 223.1±117.8; p=0.96). There were no significant differences in opioid consumption or rate of healing; however, the distant reiki group had a significantly lower heart rate (74.3±8.1 bpm vs 79.8±7.9 bpm, p=0.003) and blood pressure (106.4±9.7 mm Hg vs 111.9±11.0 mm Hg, p=0.02) post surgery. Conclusion Distant reiki had no significant effect on pain following an elective C-section. Clinical Trial Registration

  20. Preventing hypothermia in elective arthroscopic shoulder surgery patients: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Duff Jed

    2012-07-01

    Full Text Available Abstract Background Patients having arthroscopic shoulder surgery frequently experience periods of inadvertent hypothermia. This common perioperative problem has been linked to adverse patient outcomes such as myocardial ischaemia, surgical site infection and coagulopathy. International perioperative guidelines recommend patient warming, using a forced air warming device, and the use of warmed intraoperative irrigation solutions for the prevention of hypothermia in at-risk patient groups. This trial will investigate the effect of these interventions on patients’ temperature, thermal comfort, and total recovery time. Method/Design The trial will employ a randomised 2 x 2 factorial design. Eligible patients will be stratified by anaesthetist and block randomised into one of four groups: Group one will receive preoperative warming with a forced air warming device; group two will receive warmed intraoperative irrigation solutions; group three will receive both preoperative warming and warmed intraoperative irrigation solutions; and group four will receive neither intervention. Participants in all four groups will receive active intraoperative warming with a forced air warming device. The primary outcome measures are postoperative temperature, thermal comfort, and total recovery time. Primary outcomes will undergo a two-way analysis of variance controlling for covariants such as operating room ambient temperature and volume of intraoperative irrigation solution. Discussion This trial is designed to confirm the effectiveness of these interventions at maintaining perioperative normothermia and to evaluate if this translates into improved patient outcomes. Australian New Zealand Clinical Trials Registry number ACTRN12610000591055

  1. 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.

  2. 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.

    Science.gov (United States)

    Cui, Kongyong; Lyu, Shuzheng; Song, Xiantao; Yuan, Fei; Xu, Feng; Zhang, Min; Wang, Wei; Zhang, Dongfeng; Dai, Jing

    2017-01-01

    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.

  3. Second-generation versus first-generation drug-eluting stents in saphenous vein graftdisease: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Shi, Hong-Tao; Chu, Hong-Xia; Gu, Wei; Cai, Xin-Yong; Guo, Jun-Jie; Ding, Zhao-Gang; Gao, Wei; Ma, Lei-Lei; Zhu, Jian-Bing; Liu, Hai-Bo; Huang, Zhe-Yong; Wang, Qi-Bing; Ge, Jun-Bo; Wen, Shao-Jun

    2016-07-01

    Second-generation drug-eluting stents (DESs) have become increasingly popular devices for patients with saphenous vein graft (SVG) disease. Second-generation DESs were designed to have more safety and efficacy than first-generation DES, but clinical outcomes in SVG disease remain conflicting. Randomized controlled trials (RCTs) were identified when comparing second- versus first-generation DESs in SVG disease. The main endpoint was all-cause death. The time of follow-up was at least 30days. The secondary endpoints were major adverse cardiovascular events (MACEs), target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), and stent thrombosis. These endpoints were assessed at 30days, 12months and 24months. Four RCTs with 1077 SVG patients undergoing the implantation of DES were collected in the current meta-analysis. As a result, second-generation DES-treated patients had the significantly lower MACE rates at 12months (P=0.03; OR: 0.69, 95% CI: 0.49,0.97). No differences in two groups were seen in all-cause death, MI, TVR, stent thrombosis and TLR. Our limited evidence indicated that, second-generation DES in SVG patients, compared with first-generation DES, offered similar levels of safety, but were more effective than the former one. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  4. Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease.

    Science.gov (United States)

    Müller-Hülsbeck, Stefan; Keirse, Koen; Zeller, Thomas; Schroë, Herman; Diaz-Cartelle, Juan

    2016-10-01

    To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions. The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69±9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions in the native superficial femoral and/or proximal popliteal arteries. A third of the patients had diabetes. Mean lesion length was 70.8±28.1 mm, and diameter stenosis was 86.3%±16.2%; 26 (46%) lesions were occluded. Primary patency was defined as duplex ultrasound peak systolic velocity ratio ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month and target limb major amputation and TLR through 12 months. All 57 patients had a single Eluvia stent implanted, employing pre- and postdilation in 93% (53/57) and 95% (54/57) of cases, respectively. Technical success was 97% (55/57; 2 failures due to residual stenosis >30%). At 12 months, primary patency was 96% (49/51) and the MAE rate was 4% (2/53); both MAEs were TLRs. No stent fractures were identified. There were no major amputations. One death occurred 368 days postprocedure, unrelated to the device or procedure. Improvements in the Rutherford category were sustained through 1 year, with 81% (43/53) exhibiting no symptoms (category 0) and 13% (7/53) presenting with mild claudication (category 1). Mean ABI improved from 0.73±0.22 at baseline to 1.02±0.20 at 12 months. MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months. © The Author(s) 2016.

  5. Stent-assisted angioplasty for intracranial atherosclerosis

    International Nuclear Information System (INIS)

    Nakahara, Toshinori; Sakamoto, Shigeyuki; Hamasaki, Osamu; Sakoda, Katsuaki

    2002-01-01

    We report on two patients with intracranial atherosclerosis of the carotid artery or vertebral artery treated with stent-assisted angioplasty. Both patients have severe intracranial atherosclerosis (>70%) with refractory symptoms despite optimal medical treatment. In both patients, a coronary balloon-expandable stent was successfully placed using a protective balloon technique without procedural complications. The patients were asymptomatic and neurologically intact at a mean clinical follow-up of 13 months. Follow-up angiograms did not show restenosis 3 or 4 months after procedure, respectively. Stent-assisted angioplasty for intracranial atherosclerosis in the elective patient has proven effective, with an acceptable low rate of morbidity and mortality. (orig.)

  6. Elective repeat cesarean delivery compared with trial of labor after a prior cesarean delivery: a propensity score analysis.

    Science.gov (United States)

    Kok, N; Ruiter, L; Lindeboom, R; de Groot, C; Pajkrt, E; Mol, B W; Kazemier, B M

    2015-12-01

    To determine neonatal and short term maternal outcomes according to intentional mode of delivery following a cesarean delivery (CD). Women pregnant after CD between January 2000 and December 2007 were categorized according to whether they had an elective repeat CD (ERCD) or a Trial of Labor (TOL). Prognostically equal ERCD and TOL groups were created using the propensity score matching technique. Conditional logistic regression was performed to assess differences in neonatal and maternal outcomes. Women in their second ongoing pregnancy with a history of CD. After ERCD the rates of low 5min Apgar score (OR 0.3, 95%CI 0.2-0.5, p<0.001), meconium aspiration (OR 0.0, 95%CI 0-0.7, p=0.02) and birth trauma (OR 0.08, 95%CI 0.002-0.5, p<0.001) were lower compared to TOL. The rate of transient tachypnoea of the newborn (TTN) appears higher in the ERCD group (OR 1.7, 95%CI 1.0-2.8, p=0.04). Uterine rupture (OR 0.1, 95%CI 0.003-0.8, p=0.02) and hemorrhage (OR 0.6, 95%CI 0.5-0.8, p<0.001) occurred less in the ERCD group. Neonatal and short term maternal morbidity appears to be lower after ERCD than after TOL. Only TTN was seen more often after ERCD. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  7. Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: the Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Thayssen, Per

    2008-01-01

    AIMS: Patients with diabetes have increased risk of in-stent restenosis after coronary stent implantation owing to neointimal hyperplasia (NIH). The aim of the study was to evaluate the extent and distribution of NIH with intravascular ultrasound (IVUS) after coronary artery stenting with sirolimus......-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in diabetic patients. METHODS AND RESULTS: One hundred and thirty diabetic patients were randomized to Cypher or Taxus stent implantation. IVUS was performed at 8 month follow-up. NIH volume was significantly reduced in the Cypher group when compared...

  8. At what price? A cost-effectiveness analysis comparing trial of labour after previous caesarean versus elective repeat caesarean delivery.

    Directory of Open Access Journals (Sweden)

    Christopher G Fawsitt

    Full Text Available BACKGROUND: Elective repeat caesarean delivery (ERCD rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland. METHODS: Using a decision analytic model, a cost-effectiveness analysis (CEA was performed where the measure of health gain was quality-adjusted life years (QALYs over a six-week time horizon. A review of international literature was conducted to derive representative estimates of adverse maternal health outcomes following a trial of labour after caesarean (TOLAC and ERCD. Delivery/procedure costs derived from primary data collection and combined both "bottom-up" and "top-down" costing estimations. RESULTS: Maternal morbidities emerged in twice as many cases in the TOLAC group than the ERCD group. However, a TOLAC was found to be the most-effective method of delivery because it was substantially less expensive than ERCD (€ 1,835.06 versus € 4,039.87 per women, respectively, and QALYs were modestly higher (0.84 versus 0.70. Our findings were supported by probabilistic sensitivity analysis. CONCLUSIONS: Clinicians need to be well informed of the benefits and risks of TOLAC among low risk women. Ideally, clinician-patient discourse would address differences in length of hospital stay and postpartum recovery time. While it is premature advocate a policy of TOLAC across maternity units, the results of the study prompt further analysis and repeat iterations, encouraging future studies to synthesis previous research and new and relevant evidence under a single

  9. Optimised anaesthesia to reduce post operative cognitive decline (POCD in older patients undergoing elective surgery, a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Clive Ballard

    Full Text Available BACKGROUND: The study determined the one year incidence of post operative cognitive decline (POCD and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age undergoing elective orthopaedic or abdominal surgery. METHODS AND TRIAL DESIGN: The design was a prospective cohort study with a nested randomised, controlled intervention trial, using intra-operative BiSpectral index and cerebral oxygen saturation monitoring to enable optimisation of anaesthesia depth and cerebral oxygen saturation in older adults undergoing surgery. RESULTS: In the 52 week prospective cohort study (192 surgical patients and 138 controls, mild (χ(2 = 17.9 p<0.0001, moderate (χ(2 = 7.8 p = 0.005 and severe (χ(2 = 5.1 p = 0.02 POCD were all significantly higher after 52 weeks in the surgical patients than among the age matched controls. In the nested RCT, 81 patients were randomized, 73 contributing to the data analysis (34 intervention, 39 control. In the intervention group mild POCD was significantly reduced at 1, 12 and 52 weeks (Fisher's Exact Test p = 0.018, χ(2 = 5.1 p = 0.02 and χ(2 = 5.9 p = 0.015, and moderate POCD was reduced at 1 and 52 weeks (χ(2 = 4.4 p = 0·037 and χ(2 = 5.4 p = 0.02. In addition there was significant improvement in reaction time at all time-points (Vigilance Reaction Time MWU Z = -2.1 p = 0.03, MWU Z = -2.7 p = 0.004, MWU Z = -3.0 p = 0.005, in MMSE at one and 52 weeks (MWU Z = -2.9 p = 0.003, MWU Z = -3.3 p = 0.001, and in executive function at 12 and 52 weeks (Trail Making MWU Z = -2.4 p = .0.018, MWU Z = -2.4 p = 0.019. CONCLUSION: POCD is common and persistent in older adults following surgery. The results of the nested RCT indicate the potential benefits of intra-operative monitoring of anaesthetic depth and cerebral oxygenation as a pragmatic intervention to reduce post-operative cognitive impairment. TRIAL REGISTRATION

  10. Enteral stents.

    Science.gov (United States)

    Varadarajulu, Shyam; Banerjee, Subhas; Barth, Bradley; Desilets, David; Kaul, Vivek; Kethu, Sripathi; Pedrosa, Marcos; Pfau, Patrick; Tokar, Jeffrey; Wang, Amy; Song, Louis-Michel Wong Kee; Rodriguez, Sarah

    2011-09-01

    The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, with a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through August 2010 for articles related to enteral, esophageal, duodenal, and colonic stents. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment. Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. 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

    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...

  12. Intravascular ultrasound-guided vs angiography-guided drug-eluting stent implantation in complex coronary lesions: Meta-analysis of randomized trials.

    Science.gov (United States)

    Bavishi, Chirag; Sardar, Partha; Chatterjee, Saurav; Khan, Abdur Rahman; Shah, Arpit; Ather, Sameer; Lemos, Pedro A; Moreno, Pedro; Stone, Gregg W

    2017-03-01

    The relative outcomes of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI with drug-eluting stent (DES) in complex lesions have not been established. We sought to compare the efficacy and safety of IVUS-guided PCI with angiography-guided PCI in patients with complex coronary lesions treated with DES. Electronic databases were searched to identify all randomized trials comparing IVUS-guided vs angiography-guided DES implantation. We evaluated major adverse cardiac events (MACE), all-cause and cardiovascular death, myocardial infarction, target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis outcomes at the longest reported follow-up. Random-effects modeling was used to calculate pooled relative risk (RR) and 95% CIs. Eight trials comprising 3,276 patients (1,635 IVUS-guided and 1,641 angiography-guided) enrolling only patients with complex lesions were included. Mean follow-up was 1.4±0.5years. Compared with angiography-guided PCI, patients undergoing IVUS-guided PCI had significantly lower MACE (RR 0.64, 95% CI 0.51-0.80, P=.0001), TLR (RR 0.62, 95% CI 0.45-0.86, P=.004), and TVR (RR 0.60, 95% CI 0.42-0.87, P=.007). There were no significant differences for stent thrombosis, cardiovascular death, or all-cause death. In meta-regression analysis, IVUS-guided PCI was of greatest benefit in reducing MACE in patients with acute coronary syndromes, diabetes, and long lesions. The present meta-analysis demonstrates a significant reduction in MACE, TVR, and TLR with IVUS-guided DES implantation in complex coronary lesions. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Drug-eluting stents versus control therapy in the infrapopliteal disease: A meta-analysis of eight randomized controlled trials and two cohort studies.

    Science.gov (United States)

    Liu, Xiaochun; Zheng, Guofu; Wen, Song

    2017-08-01

    Drug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arteries disease. However, the long-term clinical impact of DES treatment in the vascular territory still remains uncertain. Pubmed, Embase, Cochrane data, CNKI and Wanfang Data were searched until December 20, 2016 for eligible studies according to identical strategies. Additional data were manually retrieved. STATA ver. 12.0 software were used to Meta-analyze the efficacies of DES and control treatment (BMS or PTA) for infrapopliteal arteries disease. A total of 927 patients from 10 studies (8 randomized controlled trials and 2 cohort studies) were assigned to DESs (n = 484) versus control treatment (n = 443). The results showed that infrapopliteal DES therapy yielded higher primary patency and EFS, while decreased the risk of restenosis at 12-months compared to controls significantly. At 3 years there were no significant differences between two groups, pooled RRs and 95% CI were 1.639 [0.526-5.105], P = 0.394; 1.197 [0.432-3.317], P = 0.729 and 0.992 [0.960-1.024], P = 0.661, respectively. Subgroup analysis showed that infrapopliteal DES therapy using Sirolimus-eluting stents rather than Everolimus-eluting stents provided higher clinic benefits. Infrapopliteal DES therapy yielded no significant difference for TLR, overall survival, Rutherford-Becker class improvement, limb amputation at 12-months and 3-years compared with control treatment. The results of the present meta-analysis indicate the non-superiority of infrapopliteal DES therapy over control therapies (BMS/PTA) at 3 years, although short-term benefits at 12 months after DES therapy were evident. Further randomized trials with longer follow-up are required to provide the best scientific evidence regarding the preferred endovascular treatment for patients with occlusive disease of infrapopliteal arteries. Copyright © 2017. Published by Elsevier Ltd.

  14. Routine intraoperative stenting for renal transplant recipients.

    Science.gov (United States)

    Wilson, Colin H; Bhatti, Aftab A; Rix, David A; Manas, Derek M

    2005-10-15

    Major urological complications (MUCs) after kidney transplantation contribute to patient morbidity and compromise graft function. Ureteric stents have been successfully used to treat such complications and a number of centers have adopted a policy of universal prophylactic stenting, at the time of graft implantation, to reduce the incidence of urine leaks and ureteric stenosis. In conjunction with the Cochrane Renal Group we searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, reference lists of articles, books and abstracts and contacted companies, authors and experts to identify randomized controlled trials examining the use of stents in renal transplantation. The primary outcome was the incidence of MUCs and data on this statistic was pooled and analyzed using a random effects model. Seven randomized controlled trials (1154 patients) of low or moderate quality were identified. The incidence of MUCs was significantly reduced (relative risk [RR] 0.24; 95% CI: 0.07 - 0.77; P=0.02; number needed to treat = 13) by prophylactic ureteric stenting. Urinary tract infections were more common in stented patients (RR 1.49), unless the patients were prescribed 480 mg cotrimoxazole once daily. With this antibiotic regime the incidence of infection was equivalent between the two groups (RR 0.97). Stents appeared generally well tolerated, although trials using longer stents (> or = 20 cm) for longer periods of time (>6 weeks) reported more problems with encrustation and migration. Universal prophylactic stenting reduces the incidence of MUCs and should be recommended on the basis of currently available randomized controlled trials.

  15. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial.

    Science.gov (United States)

    Ansel, Gary M; Hopkins, L Nelson; Jaff, Michael R; Rubino, Paolo; Bacharach, J Michael; Scheinert, Dierk; Myla, Subbarao; Das, Tony; Cremonesi, Alberto

    2010-07-01

    The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis. This prospective registry enrolled 262 subjects, 37 roll-in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. The ARMOUR trial demonstrated that the MO.MA(R) Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date. (c) 2010 Wiley-Liss, Inc.

  16. Emerging Stent and Balloon Technologies in the Femoropopliteal Arteries

    Directory of Open Access Journals (Sweden)

    Georgios Pastromas

    2014-01-01

    Full Text Available Endovascular procedures for the management of the superficial femoral (SFA and popliteal artery disease are increasingly common. Over the past decade, several stent technologies have been established which may offer new options for improved clinical outcomes. This paper reviews the current evidence for SFA and popliteal artery angioplasty and stenting, with a focus on randomized trials and registries of nitinol self-expanding stents, drug-eluting stents, dug-coated balloons, and covered stent-grafts. We also highlight the limitations of the currently available data and the future routes in peripheral arterial disease (PAD stent and balloon technology.

  17. Comparison among drug-eluting balloon, drug-eluting stent, and plain balloon angioplasty for the treatment of in-stent restenosis: a network meta-analysis of 11 randomized, controlled trials.

    Science.gov (United States)

    Lee, Joo Myung; Park, Jonghanne; Kang, Jeehoon; Jeon, Ki-Hyun; Jung, Ji-Hyun; Lee, Sang Eun; Han, Jung-Kyu; Kim, Hack-Lyoung; Yang, Han-Mo; Park, Kyung Woo; Kang, Hyun-Jae; Koo, Bon-Kwon; Kim, Hyo-Soo

    2015-03-01

    A Bayesian network meta-analysis was performed comparing the efficacy and safety of drug-eluting balloons (DEB), drug-eluting stents (DES), or plain old balloon angioplasty (POBA) for treatment of in-stent restenosis (ISR). Optimal treatment options for ISR have not been well established. Randomized, controlled trials comparing DEB, DES, and POBA for the treatment of ISR after percutaneous coronary intervention with bare metal stent or DES were included. The primary outcome was target lesion revascularization (TLR). The pairwise posterior median odds ratio (OR) with 95% credible interval (CrI) was the effect measure. This analysis included 2,059 patients from 11 RCTs. The risk of TLR was markedly lower in patients treated with DEB (OR: 0.22, 95% CrI: 0.10 to 0.42) or DES (OR: 0.24, 95% CrI: 0.11 to 0.47) than in those treated with POBA in a random-effects model. In a comparison of DEB and DES, the risk of TLR (OR: 0.92, 95% CrI: 0.43 to 1.90) was similar. The risk of MI or all-cause mortality was lowest in the DEB group compared with the DES and POBA groups, which did not meet statistical significance. The risk of major adverse cardiac events, which was mainly driven by TLR, was also significantly lower in the DEB or and DES group (OR: 0.28, 95% CrI: 0.14 to 0.53) than in the POBA group, but it was similar between the DEB and DES groups (OR: 0.84, 95% CrI: 0.45 to 1.50). The probability of being ranked as the best treatment was 59.9% (DEB), 40.1% (DES), and 0.1% (POBA) in terms of TLR, whereas it was 63.0% (DEB), 35.3% (POBA), and 1.7% (DES) in terms of MI. Local drug delivery by DEB or DES for ISR lesions was markedly better than POBA in preventing TLR, but not for MI or mortality. Among the 2 different strategies of drug delivery for ISR lesions, treatment with DEB showed a trend of less development of MI than did treatment with DES. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  18. Comparing the Clinical Outcomes between Drug Eluting Stents and Bare Metal Stents in Patients with Insulin-Treated Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of 10 Randomized Controlled Trials.

    Science.gov (United States)

    Bundhun, Pravesh Kumar; Bhurtu, Akash; Soogund, Mohammad Zafooruddin Sani; Long, Man-Yun

    2016-01-01

    Several studies have shown Drug Eluting Stents (DES) to be better compared to Bare Metal Stents (BMS) in patients with type 2 Diabetes Mellitus (T2DM). Since, the adverse clinical outcomes in patients with Insulin-Treated Type 2 Diabetes Mellitus (ITDM) implanted with DES and BMS have not been previously studied, we aim to compare the clinical outcomes in similar patients with cardiovascular diseases, treated with DES and BMS. Randomized Controlled Trials (RCTs) comparing patients treated with DES and BMS were searched from PubMed and EMBASE databases. Outcome data for the patients with ITDM were carefully extracted. Major Adverse Cardiac Events (MACEs), mortality, Target Vessel Revascularization (TVR), Target Lesion Revascularization (TLR), Myocardial Infarction (MI) and Stent Thrombosis (ST) were considered as the clinical endpoints for this analysis. Odds ratios (OR) with 95% confidence intervals (CIs) were calculated and the pooled analyses were performed with RevMan 5.3 software. Ten RCTs consisting of 830 patients with ITDM (477 patients in the DES group and 353 patients in the BMS group) from a total number of 9,141 patients were included in this analysis. During a follow-up period from one month to one year, MACEs were not increased with the use of DES in these patients with ITDM. At 9 months, MACEs were significantly lower in the DES group with OR: 0.40, 95% CI: 0.23-0.72; P = 0.002 with no increase in mortality. TVR and TLR also favored the DES group with OR: 0.44, 95% CI: 0.22-0.88, P = 0.02 and OR: 0.28, 95% CI: 0.14-0.53; P = 0.0001 respectively at 9 months, and OR: 0.46, 95% CI: 0.23-0.94, P = 0.03 and OR: 0.28, 95% CI: 0.14-0.55; P = 0.0003 respectively at one year. Results for MI, and ST were not statistically significant. Compared to BMS, DES were associated with a significantly lower rate of repeated revascularization, without any increase in MACEs or mortality in these patients with ITDM during a follow up period of one year. However, due to the

  19. Comparing the Clinical Outcomes between Drug Eluting Stents and Bare Metal Stents in Patients with Insulin-Treated Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of 10 Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Pravesh Kumar Bundhun

    Full Text Available Several studies have shown Drug Eluting Stents (DES to be better compared to Bare Metal Stents (BMS in patients with type 2 Diabetes Mellitus (T2DM. Since, the adverse clinical outcomes in patients with Insulin-Treated Type 2 Diabetes Mellitus (ITDM implanted with DES and BMS have not been previously studied, we aim to compare the clinical outcomes in similar patients with cardiovascular diseases, treated with DES and BMS.Randomized Controlled Trials (RCTs comparing patients treated with DES and BMS were searched from PubMed and EMBASE databases. Outcome data for the patients with ITDM were carefully extracted. Major Adverse Cardiac Events (MACEs, mortality, Target Vessel Revascularization (TVR, Target Lesion Revascularization (TLR, Myocardial Infarction (MI and Stent Thrombosis (ST were considered as the clinical endpoints for this analysis. Odds ratios (OR with 95% confidence intervals (CIs were calculated and the pooled analyses were performed with RevMan 5.3 software.Ten RCTs consisting of 830 patients with ITDM (477 patients in the DES group and 353 patients in the BMS group from a total number of 9,141 patients were included in this analysis. During a follow-up period from one month to one year, MACEs were not increased with the use of DES in these patients with ITDM. At 9 months, MACEs were significantly lower in the DES group with OR: 0.40, 95% CI: 0.23-0.72; P = 0.002 with no increase in mortality. TVR and TLR also favored the DES group with OR: 0.44, 95% CI: 0.22-0.88, P = 0.02 and OR: 0.28, 95% CI: 0.14-0.53; P = 0.0001 respectively at 9 months, and OR: 0.46, 95% CI: 0.23-0.94, P = 0.03 and OR: 0.28, 95% CI: 0.14-0.55; P = 0.0003 respectively at one year. Results for MI, and ST were not statistically significant.Compared to BMS, DES were associated with a significantly lower rate of repeated revascularization, without any increase in MACEs or mortality in these patients with ITDM during a follow up period of one year. However, due to

  20. Impact of design of coronary stents and length of dual antiplatelet therapies on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 102 735 patients.

    Science.gov (United States)

    D'Ascenzo, Fabrizio; Iannaccone, Mario; Saint-Hilary, Gaelle; Bertaina, Maurizio; Schulz-Schüpke, Stefanie; Wahn Lee, Cheol; Chieffo, Alaide; Helft, Gerard; Gili, Sebastiano; Barbero, Umberto; Biondi Zoccai, Giuseppe; Moretti, Claudio; Ugo, Fabrizio; D'Amico, Maurizio; Garbo, Roberto; Stone, Gregg; Rettegno, Sara; Omedè, Pierluigi; Conrotto, Federico; Templin, Christian; Colombo, Antonio; Park, Seung-Jung; Kastrati, Adnan; Hildick-Smith, David; Gasparini, Mauro; Gaita, Fiorenzo

    2017-11-07

    The differential impact on ischaemic and bleeding events of the type of drug-eluting stent [durable polymer stents [DES] vs. biodegradable polymer stents vs. bioresorbable scaffolds (BRS)] and length of dual antiplatelet therapy (DAPT) remains to be defined. Randomized controlled trials comparing different types of DES and/or DAPT durations were selected. The primary endpoint was Major Adverse Cardiovascular Events (MACE) [a composite of death, myocardial infarction (MI), and target vessel revascularization]. Definite stent thrombosis (ST) and single components of MACE were secondary endpoints. The arms of interest were: BRS with 12 months of DAPT (12mDAPT), biodegradable polymer stent with 12mDAPT, durable polymer stent [everolimus-eluting (EES), zotarolimus-eluting (ZES)] with 12mDAPT, EES/ZES with 12 months of DAPT (DAPT > 12 m). Sixty-four studies with 150 arms and 102 735 patients were included. After a median follow-up of 20 months, MACE rates were similar in the different arms of interest. EES/ZES with DAPT > 12 m reported a lower incidence of MI than the other groups, while BRS showed a higher rate of ST when compared to EES/ZES, irrespective of DAPT length. A higher risk of major bleedings was observed for DAPT > 12 m as compared to shorter DAPT. Durable and biodegradable polymer stents along with BRS report a similar rate of MACE irrespective of DAPT length. Fewer MI are observed with EES/ZES with DAPT > 12 m, while a higher rate of ST is reported for BRS when compared to EES/ZES, independently from DAPT length. Stent type may partially affect the outcome together with DAPT length. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

  1. The optimal discontinuation of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention with drug-eluting stents: A meta-analysis of randomized trials.

    Science.gov (United States)

    Wang, Wei; Liu, Jing; Fang, Jingxue; Liu, Yang; An, Tong; Zou, Meijuan; Cheng, Gang

    2017-05-15

    Current guidelines recommend prolonged dual antiplatelet therapy (DAPT) for patients with drug-eluting stents (DES) implantation. Nevertheless, optimal discontinuation of DAPT remains a controversy. We performed a meta-analysis of all randomized controlled trials (RCTs) that evaluate optimal discontinuation of DAPT in patients undergoing percutaneous coronary intervention (PCI) with DES. We searched electronic databases including PubMed, Cochrane Library, EMBASE and ClinicalTrials.gov from database RCTs that reported different modes of discontinuation of DAPT in patients with DES. The primary endpoints were all-cause death, cardiovascular death, myocardial infarction (MI) and probably or definite stent thrombosis (ST). Secondary endpoints were repeat revascularization, stroke, major bleeding and net adverse clinical events (NACE). We included 13 RCTs meeting the criteria with a total of 36,749 patients. No significant difference was observed in all-cause death (RR [95% CI]=0.87 [0.75, 1.01], P=0.07, I 2 =0%), cardiovascular death (RR [95% CI]=0.97 [0.79, 1.19], P=0.76, I 2 =0%), repeat revascularization (RR [95% CI]=1.07 [0.92, 1.25], P=0.36, I 2 =0%), and stroke (RR [95% CI]=1.01 [0.80, 1.28], P=0.94, I 2 =0%). Compared with shorter DAPT, longer DAPT was associated with a significant reduction in MI (RR [95% CI]=1.46 [1.26, 1.69], PDES implantation (RR [95% CI]=2.58 [1.85, 3.58], I 2 =0%) and everolimus-eluting stents (EES, RR [95% CI]=1.54 [1.12, 2.11], I 2 =0%). Conversely, there was no difference in thrombotic events in patients with zotarolimus-eluting stents (ZES, RR [95% CI]=1.17 [0.83, 1.63], I 2 =75%) and biodegradable polymer DES (BP-DES, RR [95% CI]=1.15 [0.74, 1.79]). 1) Compared with shorter DAPT, longer DAPT was associated with a significant reduction in thrombotic events (MI and ST) and a higher rate of major bleeding. 2) By the assessment of the trade-off between thrombotic and hemorrhagic events, shorter DAPT was non-inferior to longer DAPT. 3) The

  2. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis) : Angiographic Results and 1-Year Clinical Outcomes

    NARCIS (Netherlands)

    Verheye, Stefan; Vrolix, Mathias; Kumsars, Indulis; Erglis, Andrejs; Sondore, Dace; Agostoni, Pierfrancesco|info:eu-repo/dai/nl/34169276X; Cornelis, Kristoff; Janssens, Luc P F; Maeng, Michael; Slagboom, Ton; Amoroso, Giovanni; Jensen, Lisette Okkels; Granada, Juan F; Stella, Pieter|info:eu-repo/dai/nl/304814717

    2017-01-01

    Objectives The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). Background Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR

  3. Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): Rationale and study design of the randomized TWENTE III multicenter trial

    NARCIS (Netherlands)

    Lam, Ming Kai; Sen, Hanim; Sen, Hanim; Tandjung, K.; Tandjung, K.; van Houwelingen, K. Gert; de Vries, Arie G.; Danse, Peter W.; Schotborgh, Carl E.; Scholte, Martijn; Löwik, Marije M.; Linssen, Gerard C.M.; IJzerman, Maarten Joost; van der Palen, Jacobus Adrianus Maria; Doggen, Catharina Jacoba Maria; von Birgelen, Clemens

    2014-01-01

    Aim To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES. Methods and Results BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with

  4. Comparison of intravascular ultrasound versus angiography-guided drug-eluting stent implantation: A meta-analysis of one randomised trial and ten observational studies involving 19,619 patients

    NARCIS (Netherlands)

    Y. Zhang (Yaojun); V. Farooq (Vasim); H.M. Garcia-Garcia (Hector); C.V. Bourantas (Christos); N.-L. Tian (Nai-Liang); S.-J. Dong (Sheng-Jie); M. Li (Minghui); S. Yang (Shengyun); P.W.J.C. Serruys (Patrick); S.-L. Chen (Shao-Liang)

    2012-01-01

    textabstractAims: The impact of intravascular ultrasound (IVUS) guided coronary drug-eluting stent (DES) implantation on clinical outcomes remains controversial. A meta-analysis of the currently available clinical trials investi-gating IVUS-guided DES implantation was undertaken. Methods and

  5. A Randomized Trial Comparing the NeoVas Sirolimus-Eluting Bioresorbable Scaffold and Metallic Everolimus-Eluting Stents.

    Science.gov (United States)

    Han, Yaling; Xu, Bo; Fu, Guosheng; Wang, Xiaozeng; Xu, Kai; Jin, Chongying; Tao, Ling; Li, Lang; Hou, Yuqing; Su, Xi; Fang, Quan; Chen, Lianglong; Liu, Huiliang; Wang, Bin; Yuan, Zuyi; Gao, Chuanyu; Zhou, Shenghua; Sun, Zhongwei; Zhao, Yanyan; Guan, Changdong; Stone, Gregg W

    2018-02-12

    The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents. BRS have the potential to improve very late outcomes compared with metallic drug-eluting stents, but some BRS have been associated with increased rates of device thrombosis before complete bioresorption. NeoVas is a new poly-l-lactic acid BRS that elutes sirolimus from a poly-D, l-lactide coating. Eligible patients with a single de novo native coronary artery lesion with a reference vessel diameter 2.5 to 3.75 mm and a lesion length ≤20 mm were randomized 1:1 to NeoVas BRS versus cobalt-chromium everolimus-eluting stents (CoCr-EES). Angiographic follow-up was performed in all patients at 1 year. The primary endpoint was angiographic in-segment late loss (LL), and the major secondary endpoint was the rate of angina. Baseline and follow-up optical coherence tomography and fractional flow reserve were performed in a pre-specified subgroup of patients. The authors randomized 560 patients at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). One-year in-segment LL with NeoVas and CoCr-EES were 0.14 ± 0.36 mm versus 0.11 ± 0.34 mm (difference 0.03 mm; upper 1-sided 97.5% confidence interval 0.09 mm; p noninferiority  BRS was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL, and resulted in comparable 1-year clinical outcomes, including recurrent angina. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485). Copyright © 2018. Published by Elsevier Inc.

  6. Carotid Stenting in Neuroradiology : A Short Journey from the Past to Current Debates.

    Science.gov (United States)

    Berkefeld, Joachim; Wagner, Marlies; du Mesnil, Richard

    2017-12-01

    After a period of stagnation due to negative results of randomized trials for patients with symptomatic stenosis, the relevance of carotid artery stenting (CAS) is increasing again. CAS has become an important and evidence-based part of interventional stroke treatment. Our ability to manage acute recanalization of carotid occlusions and other niche indications properly led some skeptical neurologists to trust in carotid intervention for elective cases as well. The evolution of CAS from initial euphoria to more realistic views under consideration of trial results and guidelines is reviewed. Quality assurance in Germany proves that CAS complication rates within the carotid endarterectomy (CEA) quality criteria are feasible even with higher proportions of high-risk patients. Recent trial results showed that long-term efficacy of CAS or CEA are not significantly different. Other than in symptomatic stenoses, acute complication rates of both means treatment does not differ in asymptomatic patients, where medical therapy becomes increasingly competitive. Technical issues of CAS like the cell design of stents or the usefulness of embolic protection are still under discussion. We will see whether CAS results will further improve over time. Standardized techniques, proper training, and patient selection are important for acute and elective cases.

  7. Trust in Internet Election

    DEFF Research Database (Denmark)

    Markussen, Randi; Ronquillo, Lorena; Schürmann, Carsten

    2014-01-01

    This paper discusses the Decryption and Counting Ceremony held in conjunction with the internet voting trial on election day in the Ministry of Local Government and Regional Development of Norway in 2013. We examine the organizers' ambition of making the decryption and counting of electronic vote...

  8. Gastrointestinal stenting

    International Nuclear Information System (INIS)

    Zollikofer, C.L.; Schoch, E.; Jost, R.; Decurtins, M.

    2000-01-01

    Acute obstructions of the gastric outlet, the duodenum, or the large bowel require rapid treatment to relieve symptoms of retention or ileus. Large-caliber stents of 16 to 22 mm offer a new non-surgical alternative for treating these patients with minimal risks and high success rates. For gastroduodenal outlet obstructions palliated by self-expanded metal stents, clinical success rates are in the range of 80-100 %. Preoperative treatment of colorectal obstructions successfully relieves acute symptoms of ileus in 87-100 % allowing primary anastomosis and thereby reducing the costs caused by multiple operations and the need of intensive care by approximately 25 %. It is the purpose of this review to familiarize the reader with the indications, possibilities, and limits of intestinal stenting. (orig.)

  9. Late lumen loss and intima hyperplasia after sirolimus-eluting and zotarolimus-eluting stent implantation in diabetic patients: the diabetes and drug-eluting stent (DiabeDES III) angiography and intravascular ultrasound trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Thayssen, Per

    2011-01-01

    Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use quantitative coronary angiography (QCA) and volumetric intravascular ultrasound (IVUS) to evaluate the effects...

  10. 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

  11. 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

  12. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial

    DEFF Research Database (Denmark)

    Gutiérrez-Chico, Juan Luis; van Geuns, Robert Jan; Regar, Evelyn

    2011-01-01

    To compare the tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent (ZES) vs. a fluoropolymer-coated everolimus-eluting stent (EES) at 13 months, using optical coherence tomography (OCT) in an 'all-comers' population of patients, in order to clarify the mechanism of eventual...

  13. 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...

  14. Effectiveness of Positioning Stents in Radiation-Induced Xerostomia in Patients with Tongue Carcinoma: A Randomized Controlled Trial.

    Science.gov (United States)

    Mall, Priyanka; Chand, Pooran; Singh, Balendra Pratap; Rao, Jitendra; Siddarth, Ramashanker; Srivastava, Kirti

    2016-01-01

    The aim of this study was to perform an objective and subjective evaluation of the efficacy of positioning stents in radiation-induced xerostomia in patients with tongue carcinoma. A total of 30 patients with tongue carcinoma and undergoing conventional radiotherapy were randomly assigned to control (n = 15) and study (n = 15) groups, without and with a positioning stent, respectively. Assessment of salivary output reduction was done before and after radiotherapy, at 3- and 6-month intervals, by measurement of unstimulated and stimulated salivary flow rates (objective evaluation). Xerostomia (subjective evaluation) was noted using six items from the Quality of Life Head and Neck Module (QLQ-H&N35) as proposed by the European Organization for Research and Treatment of Cancer. The significance level was set at .05. Mean unstimulated and stimulated salivary flow rates at 3- and 6-month intervals revealed significantly (P xerostomia and its symptoms.

  15. Clinical outcomes of percutaneous interventions in saphenous vein grafts using drug-eluting stents compared to bare-metal stents: a comprehensive meta-analysisof all randomized clinical trials.

    Science.gov (United States)

    Alam, Mahboob; Bandeali, Salman J; Virani, Salim S; Jneid, Hani M; Shahzad, Saima A; Ramanathan, Kodangudi B; Kar, Biswajit; Kleiman, Neal S; Lakkis, Nasser

    2012-05-01

    Clinical outcomes of percutaneous coronary intervention (PCI) in patients with saphenous vein grafts (SVGs) remain poor despite the use of drug-eluting stents (DES). There is a disparity in clinical outcomes in SVG PCI based on various registries, and randomized clinical data remain scant. We conducted a meta-analysis of all existing randomized controlled trials (RCTS) comparing bare-metal stents (BMS) and DES in SVGPCIs. PCI in patients with SVG disease using DES may reduce need for repeat revascularization without an excess mortality when compared to BMS. An aggregate data meta-analysis of clinical outcomes in RCTs comparing PCI with DES vs BMS for SVGs reporting at least 12 months of follow-up was performed. A literature search between Janurary 1, 2003 and September 30, 2011 identified 4 RCTs (812 patients; DES = 416, BMS = 396). Summary odds ratio (OR) and 95% confidence interval (CI) were calculated using the random-effects model. The primary endpoint was all-cause mortality. Secondary outcomes included nonfatal myocardial infarction (MI), repeat revascularization, and major adverse cardiac events (MACE). These outcomes were assessed in a cumulative fashion at 30 days, 18 months, and 36 months. There were no intergroup differences in baseline clinical and sociodemographic characteristics. At a median follow-up of 25 months, patients in the DES and BMS group had similar rates of death (OR: 1.63, 95% CI: 0.45-5.92), MI (OR; 0.83, 95% CI: 0.27-2.60), and MACE (OR: 0.58, 95% CI: 0.25-1.32). Patients treated with DES had lower rates of repeat revascularization (OR: 0.40, 95% CI: 0.22-0.75). In this comprehensive meta-analysis of all RCTs comparing clinical outcomes of PCI using DES vs BMS in patients with SVG disease, use of DES was associated with a reduction in rate of repeat revascularization and no difference in rates of all-cause death and MI. Clin. Cardiol. 2012 DOI: 10.1002/clc.21984 Dr. Virani is supported by a Department of Veterans Affairs Health Services

  16. Comparative Effectiveness of Plain Balloon Angioplasty, Bare Metal Stents, Drug-Coated Balloons, and Drug-Eluting Stents for the Treatment of Infrapopliteal Artery Disease: Systematic Review and Bayesian Network Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Katsanos, Konstantinos; Kitrou, Panagiotis; Spiliopoulos, Stavros; Diamantopoulos, Athanasios; Karnabatidis, Dimitris

    2016-12-01

    To report a Bayesian network meta-analysis of randomized controlled trials (RCTs) comparing bare metal stents (BMS), paclitaxel-coated balloons (PCBs), and drug-eluting stents (DES) with balloon angioplasty (BA) or with each other in the infrapopliteal arteries. Sixteen RCTs comprising 1805 patients with 1-year median follow-up were analyzed. Bayesian random effects binomial models were employed (WinBUGS). Relative treatment effects were expressed as odds ratios (ORs) with 95% credible intervals (CrI), and the cumulative rank probabilities were calculated to provide hierarchies of competing treatments. Quality of evidence (QoE) was assessed with the GRADE (grading of recommendations assessment, development, and evaluation) system. Sensitivity, heterogeneity, and consistency analyses were performed. There was high QoE that infrapopliteal DES significantly reduced restenosis compared with BMS (OR 0.26, 95% CrI 0.12 to 0.51) and BA (OR 0.22, 95% CrI 0.11 to 0.45). Likewise, DES significantly reduced target lesion revascularization (TLR) compared with BA (OR 0.41, 95% CrI 0.22 to 0.75) and BMS (OR 0.26, 95% CrI 0.15 to 0.45). Paclitaxel-coated balloons also reduced TLR compared with BA (OR 0.55, 95% CrI 0.34 to 0.90) and BMS (OR 0.35, 95% CrI 0.18 to 0.67), but QoE was low to moderate. BA had lower TLR than BMS (OR 0.63, 95% CrI 0.40 to 0.99) with high QoE. DES was the only treatment that significantly reduced limb amputations compared with BA (OR 0.58, 95% CrI 0.35 to 0.96), PCB (OR 0.51, 95% CrI 0.26 to 0.98), or BMS (OR 0.38, 95% CrI 0.19 to 0.72) with moderate to high QoE. DES also significantly improved wound healing compared with BA (OR 2.02, 95% CrI 1.01 to 4.07) or BMS (OR 3.45, 95% CrI 1.41 to 8.73) with high QoE. Results were stable on sensitivity and meta-regression analyses without any significant publication bias or inconsistency. Infrapopliteal DES were associated with significantly lower rates of restenosis, TLR, and amputations and improved wound

  17. Angioplasty and Vascular Stenting

    Science.gov (United States)

    ... vessel. Covered stents or stent-grafts have additional advantages over bare stents and are becoming more commonly ... us improve RadiologyInfo.org by taking our brief survey: Survey Do you have a personal story about ...

