Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent: 4-year results of the PROTECT randomized trial

European Heart Journal

Volumn 35, Issue 40, 2014, Pages 2812-2820

  Wijns, William ^a   Steg, Ph Gabriel ^b,c,d,e   Mauri, Laura ^f   Kurowski, Volkhard ^g   Parikh, Keyur ^h   Gao, Runlin ⁱ   Bode, Christoph ^j   Greenwood, John P ^k   Lipsic, Erik ^l   Alamgir, Farqad ^m   Rademaker Havinga, Tessa ⁿ   Boersma, Eric ^o   Radke, Peter ^p   Van Leeuwen, Frank ^q   Camenzind, Edoardo ^r,s  

^a OLV HOSPITAL   (Belgium)

^b Site Xavier Bichat and Département Hospitalo Universitaire Fibrosis Inflammation and Remodeling   (France)

^c UNIVERSITÉ PARIS DESCARTES   (France)

^d BICHAT HOSPITAL   (France)

^e ROYAL BROMPTON HOSPITAL   (United Kingdom)

^f BRIGHAM AND WOMEN S HOSPITAL   (United States)

^g UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^h The Heart Care Clinic   (India)

ⁱ FUWAI HOSPITAL   (China)

^j UNIVERSITY OF FREIBURG   (Germany)

^k LEEDS GENERAL INFIRMARY   (United Kingdom)

^l UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^m CASTLE HILL HOSPITAL   (United Kingdom)

ⁿ CARDIALYSIS   (Netherlands)

^o ERASMUS MEDICAL CENTER   (Netherlands)

^p Clinic for Neurology and Clinical Neurophysiology   (Germany)

^q MEDTRONIC BAKKEN RESEARCH CENTER   (Netherlands)

^r UNIVERSITY OF GENEVA   (Switzerland)

^s UNIVERSITY HOSPITAL OF NANCY   (France)

more..

Author keywords

Drug eluting stent; Endothelialization; Late stent thrombosis; Myocardial infarction; Sirolimus; Zotarolimus

Indexed keywords

ANTITHROMBOCYTIC AGENT; RAPAMYCIN; ZOTAROLIMUS; IMMUNOSUPPRESSIVE AGENT;

ACUTE HEART INFARCTION; AGED; ARTICLE; BLEEDING; CALCIFICATION; CAUSE OF DEATH; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DUAL ANTIPLATELET THERAPY; FEMALE; FOLLOW UP; HEART DEATH; HEART DISEASE; HEART INFARCTION; HUMAN; IN-STENT RESTENOSIS; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; OPEN STUDY; OUTCOME ASSESSMENT; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SIROLIMUS ELUTING CORONARY STENT; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; STENT THROMBOSIS; TREATMENT DURATION; TREATMENT OUTCOME; UNSTABLE ANGINA PECTORIS; ZOTAROLIMUS ELUTING CORONARY STENT; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; COMPARATIVE STUDY; CORONARY RESTENOSIS; CORONARY THROMBOSIS; DRUG COMBINATION; DRUG ELUTING STENT; GRAFT OCCLUSION, VASCULAR; MIDDLE AGED; MULTICENTER STUDY; MYOCARDIAL INFARCTION; PROSTHESIS FAILURE;

CORONARY RESTENOSIS; CORONARY THROMBOSIS; DRUG THERAPY, COMBINATION; DRUG-ELUTING STENTS; FEMALE; GRAFT OCCLUSION, VASCULAR; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PLATELET AGGREGATION INHIBITORS; PROSTHESIS FAILURE; SIROLIMUS; TREATMENT OUTCOME;

EID: 84918781319     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehu318     Document Type: Article

References (25)

