Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): A randomised, controlled, non-inferiority trial

The Lancet

Volumn 381, Issue 9867, 2013, Pages 651-660

  Smits, Pieter Cornelis ^a   Hofma, Sjoerd ^b   Togni, Mario ^c   Vázquez, Nicolás ^d   Valdés, Mariano ^e   Voudris, Vassilis ^f   Slagboom, Ton ^g   Goy, Jean Jaques ^c   Vuillomenet, Andre ^h   Serra, Antoni ^i,j   Nouche, Ramiro Trillo ^k   Den Heijer, Peter ^l   Van Der Ent, Martin ^a  

^a Maasstad Hospital Rotterdam   (Netherlands)

^b MEDICAL CENTER LEEUWARDEN   (Netherlands)

^c Hopital Cantonal de Fribourg   (Switzerland)

^d Hospitalario Juan Canalejo ^*  (Spain)

^e HOSPITAL UNIVERSITARIO VIRGEN DE LA ARRIXACA   (Spain)

^f ONASSIS CARDIAC SURGERY CENTER   (Greece)

^g ONZE LIEVE VROUWE GASTHUIS   (Netherlands)

^h CANTONAL HOSPITAL AARAU   (Switzerland)

ⁱ HOSPITAL DEL MAR   (Spain)

^j Sant Pau University Hospital   (Spain)

^k Instituto de Salud Carlos III   (Spain)

^l AMPHIA HOSPITAL   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

EVEROLIMUS; POLYMER; UMIROLIMUS;

ADULT; AGE DISTRIBUTION; ARTICLE; BLOOD VESSEL PARAMETERS; CLINICAL PROTOCOL; CONTROLLED STUDY; DRUG ELUTING STENT; FEMALE; FOLLOW UP; HEART DEATH; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HOSPITAL DISCHARGE; HUMAN; LIFE EXPECTANCY; MAJOR CLINICAL STUDY; MALE; NON FATAL MYOCARDIAL INFARCTION; OPEN STUDY; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; STENT THROMBOSIS; TREATMENT OUTCOME; VESSEL DIAMETER;

EID: 84874443706     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(12)61852-2     Document Type: Article

References (39)

1. Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 2007; 370: 937-48.
2. Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus-and paclitaxel-eluting coronary stents. N Engl J Med 2007; 356: 998-1008.
3. Kotani J, Awata M, Nanto S, et al. Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings. J Am Coll Cardiol 2006; 47: 2108-11.
4. Finn AV, Joner M, Nakazawa G, et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 2007; 115: 2435-41.
5. Cook S, Ladich E, Nakazawa G, et al, Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation 2009; 120: 391-99.
6. Wenaweser P, Daemen J, Zwahlen M, et al. Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice: 4-year results from a large 2-institutional cohort study. J Am Coll Cardiol 2008; 52: 1134-40.
7. Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006; 48: 193-202.
8. Nakazawa G, Finn AV, Joner M, et al. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation 2008; 118: 1138-45.
9. Chevalier B, Silber S, Park SJ, et al. Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberté paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial-phase 2. Circ Cardiovasc Interv 2009; 2: 188-95.
10. Ostojic M, Sagic D, Beleslin B, et al. First clinical comparison of Nobori-Biolimus A9 eluting stents with Cypher-Sirolimus eluting stents: NOBORI CORE nine months angiographic and one year clinical outcomes. EuroIntervention 2008; 3: 574-79.
11. Windecker S, Serruys PW, Wandel S, 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 2008; 372: 1163-73.
12. Ormiston JA, Webster MWI. Stent thrombosis: has the firestorm been extinguished? Lancet 2012; 379: 1368-69.
13. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007; 115: 2344-51.
14. Ruygrok PN, Desaga M, Van Den Branden F, et al. One year clinical follow-up of the XIENCE V Everolimus-eluting stent system in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II study. EuroIntervention 2007; 3: 315-20.
15. Stone GW, Midei M, Newman W, et al. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA 2008; 299: 1903-13.
16. Lemos PA, Serruys PW, van Domburg RT, et al. Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the "real world": the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Circulation 2004; 109: 190-95.
17. Ong AT, Serruys PW, Aoki J, et al. The unrestricted use of paclitaxel-versus sirolimus-eluting stents for coronary artery disease in an unselected population: one-year results of the Taxus-Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) registry. J Am Coll Cardiol 2005; 45: 1135-41.
18. Galløe AM, Thuesen L, Kelbaek H, et al. Comparison of paclitaxel-and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA 2008; 299: 409-16.
19. Serruys P W, Silber S, Garg S, et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med 2010; 363: 136-46.
20. Pocock SJ, Clayton TC, Altman DG. Survival plots of time-to-event outcomes in clinical trials: good practice and pitfalls. Lancet 2002; 359: 1686-89.
21. Stone GW, Rizvi A, Sudhir K, et al. Randomized comparison of everolimus-and paclitaxel-eluting stents: 2-year follow-up from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial. J Am Coll Cardiol 2011; 58: 19-25.
22. Smits PC, Kedhi E, Royaards KJ, et al. 2-year follow-up of a randomized controlled trial of everolimus-and paclitaxel-eluting stents for coronary revascularization in daily practice: COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTÉ stent in all-comers: a randomized open label trial). J Am Coll Cardiol 2011; 58: 11-18.
23. Palmerini T, Biondi-Zoccai G, Della Riva D, et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet 2012; 379: 1393-402.
24. Kadota K, Muramatsu T, Iwabuchi M, et al. Randomized comparison of the nobori biolimus A9-eluting stent with the sirolimus-eluting stent in patients with stenosis in native coronary arteries. Catheter Cardiovasc Interv 2011; 80: 789-96.
25. Mehilli J, Byrne RA, Wieczorek A, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis. Eur Heart J 2008; 29: 1975-82.
26. Byrne RA, Kastrati A, Kufner S, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial. Eur Heart J 2009; 30: 2441-49.
27. Meredith IT, Verheye S, Dubois CL, et al. Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent. J Am Coll Cardiol 2012; 59: 1362-70.
28. Garg S, Sarno G, Serruys PW, et al. The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer. EuroIntervention 2010; 6: 233-39.
29. Stefanini GG, Kalesan B, Serruys PW, 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 2011; 378: 1940-48.
30. Wijns W, Kolh P, Danchin N, et al. Guidelines on myocardial revascularization: The task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); developed with the special contribution of the European Association for Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2010; 31: 2501-55.
31. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: executive summary-a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation 2011; 124: 2574-609.
32. Barlis P, Regar E, Serruys P W, et al. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J 2010; 31: 165-76.
33. Hamilos MI, Ostojic M, Beleslin B, et al. Differential effects of drug-eluting stents on local endothelium-dependent coronary vasomotion. J Am Coll Cardiol 2008; 51: 2123-29.
34. Pendyala LK, Matsumoto D, Shinke T, et al. Nobori stent shows less vascular inflammation and early recovery of endothelial function compared with Cypher stent. JACC Cardiovasc Interv 2012; 5: 436-44.
35. Kedhi E, Joesoef KS, McFadden E, et al. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet 2010; 375: 201-09.
36. Stone GW, Rizvi A, Newman W, et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med 2010; 362: 1663-74.
37. Jensen LO, Thayssen P, Hansen HS, 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 2012; 125: 1246-55.
38. von Birgelen C, Basalus MW, Tandjung K, et al. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial. J Am Coll Cardiol 2012; 59: 1350-61.
39. Christiansen EH, Jensen LO, Thayssen P, et al, for the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) V investigators. 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 2013; published online Jan 30. http://dx.doi.org/10.1016/S0140- 6736(12)61962-X.