  18. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents

    NARCIS (Netherlands)

    C.M. Spaulding (Christian); J. Daemen (Joost); H. Boersma (Eric); D.E. Cutlip (Donald); P.W.J.C. Serruys (Patrick)

    2007-01-01

    textabstractBACKGROUND: Although randomized studies have shown a beneficial effect of drug-eluting stents in reducing the risk of repeated revascularization, these trials were underpowered to compare rates of death and myocardial infarction. The long-term safety of drug-eluting stents has been

  19. Upper Gastrointestinal Stent

    OpenAIRE

    Kim, Sang Gyun; Yang, Chang-Hun

    2012-01-01

    Gastrointestinal (GI) stent has been developed for palliation of obstructive symptoms in various diseases causing obstruction of GI tract. Self-expanding metal stent (SEMS) has replaced old type of plastic stent, and endoscopic insertion of stent has replaced fluoroscopy-guided insertion. Nowadays, newly-designed SEMSs have been developed for prevention of complications such as stent migration and re-obstruction, and indications of stent recently have been widened into benign conditions as we...

  20. Randomised clinical trial: prucalopride, a colonic pro-motility agent, reduces the duration of post-operative ileus after elective gastrointestinal surgery.

    Science.gov (United States)

    Gong, J; Xie, Z; Zhang, T; Gu, L; Yao, W; Guo, Z; Li, Y; Lu, N; Zhu, W; Li, N; Li, J

    2016-04-01

    Previous studies have shown that recovery of colonic transit is a major determinant of post-operative ileus and clinical recovery after gastrointestinal surgery. Prucalopride is a highly selective 5-hydroxytryptamine receptor-4 agonist with colonic pro-motility effects. To evaluate the effect and safety of prucalopride on post-operative ileus and surgical outcomes after elective gastrointestinal surgery. In this phase II randomised clinical trial, 110 patients undergoing elective gastrointestinal surgery were randomised to either oral prucalopride (2 mg/day) (n = 55) or placebo (n = 55). Intervention was started 24 h after surgery and stopped after defecation or maximally at 7 days. The primary outcome was time to defecation. Secondary outcomes included time to first passage of flatus, tolerance of solid food, nasogastric tube reinsertion, post-operative length of stay, hospital readmission, overall cost, time to walk independently, surgical complications and inflammatory parameters. Patients who received prucalopride had a shorter time to defecation (65.0 vs. 94.5 h, P = 0.001), passage of flatus (53.0 vs. 73.0 h, P 5 days) (16.4% vs. 34.5%, P = 0.026) and the C-reactive protein level on post-operative day 5 (35.67 vs. 59.07 mg/L, P = 0.040) were lower in the prucalopride group. There was no significant difference in post-operative Clavien-Dindo grade III and IV complications (P = 0.606) between the groups. Prucalopride is a safe and effective treatment to reduce post-operative ileus and systemic inflammation without affecting post-operative complications in patients undergoing elective gastrointestinal surgery. ClinicalTrials.gov: NCT02004652. © 2016 John Wiley & Sons Ltd.

  1. Randomized controlled trial comparing ondansetron and placebo for the reduction of spinal anesthesia-induced hypotension during elective cesarean delivery in Egypt.

    Science.gov (United States)

    El Khouly, Nabih I; Meligy, Ashraf M

    2016-11-01

    To evaluate the effect of prophylactic ondansetron on spinal anesthesia-induced hypotension and bradycardia among patients undergoing elective cesarean deliveries. A prospective, double-blind, randomized, placebo-controlled trial enrolled patients aged 20-40years scheduled for elective cesarean delivery under spinal anesthesia between January 1, 2015 and January 31, 2016 at Menoufia University Hospital, Egypt. Patients were randomized to receive intravenous ondansetron 4mg in 10mL of saline or 10mL of saline. Participants and investigators were masked to group assignments. The primary outcomes were systolic and diastolic blood pressure, mean arterial pressure, and heart rate, measured at baseline, 10-minute intervals to 60minutes, and at 2hours. Per-protocol analyses were performed including patients who delivered under spinal anesthesia. The analyses included 50 patients in each group. Decreases in systolic blood pressure were reduced among patients receiving ondansetron at all time points (P0.05). Among patients who received ondansetron, mean arterial pressure was higher immediately and 30minutes after spinal anesthesia (Pcesarean deliveries under spinal anesthesia. Pan African Clinical Trials Registry: PACTR 201601001397193. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  2. Is there a link between nickel allergy and coronary stent restenosis?

    Science.gov (United States)

    Norgaz, Tugrul; Hobikoglu, Gultekin; Serdar, Zehra Asiran; Aksu, Huseyin; Alper, Ahmet Taha; Ozer, Orhan; Narin, Ahmet

    2005-07-01

    Although many patients with coronary artery disease are being treated by coronary stents, in-stent restenosis is the major limitation of percutaneous coronary stenting procedures. Most stents are made of stainless steel, and that, allergic reactions to nickel ions released from coronary stainless-steel stents may be one of the triggering mechanisms for in-stent restenosis. We aimed to evaluate the relationship between in-stent restenosis and nickel allergy in a prospective study. For this purpose, we applied epicutaneous patch test for nickel in 43 patients who had undergone elective intracoronary stent placement for stable angina pectoris in the day following stent placement and evaluated the presence of nickel allergy. Control angiography was performed at 6 months to determine in-stent restenosis. Three (6.9%) patients had allergic reaction to nickel and 16 (37%) patients had developed in-stent restenosis. One of the 3 patients with nickel allergy had diffuse in-stent restenosis and the others not. The present study therefore does not support the proposed relationship between nickel allergy and development of in-stent restenosis in patients having stainless steel stents. Large scale studies are needed to reach a final conclusion.

  3. Combination therapy of temporary tracheal stenting and radiofrequency ablation for multinodular thyroid goiter with airway compression

    International Nuclear Information System (INIS)

    Shin, Ji Hoon; Beak, Jung Hwan; Oh, Yeon Mok; Ha, Eun Ju; Lee, Jeong Hyun

    2013-01-01

    We report a case of multinodular thyroid goiter in an 80-year-old man who successfully underwent tracheal stent placement for respiratory distress caused by the thyroid goiter and following two radiofrequency (RF) ablation sessions performed for thyroid volume reduction. This sequential treatment allowed elective stent removals four weeks after the second RF ablation session because the thyroid volume had been progressively reduced. Combination therapy of temporary airway stenting and RF ablation for the treatment of thyroid goiter has two advantages, i.e., immediate reliefs of dyspnea with airway stenting and reductions of the thyroid volume with RF ablation, and thus, allowing symptom reliefs even after the stent removals.

  4. Combination therapy of temporary tracheal stenting and radiofrequency ablation for multinodular thyroid goiter with airway compression

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Ji Hoon; Beak, Jung Hwan; Oh, Yeon Mok; Ha, Eun Ju; Lee, Jeong Hyun [University of Ulsan College of Medicine, Asan Medical Center, Seoul (Korea, Republic of)

    2013-10-15

    We report a case of multinodular thyroid goiter in an 80-year-old man who successfully underwent tracheal stent placement for respiratory distress caused by the thyroid goiter and following two radiofrequency (RF) ablation sessions performed for thyroid volume reduction. This sequential treatment allowed elective stent removals four weeks after the second RF ablation session because the thyroid volume had been progressively reduced. Combination therapy of temporary airway stenting and RF ablation for the treatment of thyroid goiter has two advantages, i.e., immediate reliefs of dyspnea with airway stenting and reductions of the thyroid volume with RF ablation, and thus, allowing symptom reliefs even after the stent removals.

  5. Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial.

    Science.gov (United States)

    Voskanyan, Lilit; García-Feijoó, Julián; Belda, Jose I; Fea, Antonio; Jünemann, Anselm; Baudouin, Christophe

    2014-02-01

    Micro-invasive glaucoma surgical implantation of trabecular micro-bypass stents, previously shown to be safe and effective for open-angle glaucoma (OAG) subjects during cataract surgery, was considered for evaluation as a sole procedure. The aim of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy after ab interno implantation of two Glaukos Trabecular Micro-Bypass iStent inject second generation devices in subjects with OAG. This study was performed at sites in France, Germany, Italy, Republic of Armenia, and Spain. In this pan-European, multi-center prospective, post-market, unmasked study, 99 patients with OAG on at least two topical ocular hypotensive medications who required additional IOP lowering to control glaucoma disease underwent implantation of two GTS400 stents in a stand-alone procedure. Patients were qualified if they presented with preoperative mean IOP between 22 and 38 mmHg after medication washout. Postoperatively, subjects were assessed at Day 1, Months 1, 3, 6, 7, 9, and 12. IOP, medication use and safety were assessed at each visit. Sixty-six percent of subjects achieved IOP ≤18 mmHg at 12 months without medication, and 81% of subjects achieved Month 12 IOP ≤ 18 mmHg with either a single medication or no medication. Mean baseline washout IOP values decreased by 10.2 mmHg or 39.7% from 26.3 (SD 3.5) mmHg to 15.7 (SD 3.7) mmHg at Month 12. Mean IOP at 12 months was 14.7 (SD 3.1) mmHg in subjects not using ocular hypotensive medications. Reduction from preoperative medication burden was achieved in 86.9% of patients, including 15.2% with reduction of one medication and 71.7% with reduction of two or more medications. Postoperative complications occurred at a low rate and resolved without persistent effects. In this series, implantation of two trabecular micro-bypass second generation stents in subjects with OAG resulted in IOP and medication reduction and favorable safety outcomes.

  6. Symptomatic stent cast.

    LENUS (Irish Health Repository)

    Keohane, John

    2012-02-03

    Biliary stent occlusion is a major complication of endoscopic stent insertion and results in repeat procedures. Various theories as to the etiology have been proposed, the most frequently studied is the attachment of gram negative bacteria within the stent. Several studies have shown prolongation of stent patency with antibiotic prophylaxis. We report the case of stent occlusion from a cast of a previously inserted straight biliary stent; a "stent cast" in an 86-year-old woman with obstructive jaundice. This was retrieved with the lithotrypter and she made an uneventful recovery. This is the first reported case of a biliary stent cast.

  7. Clinical Events and Patient-Reported Chest Pain in All-Comers Treated With Resolute Integrity and Promus Element Stents: 2-Year Follow-Up of the DUTCH PEERS (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial (TWENTE II).

    Science.gov (United States)

    Sen, Hanim; Lam, Ming Kai; Löwik, Marije M; Danse, Peter W; Jessurun, Gillian A J; van Houwelingen, K Gert; Anthonio, Rutger L; Tjon Joe Gin, R Melvyn; Hautvast, Raymond W M; Louwerenburg, J Hans W; de Man, Frits H A F; Stoel, Martin G; van der Heijden, Liefke C; Linssen, Gerard C M; IJzerman, Maarten J; Tandjung, Kenneth; Doggen, Carine J M; von Birgelen, Clemens

    2015-06-01

    This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts). For both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce. The DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations. The 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel-related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03). During the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain

  8. Evaluation of the medtronic exponent self-expanding carotid stent system with the medtronic guardwire temporary occlusion and aspiration system in the treatment of carotid stenosis: combined from the MAVErIC (Medtronic AVE Self-expanding CaRotid Stent System with distal protection In the treatment of Carotid stenosis) I and MAVErIC II trials.

    Science.gov (United States)

    Higashida, Randall T; Popma, Jeffrey J; Apruzzese, Patricia; Zimetbaum, Peter

    2010-02-01

    Embolic protection devices and improved stent technology have advanced the endovascular treatment of carotid artery disease. A combined analysis was performed of the MAVErIC (Medtronic AVE Self-expanding CaRotid Stent System with distal protection) I and II trials to evaluate the safety and feasibility of this system among patients at high risk for surgical endarterectomy. Four hundred ninety-eight patients were enrolled in the MAVErIC I (99 patients) and MAVErIC II (399 patients) studies from June 2001 to October 2004. The results were pooled for statistical analysis of a common primary end point, the 365-day rate of major adverse events. Clinical follow-up took place at 30 days, 6 months, and 365 days postprocedure. The 365-day major adverse event rate, defined as death, stroke, or myocardial infarction within 30 days, and death, ipsilateral stroke, or myocardial infarction from days 31 to 365 was 12.5%. The incidence of neurological death through 365 days was 1.1%. The 30-day major adverse event rate was 5.4%. Subgroup analyses showed no notable differences in the 365-day major adverse event rate for symptomatic patients compared with asymptomatic patients. Treatment of carotid artery disease with carotid artery stenting with a self-expanding stent and distal embolic protection results in a low 30-day adverse event rate, including the occurrence of stroke in patients at high risk for carotid endarterectomy.

  9. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials.

    Science.gov (United States)

    Gao, Zhan; Zhang, Ruiyan; Xu, Bo; Yang, Yuejin; Ma, Changsheng; Li, Hui; Chen, Shaoliang; Han, Yaling; Yuan, Zuyi; Lansky, Alexandra J; Guan, Changdong; Leon, Martin B; Gao, Runlin

    2015-03-01

    We aimed to evaluate the safety and effectiveness of the novel abluminal groove-filled biodegradable polymer-coated sirolimus-eluting FIREHAWK stent (MicroPort Medical, Shanghai, China) in a large cohort of patients. Trials on the FIREHAWK stent allowing targeted sirolimus release were not individually powered to reliably estimate low-frequency safety endpoints such as stent thrombosis (ST) or to examine long-term safety and efficacy. Additionally, the China Food and Drug Administration requires an objective performance criterion (OPC) study for new drug-eluting stents. The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization at 12 months. Patient-level data from 1,007 patients with de novo native coronary lesions exclusively treated with the FIREHAWK stent in the TARGET serial studies (I and II) were prospectively collected, pooled and analyzed throughout a 2-year follow-up. The 12-month rate of TLF in 1,003 patients (follow-up rate, 99.6%) was 3.9% (upper 95% confidence interval (CI): 5.3%), which was significantly lower than the performance goal of 9.0% (P < 0.0001). The 24-month rates of TLF, PoCE (a composite of all-cause death, all MI, or any revascularization), and ARC definite or probable ST were 4.6%, 7.8% and 0.1%, respectively. In subgroup analysis, long lesion (≥ 30 mm) was an independent predictor of TLF within 2 years (hazard ratio [95%CI]: 2.44 [1.32, 4.53], P < 0.01). This pooled, patient-level analysis indicates that the FIREHAWK stent exhibits a promising 2-year efficacy and safety profile. © 2015 Wiley Periodicals, Inc.

  10. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes.

    Science.gov (United States)

    Verheye, Stefan; Vrolix, Mathias; Kumsars, Indulis; Erglis, Andrejs; Sondore, Dace; Agostoni, Pierfrancesco; Cornelis, Kristoff; Janssens, Luc; Maeng, Michael; Slagboom, Ton; Amoroso, Giovanni; Jensen, Lisette Okkels; Granada, Juan F; Stella, Pieter

    2017-10-23

    The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR. In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. Meta-Analysis of Randomized Control Trials Comparing Drug-Eluting Stents Versus Coronary Artery Bypass Grafting for Significant Left Main Coronary Narrowing.

    Science.gov (United States)

    Qian, Cheng; Feng, Hong; Cao, Jianlei; Wei, Baozhu; Wang, Yanggan

    2017-05-01

    Previous meta-analyses showed that drug-eluting stent (DES) implantation may serve as an alternative to coronary artery bypass grafting (CABG) for unprotected left main coronary artery (ULMCA) stenosis, largely driven by data from registries. Hence, we performed a meta-analysis of randomized controlled trials (RCTs) to overcome this limitation. PubMed, the Cochrane Library, and Scopus were systematically searched through October 2016 to identify eligible RCTs. The primary outcomes were major adverse cardiac and cerebrovascular events (MACCE) at 1-year and long-term (≥3 years) follow-ups. This meta-analysis included 5 RCTs, totaling 4,595 patients with ULMCA disease. Compared with CABG, DES showed similar 1-year rates of MACCE (risk ratio [RR] 1.14, 95% confidence interval [CI] 0.91-1.42), all-cause death, and myocardial infarction, with a higher incidence of revascularization (RR 1.68, 95% CI 1.24-2.27) and lower incidence of stoke (RR 0.43, 95% CI 0.23-0.78). At long-term follow-up, DES placement was inferior to CABG in terms of MACCE (RR 1.27, 95% CI 1.13-1.43) and revascularization (RR 1.70, 95% CI 1.43-2.01). There was no difference in long-term risk of other outcomes between these 2 strategies. In conclusion, DES stenting and CABG for ULMCA disease yield comparable rates of MACCE at 1-year follow-up; however, CABG is associated with a decreased risk of long-term MACCE compared with DES, exclusively driven by the considerable reduction in revascularization events. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Does intravascular ultrasound provide clinical benefits for percutaneous coronary intervention with bare-metal stent implantation? A meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Lodi-Junqueira Lucas

    2012-09-01

    Full Text Available Abstract Background The role of intravascular ultrasound (IVUS in percutaneous coronary interventions (PCI is still controversial despite several previously published meta-analyses. A meta-analysis to evaluate the controversial role of IVUS-guided PCI with bare-metal stenting was performed and a previous published meta-analysis was re-evaluated in order to clarify the discrepancy between results of these studies. Methods A systematic review was performed by an electronic search of the PubMed, Embase and Web of Knowledge databases and by a manual search of reference lists for randomized controlled trials published until April 2011, with clinical outcomes and, at least, six months of clinical follow-up. A meta-analysis based on the intention to treat was performed with the selected studies. Results Five studies and 1,754 patients were included. There were no differences in death (OR = 1.86; 95% CI = 0.88-3.95; p = 0.10, non-fatal myocardial infarction (OR = 0.65; 95% CI = 0.27-1.58; p = 0.35 and major adverse cardiac events (OR = 0.74; 95% CI = 0.49-1.13; p = 0.16. An analysis of the previous published meta-analysis strongly suggested the presence of publication bias. Conclusions There is no evidence to recommend routine IVUS-guided PCI with bare-metal stent implantation. This may be explained by the paucity and heterogeneity of the studies published so far.

  13. Comparison of drug-eluting balloon versus drug-eluting stent for treatment of coronary artery disease: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Liu, Lulu; Liu, Bin; Ren, Jiajun; Hui, Gang; Qi, Chao; Wang, Junnan

    2018-03-02

    Drug-eluting balloons (DEB) have significant value for treating coronary artery disease (CAD). However, the merits of using DEB versus drug-eluting stents (DES) to treat CAD remain controversial. Herein, we conducted a meta-analysis to compare the safety and efficacy of DEB and DES for treatment of CAD. We searched MEDLINE, EMBASE, and CENTRAL databases for eligible trials comparing DEB with DES for treatment of CAD. The primary endpoint was major adverse cardiac events (MACE); the secondary endpoints included in-lesion late lumen loss (LLL), binary restenosis (BR), myocardial infarction (MI), target lesion revascularization (TLR) and mortality. Twenty-three trials with a total of 2712 patients were included. There were no significant differences in the primary endpoint of MACE between the DEB and DES groups (Risk Ratio (RR) 1.19; 95% confidence interval (CI) (0.87, 1.63); P = 0.27), or in the clinical outcomes of each of MACE's components, including TLR, MI and mortality. However, efficacy was significantly different between the DEB and DES groups, especially when we compared DEB to second-generation DES: in-lesion LLL (Mean Difference (MD) 0.11; (0.01, 0.22); P = 0.03); binary restenosis (RR 1.46; (1.00, 2.13); P = 0.05). DEB is equivalent to DES in terms of safety for managing CAD, and DEB may be considered as an alternative choice for treatment of CAD.

  14. Coronary surgery is superior to drug eluting stents in multivessel disease. Systematic review and meta-analysis of contemporary randomized controlled trials.

    Science.gov (United States)

    Benedetto, Umberto; Gaudino, Mario; Ng, Colin; Biondi-Zoccai, Giuseppe; D'Ascenzo, Fabrizio; Frati, Giacomo; Girardi, Leonard N; Angelini, Gianni D; Taggart, David P

    2016-05-01

    Current randomized controlled trials (RCTs) comparing percutaneous coronary intervention with drug eluting stent (DES-PCI) with coronary artery bypass grafting (CABG) in multivessel disease are underpowered to detect a difference in hard clinical end-points such as mortality, myocardial infarction and stroke. We aimed to overcome this limitation by conducting a meta-analysis of contemporary RCTs. A systematic literature search was conducted for all RCTs comparing DES-PCI versus CABG in multivessel disease published through May 2015. Inverse variance weighting was used to pool data from individual studies (DES-PCI and >1 CABG favouring surgery). A total of five randomized trials including 4563 subjects were analysed. After an average follow-up of 3.4 years, DES-PCI was associated with a significantly increased risk of overall mortality (HR 1.51; 95%CI 1.23-1.84; PDES-PCI. In patients with multivessel coronary disease, CABG was found to be superior to DES-PCI by reducing the risk of mortality and subsequent myocardial infarction at the expense of a marginally increased risk of stroke. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  15. Vaginal misoprostol prior to intrauterine device insertion in women delivered only by elective cesarean section: a randomized double-blind clinical trial.

    Science.gov (United States)

    Abdellah, Mohamed S; Abbas, Ahmed M; Hegazy, Aml M; El-Nashar, Ihab M

    2017-06-01

    The current study aims to evaluate if vaginal misoprostol (400 mcg) administered prior to intrauterine device (IUD) insertion increases the ease and success of insertion among women who had delivered only by elective cesarean delivery (CD). The current study was a randomized, double-blind, placebo-controlled trial conducted in Assiut Women's Health Hospital, Egypt, between the 1st of April 2015 and the 31st of March 2016 and included women who delivered only by elective CD. One hundred forty women were randomized into two groups; misoprostol group received two misoprostol 400-mcg tablets vaginally, and placebo group received two placebo tablets 3 h before a copper T380A IUD insertion. The primary outcome measure was the difference in the ease of insertion score using a 10-cm visual analog scale between both groups with 0=very easy insertion, and 10=terribly difficult insertion. The ease of insertion score was lower in the misoprostol group (2.2±0.5 vs. 4.2±0.5, p=.0001) with higher number of successful IUD insertions than the placebo group (69 [98.6%] vs. 61 [87.1%], p=.009). The mean pain score reported by the women was lower in misoprostol group (2.7±0.6 vs. 4.3±0.8) with higher level of satisfaction from the whole procedure (8.9±0.4 vs. 7.9±0.2) with p=.001 for both. Misoprostol 400 mcg vaginally prior to IUD insertion eases and increase the success of insertion with reduction of pain among women who had delivered only by elective CD. The use of vaginal misoprostol before IUD insertion in women who had never delivered vaginally before may increase the ease and success of insertion. Moreover, it may reduce the pain felt by women during the procedure. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. 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

    BACKGROUND: Approximately 3.7 million people died from acute coronary syndrome worldwide in 2012. Acute coronary syndrome, also known as myocardial infarction or unstable angina pectoris, is caused by a sudden blockage of the blood supplied to the heart muscle. Percutaneous coronary intervention...... CRITERIA: Randomised clinical trials assessing the effects of drug-eluting stents versus bare-metal stents for acute coronary syndrome. We included trials irrespective of publication type, status, date, or language. DATA COLLECTION AND ANALYSIS: We followed our published protocol and the methodological......-eluting stents group compared with 6.63% in the bare-metal stents group based on the RR of 0.96 (95% CI 0.83 to 1.11, 10,939 participants, 19 trials/20 comparisons, very low-quality evidence). The results of Trial Sequential Analysis showed that we did not have sufficient information to confirm or reject our...

  17. Election Fever

    Science.gov (United States)

    Strom, Erich

    2012-01-01

    Kids learn by doing, which, experts agree, is the only real way to teach citizenship. This article presents election-year activities that stress action. These activities will show students what it means to be a good citizen. (Contains 6 online resources.)

  18. Comparison of Prophylactic Infusion of Phenylephrine with Ephedrine for Prevention of Hypotension in Elective Cesarean Section under Spinal Anesthesi: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Farnaz Moslemi

    2015-01-01

    Full Text Available Background: Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. The aim of this study is to compare the effect of prophylactic infusion of Phenylephrine versus Ephedrine in the prevention of hypotension during spinal anesthesia in elective cesarean section. Methods: Eighty-three patients were enrolled in this study and randomly divided into three groups. Group Ph received phenylephrine infusion, group E received ephedrine infusion while group P were delivered placebo. Vital signs (blood pressure, heart rate, and arterial oxygen saturation were recorded throughout the surgery. Maternal and neonatal perioperative complications were also controlled and recorded. Results: There was an insignificant difference in demographic data between the groups. Systolic and diastolic blood pressures were higher in the phenylephrine group than control, but not higher than the ephedrine group. Maternal dysrhythmias were more common in ephedrine and phenylephrine groups than the control group. Vomiting was more common in ephedrine group (P<0.05. In addition, the fifth-minute Apgar score of neonates was higher in phenylephrine and ephedrine groups than the control group (P<0.05. Neonates of phenylephrine group had less acidosis than the other groups. Conclusion: Prophylactic infusion of phenylephrine can effectively decrease spinal anesthesia related hypotension without any significant complication for mother or her fetus. Trial Registration Number: IRCT2012120911700N1

  19. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention.

    Science.gov (United States)

    Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

    2016-06-22

    Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. ChiCTR-IOR-15006971. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  20. Remote ischemic preconditioning reduces perioperative cardiac and renal events in patients undergoing elective coronary intervention: a meta-analysis of 11 randomized trials.

    Directory of Open Access Journals (Sweden)

    Hanjun Pei

    Full Text Available BACKGROUND: Results from randomized controlled trials (RCT concerning cardiac and renal effect of remote ischemic preconditioning(RIPC in patients with stable coronary artery disease(CAD are inconsistent. The aim of this study was to explore whether RIPC reduce cardiac and renal events after elective percutaneous coronary intervention (PCI. METHODS AND RESULTS: RCTs with data on cardiac or renal effect of RIPC in PCI were searched from Pubmed, EMBase, and Cochrane library (up to July 2014. Meta-regression and subgroup analysis were performed to identify the potential sources of significant heterogeneity(I(2 ≥ 40%. Eleven RCTs enrolling a total of 1713 study subjects with stable CAD were selected. Compared with controls, RIPC significantly reduced perioperative incidence of myocardial infarction (MI [odds ratio(OR = 0.68; 95% CI, 0.51 to 0.91; P = 0.01; I(2 = 41.0%] and contrast-induced acute kidney injury(AKI (OR = 0.61; 95% CI, 0.38 to 0.98; P = 0.04; I(2 = 39.0%. Meta-regression and subgroup analyses confirmed that the major source of heterogeneity for the incidence of MI was male proportion (coefficient  = -0.049; P = 0.047; adjusted R(2 = 0.988; P = 0.02 for subgroup difference. CONCLUSIONS: The present meta-analysis of RCTs suggests that RIPC may offer cardiorenal protection by reducing the incidence of MI and AKI in patients undergoing elective PCI. Moreover, this effect on MI is more pronounced in male subjects. Future high-quality, large-scale clinical trials should focus on the long-term clinical effect of RIPC.

  1. The effect of elective sham dose escalation on the placebo response during an antimuscarinic trial for overactive bladder symptoms

    NARCIS (Netherlands)

    Staskin, David R.; Michel, Martin C.; Sun, Franklin; Guan, Zhonghong; Morrow, Jon D.

    2012-01-01

    We analyzed the effects of baseline symptom severity and placebo response magnitude on the decision to dose escalate in a 12-week, randomized, double-blind, flexible dose antimuscarinic trial of subjects with overactive bladder symptoms. Data from the placebo arm of the trial were used for this post

  2. Electronic Elections

    DEFF Research Database (Denmark)

    Schürmann, Carsten

    2009-01-01

    Electronic voting technology is a two edged sword. It comes with many risks but brings also many benefits. Instead of flat out rejecting the technology as uncontrollably dangerous, we advocate in this paper a different technological angle that renders electronic elections trustworthy beyond...... the usual levels of doubt. We exploit the trust that voters currently have into the democratic process and model our techniques around that observation accordingly. In particular, we propose a technique of trace emitting computations to record the individual steps of an electronic voting machine...... for a posteriori validation on an acceptably small trusted computing base. Our technology enables us to prove that an electronic elections preserves the voter’s intent, assuming that the voting machine and the trace verifier are independent....

  3. The prognostic utility of the SYNTAX score on 1-year outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial

    DEFF Research Database (Denmark)

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

    2011-01-01

    This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents.......This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents....

  4. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials.

    NARCIS (Netherlands)

    Luca, G. De; Dirksen, M.T.; Spaulding, C.; Kelbaek, H.; Schalij, M.; Thuesen, L.; Hoeven, B. van der; Vink, M.A.; Kaiser, C.; Musto, C.; Chechi, T.; Spaziani, G.; Diaz de la Llera, L.S.; Pasceri, V.; Lorenzo, E. Di; Violini, R.; Cortese, G.; Suryapranata, H.; Stone, G.W.

    2012-01-01

    BACKGROUND: Concerns have emerged regarding a higher risk of stent thrombosis after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Our objective was to perform a meta-analysis using individual patient data to evaluate the

  5. Comparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Junker, Anders

    2012-01-01

    (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point...

  6. Impact of the New American Heart Association/American Stroke Association Definition of Stroke on the Results of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial.

    Science.gov (United States)

    Al Kasab, Sami; Lynn, Michael J; Turan, Tanya N; Derdeyn, Colin P; Fiorella, David; Lane, Bethany F; Janis, L Scott; Chimowitz, Marc I

    2017-01-01

    An American Heart Association/American Stroke Association (AHA/ASA) writing committee has recently recommended that tissue evidence of cerebral infarction associated with temporary symptoms (CITS) lasting Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial. We compared outcomes in the medical (n = 227) and stenting (n = 224) groups in SAMMPRIS using the following primary end point (new components in bold): any stroke, CITS, or death within 30 days after enrollment or within 30 days after a revascularization procedure for the qualifying lesion during follow-up; or ischemic stroke or CITS in the territory of the qualifying artery beyond 30 days. We also compared the use of brain magnetic resonance imaging (MRI) after transient ischemic attacks (TIAs) in both treatment groups. By considering CITS as equivalent to stroke, the number of primary end points increased from 34 to 43 in the medical group and from 52 to 66 in the stenting group of SAMMPRIS. The Kaplan-Meier curves for the primary end points in the 2 groups were significantly different (P = .009). The percentage of patients with reported TIAs who underwent brain MRI was 69% in the medical group and 61% in the stenting group (P = .40). Using the AHA/ASA definition of stroke resulted in a substantially higher primary end point rate in both treatment groups and an even higher benefit from medical therapy over stenting than originally shown in SAMMPRIS. The higher rate of CITS in the stenting group was not due to ascertainment bias. Published by Elsevier Inc.

  7. [Drug-eluting stent thrombosis and its pharmacological prevention].

    Science.gov (United States)

    Pershukov, I V; Batyraliev, T A

    2007-01-01

    The problem of drug eluting stents (DES) safety has been actively discussed throughout 2006 because of increase of frequency of development of late stent thromboses which were noted during almost 2 years after stenting. In December 2006 US Food and Drug Administration (FDA) advisory panel acknowledged increase of development of late stent thrombosis. At the same time FDA accepted new definition of stent-thrombosis suggested by the Academic Research Consortium. According to this definition thrombosis can be definite, probable and possible. Any unexplained death before end of follow-up in a trial should be considered thrombosis related. Recalculation of thrombosis rate using this definition caused pronounced increase of this parameter in previously conducted trials. Thrombosis rate rose from 0,6 to 3,3% for bare metal stents, from 0,8 to 3,6% for sirolimus eluting stents and from 1,3 to 3,5% for paclitaxel eluting stents. Professional cardiological and angiographical societies (ACC, AHA, SCAI) responding to FDA advisory panel published their proofs and vision of the problem of stent thrombosis. In February 2007 ACC, AHA, SCAI, American College of Surgeons and Association of Dentists published scientific bulletin in which described preventive measures aimed at lowering of risk of thrombosis development. This document contains strict recommendation to continue double antithrombotic therapy with aspirin and clopidogrel for 12 months after implantation of DES or abandonment of the use of this type of stents when long term double antithrombotic therapy is not possible.

  8. Randomized Controlled Trial for Evaluation of the Routine Use of Nasogastric Tube Decompression After Elective Liver Surgery.

    Science.gov (United States)

    Ichida, Hirofumi; Imamura, Hiroshi; Yoshimoto, Jiro; Sugo, Hiroyuki; Ishizaki, Yoichi; Kawasaki, Seiji

    2016-07-01

    The value of routine nasogastric tube (NGT) decompression after elective hepatetctomy is not yet established. Previous studies in the setting of non-liver abdominal surgery suggested that the use of NGT decreased the incidence of nausea or vomiting, while increasing the frequency of pulmonary complications. Out of a total of 284 consecutive patients undergoing hepatectomy, 210 patients were included in this study. The patients were randomized to a group that received NGT decompression (NGT group; n = 108), in which a NGT was left in place after surgery until the patient passed flatus or stool, or a group that did not receive NGT decompression (no-NGT group; n = 102), in which the NGT was removed at the end of surgery. There were no differences between the NGT group and no-NGT group in terms of the overall morbidity (34.3 vs 35.3 %; P = 0.99), incidence of pulmonary complications (18.5 vs 19.5 %; P = 0.84), frequency of postoperative vomiting (6.5 vs 7.8 %; P = 0.70), time to start of oral intake (median (range) 3 (2-6) vs 3 (2-6) days; P = 0.69), or postoperative duration of hospital stay (19 (7-74) vs 18 (9-186) days; P = 0.37). In the no-NGT group, three patients required reinsertion of the tube 0 (0-3) days after surgery. In the NGT group, severe discomfort was recorded in five patients. Routine NGT decompression after elective hepatectomy does not appear to have any advantages.

  9. Intravascular ultrasound-guided drug-eluting stent implantation: An updated meta-analysis of randomized control trials and observational studies.

    Science.gov (United States)

    Steinvil, Arie; Zhang, Yao-Jun; Lee, Sang Yeub; Pang, Si; Waksman, Ron; Chen, Shao-Liang; Garcia-Garcia, Hector M

    2016-08-01

    The use of intravascular ultrasound (IVUS) guidance for drug-eluting stent (DES) optimization is limited by the number of adequately powered randomized control trials (RCTs). We performed an updated meta-analysis, including data from recently published RCTs and observational studies, by reviewing the literature in Medline and the Cochrane Library to identify studies that compared clinical outcomes between IVUS-guided and angiography-guided DES implantation from January 1995 to January 2016. This meta-analysis included 25 eligible studies, including 31,283 patients, of whom 3192 patients were enrolled in 7 RCTs. In an analysis of all 25 studies, the summary results for all the events analyzed were significantly in favor of IVUS-guided DES implantation [major adverse cardiac events (MACE, odds ratio [OR] 0.76, 95% confidence intervals [CI]: 0.70-0.82, PDES implantation was found only for MACE (OR 0.66, 95% CI: 0.52-0.84, P=0.001), TLR (OR 0.61, 95% CI: 0.43-0.87, P=0.006), and TVR (OR 0.61, 95% CI: 0.41-0.90, P=0.013). IVUS-guided percutaneous coronary intervention was associated with better overall clinical outcomes than angiography-guided DES implantation. However, in a solely RCT meta-analysis, this benefit was mainly driven by reduced rates of revascularizations. Copyright © 2016. Published by Elsevier Ireland Ltd.

  10. 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.

  11. Relation of Nickel Allergy with in-Stent Restenosis in Patients Treated with Cobalt Chromium Stents.

    Science.gov (United States)

    Aliağaoğlu, Cihangir; Turan, Hakan; Erden, Ismail; Albayrak, Hülya; Ozhan, Hakan; Başar, Cengiz; Gürlevik, Zehra; Alçelik, Ayşegül

    2012-11-01

    In-stent restenosis (ISR) is the major limitation of percutaneous coronary stenting procedure. The elements like nickel, chromate and molybdenum are known to cause contact allergy. Hypersensitivity reaction, against these metal ions, may be one of the reasons of ISR. Cobalt chromium coronary stents, which are increasingly being used in percutaneous coronary interventions, have more nickel amount than the stainless steel stents. We aimed to investigate the association between nickel hypersensitivity reaction and ISR in patients treated with cobalt chromium coronary stents. Epicutaneous patch tests for nickel were applied to 31 patients who had undergone elective cobalt chromium coronary stent implantation and had ISR in control angiogram. Thirty patients, without ISR, were included as the control group. Patch test results and other clinical variables were compared. There was no statistically significant difference of the mean age, sex, body mass index, rate of hypercholesterolemia, diabetes, hypertension and smoking between the patients with and without ISR. All other lesion characteristics were similar in the 2 groups. According to the patch test results, 7 patients had nickel contact allergy. All of these patients were in the ISR group, which was statistically significant (pnickel allergy than the control group. Nickel allergy may play role in restenosis pathophysiology.

  12. Cost‐Effectiveness of Supervised Exercise, Stenting, and Optimal Medical Care for Claudication: Results From the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) Trial

    Science.gov (United States)

    Reynolds, Matthew R.; Apruzzese, Patricia; Galper, Benjamin Z.; Murphy, Timothy P.; Hirsch, Alan T.; Cutlip, Donald E.; Mohler, Emile R.; Regensteiner, Judith G.; Cohen, David J.

    2014-01-01

    Background Both supervised exercise (SE) and stenting (ST) improve functional status, symptoms, and quality of life compared with optimal medical care (OMC) in patients with claudication. The relative cost‐effectiveness of these strategies is not well defined. Methods and Results The Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study randomized patients with claudication due to aortoiliac stenosis to a 6‐month SE program, to ST, or to OMC. Participants who completed 6‐month follow‐up (n=98) were included in a health economic analysis through 18 months. Costs were assessed using resource‐based methods and hospital billing data. Quality‐adjusted life‐years were estimated using the EQ‐5D. Markov modeling based on the in‐trial results was used to explore the impact of assumptions about the longer term durability of observed differences in quality of life. Through 18 months, mean healthcare costs were $5178, $9804, and $14 590 per patient for OMC, SE, and ST, respectively. Measured quality‐adjusted life‐years through 18 months were 1.04, 1.16, and 1.20. In our base case analysis, which assumed that observed differences in quality of life would dissipate after 5 years, the incremental cost‐effectiveness ratios were $24 070 per quality‐adjusted life‐year gained for SE versus OMC, $41 376 for ST versus OMC, and $122 600 for ST versus SE. If the treatment effect of ST was assumed to be more durable than that of SE, the incremental cost‐effectiveness ratio for ST versus SE became more favorable. Conclusions Both SE and ST are economically attractive by US standards relative to OMC for the treatment of claudication in patients with aortoiliac disease. ST is more expensive than SE, with uncertain incremental benefit. Clinical Trial Registration URL: www.clinicaltrials.gov, Unique identifier: NCT00132743. PMID:25389284

  13. Do pregnant women prefer timing of elective cesarean section prior to versus after 39 weeks of gestation? Secondary analyses from a randomized controlled trial.

    Science.gov (United States)

    Glavind, J; Henriksen, T B; Kindberg, S F; Uldbjerg, N

    2014-11-01

    To evaluate women's preferences for timing of elective cesarean section (ECS) scheduled prior to versus after 39 completed weeks. Secondary analyses from a randomized controlled open-label trial were conducted at seven Danish tertiary hospitals from March 2009 to June 2011 with inclusion of singleton pregnant women with a healthy fetus. The women were allocated by a computerized telephone system to ECS scheduled at 38(+3) weeks or 39(+3) weeks of gestation. Dissatisfaction with timing of ECS and preferred timing of the procedure in a proposed future ECS delivery were evaluated. Data analyses were done by intention-to-treat, using logistic regression. A total of 1196 women (94%) completed an online questionnaire at follow-up eight weeks postpartum. In the 38 weeks group, 61 (10%) women 601 were dissatisfied with the timing of their ECS, whereas in the 39 weeks group 157 (26%) of 595 were dissatisfied (adjOR 3.18, 95% CI 2.30; 4.40). The proportion of women who preferred the same timing in a future ECS were 272 (45%) in the 38 weeks group compared to 232 (39%) in the 39(+3) weeks group (adjOR 0.75, 95% CI 0.60; 0.95). The women in this trial preferred ECS scheduled prior to 39 weeks of gestation.

