Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: Results of the randomized BIOFLOW-II trial

Circulation: Cardiovascular Interventions

Volumn 8, Issue 2, 2015, Pages

  Windecker, Stephan ^a   Haude, Michael ^b   Neumann, Franz Josef ^c   Stangl, Karl ^d   Witzenbichler, Bernhard ^d   Slagboom, Ton ^e   Sabaté, Manel ^f,g   Goicolea, Javier ^h   Barragan, Paul ⁱ   Cook, Stéphane ^j   Piot, Christophe ^k   Richardt, Gert ^l   Merkely, Béla ^m   Schneider, Henrik ⁿ   Bilger, Johannes ^o   Erne, Paul ^p   Waksman, Ron ^q   Zaugg, Serge ^r   Jüni, Peter ^r   Lefèvre, Thierry ^s  

^a UNIVERSITY OF BERN   (Switzerland)

^b Lukaskrankenhaus GmbH   (Germany)

^c UNIVERSITY HEART CENTER FREIBURG BAD KROZINGEN   (Germany)

^d CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^e ONZE LIEVE VROUWE GASTHUIS   (Netherlands)

^f HOSPITAL CLÍNIC   (Spain)

^g UNIVERSITY OF BARCELONA   (Spain)

^h HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

ⁱ Hospital Puerta de Hierro ^*  (France)

^j University Hospital Fribourg   (Switzerland)

^k UNIV MONTPELLIER   (France)

^l Segeberger Kliniken   (Germany)

^m SEMMELWEIS UNIVERSITY   (Hungary)

ⁿ ROSTOCK UNIVERSITY MEDICAL CENTER   (Germany)

^o KLINIKUM NÜRNBERG   (Germany)

^p LUZERNER KANTONSSPITAL   (Switzerland)

^q MEDSTAR RESEARCH INSTITUTE   (United States)

^r UNIVERSITY OF BERN   (Switzerland)

^s INSTITUT CARDIOVASCULAIRE PARIS SUD   (France)

more..

Author keywords

Percutaneous coronary intervention; Risk factors

Indexed keywords

EVEROLIMUS; POLYLACTIC ACID; POLYMER; RAPAMYCIN; CARDIOVASCULAR AGENT;

ADULT; AGED; ANGIOCARDIOGRAPHY; ARTICLE; CARDIOVASCULAR RISK; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DEVICE COMPARISON; DEVICE FAILURE; DIABETES MELLITUS; DRUG ELUTING CORONARY STENT; FEMALE; FOLLOW UP; HEART LEFT VENTRICLE FUNCTION; HUMAN; INTRAVASCULAR ULTRASOUND; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); NEOINTIMA; OPTICAL COHERENCE TOMOGRAPHY; OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); STENT COMPLICATION; STENT MALAPPOSITION; TREATMENT OUTCOME; ADVERSE EFFECTS; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; COMPARATIVE STUDY; CORONARY BLOOD VESSEL; CORONARY RESTENOSIS; DEVICES; DRUG EFFECTS; DRUG ELUTING STENT; ECHOGRAPHY; ENDOSCOPIC ECHOGRAPHY; EUROPE; KAPLAN MEIER METHOD; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PREDICTIVE VALUE; PROSTHESIS; RISK FACTOR; TIME; TRANSLUMINAL CORONARY ANGIOPLASTY;

AGED; ANGIOPLASTY, BALLOON, CORONARY; CARDIOVASCULAR AGENTS; CORONARY ARTERY DISEASE; CORONARY RESTENOSIS; CORONARY VESSELS; DRUG-ELUTING STENTS; EUROPE; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEOINTIMA; POLYMERS; PREDICTIVE VALUE OF TESTS; PROSTHESIS DESIGN; RISK FACTORS; SIROLIMUS; TIME FACTORS; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME; ULTRASONOGRAPHY, INTERVENTIONAL;

EID: 84925863229     PISSN: 19417640     EISSN: 19417632     Source Type: Journal    
DOI: 10.1161/CIRCINTERVENTIONS.114.001441     Document Type: Article

References (33)

