Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): A randomised, single-blind, non-inferiority trial

The Lancet

Volumn 384, Issue 9960, 2014, Pages 2111-2122

  Pilgrim, Thomas ^a   Heg, Dik ^j   Roffi, Marco ^b   Tüller, David ^c   Muller, Olivier ^d   Vuilliomenet, André ^e   Cook, Stéphane ^f   Weilenmann, Daniel ^g   Kaiser, Christoph ^h   Jamshidi, Peiman ⁱ   Fahrni, Therese ^a   Moschovitis, Aris ^a   Noble, Stéphane ^b   Eberli, Franz R ^c   Wenaweser, Peter ^a   Jüni, Peter ^j   Windecker, Stephan ^a  

^a BERN UNIVERSITY HOSPITAL   (Switzerland)

^b UNIVERSITY HOSPITAL   (Switzerland)

^c TRIEMLI HOSPITAL   (Switzerland)

^d LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^e CANTONAL HOSPITAL AARAU   (Switzerland)

^f NONE   (Switzerland)

^g CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^h UNIVERSITY HOSPITAL BASEL   (Switzerland)

ⁱ LUZERNER KANTONSSPITAL   (Switzerland)

^j UNIVERSITY OF BERN   (Switzerland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; CARDIOVASCULAR AGENT; CHROMIUM; COBALT; POLYMER; ULTRATHIN STRUT BIODEGRADABLE POLYMER; UNCLASSIFIED DRUG; ANTIINFECTIVE AGENT; EVEROLIMUS; RAPAMYCIN;

ACUTE CORONARY SYNDROME; AGED; ANTICOAGULANT THERAPY; ARTICLE; ATTRIBUTABLE RISK; BIODEGRADABILITY; BLOOD CLOT LYSIS; CARDIAC PATIENT; CHRONIC DISEASE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DEVICE SAFETY; DIABETES MELLITUS; DRUG ELUTING CORONARY STENT; FEMALE; HEART DEATH; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL DEVICE COMPLICATION; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; OFF LABEL DRUG USE; OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; RANDOMIZED CONTROLLED TRIAL; RESTENOSIS; SINGLE BLIND PROCEDURE; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; STENT THROMBOSIS; ANALOGS AND DERIVATIVES; BIODEGRADABLE IMPLANT; CLINICAL TRIAL; COMPARATIVE STUDY; DEVICES; DRUG ELUTING STENT; MULTICENTER STUDY; MYOCARDIAL INFARCTION; PROCEDURES; TREATMENT OUTCOME;

ABSORBABLE IMPLANTS; AGED; ANTI-BACTERIAL AGENTS; DRUG-ELUTING STENTS; FEMALE; HUMANS; MALE; MYOCARDIAL INFARCTION; PERCUTANEOUS CORONARY INTERVENTION; POLYMERS; SINGLE-BLIND METHOD; SIROLIMUS; TREATMENT OUTCOME;

EID: 84916894797     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(14)61038-2     Document Type: Article

References (42)