  14. The Sigma-trial protocol: a prospective double-blind multi-centre comparison of laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis

    Directory of Open Access Journals (Sweden)

    Lacy Antonio M

    2007-08-01

    Full Text Available Abstract Backround Diverticulosis is a common disease in the western society with an incidence of 33–66%. 10–25% of these patients will develop diverticulitis. In order to prevent a high-risk acute operation it is advised to perform elective sigmoid resection after two episodes of diverticulitis in the elderly patient or after one episode in the younger ( Method Indication for elective resection is one episode of diverticulitis in patients 50 years or in case of progressive abdominal complaints due to strictures caused by a previous episode of diverticulits. The diagnosis is confirmed by CT-scan, barium enema and/or coloscopy. It is required that the participating surgeons have performed at least 15 laparoscopic and open sigmoid resections. Open resection is performed by median laparotomy, laparoscopic resection is approached by 4 or 5 cannula. Sigmoid and colon which contain serosal changes or induration are removed and a tension free anastomosis is created. After completion of either surgical procedure an opaque dressing will be used, covering from 10 cm above the umbilicus to the pubic bone. Surgery details will be kept separate from the patient's notes. Primary endpoints are the postoperative morbidity and mortality. We divided morbidity in minor (e.g. wound infection, major (e.g. anastomotic leakage and late (e.g. incisional hernias complications, data will be collected during hospital stay and after six weeks and six months postoperative. Secondary endpoints are the operative and the postoperative recovery data. Operative data include duration of the operation, blood loss and conversion to laparotomy. Post operative recovery consists of return to normal diet, pain, analgesics, general health (SF-36 questionnaire and duration of hospital stay. Discussion The Sigma-trial is a prospective, multi-center, double-blind, randomized study to define the role of laparoscopic sigmoid resection in patients with symptomatic diverticulitis.

  15. Predictors of perioperative major bleeding in patients who interrupt warfarin for an elective surgery or procedure: Analysis of the BRIDGE trial.

    Science.gov (United States)

    Clark, Nathan P; Douketis, James D; Hasselblad, Vic; Schulman, Sam; Kindzelski, Andrei L; Ortel, Thomas L

    2018-01-01

    The use of low-molecular weight heparin bridge therapy during warfarin interruption for elective surgery/procedures increases bleeding. Other predictors of bleeding in this setting are not well described. BRIDGE was a randomized, double-blind, placebo-controlled trial of bridge therapy with dalteparin 100 IU/kg twice daily in patients with atrial fibrillation requiring warfarin interruption. Bleeding outcomes were documented from the time of warfarin interruption until up to 37 days postprocedure. Multiple logistic regression and time-dependent hazard models were used to identify major bleeding predictors. We analyzed 1,813 patients of whom 895 received bridging and 918 received placebo. Median patient age was 72.6 years, and 73.3% were male. Forty-one major bleeding events occurred at a median time of 7.0 days (interquartile range, 4.0-18.0 days) postprocedure. Bridge therapy was a baseline predictor of major bleeding (odds ratio [OR]=2.4, 95% CI: 1.2-4.8), as were a history of renal disease (OR=2.9, 95% CI: 1.4-6.0), and high-bleeding risk procedures (vs low-bleeding risk procedures) (OR=2.9, 95% CI: 1.4-5.9). Perioperative aspirin use (OR=3.6, 95% CI: 1.1-11.9) and postprocedure international normalized ratio >3.0 (OR=2.1, 95% CI: 1.5-3.1) were time-dependent predictors of major bleeding. Major bleeding was most common in the first 10 days compared with 11-37 days postprocedure (OR=3.5, 95% CI: 1.8-6.9). In addition to bridge therapy, perioperative aspirin use, postprocedure international normalized ratio >3.0, a history of renal failure, and having a high-bleeding risk procedure increase the risk of major bleeding around the time of an elective surgery/procedure requiring warfarin interruption. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Multiple-injection thoracic paravertebral block as an alternative to general anaesthesia for elective breast surgeries: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sabyasachi Das

    2012-01-01

    Full Text Available Background: General anaesthesia is currently the conventional technique used for surgical treatment of breast lump. Paravertebral block (PVB has been used for unilateral procedures such as thoracotomy, breast surgery, chest wall trauma, hernia repair or renal surgery. Methods: We compared unilateral thoracic PVB with general anaesthesia (GA in 60 consenting ASA physical status I and II female patients of 18-65 years age, scheduled for unilateral breast surgery. Patients were randomly assigned into two groups, P (n=30 or G (n=30, to receive either PVB or GA, respectively. Results: The average time to first post-operative analgesic requirement at visual analogue scale score≥4 (primary endpoint was significantly longer in group P (303.97±76.08 min than in group G (131.33±21.36 min, P<0.001. Total rescue analgesic (Inj. Tramadol requirements in the first 24 h were 105.17±20.46 mg in group P as compared with 176.67±52.08 mg in group G (P<0.001. Significant post-operative nausea and vomiting requiring treatment occurred in three (10.34% patients of the PVB group and eight (26.67% patients in the GA group. Conclusion: The present study concludes that unilateral PVB is more efficacious in terms of prolonging post-operative analgesia and reducing morbidities in patients undergoing elective unilateral breast surgery.

  17. Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2009-01-01

    BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  18. Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

    BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  19. Study Protocol. ECSSIT – Elective Caesarean Section Syntocinon® Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon® 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section

    Directory of Open Access Journals (Sweden)

    Montgomery Alan A

    2009-08-01

    Full Text Available Abstract Background Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4–10 minutes therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. Methods and design A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml. A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. Discussion It is both important and timely that we evaluate the optimal approach to the management

  20. Study Protocol. ECSSIT – Elective Caesarean Section Syntocinon® Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon®) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section

    Science.gov (United States)

    Murphy, Deirdre J; Carey, Michael; Montgomery, Alan A; Sheehan, Sharon R

    2009-01-01

    Background Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4–10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. Methods and design A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. Discussion It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  1. 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...

  2. Late clinical outcomes after implantation of drug-eluting stents coated with biodegradable polymers: 3-year follow-up of the PAINT randomised trial.

    Science.gov (United States)

    Lemos, Pedro A; Moulin, Bruno; Perin, Marco A; Oliveira, Ludmilla A R R; Arruda, J Airton; Lima, Valter C; Lima, Antonio A G; Caramori, Paulo R A; Medeiros, Cesar R; Barbosa, Mauricio R; Brito, Fabio S; Ribeiro, Expedito E

    2012-05-15

    The long-term clinical performance of drug-eluting stents (DES) coated with biodegradable polymers is poorly known. A total of 274 coronary patients were randomly allocated to paclitaxel-eluting stents, sirolimus-eluting stents, or bare metal stents (2:2:1 ratio). The two DES used the same biodegradable polymers and were identical except for the drug. At three years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9.0% vs. 7.1; p=0.6), but lower risk of repeat interventions (10.0% vs. 29.9%; pbiodegradable-polymer coated DES releasing either paclitaxel or sirolimus were effective in reducing the 3-year rate of re-interventions.

  3. Safety of an abbreviated duration of dual antiplatelet therapy (≤6 months) following second-generation drug-eluting stents for coronary artery disease: A systematic review and meta-analysis of randomized trials.

    Science.gov (United States)

    Ziada, Khaled M; Abdel-Latif, Ahmed K; Charnigo, Richard; Moliterno, David J

    2016-03-01

    Dual antiplatelet therapy (DAPT) is recommended for ≥12 months following coronary drug-eluting stents (DES) to reduce risk of major adverse ischemic events. Randomized trials suggest an abbreviated DAPT duration (≤6 months) is adequately protective. However, these trials are individually underpowered to detect differences in rare but serious events such as stent thrombosis (ST). We performed a meta-analysis of published randomized trials to define the impact of abbreviated DAPT (≤6 months) on death, myocardial infarction (MI), stent thrombosis (ST), and bleeding complications compared to standard-duration DAPT (≥12 months). Seven randomized controlled trials comparing abbreviated vs. standard DAPT regimens following DES use were identified by two independent investigators. Study characteristics were reviewed and clinical endpoint data were abstracted and analyzed in aggregate using fixed and random-effects models. The seven trials included 15,874 randomized patients. Second-generation DES were used in most patients. Compared to standard-duration DAPT, abbreviated DAPT was not associated with an increase in mortality (OR 0.93; CI: 0.73 to 1.17; P = 0.52), MI (OR 1.14; CI: 0.89 to 1.45; P = 0.30) or ST (OR 1.25; CI: 0.81 to 1.93; P = 0.31). Abbreviated DAPT was associated with significantly fewer major bleeding complications (OR 0.52; CI: 0.34 to 0.82; P = 0.005). The results were consistent between fixed and random-effects models, with no heterogeneity. Sensitivity analyses adjusting for inclusion of bare metal stents, 1st generation DES and/or abbreviated DAPT regimens of 3 months resulted in similar conclusions. In a meta-analysis of >15,000 patients primarily treated with second-generation DES, abbreviated-duration DAPT (≤6 months) was associated with a significant reduction in major bleeding complications with no evidence of a significant increase in risk of death, MI or ST. Accordingly, abbreviated DAPT should be strongly considered

  4. Safety of an Abbreviated Duration of Dual Antiplatelet Therapy (≤ Six Months) Following Second-Generation Drug-Eluting Stents for Coronary Artery Disease: A Systematic Review and Meta-Analysis of Randomized Trials

    Science.gov (United States)

    Charnigo, Richard; Moliterno, David J.

    2015-01-01

    Background Dual antiplatelet therapy (DAPT) is recommended for ≥12 months following coronary drug-eluting stents (DES) to reduce risk of major adverse ischemic events. Randomized trials suggest an abbreviated DAPT duration (≤6 months) is adequately protective. However, these trials are individually underpowered to detect differences in rare but serious events such as stent thrombosis (ST). Objectives We performed a meta-analysis of published randomized trials to define the impact of abbreviated DAPT (≤6 months) on death, myocardial infarction (MI), stent thrombosis(ST) and bleeding complications compared to standard-duration DAPT (≥12 months). Methods Seven randomized controlled trials comparing abbreviated vs. standard DAPT regimens following DES use were identified by 2 independent investigators. Study characteristics were reviewed and clinical endpoint data were abstracted and analyzed in aggregate using fixed and random-effects models. Results The 7 trials included 15,874 randomized patients. Second-generation DES were used in most patients. Compared to standard-duration DAPT, abbreviated DAPT was not associated with an increase in mortality (OR 0.93; CI: 0.73 to 1.17; p = 0.52), MI (OR 1.14; CI: 0.89 to 1.45; p = 0.30) or ST (OR 1.25; CI: 0.81 to 1.93; p = 0.31). Abbreviated DAPT was associated with significantly fewer major bleeding complications (OR 0.52; CI: 0.34 to 0.82; p = 0.005). The results were consistent between fixed and random-effects models, with no heterogeneity. Sensitivity analyses adjusting for inclusion of bare metal stents, 1st generation DES and/or abbreviated DAPT regeimens of 3 months resulted in similar conclusions. Conclusions In a meta-analysis of >15,000 patients primarily treated with second-generation DES, abbreviated-duration DAPT (≤6 months) was associated with a significant reduction in major bleeding complications with no evidence of a significant increase in risk of death, MI or ST. Accordingly, abbreviated DAPT

  5. Association between age and risk of stroke or death from carotid endarterectomy and carotid stenting: a meta-analysis of pooled patient data from four randomised trials.

    Science.gov (United States)

    Howard, George; Roubin, Gary S; Jansen, Olav; Hendrikse, Jeroen; Halliday, Alison; Fraedrich, Gustav; Eckstein, Hans-Henning; Calvet, David; Bulbulia, Richard; Bonati, Leo H; Becquemin, Jean-Pierre; Algra, Ale; Brown, Martin M; Ringleb, Peter A; Brott, Thomas G; Mas, Jean-Louis

    2016-03-26

    Age was reported to be an effect-modifier in four randomised controlled trials comparing carotid artery stenting (CAS) and carotid endarterectomy (CEA), with better CEA outcomes than CAS outcomes noted in the more elderly patients. We aimed to describe the association of age with treatment differences in symptomatic patients and provide age-specific estimates of the risk of stroke and death within narrow (5 year) age groups. In this meta-analysis, we analysed individual patient-level data from four randomised controlled trials within the Carotid Stenosis Trialists' Collaboration (CSTC) involving patients with symptomatic carotid stenosis. We included only trials that randomly assigned patients to CAS or CEA and only patients with symptomatic stenosis. We assessed rates of stroke or death in 5-year age groups in the periprocedural period (between randomisation and 120 days) and ipsilateral stroke during long-term follow-up for patients assigned to CAS or CEA. We also assessed differences between CAS and CEA. All analyses were done on an intention-to-treat basis. Collectively, 4754 patients were randomly assigned to either CEA or CAS treatment in the four studies. 433 events occurred over a median follow-up of 2·7 years. For patients assigned to CAS, the periprocedural hazard ratio (HR) for stroke and death in patients aged 65-69 years compared with patients younger than 60 years was 2·16 (95% CI 1·13-4·13), with HRs of roughly 4·0 for patients aged 70 years or older. We noted no evidence of an increased periprocedural risk by age group in the CEA group (p=0·34). These changes underpinned a CAS-versus CEA periprocedural HR of 1·61 (95% CI 0·90-2·88) for patients aged 65-69 years and an HR of 2·09 (1·32-3·32) for patients aged 70-74 years. Age was not associated with the postprocedural stroke risk either within treatment group (p≥0·09 for CAS and 0·83 for CEA), or between treatment groups (p=0·84). In these RCTs, CEA was clearly superior to CAS in

  6. Long-term prognostic value of risk scores after drug-eluting stent implantation for unprotected left main coronary artery: A pooled analysis of the ISAR-LEFT-MAIN and ISAR-LEFT-MAIN 2 randomized clinical trials.

    Science.gov (United States)

    Xhepa, Erion; Tada, Tomohisa; Kufner, Sebastian; Ndrepepa, Gjin; Byrne, Robert A; Kreutzer, Johanna; Ibrahim, Tareq; Tiroch, Klaus; Valgimigli, Marco; Tölg, Ralf; Cassese, Salvatore; Fusaro, Massimiliano; Schunkert, Heribert; Laugwitz, Karl L; Mehilli, Julinda; Kastrati, Adnan

    2017-01-01

    To evaluate the long-term prognostic value of risk scores in the setting of drug-eluting stent (DES) implantation for uLMCA. Data on the prognostic value of novel risk scores developed to select the most appropriate revascularization strategy in patients undergoing DES implantation for uLMCA disease are relatively limited. The study represents a patient-level pooled analysis of the ISAR-LEFT-MAIN (607 patients randomized to paclitaxel-eluting or sirolimus-eluting stents) and the ISAR-LEFT-MAIN-2 (650 patients randomized to everolimus-eluting or zotarolimus-eluting stents) randomized trials. The Syntax Score (SxScore) as well the Syntax Score II (SS-II), the EuroSCORE and the Global Risk Classification (GRC) were calculated. The primary outcome was all-cause mortality. At a mean follow-up of 3 years there were 160 deaths (12.7%). The death-incidence was significantly higher in the upper tertiles than in the intermediate or lower ones for all risk scores (log-rank test P risk scores were able to stratify the mortality risk at long-term follow-up. EuroSCORE was the only risk score that significantly improved the discriminatory power of a multivariable model to predict long-term mortality. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  7. Mechanisms of biliary stent clogging: confocal laser scanning and scanning electron microscopy.

    Science.gov (United States)

    van Berkel, A M; van Marle, J; Groen, A K; Bruno, M J

    2005-08-01

    Endoscopic insertion of plastic biliary endoprostheses is a well-established treatment for obstructive jaundice. The major limitation of this technique is late stent occlusion. In order to compare events involved in biliary stent clogging and identify the distribution of bacteria in unblocked stents, confocal laser scanning (CLS) and scanning electron microscopy (SEM) were carried out on two different stent materials - polyethylene (PE) and hydrophilic polymer-coated polyurethane (HCPC). Ten consecutive patients with postoperative benign biliary strictures were included in the study. Two 10-Fr stents 9 cm in length, one made of PE and the other of HCPC, were inserted. The stents were electively exchanged after 3 months and examined using CLS and SEM. No differences were seen between the two types of stent. The inner stent surface was covered with a uniform amorphous layer. On top of this layer, a biofilm of living and dead bacteria was found, which in most cases was unstructured. The lumen was filled with free-floating colonies of bacteria and crystals, surrounded by mobile laminar structures of mucus. An open network of large dietary fibers was seen in all of the stents. The same clogging events occurred in both PE and HCPC stents. The most remarkable observation was the identification of networks of large dietary fibers, resulting from duodenal reflux, acting as a filter. The build-up of this intraluminal framework of dietary fibers appears to be a major factor contributing to the multifactorial process of stent clogging.

  8. Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events

    DEFF Research Database (Denmark)

    Valgimigli, Marco; Sabaté, Manel; Kaiser, Christoph

    2014-01-01

    eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. PRIMARY OUTCOMES: The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite...... a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P... coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets. CONCLUSIONS: This meta-analysis offers evidence that compared with bare metal stents the use of cobalt...

  9. Relationship between Risk Factor Control and Compliance with a Lifestyle Modification Program in the Stenting Aggressive Medical Management for Prevention of Recurrent Stroke in Intracranial Stenosis Trial.

    Science.gov (United States)

    Turan, Tanya N; Al Kasab, Sami; Nizam, Azhar; Lynn, Michael J; Harrell, Jamie; Derdeyn, Colin P; Fiorella, David; Janis, L Scott; Lane, Bethany F; Montgomery, Jean; Chimowitz, Marc I

    2018-03-01

    Lifestyle modification programs have improved the achievement of risk factor targets in a variety of clinical settings, including patients who have previously suffered a stroke or transient ischemic attack and those with multiple risk factors. Stenting Aggressive Medical Management for Prevention of Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) was the first vascular disease prevention trial to provide a commercially available lifestyle modification program to enhance risk factor control. We sought to determine the relationship between compliance with this program and risk factor control in SAMMPRIS. SAMMPRIS aggressive medical management included a telephonic lifestyle modification program provided free of charge to all subjects (n = 451) during their participation in the study. Subjects with fewer than 3 expected lifestyle-coaching calls were excluded from these analyses. Compliant subjects (n = 201) had  greater than or equal to 78.5% of calls (median % of completed/expected calls). Noncompliant subjects (n = 200) had less than 78.5% of calls or refused to participate. Mean risk factor values or % in-target for each risk factor was compared between compliant versus noncompliant subjects, using t tests and chi-square tests. Risk factor changes from baseline to follow-up were compared between the groups to account for baseline differences. Compliant subjects had better risk factor control throughout follow-up for low-density lipoprotein, systolic blood pressure (SBP), hemoglobin A1c (HgA1c), non-high-density lipoprotein, nonsmoking, and exercise than noncompliant subjects, but there was no difference for body mass index. After adjusting for baseline differences between the groups, compliant subjects had a greater change from baseline than noncompliant subjects for SBP did at 24 months and HgA1c at 6 months. SAMMPRIS subjects who were compliant with the lifestyle modification program had better risk factor control during the study for almost

  10. 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.

  11. Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial.

    Science.gov (United States)

    Baron, Suzanne J; Lei, Yang; Chinnakondepalli, Khaja; Vilain, Katherine; Magnuson, Elizabeth A; Kereiakes, Dean J; Ellis, Stephen G; Stone, Gregg W; Cohen, David J

    2017-04-24

    The purpose of this study was to evaluate the economic impact of the Absorb bioresorbable vascular scaffold compared with the Xience everolimus-eluting stent in patients undergoing percutaneous coronary intervention. The ABSORB III trial (Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease) demonstrated that the Absorb scaffold was noninferior to the Xience stent with respect to target lesion failure at 1 year. Whether health care costs differ between the Absorb scaffold and the Xience stent is unknown. We performed a prospective health economic study alongside the ABSORB III trial, in which patients undergoing percutaneous coronary intervention for stable or unstable angina were randomized to receive the Absorb scaffold (n = 1,322) or Xience stent (n = 686). Resource use data were collected through 1 year of follow-up. Costs were assessed using resource-based accounting (for procedures), MedPAR data (for other index hospitalization costs), and Medicare reimbursements (for follow-up costs and physician fees). Initial procedural costs were higher with the Absorb scaffold than the Xience stent ($6,316 ± 1,892 vs. $6,103 ± 1,895; p = 0.02), driven mainly by greater balloon catheter use and the higher cost of the scaffold in the Absorb group. Nonetheless, index hospitalization costs ($15,035 ± 2,992 for Absorb vs. $14,903 ± 3,449 for Xience; p = 0.37) and total 1-year costs ($17,848 ± 6,110 for Absorb vs. $17,498 ± 7,411 for Xience; p = 0.29) were similar between the 2 groups. Although initial procedural costs were higher with the Absorb scaffold, there were no differences in total 1-year health care costs between the 2 cohorts. Longer term follow-up is needed to determine whether meaningful cost savings emerge after scaffold resorption. (A Clinical Evaluation of Absorb™ BVS, the Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT01751906). Copyright © 2017

  12. 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

  13. Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial.

    Science.gov (United States)

    Baron, Suzanne J; Chinnakondepalli, Khaja; Magnuson, Elizabeth A; Kandzari, David E; Puskas, John D; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Taggart, David P; Morice, Marie-Claude; Lembo, Nicholas J; Brown, W Morris; Banning, Adrian; Simonton, Charles A; Kappetein, A Pieter; Sabik, Joseph F; Serruys, Patrick W; Stone, Gregg W; Cohen, David J

    2017-12-26

    The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left main coronary artery disease (LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) using everolimus-eluting stents. Whereas rates of death, stroke, and myocardial infarction were similar at 36 months, event timing and repeat revascularization rates differed by treatment group. To understand the effects of revascularization strategy from the patient's perspective, a prospective quality of life (QoL) substudy was performed alongside the EXCEL trial. Between September 2010 and March 2014, 1,905 patients with LMCAD were randomized to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy. QoL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models. Over 36 months, both PCI and CABG were associated with significant improvements in QoL compared with baseline. At 1 month, PCI was associated with better QoL than CABG. By 12 months though, these differences were largely attenuated, and by 36 months, there were no significant QoL differences between PCI and CABG. Among selected patients with LMCAD, both PCI and CABG result in similar QoL improvement through 36 months, although a greater early benefit is seen with PCI. Taken together with the 3-year clinical results of EXCEL, these findings suggest that PCI and CABG provide similar intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier

  14. Randomized clinical trial of fluid and salt restriction compared with a controlled liberal regimen in elective gastrointestinal surgery.

    Science.gov (United States)

    Kalyan, J P; Rosbergen, M; Pal, N; Sargen, K; Fletcher, S J; Nunn, D L; Clark, A; Williams, M R; Lewis, M P N

    2013-12-01

    Excessive intravenous fluid prescription may play a causal role in postoperative complications following major gastrointestinal resectional surgery. The aim of this study was to investigate whether fluid and salt restriction would decrease postoperative complications compared with a more modern controlled liberal regimen. In this observer-blinded single-site randomized clinical trial consecutive patients undergoing major gastrointestinal resectional surgery were randomized to receive either a liberal control fluid regimen or a restricted fluid and salt regimen. The primary outcome was postoperative complications of grade II and above (moderate to severe). Some 240 patients (194 colorectal resections and 46 oesophagogastric resections) were enrolled in the study; 121 patients were randomized to the restricted regimen and 119 to the control (liberal) regimen. During surgery the control group received a median (interquartile range) fluid volume of 2033 (1576-2500) ml and sodium input of 282 (213-339) mmol, compared with 1000 (690-1500) ml and 142 (93-218) mmol respectively in the restricted group. There was no significant difference in major complication rate between groups (38·0 and 39·0 per cent respectively). Median (range) hospital stay was 8 (3-101) days in the controls and 8 (range 3-76) days among those who received restricted fluids. There were four in-hospital deaths in the control group and two in the restricted group. Substantial differences in weight change, serum sodium, osmolality and urine : serum osmolality ratio were observed between the groups. There were no significant differences in major complication rates, length of stay and in-hospital deaths when fluid restriction was used compared with a more liberal regimen. ISRCTN39295230 (http://www.controlled-trials.com). © 2013 The Authors. British Journal of Surgery published by John Wiley & Sons Ltd on behalf of British Journal of Surgery Society Ltd.

  15. Acute stent thrombosis after primary percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Clemmensen, Peter; Wiberg, Sebastian; Van't Hof, Arnoud

    2015-01-01

    OBJECTIVES: This study sought to determine clinical, procedural, and treatment factors associated with acute stent thrombosis (AST) in the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial. BACKGROUND: Bivalirudin started during transport for primary percutaneous coronary int...

  16. Can phone-based motivational interviewing improve medication adherence to antiplatelet medications after a coronary stent among racial minorities? A randomized trial.

    Science.gov (United States)

    Palacio, Ana M; Uribe, Claudia; Hazel-Fernandez, Leslie; Li, Hua; Tamariz, Leonardo J; Garay, Sylvia D; Carrasquillo, Olveen

    2015-04-01

    Minorities have lower adherence to cardiovascular medications and have worst cardiovascular outcomes post coronary stent placement The aim of this study is to compare the efficacy of phone-delivered Motivational Interviewing (MINT) to an educational video at improving adherence to antiplatelet medications among insured minorities. This was a randomized study. We identified minorities with a recently placed coronary stent from an administrative data set by using a previously validated algorithm. MINT subjects received quarterly phone calls and the DVD group received a one-time mailed video. Outcome variables were collected at baseline and at 12-month post-stent, using surveys and administrative data. The primary outcome was antiplatelet (clopidogrel and prasugrel) adherence measured by Medication Possession Ratio (MPR) and self- reported adherence (Morisky score). We also measured appropriate adherence defined as an MPR ≥ 0.80. We recruited 452 minority subjects with a new coronary stent (44 % Hispanics and 56 % Black). The patients had a mean age of 69.5 ± 8.8, 58 % were males, 78 % had an income lower than $30,000 per year and only 22 % had achieved high school education or higher. The MPR for antiplatelet medications was 0.77 for the MINT group compared to 0.70 for the DVD group (p motivational interview is effective at improving adherence to antiplatelet medications post coronary stent placement. Phone-based MINT seems to be a promising and cost-effective strategy to modify risk behaviors among minority populations at high cardiovascular risk.

  17. Role of stent type and of duration of dual antiplatelet therapy in patients with chronic kidney disease undergoing percutaneous coronary interventions. Is bare metal stent implantation still a justifiable choice? A post-hoc analysis of the all comer PRODIGY trial.

    Science.gov (United States)

    Crimi, Gabriele; Leonardi, Sergio; Costa, Francesco; Adamo, Marianna; Ariotti, Sara; Valgimigli, Marco

    2016-06-01

    Chronic kidney disease (CKD) is a powerful predictor of major cardiovascular events and stent thrombosis (ST) in patients undergoing percutaneous coronary interventions (PCI). No randomized data are available to compare, and guide the selection of type of stent between bare metal (BMS) or drug eluting stent (DES) in this population. We performed a post-hoc analysis of the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) trial, in which stable or unstable patients with coronary artery disease undergoing PCI were randomized 1:1:1:1 to receive BMS, paclitaxel- (PES), zotarolimus- (ZES-S), or everolimus- (EES) eluting stent. A total of 2003 patients were randomized, and 22 patients were excluded for missing serum creatinine leading to a final population of 1981 patients. Primary outcome was definite or probable ST. We also assessed MACE (myocardial infarction, stroke, or death), and all-cause death, as secondary outcome. CKD, defined with estimated glomerular filtration rate <60ml/min/1.73m(2), was found in 373 patients (18.8%). The incidence of ST at 2years was 5.1% in CKD and 2.1% in non-CKD patients (HR 2.57, 95% confidence interval (CI) 1.46 to 4.52, p<0.001). At multivariable regression we found that patients randomized to EES or ZES-S, but not PES, had lower risk of ST at two years as compared with BMS: adjusted HR=0.288, 95% CI [0.107-0.778, p=0.014] and HR=0.394, 95% CI [0.164-0.947, p=0.037] respectively. The number of patients needed to be treated to prevent 1 ST with an EES vs BMS was 20 in CKD and 50 in patients without CKD. EES patients had the lowest incident MACE events 26.4% as compared to BMS 35.1%, ZES-S 33.0%, or PES 35.7% patients, p=0.551. All-cause death was lowest in ZES-S group 10.6% as compared to BMS 18.1%, PES 25.5% and EES 14.9%, p=0.040. We found no significant interaction between DAPT duration (6 vs 24months) and stent type on primary outcome, PINT=0.47 for BMS, PINT=0.57 for PES, PINT

  18. Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

    Science.gov (United States)

    Schmidt, Arthur; Riecken, Bettina; Rische, Susanne; Klinger, Christoph; Jakobs, Ralf; Bechtler, Matthias; Kähler, Georg; Dormann, Arno; Caca, Karel

    2015-05-01

    Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (< 8 weeks after placement) occurred in 8 patients (50 %) vs. 2 patients (11.1 %), respectively (P = 0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns. The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634). © Georg Thieme Verlag KG Stuttgart · New York.

  19. Elections to Staff Council

    CERN Multimedia

    Saff Association

    2013-01-01

    2013 Elections to Staff Council   Vote! Make your voice heard and be many to elect the new Staff Council. More details on the elections can be found on the Staff Association web site (https://ap-vote.web.cern.ch/elections-2013).   Timetable elections Monday 28 October to Monday 11 November, 12:00 am voting Monday 18 and Monday 25 November, publication of the results in Echo Tuesday 19 November, Staff Association Assizes Tuesday 3 December, first meeting of the new Staff Council and election of the new Executive Committee The voting procedure is monitored by the Election Committee.

  20. Direct comparison of Neuroform and Enterprise stents in the treatment of wide-necked intracranial aneurysms

    International Nuclear Information System (INIS)

    Durst, C.R.; Khan, P.; Gaughen, J.; Patrie, J.; Starke, R.M.; Conant, P.; Liu, K.C.; Jensen, M.E.; Evans, A.J.

    2014-01-01

    Aim: To compare the complications and outcomes of Neuroform and Enterprise stents in the treatment of unruptured wide-necked aneurysms. Materials and methods: Under the auspices of the institutional review board, a review of a prospectively collected patient log identified 130 patients who underwent elective stent-assisted coil embolization of a wide-necked aneurysm, including 53 patients treated with an Enterprise stent and 77 patients treated with a Neuroform stent. Immediate and long-term clinical and radiographic outcomes were recorded for all patients. All patient data were handled in accordance with Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations. Results: The technical success rate was 94%. Overall morbidity was 15% with Enterprise stents and 3% with Neuroform stents (p = 0.020). However, the type of stent used was not predictive of clinical outcomes as measured by the modified Rankin scale. In a multivariate analysis, the use of a Neuroform stent was one of the predictors of retreatment (p = 0.034). Conclusion: Multivariate analyses identified the use of Neuroform stents as an independent predictor of the need for retreatment and the use of Enterprise stents as an independent predictor of morbidity. However, the type of stent was not predictive of clinical outcome as measured by the modified Rankin scale. - Highlights: • The use of Enterprise stents was an independent predictor of morbidity. • The use of Neuroform stents was an independent predictor for retreatment. • The type of stent was not predictive of clinical outcome as measured by the mRS

  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. Effects of Intrathecal Clonidine on Spinal Analgesia during Elective Cesarean Delivery: A Randomized Double Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Houshang Talebi

    2016-05-01

    Full Text Available In order To investigate the effect of addition of clonidine to lidocaine on duration of spinal analgesia and need for postoperative analgesics after Caesarean section delivery, this randomized case-controlled double-blind clinical trial was designed and conducted. 166 eligible women were randomly allocated to either case or control group (n=83, Spinal anesthesia was done by 75-100 mg lidocaine 0.5% in control group and by 75-100 mg lidocaine 0.5% plus 75µg clonidine in case group. Onset of analgesia, Blood pressure, Hypotension, Bradycardia, and Neonates Apgar scores were recorded during surgery. After surgery, duration of sensory and motor functions, Intensity of post-operative nausea and vomiting, Total analgesic consumption and time to first analgesic request were assessed. Data were analyzed by SPSS and an alpha level < 0.05 was considered to be statistically significant. Onset of analgesia, Duration of Motor and sensory block, mothers’ systolic blood pressure and pulse rate in different recorded times, and Total Analgesic consumption in case group showed a statically significant difference in comparison to the control group. Analgesia demanding, Time of first request for analgesics, Intensity of Nauseas and vomiting, Apgar score showed no significant difference. We have demonstrated that addition of 75 µg clonidine to lidocaine extends spinal analgesia along with sensory and motor block after Caesarean section and improves early analgesia without clinically significant maternal or neonatal side-effects. This single 75 µg intrathecal clonidine dose also reduced the amount of subsequent analgesic consumption during the first 12 hours after delivery.

  3. Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

    International Nuclear Information System (INIS)

    Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

    2013-01-01

    Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

  4. Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

    Energy Technology Data Exchange (ETDEWEB)

    Brodmann, Marianne, E-mail: marianne.brodmann@medunigraz.at; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz [Medical University of Graz, Division of Angiology (Austria); Deutschmann, Hannes [Medical University Graz, Division of Interventional Radiology (Austria); Seinost, Gerald; Pilger, Ernst [Medical University of Graz, Division of Angiology (Austria)

    2013-02-15

    Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

  5. Invention of a nasolacrimal stent retrieval hook

    International Nuclear Information System (INIS)

    Kim, Tae Hyung; Kim, Yeong Kyun; Park, Sang Soo; Song, Ho Young

    1997-01-01

    To evaluate the clinical usefulness of a nasolacrimal stent retrieval hook The retrieval hook consisted of two parts, a hook and pusher. The head of the hook part was made of 0.7mm stainless steel wire and was question mark-shaped, while the body of this part was constructed by soldering together four stainless steel pipes ranging in thickness from 1.25 to 3.5mm, serially. The pusher part was made of two plastic tubes and was designed in such a way that the hook grasped the stent tightly. The device was used to remove 46 stents in 40 patients, and tested for 1) average number of trials;2) success rate;and 3) average time of the procedure. The average number of trials, success rate, and average time taken to remove the stent was 4.7, 91%, and 1.8 minutes, respectively. In the removal of nasolacrimal stents, the retrieval hook was easy to use, useful and effective

  6. 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.

  7. Neointimal hyperplasia after silverhawk atherectomy versus percutaneous transluminal angioplasty (PTA) in femoropopliteal stent reobstructions: a controlled, randomized pilot trial.

    Science.gov (United States)

    Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

    2013-02-01

    Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

  8. Update in urethral stents.

    Science.gov (United States)

    Bahouth, Z; Meyer, G; Yildiz, G; Nativ, O; Moskovitz, B

    2016-10-01

    Urethral stents were first introduced in 1988, and since then, they have undergone significant improvements. However, they did not gain a wide popularity and their use is limited to a small number of centers around the world. Urethral stents can be used in the entire urethra and for various and diverse indications. In the anterior urethra, it can be used to treat urethral strictures. In the prostatic urethra, they can be used for the treatment of prostatic obstruction, including benign, malignant and iatrogenic prostatic obstruction. Moreover, although not widely used, it can be also applied for the treatment of posterior urethral stricture and bladder neck contracture, usually resulting in urinary incontinence and the need for subsequent procedures. Our main experience are with Allium urethral stents, and as such, we provide the latest updates in urethral stents with special emphasis on the various types of Allium urethral stents: bulbar, prostatic and bladder neck stents.

  9. Modified nasolacrimal duct stenting

    International Nuclear Information System (INIS)

    Tian Min; Jin Mei; Chen Huanjun; Li Yi

    2008-01-01

    Objective: Traditional nasolacrimal duct stenting possesses some shortcoming including difficulty of pulling ball head guide wire from the nasal cavity with turbinate hypertrophy and nasal septal deviation. The new method of nose-oral tube track establishment can overcome the forementioned and increase the successful rate. Methods: 5 F catheter and arterial sheath were modified to be nasolacrimal duct stent delivery device respectively. Antegrade dacryocystography was taken firstly to display the obstructed site and followed by the modified protocol of inserting the guide wire through nasolacrimal duct and nasal cavity, and establishing the stent delivery track for retrograde stent placement. Results: 5 epiphora patients with failure implantation by traditional method were all succeeded through the modified stenting (100%). During 6-mouth follow-up, no serious complications and reocclusion occurred. Conclusion: The establishment of eye-nose-mouth-nose of external nasal guide wire track can improve the successful rate of nasolacrimal duct stenting. (authors)

  10. Intravascular imaging comparison of two metallic limus-eluting stents abluminally coated with biodegradable polymers: IVUS and OCT results of the DESTINY trial.

    Science.gov (United States)

    Costa, J Ribamar; Chamié, Daniel; Abizaid, Alexandre A C; Ribeiro, Expedito; Meireles, George C; Prudente, Maurício; Campos, Carlos A; Castro, Juliana P; Costa, Ricardo; Lemos, Pedro A

    2017-02-01

    We sought to compare, by means of IVUS and OCT imaging, the performance of a novel sirolimus-eluting drug-eluting stent (DES) with biodegradable polymer (Inspiron™) to the Biomatrix™ DES. From the DESTINY trial, a total of 70 randomized patients (2:1) were enrolled in the IVUS substudy (Inspiron™, n = 46; Biomatrix™: n = 20) while 25 patients were evaluated with OCT (Inspiron™, n = 19; Biomatrix™: n = 06) at 9-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at 9 months. Patients treated with both DES had very little NIH formation at 9 months either by IVUS (% of NIH obstruction of 4.9 ± 4.1 % with Inspiron™ vs. 2.7 ± 2.9 % with Biomatrix™, p = 0.03) or by OCT (neointimal thickness of 144.2 ± 72.5 µm Inspiron™ vs. 115.0 ± 53.9 µm with Biomatrix™, p = 0.45). Regarding OCT strut-level assessment, again both devices showed excellent 9-month performance, with high rates of strut coverage (99.49 ± 1.01 % with Inspiron™ vs. 97.62 ± 2.21 % with Biomatrix™, p < 0.001) and very rare malapposition (0.29 ± 1.06 % with Inspiron™ vs. 0.53 ± 0.82 % with Biomatrix™, p = 0.44). Patients with any uncovered struts were more frequently identified in the Biomatrix™ group (9.78 ± 7.13 vs. 2.29 ± 3.91 %, p < 0.001). In the present study, midterm IVUS and OCT evaluations showed that both new generation DES with biodegradable polymer were effective in terms of suppressing excessive neointimal response, with very high rates of apposed and covered struts, suggesting a consistent and benign healing pattern.

  11. Benign and malignant tracheobronchial stritures:long term follow-up of treatment with polyurethance;covered retrievable expandable nitinol stents

    International Nuclear Information System (INIS)

    Kim, Ho Sung; Song, Ho Young; Kim, Tae Hyung; Kang, Sung Gwon; Yoon, Hyun Ki; Sung, Kyu Bo

    2001-01-01

    To assess the safety and long term effectiveness of polyurethane-covered retrievable expandable nitinol stents in the treatment of benign and malignant tracheobronchial strctures. Under fluoroscopic guidance, the stents were placed in 32 patients with dyspnea whose strictures were malignant in 15 cases and benign 17. A stent was removed when complications occurred, or -electively- 2-6 months after placement in patients with benign strictures. The range of follow- up period was 1-98 weeks (median, 47; range,50) weeks. Stent placement was well tolerated in 30 patients. After placement, all 32 showed immdiate symptom improvment and in none were complications such as ingrowth of a tumor or granulation tissue oaserved during the follow up period. Stent migration occurred in six patients. In one of six and four of five patients from whom, respectively, stents head been electively removed two and six months after placement, tracheobronchial rsetenosis did not occur during follow up. Second stents were placed in six patients in whom dyspnea recurred due to restenosis after elective stent removal. In two of these six, stents were removed six months after placement and dyspnea did not recur during follow up. The use of covered retrievable tracheobronchial stents is safe and feasible in the conservative treatment of patients with malignant tracheobronchial strictures as well as for selected patients with benign strictures

  12. A quantitative coronary angiography-matched comparison between a prospective randomised multicentre cutting balloon angioplasty and bare metal stent trial (REDUCE III) and the Rapamycin-Eluting Stent Evaluation At Rotterdam Cardiology Hospital (RESEARCH) study.

    Science.gov (United States)

    Ozaki, Yukio; Lemos, Pedro A; Yamaguchi, Tetsu; Suzuki, Takahiko; Nakamura, Masato; Ismail, Tevfik F; Kitayama, Michihiko; Nishikawa, Hideo; Kato, Osamu; Serruys, Patrick W

    2010-08-01

    There remains significant concern about the long-term safety of drug-eluting stents (DES). However, bare metal stents (BMS) have been used safely for over two decades. There is therefore a pressing need to explore alternative strategies for reducing restenosis with BMS. This study was designed to examine whether IVUS-guided cutting balloon angioplasty (CBA) with BMS could convey similar restenosis rates to DES. In the randomised REstenosis reDUction by Cutting balloon angioplasty Evaluation (REDUCE III) study, 521 patients were divided into four groups based on device and IVUS use before BMS (IVUS-CBA-BMS: 137 patients; Angio-CBA-BMS: 123; IVUS-BA-BMS: 142; and Angio-BA-BMS: 119). At follow-up, the IVUS-CBA-BMS group had a significantly lower restenosis rate (6.6%) than the other groups (p=0.016). We performed a quantitative coronary angiography (QCA) based matched comparison between an IVUS-guided CBA-BMS strategy (REDUCE III) and a DES strategy (Rapamycin-Eluting-Stent Evaluation At Rotterdam Cardiology Hospital, the RESEARCH study). We matched the presence of diabetes, vessel size, and lesion severity by QCA. Restenosis (>50% diameter stenosis at follow-up) and target vessel revascularisation (TVR) were examined. QCA-matched comparison resulted in 120-paired lesions. While acute gain was significantly greater in IVUS-CBA-BMS than DES (1.65±0.41 mm vs. 1.28±0.57 mm, p=0.001), late loss was significantly less with DES than with IVUS-CBA-BMS (0.03±0.42 mm vs. 0.80±0.47 mm, p=0.001). However, no difference was found in restenosis rates (IVUS-CBA-BMS: 6.6% vs. DES: 5.0%, p=0.582) and TVR (6.6% and 6.6%, respectively). An IVUS-guided CBA-BMS strategy yielded restenosis rates similar to those achieved by DES and provided an effective alternative to the use of DES.