1. Stefanini GG, Holmes DR Jr. Drug-eluting coronary-artery stents. N Engl J Med. 2013;368:254-265. doi: 10.1056/NEJMra1210816.
2. Stefanini GG, Kalesan B, Serruys PW, Heg D, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, van Es GA, Meier B, Windecker S, Jüni P. 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;378:1940-1948. doi: 10.1016/S0140-6736 (11) 61672-3.
3. Räber L, Magro M, Stefanini GG, Kalesan B, van Domburg RT, Onuma Y, Wenaweser P, Daemen J, Meier B, Jüni P, Serruys PW, Windecker S. Very late coronary stent thrombosis of a newer-generation everolimuseluting stent compared with early-generation drug-eluting stents: a prospective cohort study. Circulation. 2012;125:1110-1121. doi: 10.1161/CIRCULATIONAHA.111.058560.
4. Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D'Ascenzo F, Kimura T, Briguori C, Sabatè M, Kim HS, De Waha A, Kedhi E, Smits PC, Kaiser C, Sardella G, Marullo A, Kirtane AJ, Leon MB, Stone GW. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;379:1393-1402. doi: 10.1016/S0140-6736 (12) 60324-9.
5. Stefanini GG, Windecker S. Stent thrombosis: no longer an issue with newer-generation drug-eluting stents? Circ Cardiovasc Interv. 2012;5:332-335. doi: 10.1161/CIRCINTERVENTIONS.112.970970.
6. Claessen BE, Beijk MA, Legrand V, Ruzyllo W, Manari A, Varenne O, Suttorp MJ, Tijssen JG, Miquel-Hebert K, Veldhof S, Henriques JP, Serruys PW, Piek JJ. Two-year clinical, angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II trial. Circ Cardiovasc Interv. 2009;2:339-347. doi: 10.1161/CIRCINTERVENTIONS.108.831800.108.831800.
7. Garg S, Räber L, Serruys PW, Windecker S. Coronary artery stents. In: Eeckhout E, Serruys PW, Wijns W, Vahanian A, van Sambeek M, de Palma R, eds. Percutaneous Interventional Cardiovascular Medicine: The PCR-EAPCI Textbook. Toulouse, France: PCR Publishing; 2012:51-144.
8. Nakazawa G, Otsuka F, Nakano M, Vorpahl M, Yazdani SK, Ladich E, Kolodgie FD, Finn AV, Virmani R. The pathology of neoatherosclerosis in human coronary implants bare-metal and drug-eluting stents. J Am Coll Cardiol. 2011;57:1314-1322. doi: 10.1016/j.jacc.2011.01.011.
9. Park SJ, Kang SJ, Virmani R, Nakano M, Ueda Y. In-stent neoatherosclerosis: a final common pathway of late stent failure. J Am Coll Cardiol. 2012;59:2051-2057. doi: 10.1016/j.jacc.2011.10.909.
10. Kalnins U, Erglis A, Dinne I, Kumsars I, Jegere S. Clinical outcomes of silicon carbide coated stents in patients with coronary artery disease. Med Sci Monit. 2002;8:PI16-PI20.
11. Amon A, Bolz M, Schaldach M. Improvement of stenting therapy with a silicon carbide coated tantalum stent. J Mater Sci Mater Med. 1996;7:273-278.
12. Koppara T, Joner M, Bayer G, Steigerwald K, Diener T, Wittchow E. Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation. Thromb Haemost. 2012;107:1161-1171. doi: 10.1160/TH12-01-0043.
13. Hamon M, Niculescu R, Deleanu D, Dorobantu M, Weissman NJ, Waksman R. 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. 2013;8:1006-1011. doi: 10.4244/EIJV8I9A155.
14. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012;33:2551-2567. doi: 10.1093/eurheartj/ehs184.
15. 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, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344-2351. doi: 10.1161/CIRCULATIONAHA.106.685313.
16. Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008;299:1903-1913. doi: 10.1001/jama.299.16.1903.
17. Serruys PW, 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 everolimuseluting coronary stents. N Engl J Med. 2010;363:136-146. doi: 10.1056/NEJMoa1004130.
18. Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010;362:1663-1674. doi: 10.1056/NEJMoa0910496.
19. Dangas GD, Serruys PW, Kereiakes DJ, Hermiller J, Rizvi A, Newman W, Sudhir K, Smith RS Jr, Cao S, Theodoropoulos K, Cutlip DE, Lansky AJ, Stone GW. 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. 2013;6:914-922. doi: 10.1016/j.jcin. 2013.05.005.