1. Camenzind E, WijnsW, Mauri L, Boersma E, Parikh K, Kurowski V, Gao R, Bode C, Greenwood JP, Gershlick A,O'NeillW, SerruysPW, Jorissen B, Steg PG, Committee PS, Investigators. Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation. Am Heart J 2009;158:902-909.
2. Kandzari DE, Leon MB, Popma JJ, Fitzgerald PJ, O'Shaughnessy C, BallMW, Turco M, Applegate RJ, Gurbel PA, Midei MG, Badre SS, Mauri L, Thompson KP, LeNarz LA, Kuntz RE. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J Am Coll Cardiol 2006;48:2440-2447.
3. Joner M, Nakazawa G, Finn AV, Quee SC, Coleman L, Acampado E, Wilson PS, Skorija K, Cheng Q, Xu X, Gold HK, Kolodgie FD, Virmani R. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol 2008; 52:333-342.
4. Camenzind E, Wijns W, Mauri L, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Boersma E, Vranckx P, McFadden E, Serruys PW, O'Neil WW, Jorissen B, Van Leeuwen F, Steg PG, Committee PS, Investigators. Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial. Lancet 2012;380:1396-1405.
5. Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007;356: 1020-1029.
6. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, SerruysPW, for the Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-2351.
7. Vranckx P, Cutlip DE, Mehran R, Kint PP, Silber S, Windecker S, Serruys PW. Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. Addendum to the historical MI definitions used in stent studies. EuroIntervention 2010;5:871-874.
8. Thygesen K, Alpert JS, White HD. Universal definition of myocardial infarction. Eur Heart J 2007;28:2525-2538.
9. SerruysPW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med 2010;363: 136-146.
10. von Birgelen C, Sen H, Lam MK, Danse PW, Jessurun GA, Hautvast RW, van Houwelingen GK, Schramm AR, Gin RM, Louwerenburg JW, de Man FH, Stoel MG, Lowik MM, Linssen GC, Said SA, Nienhuis MB, Verhorst PM, Basalus MW, Doggen CJ, Tandjung K. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, noninferiority trial. Lancet 2014;383:413-423.
11. StoneGW, Rizvi A,NewmanW, Mastali K,Wang JC, Caputo R,Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ, Investigators SI. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med 2010;362:1663-1674.
12. Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, WijnsW, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet 2008; 372:1163-1173.
13. Camenzind E, Boersma E, WijnsW, Mauri L, Rademaker-Havinga T, Suttorp MJ, Al Kurdi M, Steg PG. Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type. Eur Heart J 2014;35: 1932-1948.
14. Schomig A, Neumann FJ, Kastrati A, Schuhlen H, Blasini R, Hadamitzky M,Walter H, Zitzmann-Roth EM, Richardt G, Alt E, Schmitt C, Ulm K. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-Artery stents. N Engl J Med 1996;334:1084-1089.
15. Moussa I, Di Mario C, Reimers B, Akiyama T, Tobis J, Colombo A. Subacute stent thrombosis in the era of intravascular ultrasound-guided coronary stenting without anticoagulation: frequency, predictors and clinical outcome. J Am Coll Cardiol 1997;29:6-12.
16. Colombo A, Hall P, Nakamura S, Almagor Y, Maiello L, Martini G, Gaglione A, Goldberg SL, Tobis JM. Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. Circulation 1995;91:1676-1688.
17. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005;293: 2126-2130.
18. Kereiakes DJ, Choo JK, Young JJ, Broderick TM. Thrombosis and drug-eluting stents: a critical appraisal. Rev Cardiovasc Med 2004;5:9-15.
19. Daemen J,Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 2007;369:667-678.
20. Lagerqvist B, Carlsson J, Frobert O, Lindback J, Schersten F, Stenestrand U, James SK, Swedish Coronary A, Angioplasty Registry Study G. Stent thrombosis in Sweden: a report from the Swedish Coronary Angiography and Angioplasty Registry. Circ Cardiovasc Interv 2009;2:401-408.
21. Stettler C,Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-Analysis. Lancet 2007;370:937-948.
22. Feres F, Costa RA, Abizaid A, Leon MB, Marin-Neto JA, Botelho RV, King SB III, Negoita M, Liu M, de Paula JE, Mangione JA, Meireles GX, Castello HJ Jr., Nicolela EL Jr., Perin MA, Devito FS, Labrunie A, Salvadori D Jr., Gusmao M, Staico R, Costa JR Jr., de Castro JP, Abizaid AS, Bhatt DL, Investigators OT. Three vs. twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial. JAMA 2013;310:2510-2522.
23. Eisenstein EL, Wijns W, Fajadet J, Mauri L, Edwards R, Cowper PA, Kong DF, Anstrom KJ. Long-term clinical and economic analysis of the Endeavor drug-eluting stent versus the Driver bare-metal stent: 4-year results from theENDEAVORII 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). JACC Cardiovasc Interv 2009;2:1178-1187.
24. Spaulding C, Daemen J, Boersma E, Cutlip DE, SerruysPW. Apooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007;356: 989-997.
25. Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, Juni P, Schomig A, Windecker S, Kastrati A. 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 2012;33: 1214-1222.