  13. Short Duration vs Standard Duration of Dual-Antiplatelet Therapy After Percutaneous Coronary Intervention With Second-Generation Drug-Eluting Stents - A Systematic Review, Meta-Analysis, and Meta-Regression Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Wassef, Anthony W A; Khafaji, Hadi; Syed, Ishba; Yan, Andrew T; Udell, Jacob A; Goodman, Shaun G; Cheema, Asim N; Bagai, Akshay

    2016-12-01

    Current guidelines recommend 12 months of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Whether the duration of DAPT can be safely shortened with use of second-generation DESs is unclear. We conducted a meta-analysis of randomized controlled trials comparing short duration (SD) (3-6 months) with standard longer duration (LD) (≥12 months) DAPT in patients treated with primarily second-generation DES implantation. Meta-regression was performed to explore the relationship between acute coronary syndrome (ACS) and the effect of DAPT duration. Six studies were included, with 12,752/13,928 (91.5%) patients receiving second-generation DESs. A total of 5367 patients (39%) had PCI in the setting of ACS. There was no difference in all-cause mortality (1.1% vs 1.2%; odds ratio [OR], 0.86; 95% confidence interval [CI], 0.63-1.18; P=.36) or cardiac mortality (0.9% vs 1.0%; OR, 0.92; 95% CI, 0.61-1.39; P=.69) with SD-DAPT vs LD-DAPT, respectively. Definite/probable stent thrombosis (0.5% vs 0.3%; OR, 1.33; 95% CI, 0.75-2.34; P=.51), myocardial infarction (1.5% vs 1.3%; OR, 1.17; 95% CI, 0.88-1.56; P=.29), and stroke (0.4% vs 0.4%; OR, 1.04; 95% CI, 0.60-1.81; P=.88) were similar between the groups. Compared with LD-DAPT, SD-DAPT was associated with lower clinically significant bleeding (0.9% vs 1.4%; OR, 0.64; 95% CI, 0.46-0.89; P=.01). Meta-regression analysis showed no significant association between the proportion of ACS patients in trials and duration of DAPT for the outcomes of mortality (P=.95), myocardial infarction (P=.98), or stent thrombosis (P=.89). In low-risk patients treated with contemporary second-generation DES implantation, SD-DAPT has similar rates of mortality, myocardial infarction, and stent thrombosis, with lower rates of bleeding compared with LD-DAPT.

  14. Evaluation of in-stent restenosis in the APPROACH trial (assessment on the prevention of progression by Rosiglitazone on atherosclerosis in diabetes patients with cardiovascular history)

    NARCIS (Netherlands)

    H.M. Garcia-Garcia (Hector); S.A. Garg (Scot); S. Brugaletta (Salvatore); G. Morocutti (Giorgio); R.E. Ratner (Robert); N.S. Kolatkar (Nikheel); B.G. Kravitz (Barbara); D.M. Miller (Diane); C. Huang (Chunmei); R.W. Nesto (Richard); P.W.J.C. Serruys (Patrick); R.P. Aftring (R.); N.S. Kolatkar (Nikheel); B.G. Kravitz (Barbara); J. Wolstenholme (Jane); J. Saarinen (Jari); R. Fowler (R.); J. Hoffman (Jonathan); D. Steele-Norwood (D.); R. Russell (Robert); S. Young (S.); Y.F. Chou; S. McMorn (Steve); C. Kirsch (Courtney); B. Louridas (Bonnie); T. Olivieria (Teresa); D. Mattioli (Debra); D. Miller (D.); C. Huang (Chunmei); C. Nguyen (C.); K. Jahnke (Kristoph); G.S. Mintz (Gary); J. Lachin (J.); M. Abrahamson (M.); P. Carson (P.); P. Jones

    2012-01-01

    textabstractTo determine (1) the medium-term effect of rosiglitazone and glipizide on intra-stent neointima hyperplasia, (2) restenosis pattern as assessed by intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) in patients with T2DM and coronary artery disease. A total of 462

  15. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial.

    Science.gov (United States)

    Eijlers, Robin; Legerstee, Jeroen S; Dierckx, Bram; Staals, Lonneke M; Berghmans, Johan; van der Schroeff, Marc P; Wijnen, Rene Mh; Utens, Elisabeth Mwj

    2017-09-11

    Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater. The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU). The VRE tool is highly realistic and resembles the operating room environment accurately. With this tool, children will not only be able to explore the operating room environment, but also get accustomed to general anesthesia procedures. The PREoperative Virtual reality Intervention to Enhance Wellbeing (PREVIEW) study will be conducted. In this single-blinded RCT, 200 consecutive patients (aged 4 to 12 years) undergoing elective day care surgery for dental, oral, or ear-nose-throat problems, will be randomly allocated to the preoperative VRE intervention or CAU. The primary outcome is change in child state anxiety level between baseline and induction of anesthesia. Secondary outcome measures include child's postoperative anxiety, emergence delirium, postoperative pain, use of analgesics, health care use, and pre- and postoperative parental anxiety. The VRE tool has been developed. Participant recruitment began March 2017 and is expected to be completed by September 2018. To our knowledge, this is the first RCT evaluating the effect of a VRE tool to prepare children for surgery. The VRE intervention is expected to significantly diminish preoperative anxiety, postoperative pain, and the use of postoperative analgesics in pediatric patients. The tool could create a less stressful experience for both

  16. Outcome According to Elective Pelvic Radiation Therapy in Patients With High-Risk Localized Prostate Cancer: A Secondary Analysis of the GETUG 12 Phase 3 Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Blanchard, Pierre, E-mail: pierre.blanchard@gustaveroussy.fr [Radiation Oncology, Gustave Roussy Cancer Center, Villejuif (France); University of Paris-Sud, Cancer Campus, Villejuif (France); Faivre, Laura [Biostatistics, Gustave Roussy Cancer Center, Villejuif (France); Lesaunier, François [Radiation Oncology, Centre Francois Baclesse, Caen (France); Salem, Naji [Radiation Oncology, Institut Paoli Calmette, Marseille (France); Mesgouez-Nebout, Nathalie [Radiation Oncology, Institut de Cancérologie de l' Ouest, Angers (France); Deniau-Alexandre, Elisabeth [Centre Hospitalier La Roche sur Yon, La Roche sur Yon (France); Rolland, Frédéric [Medical Oncology, Institut de Cancérologie de l' Ouest, Nantes (France); Ferrero, Jean-Marc [Medical Oncology, Centre Antoine Lacassagne, Nice (France); Houédé, Nadine [Medical Oncology, Institut Bergonié, Bordeaux (France); Mourey, Loïc [Institut Claudius Regaud, Toulouse (France); Théodore, Christine [Hospital Foch, Suresnes (France); Krakowski, Ivan [Centre Alexis Vautrin, Vandoeuvre-lès-Nancy (France); Berdah, Jean-François [Clinique Sainte Marguerite, Hyeres (France); Baciuchka, Marjorie [Centre Hospitalier de la Timone, Marseille (France); Laguerre, Brigitte [Centre Eugène Marquis, Rennes (France); Davin, Jean-Louis [Clinique Sainte Catherine, Avignon (France); Habibian, Muriel [R& D UNICANCER, Paris (France); UNICANCER, Paris (France); Culine, Stéphane [Department of Medical Oncology, Hopital Saint-Louis, APHP, Paris (France); and others

    2016-01-01

    Purpose: The role of pelvic elective nodal irradiation (ENI) in the management of prostate cancer is controversial. This study analyzed the role of pelvic radiation therapy (RT) on the outcome in high-risk localized prostate cancer patients included in the Groupe d'Etude des Tumeurs Uro-Genitales (GETUG) 12 trial. Methods and Materials: Patients with a nonpretreated high-risk localized prostate cancer and a staging lymphadenectomy were randomly assigned to receive either goserelin every 3 months for 3 years and 4 cycles of docetaxel plus estramustine or goserelin alone. Local therapy was administered 3 months after the start of systemic treatment. Performance of pelvic ENI was left to the treating physician. Only patients treated with primary RT were included in this analysis. The primary endpoint was biochemical progression-free survival (bPFS). Results: A total of 413 patients treated from 2002 to 2006 were included, of whom 358 were treated using primary RT. A total of 208 patients received pelvic RT and 150 prostate-only RT. Prostate-specific antigen (PSA) concentration, Gleason score, or T stage did not differ according to performance of pelvic RT; pN+ patients more frequently received pelvic RT than pN0 patients (P<.0001). Median follow-up was 8.8 years. In multivariate analysis, bPFS was negatively impacted by pN stage (hazard ratio [HR]: 2.52 [95% confidence interval [CI]: 1.78-3.54], P<.0001), Gleason score 8 or higher (HR: 1.41 [95% CI: 1.03-1.93], P=.033) and PSA higher than 20 ng/mL (HR: 1.41 [95% CI: 1.02-1.96], P=.038), and positively impacted by the use of chemotherapy (HR: 0.66 [95% CI: 0.48-0.9], P=.009). There was no association between bPFS and use of pelvic ENI in multivariate analysis (HR: 1.10 [95% CI: 0.78-1.55], P=.60), even when analysis was restricted to pN0 patients (HR: 0.88 [95% CI: 0.59-1.31], P=.53). Pelvic ENI was not associated with increased acute or late patient reported toxicity. Conclusions: This unplanned analysis of

  17. Placement of a triple-layered covered versus uncovered metallic stent for palliation of malignant gastric outlet obstruction: a multicenter randomized trial.

    Science.gov (United States)

    Maetani, Iruru; Mizumoto, Yoshinori; Shigoka, Hiroaki; Omuta, Shigefumi; Saito, Michihiro; Tokuhisa, Junya; Morizane, Toshio

    2014-03-01

    Usually, uncovered self-expandable metallic stents (SEMS) are used for palliation of malignant gastric outlet obstruction (GOO). A triple-layered covered SEMS is reported to be efficacious, but its performance has not been compared with uncovered SEMS. The present study is the first to compare the efficacy and safety of a triple-layered covered versus uncovered SEMS. A multicenter randomized study was conducted in two tertiary referral centers, with 62 eligible patients with symptomatic GOO to receive covered (n = 31) or uncovered SEMS (n = 31). The primary endpoint was SEMS patency, and secondary endpoints were success rate and adverse events after complete follow up. Both groups had a technical success rate of 100% and comparable clinical success rates (P = 0.67). There was nostatistically significant difference in stent patency and adverse events between the two groups (P = 0.52 and P = 0.38, respectively). Although the occurrence rate of persistent obstructive symptoms was comparable (P = 0.42), that of recurrent obstructive symptoms was higher in the uncovered group (29% vs 3.6%, P = 0.0125). Patient survival did not differ between groups (P = 0.34). There was no statistically significant difference in stent patency, but use of a triple-layered covered SEMS was associated with less frequent stent dysfunction more than 4 weeks after stenting, despite similar short-term outcomes. © 2013 The Authors. Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society.

  18. Treatment of symptomatic intracranial arterial stenosis with Wingspan stent system

    International Nuclear Information System (INIS)

    Luo Wangchi; Li Guifu; Li Tielin; Zhu Jixiang; You Jinsong; Ma Zhaohui; Huang Yan

    2011-01-01

    Objective: To discuss the safety of Gateway-Wingspan stent system in treating symptomatic intracranial atherosclerotic stenosis and its effect of preventing and treating cerebral ischemic events. Methods: Interventional treatment by using Gateway-Wingspan sent system was carried out in 36 patients with symptomatic intracranial atherosclerotic arterial stenosis (a total of 38 lesions) who had failed to response the medication. Of the 32 cases, elective surgery was performed in 32 and emergent surgery in 4. Of the total 38 stenotic sites, 22 were located at the posterior cerebral blood circulation region, while 16 at the anterior circulation region. Results: The average degree of stenosis before stenting procedure was 72.6%±12.6%, the residual stenosis degree after balloon dilatation and stenting was 33.8%±15.2% and 23.6%±13.9%, respectively. The successful rate of treatment was 97.4%. Perioperative complications occurred in 4 patients, two from 32 cases who received elective surgery and other two from 4 cases who received emergent stent implantation. In cases receiving elective surgery, one suffered from perforating arterial branch occlusion and one occurred cerebral bleeding due to the rupture of middle cerebral artery caused by guide-wire. In patients receiving emergent stent implantation, acute stent thrombosis occurred in 2 cases during the interventional management (n=1) or 24 hours after stent placement (n=1). The overall complication rate was 11.1% (4/36). The 30-day composite ipsilateral stroke rate was 5.5% and the frequency of ipsilateral stroke within 30 days or ipsilateral stroke between 30 days and 12 months was 11.1% (4/36) during a mean follow-up time of 9.6 months (ranged between 1-24 months). DSA check-up was conducted in 10 cases and restenosis at the middle cerebral artery was detected in 2 cases. Conclusion: It is quite safe to use Gateway-Wingspan stent system for the treatment of symptomatic intracranial stenosis and its short-term clinical

  19. AGU election FAQs

    Science.gov (United States)

    Robinson, Robert

    2012-08-01

    Many of you are aware that this is an election year, and I don't mean electing the next president of the United States! This is AGU's election year, and the polls are opening soon. Your vote matters. Eligible voters should vote, and now is the time to learn about the candidates. There are no TV ads, and the candidates won't be covered in the news. However, electing AGU leaders for the next term affects the future direction of the Union. Please take a few minutes to visit the election Web site (http://sites.agu.org/elections/) and review the candidate bios.

  20. A critical assessment of the effects of tamsulosin and solifenacin as monotherapies and as a combination therapy for the treatment of ureteral stent-related symptoms: a 2 × 2 factorial randomized trial.

    Science.gov (United States)

    Park, Jinsung; Yoo, Changhee; Han, Deok Hyun; Shin, Dong Wook

    2015-11-01

    To assess the efficacy of tamsulosin, solifenacin, and combination therapy of both agents for the treatment of ureteral stent-related symptoms (SRSs). An open-label, randomized controlled trial was conducted with 112 patients who underwent unilateral ureteral stent insertion following ureteroscopic stone surgery. Patients were randomized with a 2 × 2 factorial design to one of four groups, i.e., A (control), B (tamsulosin 0.2 mg once daily), C (solifenacin 5 mg once daily), and D (both active treatments). Patients were evaluated at week 2 by the ureteral stent symptom questionnaire (USSQ). The primary efficacy outcome was the urinary symptom score of the USSQ, and the secondary efficacy outcomes were the scores in the other five USSQ domains, the Euro-QOL score, and oral analgesic requirements during the 2 weeks. Efficacy outcomes were primarily analyzed for the per-protocol set population. The four groups were generally well balanced in terms of baseline characteristics. Eighty-one patients (72.3 %) completed the study protocol. Comparison of the six USSQ domain scores at week 2 showed no differences between the four groups. Similarly, comparison of the domain scores stratified by tamsulosin or solifenacin medication showed no differences for either medication. The other secondary outcomes were also similar in the group comparisons. Neither tamsulosin nor solifenacin medications provide beneficial effects for relieving various SRSs. In addition, the combination therapy did not have beneficial effects. Further studies are warranted to determine the benefit of medical therapy for the treatment of SRSs and to determine the optimal management strategy for SRSs.

  1. A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section--pilot study. ISRCTN 40302163.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

    OBJECTIVE: To compare the blood loss at elective lower segment caesarean section with administration of oxytocin 5IU bolus versus oxytocin 5IU bolus and oxytocin 30IU infusion and to establish whether a large multi-centre trial is feasible. STUDY DESIGN: Women booked for an elective caesarean section were recruited to a pilot randomised controlled trial and randomised to either oxytocin 5IU bolus and placebo infusion or oxytocin 5IU bolus and oxytocin 30IU infusion. We wished to establish whether the study design was feasible and acceptable and to establish sample size estimates for a definitive multi-centre trial. The outcome measures were total estimated blood loss at caesarean section and in the immediate postpartum period and the need for an additional uterotonic agent. RESULTS: A total of 115 women were randomised and 110 were suitable for analysis (5 protocol violations). Despite strict exclusion criteria 84% of the target population were considered eligible for study participation and of those approached only 15% declined to participate and 11% delivered prior to the planned date. The total mean estimated blood loss was lower in the oxytocin infusion arm compared to placebo (567 ml versus 624 ml) and fewer women had a major haemorrhage (>1000 ml, 14% versus 17%) or required an additional uterotonic agent (5% versus 11%). A sample size of 1500 in each arm would be required to demonstrate a 3% absolute reduction in major haemorrhage (from baseline 10%) with >80% power. CONCLUSION: An additional oxytocin infusion at elective caesarean section may reduce blood loss and warrants evaluation in a large multi-centre trial.

  2. Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans.

    Science.gov (United States)

    Tamai, H; Igaki, K; Kyo, E; Kosuga, K; Kawashima, A; Matsui, S; Komori, H; Tsuji, T; Motohara, S; Uehata, H

    2000-07-25

    Although metallic stents are effective in preventing acute occlusion and reducing late restenosis after coronary angioplasty, many concerns still remain. Compared with metallic stents, poly-l-lactic acid (PLLA) stents are biodegradable and can deliver drugs locally. The aim of this study was to evaluate the feasibility, safety, and efficacy of the PLLA stent. Fifteen patients electively underwent PLLA Igaki-Tamai stent implantation for coronary artery stenoses. The Igaki-Tamai stent is made of a PLLA monopolymer, has a thickness of 0.17 mm, and has a zigzag helical coil pattern. A balloon-expandable covered sheath system was used, and the stent expanded by itself to its original size with an adequate temperature. A total of 25 stents were successfully implanted in 19 lesions in 15 patients, and angiographic success was achieved in all procedures. No stent thrombosis and no major cardiac event occurred within 30 days. Coronary angiography and intravascular ultrasound were serially performed 1 day, 3 months, and 6 months after the procedure. Angiographically, both the restenosis rate and target lesion revascularization rate per lesion were 10.5%; the rates per patient were 6.7% at 6 months. Intravascular ultrasound findings revealed no significant stent recoil at 1 day, and they revealed stent expansion at follow-up. No major cardiac event, except for repeat angioplasty, developed within 6 months. Our preliminary experience suggests that coronary PLLA biodegradable stents are feasible, safe, and effective in humans. Long-term follow-up with more patients will be required to validate the long-term efficacy of PLLA stents.

  3. Clinical Aspects on Chimney Stent Graft Technique in Endovascular Repair of the Aorta.

    OpenAIRE

    BinJabr, Adel

    2015-01-01

    Introduction: Open repair of the aorta carries a high risk for morbidity and mortality especially in the elderly population and in patients unfit for major surgery. Endovascular aortic repair is safe, durable and effective when there is adequate proximal and distal sealing zone for the aortic stent graft. Fenestrated and branched stent grafts have made the repair possible for complex but elective cases that do not have an adequate sealing zone. Urgent complex cases and patients with midaortic...

  4. A cost analysis of stenting in uncomplicated semirigid ureteroscopic stone removal.

    Science.gov (United States)

    Seklehner, Stephan; Sievert, Karl-Dietrich; Lee, Richard; Engelhardt, Paul F; Riedl, Claus; Kunit, Thomas

    2017-05-01

    To evaluate the outcome and the costs of stenting in uncomplicated semirigid ureteroscopic stone removal. A decision tree model was created to evaluate the economic impact of routine stenting versus non-stenting strategies in uncomplicated ureteroscopy (URS). Probabilities of complications were extracted from twelve randomized controlled trials. Stone removal costs, costs for complication management, and total costs were calculated using Treeage Pro (TreeAge Pro Healthcare version 2015, Software, Inc, Williamstown Massachusetts, USA). Stone removal costs were higher in stented URS (€1512.25 vs. €1681.21, respectively). Complication management costs were higher in non-stented procedures. Both for complications treated conservatively (€189.43 vs. €109.67) and surgically (€49.26 vs. €24.83). When stone removal costs, costs for stent removal, and costs for complication management were considered, uncomplicated URS with stent placement yielded an overall cost per patient of €1889.15 compared to €1750.94 without stent placement. The incremental costs of stented URS were €138.25 per procedure. Semirigid URS with stent placement leads to higher direct procedural costs. Costs for managing URS-related complications are higher in non-stented procedures. Overall, a standard strategy of deferring routine stenting uncomplicated ureteroscopic stone removal is more cost efficient.

  5. What Is a Stent?

    Science.gov (United States)

    ... clot at the stent site. Blood clots can cause a heart attack , stroke , or other serious problems. The risk of blood clots is greatest during the first few months after the stent is placed in the artery. Your doctor will likely recommend that you take aspirin and another anticlotting ...

  6. Birth after caesarean study – planned vaginal birth or planned elective repeat caesarean for women at term with a single previous caesarean birth: protocol for a patient preference study and randomised trial

    Directory of Open Access Journals (Sweden)

    Haslam Ross R

    2007-08-01

    Full Text Available Abstract Background For women who have a caesarean section in their preceding pregnancy, two care policies for birth are considered standard: planned vaginal birth and planned elective repeat caesarean. Currently available information about the benefits and harms of both forms of care are derived from retrospective and prospective cohort studies. There have been no randomised trials, and recognising the deficiencies in the literature, there have been calls for methodologically rigorous studies to assess maternal and infant health outcomes associated with both care policies. The aims of our study are to assess in women with a previous caesarean birth, who are eligible in the subsequent pregnancy for a vaginal birth, whether a policy of planned vaginal birth after caesarean compared with a policy of planned repeat caesarean affects the risk of serious complications for the woman and her infant. Methods/Design Design: Multicentred patient preference study and a randomised clinical trial. Inclusion Criteria: Women with a single prior caesarean presenting in their next pregnancy with a single, live fetus in cephalic presentation, who have reached 37 weeks gestation, and who do not have a contraindication to a planned VBAC. Trial Entry & Randomisation: Eligible women will be given an information sheet during pregnancy, and will be recruited to the study from 37 weeks gestation after an obstetrician has confirmed eligibility for a planned vaginal birth. Written informed consent will be obtained. Women who consent to the patient preference study will be allocated their preference for either planned VBAC or planned, elective repeat caesarean. Women who consent to the randomised trial will be randomly allocated to either the planned vaginal birth after caesarean or planned elective repeat caesarean group. Treatment Groups: Women in the planned vaginal birth group will await spontaneous onset of labour whilst appropriate. Women in the elective repeat

  7. Multi-center randomized trial on the impact of “CONFIDENCE” communication program aimed at evaluating therapy adherence of patients with registered myocardial infarction who underwent successful revascularization by stenting or thrombolysis after discharg

    Directory of Open Access Journals (Sweden)

    А. Р. Таркова

    2017-04-01

    Full Text Available Aim. The article looks at the effect of the program "Confidence" to increase the proportion of patients’ therapy in patients with coronary heart disease for two years after successful revascularization using thrombolytic or stenting of the coronary arteries on the myocardial infarction.Methods. This is a prospective, randomized, controlled, parallel-group trial including 4.000 patients. They will be divided into two groups: patients receiving standard outpatient observation (n=2000 and those enrolled for the program "Confidence" (n=2000. The total duration is 24 months. The trial will take place in two stages. In the first stage (0-12 months the impact of the program "Confidence" on therapy adherence and outcomes of cardiovascular diseases will be assessed. In the second stage (after the change of groups in 12 months, 12-24 months the effect of changing the way to remind patients of therapy adherence will be evaluated.Conclusion. The trial was designed in such a way as to show that the proposed program "Confidence" increases the proportion of patients who adhere to therapy in the cohort of those with coronary heart disease for two years after successful revascularization by using thrombolytic or stenting of the coronary arteries against the background of myocardial infarction.Received 13 February 2017. Accepted 9 March 2017.Financing: KRKA company’s grant. Sponsorship had no effect on data acquisition, analysis and interpretation.Conflict of interest: Kretov E.I. served as executive editor of “Endovascular surgery” section. All other authors declare no conflict of interest.Author contributionsStudy conception and design: Kretov E.I., Grazhdankin I.O., Baystrukov V.I., Zubarev D.D. Statistical data processing: Krestyaninov O.V., Kozyr K.V., Obedinskiy A.A., Prokhorikhin A.A.Drafting the article: Tarkova A.R., Anisimova V.D.Critical revision: Tarkova A.R., Anisimova V.D., Kretov E.I.

  8. The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent.

    Science.gov (United States)

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

    2017-02-01

    This article contains data related to the research article entitled "Results of genotype-guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent" (J. Sánchez-Ramos, C.L. Dávila-Fajardo, P. Toledo Frías, X. Díaz Villamarín, L.J. Martínez-González, S. Martínez Huertas, F. Burillo Gómez, J. Caballero Borrego, A. Bautista Pavés, M.C. Marín Guzmán, J.A. Ramirez Hernández, C. Correa Vilches, J. Cabeza Barrera, 2016) (1). This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype-guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI) with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up), study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33).

  9. Outcome of renal stenting for renal artery coverage during endovascular aortic aneurysm repair.

    Science.gov (United States)

    Hiramoto, Jade S; Chang, Catherine K; Reilly, Linda M; Schneider, Darren B; Rapp, Joseph H; Chuter, Timothy A M

    2009-05-01

    This study was conducted to determine the outcome of adjunctive renal artery stenting for renal artery coverage at the time of endovascular abdominal aortic aneurysm repair (EVAR). Between August 2000 and August 2008, 29 patients underwent elective EVAR using bifurcated Zenith stent grafts (Cook, Indianapolis, Ind) and simultaneous renal artery stenting. Renal artery stenting during EVAR was performed with endograft "encroachment" on the renal artery ostium (n = 23) or placement of a renal stent parallel to the main body of the endograft ("snorkel," n = 8). Follow-up included routine contrast-enhanced computed tomography (CT), multiview abdominal radiographs, and serum creatinine measurement at 1, 6, and 12 months, and then yearly thereafter. Thirty-one renal arteries were stented successfully in 29 patients. The 18 patients with planned renal artery stent placement had a proximal neck length technique (6.9 +/- 3.1 mm) compared with those with planned endograft encroachment (9.9 +/- 2.6 mm). None of the patients with unplanned endograft encroachment had neck lengths 1 month postoperatively) or stent graft migrations. Adjunctive renal artery stenting during endovascular AAA repair using the "encroachment" and "snorkel" techniques is safe and effective. Short- and medium-term primary patency rates are excellent, but careful follow-up is needed to determine the durability of these techniques.

  10. Serbian Elections 2016

    Directory of Open Access Journals (Sweden)

    Dušan Pavlović

    2016-06-01

    Full Text Available Elections in Serbia have been held quite often over the past 26 years. Yet, of all elections that have taken place since the introduction of the multiparty system in 1990, the elections held on April 24 2016, were the most confusing. They were held early, but were neither a product of political, nor economic crisis. So why were they necessary?

  11. Randomized Controlled Trial to Compare the Safety and Efficacy of Tamsulosin, Solifenacin, and Combination of Both in Treatment of Double-J Stent-Related Lower Urinary Symptoms

    Directory of Open Access Journals (Sweden)

    Essam Shalaby

    2013-01-01

    Full Text Available Purpose. We evaluated the effectiveness and safety of tamsulosin, solifenacin, and combination of both in reducing double-J stent-related lower urinary symptoms. Materials and Methods. A total of 338 patients with double-J ureteral stenting were randomly divided, postoperatively, into 4 groups. In group I (, no treatment was given (control group, group II ( received tamsulosin 0.4 mg daily, group III ( received solifenacin 10 mg daily, and group IV ( received a combination of both medications. Before insertion and 2 weeks after, all patients completed the International Prostate Symptom Score (IPSS, quality of life component of the IPSS (IPSS/Qol, Overactive Bladder Questionnaire (OAB-q, and Visual Analogue Pain Scale (VAPS questionnaire. Results. The demographics and preoperative questionnaires scores of all groups were comparable. There were statistically significant differences in all scores in favour of groups II, III, and IV as compared to control group ( value < 0.005. Group IV showed statistically significant differences in total IPSS, QoL score, and OAB-q score as compared to groups II and III ( value < 0.001. Conclusions. Combined therapy of tamsulosin and solifenacin significantly alleviated lower urinary symptoms associated with double-J stents as compared to either medication alone.

  12. A Randomized Controlled Trial to Compare the Safety and Efficacy of Tadalafil and Tamsulosin in Relieving Double J Stent Related Symptoms

    Directory of Open Access Journals (Sweden)

    Satinder Pal Aggarwal

    2015-01-01

    Full Text Available Objectives. To evaluate the safety and efficacy of Tadalafil and Tamsulosin in treating Double J stent related symptoms. Methods. In a prospective study, 161 patients with DJ related symptoms were randomized into 3 groups: Group A patients (54, Group B patients (53, and Group C patients (54. They were given Tadalafil, Tamsulosin, and placebo, respectively, at 1st week till removal of DJ stent at 3rd week. All patients completed Ureteral Stent Symptom Questionnaire (USSQ at 1st week and at 3rd week. The statistical significant difference among groups was determined by the t-test, Kruskal-Wallis test and multivariate analysis were used to assess association of the variables within the three groups, and the level of significance was set at P<0.05. Results. Tadalafil and Tamsulosin were comparable in relieving urinary symptoms, general health, and work performance (OR = 0.65, 1.8, and 0.92. But Tadalafil was more effective in relieving body pain, sexual problems, and additional problems than Tamsulosin (OR = 5.95, 19.25, and 2.69 and was statistically significant as P<0.05. Conclusion. Tadalafil was as effective as Tamsulosin in relieving urinary symptom but more effective in relieving sexual symptoms and body pain.

  13. Stent intussusception after thromboaspiration through a platinum chrome stent: a particular case of longitudinal stent deformation.

    Science.gov (United States)

    Mila, Rafael; Vignolo, Gustavo; Trujillo, Pedro

    2015-04-01

    The need to improve stent deliverability has led to the development of thinner and more flexible stents. However, there is concern about decreased longitudinal strength. The number of longitudinal stent deformation reports has dramatically increased. We report a case of stent longitudinal deformation after thromboaspiration through a new generation platinum chrome bare metal stent. Images show an "intussusception effect," an extreme form of the previously described "concertina deformation," as the mechanism of shortening. Since stent technology is constantly evolving, newer devices will probably be designed to have less susceptibility to longitudinal stent deformation.

  14. Influence of covered stent versus bare stent on long-term efficacy of transjugular intrahepatic portosystemic shunt: a meta-analysis

    Directory of Open Access Journals (Sweden)

    XU Lu

    2016-10-01

    Full Text Available Objective To investigate the long-term postoperative efficacy of transjugular intrahepatic portosystemic shunt (TIPS using polytetrafluoroethylene (PTFE-covered stent or bare stent, and to provide a basis of evidence-based medicine for the selection of stent in TIPS. Methods CBM, Wanfang Data, CNKI, VIP, MEDLINE, and PubMed were searched for controlled trials on TIPS in the treatment of cirrhotic portal hypertension published form 1989 to 2015; the studies which met the inclusion criteria were selected, and quality assessment was performed for these articles. RevMan 5.3 software was used to analyze the incidence rates of stent dysfunction and hepatic encephalopathy and 1-year survival rate after TIPS, and funnel plots were used to analyze publication bias. Results A total of 11 studies were included, consisting of 698 patients in PTFE-covered stent group and 1283 patients in bare stent group. The results of the meta-analysis showed that the PTFE-covered stent group showed a significantly lower incidence rate of stent dysfunction than the bare stent group (14.8% vs 47.0%, OR=0.18, 95% CI: 0.13-0.24, P<0.001. There was no significant difference in the incidence rate of hepatic encephalopathy between the two groups (23.5% vs 25.7%, OR=0.88, 95% CI: 0.66-1.17, P=0.37. The PTFE-covered stent group had a significantly higher 1-year survival rate than the bare stent group (76.9% vs 62.7%, OR=2.10, 95% CI: 1.54-2.85, P<0.001. The funnel plots which were plotted based on the incidence rates of stent dysfunction and hepatic encephalopathy and 1-year survival rate lacked symmetry, which suggested that a certain degree of publication bias might exist. Conclusion Compared with the bare stent, the PTFE-covered stent can improve stent dysfunction and 1-year survival rate after TIPS, while there is no significant change in the incidence rate of hepatic encephalopathy. Therefore, the PTFE-covered stent has certain advantages over the bare stent in TIPS. In

  15. SU-F-P-52: A Meta-Analysis of Controlled Clinical Trials Comparing Elective Nodal Irradiation with Involved-Field Irradiation for Conformal Or Intensity-Modulated Radiotherapy in Patients with Esophageal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Bai, W; Zhang, R; Zhou, Z; Qiao, X [The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei (China)

    2016-06-15

    Purpose: To compare elective nodal irradiation with involved-field irradiation for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer by a metaanalysis. Methods: Wanfang, CNKI, VIP, CBM databases, PubMed, Embase and Cochrane Library were searched to identify the controlled clinical trials of elective nodal irradiation with involved-field irradiation for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer. The obtained data were analyzed using Stata 11.0. The difference between two groups was estimated by calculating the odds ratio (OR) with 95% confidence interval (95% CI). Results: A total of 12 controlled clinical trials involving 1095 esophageal cancer patients, which were selected according to inclusion and exclusion criteria, were included in this meta-analysis. The meta-analysis showed that the elective nodal irradiation group reduced the rates of out-field failure comparing with involved-field irradiation group (OR=3.727, P=0.007). However, the rates of ≥grades 3 acute radiation pneumonitis and esophagitis were significantly higher in the elective nodal irradiation group than in the involved-field irradiation group (OR=0.348, P=0.001, OR=0.385, P=0.000). 1-, 2-, 3-year local control rates (OR=0.966, P=0.837, OR=0.946, P=0.781; OR=0.732P=0.098) and 1-, 3-, 5-year survival rates were similar in the two groups ( OR=0.966, P=0.837; OR=0.946, P=0.781; OR=0.732, P=0.098; OR=0.952, P=0.756; OR=1.149, P=0.422; OR=0.768, P=0.120). It is the same with the rates of distant metastasis (OR=0.986, P=0.937). Conclusion: Compared with involved-field irradiation, the elective nodal irradiation can reduce the rates of out-field failure for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer. However, its advantage of local control and survival rates is not obvious and it increases the incidence

  16. Stents and surgical interventions in the palliation of gastric outlet obstruction: a systematic review

    Science.gov (United States)

    Minata, Mauricio Kazuyoshi; Bernardo, Wanderley Marques; Rocha, Rodrigo Silva de Paula; Morita, Flavio Hiroshi Ananias; Aquino, Julio Cesar Martins; Cheng, Spencer; Zilberstein, Bruno; Sakai, Paulo; de Moura, Eduardo Guimarães Hourneaux

    2016-01-01

    Background and study aims: Palliative treatment of gastric outlet obstruction can be done with surgical or endoscopic techniques. This systematic review aims to compare surgery and covered and uncovered stent treatments for gastric outlet obstruction (GOO). Patients and methods: Randomized clinical trials were identified in MEDLINE, Embase, Cochrane, LILACs, BVS, SCOPUS and CINAHL databases. Comparison of covered and uncovered stents included: technical success, clinical success, complications, obstruction, migration, bleeding, perforation, stent fracture and reintervention. The outcomes used to compare surgery and stents were technical success, complications, and reintervention. Patency rate could not be included because of lack of uniformity of the extracted data. Results: Eight studies were selected, 3 comparing surgery and stents and 5 comparing covered and uncovered stents.The meta-analysis of surgical and endoscopic stent treatment showed no difference in the technical success and overall number of complications. Stents had higher reintervention rates than surgery (RD: 0.26, 95 % CI [0.05, 0.47], NNH: 4). There is no significant difference in technical success, clinical success, complications, stent fractures, perforation, bleeding and the need for reintervention in the analyses of covered and uncovered stents. There is a higher migration rate in the covered stent therapy compared to uncovered self-expanding metallic stents (SEMS) in the palliation of malignant GOO (RD: 0.09, 95 % CI [0.04, 0.14], NNH: 11). Nevertheless, covered stents had lower obstruction rates (RD: – 0.21, 95 % CI [-0.27, – 0.15], NNT: 5). Conclusions: In the palliation of malignant GOO, covered SEMS had higher migration and lower obstruction rates when compared with uncovered stents. Surgery is associated with lower reintervention rates than stents. PMID:27857965

  17. 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.

    Science.gov (United States)

    Campos, Carlos M; van Klaveren, David; Farooq, Vasim; Simonton, Charles A; Kappetein, Arie-Pieter; Sabik, Joseph F; Steyerberg, Ewout W; Stone, Gregg W; Serruys, Patrick W

    2015-05-21

    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. Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization is a prospective, randomized multicenter trial designed to establish the efficacy and safety of percutaneous coronary intervention (PCI) with the everolimus-eluting stent compared with coronary artery bypass graft (CABG) surgery in subjects with unprotected left-main coronary artery (ULMCA) disease and low-intermediate anatomical SYNTAX scores (EXCEL, the SYNTAX Score II was prospectively applied to predict 4-year mortality in the CABG and PCI arms. The 95% prediction intervals (PIs) for mortality were computed using simulation with bootstrap resampling (10 000 times). For the entire study cohort, the 4-year predicted mortalities were 8.5 and 10.5% in the PCI and CABG arms, respectively [odds ratios (OR) 0.79; 95% PI 0.43-1.50). In subjects with low (≤22) anatomical SYNTAX scores, the predicted OR was 0.69 (95% PI 0.34-1.45); in intermediate anatomical SYNTAX scores (23-32), the predicted OR was 0.93 (95% PI 0.53-1.62). Based on 4-year mortality predictions in EXCEL, clinical characteristics shifted long-term mortality predictions either in favour of PCI (older age, male gender and COPD) or CABG (younger age, lower creatinine clearance, female gender, reduced left ventricular ejection fraction). The SYNTAX Score II indicates at least an equipoise for long-term mortality between CABG and PCI in subjects with ULMCA disease up to an intermediate anatomical complexity. Both anatomical and clinical characteristics had a clear impact on long-term mortality predictions and decision making between CABG and PCI. Published on behalf of the European Society of Cardiology. All rights reserved. © The

  18. Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY (Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial.

    Science.gov (United States)

    Costa, Francesco; Vranckx, Pascal; Leonardi, Sergio; Moscarella, Elisabetta; Ando, Giuseppe; Calabro, Paolo; Oreto, Giuseppe; Zijlstra, Felix; Valgimigli, Marco

    2015-05-21

    We investigated if acute coronary syndrome (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual-antiplatelet therapy (DAPT) in patients undergoing coronary stenting. In the Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial, a total of 1465 (74.3%) patients presented ACS whereas 505 (25.7%) had SCAD and were randomized to 6- or 24-month DAPT. At 24 months, the composite of death, myocardial infarction (MI), or cerebrovascular accident (CVA) did not differ between the long- and short-term DAPT arms in both ACS (11.1 vs. 11.7%; P = 0.67) and SCAD (7.5 vs. 4.8%; P = 0.21) patients, respectively. Long-term DAPT was associated with a 75% increase of Bleeding Academic Research Consortium (BARC)-class 2, 3, or 5 bleeding in ACS [7.1 vs. 4.1%; hazard ratio (HR) 1.75, 95% confidence interval (CI) 1.11-2.74, P = 0.015; number needed to treat for harm (NNTH): 33.3] and a five-fold increase in SCAD (8.2 vs. 1.6%; HR 5.37, 95% CI 1.84-15.74, P = 0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (PINT = 0.056). As a result, net adverse cardiovascular events (death, MI, CVA, BARC class 2, 3, or 5 bleeding) were more than doubled in SCAD patients receiving 24-month DAPT, whereas they did not differ in ACS patients (PINT = 0.024). This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD-but not ACS-patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy. clinicaltrials.gov Identifier: NCT00611286. http://clinicaltrials.gov/ct2/show/NCT00611286?term=prodigy&rank=2. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  19. Auxetic coronary stent endoprosthesis

    DEFF Research Database (Denmark)

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

    2014-01-01

    to determine the effects of fabrication processes on the topography of the auxetic stent. RESULTS AND CONCLUSIONS: The elastic recoil (3.3%) of the in vitro mechanical analysis showed that the auxetic stent design effectively maintained the luminal patency of the coronary artery. Also, the auxetic coronary...... 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...

  20. The Sigma-trial protocol: a prospective double-blind multi-centre comparison of laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis

    NARCIS (Netherlands)

    Klarenbeek, Bastiaan R.; Veenhof, Alexander A. F. A.; de Lange, Elly S. M.; Bemelman, Willem A.; Bergamaschi, Roberto; Heres, Piet; Lacy, Antonio M.; van den Broek, Wim T.; van der Peet, Donald L.; Cuesta, Miguel A.

    2007-01-01

    BACKGROUND: Diverticulosis is a common disease in the western society with an incidence of 33-66%. 10-25% of these patients will develop diverticulitis. In order to prevent a high-risk acute operation it is advised to perform elective sigmoid resection after two episodes of diverticulitis in the

  1. Tracheomalatia, to stent or not to stent

    Directory of Open Access Journals (Sweden)

    Irena Perić

    2015-01-01

    Full Text Available Benign thyroid disorders such as goiter, especially retrosternal, can cause tracheostenosis by extrinsic tracheal compression, which is due to the lack of specific symptoms often misdiagnosed. Tracheomalatia develops as a result to long term tracheal compression and refers to weakness of the trachea characterized by softness of the tracheal cartilage arches and by loss of regular tracheal structure. Tracheomalatia is characterized by reduction of the endotracheal lumen and may affect the entire trachea or may be localized to one portion of it. We present the case of a 72-year old patient with distinct tracheostenosis and tracheomalatia, caused by long term pressure by the retrosternal goiter. We have been monitoring the patient for last 20 years after the second endotracheal stent had been placed. The first one was placed 34 years ago, in 1981. On both occasions granulation tissue and colonization of bacteria occurred. In the end the placed stents were rejected and migrated to the main carina. Despite the tracheal diameter narrower than 5 mm the patient has been living normally without the stent for 17 years, with the exception of no hard physical labor. He had a few short term antibiotic therapies and bronchial toilets during symptomatic deteriorations. Diagnosing retrosternal goiter and surgical treatment on time is of crucial importance in cases such as this one. Considering the complications caused by the stent, our opinion is that the majority of patients may require conservative treatment with closely monitoring during respiratory infections.