20. Bangalore S, Kumar S, Fusaro M, Amoroso N, Attubato MJ, Feit F, Bhatt DL, Slater J. 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. 2012;125:2873-2891. doi: 10.1161/CIRCULATIONAHA.112.097014.
21. Meredith IT, Worthley S, Whitbourn R, Walters DL, McClean D, Horrigan M, Popma JJ, Cutlip DE, DePaoli A, Negoita M, Fitzgerald PJ; RESOLUTE Investigators. Clinical and angiographic results with the next-generation resolute stent system: a prospective, multicenter, first-inhuman trial. JACC Cardiovasc Interv. 2009;2:977-985. doi: 10.1016/j. jcin. 2009.07.007.
22. Meredith IT, Verheye S, Dubois CL, Dens J, Fajadet J, Carrié D, Walsh S, Oldroyd KG, Varenne O, El-Jack S, Moreno R, Joshi AA, Allocco DJ, Dawkins KD. Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimuseluting coronary stent. J Am Coll Cardiol. 2012;59:1362-1370. doi: 10.1016/j.jacc.2011.12.016.
23. Serruys PW, Garg S, Abizaid A, Ormiston J, Windecker S, Verheye S, Dubois C, Stewart J, Hauptmann KE, Schofer J, Stangl K, Witzenbichler B, Wiemer M, Barbato E, de Vries T, den Drijver AM, Otake H, Meredith L, Toyloy S, Fitzgerald P. A randomised comparison of novolimus-eluting and zotarolimus-eluting coronary stents: 9-month follow-up results of the EXCELLA II study. EuroIntervention. 2010;6:195-205. doi: 10.4244/.
24. Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni 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. doi: 10.1016/S0140-6736 (08) 61244-1.
25. Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H, Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S, Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus®, paclitaxeleluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention. 2007;2:426-434.
26. Mehilli J, Byrne RA, Wieczorek A, Iijima R, Schulz S, Bruskina O, Pache J, Wessely R, Schömig A, Kastrati A; Intracoronary Stenting and Angiographic Restenosis Investigators-Test Efficacy of Rapamycineluting Stents with Different Polymer Coating Strategies (ISAR-TEST-3). Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis. Eur Heart J. 2008;29:1975-1982. doi: 10.1093/eurheartj/ehn253.
27. Ormiston JA, Abizaid A, Spertus J, Fajadet J, Mauri L, Schofer J, Verheye S, Dens J, Thuesen L, Dubois C, Hoffmann R, Wijns W, Fitzgerald PJ, Popma JJ, Macours N, Cebrian A, Stoll HP, Rogers C, Spaulding C; NEVO ResElution-I Investigators. Six-month results of the NEVO Res-Elution I (NEVO RES-I) trial: a randomized, multicenter comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberté paclitaxel-eluting stent in de novo native coronary artery lesions. Circ Cardiovasc Interv. 2010;3:556-564. doi: 10.1161/CIRCINTERVENTIONS.110.946426.
28. Haude M, Lee SW, Worthley SG, Silber S, Verheye S, Erbs S, Rosli MA, Botelho R, Meredith I, Sim KH, Stella PR, Tan HC, Whitbourn R, Thambar S, Abizaid A, Koh TH, Den Heijer P, Parise H, Cristea E, Maehara A, Mehran R. The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent. JACC Cardiovasc Interv. 2013;6:334-343. doi: 10.1016/j.jcin. 2012.10.018.
29. Pache J, Kastrati A, Mehilli J, Schühlen H, Dotzer F, Hausleiter J, Fleckenstein M, Neumann FJ, Sattelberger U, Schmitt C, Müller M, Dirschinger J, Schömig A. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol. 2003;41:1283-1288.
30. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773-1780. doi: 10.1056/NEJMoa012843.
31. Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008;371:899-907. doi: 10.1016/S0140-6736 (08) 60415-8.
32. Otsuka F, Nakano M, Ladich E, Kolodgie FD, Virmani R. Pathologic etiologies of late and very late stent thrombosis following first-generation drug-eluting stent placement. Thrombosis. 2012;2012:608593. doi: 10.1155/2012/608593.
33. Nakazawa G, Finn AV, Vorpahl M, Ladich ER, Kolodgie FD, Virmani R. Coronary responses and differential mechanisms of late stent thrombosis attributed to first-generation sirolimus- and paclitaxel-eluting stents. J Am Coll Cardiol. 2011;57:390-398. doi: 10.1016/j.jacc.2010.05.066.