1. GG Stefanini, DR Holmes Jr Drug-eluting coronary-artery stents N Engl J Med 368 2013 254 265
2. S Bangalore, S Kumar, M Fusaro et al. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117-762 patient-years of follow-up from randomized trials Circulation 125 2012 2873 2891
3. GD Dangas, PW Serruys, DJ Kereiakes et al. Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) JACC Cardiovasc Interv 6 2013 914 922
4. U Baber, R Mehran, SK Sharma et al. Impact of the everolimus-eluting stent on stent thrombosis: a meta-analysis of 13 randomized trials J Am Coll Cardiol 58 2011 1569 1577
5. GG Stefanini, U Baber, S Windecker et al. Safety and efficacy of drug-eluting stents in women: a patient-level pooled analysis of randomised trials Lancet 382 2013 1879 1888
6. EP Navarese, K Tandjung, B Claessen et al. Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis BMJ 347 2013 f6530
7. T Palmerini, G Biondi-Zoccai, D Della Riva et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis Lancet 379 2012 1393 1402
8. M Taniwaki, GG Stefanini, S Silber et al. 4-Year clinical outcomes and predictors of repeat revascularization in patients treated with new-generation drug-eluting stents: a report from the RESOLUTE all-comers trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention) J Am Coll Cardiol 63 2014 1617 1625
9. M Sabate, L Raber, D Heg et al. Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trials JACC Cardiovasc Interv 7 2014 55 63
10. M Joner, AV Finn, A Farb et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk J Am Coll Cardiol 48 2006 193 202
11. M Natsuaki, K Kozuma, T Morimoto, H Shiomi, T Kimura Two-year outcome of a randomized trial comparing second-generation drug-eluting stents using biodegradable or durable polymer JAMA 311 2014 2125 2127
12. S Windecker, PW Serruys, S Wandel et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial Lancet 372 2008 1163 1173
13. Smits PC. The 3-year results from the COMPARE II trial. Presented at EuroPCR 2014, Paris, France; May 21-24, 2013.
14. GG Stefanini, B Kalesan, PW Serruys et al. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial Lancet 378 2011 1940 1948
15. GG Stefanini, RA Byrne, PW Serruys et al. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials Eur Heart J 33 2012 1214 1222
16. PW Serruys, V Farooq, B Kalesan et al. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial JACC Cardiovasc Interv 6 2013 777 789
17. Windecker S. BioFLOW-II trial: Safety and clinical performance of the drug-eluting Orsiro stent in the treatment of subjects with single de novo coronary artery lesions-II. Presented at EuroPCR 2013; Paris, France; May 21-25, 2013.
18. T Pilgrim, M Roffi, D Tüller et al. Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: rationale and design of the BIOSCIENCE Trial Am Heart J 2014 10.1016/j.ahj.2014.06.004 published online June 6.
19. M Hamon, R Niculescu, D Deleanu, M Dorobantu, NJ Weissman, R Waksman Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study EuroIntervention 8 2013 1006 1011
20. JB Dahm, T Willems, HG Wolpers, H Nordbeck, J Becker, J Ruppert Clinical investigation into the observation that silicon carbide coating on cobalt chromium stents leads to early differentiating functional endothelial layer, increased safety and DES-like recurrent stenosis rates: results of the PRO-Heal Registry (PRO-Kinetic enhancing rapid in-stent endothelialisation) EuroIntervention 4 2009 502 508
21. W Wijns, P Kolh, N Danchin the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) the European Association for Cardio-Thoracic Surgery (EACTS) European Association for Percutaneous Cardiovascular Interventions (EAPCI) Guidelines on myocardial revascularization Eur Heart J 31 2010 2501 2555
22. R Prineas, R Crow, H Blackburn The Minnesota code manual of electrocardiographic findings 1982 John Wright-PSG Littleton, MA
23. K Thygesen, JS Alpert, AS Jaffe the Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction The universal definition of myocardial infarction Circulation 116 2007 2634 2653
24. AJ Lansky, GW Stone Periprocedural myocardial infarction: prevalence, prognosis, and prevention Circ Cardiovasc Interv 3 2010 602 610
25. P Vranckx, DE Cutlip, R Mehran et al. Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. Addendum to the historical MI definitions used in stent studies EuroIntervention 5 2010 871 874
26. DE Cutlip, S Windecker, R Mehran et al. Clinical end points in coronary stent trials: a case for standardized definitions Circulation 115 2007 2344 2351
27. E Kedhi, KS Joesoef, E McFadden et al. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial Lancet 375 2010 201 209
28. PW Serruys, S Silber, S Garg et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents N Engl J Med 363 2010 136 146
29. L Raber, M Magro, GG Stefanini et al. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study Circulation 125 2012 1110 1121
30. R Mehran, SV Rao, DL Bhatt et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium Circulation 123 2011 2736 2747
31. C von Birgelen, H Sen, MK Lam et al. 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 Lancet 383 2014 413 423
32. PC Smits, S Hofma, M Togni et al. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial Lancet 381 2013 651 660
33. EH Christiansen, LO Jensen, P Thayssen et al. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial Lancet 381 2013 661 669
34. LO Jensen, P Thayssen, HS Hansen et al. 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) Circulation 125 2012 1246 1255
35. S Saito, M Valdes-Chavarri, G Richardt et al. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial Eur Heart J 2014 10.1093/eurheartj/ehu210 published online May 19.
36. A Kastrati, J Mehilli, J Dirschinger et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial Circulation 103 2001 2816 2821
37. S Windecker, S Stortecky, GG Stefanini et al. Revascularization versus medical treatment in patients with stable coronary artery disease: a network meta-analysis BMJ 348 2014 g3859
38. A de Waha, LA King, GG Stefanini et al. Long-term outcomes of biodegradable versus durable polymer drug-eluting stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of individual patient data from three randomised trials EuroIntervention 2014 published online Feb 28. pii: 20130419-04.
39. A de Belder, JM de la Torre Hernandez, R Lopez-Palop et al. A prospective randomized trial of everolimus-eluting stents versus bare-metal stents in octogenarians: the XIMA Trial (Xience or Vision Stents for the Management of Angina in the Elderly) J Am Coll Cardiol 63 2014 1371 1375
40. C Kaiser, S Galatius, P Erne et al. Drug-eluting versus bare-metal stents in large coronary arteries N Engl J Med 363 2010 2310 2319
41. GW Stone, A Rizvi, W Newman et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease N Engl J Med 362 2010 1663 1674
42. GW Stone, M Midei, W Newman et al. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial JAMA 299 2008 1903 1913