  2. Treatment of proximal segment stenoses of vertebral arteries with baloon expandable silicon carbide coated stents

    Directory of Open Access Journals (Sweden)

    Šeruga Tomaž

    2013-01-01

    Conclusions: Stenting of the vertebral arteries can significantly improve hemodynamic conditions in the posterior circulation and prevent recurrent transient ischemic attacks and worsening of vertebro-basilar symptoms. So far, less than twenty studies have been published on the stenting of vertebral arteries worldwide. Randomized larger prospective trials are needed to confirm the benefit of endovascular treatment of vertebral artery stenosis, also by use of drugeluting stents.

  3. Automated detection of vessel lumen and stent struts in intravascular optical coherence tomography to evaluate stent apposition and neointimal coverage

    Energy Technology Data Exchange (ETDEWEB)

    Nam, Hyeong Soo; Kim, Chang-Soo; Yoo, Hongki, E-mail: kjwmm@korea.ac.kr, E-mail: hyoo@hanyang.ac.kr [Department of Biomedical Engineering, Hanyang University, Seoul 04763 (Korea, Republic of); Lee, Jae Joong; Song, Joon Woo; Kim, Jin Won, E-mail: kjwmm@korea.ac.kr, E-mail: hyoo@hanyang.ac.kr [Division of Interventional Cardiology, Cardiovascular Center, Korea University Guro Hospital, Seoul 08308 (Korea, Republic of)

    2016-04-15

    various clinical cases to demonstrate its reliability. Therefore, this technique can be effectively utilized for clinical trials on stent-related side effects, including in-stent thrombosis and in-stent restenosis.

  4. Agreement of duplex ultrasonography vs. computed tomography angiography for evaluation of native and in-stent SFA re-stenosis--findings from a randomized controlled trial.

    Science.gov (United States)

    Langenberger, Herbert; Schillinger, Martin; Plank, Christina; Sabeti, Schila; Dick, Petra; Cejna, Manfred; Lammer, Johannes; Minar, Erich; Loewe, Christian

    2012-09-01

    Multidetector CT angiography (CTA) is a non-invasive imaging technique for evaluation of peripheral vascular disease. CTA might be particularly useful for assessment of intermediate- and long-term morphological outcome after endovascular treatment. Validation of CTA vs. the current imaging standard, colour Doppler ultrasonography (CDUS), for quantification of native and in-stent re-stenosis in the superficial femoral artery (SFA) is required. Seventy randomized patients who underwent stent implantation (n=47) or balloon angioplasty (n=23) underwent 6-month follow-up with CDUS and CTA. CTA was compared with CDUS in both sub-groups of patients in terms of binary re-stenosis (>50% lumen narrowing) and re-occlusion. Agreement between CTA and CDUS was assessed using Kappa (κ) statistics with 95% confidence intervals, and correlation coefficients. Binary re-stenosis was detected in 16/70 (22.9%) patients by CTA and 17/70 (24.3%) patients by CDUS (κ=0.88, 95% CI: 0.80-0.96). Re-stenosis rates after balloon angioplasty were 39.1% (9/23) on CTA and CDUS (κ=0.82, 95% CI: 0.66-0.98), and after stent implantation 14.9% (7/47) on CTA and 17.0% (8/47) on CDUS (κ=0.92, 95% CI: 0.84-1.00). Re-occlusions were detected in 3/70 (4.3%) patients by both CTA and CDUS (κ=0.65; 95% CI 0.54-0.76). Significant correlations (r=0.85, pSFA obstructions. CTA is an appropriate non-invasive imaging modality for follow-up after endovascular therapy. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  5. 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

    (s). A final OCT was performed in case of reintervention. Six-month OCT follow-up was available in 85 patients. Twenty-three (46%) OCT-guided patients had additional postdilation or stenting. The percentage of acutely malapposed struts was substantially lower in the OCT-guided group (3.4% [interquartile range......, 0.3-7.6] versus 7.8% [interquartile range, 2.3-19.4]; Pinterquartile range, 1.2-9.8] versus 9.0% [interquartile range, 5.5-14.5], P

  6. Randomized Comparison of Final Kissing Balloon Dilatation Versus No Final Kissing Balloon Dilatation in Patients With Coronary Bifurcation Lesions Treated With Main Vessel Stenting. Five Year Clinical Outcome in The Nordic-Baltic Bifurcation Study III

    DEFF Research Database (Denmark)

    Niemelä, Matti; Holm, Niels R; Kervinen, Kari

    2015-01-01

    Background- It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting...... angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http...

  7. Advantages and disadvantages of biodegradable platforms in drug eluting stents.

    Science.gov (United States)

    Rodriguez-Granillo, Agustina; Rubilar, Bibiana; Rodriguez-Granillo, Gaston; Rodriguez, Alfredo E

    2011-03-26

    Coronary angioplasty with drug-eluting stent (DES) implantation is currently the most common stent procedure worldwide. Since the introduction of DES, coronary restenosis as well as the incidence of target vessel and target lesion revascularization have been significantly reduced. However, the incidence of very late stent thrombosis beyond the first year after stent deployment has more commonly been linked to DES than to bare-metal stent (BMS) implantation. Several factors have been associated with very late stent thrombosis after DES implantation, such as delayed healing, inflammation, stent mal-apposition and endothelial dysfunction. Some of these adverse events were associated with the presence of durable polymers, which were essential to allow the elution of the immunosuppressive drug in the first DES designs. The introduction of erodable polymers in DES technology has provided the potential to complete the degradation of the polymer simultaneously or immediately after the release of the immunosuppressive drug, after which a BMS remains in place. Several DES designs with biodegradable (BIO) polymers have been introduced in preclinical and clinical studies, including randomized trials. In this review, we analyze the clinical results from 6 observational and randomized studies with BIO polymers and discuss advantages and disadvantages of this new technology.

  8. Stent Fracture after Everolimus-Eluting Stent Implantation

    Directory of Open Access Journals (Sweden)

    Ali S. Almasood

    2011-01-01

    Full Text Available Compared with bare-metal stents, drug-eluting stents (DES have greatly reduced the risk of in-stent restenosis (ISR by inhibiting neointimal growth. Nevertheless, DES are still prone to device failure, which may lead to cardiac events. Recently, stent fracture (SF has emerged as a potential mechanism of DES failure that is associated with ISR. Stent fracture is strongly related to stent type, and prior reports suggest that deployment of sirolimus eluting stents (SES may be associated with a higher risk of SF compared to other DES. Everolimus eluting stents (EESs represent a new generation of DES with promising results. The occurrence of SF with EES has not been well established. The present paper describes two cases of EES fracture associated with ISR.

  9. 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

  10. Clinical outcomes of secondary stent-in-stent self-expanding metal stent placement for primary stent malfunction in malignant gastric outlet obstruction.

    Science.gov (United States)

    Park, Jun Chul; Park, Jae Jun; Cheoi, Kungseok; Chung, Hyunsoo; Lee, Hyuk; Shin, Sung Kwan; Lee, Sang Kil; Lee, Yong Chan

    2012-12-01

    Although a substantial number of patients require secondary stents insertion due to primary stent malfunction in malignant gastric outlet obstruction, data on the outcomes of secondary self-expanding metal stents are sparse. To investigate clinical outcomes and factors related with secondary stent malfunction in patients with malignant gastric outlet obstruction given secondary stent-in-stent self-expanding metal stent insertion. For this retrospective study, a total 77 patients who underwent secondary stent-in-stent self-expanding metal stent placement for primary stent malfunction in malignant gastric outlet obstruction were enrolled. We compared the effectiveness and complications of secondary covered and uncovered stents and explored the predictive factors for stent malfunction. Stent-in-stent self-expanding metal stent placements were technically successful in all patients. Both groups also had comparable clinical success rates (covered stent, 87.2% and uncovered stent, 90.0%, P = 1.000). Stent malfunction rates (31.9% and 36.7% respectively, P = 0.805) and median patency time of stent (165 [95% confidence interval: 112-218] and 165 [95% confidence interval: 126-204] days, respectively, P = 0.358) were similar between secondary covered and uncovered stents. Longer patients' survival time (≥ 100 days) was associated with increased risk of stent malfunction (odds ratio: 4.598; 95% confidence interval: 1.473-14.355; P = 0.009). Secondary stent-in-stent self-expanding metal stent placement is feasible and effective treatment for primary stent malfunctions in malignant gastric outlet obstruction. Covered and uncovered stent are equally acceptable in terms of stent-related complications and stent patency, regardless of primary stent type. Copyright © 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  11. A multicentre, prospective, randomised, blinded clinical trial to compare some perioperative effects of buprenorphine or butorphanol premedication before equine elective general anaesthesia and surgery

    OpenAIRE

    Taylor, P. M.; Hoare, H. R.; de Vries, A.; Love, E. J.; Coumbe, K. M.; White, KL; Murrell, J. C.

    2016-01-01

    Reasons for performing study: Buprenorphine, a μ-agonist opioid, has recently been licensed for equine use, but butorphanol, a κ-agonist opioid, is more commonly used in horses. The effect of the 2 opioids has not previously been compared in a large clinical study. Objectives: To compare post operative analgesia and physiological variables in horses undergoing elective surgery following premedication with either buprenorphine or butorphanol in a conventional clinical setting. Study design: Mu...

  12. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial.

    Science.gov (United States)

    Sambola, Antonia; Montoro, J Bruno; Del Blanco, Bruno García; Llavero, Nadia; Barrabés, José A; Alfonso, Fernando; Bueno, Héctor; Cequier, Angel; Serra, Antonio; Zueco, Javier; Sabaté, Manel; Rodríguez-Leor, Oriol; García-Dorado, David

    2013-10-01

    Oral anticoagulation (OAC) is the recommended therapy for patients with atrial fibrillation (AF) because it reduces the risk of stroke and other thromboembolic events. Dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention and stenting (PCI-S). In patients with AF requiring PCI-S, the association of DAPT and OAC carries an increased risk of bleeding, whereas OAC therapy or DAPT alone may not protect against the risk of developing new ischemic or thromboembolic events. The MUSICA-2 study will test the hypothesis that DAPT compared with triple therapy (TT) in patients with nonvalvular AF at low-to-moderate risk of stroke (CHADS2 score ≤2) after PCI-S reduces the risk of bleeding and is not inferior to TT for preventing thromboembolic complications. The MUSICA-2 is a multicenter, open-label randomized trial that will compare TT with DAPT in patients with AF and CHADS2 score ≤2 undergoing PCI-S. The primary end point is the incidence of stroke or any systemic embolism or major adverse cardiac events: death, myocardial infarction, stent thrombosis, or target vessel revascularization at 1 year of PCI-S. The secondary end point is the combination of any cardiovascular event with major or minor bleeding at 1 year of PCI-S. The calculated sample size is 304 patients. The MUSICA-2 will attempt to determine the most effective and safe treatment in patients with nonvalvular AF and CHADS2 score ≤2 after PCI-S. Restricting TT for AF patients at high risk for stroke may reduce the incidence of bleeding without increasing the risk of thromboembolic complications. © 2013.

  13. Clinical studies with sirolimus, zotarolimus, everolimus, and biolimus A9 drug-eluting stent systems

    NARCIS (Netherlands)

    Claessen, Bimmer E.; Henriques, José P. S.; Dangas, George D.

    2010-01-01

    The introduction of the drug-eluting stent (DES) has revolutionized the field of interventional cardiology during the past decade. Initial pivotal randomized clinical trials showed a large reduction in restenosis rates and the need for repeat intervention with DES compared with bare-metal stents.

  14. Self-Expandable Metal Stents for Colorectal Cancer: From Guidelines to Clinical Practice

    Directory of Open Access Journals (Sweden)

    Maria Pia Costa Santos

    2016-11-01

    Conclusions: In this study, stent placement was an effective procedure in obstructive colorectal cancer. It was mainly used as a bridge to elective surgery. However, a significant rate of silent perforation was observed, which may compromise the oncological outcome of these potentially curable patients. Prospective real life studies are warranted for a better definition of actual recommendations.

  15. New generation urethral stents in treatment bladder outlet obstruction caused by prostate cancer.

    Science.gov (United States)

    Markovic, B; Markovic, Z; Filimonovic, J; Hadzi Djokic, J

    2005-01-01

    Our clinical trial included until now, 22 patients in whom new generation urethral stent named Allium, were inserted due to bladder outlet obstruction caused in 7 patients (pt) with benign prostate hyperplasia, in 13 pt with bulbar urethral stricture of different ethiology and in 2 pt with prostate cancer. Allium prostatic stents, designed by Daniel Yachia differs in some crucial characteristics from previously used stents: they are covered for the first time in urethra stenting history, without relatively low radiation force and because of that nonirritative. The indications, contraindications and preliminary results in this study are discussed concerning the patients with cancer of the prostate.

  16. Ultrasound thrombolysis in stent thrombosis.

    Science.gov (United States)

    Rassin, T; Desmet, W; Piessens, J; Rosenschein, U

    2000-11-01

    Recent refinement in stent implantation technique and peri-procedural pharmacological treatment has lowered the incidence of stent thrombosis significantly. Still, all stent thromboses are associated with major adverse events. In previous studies it has been suggested that intravascular ultrasound fibrinolysis is safe and effective. In this report, ultrasound successfully reperfused thrombotically occluded stents. These observations suggest that ultrasound may dissolve occlusive platelet-rich thrombus effectively and safely. Cathet. Cardiovasc. Intervent. 51:332-334, 2000. Copyright 2000 Wiley-Liss, Inc.

  17. Clinical Events and Patient-Reported Chest Pain in All-Comers Treated With Resolute Integrity and Promus Element Stents : 2-Year Follow-Up of the DUTCH PEERS (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial (TWENTE II)

    NARCIS (Netherlands)

    Sen, Hanim; Sen, Hanim; Lam, Ming Kai; Löwik, Marije M.; Danse, Peter W.; Jessurun, Gillian A.J.; van Houwelingen, K. Gert; Anthonio, Rutger; Gin, R. Melvyn Tjon Joe; Hautvast, Raymond W.M.; Louwerenburg, J. (Hans) W.; de Man, Frits H.A.F.; Stoel, Martin G.; van der Heijden, Liefke C.; Linssen, Gerard C.M.; IJzerman, Maarten Joost; Tandjung, K.; Tandjung, Kenneth; Doggen, Catharina Jacoba Maria; von Birgelen, Clemens

    2015-01-01

    Objectives This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick,

  18. Future developments in biliary stenting

    Directory of Open Access Journals (Sweden)

    Hair CD

    2013-06-01

    Full Text Available Clark D Hair,1 Divyesh V Sejpal21Department of Medicine, Section of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, TX, USA; 2Department of Medicine, Section of Gastroenterology, Hofstra North Shore-LIJ School of Medicine, North Shore University Hospital, Manhasset, NY, USAAbstract: Biliary stenting has evolved dramatically over the past 30 years. Advancements in stent design have led to prolonged patency and improved efficacy. However, biliary stenting is still affected by occlusion, migration, anatomical difficulties, and the need for repeat procedures. Multiple novel plastic biliary stent designs have recently been introduced with the primary goals of reduced migration and improved ease of placement. Self-expandable bioabsorbable stents are currently being investigated in animal models. Although not US Food and Drug Administration approved for benign disease, fully covered self-expandable metal stents are increasingly being used in a variety of benign biliary conditions. In malignant disease, developments are being made to improve ease of placement and stent patency for both hilar and distal biliary strictures. The purpose of this review is to describe recent developments and future directions of biliary stenting.Keywords: plastic stents, self-expandable metal stents, drug eluting stents, bioabsorbable stents, malignant biliary strictures, benign biliary strictures

  19. Management Of Encrusted Ureteral stents

    African Journals Online (AJOL)

    imac-3

    Mohammed V Military Hospital of Rabat, Morocco. Received 1November 2011; received in revised form 18 May 2012; accepted 14 July 2012. KEYWORDS. Ureteral stent;. JJ stent;. Encrustation. Abstract. Objectives: To present our experience in managing encrusted ureteral stents and to review the literature on the subject.

  20. Postoperative antibacterial prophylaxis for the prevention of infectious complications associated with tube thoracostomy in patients undergoing elective general thoracic surgery: a double-blind, placebo-controlled, randomized trial.

    Science.gov (United States)

    Oxman, David A; Issa, Nicolas C; Marty, Francisco M; Patel, Alka; Panizales, Christia Z; Johnson, Nathaniel N; Licona, J Humberto; McKenna, Shannon S; Frendl, Gyorgy; Mentzer, Steven J; Jaklitsch, Michael T; Bueno, Raphael; Colson, Yolonda; Swanson, Scott J; Sugarbaker, David J; Baden, Lindsey R

    2013-05-01

    To determine whether extended postoperative antibacterial prophylaxis for patients undergoing elective thoracic surgery with tube thoracostomy reduces the risk of infectious complications compared with preoperative prophylaxis only. Prospective, randomized, double-blind, placebo-controlled trial. Brigham and Women's Hospital, an 800-bed tertiary care teaching hospital in Boston, Massachusetts. A total of 251 adult patients undergoing elective thoracic surgery requiring tube thoracostomy between April 2008 and April 2011. Patients received preoperative antibacterial prophylaxis with cefazolin sodium (or other drug if the patient was allergic to cefazolin). Postoperatively, patients were randomly assigned (at a 1:1 ratio) using a computer-generated randomization sequence to receive extended antibacterial prophylaxis (n = 125) or placebo (n = 126) for 48 hours or until all thoracostomy tubes were removed, whichever came first. The combined occurrence of surgical site infection, empyema, pneumonia, and Clostridium difficile colitis by postoperative day 28. A total of 245 patients were included in the modified intention-to-treat analysis (121 in the intervention group and 124 in the placebo group). Thirteen patients (10.7%) in the intervention group and 8 patients (6.5%) in the placebo group had a primary end point (risk difference, -4.3% [95% CI, -11.3% to 2.7%]; P = .26). Six patients (5.0%) in the intervention group and 5 patients (4.0%) in the placebo group developed surgical site infections (risk difference, -0.93% [95% CI, -6.1% to 4.3%]; P = .77). Seven patients (5.8%) in the intervention group and 3 patients (2.4%) in the placebo group developed pneumonia (risk difference, -3.4% [95% CI, -8.3% to 1.6%]; P = .21). One patient in the intervention group developed empyema. No patients experienced C difficile colitis. Extended postoperative antibacterial prophylaxis for patients undergoing elective thoracic surgery requiring tube thoracostomy did not reduce the

  1. Stent sizing strategies in renal artery stenting: the comparison of conventional invasive renal angiography with renal computed tomographic angiography

    Directory of Open Access Journals (Sweden)

    Jacek Kadziela

    2016-05-01

    Full Text Available Introduction : Randomized trials comparing invasive treatment of renal artery stenosis with standard pharmacotherapy did not show substantial benefit from revascularization. One of the potential reasons for that may be suboptimal procedure technique. Aim : To compare renal stent sizing using two modalities: three-dimensional renal computed tomography angiography (CTA versus conventional angiography. Material and methods: Forty patients (41 renal arteries, aged 65.1 ±8.5 years, who underwent renal artery stenting with preprocedural CTA performed within 6 months, were retrospectively analyzed. In CTA analysis, reference diameter (CTA-D and lesion length (CTA_LL were measured and proposed stent diameter and length were recorded. Similarly, angiographic reference diameter (ANGIO_D and lesion length (ANGIO_LL as well as proposed stent dimensions were obtained by visual estimation. Results: The median CTA_D was 0.5 mm larger than the median ANGIO_D (p < 0.001. Also, the proposed stent diameter in CTA evaluation was 0.5 mm larger than that in angiography (p < 0.0001. The median CTA_LL was 1 mm longer than the ANGIO_LL (p = NS, with significant correlation of these variables (r = 0.66, p < 0.0001. The median proposed stent length with CTA was equal to that proposed with angiography. The median diameter of the implanted stent was 0.5 mm smaller than that proposed in CTA (p < 0.0005 and identical to that proposed in angiography. The median length of the actual stent was longer than that proposed in angiography (p = 0.0001. Conclusions : Renal CTA has potential advantages as a tool adjunctive to angiography in appropriate stent sizing. Careful evaluation of the available CTA scans may be beneficial and should be considered prior to the planned procedure.

  2. Stent sizing strategies in renal artery stenting: the comparison of conventional invasive renal angiography with renal computed tomographic angiography.

    Science.gov (United States)

    Kadziela, Jacek; Michalowska, Ilona; Pregowski, Jerzy; Janaszek-Sitkowska, Hanna; Lech, Katarzyna; Kabat, Marek; Staruch, Adam; Januszewicz, Andrzej; Witkowski, Adam

    2016-01-01

    Randomized trials comparing invasive treatment of renal artery stenosis with standard pharmacotherapy did not show substantial benefit from revascularization. One of the potential reasons for that may be suboptimal procedure technique. To compare renal stent sizing using two modalities: three-dimensional renal computed tomography angiography (CTA) versus conventional angiography. Forty patients (41 renal arteries), aged 65.1 ±8.5 years, who underwent renal artery stenting with preprocedural CTA performed within 6 months, were retrospectively analyzed. In CTA analysis, reference diameter (CTA-D) and lesion length (CTA_LL) were measured and proposed stent diameter and length were recorded. Similarly, angiographic reference diameter (ANGIO_D) and lesion length (ANGIO_LL) as well as proposed stent dimensions were obtained by visual estimation. The median CTA_D was 0.5 mm larger than the median ANGIO_D (p < 0.001). Also, the proposed stent diameter in CTA evaluation was 0.5 mm larger than that in angiography (p < 0.0001). The median CTA_LL was 1 mm longer than the ANGIO_LL (p = NS), with significant correlation of these variables (r = 0.66, p < 0.0001). The median proposed stent length with CTA was equal to that proposed with angiography. The median diameter of the implanted stent was 0.5 mm smaller than that proposed in CTA (p < 0.0005) and identical to that proposed in angiography. The median length of the actual stent was longer than that proposed in angiography (p = 0.0001). Renal CTA has potential advantages as a tool adjunctive to angiography in appropriate stent sizing. Careful evaluation of the available CTA scans may be beneficial and should be considered prior to the planned procedure.

  3. Impact of gender on infarct size, ST-segment resolution, myocardial blush and clinical outcomes after primary stenting for acute myocardial infarction: Substudy from the EMERALD trial.

    Science.gov (United States)

    Ng, Vivian G; Mori, Ken; Costa, Ricardo A; Kish, Mitra; Mehran, Roxana; Urata, Hidenori; Saku, Keijiro; Stone, Gregg W; Lansky, Alexandra J

    2016-03-15

    Women with AMI may have worse outcomes than men. However, it is unclear if this is related to differences in treatment, treatment effect or gender specific factors. We sought to determine whether primary percutaneous intervention (PCI) has a differential impact on infarct size, myocardial perfusion and ST segment resolution in men and women with acute myocardial infarction (AMI). A total of 501 AMI patients were prospectively enrolled in the EMERALD study and underwent PCI with or without distal protection. Post hoc gender subset analysis was performed. 501 patients (108 women, 393 men) with ST-segment elevation AMI presenting within 6h underwent primary (or rescue) PCI with stenting and a distal protection device. Women were older, had more hypertension, less prior AMI, smaller BSA, and smaller vessel size, but had similar rates of diabetes (30% versus 20.2%, p=0.87), LAD infarct, and time-to-reperfusion compared to men. Women more frequently had complete ST-resolution (>70%) at 30days (72.8% versus 59.8%, p=0.02), and smaller infarct size compared to males (12.2±19.6% versus 18.4±18.5%, p=0.006). At 6months, TLR (6.9% versus 5.2%) and MACE (11.4% versus 10.3%) were similar for women and men. Despite worse comorbidities, women with AMI treated with primary PCI with stenting showed similar early and midterm outcomes compared to men. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  4. Impact of changing PSVR thresholds on the patency rates of SFA recanalisation with self-expanding nitinol stents.

    Science.gov (United States)

    Higashimori, Akihiro; Kawarada, Osami; Morioka, Nobuyuki; Shiotani, Shinji; Fujihara, Masahiko; Fukuda, Keisuke; Yokoi, Yoshiaki

    2013-12-01

    The primary patency of superficial femoral artery (SFA) stents is evaluated by measuring PSVR. However, each trial uses a different definition of PSVR. We investigated the impact of changing PSVR thresholds on the patency rates of SFA recanalisation with self-expanding nitinol stents. A single-centre retrospective study was conducted. Between 2003 and 2006, 76 consecutive patients (83 limbs) were treated using nitinol self-expanding stents for SFA disease. Primary patency was defined as categories 1 (PSVR SFA stent. We should consider the definition of restenosis in each trial.

  5. Endoscopic Dilatation versus Oesophageal Stent in Benign Oesophageal Stricture

    Directory of Open Access Journals (Sweden)

    Hadyanto Caputra

    2016-09-01

    Full Text Available Aim: Oesophageal stricture is one of the causes of dysphagia. It is a condition in which the lumen of oesophagus is narrowed by fibrotic tissue in the oesophageal wall. It is usually caused by inflammation or any other cause that leads to necrotizing of tissue. It is mainly differentiated into benign or malignant. The aim of this article is to answer the clinical question on the effectiveness of oesophageal stenting compared to endoscopic dilatation in patient with benign oesophageal stricture due to ingestion of corrosive substances, who had undergone several endoscopic dilatations. Method: We conducted search of relevant articles using PubMed search engine to answer the clinical question. Keywords being used during the search process were: ("oesophageal stricture"[All Fields] OR "oesophageal stenosis"[All Fields] AND (("dilatation"[All Fields] AND ("stents"[MeSH Terms] OR "stents"[All Fields] OR "stent"[All Fields]. Results were further converged by adding specific filters, which were full text articles and clinical trial. Results: The chosen article was further appraised in order to identify its validity and eligibility to answer the clinical question. We chose to use CONSORT (statement to improve the quality of reporting of RCTs to facilitate the critical appraisal and interpretation of RCTs. Conclusion: Stenting was associated with greater dysphagia, co-medication and adverse events. No randomized controlled trials which compared biodegradable stents with other stents or with balloon dilatation was identified. Lack of adequately robust evidence for effectiveness and cost-effectiveness formed the rationale of this trial.

  6. A multicentre, prospective, randomised, blinded clinical trial to compare some perioperative effects of buprenorphine or butorphanol premedication before equine elective general anaesthesia and surgery.

    Science.gov (United States)

    Taylor, P M; Hoare, H R; de Vries, A; Love, E J; Coumbe, K M; White, K L; Murrell, J C

    2016-07-01

    Buprenorphine, a μ-agonist opioid, has recently been licensed for equine use, but butorphanol, a κ-agonist opioid, is more commonly used in horses. The effect of the 2 opioids has not previously been compared in a large clinical study. To compare post operative analgesia and physiological variables in horses undergoing elective surgery following premedication with either buprenorphine or butorphanol in a conventional clinical setting. Multicentre, prospective, randomised, blinded clinical investigation. Eighty-nine healthy horses admitted for elective surgery to one of 6 UK equine veterinary clinics were premedicated with acepromazine, a nonsteroidal anti-inflammatory drug, and romifidine followed by intravenous (i.v.) buprenorphine or butorphanol. Anaesthesia was induced with diazepam/ketamine and maintained with isoflurane in oxygen. A range of surgical procedures were performed and supplementary anaesthetic agents given as required. Physiological variables were monitored during anaesthesia and pain, ataxia, sedation and vital function were assessed post operatively. Data were analysed using t-tests, ANOVA, Mann-Whitney U-test and Chi-squared test as appropriate and Pbuprenorphine than after butorphanol. Horses experienced less post operative pain after buprenorphine than after butorphanol premedication. Compared with butorphanol, buprenorphine did not cause any different effects on vital function. © 2015 The Authors. Equine Veterinary Journal published by John Wiley & Sons Ltd on behalf of British Equine Veterinary Association.

  7. Comparison of Prophylactic Infusion of Phenylephrine with Ephedrine for Prevention of Hypotension in Elective Cesarean Section under Spinal Anesthesi: A Randomized Clinical Trial.

    Science.gov (United States)

    Moslemi, Farnaz; Rasooli, Sousan

    2015-01-01

    Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. The aim of this study is to compare the effect of prophylactic infusion of Phenylephrine versus Ephedrine in the prevention of hypotension during spinal anesthesia in elective cesarean section. Eighty-three patients were enrolled in this study and randomly divided into three groups. Group Ph received phenylephrine infusion, group E received ephedrine infusion while group P were delivered placebo. Vital signs (blood pressure, heart rate, and arterial oxygen saturation) were recorded throughout the surgery. Maternal and neonatal perioperative complications were also controlled and recorded. There was an insignificant difference in demographic data between the groups. Systolic and diastolic blood pressures were higher in the phenylephrine group than control, but not higher than the ephedrine group. Maternal dysrhythmias were more common in ephedrine and phenylephrine groups than the control group. Vomiting was more common in ephedrine group (Pcomplication for mother or her fetus. IRCT2012120911700N1.

  8. Intravascular ultrasound assessed incomplete stent apposition and stent fracture in stent thrombosis after bare metal versus drug-eluting stent treatment the Nordic Intravascular Ultrasound Study (NIVUS)

    DEFF Research Database (Denmark)

    Kosonen, Petteri; Vikman, Saila; Jensen, Lisette Okkels

    2013-01-01

    This prospective multicenter registry used intravascular ultrasound (IVUS) in patients with definite stent thrombosis (ST) to compare rates of incomplete stent apposition (ISA), stent fracture and stent expansion in patients treated with drug-eluting (DES) versus bare metal (BMS) stents. ST...

  9. Optimal training strategies for carotid stenting.

    Science.gov (United States)

    Schneider, Peter A

    2005-06-01

    Future participation in the treatment of carotid occlusive disease is dependent on training to perform carotid stent placement. Reviewed herein are strategies for training in carotid stenting. Included in this discussion are; the skills required for carotid stenting, the carotid stent learning curve, a comparison of training and credentialing, and the roles of simulators, courses, and hands-on experience in carotid stent training.

  10. 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

  11. Acupuncture and PC6 stimulation for the prevention of postoperative nausea and vomiting in patients undergoing elective laparoscopic resection of colorectal cancer: a study protocol for a three-arm randomised pilot trial.

    Science.gov (United States)

    Kim, Kun Hyung; Kim, Dae Hun; Bae, Ji Min; Son, Gyung Mo; Kim, Kyung Hee; Hong, Seung Pyo; Yang, Gi Young; Kim, Hee Young

    2017-01-04

    This study aims to assess the feasibility of acupuncture and a Pericardium 6 (PC6) wristband as an add-on intervention of antiemetic medication for the prevention of postoperative nausea and vomiting (PONV) in patients undergoing elective laparoscopic colorectal cancer resection. A total of 60 participants who are scheduled to undergo elective laparoscopic resection of colorectal cancer will be recruited. An enhanced recovery after surgery protocol using standardised antiemetic medication will be provided for all participants. Participants will be equally randomised into acupuncture plus PC6 wristband (Acupuncture), PC6 wristband alone (Wristband), or no acupuncture or wristband (Control) groups using computer-generated random numbers concealed in opaque, sealed, sequentially numbered envelopes. For the acupuncture combined with PC6 wristband group, the embedded auricular acupuncture technique for preoperative anxiolysis and up to three sessions of acupuncture treatments with manual and electrical stimulation within 48 hours after surgery will be provided by qualified Korean medicine doctors. The PC6 wristband will be applied in the Acupuncture and Wristband groups, beginning 1 hour before surgery and lasting 48 hours postoperatively. The primary outcome will be the number of participants who experience moderate or severe nausea, defined as nausea at least 4 out of 10 on a severity numeric rating scale or vomiting at 24 hours after surgery. Secondary outcomes, including symptom severity, participant global assessments and satisfaction, quality of life, physiological recovery, use of medication and length of hospital stay, will be assessed. Adverse events and postoperative complications will be measured for 1 month after surgery. All participants will provide written informed consent. The study has been approved by the institutional review board (IRB). This pilot trial will inform a full-scale randomised trial of acupuncture combined with PC6 stimulation

  12. 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.

  13. 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

  14. A comparison of equivolume, equiosmolar solutions of hypertonic saline and mannitol for brain relaxation in patients undergoing elective intracranial tumor surgery: a randomized clinical trial.

    Science.gov (United States)

    Dostal, Pavel; Dostalova, Vlasta; Schreiberova, Jitka; Tyll, Tomas; Habalova, Jirina; Cerny, Vladimir; Rehak, Svatopluk; Cesak, Tomas

    2015-01-01

    Hyperosmolar solutions have been used in neurosurgery to modify brain bulk and prevent neurological deterioration. The purpose of the study was to compare the effects of equivolume, equiosmolar solutions of mannitol and hypertonic saline (HTS) on brain relaxation and postoperative complications in patients undergoing elective intracranial tumor surgery. In this prospective, randomized study, patients with American Society of Anesthesiologists physical status I to III scheduled to undergo a craniotomy for intracranial tumors were enrolled. Patients received a 3.75 mL/kg intravenous infusion of either 3.2% HTS (group HTS, n=36) or 20% mannitol (group M, n=38). The surgeon assessed the condition of the brain using a 4-point scale after opening the dura. Recorded measures included duration of surgery, blood loss, urine output, volume and type of infused fluids, hemodynamic variables, electrolytes, glucose, creatinine, predefined postoperative complications, and length of intensive care unit and hospital stays. Brain relaxation conditions in group HTS (score 1/2/3/4, n=10/17/2/7) were better than those in group M (score 1/2/3/4, n=3/18/3/14, P=0.0281). Patients in group M had higher urine output, received more crystalloids during surgery, and displayed lower central venous pressure and lower natremia at the end of surgery than did patients in group HTS. No significant differences in postoperative complications or lengths of intensive care unit and hospital stays were observed between the groups. Our results suggest that HTS provides better brain relaxation than mannitol during elective intracranial tumor surgery.

  15. 2016 Presidential Election Durham

    Data.gov (United States)

    City and County of Durham, North Carolina — Voting totals for the 2016 Presidential Election by voting method and precinct. Voting Method Definitions: PROV = Provisional IN-PERSON = In PersonABS-1STOP =...

  16. Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials.

    Science.gov (United States)

    Sotomi, Yohei; Onuma, Yoshinobu; Cavalcante, Rafael; Ahn, Jung-Min; Lee, Cheol Whan; van Klaveren, David; de Winter, Robbert J; Wykrzykowska, Joanna J; Farooq, Vasim; Morice, Marie-Claude; Steyerberg, Ewout W; Park, Seung-Jung; Serruys, Patrick W

    2017-05-01

    The impact of sex on clinical outcomes of percutaneous coronary intervention and coronary artery bypass graft for patients with multivessel coronary disease and unprotected left main disease could be dissimilar between Western and Asian populations. To assess clinical outcomes after percutaneous coronary intervention or coronary artery bypass graft in women and men with multivessel coronary disease and unprotected left main disease, a pooled analysis (n=3280) was performed using the patient-level data from 3 large randomized trials: SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. The primary end point was all-cause death. Of 3280 patients, 794 patients (24.2%) were women. The median follow-up period was 1806 days (1611-1837 days). In women, a high heterogeneity of the treatment effect among the 3 trials was found for all-cause death ( I 2 >50%), whereas in men, it was consistent across the 3 trials. In the Western trial (SYNTAX), female sex favored coronary artery bypass graft compared with percutaneous coronary intervention (hazard ratio (percutaneous coronary intervention) 2.213; 95% confidence interval, 1.242-3.943; P =0.007), whereas in the Asian women (PRECOMBAT and BEST), the treatment effect was neutral between both strategies. Sex interaction with treatment strategy was evident in the Western trial ( P interaction =0.019) but not in the Asian trials (PRECOMBAT P interaction =0.469 and BEST P interaction =0.472; I 2 =58%). The present meta-analysis suggested the presence of the heterogeneous sex-treatment interaction across Asian and Western trials. Considering the ongoing globalization of our medical practice, the heterogeneity of the sex-treatment interaction needs to be

  17. Reduction in cardiac mortality with bivalirudin in patients with and without major bleeding: The HORIZONS-AMI trial (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction).

    Science.gov (United States)

    Stone, Gregg W; Clayton, Tim; Deliargyris, Efthymios N; Prats, Jayne; Mehran, Roxana; Pocock, Stuart J

    The purpose of this study was to determine whether, in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (UFH+GPI) can be fully attributed to reduced bleeding. The association between hemorrhagic complications and mortality may explain the survival benefit with bivalirudin. A total of 3,602 STEMI patients undergoing primary PCI were randomized to bivalirudin versus UFH+GPI. Three-year cardiac mortality was analyzed in patients with and without major bleeding. When compared with UFH+GPI, bivalirudin resulted in lower 3-year rates of major bleeding (6.9% vs. 10.5%, hazard ratio [HR]: 0.64 [95% confidence interval (CI): 0.51 to 0.80], p accounting for major bleeding and other adverse events, bivalirudin was still associated with a 43% reduction in 3-year cardiac mortality (adjusted HR: 0.57 [95% CI: 0.39 to 0.83], p = 0.003). Bivalirudin reduces cardiac mortality in patients with STEMI undergoing primary PCI, an effect that can only partly be attributed to prevention of bleeding. Further studies are required to identify the nonhematologic benefits of bivalirudin. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  18. Stent versus gastrojejunostomy for the palliation of gastric outlet obstruction: a systematic review

    Directory of Open Access Journals (Sweden)

    Kuipers Ernst J

    2007-06-01

    Full Text Available Abstract Background Gastrojejunostomy (GJJ is the most commonly used palliative treatment modality for malignant gastric outlet obstruction. Recently, stent placement has been introduced as an alternative treatment. We reviewed the available literature on stent placement and GJJ for gastric outlet obstruction, with regard to medical effects and costs. Methods A systematic review of the literature was performed by searching PubMed for the period January 1996 and January 2006. A total of 44 publications on GJJ and stents was identified and reported results on medical effects and costs were pooled and evaluated. Results from randomized and comparative studies were used for calculating odds ratios (OR to compare differences between the two treatment modalities. Results In 2 randomized trials, stent placement was compared with GJJ (with 27 and 18 patients in each trial. In 6 comparative studies, stent placement was compared with GJJ. Thirty-six series evaluated either stent placement or GJJ. A total of 1046 patients received a duodenal stent and 297 patients underwent GJJ. No differences between stent placement and gastrojejunostomy were found in technical success (96% vs. 100%, early and late major complications 7% vs. 6% and 18% vs. 17%, respectively and persisting symptoms (8% vs. 9%. Initial clinical success was higher after stent placement (89% vs. 72%. Minor complications were less frequently seen after stent placement in the patient series (9% vs. 33%, however the pooled analysis showed no differences (OR: 0.75, p = 0.8. Recurrent obstructive symptoms were more common after stent placement (18% vs. 1%. Hospital stay was prolonged after GJJ compared to stent placement (13 days vs. 7 days. The mean survival was 105 days after stent placement and 164 days after GJJ. Conclusion These results suggest that stent placement may be associated with more favorable results in patients with a relatively short life expectancy, while GJJ is preferable in

  19. Late in-stent thrombosis following carotid angioplasty and stenting.

    Science.gov (United States)

    Buhk, Jan-Hendrik; Wellmer, Andreas; Knauth, Michael

    2006-05-23

    Acute in-stent thrombosis is a well-known complication of carotid angioplasty and stenting (CAS) and often due to resistance to or inadequate treatment with platelet-inhibiting agents. The authors report three cases of a delayed in-stent thrombosis after more than a week but less than 3 months after CAS. In all cases, the postprocedural antiplatelet regimen was discontinued to enable the treatment of a relevant comorbidity.

  20. Vascular response to percutaneous coronary intervention with biodegradable-polymer vs. new-generation durable-polymer drug-eluting stents: a meta-analysis of optical coherence tomography imaging trials.

    Science.gov (United States)

    Cassese, Salvatore; Xhepa, Erion; Ndrepepa, Gjin; Kufner, Sebastian; Colleran, Roisin; Giacoppo, Daniele; Koppara, Tobias; Mankerious, Nader; Byrne, Robert A; Laugwitz, Karl-Ludwig; Schunkert, Heribert; Fusaro, Massimiliano; Kastrati, Adnan; Joner, Michael

    2018-01-02

    Whether biodegradable-polymer drug-eluting stents (BP-DES) induce a vascular response at follow-up more favourable than that of new-generation durable-polymer drug-eluting stents (DP-DES) remains controversial. We sought to evaluate the vascular response to percutaneous coronary intervention (PCI) with BP-DES vs. new-generation DP-DES as assessed by optical coherence tomography (OCT) imaging at follow-up. We undertook a meta-analysis of aggregate data by searching electronic scientific databases for investigations of PCI-patients receiving BP-DES vs. new-generation DP-DES and OCT imaging at follow-up. The primary outcome was neointima hyperplasia (NIH) thickness. The co-primary outcome was the incidence of lesions with uncovered struts. The main secondary outcome was the incidence of lesions with malapposed struts. Among 10 trials, a total of 544 PCI-patients were assigned to BP-DES (n = 282) or new-generation DP-DES (n = 262). Of these, 447 participants with 480 treated lesions had analysable OCT imaging at a weighted median follow-up of 7 months. Lesions treated with BP-DES vs. new-generation DP-DES showed comparable NIH thickness [weighted mean difference 95% confidence intervals (CI)  = -11.37 (-29.25, 6.52); P = 0.21]. However, thick-struts (>100 μm) BP-DES showed less NIH thickness as compared to new-generation DP-DES [-20.39 (-33.83, -6.95); P = 0.003]. BP-DES vs. new-generation DP-DES showed a higher risk for uncovered struts [odds ratio 95% CI = 3.50 (1.69-7.26); P = 0.0008] and a trend towards higher risk for malapposed struts [2.01 (0.98-4.12); P = 0.06]. In PCI-patients with available OCT imaging at follow-up, BP-DES with thicker backbones delay vascular response as compared with new-generation DP-DES. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com.

  1. Self-expandable metalic endotracheal stent

    International Nuclear Information System (INIS)

    Do, Young Soo; Cho, Dae Soon; Cho, Kyung Ja; Lee, Young Soo; Lee, Mi Jae

    1993-01-01

    Six bare stents and six covered stents were inserted in the trachea of 12 dogs under general anesthesia. After 1-10 weeks of observation, the dogs were killed, and the trachea and lung were examined grossly and histologically. Pneumonia and stent migration were observed more frequently at covered stent group. Inflammatory change of the trachea was more severe at covered stent group. In conclusion, we believe that it is inadequate to insert silicone covered stent in the tracheobronchial tree. (Author)

  2. Impact of final kissing balloon inflation on vessel healing following drug-eluting stent implantation: Insight from the optical coherence tomography sub-study of the J-REVERSE trial.

    Science.gov (United States)

    Takahashi, Hachidai; Otake, Hiromasa; Shinke, Toshiro; Murasato, Yoshinobu; Kinoshita, Yoshihisa; Yamawaki, Masahiro; Takeda, Yoshihiro; Fujii, Kenichi; Yamada, Shin-Ichiro; Shimada, Yoshihisa; Yamashita, Takehiro; Yumoto, Kazuhiko; Hirata, Ken-Ichi

    2016-12-01

    We sought to clarify the impact of final kissing inflation (FKI) after single stenting of bifurcation lesions on vessel healing. From the J-REVERSE registry enrolling 303 bifurcation lesions treated with provisional single stenting using sirolimus- (SES) or everolimus-eluting stent (EES), 65 lesions treated with (n=30) and without (n=35) FKI underwent 9-month follow-up optical coherence tomography. Average stent eccentricity index (SEI: minimum/maximum stent diameter) and neointimal unevenness score (NUS: maximum/average neointimal thickness of the same cross-section) for the proximal, bifurcation, and distal segments were compared between FKI and non-FKI groups. At the proximal segment, the FKI group demonstrated significantly larger average stent area with greater asymmetric stent expansion, and average lumen area remained significantly larger at 9-month follow-up despite a tendency toward greater neointimal proliferation. Jailed strut and thrombus incidence were also significantly lower at the side branch orifice, and NUS was significantly smaller at the bifurcation and proximal segments in the FKI group. Nine months after SES and EES treatment of bifurcation lesions, FKI reduced proximal-segment luminal narrowing. Considering its homogeneous neointimal distribution and fewer jailed struts, FKI may be beneficial for treating bifurcation lesions. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  3. Two-year results of an open-label randomized comparison of everolimus-eluting stents and sirolimus-eluting stents.

    Directory of Open Access Journals (Sweden)

    Matthijs A Velders

    Full Text Available BACKGROUND: Second generation drug-eluting stents were developed to improve the safety and efficacy of first generation stents. So far, limited long term randomized data exist comparing the second generation everolimus-eluting stents (EES with first generation sirolimus-eluting stents (SES. METHODS: A prospective, open-label, randomized, single center trial comparing EES and SES in all-comer patients. The primary endpoint was a composite of cardiac mortality, myocardial infarction and target vessel revascularization. Secondary endpoints included individual components of the composite, along with target lesion revascularization and stent thrombosis. RESULTS: In total, 977 patients were randomized, of which 498 patients to EES and 479 to SES. Average age was 65.2 ± 11.2 years and 71.6% of the population was male. Fifty percent of patients were treated for acute coronary syndrome, more often for ST-elevation myocardial infarctions in EES patients (13.7% vs. 9.2% in SES. In contrast, SES patients more often had prior interventions and showed more calcified lesions. Two-year follow-up was available in 98% of patients. The primary endpoint occurred in 10.7% of EES patients compared to 10.6% of SES patients (HR 1.00, 95% CI 0.68-1.48. Additionally, secondary endpoints were similar between groups. The rate of stent thrombosis was low for both stent types. CONCLUSION: In this all-comer population, there were no differences in endpoints between EES and SES during two-year follow-up. Stent thrombosis rates were low, supporting the safety of drug-eluting stent appliance in clinical practice. TRIAL REGISTRATION: TrialRegister.nl NTR3170.

  4. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Rezaei, Yousef; Khademvatani, Kamal; Rahimi, Behzad; Khoshfetrat, Mehran; Arjmand, Nasim; Seyyed-Mohammadzad, Mir-Hossein

    2016-03-15

    Contrast medium-induced acute kidney injury (CIAKI) is a leading cause of acquired renal impairment. The effects of antioxidants have been conflicting regarding the prevention of CIAKI. We performed a study of vitamin E use to decrease CIAKI in patients undergoing elective coronary angiography. In a placebo-controlled randomized trial at 2 centers in Iran, 300 patients with chronic kidney disease-defined as estimated glomerular filtration rate vitamin E 12 hours before plus 400 mg vitamin E 2 hours before coronary angiography or to receive placebo. The primary end point was the development of CIAKI, defined as an increase ≥0.5 mg/dL or ≥25% in serum creatinine that peaked within 72 hours. Based on an intention-to-treat analysis, CIAKI developed in 10 (6.7%) and 21 (14.1%) patients in the vitamin E and placebo groups, respectively (P=0.037). Change in white blood cell count from baseline to peak value was greater in the vitamin E group compared with the placebo group (-500 [-1500 to 200] versus 100 [-900 to 600]×10(3)/mL, P=0.001). In multivariate analysis, vitamin E (odds ratio 0.408, 95% CI 0.170-0.982, P=0.045) and baseline Mehran score (odds ratio 1.257, 95% CI 1.007-1.569; P=0.043) predicted CIAKI. Prophylactic short-term high-dose vitamin E combined with 0.9% saline infusion is superior to placebo for prevention of CIAKI in patients undergoing elective coronary angiography. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02070679. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  5. Electives during Medical Internship

    International Nuclear Information System (INIS)

    Al-Sultan, Ali I.; Parashar, Shyam K; Al-Ghamdi, Abulmohsin A.

    2003-01-01

    The purpose of study was to find out the reasons for selecting elective rotations during a rotating medical internship.One hundred and seventy-eight medical interns in the College of Medicine, King Faisal University,Dammam, Kingdom of Saudi Arabia during the period March 2001 to August 2002 completed a questionnaire for their selection reasons with responses on a scale of 1-5.The study comprised 60% males and 98.3% Saudis. The most frequently chosen elective is Dermatology 28.1% ,radiology 20.8%, anesthesia 9.6% and otorhinolaryngology (ear, nose and throat [ENT]) 9%. Significantly, more males (89.2%) chose radiology rotation and more females (75%) chose ENT rotation.The leading reasons to choose an elective rotations are;1, to gain broad medical training and education,2, to assist in choice of future speciality and,3, being relevant to future speciality .The mean score for ENT and dermatology is higher than radiology and anesthesia for the response to participate in medical practice in different institute , while dermatology is higher than anesthesia for response to help for getting aceptance for job in the same instituteand radiology is higher than ENT and anesthesia for the response i t has infrequent or no night duties . The reason chosen reflect the educational value of electives and their important role in choosing future career. Dermatology and radiology rotations are most popular electives ,with additional and though different reasons. (author)

  6. Stenting of the right ventricular outflow tract in the high-risk infant with cyanotic teratology of Fallot.

    Science.gov (United States)

    Castleberry, Chesney D; Gudausky, Todd M; Berger, Stuart; Tweddell, James S; Pelech, Andrew N

    2014-03-01

    Neonatal tetralogy of Fallot (TOF) repair carries an increased risk of low birthweight or premature infants. Studies are investigating stents in the right ventricular outflow tract (RVOT) as an alternative to aortopulmonary shunts. The authors review their institutional experience with RVOT stenting in the high-risk infant with TOF. Data on sequential patients who received RVOT stents were reviewed, with collection of their surgical, echocardiographic, and catheterization data. Size-matched control subjects were identified and outcomes compared. Six infants went to the catheterization lab for RVOT stenting from 2008 to 2010. Five of these patients had placement of an RVOT stent after balloon dilation. The median saturations were 71% on 48% fraction of inspired oxygen (FiO2), with improvement to 94% (p < 0.001) on 39% FiO2 24 h after stent placement. As shown by echocardiography, the diameter of the median right pulmonary artery (RPA) was 2.6 mm (z-score, -3.3), and the diameter of the left pulmonary artery (LPA) was 2.0 mm (z-score, -4.5). Repeat echocardiography before surgery showed a statistically significant increase in RPA and LPA size as well as a modified McGoon ratio (p < 0.05). Four of the five patients subsequently underwent TOF repair. No stent fractures occurred. One patient had repair 10 days after stent placement secondary to stent malposition and tricuspid valve injury. The authors' experience with stents in the RVOT of TOF patients has yielded good results, with significant improvement in oxygen saturations. Patients had successful elective surgical repair and stent removal without longer cardiopulmonary bypass times or recognizable complications compared with shunted patients.

  7. Long-term outcome of tandem stenting for stenoses of the intracranial vertebrobasilar artery and vertebral ostium.

    Science.gov (United States)

    Du, B; Wong, E H C; Jiang, W-J

    2009-04-01

    Patients with symptomatic atherosclerotic stenosis of the intracranial vertebrobasilar artery (VBA) have a poor prognosis, and those with coexistent intracranial and extracranial stenoses have worse outcomes despite medical therapy. Our aim was to study the long-term outcome of patients with symptomatic atherosclerotic tandem stenoses at the intracranial VBA and the vertebral artery ostium (VAO) after elective stent placement. Ten consecutive patients (mean age, 65.3 years) with this condition underwent elective stent placement at our institution between September 2001 and December 2007. Technical success was defined as stent placement of both VAO and intracranial VBA stenoses with complete stent coverage of the lesions, residual stenosis of VBA territory after 30 days. Technical success was obtained in 9 of 10 patients without any stroke or death within 30 days. During a median follow-up duration of 32 months, 1 patient had a fatal ischemic stroke in the VBA territory at 4 months, and the other 9 patients were free from stroke recurrence. Thus, the annual stroke rate in VBA territory (including any stroke or death within 30 days) was 3.8%. This pilot study shows that elective stent placement for patients with symptomatic atherosclerotic tandem stenoses at the intracranial VBA and VAO has an acceptable long-term outcome and may be considered as an alternative to medical therapy.

  8. Complication rate in unprotected carotid artery stenting with closed-cell stents

    International Nuclear Information System (INIS)

    Tietke, Marc W.K.; Kerby, Tina; Alfke, Karsten; Riedel, Christian; Rohr, Axel; Jensen, Ulf; Jansen, Olaf; Zimmermann, Phillip; Stingele, Robert

    2010-01-01

    The discussion on the use of protection devices (PDs) in carotid artery stenting (CAS) is gaining an increasing role in lowering the periprocedural complication rates. While many reviews and reports with retrospective data analysis do promote the use of PDs the most recent multi-centre trials are showing advantages for unprotected CAS combined with closed-cell stent designs. We retrospectively analysed 358 unprotected CAS procedures performed from January 2003 to June 2009 in our clinic. Male/female ratio was 2.68/1. The average age was 69.3 years. Seventy-three percent (261/358) showed initial neurological symptoms. All patients were treated on a standardised interventional protocol. A closed and small-sized cell designed stent was implanted in most cases (85.2%). One hundred seventy-one (47.8%) were controlled by Doppler ultrasonography usually at first in a 3-month and later in 6-month intervals. The peri-interventional and 30-day mortality/stroke rate was 4.19% (15/358). These events included three deaths, five hyperperfusion syndromes (comprising one death by a secondary fatal intracranial haemorrhage), one subarachnoid haemorrhage and seven ischaemic strokes. Only 20% (3/15) of all complications occurred directly peri-interventional. The overall peri-interventional complication rate was 0.8% (3/358). Most complications occurred in initial symptomatic patients (5.36%). The in-stent restenosis rate for more than 70% was 7% (12/171) detected at an average of 9.8 month. Our clinical outcome demonstrates that unprotected CAS with small cell designed stents results in a very low procedural complication rate, which makes the use of a protection device dispensable. (orig.)

  9. The Election Machine

    DEFF Research Database (Denmark)

    Vadgaard, Anne Kathrine Pihl

    When democratic elections run smoothly, the practices that ensure a direct – free and fair – link from the will of the people to those who govern are mostly hidden in the bureaucratic machinery of elections. These administrative aspects of elections are seen as a background to the political...... and representational democracy by examining the inner workings of democracy, and as practical achievement for the public administration. In this approach reside at least two claims about democracy. Firstly, in Latourian fashion this thesis argues against the existence of an ahistorical pure form of democracy. Although......, the understanding of the Danish deliberative and representational democracy can be traced back to Hal Koch and Alf Ross, the thesis does not take democratic principles as the point of departure, but as a topic for investigation; as practices in their own right and as practices linked to and intertwined with other...

  10. 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......), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual...... antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. RESULTS: We enrolled 2466 patients. At 390 days...

  11. Delay of surgery after stent placement for resectable malignant colorectal obstruction is associated with higher risk of recurrence

    DEFF Research Database (Denmark)

    Broholm, Malene; Kobborg, Martin; Frostberg, Erik

    2017-01-01

    BACKGROUND: Self-expanding metal stents can be used as bridge to elective surgery for acute malignant colonic obstruction. However, the impact on long-term oncological outcome and the optimal timing of surgery are still unknown. METHOD: This was a retrospective multicenter study performed at four...

  12. Colonic stenting as a bridge to surgery in malignant large-bowel obstruction: a report from two large multinational registries

    DEFF Research Database (Denmark)

    Jiménez-Pérez, J; Casellas, J; García-Cano, J

    2011-01-01

    To date, this is the largest prospective series in patients with malignant colorectal obstruction to evaluate the effectiveness and safety of colonic self-expanding metal stents (SEMSs) as an alternative to emergency surgery. SEMSs allow restoration of bowel transit and careful tumor staging...... in preparation for elective surgery, hence avoiding the high morbidity and mortality associated with emergency surgery and stoma creation....

  13. 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

    disease who were receiving routine clinical care with no direct follow-up. METHODS: We did a single-blind, all-comer superiority trial in adult patients with chronic stable coronary artery disease or acute coronary syndromes, and at least one target lesion. Patients were treated at one of five...

  14. Clinical results of carotid artery stenting with a nitinol self-expanding stent (SMART stent)

    Energy Technology Data Exchange (ETDEWEB)

    Drescher, Robert; Mathias, Klaus D.; Jaeger, Horst J.; Bockisch, Georg; Demirel, Eren; Gissler, Martin H.; Hauth, Elke [Department of Radiology, Staedtische Kliniken Dortmund, Beurhausstrasse 40, 44139 Dortmund (Germany); Department of Radiology and Microtherapy, University Witten/Herdecke (Germany)

    2002-10-01

    Our objective was to assess the technical feasibility and the clinical results of internal carotid artery (ICA) stenting using a nitinol self-expanding stent (SMART stent). In 13 patients 13 high-grade stenoses of the internal carotid artery were treated via an implantation of a SMART stent. In all cases a predilation of the stenosis and a postdilation within the stent were performed. Follow-up examinations were carried out in all patients after a period of 6 months. In each case the implantation of the stent was performed without technical complications. In 12 of 13 cases the stent was placed in the patients' internal carotid artery, in 1 case from the internal to the common carotid artery (CCA). The average degree of stenosis of 78% (70-95%) was reduced to an average of 2.8% (0-21%). The 6-month follow-up angiography showed an average degree of restenosis of 11.8% (0-29%) in 8 of 13 patients. Duplex sonography in the remaining 5 patients demonstrated patent stents. One patient showed brief neurological symptoms during the intervention. No further complications occurred during follow-up time. Treatment of internal carotid artery stenosis with the SMART stent seems technically feasible, safe, and promises long-term patency. (orig.)

  15. 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

    as time-dependent variables. A total of 12,277 patients were treated with stent implantation. Stent thrombosis was observed in 111 (0.9%) patients and in-stent restenosis in 503 (4.1%) patients within 12 months after the index PCI. Occurrence of stent thrombosis was associated with an increased risk...

  16. Does nickel allergy play a role in the development of in-stent restenosis?

    Science.gov (United States)

    El-Mawardy, R; Fuad, H; Abdel-Salam, Z; Ghazy, M; Nammas, W

    2011-11-01

    It was suggested that coronary in-stent restenosis might be triggered by allergy to nickel and molybdenum ions released from stainless-steel stents. We sought to explore any possible relationship between nickel allergy and in-stent restenosis. 50 patients were studied, who underwent elective follow-up coronary angiography for recurrent symptoms after prior coronary stenting, at least 3 months following the index procedure. Consecutively, we enrolled 25 patients with > or = 50% in-stent restenosis (study group), and 25 others with nickel allergy was performed using 5% nickel sulphate solution in petroleum applied as a patch test to the interscapular region by the Finn chamber method. A positive test was defined as an inflammatory response with erythema, edema, papulovesicles, or infiltration after 48 or 72 hours. The mean age of the whole study cohort was 55.9 +/- 13.9 years, 44 (88%) being males. Two patients of the study group (8%) had a history of contact allergy to metals. However, both of them showed a negative patch test result. No patient in the control group had a history of metal allergy (p > 0.05). Only one patient in the study group (4%) had a positive patch test result for nickel contact allergy, whereas all patients in the control group had a negative result (p > 0.05). Based on the available evidence, a cause-effect relationship between nickel allergy and in-stent restenosis cannot be confirmed.

  17. Risk of Stroke or Death Is Associated With the Timing of Carotid Artery Stenting for Symptomatic Carotid Stenosis: A Secondary Data Analysis of the German Statutory Quality Assurance Database.

    Science.gov (United States)

    Tsantilas, Pavlos; Kuehnl, Andreas; Kallmayer, Michael; Knappich, Christoph; Schmid, Sofie; Breitkreuz, Thorben; Zimmermann, Alexander; Eckstein, Hans-Henning

    2018-03-27

    Subgroup analyses from randomized trials indicate that the time interval between the neurologic index event and carotid artery stenting is associated with periprocedural stroke and death rates in patients with symptomatic carotid stenosis. The aim of this article is to analyze whether this observation holds true under routine conditions in Germany. Secondary data analysis was done on 4717 elective carotid artery stenting procedures that were performed for symptomatic carotid stenosis. The patient cohort was divided into 4 groups according to the time interval between the index event and intervention (group I 0-2, II 3-7, III 8-14, and IV 15-180 days). Primary outcome was any in-hospital stroke or death. For risk-adjusted analyses, a multilevel multivariable regression model was used. The in-hospital stroke or death rate was 3.7% in total and 6.0%, 4.4%, 2.4%, and 3.0% in groups I, II, III, and IV, respectively. Adjusted analysis showed a decreased risk for any stroke or death in group III, a decreased risk for any major stroke or death in groups III and IV, and a decreased risk for any death in groups II and III compared to the reference group I. A short time interval between the neurologic index event and carotid artery stenting of up to 7 days is associated with an increased risk for stroke or death under routine conditions in Germany. Although results cannot prove causal relationships, carotid artery stenting may be accompanied by an increased risk of stroke or death during the early period after the index event. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  18. Combined Arterial Infusion and Stent Implantation Compared with Metal Stent Alone in Treatment of Malignant Gastroduodenal Obstruction

    International Nuclear Information System (INIS)

    Wang Zhongmin; Chen Kemin; Gong Ju; Zheng Yunfeng; Wang Tianxiang

    2009-01-01

    .38 to 1.48 (p < 0.01). There were no short-term complications. Late complications including hematemesis (n = 3), migration (n = 12), and stent occlusion due to tumor overgrowth (n = 5) were evenly distributed between the groups. In the DIT group chemotherapy-induced neutropenia and transient renal dysfunction were detected in six patients, which improved after symptomatic management. Mean survival time after the procedure was 5.9 and 11.1 months for MSI and DIT, respectively (P < 0.001). In conclusion, both MSI and DIT offer effective palliation for malignant gastroduodenal obstruction, but DIT appears to offer superior survival over MSI alone. Ideally, a prospective randomized trial comparing these two techniques should be carried out to validate this result.

  19. Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials.

    Science.gov (United States)

    Campos, Carlos M; Caixeta, Adriano; Franken, Marcelo; Bartorelli, Antonio L; Whitbourn, Robert J; Wu, Chiung-Jen; Li Paul Kao, Hsien; Rosli, Mohd Ali; Carrie, Didier; De Bruyne, Bernard; Stone, Gregg W; Serruys, Patrick W; Abizaid, Alexandre

    2018-02-15

    to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups. In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  20. Transanal stent in anterior resection does not prevent anastomotic leakage

    DEFF Research Database (Denmark)

    Bülow, Steffen; Bulut, O; Christensen, Ib Jarle

    2006-01-01

    OBJECTIVE: A defunctioning transanal stent may theoretically reduce the leakage rate after anterior rectal resection. We present a randomized open study with the aim of comparing the leakage rate after anterior resection with a loop ileostomy, a transanal stent, both or neither. PATIENTS AND METH....... On this basis it was decided to discontinue the study prematurely for ethical reasons. CONCLUSION: Decompression of the anastomosis with a transanal stent does not reduce the risk of anastomotic leakage after anterior resection.......OBJECTIVE: A defunctioning transanal stent may theoretically reduce the leakage rate after anterior rectal resection. We present a randomized open study with the aim of comparing the leakage rate after anterior resection with a loop ileostomy, a transanal stent, both or neither. PATIENTS...... AND METHODS: Randomized open trial of 194 patients operated in 11 hospitals during September 2000 to September 2003 with anterior resection for a mobile rectal tumour, 115 men and 79 women, median age 68 years (range 37-90 years). The surgeon decided upon the use of a protective ileostomy, and after...

  1. Engineering Radioactive Stents for the Prevention of Restenosis

    International Nuclear Information System (INIS)

    Bruce Thomadsen; Nickles, Robert J.; Larry DeWerd; Douglass Henderson; Jonathan Nye; Wes Culberson; Stephen Peterson; Michael Meltsner; Liyong Lin

    2004-01-01

    Radiation has become an accepted treatment for the prevention of restenosis (re-blockage) of coronary arteries following angioplasty. Radioactive stents could be the easiest method of delivery for the radiation, although clinical trials were disappointing. One likely reason was the choice of P-32 as the radionuclide, which fails to match the biological needs of the problem. What radionuclide would perform best remains unknown. This project established the physical infrastructure necessary for a rational investigation to determine the optimum radiological characteristics for radioactive stents in the prevention of restenosis following angioplasty. The project investigated methods to activate coronary stents with radionuclides that spanned a range of energies and radiation types that could provide a mapping of the biological response. The project also provided calibration methods to determine the strength of the stents, an a process to calculate the dose distribution actually delivered to the patient's artery--quantities necessary for any future scientific study to improve the effectiveness of radioactive stents. Such studies could benefit the thousands of patients who receive angioplasty each year

  2. Engineering Radioactive Stents for the Prevention of Restenosis

    Energy Technology Data Exchange (ETDEWEB)

    Bruce Thomadsen; Robert J. Nickles; Larry DeWerd; Douglass Henderson; Jonathan Nye; Wes Culberson; Stephen Peterson; Michael Meltsner; Liyong Lin

    2004-09-10

    Radiation has become an accepted treatment for the prevention of restenosis (re-blockage) of coronary arteries following angioplasty. Radioactive stents could be the easiest method of delivery for the radiation, although clinical trials were disappointing. One likely reason was the choice of P-32 as the radionuclide, which fails to match the biological needs of the problem. What radionuclide would perform best remains unknown. This project established the physical infrastructure necessary for a rational investigation to determine the optimum radiological characteristics for radioactive stents in the prevention of restenosis following angioplasty. The project investigated methods to activate coronary stents with radionuclides that spanned a range of energies and radiation types that could provide a mapping of the biological response. The project also provided calibration methods to determine the strength of the stents, an a process to calculate the dose distribution actually delivered to the patient's artery--quantities necessary for any future scientific study to improve the effectiveness of radioactive stents. Such studies could benefit the thousands of patients who receive angioplasty each year.

  3. Elections to Staff Council

    CERN Multimedia

    Staff Association

    2011-01-01

    Elections to fill all seats in the Staff Council are being organized this month. The voting takes place from the 31st of October to the 14th of November, at noon. As you may have noted when reading Echo, many issues concerning our employment conditions are on the agenda of the coming months and will keep the next Staff Council very busy. So, make your voice heard and take part in the elections for a new Staff Council. By doing so, you will be encouraging the men and women who will be representing you over the next two years and they will doubtless appreciate your gratitude. Every member of the Staff Association will have received an email containing a link to the webpage which will allow voting. If you are a member of the Staff Association and you did not receive such an email, please contact the Staff Association secretariat (staff.association@cern.ch). Do not forget to vote * * * * * * * Vote Make your voice heard and be many to elect the new Staff Council. More details on the election...

  4. AGU elects 1989 Fellows

    Science.gov (United States)

    Twenty-two distinguished scientists have been elected Fellows of the Union. Fellows are scientists who are judged by their peers as having attained ackowledged eminence in a branch of geophysics. The number of Fellows elected each year is limited to 0.1 % of the total membership at the time of election. The newly elected Fellows are Walter Alvarez, University of California, Berkeley; John R. Booker, University of Washington, Seattle; Peter G. Brewer, Woods Hole Oceanographie Institution, Woods Hole, Mass.; Michael H. Carr, U.S. Geological Survey, Menlo Park, Calif.; Gedeon Dagan, Tel Aviv University, Israel; James H. Dieterich, USGS, Menlo Park; Thomas Dunne, University of Washington, Seattle; Jack Fooed Evernden, USGS, Menlo Park; Edward A. Flinn, NASA Headquarters, Washington, D.C.; Arnold L. Gordon, Lamont-Doherty Geological Observatory, Palisades, N.Y.; Gerhard Haerendel, Max Planck Institut, Garching, Federal Republic of Germany; David L. Kohlstedt, Cornell University, Ithaca, N.Y.; Robert A. Langel, NASA Goddard Space Flight Center, Greenbelt, MD; James G. Moore, USGS, Menlo Park; Marcia Neugebauer, Jet Propulsion Laboratory, Pasadena, Calif. Robert C. Newton, University of Chicago, Illinois; John A. Orcutt, Scripps Institution of Oceanography, La Jolla, Calif.; Robert B. Smith, University of Utah, Salt Lake City; Bengt U. Sonnerup, Dartmouth College, Hanover, N.H.; Martin A. Uman, University of Florida, Gainesville; Joe Veverka, Cornell University; and James C.G. Walker, University of Michigan, Ann Arbor.

  5. 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

  6. Iraq: Politics, Elections, and Benchmarks

    National Research Council Canada - National Science Library

    Katzman, Kenneth

    2009-01-01

    ... in the January 31, 2009 provincial elections. However, campaigning for the provincial elections, held in all provinces except Kirkuk and the Kurdish-controlled provinces, was relatively peaceful and enthusiastic and there was a more diverse...

  7. 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.

  8. Individualization of metal stents for management of gastric outlet obstruction caused by distal stomach cancer: a prospective study.

    Science.gov (United States)

    Shi, Ding; Bao, Yin-Su; Liu, Yong-Pan

    2013-08-01

    The use of various kinds of metal stents has emerged as an effective palliative treatment for malignant gastric outlet obstruction (GOO). However, most of these metal stents were designed for use in the esophagus or intestine and have a high incidence of stent obstruction and stent migration when used elsewhere. To evaluate the efficacy and safety of individualized stents (designed according to the shape and size of the GOO) in order to determine whether such stents could reduce the incidence of stent obstruction and migration. Multicenter, prospective, clinical trial. Two tertiary-care referral centers. Thirty-seven patients who presented with symptomatic unresectable malignant GOO caused by distal gastric cancer between April 2005 and June 2009. Placement of the individualized metal stents. The primary endpoint was to optimize stent resolution of proximal obstruction as determined by a GOO scoring system. Secondary endpoints were success rates, survival rates, and adverse events. Technical and clinical success was achieved in 97.3% and 94.4% of patients, respectively. The rate of resolution of proximal obstruction by a proximal stent was 97.3%. There were no procedure-related perforations or deaths. No stent migration or obstruction by tumor growth were found. The mean survival time was 232 days (range 28-387 days). A single-arm study in tertiary-care centers. Placement of individualized stents is a safe and effective modality for the palliation of malignant GOO caused by distal stomach cancer and can help reduce tumor ingrowth and stent migration. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  9. Endovascular treatment of isolated common iliac artery aneurysms with short necks using bifurcated stent-grafts.

    Science.gov (United States)

    Wi, Jin; Ko, Young-Guk; Kim, Jung-Sun; Choi, Donghoon; Hong, Myeong-Ki; Lee, Do-Youn; Jang, Yangsoo; Shim, Won-Heum

    2010-07-01

    Elective surgical repair has traditionally been considered to be the treatment of choice for the exclusion of isolated iliac artery aneurysms (IAAs). Recently, endovascular repair has evolved as an alternative to surgical repair, especially in patients at high surgical risk. However, in the absence of sufficient proximal necks, iliac artery aneurysms are not suitable for direct deployment of a tubular-shaped endograft. Here we report two cases of IAAs with short proximal necks that were excluded using an endovascular bifurcated stent-graft. The bifurcated stent-graft was successfully deployed with complete exclusion of the aneurysm. In neither case was there evidence of procedural failures. There were no signs of significant complications. We conclude that endovascular repair of IAAs with short proximal necks is feasible and efficient using an endovascular bifurcated stent-graft.

  10. High-Dose Statin Pretreatment Decreases Periprocedural Myocardial Infarction and Cardiovascular Events in Patients Undergoing Elective Percutaneous Coronary Intervention: A Meta-Analysis of Twenty-Four Randomized Controlled Trials

    Science.gov (United States)

    Wang, Le; Peng, Pingan; Zhang, Ou; Xu, Xiaohan; Yang, Shiwei; Zhao, Yingxin; Zhou, Yujie

    2014-01-01

    Background Evidence suggests that high-dose statin pretreatment may reduce the risk of periprocedural myocardial infarction (PMI) and major adverse cardiac events (MACE) for certain patients; however, previous analyses have not considered patients with a history of statin maintenance treatment. In this meta-analysis of randomized controlled trials (RCTs), we reevaluated the efficacy of short-term high-dose statin pretreatment to prevent PMI and MACE in an expanded set of patients undergoing elective percutaneous coronary intervention. Methods We searched the PubMed/Medline database for RCTs that compared high-dose statin pretreatment with no statin or low-dose statin pretreatment as a prevention of PMI and MACE. We evaluated the incidence of PMI and MACE, including death, spontaneous myocardial infarction, and target vessel revascularization at the longest follow-up for each study for subgroups stratified by disease classification and prior low-dose statin treatment. Results Twenty-four RCTs with a total of 5,526 patients were identified. High-dose statin pretreatment was associated with 59% relative reduction in PMI (odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.34–0.49; Pstatin pretreatment on MACE was significant for statin-naive patients (OR: 0.69; 95% CI: 0.50–0.95; P = 0.02) and prior low dose statin-treated patients (OR: 0.28; 95% CI: 0.12–0.65; P = 0.003); and for patients with acute coronary syndrome (OR: 0.52; 95% CI: 0.34–0.79; P = 0.003), but not for patients with stable angina (OR: 0.71; 95% CI 0.45–1.10; P = 0.12). Long-term effects on survival were less obvious. Conclusions High-dose statin pretreatment can result in a significant reduction in PMI and MACE for patients undergoing elective PCI. The positive effect of high-dose statin pretreatment on PMI and MACE is significant for statin-naïve patients and patients with prior treatment. The positive effect of high-dose statin pretreatment on MACE is significant for

  11. Dissemination of Election Returns Information: The News Election Service during Election 1980.

    Science.gov (United States)

    Garrison, Bruce

    In 1964, the Associated Press, ABC News, CBS News, NBC News, and United Press International formed a consortium called the News Election Service (NES) that was designed to collect one set of election returns for the entire United States. A study was made of NES operations during the presidential election year of 1980 to determine (1) the nature of…

  12. Effect of low-dose ketamine on post-operative serum IL-6 production among elective surgical patients: a randomized clinical trial.

    Science.gov (United States)

    Luggya, Tonny Stone; Roche, Tony; Ssemogerere, Lameck; Kintu, Andrew; Kasumba, John Mark; Kwizera, Arthur; Tindimwebwa, Jose Vb

    2017-06-01

    Surgery and Anesthesia cause an excessive pro-inflammatory response. Mulago Hospital is faced with staff shortage making post-operative pain management difficult.Interleukin-6 (IL-6) drives inflammatory pain, endothelial cell dysfunction and fibrogenesis. Ketamine is cheap and, readily available. We hypothesized that its attenuation of serum IL-6 was a surrogate for clinical benefit. Institutional Review Board's approval was sought and RCT was registered at clinical trials.gov (identifier number: NCT01339065). Consenting patients were randomized to receive pre-incision intravenous ketamine - 0.5mg/kg or 0.9% saline placebo in weighted dosing. Blood samples were collected and laboratory analyzed at baseline, post-operatively in PACU, 24 and 48 hours respectively. We recruited 39 patients of whom 18 were randomized to the ketamine arm and 21 in the placebo arm with follow up at 24 and 48 hours. Serum IL-6 and IL-1β levels were analyzed using ELIZA assay of pre-coated micro wells. Ketamine suppressed serum IL-6 at PACU with reduced increase at 24 hours. There was no reaction in 98% of IL-1β assayed. Low-dose ketamine attenuated early serum IL-6 levels due to surgical response with reduced 24 hour increase, but the difference was not statistically significant and we recommend more studies.

  13. Drug-eluting versus bare metal stents in patients with st-segment-elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) trial

    DEFF Research Database (Denmark)

    Kelbaek, Henning; Thuesen, Leif; Helqvist, Steffen

    2008-01-01

    BACKGROUND: Implantation of drug-eluting stents (DES) limits the rate of coronary restenosis in most patients with coronary artery disease, but data are scarce with regard to their use in patients with ST-segment-elevation myocardial infarction and in connection with distal protection of the micr......BACKGROUND: Implantation of drug-eluting stents (DES) limits the rate of coronary restenosis in most patients with coronary artery disease, but data are scarce with regard to their use in patients with ST-segment-elevation myocardial infarction and in connection with distal protection...... comparable with regard to baseline demographic and angiographic characteristics. The mean late lumen loss was significantly lower in patients treated with a DES (0.06 mm; SD, 0.66 mm) than in patients who had a bare metal stent implanted (0.47 mm; SD, 0.69 mm; Pcomposite end point...

  14. And after the elections!

    CERN Multimedia

    Staff Association

    2015-01-01

    What happens to the newly elected, and the re-elected delegates after the election of the new Staff Council? (see Écho No 47-48 / 2016). It is the outgoing Staff Council which is responsible for preparing the new staff representatives to take on their new roles. To do this, information days are organized in the form of assizes. This year they took place on November 23 in the afternoon; as well as on November 24, bringing together the new Staff Council. These days mainly aim to inform delegates about the role of the Staff Association (SA) at CERN, ist the organs, committees, forums, etc.; with whom the SA interacts, how the work of the Staff Association is organization, the issues on which it works (e.g., the Five-Yearly Review..). These days are like a kind of "induction". Inform, but not only! Assizes are also aiming to integrate the newcomers, inviting them to discover the various internal committees of the SA, explaining to them the challenges ahead as well as defining the act...

  15. And after the Elections!

    CERN Multimedia

    Staff Association

    2017-01-01

    What happens to the newly elected, and the re-elected delegates after the election of the new Staff Council? It is the outgoing Staff Council which is responsible for preparing the new staff representatives to take on their new roles. To do this, information days are organized in the form of assizes. This year they will take place on November 27 in the morning; as well as on November 28, bringing together the new Staff Council. These days mainly aim to inform delegates about the role of the Staff Association (SA) at CERN, the bodies, committees, forums, etc.; with whom the SA interacts, how the work of the SA is organized, the issues on which it works. These days are like a kind of "induction". Inform, but not only! Assizes are also aiming to integrate the newcomers, inviting them to discover the various internal committees of the SA, explaining to them the challenges ahead as well as defining the action plan for 2018. They offer new delegates, if they wish, a godparent (a kind of mentor). I...

  16. Direct implantation of rapamycin-eluting stents with bioresorbable drug carrier technology utilising the Svelte coronary stent-on-a-wire: the DIRECT II study.

    Science.gov (United States)

    Verheye, Stefan; Khattab, Ahmed A; Carrie, Didier; Stella, Pieter; Slagboom, Ton; Bartunek, Jozef; Onuma, Yoshinobu; Serruys, Patrick W

    2016-08-05

    Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions. Direct stenting, particularly in conjunction with transradial intervention (TRI), has been associated with reduced bleeding complications, procedure time, radiation exposure and contrast administration compared to conventional stenting with wiring and predilatation. The low-profile Svelte IDS is designed to facilitate TRI and direct stenting, reducing the number of procedural steps, time and cost associated with coronary stenting. DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomisation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Target vessel failure (TVF), as well as secondary clinical endpoints, will be assessed annually up to five years. At six months, in-stent LLL was 0.09±0.31 mm in the Svelte IDS group compared to 0.13±0.27 mm in the Resolute Integrity group (p<0.001 for non-inferiority). TVF at one year was similar across the Svelte IDS and Resolute Integrity groups (6.5% vs. 9.8%, respectively). DIRECT II demonstrated the non-inferiority of the Svelte IDS to Resolute Integrity with respect to in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

  17. Nigerian Election Management Bodies and their Associated Election Challenges

    Directory of Open Access Journals (Sweden)

    Moses Etila Shaibu

    2018-01-01

    Full Text Available The paper examined the challenges that confront Election Management Bodies (EMBs in conducting free and fair elections in Nigeria. It aligns with the position of extant literature on the subject that elections in Nigeria have been anything but free and fair, and argues that all the EMBs that have so far conducted elections in Nigeria are complicit in perpetrating electoral malpractices. In other words, though there are external factors that undermine the conduct of free, fair and credible elections in Nigeria, EMBs in Nigeria also present themselves as willing tools in the hands of politicians to compromise the integrity of the electoral process. The number of litigations and level of both international and local denunciations that attend every election in Nigeria underscores the magnitude of electoral malfeasance inherent in the elections conducted by successive EMBs in Nigeria. The paper analysed the major challenges that inhibit the conduct of free and fair elections in Nigeria and proffered solutions to them. Relying heavily on the documentary methods of data collection, the paper concludes that until all these challenges confronting EMBs in Nigeria in the conduct of free and fair elections are comprehensively addressed, credible elections will continue to be a mirage in the country.

  18. Ureteric stent placement with extraction string: no strings attached?

    Science.gov (United States)

    Bockholt, Nathan A; Wild, Trevor T; Gupta, Amit; Tracy, Chad R

    2012-12-01

    .8%) included an extraction string. • In all, 34.3% of all patients had a PRE, including 37.2% and 33.3% of patients with and without extraction string, respectively (P = 0.64). • PRE occurred in men with or without an extraction string (27.8 vs 32.4%, respectively; P = 0.71) and women with or without an extraction string (44.0 vs 34.3%, respectively, P = 0.39). • PRE occurred with relatively equal frequency between men and women (P = 0.28). • Only two women (4.7%) reported removing their stent prematurely, on postoperative days 2 and 6. • Ureteric stent placement with extraction string after ureteroscopy for stone disease does not seem to result in more PRE, regardless of gender. • Prospective randomised trials are needed to determine the benefits and disadvantages of ureteric stents with extraction string. © 2012 BJU INTERNATIONAL.

  19. Evaluating Stent Optimisation Technique (StentBoost®) in a Dedicated Bifurcation Stent (the Tryton™)

    International Nuclear Information System (INIS)

    Fysal, Zamil; Hyde, Thomas; Barnes, Edward; McCrea, William; Ramcharitar, Steve

    2014-01-01

    Background/Purpose: To evaluate the use of StentBoost® in the Tryton™ dedicated SideBranch Stent. Methods and Results: The Tryton™ SideBranch Stent has been effectively used to manage complex bifurcations. However, the paucity of scaffolding in the proximal part of the stent makes it often difficult to visualise under standard radiographic imaging. We set out to evaluate whether by using an augmented radiographic imaging technique it was possible to aid visualisation of the stent. In particular the so call 'wedding ring' band which is crucial to the procedural success. We further evaluated whether it was possible to determine the apposition of the stent at the carina, its coverage and the ability to aid recrossing of the struts closest to the carina as well as the added radiation exposure. Conclusions: StentBoost® was found to be invaluable to the procedural success of the Tryton™ deployment without adding any extra cost to the procedure and with only a 3.7% increase in radiation to the patient. It allowed enhanced visualisation in all cases to aid apposition, recrossing and coverage

  20. Evaluating Stent Optimisation Technique (StentBoost®) in a Dedicated Bifurcation Stent (the Tryton™)

    Energy Technology Data Exchange (ETDEWEB)

    Fysal, Zamil; Hyde, Thomas; Barnes, Edward; McCrea, William; Ramcharitar, Steve, E-mail: steve.ramcharitar@chem.ox.ac.uk

    2014-03-15

    Background/Purpose: To evaluate the use of StentBoost® in the Tryton™ dedicated SideBranch Stent. Methods and Results: The Tryton™ SideBranch Stent has been effectively used to manage complex bifurcations. However, the paucity of scaffolding in the proximal part of the stent makes it often difficult to visualise under standard radiographic imaging. We set out to evaluate whether by using an augmented radiographic imaging technique it was possible to aid visualisation of the stent. In particular the so call 'wedding ring' band which is crucial to the procedural success. We further evaluated whether it was possible to determine the apposition of the stent at the carina, its coverage and the ability to aid recrossing of the struts closest to the carina as well as the added radiation exposure. Conclusions: StentBoost® was found to be invaluable to the procedural success of the Tryton™ deployment without adding any extra cost to the procedure and with only a 3.7% increase in radiation to the patient. It allowed enhanced visualisation in all cases to aid apposition, recrossing and coverage.

  1. Stenting of major airway constriction

    International Nuclear Information System (INIS)

    Wu Xiaomei

    2002-01-01

    Objective: To investigate the correlated issues in the stenting treatment of major airway constriction. Methods: Nineteen cases of major airway stenting procedure were studied retrospectively. The clinical choice of stents of different advantages or deficiencies were discussed. The importance of intravenous anesthesia supporting, life-parameters monitoring during the procedures and the prevention of complications were analysed. Results: Under intravenous and local anesthesia, 19 Wallstents had been successively placed and relieved 19 cases of major airway constrictions due to malignant or benign diseases (15 of tumors, 3 of tuberculosis, 1 of tracheomalacia). Intravenous anesthesia and life-parameters monitoring had made the procedures more safe and precise. Conclusions: Major airway stenting is an reliable method for relieving tracheobronchial stenosis; and intravenous anesthesia supporting and life-parameters monitoring guarantee the satisfactions of procedures

  2. Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials.

    Science.gov (United States)

    Sawaya, Fadi J; Morice, Marie-Claude; Spaziano, Marco; Mehran, Roxana; Didier, Romain; Roy, Andrew; Valgimigli, Marco; Kim, Hyo-Soo; Woo Park, Kyung; Hong, Myeong-Ki; Kim, Byeong-Keuk; Jang, Yangsoo; Feres, Fausto; Abizaid, Alexandre; Costa, Ricardo A; Colombo, Antonio; Chieffo, Alaide; Giustino, Gennaro; Stone, Gregg W; Bhatt, Deepak L; Palmerini, Tullio; Gilard, Martine

    2017-02-01

    Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short- (≤6 months) versus long-term (≥1 year) DAPT after drug-eluting stent (DES) placement in women and men. We pooled individual patient data from 6 randomized trials of DAPT (EXCELLENT, OPTIMIZE, PRODIGY, RESET, SECURITY, ITALIC PLUS). The primary outcome was 1-year risk of major adverse cardiac events (MACE). The main secondary outcome was 1-year risk of any bleeding. Out of the 11,473 randomized patients included in the pooled dataset, 3,454 (30%) were females. At 1-year follow-up, women had higher risk of MACE (3.6% vs. 2.8%; P = 0.01) but similar risk of bleeding (1.9% vs. 1.6%; P = 0.16) as compared with men. Compared with long-term DAPT, short-term DAPT was associated with similar rates of MACE in both women (HR 0.88; 95% CI 0.62-1.25) and men (HR 1.25; 95% CI 0.95-1.6; P interaction = 0.08)]. At 1-year follow-up, short-term DAPT was associated with lower rates of bleeding as compared with long-term DAPT in both women (HR 0.84; 95% CI 0.51-1.37) and men (HR 0.58; 95% CI 0.40-0.84; P-interaction = 0.25). The presence of MVD was associated with higher MACE rates in the short-term DAPT group in women (HR: 1.16; CI 0.60-2.23) and men (HR: 2.29; CI 1.22-4.29; P interaction = 0.25). Short-term DAPT is associated with similar rates of MACE but lower risk of bleeding when as compared with prolonged DAPT. There was no significant difference between sexes in the population studied. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  3. Carotid artery stenting versus no stenting assisting thrombectomy for acute ischaemic stroke

    DEFF Research Database (Denmark)

    Steglich-Arnholm, Henrik; Holtmannspötter, Markus; Gluud, Christian

    2016-01-01

    stroke. METHODS: International and regional electronic databases will be searched to identify eligible randomised clinical trials. To identify further published, unpublished, or on-going and planned trials searches of Google Scholar, Worldwide Food and Drug Administrations, Worldwide Medicines Agencies...... will be applied to these searches. Randomised clinical trials will be included for assessing benefits and harms and quasi-randomised studies, and observational studies will be included for assessing harms of the intervention. Meta-analyses will be performed according to the recommendations of the Cochrane...... and harms of this intervention and assesses whether carotid stenting should be encouraged or avoided in acute ischaemic stroke and identify targets for further research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016033346....

  4. Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center experience from a prospective, randomized trial.

    Science.gov (United States)

    Saxon, Richard R; Coffman, Jeanine M; Gooding, Justin M; Natuzzi, Eileen; Ponec, Donald J

    2003-03-01

    To describe a single-center experience as part of a U.S. multicenter prospective randomized trial of PTA versus percutaneous transluminal angioplasty (PTA)- and ePTFE (expanded polytetrafluoroethylene)-covered endoprosthesis placement for the treatment of superficial femoral artery (SFA) and proximal popliteal artery stenoses and occlusions. Twenty-eight patients with claudication or ischemia were treated by PTA alone (n = 13) or PTA and endoprosthesis placement (n = 15). Baseline characteristics, including exercise ankle/brachial index (ABI), number of patent runoff vessels, Rutherford-Becker ischemia score, and lesion length, were equivalent. Follow-up included postprocedure, objective, noninvasive vascular evaluation and a clinical status scale for a minimum of 24 months. Technical success was achieved in 15 of 15 patients (100%) in the endoprosthesis group and 12 of 13 patients (92%) in the PTA group. Complications in the endoprosthesis group included clinically significant embolization (n = 1, successfully treated by thrombolysis) and transient thigh pain that required medication in three patients (20%). Clinical improvement was achieved initially in all patients with a significant increase in exercise ABI in both groups (mean increase from baseline was 0.51 with 95% CI: 0.37-0.64 in endoprosthesis patients and 0.39 with 95% CI: 0.31-0.47 in PTA patients; P =.13). At 6-month follow-up with duplex US, 93% of patients (14 of 15) treated with the Hemobahn endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ) remained primarily patent versus 42% of patients (five of 12) treated with PTA alone. At 2 years follow-up, primary patency remained 87% (13 of 15 patients) in the endoprosthesis group versus only 25% (three of 12 patients) in the PTA group (P =.002). Exercise ABI was >0.15 higher than baseline in 93% of patients (14 of 15) treated with endoprosthesis placement versus 54% of patients (seven of 13) treated by PTA alone. Clinical success was maintained in 87

  5. Management of acute malignant colorectal obstruction with a novel self-expanding metallic stent as a bridge to surgery

    International Nuclear Information System (INIS)

    Li Yongdong; Cheng Yingsheng; Li Minghua; Fan Youben; Chen Niwei; Wang Yu; Zhao Jungong

    2010-01-01

    Purpose: To prospectively evaluate the safety and clinical efficacy of a newly designed self-expandable metallic stent (SEMS) in the treatment of patients with acute malignant colorectal obstruction. Methods: Between April 2001 and October 2007, 52 patients with acute malignant colorectal obstruction were treated with a new designed SEMS as an investigational bridge to surgery. Patients were prospectively followed and relevant data collection was collected, including details regarding technique, clinical symptoms, complications, need for elective surgery, and overall survival. Results: Stent placement was technically successful in all but two patients (due to complete obstruction) with no procedure-related complications. Complications included stent migration (n = 4), anal pain (n = 2) and stool impaction (n = 1). Clinical success was achieved in 49 (98%) of 50 patients with resolution of bowel obstruction within 2 days of stent placement. In one patient with stool impaction 2 days after stent placement, endoscopic disimpaction was successfully performed. An elective one-stage surgical procedure was performed in all 50 patients who successfully received a SEMS as a bridge to surgery within a mean of 8 ± 2 days (range: 4-11 days) after stent placement. Mean follow-up time was 36 ± 12 months (range 3-70 months), and all patients remained alive at the time of this report. Conclusion: The newly designed SEMS placement as a bridge to surgery was a safe and effective intervention for colonic decompression in patients with acute malignant colorectal obstruction and allowed a high proportion of patients to be successfully proceeded to elective surgery.

  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 3 mm in diameter. We analyzed the impact of stent length and stent diameter on in......-stent restenosis (ISR) in the BASKET-PROVE study population and evaluated the cost-effectiveness of DES compared to BMS. METHODS/RESULTS: The BASKET-PROVE trial compared DES vs BMS in large coronary arteries (≥3 mm). We calculated incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability...... of 10 000 CHF per TLR avoided, DES had a high probability of being cost-effective. CONCLUSION: In the BASKET-PROVE study population, the strongest predictor of ISR is the use of a BMS, even in patients in need of stents ≥3.0 mm and ≤15 mm lesion length and DES were cost-effective. This should prompt...

  7. Endovascular treatment with angioplasty or stenting versus endarterectomy in patients with carotid artery stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.

    LENUS (Irish Health Repository)

    Ederle, Jörg

    2009-10-01

    Endovascular treatment (angioplasty with or without stenting) is an alternative to carotid endarterectomy for carotid artery stenosis but there are scarce long-term efficacy data showing that it prevents stroke. We therefore report the long-term results of the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS).

  8. First-generation versus second-generation drug-eluting stents in current clinical practice: updated evidence from a comprehensive meta-analysis of randomised clinical trials comprising 31 379 patients

    NARCIS (Netherlands)

    Navarese, E.P.; Kowalewski, M.; Kandzari, D.; Lansky, A.; Gorny, B.; Koltowski, L.; Waksman, R.; Berti, S.; Musumeci, G.; Limbruno, U.; Schaaf, R.J. van der; Kelm, M.; Kubica, J.; Suryapranata, H.

    2014-01-01

    BACKGROUND: First-generation drug-eluting stents (DES) have become the most widely used devices worldwide for management of coronary artery disease. As remote follow-up data were becoming available, concerns emerged in regard to their long-term safety. Second-generation DES were designed to overcome

  9. Right Ventricular Outflow Tract Stenting in Tetralogy of Fallot Infants With Risk Factors for Early Primary Repair.

    Science.gov (United States)

    Sandoval, Juan Pablo; Chaturvedi, Rajiv R; Benson, Lee; Morgan, Gareth; Van Arsdell, Glen; Honjo, Osami; Caldarone, Christopher; Lee, Kyong-Jin

    2016-12-01

    Tetralogy of Fallot with cyanosis requiring surgical repair in early infancy reflects poor anatomy and is associated with more clinical instability and longer hospitalization than those who can be electively repaired later. We bridged symptomatic infants with risk factors for early primary repair by right ventricular outflow tract stenting (stent). Four groups of tetralogy of Fallot with confluent central pulmonary arteries were studied: stent group (n=42), primary repair (aged 3mo group; n=45). Stent patients had the smallest pulmonary arteries with a median (95% credible intervals) Nakata index (mm 2 /m 2 ) of 79 (66-85) compared with the early-PA 139 (129-154), early-PS 136 (121-153), and surg>3mo 167 (153-200) groups. Only stent infants required unifocalization of aortopulmonary collaterals (17%). Stent and early-PA infants had younger age and lower weight than early-PS infants. Stent infants had the most multiple comorbidities. Stenting allowed deferral of complete surgical repair to an age (6 months), weight (6.3 [5.8-7.0] kg), and Nakata index (147 [132-165]) similar to the low-risk surg>3mo group. The 3 early treatment groups had similar intensive care unit/hospital stays and high reintervention rates in the first 12 months after repair, compared with the surg>3mo group. Right ventricular outflow tract stenting of symptomatic tetralogy of Fallot with poor anatomy (small pulmonary arteries) and adverse factors (multiple comorbidities, low weight) relieves cyanosis and defers surgical repair. This allowed pulmonary arterial and somatic growth with clinical results comparable to early surgical repair in more favorable patients. © 2016 American Heart Association, Inc.

  10. 2011 Elections to Staff Council

    CERN Multimedia

    Staff Association

    2011-01-01

    Vote Elections to fill all seats in the Staff Council are being organized this month. Voting will begin on Monday 31 October. Make your voice heard and be many to elect the new Staff Council. By doing so, you will be encouraging the men and women who will  represent you over the next two years and they will doubtless appreciate your gratitude. More details on the elections can be found on the Staff Association web site. (http://association.web.cern.ch) Elections Timetable Monday 31 October, at noon start date for voting Monday 14 November, at noon closing date for voting Monday 21 November, publication of the results in Echo Tuesday 22 and Wednesday 29 November Staff Association Assizes Tuesday 6 December, at 10.00 a.m. first meeting of the new Staff Council and election of the new Executive Committee The voting procedure is monitored by the Election Committee. 

  11. 2015 Elections to Staff Council

    CERN Multimedia

    Staff Asscociation

    2015-01-01

    Make your voice heard, support your candidates! Be many to vote and to elect the new Staff Council. By doing so, you will be encouraging the men and women who will represent you over the next two years and they will without doubt appreciate your gratitude. The voting takes place from the 26th of October to the 9th of November, at noon at https://ap-vote.web.cern.ch/elections-2015.   Elections Timetable Monday 9 November, at noon Closing date for voting Monday 16 and Monday 23 November, publication of the results in Echo Tuesday 8 December, at 10.00 a.m. first meeting of the new Staff Council and election of the new Executive Committee The voting procedure will be monitored by the Election Committee, which is also in charge of announcing the results in Echo on 16 and 24 November. Candidates for the 2015 elections

  12. 2017 Elections to Staff Council

    CERN Multimedia

    Staff Association

    2017-01-01

    Make your voice heard, support your candidates! We hope that you will be many to vote and to elect the new Staff Council! By doing so, you can support and encourage the women and men, who will represent you over the next two years. The voting takes place from 23 October to 13 November, at noon at https://ap-vote.web.cern.ch/elections-2017. Elections Timetable Monday 13 November, at noon Closing date for voting Tuesday 21 November and Tuesday 5 December Publication of the results in Echo Monday 27 and Tuesday 28 November Staff Association Assizes Tuesday 5 December (afternoon) First meeting of the new Staff Council and election of the new Executive Committee The voting procedure will be monitored by the Election Committee, which is also in charge of announcing the results in Echo on 21 November and 5 December. Candidates for the 2017 Elections

  13. Germany after Federal elections

    International Nuclear Information System (INIS)

    Niedzballa, G.

    2010-01-01

    The political, economical and social situation in Germany after the election and attitude to nuclear energy are summarised. The Coalition agreement include: 1.Extension of the remaining lifetimes of the nuclear power plants (Nuclear Power considered as “Bridging technology”; Safety first; Skimming of additional profits) 2. No nuclear new builds in Germany 3. Approval and promotion (loan guarantees) of nuclear exports 4. Reversal of the moratorium regarding the exploration of Gorleben salt dome (Completion of the exploration; International Peer Review Group) 5.Further research regarding competence preservation and safety

  14. Ureteral stents: coil strength and durometer.

    Science.gov (United States)

    Hendlin, Kari; Dockendorf, Kelly; Horn, Christina; Pshon, Nicole; Lund, Brynn; Monga, Manoj

    2006-07-01

    To evaluate the coil strength before and after urine exposure and the stiffness of commercially available double-J ureteral stents because both properties may affect stent performance and patient comfort. Twelve commercially available 6F ureteral stents were tested for coil strength before and after 30 days of urine exposure. The proximal end of each stent was inserted through a 2-mm hole in bologna, allowed to recoil, and then pulled using a handheld force gauge. Ten different commercially available ureteral stent models were tested for tensile strength using an MTS MicroBionix Testing System and Testworks II software and a 5 N load cell. The Cook Black Silicone and Cook C-Flex stents had the strongest coil strengths before urine exposure at 0.480 +/- 0.0 lb (P Circon Double J stent and Bard InLay. Ureteral stents can be differentiated according to their coil strength and stiffness. The impact of these properties on stent performance and patient comfort deserve additional evaluation. The significant variability found in stent stiffness among stents from different lot numbers suggests poor quality assurance in biomaterials or stent processing and increases the complexity of cross-stent comparisons.

  15. Retrograde or antegrade double-pigtail stent placement for malignant ureteric obstruction?

    International Nuclear Information System (INIS)

    Uthappa, M.C.; Cowan, N.C.

    2005-01-01

    AIM: To determine the optimum approach for double-pigtail stent placement in malignant ureteric obstruction. PATIENTS AND METHODS: Retrograde stent placement was attempted in a consecutive series of patients presenting with malignant ureteric obstruction. If retrograde stent placement was unsuccessful, percutaneous nephrostomy was performed immediately followed by elective antegrade stent placement. Identical digital C-arm fluoroscopy for image-guidance and conditions for anaesthesia and analgesia were employed for both retrograde and antegrade procedures. Identical 8 Fr (20-26 cm) double-pigtail hydrophilic coated stents were used for each approach. RESULTS: Retrograde placement was attempted in 50 ureters in 30 patients {19 male, 11 female, average age 61.4 yr (range 29-90 yr)} over a 24-month period. The success rate for retrograde ureteric stent placement was 50% (n=25/50). Technical failures were due to failure to identify the ureteric orifice (n=22), failure to cross the stricture (n=1), failure to pass the stent (n=1) and failure to pass a 4 Fr catheter (n=1). Antegrade placement was attempted in 25 ureters with a success rate of 96% (n=24/25). Failure in the one case was due to inability to cross an upper third stricture secondary to pyeloureteritis cystica. CONCLUSION: It is suggested that retrograde route should be the initial approach if imaging shows no involvement of ureteric orifice (UO), when nephrostomy is technically very difficult or in cases of solitary kidney. The antegrade route is preferred if imaging shows tumour occlusion of the UO or if there is a tight stricture very close to the uretero-vesical junction (UVJ) making purchase within the ureter difficult for crossing the stricture

  16. Applied Formal Methods for Elections

    DEFF Research Database (Denmark)

    Wang, Jian

    development time, or second dynamically, i.e. monitoring while an implementation is used during an election, or after the election is over, for forensic analysis. This thesis contains two chapters on this subject: the chapter Analyzing Implementations of Election Technologies describes a technique...... process. The chapter Measuring Voter Lines describes an automated data collection method for measuring voters' waiting time, and discusses statistical models designed to provide an understanding of the voter behavior in polling stations....

  17. Stent migration after right ventricular outflow tract stenting in the severe cyanotic Tetralogy of Fallot case

    Directory of Open Access Journals (Sweden)

    Tamaki Hayashi

    2017-01-01

    Full Text Available We report our experience with a stent migration after right ventricle outflow tract stenting and converted to patent ductus arteriosus stenting in Tetralogy of Fallot (TOF with severe infundibular stenosis. Finally, the patient achieved to TOF repair, and the migrated stent was removed without any complication.

  18. Elections to Staff Council

    CERN Multimedia

    Staff Association

    2013-01-01

    Elections to fill all seats in the Staff Council are being organized this month. The voting takes place from the 28 of October to the 11th of November, at noon. As you may have noted when reading Echo, many issues concerning our employment conditions are on the agenda of the coming months, and in particular the Five-yearly-Review 2015, subject of the questionnaire that you probably recently filled out. All this will keep the next Staff Council very busy indeed. So, make your voice heard and take part in the elections for a new Staff Council. By doing so, you will be encouraging the men and women who will be representing you over the next two years and they will doubtless appreciate your gratitude. Every member of the Staff Association will have received an email containing a link to the webpage which will allow voting. If you are a member of the Staff Association and you did not receive such an email, please contact the Staff Association secretariat (staff.association@cern.ch). Do not forget to v...

  19. ELECTIONS PENSION FUND

    CERN Multimedia

    2001-01-01

    ORGANISATION EUROPEENNE POUR LA RECHERCHE NUCLEAIRE CERN EUROPEAN ORGANIZATION FOR NUCLEAR RESEARCH CAISSE DE PENSIONS / PENSION FUND Caisse de Pensions - ELECTIONS - Pension Fund This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund. Candidate : Name : CHIAVERI First Name : Enrico I have been a CERN staff member since 1973 and have always been interested in our working conditions. As a member of the Executive Committee of the Staff Association I participated from 1980 to 1984 in the Working Group on Pensions mandated by the CERN Council. This commitment led to my becoming a member of the Governing Board of the Pension Fund in 1983, since when I have taken an active part in various commissions and working groups (Real Estate Asset Management Committee, Working Group on Actuarial Matters etc.); in so doing I have gained a thorough knowledge of different areas of the Pension Fund. Since ...

  20. ELECTIONS - Pension Fund

    CERN Document Server

    2006-01-01

    CERN - EUROPEAN ORGANIZATION FOR NUCLEAR RESEARCH PENSION FUND ELECTIONS - Pension Fund This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund. Candidate: First name: Michel Name: Goossens The CERN/ESO Pension Fund represents, for most staff, the sole source of income when they retire. The health of our Pension Fund is thus of the utmost importance to ensure the payment of pensions up to the death of the last beneficiary. The 2003 actuarial review showed a large deficit and several corrective measures have already been taken. The next months will see the results of the 2006 actuarial review. We hope they will show that the measures taken last year are going in the right direction. However, we must remain proactive since further measures will no doubt be necessary. New and imaginative proposals must be prepared and discussed in the widest possible forum, by regular direct contact ...

  1. ELECTIONS - Pension Fund

    CERN Multimedia

    2006-01-01

    CERN - EUROPEAN ORGANIZATION FOR NUCLEAR RESEARCH PENSION FUND ELECTIONS - Pension Fund This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund. Candidate: First name: Michel Name: Goossens The CERN/ESO Pension Fund represents, for most staff, the sole source of income when they retire. The health of our Pension Fund is thus of the utmost importance to ensure the payment of pensions up to the death of the last beneficiary. The 2003 actuarial review showed a large deficit and several corrective measures have already been taken. The next months will see the results of the 2006 actuarial review. We hope they will show that the measures taken last year are going in the right direction. However, we must remain proactive since further measures will no doubt be necessary. New and imaginative proposals must be prepared and discussed in the widest possible forum, by regular direct contact with staff...

  2. ELECTIONS - Pension Fund

    CERN Multimedia

    2006-01-01

    CERN - EUROPEAN ORGANIZATION FOR NUCLEAR RESEARCH PENSION FUND ELECTIONS - Pension Fund This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund. Candidate: First name: Michel Name: Goossens The CERN/ESO Pension Fund represents, for most staff, the sole source of income when they retire. The health of our Pension Fund is thus of the utmost importance to ensure the payment of pensions up to the death of the last beneficiary. The 2003 actuarial review showed a large deficit and several corrective measures have already been taken. The next months will see the results of the 2006 actuarial review. We hope they will show that the measures taken last year are going in the right direction. However, we must remain proactive since further measures will no doubt be necessary. New and imaginative proposals must be prepared and discussed in the widest possible forum, by regular direct contact with staf...

  3. Short- versus long-term dual antiplatelet therapy after drug-eluting stent implantation: An individual patient data pairwise and network meta-analysis

    NARCIS (Netherlands)

    T. Palmerini (Tullio); D. Sangiorgi (Diego); M. Valgimigli (Marco); G.G. Biondi-Zoccai (Giuseppe); F. Feres (Fausto); A.C. Abizaid (Alexandre); R.A. Costa (Ricardo); M.K. Hong (Myeong); B.-K. Kim (Byeong-Keuk); Y. Jang (Yangsoo); H-S. Kim (Hyo-Soo); K.W. Park (Kyung Woo); A. Mariani (Andrea); D. Della Riva (Diego); P. Généreux (Philippe); M.B. Leon (Martin); D.L. Bhatt (Deepak); U. Bendetto (Umberto); C. Rapezzi (Claudio); G.W. Stone (Gregg)

    2015-01-01

    textabstractBackground Randomized controlled trials comparing short- (≤6 months) with long-term (≥1 year) dual antiplatelet therapy (DAPT) after drug-eluting stent(s) (DES) placement have been insufficiently powered to detect significant differences in the risk of major adverse cardiac events

  4. 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

  5. 2014 Election forecast - a post-election analysis

    CSIR Research Space (South Africa)

    Ittmann, HW

    2017-06-01

    Full Text Available –55 http://orion.journals.ac.za ORiON ISSN 0259–191X (print) ISSN 2224–0004 (online) ©2017 2014 Election forecast — a post-election analysis HW Ittmann* JP Holloway„ N Dudeni-Tlhone„ Received: 3 September 2016; Revised: 2 March 2017; Accepted: 8 May 2017...

  6. Percutaneous coronary revascularization using a trilayer metal phosphorylcholine-coated zotarolimus-eluting stent.

    Science.gov (United States)

    Abizaid, Alexandre; Lansky, Alexandra J; Fitzgerald, Peter J; Tanajura, Luis Fernando; Feres, Fausto; Staico, Rodolfo; Mattos, Luiz; Abizaid, Andrea; Chaves, Aurea; Centemero, Marinella; Sousa, Amanda G M R; Sousa, J Eduardo; Zaugg, Margo J; Schwartz, Lewis B

    2007-05-15

    The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.

  7. Optical coherence tomography analysis of the stenting of saphenous vein graft (SOS) Xience V Study: use of the everolimus-eluting stent in saphenous vein graft lesions.

    Science.gov (United States)

    Papayannis, Aristotelis C; Michael, Tesfaldet T; Yangirova, Dinara; Abdel-Karim, Abdul-Rahman; Kohlhaas, Julia; Mahmood, Arif; Addo, Tayo; Haagen, Donald; Makke, Lorenza; Roesle, Michele; Rangan, Bavana; Banerjee, Subhash; Brilakis, Emmanouil S

    2012-08-01

    The Stenting of Saphenous Grafts-Xience V (SOS-Xience V) trial prospectively examined the frequency of angiographic in-stent restenosis in saphenous vein graft (SVG) lesions 12 months after implantation of a Xience V everolimus-eluting stent (EES; Abbott Vascular). Optical coherence tomography (OCT) during follow-up angiography was added to the protocol after OCT was approved for clinical use in the United States. Forty patients with 40 SVG lesions were enrolled in the study, of whom 27 underwent 12-month coronary angiography and 12 (only 1 of whom had in-stent restenosis) also had follow-up OCT evaluation. OCT strut-level analysis was performed to determine the percentage of strut coverage, malapposition, strut protrusion, neointimal thickness, and the existence of thrombus. Mean patient age was 67 ± 7 years, and 95% were men. A total of 2584 struts were evaluated by OCT. The percentages for uncovered, malapposed, and protruding struts were 4%, 9%, and 15%, respectively. The mean strut neointimal thickness was 0.094 ± 0.094 mm. Of the 12 stents analyzed, 4 (33%) showed full neointimal coverage, 2 (17%) had all the struts embedded, 7 (58%) had at least 1 malapposed strut, and 10 (83%) had at least 1 protruding strut. The mean difference between the stent area and the lumen area was 0.36 ± 1.6 mm². No thrombus was detected in the stented areas. Use of EES in SVGs is associated with high rates of stent strut coverage and high malapposition rates at 12 months post implantation.

  8. Endoscopic stent placement throughout the gastrointestinal tract

    NARCIS (Netherlands)

    van den Berg, M.W.

    2014-01-01

    In this thesis we focussed our research on stent placement throughout the GI tract. In search for ideal stents for treatment of malignant oesophageal stenosis and gastric outlet obstruction we evaluated new stent designs in prospective cohort studies. Smaller research projects mainly aimed to

  9. Therapies targeting inflammation after stent implantation.

    Science.gov (United States)

    Okura, Hiroyuki; Takagi, Tsutomu; Yoshida, Kiyoshi

    2013-07-01

    Since the introduction of coronary vessel scaffold by metallic stent, percutaneous coronary intervention has become widely performed all over the world. Although drug-eluting stent technology has further decrease the incidence of in-stent restenosis, there still remaining issues related to stent implantation. Vessel inflammation is one of the causes that may be related to stent restenosis as well as stent thrombosis. Therefore, systemic therapies targeting inflammation emerged as adjunctive pharmacological intervention to improve outcome. Statins, corticosteroids, antiplatelets, and immunosuppresive or anti-cancer drugs are reported to favorably impact outcome after bare-metal stent implantation. In type 2 diabetic patients, pioglitazone may be the most promising drug that can lower neointimal proliferation and, as a result, lower incidence of restenosis and target lesion revascularization. On the other hand, several new stent platforms that might decrease inflammatory response after drug-eluting stent implantation have been introduced. Because durable polymer used in the first generation drug-eluting stents are recognized to be responsible for unfavorable vessel response, biocompatible or bioabsorbable polymer has been introduce and already used clinically. Furthermore, polymer-free drug-eluting stent and bioresorbable scaffold are under investigation. Although vessel inflammation may be reduced by using these new drug-eluting stents or scaffold, long-term impact needs to be investigated further.

  10. 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...... thrombosis....

  11. Plastic biliary stents for malignant biliary diseases

    NARCIS (Netherlands)

    Huibregtse, Inge; Fockens, Paul

    2011-01-01

    Plastic biliary endoprostheses have not changed much since their introduction more than 3 decades ago. Although their use has been challenged by the introduction of metal stents, plastic stents still remain commonly used. Much work has been done to improve the problem of stent obstruction but

  12. Percutaneous ureteral stent placement for the treatment of a benign ureteral obstruction in a Sumatran tiger (Panthera tigris sumatrae).

    Science.gov (United States)

    Delk, Katie W; Wack, Raymund F; Burgdorf-Moisuk, Anne; Palm, Carrie A; Zwingenberger, Allison; Glaiberman, Craig B; Ferguson, Kenneth H; Culp, William T N

    2015-01-01

    A 15-year-old, 113 kg intact male Sumatran tiger (Panthera tigris sumatrae) was evaluated for weight loss, polydipsia, and intermittent hematuria. The tiger was immobilized for diagnostic testing including blood work, urinalysis, and abdominal ultrasound. Laboratory testing demonstrated macro- and microhematuria, azotemia, and an increased urine protein:creatinine ratio. Abdominal ultrasound revealed bilateral ureterolithiasis as well as hydronephrosis and ureteral dilation. Ultrasonography performed 5 months later revealed worsening of the right-sided hydronephrosis and hydroureter and a decrease in the severity of dilation on the left side presumably from passage of the left-sided ureteral calculi. Nephroureteral decompression via the placement of a stent was elected. A pigtail ureteral catheter (8.2 French diameter) was placed in the right ureter via an antegrade percutaneous approach utilizing ultrasound and fluoroscopic-guidance. Following stent placement, macrohematuria resolved although microhematuria was noted in opportunistic urine samples. Five months after stent placement, the azotemia had mildly progressed, the urine protein:creatinine ratio was improved, the right hydronephrosis and hydroureter had completely resolved, and the ureteral stent remained in the appropriate position. The tiger had clinically improved with a substantial increase in appetite, weight, and activity level. Ureteral stenting allowed for nephroureteral decompression in the captive large felid of this report, and no complications were encountered. Ureteral stenting provided a minimally invasive method of managing ureteral obstruction in this patient and could be considered in future cases due to the clinical improvement and low morbidity. © 2015 Wiley Periodicals, Inc.

  13. Study of the Behavior of a Bell-Shaped Colonic Self-Expandable NiTi Stent under Peristaltic Movements

    Directory of Open Access Journals (Sweden)

    Sergio Puértolas

    2013-01-01

    Full Text Available Managing bowel obstruction produced by colon cancer requires an emergency intervention to patients usually in poor conditions, and it requires creating an intestinal stoma in most cases. Regardless of that the tumor may be resectable, a two-stage surgery is mandatory. To avoid these disadvantages, endoscopic placement of self-expanding stents has been introduced more than 10 years ago, as an alternative to relieve colonic obstruction. It can be used as a bridge to elective single-stage surgery avoiding a stoma or as a definitive palliative solution in patients with irresectable tumor or poor estimated survival. Stents must be capable of exerting an adequate radial pressure on the stenosed wall, keeping in mind that stent must not move or be crushed, guaranteeing an adequate lumen when affected by peristaltic waves. A finite element simulation of bell-shaped nitinol stent functionality has been done. Catheter introduction, releasing at position, and the effect of peristaltic wave were simulated. To check the reliability of the simulation, a clinical experimentation with porcine specimens was carried out. The stent presented a good deployment and flexibility. Stent behavior was excellent, expanding from the very narrow lumen corresponding to the maximum peristaltic pressure to the complete recovery of operative lumen when the pressure disappears.

  14. [Procedural aspects in primary PCI: arterial access, stent selection, thrombectomy and treatment of non-culprit lesions].

    Science.gov (United States)

    Boeder, N F; Hamm, C W; Nef, H M

    2014-09-01

    Acute myocardial infarction was one of the most common causes of death in Germany in 2011. According to the guidelines of the European Society for Cardiology, systemic fibrinolysis and primary percutaneous coronary intervention (PCI) are the methods of choice for acute treatment. Primary PCI should be given priority due to its superiority. The transradial access should be preferred due to the lower bleeding complication rate. In the selection of stents the new generation of drug-eluting stents (DES) are superior to the first generation of bare metal stents (BMS). It has now been demonstrated that the incident rates of DES (e.g. mortality, target vessel revascularization, early and late stent thrombosis and myocardial infarction) are significantly lower. For bioresorbable scaffolds (BRS) long-term results for the use in treatment of ST-elevation myocardial infarction (STEMI) are not yet available but initial results are very promising. However, the selection of a stent needs to be done on an individual basis in order to do justice to all aspects. Data with respect to thrombectomy in acute treatment are heterogeneous. Currently, a thorough consideration of all aspects is necessary because thrombus aspiration can also be associated with an increased rate of incidents. In a state of hemodynamic stability only so-called culprit lesions should currently be treated with a stent. Elective interventions on further stenoses should be carried out after consideration of individual factors and if necessary evaluation of the hemodynamic relevance.

  15. A novel biodegradable pancreatic stent for human pancreatic applications: a preclinical safety study in a large animal model.

    Science.gov (United States)

    Laukkarinen, Johanna; Lämsä, Teemu; Nordback, Isto; Mikkonen, Joonas; Sand, Juhani

    2008-06-01

    Endoscopic stenting is one treatment method for pancreatic strictures or pseudocysts in patients with symptomatic chronic pancreatitis. With a biodegradable stent, the later removal of the stent could be avoided. We investigated the degradation, patency, and toxicity of a novel biodegradable, self-expanding radiopaque polylactide-barium sulfate pancreatic stent in a large animal model. Animal study. Five swine had a biodegradable pancreatic stent placed into the pancreatic duct (PD) and were followed-up for 6 months. Repeated blood tests and radiographs were studied during the follow-up. The animals were euthanized at 6 months, at which time, the PD inner diameter was measured, and histology was analyzed and graded. For comparison, histology from 5 nonstented animals was also analyzed. The stent was correctly inserted into the PD in 4 of 5 animals. All the animals remained healthy, gained weight, and showed no signs of pancreatitis. A radiograph showed that the stent was in its original place in all animals at 1 month but had disappeared in all animals by 3 months. At 6 months, the autopsied pancreatic tissue was soft, and the PD was patent in all of the animals. The PD was slightly dilated at the site of the stent in the head of the pancreas compared with the preoperative diameter (5 mm [range 3-6 mm] vs 2 mm [range 1-3 mm], P parts of the biodegradable pancreatic stent compared with the distal nonexposed parts, or to the samples from the nonstented animals. This novel biodegradable pancreatic stent, studied in these swine, appeared to be safe for use in the PD. These encouraging results warrant further clinical trials with this biodegradable pancreatic stent in pancreatic applications in human beings.

  16. Is fasting necessary for elective cerebral angiography?

    Science.gov (United States)

    Kwon, O-K; Oh, C W; Park, H; Bang, J S; Bae, H-J; Han, M K; Park, S-H; Han, M H; Kang, H-S; Park, S-K; Whang, G; Kim, B-C; Jin, S-C

    2011-05-01

    In order to prevent unexpected events such as aspiration pneumonia, cerebral angiography has been performed under fasting in most cases. We investigated prospectively the necessity of fasting before elective cerebral angiography. The study is an open-labeled clinical trial without random allocation. In total, 2554 patients who underwent elective cerebral angiography were evaluated on development of nausea, vomiting, and pulmonary aspiration during and after angiography. Potential risks and benefits associated with fasting were provided in written documents and through personal counseling to patients before the procedure. The patients chose their fasting or nonfasting option. No restriction in diet was given after angiography. The patients were observed for 24 hours. Nausea and vomiting during and within 1 hour after angiography was considered as a positive event associated with cerebral angiography. The overall incidence of nausea and vomiting during and within 1 hour after angiography was 1.05% (27/2554 patients). There was no patient with pulmonary aspiration. No statistical difference in nausea and vomiting development between the fasting and the diet groups was found. The incidence of nausea and vomiting associated with cerebral angiography is low and not affected by diet or fasting. Pulmonary aspiration had no difference between the diet and the fasting group. Our study suggests that fasting may not be necessary for patients who undergo elective cerebral angiography.

  17. Women, Politics, Elections, and Citizenship.

    Science.gov (United States)

    Webster, Gerald R.

    2000-01-01

    Outlines the historical development of women's legal and political status in the United States, focusing on suffrage, the three "waves" of women's movements, and access to elected office. Discusses three impediments of electing women candidates to public office: (1) solidarity; (2) political culture; and (3) the impact of the single-member…

  18. Certification of ICTs in Elections

    DEFF Research Database (Denmark)

    Schürmann, Carsten; Barrat, Jordi; Bolo, Eden

    2015-01-01

    Information and communication technologies play a critical role in the administration and organization of modern elections. Any breakdown of an election technology, security breach or programming error can incur tremendous cost for the electoral management body (EMB)—and may undermine voters’ tru...

  19. All quiet on election day? International election observation and incentives for pre-election violence in African elections

    NARCIS (Netherlands)

    Daxecker, U.E.

    2014-01-01

    This article argues that the increasing international interest in elections as exemplified by the rise of international election monitoring induces temporal shifts in the use of violent intimidation by political actors. The presence of international electoral missions lowers the potential for

  20. Hindsight bias in political elections.

    Science.gov (United States)

    Blank, Hartmut; Fischer, Volkhard; Erdfelder, Edgar

    2003-01-01

    Two studies on political hindsight bias were conducted on the occasions of the German parliament election in 1998 and the Nordrhein-Westfalen state parliament election in 2000. In both studies, participants predicted the percentage of votes for several political parties and recalled these predictions after the election. The observed hindsight effects were stronger than those found in any prior study on political elections (using percentage of votes as the dependent variable). We argue that the length of the retention interval between original judgement and recollection is mainly responsible for this difference. In our second study, we investigated possible artifacts in political hindsight biases using a control-group design where half of the participants recalled their predictions shortly before or after the election. Hindsight bias was preserved, reinforcing the results of earlier studies with non-control-group designs. Finally, we discuss the possibility that the hindsight experience (in political judgement and in general) actually consists of three different, partly independent components.

  1. Bayesian Inference on Proportional Elections

    Science.gov (United States)

    Brunello, Gabriel Hideki Vatanabe; Nakano, Eduardo Yoshio

    2015-01-01

    Polls for majoritarian voting systems usually show estimates of the percentage of votes for each candidate. However, proportional vote systems do not necessarily guarantee the candidate with the most percentage of votes will be elected. Thus, traditional methods used in majoritarian elections cannot be applied on proportional elections. In this context, the purpose of this paper was to perform a Bayesian inference on proportional elections considering the Brazilian system of seats distribution. More specifically, a methodology to answer the probability that a given party will have representation on the chamber of deputies was developed. Inferences were made on a Bayesian scenario using the Monte Carlo simulation technique, and the developed methodology was applied on data from the Brazilian elections for Members of the Legislative Assembly and Federal Chamber of Deputies in 2010. A performance rate was also presented to evaluate the efficiency of the methodology. Calculations and simulations were carried out using the free R statistical software. PMID:25786259

  2. The 2015 Nigerian General Elections

    Directory of Open Access Journals (Sweden)

    Nkwachukwu Orji

    2015-01-01

    Full Text Available The high level of success of Nigeria’s 2015 general elections was unexpected, considering the difficult political and security environment in which the elections were conducted. The major obstacles to the smooth conduct of the elections include the grave security threat posed by the Boko Haram insurgency, the competing claims to the presidency by northern and southern politicians, a keenly contested campaign smeared by inflammatory messages, and serious gaps in electoral preparations. Against the backdrop of these challenges, this article assesses Nigeria’s 2015 general elections, looking closely at the key issues that affected the polls, the major electoral outcomes, and the critical post-election issues raised by the outcomes.

  3. Bayesian inference on proportional elections.

    Directory of Open Access Journals (Sweden)

    Gabriel Hideki Vatanabe Brunello

    Full Text Available Polls for majoritarian voting systems usually show estimates of the percentage of votes for each candidate. However, proportional vote systems do not necessarily guarantee the candidate with the most percentage of votes will be elected. Thus, traditional methods used in majoritarian elections cannot be applied on proportional elections. In this context, the purpose of this paper was to perform a Bayesian inference on proportional elections considering the Brazilian system of seats distribution. More specifically, a methodology to answer the probability that a given party will have representation on the chamber of deputies was developed. Inferences were made on a Bayesian scenario using the Monte Carlo simulation technique, and the developed methodology was applied on data from the Brazilian elections for Members of the Legislative Assembly and Federal Chamber of Deputies in 2010. A performance rate was also presented to evaluate the efficiency of the methodology. Calculations and simulations were carried out using the free R statistical software.

  4. Long-term outcome of sirolimus-eluting and zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a Danish Organization for Randomized Trials on Clinical Outcome III substudy)

    DEFF Research Database (Denmark)

    Olesen, Kevin K W; Tilsted, Hans-Henrik; Jensen, Lisette O

    2015-01-01

    vessel revascularization (TVR), and definite stent thrombosis. Among diabetic patients, MACE occurred more frequently in patients treated with ZESs than SESs (48 [28.4%] vs 31 [18.5%]; odds ratio [OR] 1.75, 95% confidence interval [CI] 1.05 to 2.93, p = 0.032) because of a higher rate of TVR (32 [18.......9%] vs 14 [8.3%]; OR 2.57, 95% CI 1.32 to 5.02, p = 0.006). Among nondiabetic patients, ZES and SES had similar MACE rates at 5-year follow-up but SES was associated with a significantly higher risk of definite stent thrombosis (10 [1.0%] vs 23 [2.3%]; OR 0.43, 95% CI 0.20 to 0.91, p = 0.028). Moreover...

  5. Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated With Percutaneous Coronary Intervention: The Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV)

    DEFF Research Database (Denmark)

    Okkels Jensen, Lisette; Thayssen, Per; Hansen, Henrik Steen

    2012-01-01

    was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were.......71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0...

  6. 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...

  7. Indications for stenting during thrombolysis

    DEFF Research Database (Denmark)

    Bækgaard, N; Broholm, R; Just, Sven Richardt Lundgren

    2013-01-01

    . The compression from adjacent structures, predominantly on the left side is known as the iliac vein compression syndrome. Therefore, it is essential that supplementary endovenous procedures have to be performed in case of persistent obstructive lesions following catheter-directed thrombolysis. Insertion...... the challenges in this low-pressure system. The characteristics of the anatomy with external compression and often a curved vein segment with diameter difference make stent placement necessary. Ballooning alone has no place in this area. The proportion of inserted stents varies in the published materials...

  8. Local Delivery of Antiproliferative Agents via Stents

    Directory of Open Access Journals (Sweden)

    Hyuck Joon Kwon

    2014-03-01

    Full Text Available A stent is a medical device for serving as an internal scaffold to maintain or increase the lumen of a body conduit. Stent placement has become a primary treatment option in coronary artery disease for more than the last two decades. The stenting is also currently used for relieving the symptoms of narrowed lumen of nonvascular organs, such as esophagus, trachea and bronchi, small and large intestines, biliary, and urinary tract. Local delivery of active pharmaceutical agents via the stents can not only enhance healing of certain diseases, but it can also help decrease the potential risk of the stenting procedure to the surrounding tissue. In this review, we focus on reviewing a variety of drug-impregnated stents and local drug delivery systems using the stents.

  9. Ureteral stenting and urinary stone management: A systematic review

    NARCIS (Netherlands)

    Haleblian, George; Kijvikai, Kittinut; de la Rosette, Jean; Premingert, Glenn

    2008-01-01

    Purpose: Ureteral stents are widely used in many urological procedures. We evaluated the recent literature, providing an update on materials and stent designs, and indications for stent placement and stent complications, including the management of such stent related problems. Materials and Methods:

  10. Retrieval of Migrated Colonic Stents from the Rectum

    International Nuclear Information System (INIS)

    Wholey, Michael H.; Ferral, Hector; Reyes, Ricardo; Lopera, Jorge; Castaneda-Zuniga, Wilfrido; Maynar, Manual

    1997-01-01

    Palliative stenting of malignant colonic obstruction may be complicated by stent migration. Stents that migrate into the rectum cannot be passed with bowel movements and frequently cause obstruction. We present two simple means to retrieve stents from the rectum using fluoroscopic guidance. These techniques were used successfully without complication in four stent migrations

  11. [Endovascular stent-grafting for mycotic thoracic aortic aneurysm].

    Science.gov (United States)

    Okada, S; Kaneko, T; Ezure, M; Satoh, Y; Hasegawa, Y; Koike, N; Okonogi, S; Takihara, H

    2009-02-01

    We report 3 cases of endovascular stent-grafting (ESG) for mycotic thoracic aortic aneurysm. The case 1 was a rupture of pseudoaneurysm of the descending aorta caused by mediastinitis due to perforation of esophageal ulcer. The patient underwent emergent ESG for temporary control of the rupture. He underwent esophagus reconstruction 5 month after ESG. The case 2 was admitted due to inflammatory reaction. She was diagnosed with mycotic descending aortic aneurysm and underwent elective ESG because of her old age. Her postoperative course was uneventful and no infection recurred. The case 3 underwent ESG for a ruptured mycotic descending aortic aneurysm. But 113 days after ESG, he underwent ESG again for a ruptured endoleak of the stentgraft. His blood culture demonstrated methillin-resistant Staphylococcus aureus (MRSA). He died of rupture to bronchus and esophagus at 18th day after ESG. We believe that ESG is useful in high risk patients for temporary management of the rupture.

  12. External pancreatic duct stent reduces pancreatic fistula: a meta-analysis and systematic review.

    Science.gov (United States)

    Patel, Krishen; Teta, Anthony; Sukharamwala, Prashant; Thoens, Jonathan; Szuchmacher, Mauricio; DeVito, Peter

    2014-01-01

    Postoperative pancreatic fistula formation (POPF) remains one of the most common and detrimental complications following pancreaticojejunostomy (PJ). The aim of this meta-analysis is to analyze the efficacy of external pancreatic duct stent placement in preventing POPF formation following PJ. The primary end-point was the incidence of POPF formation following pancreaticoduodenectomy (PD) in the presence and absence of external stent placement. Secondary outcomes examined were the incidence of perioperative mortality, delayed gastric emptying, postoperative wound infection, operative time, blood loss, and length of hospital stay. Four trials were included comprising 416 patients. External pancreatic duct stenting was found to reduce the incidence of both any grade POPF formation (OR 0.37, 95% CI = 0.23 to 0.58, p = 0.0001) and clinically significant (grade B or C) POPF formation (OR 0.50, 95% CI = 0.30 to 0.84, p = 0.0009) following PD. The use of an external stent was also found to significantly lessen length of hospital stay (SMD -0.39, 95% CI = -0.63 to -0.15, p = 0.001). This analysis has shown that external pancreatic duct stenting is indeed efficacious in the incidence of both any grade as well as clinically significant POPF formation following PD. Length of hospital stay was also found to be significantly less by external duct stenting. Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  13. An in Vitro Twist Fatigue Test of Fabric Stent-Grafts Supported by Z-Stents vs. Ringed Stents

    Directory of Open Access Journals (Sweden)

    Jing Lin

    2016-02-01

    Full Text Available Whereas buckling can cause type III endoleaks, long-term twisting of a stent-graft was investigated here as a mechanism leading to type V endoleak or endotension. Two experimental device designs supported with Z-stents having strut angles of 35° or 45° were compared to a ringed control under accelerated twisting. Damage to each device was assessed and compared after different durations of twisting, with focus on damage that may allow leakage. Stent-grafts with 35° Z-stents had the most severe distortion and damage to the graft fabric. The 45° Z-stents caused less fabric damage. However, consistent stretching was still seen around the holes for sutures, which attach the stents to the graft fabric. Larger holes may become channels for fluid percolation through the wall. The ringed stent-graft had the least damage observed. Stent apexes with sharp angles appear to be responsible for major damage to the fabrics. Device manufacturers should consider stent apex angle when designing stent-grafts, and ensure their devices are resistant to twisting.

  14. Stent malapposition, as a potential mechanism of very late stent thrombosis after bare-metal stent implantation: A case report

    Energy Technology Data Exchange (ETDEWEB)

    Higuma, Takumi, E-mail: higuma@cc.hirosaki-u.ac.jp; Abe, Naoki; Hanada, Kenji; Yokoyama, Hiroaki; Tomita, Hirofumi; Okumura, Ken

    2014-04-15

    A 90-year-old man was admitted to our hospital with acute ST-segment elevation myocardial infarction. He had a history of post-infarction angina pectoris 79 months ago and had a bare-metal stent (BMS) implanted in the proximal left anterior descending artery at our hospital. Emergent coronary angiography demonstrated thrombotic occlusion in the previously stented segment. After catheter thrombectomy, antegrade flow was restored, but 90% stenosis with haziness persisted in the proximal and distal portions of the previously stented segment. Intravascular ultrasound imaging showed interstrut cavities or stent malapposition at the proximal and distal sites of stented segment. In close proximity to the sites, residual thrombi were also observed. Optical coherence tomography (OCT) demonstrated neither lipid-laden neointimal tissue nor rupture but clearly demonstrated residual thrombus adjacent to the malapposed region in addition to the stent malapposition. PCI with balloon was successfully performed and stent apposition was confirmed by OCT. Stent malapposition is an unusual mechanism of very late stent thrombosis after BMS implantation. OCT can clearly reveal the etiology of stent thrombosis.

  15. Three-Year Clinical Outcomes of a Polymer-Free Paclitaxel-Eluting Microporous Stent in Real-World Practice: Final Results of the Safety and Efficacy Registry of the Yinyi Stent (SERY-I).

    Science.gov (United States)

    Zhu, Jinzhou; Zhang, Qi; Chen, Lianglong; Zhang, Chenyun; Zhou, Xuchen; Yuan, Yong; Zhang, Ruiyan

    2017-01-01

    The safety and efficacy of a China-made polymer-free paclitaxel-eluting microporous stent (Yinyi) at 1-year has been previously reported. However, limited evidence exists regarding the long-term performance of this novel drug-eluting stent (DES). This study investigated the 3-year efficacy and safety of the Yinyi stent in the setting of safety and efficacy registry of the Yinyi stent (SERY-I) clinical trial. Between June 2008 and August 2009, a total of 1045 patients undergoing percutaneous coronary intervention (PCI) were implanted with ≥ 1 Yinyi stents at 27 medical centers in mainland China. Thereafter, clinical follow-up was performed for a period of 3 years after enrollment. The primary endpoint was the cumulative rate of composite major adverse cardiac events (MACE) including target lesion revascularization (TLR), the combined incidence of cardiac death, and non-fatal myocardial infarction; the second endpoint was the incidence of stent thrombosis. Overall, 1376 lesions were treated successfully with 1713 Yinyi stents, and 1019 (98.7%) patients received dual antiplatelet therapy for at least 12 months. At 3 years, a total of 13 (1.33%) patients had suffered cardiac death. The incidence of non-fatal myocardial infarction and TLR was 9 (0.92%) and 58 (5.92%) among the patients. Stent thrombosis occurred in 13 (1.33%) patients, and the rate of Academic Research Consortium (ARC) definite or probable stent thrombosis was 0.82%. Given the limitations that SERY-I was a single arm, nonrandomized study and only telephone follow-up was performed without angiographic analysis, the safety and efficacy of Yinyi stent observed in this extended follow-up Registry needs further verification.

  16. PENSION FUND - ELECTIONS

    CERN Multimedia

    2000-01-01

    This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund.   Candidate: Name: MAURIN First Name: Guy I have been a member of the personnel since 1967 and as early as 1972 I was involved, in my capacity as President of the Staff Association, in the improvement of the Pension Fund benefits. As for most of us the Pension Fund is the only social provident scheme to which we belong, it is important to ensure that it is well managed and in balance. As a member of the Governing Board since 1974 and Vice-Chairman of this Board since 1977, I have continued to pursue these objectives. One of the main responsibilities of the Governing Board is our asset investment policy. The Investment Committee, of which I am Chairman, must have an overall view of the management of our 4 billion Swiss francs and seek the best yield with minimum risk. The investment structure must continuously be adapted i...

  17. PENSION FUND - ELECTIONS

    CERN Multimedia

    2000-01-01

    This candidature has been duly registered and is hereby presented in accordance with paragraph 6.h of the Regulations for Elections to the Governing Board of the Pension Fund.   Candidate: Name: RANJARD First Name: Florence Having been a member of the Governing Board of the Pension Fund since 1983 as Guy Maurin’s alternate, I am standing for a further 3-year term of office. Over the past few years work has concentrated essentially on following items: Monitoring of the work of the fund managers and their performances. The three-yearly study of the Fund’s actuarial situation. The pension guarantees ­ second phase. The Fund is approaching its maturity: the level of benefits exceeds contributions. In this context it has to strike a suitable balance between management of the risk from a dynamic investment policy, while by a prudent policy avoiding any significant loss of its capital. These will be my concerns within the Governing Board of the Pension Fund if you give me your support.

  18. Elections in November

    CERN Multimedia

    Staff Association

    2011-01-01

    Become a delegate, it’s simple! CERN’s employment conditions have had a rather hard time over the past few years. The Staff Association, with the support of the staff, has managed to avoid the worst on many occasions. The next few years will be decisive, which is why we must continue to be on the scene, active, a source of proposals, and a real negotiating partner. The Staff Association is your only formal representative vis-à-vis the Management and the Member States, and the Staff Council your voice. A rapidly evolving Staff Association In November, all 60 seats in the Staff Council must be filled. All delegates are therefore outgoing. About a dozen current delegates have informed us that they will not stand for election again, which corresponds to a standard turnover. We thank these outgoing delegates for their past investment. If you are interested in the work of the Staff Association, become involved. We need new, talented, enthusiastic people who are willing to inv...

  19. Circumferential stent fracture repaired using a covered stent in a 42-year-old man with coarctation of the aorta.

    Science.gov (United States)

    Ayoub, Fares; AlShelleh, Sameeha; A L-Ammouri, Iyad

    2016-02-01

    We present a case of circumferential fracture of aortic coarctation stent with severe re-stentosis presenting 16 years after initial stent implantation with end-stage renal disease. The patient was treated with a covered stent using the stent-in-stent technique. The use of an ultra-high-pressure balloon was proved necessary to overcome the tight, non-compliant stenosis.

  20. Metallic stent placement for the management of acute colorectal obstruction caused by colorectal carcinomas: its effect on scheduled surgery

    International Nuclear Information System (INIS)

    Cao Yan; Liu Bingyan; Mao Aiwu; Yin Xiang; Gao Zhongdu

    2011-01-01

    Objective: To prospectively evaluate the safety and clinical efficacy of a newly designed self-expandable metallic stent (SEMS) placement in the treatment of patients with acute malignant colorectal obstruction due to colorectal carcinomas. Methods: During the period from April 2001 to October 2007, a total of 52 patients with acute malignant colorectal obstruction were treated with stent placement by using a new designed SEMS, which was employed as a preoperative transit means. All the patients were followed up and the relevant data, including technical success rate, clinical efficacy, complications and overall survival rate, were documented. The results were analyzed. Results: Stent placement was successfully carried out in all patients except for two patients who showed complete colorectal obstruction. No procedure-related complications occurred. Technical success rate was 96% (50/52). Two days after the treatment, the relief rate of colorectal obstruction was 98% (49/50). Postoperative complications included stent migration (n=4), anal pain (n=2) and stool impaction (n=1). The stool impaction seen in one patient was successfully removed away with endoscopic manipulation two days after stent placement. An elective one-stage surgical procedure was performed in all 50 patients who successfully received a SEMS placement within a mean interval of (8±2) days (ranged 4-11 days) after stent placement. Mean follow-up time was (36±12) months with a range of (3-70) months. All patients remained alive at the time of this report. Conclusion: The newly designed SEMS placement used as a preoperative transit means is a safe and effective intervention for colonic decompression in patients with acute malignant colorectal obstruction due to colorectal carcinomas. It can reliably ensure most of patients with colorectal carcinomas to successfully accomplish an elective surgery. (authors)

  1. Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study).

    Science.gov (United States)

    Schulte, Karl-Ludwig; Pilger, Ernst; Schellong, Sebastian; Tan, Kong Ten; Baumann, Frederic; Langhoff, Ralf; Torsello, Giovanni; Zeller, Thomas; Amendt, Klaus; Brodmann, Marianne

    2015-10-01

    To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months. Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different. Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions. © The Author(s) 2015.

  2. Comparison of a New Polytetrafluoroethylene-Covered Metallic Stent to a Noncovered Stent in Canine Ureters

    International Nuclear Information System (INIS)

    Chung, Hwan-Hoon; Lee, Seung Hwa; Cho, Sung Bum; Park, Hong Suk; Kim, Young Sik; Kang, Byung Chul; Frisoli, Joan K.; Razavi, Mahmood K.

    2008-01-01

    The aim of this study was to determine the feasibility of using a newly designed polytetrafluoroethylene (PTFE)-covered metallic stent in the ureter by comparing its effectiveness with that of the noncovered stent in a canine model. We placed 14 stents in the ureters of seven mongrel dogs that weighed 30-40 kg each. The covered and noncovered stents were deployed in the right and left ureters, respectively, of six dogs. In the seventh dog, a covered stent and a double-J catheter were inserted in the right ureter, and a covered stent only was inserted in the left ureter. The first six dogs were sacrificed at 5, 10, and 15 weeks after deployment of the stents (two for each follow-up period), and the seventh dog was sacrificed at 30 weeks. There was no migration or poor expansion of any of the stents observed on plain radiography. On intravenous pyelogram and retrograde pyelogram, all of the covered stents at each follow-up period had patent lumens at the stented segments without hydronephrosis, and the passage of contrast material through it was well preserved. The noncovered stents in the dogs sacrificed at 5 and 10 weeks and one of the two dogs sacrificed at 15 weeks showed near-complete occlusion of the stent lumen due to ingrowth of the soft tissue, and severe hydronephrosis was also noted. The noncovered stent in the other dog sacrificed at 15 weeks showed the passage of contrast material without hydronephrosis, but the lumen of the stent was still nearly occluded by the soft tissue. There was no evidence of hydronephrosis or passage disturbance of the contrast material in both ureters of the dog sacrificed at 30 weeks. We conclude that the newly designed PTFE-covered stent effectively prevented the luminal occlusion caused by urothelial hyperplasia compared to the near-total occlusion of the noncovered stents, and no migration of the covered stents was noted

  3. Expandable metallic ureteral stent: indications and results. Analysis of the current literature.

    Science.gov (United States)

    Sampogna, Gianluca; Grasso, Angelica; Montanari, Emanuele

    2018-03-28

    Ureteral obstructions are managed by complex surgery not always feasible for surgical field complexity or poor patient conditions. Various surgical maneuvers, as ureteral dilation, stenting and percutaneous nephrostomy, can be offered, but they are related to considerable failure rates and negative impact on quality of life. In selected cases, the positioning of long-term expandable metallic ureteral stents (EMUSs) may be an appropriate and successful choice. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria, a systematic review of the literature was performed in July 2017 using PubMed, Cochrane Library, Scopus and Web of Science databases. The search was conducted by typing the following terms: "Expandable metallic ureteral stent", "Memokath ureteral stent", "Allium ureteral stent" and "Uventa ureteral stent". Twenty studies reported the safety, efficacy and clinical outcomes related to the common available EMUSs. Most studies were single-arm, retrospective and involving a low number of clinical cases, resulting in significant difficulties with outlining indications and drawing conclusions. Available papers showed EMUSs offered a high rate of patency, a long duration and a good quality of life, even if they are associated with significant complications. Since the first description of ureteral stents 50 years ago, we have faced a significant evolution in stent design. The current generation of EMUSs offers many advantages, but the onset of adverse effects is still significant and limits their use to selected cases. Further research should be addressed to the realization of prospective, multi-institutional randomized clinical trials to highlight indications to manage appropriately ureteral obstructions.

  4. MR Angiography of Peripheral Arterial Stents: In Vitro Evaluation of 22 Different Stent Types.

    Science.gov (United States)

    Burg, Matthias C; Bunck, Alexander C; Seifarth, Harald; Buerke, Boris; Kugel, Harald; Hesselmann, Volker; Köhler, Michael; Heindel, Walter; Maintz, David

    2011-01-01

    Purpose. To evaluate stent lumen visibility of a large sample of different peripheral arterial (iliac, renal, carotid) stents using magnetic resonance angiography in vitro. Materials and Methods. 21 different stents and one stentgraft (10 nitinol, 7 316L, 2 tantalum, 1 cobalt superalloy, 1 PET + cobalt superalloy, and 1 platinum alloy) were examined in a vessel phantom (vessel diameters ranging from 5 to 13 mm) filled with a solution of Gd-DTPA. Stents were imaged at 1.5 Tesla using a T1-weighted 3D spoiled gradient-echo sequence. Image analysis was performed measuring three categories: Signal intensity in the stent lumen, lumen visibility of the stented lumen, and homogeneity of the stented lumen. The results were classified using a 3-point scale (good, intermediate, and poor results). Results. 7 stents showed good MR lumen visibility (4x nitinol, 2x tantalum, and 1x cobalt superalloy). 9 stents showed intermediate results (5x nitinol, 2x 316L, 1x PET + cobalt superalloy, and 1x platinum alloy) and 6 stents showed poor results (1x nitinol, and 5x 316L). Conclusion. Stent lumen visibility varies depending on the stent material and type. Some products show good lumen visibility which may allow the detection of stenoses inside the lumen, while other products cause artifacts which prevent reliable evaluation of the stent lumen with this technique.

  5. MR Angiography of Peripheral Arterial Stents: In Vitro Evaluation of 22 Different Stent Types

    Directory of Open Access Journals (Sweden)

    Matthias C. Burg

    2011-01-01

    Full Text Available Purpose. To evaluate stent lumen visibility of a large sample of different peripheral arterial (iliac, renal, carotid stents using magnetic resonance angiography in vitro. Materials and Methods. 21 different stents and one stentgraft (10 nitinol, 7 316L, 2 tantalum, 1 cobalt superalloy, 1 PET + cobalt superalloy, and 1 platinum alloy were examined in a vessel phantom (vessel diameters ranging from 5 to 13 mm filled with a solution of Gd-DTPA. Stents were imaged at 1.5 Tesla using a T1-weighted 3D spoiled gradient-echo sequence. Image analysis was performed measuring three categories: Signal intensity in the stent lumen, lumen visibility of the stented lumen, and homogeneity of the stented lumen. The results were classified using a 3-point scale (good, intermediate, and poor results. Results. 7 stents showed good MR lumen visibility (4x nitinol, 2x tantalum, and 1x cobalt superalloy. 9 stents showed intermediate results (5x nitinol, 2x 316L, 1x PET + cobalt superalloy, and 1x platinum alloy and 6 stents showed poor results (1x nitinol, and 5x 316L. Conclusion. Stent lumen visibility varies depending on the stent material and type. Some products show good lumen visibility which may allow the detection of stenoses inside the lumen, while other products cause artifacts which prevent reliable evaluation of the stent lumen with this technique.

  6. Intravascular Stenting in Microvascular Anastomoses

    DEFF Research Database (Denmark)

    Assersen, Kristine; Sørensen, Jens

    2015-01-01

    Background The effect of intravascular stenting (IVaS) on microvascular anastomoses has given adverse results. For experienced microsurgeons the benefit of IVaS is doubtful. We have investigated the potential benefit of the IVaS technique for two groups of inexperienced microsurgeons with differe...

  7. 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.

  8. Iraq: Politics, Elections, and Benchmarks

    National Research Council Canada - National Science Library

    Katzman, Kenneth

    2009-01-01

    Iraq's political system, the result of a U.S.-supported election process, is increasingly exhibiting peaceful competition but continues to be riven by sectarianism and ethnic and factional infighting...

  9. Iraq: Politics, Elections, and Benchmarks

    National Research Council Canada - National Science Library

    Katzman, Kenneth

    2008-01-01

    .... The Administration is expressing optimism that the passage of key laws in 2008, including a law to govern new provincial elections to held in early 2009, will heal remaining rifts and continue to reduce violence...

  10. Tactical Voting in Plurality Elections

    Science.gov (United States)

    Araújo, Nuno A. M.; Andrade, José S.; Herrmann, Hans J.

    2010-01-01

    How often will elections end in landslides? What is the probability for a head-to-head race? Analyzing ballot results from several large countries rather anomalous and yet unexplained distributions have been observed. We identify tactical voting as the driving ingredient for the anomalies and introduce a model to study its effect on plurality elections, characterized by the relative strength of the feedback from polls and the pairwise interaction between individuals in the society. With this model it becomes possible to explain the polarization of votes between two candidates, understand the small margin of victories frequently observed for different elections, and analyze the polls' impact in American, Canadian, and Brazilian ballots. Moreover, the model reproduces, quantitatively, the distribution of votes obtained in the Brazilian mayor elections with two, three, and four candidates. PMID:20856800

  11. Improving Predictive Accuracy in Elections.

    Science.gov (United States)

    Sathiaraj, David; Cassidy, William M; Rohli, Eric

    2017-12-01

    The problem of accurately predicting vote counts in elections is considered in this article. Typically, small-sample polls are used to estimate or predict election outcomes. In this study, a machine-learning hybrid approach is proposed. This approach utilizes multiple sets of static data sources, such as voter registration data, and dynamic data sources, such as polls and donor data, to develop individualized voter scores for each member of the population. These voter scores are used to estimate expected vote counts under different turnout scenarios. The proposed technique has been tested with data collected during U.S. Senate and Louisiana gubernatorial elections. The predicted results (expected vote counts, predicted several days before the actual election) were accurate within 1%.

  12. Dynamic elections and ideological polarization

    Czech Academy of Sciences Publication Activity Database

    Nunnari, S.; Zápal, Jan

    2017-01-01

    Roč. 25, č. 4 (2017), s. 505-534 ISSN 1047-1987 Institutional support: Progres-Q24 Keywords : elections * political polarization Subject RIV: AH - Economics OBOR OECD: Economic Theory Impact factor: 3.361, year: 2016

  13. Dynamic elections and ideological polarization

    Czech Academy of Sciences Publication Activity Database

    Nunnari, S.; Zápal, Jan

    2017-01-01

    Roč. 25, č. 4 (2017), s. 505-534 ISSN 1047-1987 Institutional support: RVO:67985998 Keywords : elections * political polarization Subject RIV: AH - Economics OBOR OECD: Economic Theory Impact factor: 3.361, year: 2016

  14. Polymeric Biodegradable Stent Insertion in the Esophagus

    Directory of Open Access Journals (Sweden)

    Kai Yang

    2016-04-01

    Full Text Available Esophageal stent insertion has been used as a well-accepted and effective alternative to manage and improve the quality of life for patients diagnosed with esophageal diseases and disorders. Current stents are either permanent or temporary and are fabricated from either metal or plastic. The partially covered self-expanding metal stent (SEMS has a firm anchoring effect and prevent stent migration, however, the hyperplastic tissue reaction cause stent restenosis and make it difficult to remove. A fully covered SEMS and self-expanding plastic stent (SEPS reduced reactive hyperplasia but has a high migration rate. The main advantage that polymeric biodegradable stents (BDSs have over metal or plastic stents is that removal is not require and reduce the need for repeated stent insertion. But the slightly lower radial force of BDS may be its main shortcoming and a post-implant problem. Thus, strengthening support of BDS is a content of the research in the future. BDSs are often temporarily effective in esophageal stricture to relieve dysphagia. In the future, it can be expect that biodegradable drug-eluting stents (DES will be available to treat benign esophageal stricture, perforations or leaks with additional use as palliative modalities for treating malignant esophageal stricture, as the bridge to surgery or to maintain luminal patency during neoadjuvant chemoradiation.

  15. Getting elections right? Measuring electoral integrity

    NARCIS (Netherlands)

    van Ham, C.T.

    2015-01-01

    Holding elections has become a global norm. Unfortunately, the integrity of elections varies strongly, ranging from “free and fair” elections with genuine contestation to “façade” elections marred by manipulation and fraud. Clearly, electoral integrity is a topic of increasing concern. Yet electoral

  16. 12 CFR 1261.7 - Election process.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Election process. 1261.7 Section 1261.7 Banks... Federal Home Loan Bank Boards of Directors: Eligibility and Elections § 1261.7 Election process. (a... at least 20 percent of the votes eligible to be cast, the Bank shall continue the election process...

  17. Endovascular stent graft repair for thoracic aortic aneurysms: the history and the present in Japan.

    Science.gov (United States)

    Kawaguchi, Satoshi; Shimizu, Hideyuki; Yoshitake, Akihiro; Shimazaki, Taro; Iwahashi, Toru; Ogino, Hitoshi; Ishimaru, Shin; Shigematsu, Hiroshi; Yozu, Ryohei

    2013-01-01

    Stent-grafts for endovascular repair of thoracic aortic aneurysms have been commercially available for more than ten years in the West, whereas, in Japan, a manufactured stent-graft was not approved for the use until March 2008. Nevertheless, endovascular thoracic intervention began to be performed in Japan in the early 1990s, with homemade devices used in most cases. Many researchers have continued to develop their homemade devices. We have participated in joint design and assessment efforts with a stent-graft manufacturer, focusing primarily on fenestrated stent-grafts used in repairs at the distal arch, a site especially prone to aneurysm. In March 2008, TAG (W.L. Gore & Associates, Inc., Flagstaff, Arizona, USA) was approved as a stent graft for the thoracic area first in Japan, which was major turning point in treatment for thoracic aortic aneurysms. Subsequently, TALENT (Medtronic, Inc., Minneapolis, Minnesota, USA) was approved in May 2009, and TX2 (COOK MEDICAL Inc., Bloomington, Indiana, USA) in March 2011. Valiant as an improved version of TALENT was approved in November 2011, and TX2 Proform as an improved version of TX2 began to be supplied in October 2012. These stent grafts are excellent devices that showed good results in Western countries, and marked effectiveness can be expected by making the most of the characteristics of each device. A clinical trial in Japan on Najuta (tentative name) (Kawasumi Labo., Inc., Tokyo, Japan) as a line-up of fenestrated stent grafts that can be applied to distal arch aneurysms showing a high incidence, and allow maintenance of blood flow to the arch vessel was initiated. This trial was completed, and Najuta has just been approved in January of 2013 in Japan, and further development is expected. In the U.S., great efforts have recently been made to develop and manufacture excellent stent grafts for thoracic aneurysms, and rapid progress has been achieved. In particular, in the area of the aortic arch, in which we

  18. Randomized comparison of 6- versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention Design and rationale for the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study (PRODIGY).

    Science.gov (United States)

    Valgimigli, Marco; Campo, Gianluca; Percoco, Gianfranco; Monti, Monia; Ferrari, Fabrizio; Tumscitz, Carlo; Zuffi, Andrea; Colombo, Federico; Kubbajeh, Moh'd; Cavazza, Caterina; Cangiano, Elisa; Tebaldi, Matteo; Minarelli, Monica; Arcozzi, Chiara; Scalone, Antonella; Frangione, Alice; Borghesi, Marco; Marchesini, Jlenia; Parrinello, Giovanni; Ferrari, Roberto

    2010-11-01

    The optimal duration of clopidogrel therapy after coronary stenting is debated because of the scarcity of randomized controlled trials and inconsistencies arising from registry data. Although prolonged clopidogrel therapy after bare metal stenting is regarded as an effective secondary prevention measure, the safety profile of drug-eluting stents itself has been questioned in patients not receiving ≥ 12 months of dual-antiplatelet therapy. Twenty-four months of clopidogrel therapy after coronary stenting reduces the composite of death, myocardial infarction, or stroke compared with 6 months of treatment. PRODIGY is an unblinded, multicenter, 4-by-2 randomized trial. All-comer patients with indication to coronary stenting are randomly treated-balancing randomization-with bare metal stent (no active late loss inhibition), Endeavor Sprint zotarolimus-eluting stent (Medtronic, Santa Rosa, CA) (mild late loss inhibition), Taxus paclitaxel-eluting stent (Boston Scientific, Natick, MA) (moderate late loss inhibition), or Xience V everolimus-eluting stent (Abbott Vascular, Santa Clara, CA) (high late loss inhibition). At 30 days, patients in each stent group are randomly allocated to receive 24 or up to 6 months of clopidogrel therapy-primary end point randomization. With 1,700 individuals, this study will have >80% power to detect a 40% difference in the primary end point after sample size augmentation of 5% and a background event rate of 8%. The PRODIGY trial aims to assess whether 24 months of clopidogrel therapy improves cardiovascular outcomes after coronary intervention in a broad all-comer patient population receiving a balanced mixture of stents with various anti-intimal hyperplasia potency. Copyright © 2010 Mosby, Inc. All rights reserved.

  19. Relation of Nickel Allergy with in-Stent Restenosis in Patients Treated with Cobalt Chromium Stents

    OpenAIRE

    Aliağaoğlu, Cihangir; Turan, Hakan; Erden, İsmail; Albayrak, Hülya; Özhan, Hakan; Başar, Cengiz; Gürlevik, Zehra; Alçelik, Ayşegül

    2012-01-01

    Background In-stent restenosis (ISR) is the major limitation of percutaneous coronary stenting procedure. The elements like nickel, chromate and molybdenum are known to cause contact allergy. Hypersensitivity reaction, against these metal ions, may be one of the reasons of ISR. Cobalt chromium coronary stents, which are increasingly being used in percutaneous coronary interventions, have more nickel amount than the stainless steel stents. Objective We aimed to investigate the association betw...

  20. International electives in neurology training

    Science.gov (United States)

    Lyons, Jennifer L.; Coleman, Mary E.; Engstrom, John W.

    2014-01-01

    Objective: To ascertain the current status of global health training and humanitarian relief opportunities in US and Canadian postgraduate neurology programs. Background: There is a growing interest among North American trainees to pursue medical electives in low- and middle-income countries. Such training opportunities provide many educational and humanitarian benefits but also pose several challenges related to organization, human resources, funding, and trainee and patient safety. The current support and engagement of neurology postgraduate training programs for trainees to pursue international rotations is unknown. Methods: A survey was distributed to all program directors in the United States and Canada (December 2012–February 2013) through the American Academy of Neurology to assess the training opportunities, institutional partnerships, and support available for international neurology electives. Results: Approximately half of responding programs (53%) allow residents to pursue global health–related electives, and 11% reported that at least 1 trainee participated in humanitarian relief during training (survey response rate 61%, 143/234 program directors). Canadian programs were more likely to allow residents to pursue international electives than US programs (10/11, 91% vs 65/129, 50%, p = 0.023). The number of trainees participating in international electives was low: 0%–9% of residents (55% of programs) and 10%–19% of residents (21% of programs). Lack of funding was the most commonly cited reason for residents not participating in global health electives. If funding was available, 93% of program directors stated there would be time for residents to participate. Most program directors (75%) were interested in further information on global health electives. Conclusions: In spite of high perceived interest, only half of US neurology training programs include international electives, mostly due to a reported lack of funding. By contrast, the majority

  1. 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

    . Notably, definite stent thrombosis was more frequent in female than male STEMI patients (81.8% vs. 56.8%, p=0.09), and in very late STEMIs (p=0.06). Female sex (OR 3.53 [1.01-12.59]) and clopidogrel (OR 4.43 [1.03-19.01]) was associated with increased for definite stent thrombosis, whereas age, time since...... treated with coronary stents in the randomized SORT OUT II trial (mean age 63.6 yrs. 74.8% men). Patients who following stent implantation were readmitted with STEMI were included and each patient was categorized ranging from definite-to ruled-out stent thrombosis according to the Academic Research...... Consortium definitions. Multivariate logistic regression was performed on selected covariates to assess odds ratios (ORs) for definite stent thrombosis. Results: 85 patients (4.1%), mean age 62.7 years, 77.1% men, were admitted with a total of 96 STEMIs, of whom 60 (62.5%) had definite stent thrombosis...

  2. Is oesophageal stenting for cancer the answer? A report from a ...

    African Journals Online (AJOL)

    Many prospective randomised trials of palliative treatment have been done in the developed world, not taking into account these socio-economic constraints. We present a study from Tshepong Hospital, a secondary hospital in South Africa, comparing stenting with radiation therapy in the palliative treatment of oesophageal ...

  3. Prevention of stent thrombosis: challenges and solutions

    Science.gov (United States)

    Reejhsinghani, Risheen; Lotfi, Amir S

    2015-01-01

    Stent thrombosis is an uncommon but serious complication which carries with it significant mortality and morbidity. This review analyzes the entity of stent thrombosis from a historical and clinical perspective, and chronicles the evolution of this condition through the various generations of stent development, from bare metal to first-generation, second-generation, and third-generation drug-eluting stents. It also delineates the specific risk factors associated with stent thrombosis and comprehensively examines the literature related to each of these risks. Finally, it highlights the preventative strategies that can be garnered from the existing data, and concludes that a multifactorial approach is necessary to combat the occurrence of stent thrombosis, with higher risk groups, such as patients with ST segment elevation myocardial infarction, meriting further research. PMID:25657588

  4. Radioactive stents delay but do not prevent in-stent neointimal hyperplasia

    NARCIS (Netherlands)

    I.P. Kay (Ian Patrick); A.J. Wardeh (Alexander); K. Kozuma (Ken); A.H.M. Knook (Marco); A. Thury (Attila); P.W.J.C. Serruys (Patrick); D.P. Foley (David); P.C. Levendag (Peter); W.J. van der Giessen (Wim); G. Sianos (Georgios)

    2001-01-01

    textabstractBACKGROUND: Restenosis after conventional stenting is almost exclusively caused by neointimal hyperplasia. Beta-particle-emitting radioactive stents decrease in-stent neointimal hyperplasia at 6-month follow-up. The purpose of this study was to evaluate the 1-year outcome of (32)P

  5. Angulated Stents-A Novel Stent Improvisation to Manage Difficult Post-tuberculosis Bronchial Stenosis.

    Science.gov (United States)

    Tay, Chee Kiang; Jeong, Byeong-Ho; Kim, Hojoong

    2017-10-18

    Post-tuberculosis bronchostenosis (PTBS), a complication of endobronchial tuberculosis is currently treated by bronchial stenting. However, in cases of angulated bronchial stenoses, difficulty is often encountered in stent insertion and maintenance, resulting in stent migration, granulation tissue overgrowth, and restenosis. To accommodate the angulated alignment of the stenosis, we devised an "angulated stent"-a novel improvisation of the conventional stent via splicing and suturing to achieve a resultant angulated shape. A retrospective review was undertaken to evaluate the performance of this stent. Among 283 PTBS patients who underwent interventional bronchoscopy at our center from 2004 to 2014, 21 were treated with at least one angulated stent. Clinical outcomes, including the stenting duration were investigated. After a median follow-up of 26 months, stent removal was successful in 7 (33.3%) out of 21 patients. In patients managed with angulated stents, the median duration to stent change or eventual removal was longer than those treated with straight tube stents (392 days vs. 86 days; p changing interval.

  6. 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...... after third-generation biolimus-eluting stent implantation....

  7. Mechanical behavior of peripheral stents and stent-vessel interaction: A computational study

    Science.gov (United States)

    Dottori, Serena; Flamini, Vittoria; Vairo, Giuseppe

    2016-05-01

    In this paper stents employed to treat peripheral artery disease are analyzed through a three-dimensional finite-element approach, based on a large-strain and large-displacement formulation. Aiming to evaluate the influence of some stent design parameters on stent mechanics and on the biomechanical interaction between stent and arterial wall, quasi-static and dynamic numerical analyses are carried out by referring to computational models of commercially and noncommercially available versions of both braided self-expandable stents and balloon-expandable stents. Addressing isolated device models, opening mechanisms and flexibility of both opened and closed stent configurations are numerically experienced. Moreover, stent deployment into a stenotic peripheral artery and possible postdilatation angioplasty (the latter for the self-expandable device only) are simulated by considering different idealized vessel geometries and accounting for the presence of a stenotic plaque. Proposed results highlight important differences in the mechanical response of the two types of stents, as well as a significant influence of the vessel shape on the stress distributions arising upon the artery-plaque system. Finally, computational results are used to assess both the stent mechanical performance and the effectiveness of the stenting treatment, allowing also to identify possible critical conditions affecting the risk of stent fracture, tissue damage, and/or pathological tissue response.

  8. 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 or resteno......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...

  9. Clinical outcomes of secondary gastroduodenal self-expandable metallic stent placement by stent-in-stent technique for malignant gastric outlet obstruction.

    Science.gov (United States)

    Sasaki, Takashi; Isayama, Hiroyuki; Nakai, Yousuke; Takahara, Naminatsu; Hamada, Tsuyoshi; Mizuno, Suguru; Mohri, Dai; Yagioka, Hiroshi; Kogure, Hirofumi; Arizumi, Toshihiko; Togawa, Osamu; Matsubara, Saburo; Ito, Yukiko; Yamamoto, Natsuyo; Sasahira, Naoki; Hirano, Kenji; Toda, Nobuo; Tada, Minoru; Koike, Kazuhiko

    2015-01-01

    To evaluate the efficacy and safety of secondary gastroduodenal stent placement after first stent dysfunction for malignant gastric outlet obstruction. We conducted a retrospective analysis to investigate the efficacy and safety of secondary stent-in-stent gastroduodenal stent placement. Among 260 patients who had been treated with first gastroduodenal stent placement for malignant gastric outlet obstruction, 29 patients (11.2%) were treated with secondary gastroduodenal stent placement because of first stent dysfunction. Pancreatic cancer was the major primary cancer (55.2%). A WallFlex duodenal stent was the most frequently inserted stent both as a first stent (75.9%) and as a secondary stent (62.1%). There were 22 patients (75.9%) that received gastroduodenal stents at the bending site (supraduodenal angle or infraduodenal angle). Technical and clinical success rates were 100% and 86.2%, respectively. Median eating period was 3.0 months, and median survival time was 3.5 months. As for related complications, gastrointestinal perforation, insufficient stent expansion, tumor ingrowth, tumor overgrowth, and cholangitis were experienced in 13.8% (four cases), 6.9% (two cases), 6.9% (two cases), 3.4% (one case), and 3.4% (one case), respectively. Secondary gastroduodenal stent placement might be effective for managing first stent dysfunction in malignant gastric outlet obstruction. However, gastrointestinal perforation was the major complication. © 2014 The Authors. Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society.

  10. Procedural resources utilization and clinical outcomes with bioresorbable everolimus-eluting scaffolds and Pt-Cr everolimus-eluting stent with resorbable abluminal polymer in clinical practice. A randomized trial.

    Science.gov (United States)

    de la Torre Hernandez, Jose M; Garcia Camarero, Tamara; Lee, Dae-Hyun; Sainz Laso, Fermin; Veiga Fernandez, Gabriela; Pino, Tania; Rubio, Silvia; Legarra, Pablo; Valdivia, Jorge R; Zueco Gil, Javier

    2017-08-01

    We sought to compare the procedural implications of using bioresorbable everolimus-eluting scaffolds (BVS) and Pt-Cr everolimus-eluting stent with abluminal bioabsorbable polymer (Synergy). There are important differences in the respective platforms, which could impact on procedural performance, complications and outcomes. A prospective, randomized single center study including consecutive patients in stable clinical condition and with lesions amenable to be treated with BVS according to predefined criteria. Patients were randomized to either treatment with BVS or Synergy. All procedural data were collected and 12 months clinical follow up conducted. Primary objectives were fluoroscopy time, median dose-area product, contras agent volumen, and peri-procedural troponin release. A total of 200 patients were included, 100 in BVS group and 100 in Synergy group. No significant differences were observed in baseline clinical and angiographic characteristics. Predilatation (97.6 vs. 25.4%; P procedural increase of creatinine was similar and amount of TnI release was significantly higher with BVS but incidence of peri-procedural infarction was comparable. Clinical outcomes at 12 months were similar with definite thrombosis being 1% with BVS and 0% with Synergy. The use of BVS in comparison with the Synergy stent in a similar lesional setting is associated with a higher use of resources in the procedure, more radiation, and higher TnI release. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  11. Temporary metal stents in bladder outflow obstruction.

    Science.gov (United States)

    Yachia, D

    1997-12-01

    The use of stents in the management of prostatic obstruction started in 1980 with the development of the "partial catheter" by Fabian in Germany. Since then, a variety of metals and biostable and biodegradable polymers have been made into temporary or permanent stents for the management of infravesical obstructions such as benign or malignant prostatic enlargement, bladder neck stenoses, or urethral strictures. This paper is an overview of two generations of temporary metal stents used in the patients with infravesical obstruction.

  12. Surgical treatment of acute recurrent diverticulitis: early elective or late elective surgery. An analysis of 237 patients.

    Science.gov (United States)

    Hoffmann, Henry; Dell-Kuster, Salome; Genstorfer, Jörg; Kettelhack, Christoph; Langer, Igor; Rosenthal, Rachel; Oertli, Daniel; Heizmann, Oleg

    2012-04-01

    The optimal timing of elective surger