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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial

Authors: Diego Arroyo, Mario Togni, Serban Puricel, Baeriswyl Gerard, Lehmann Sonja, Noé Corpataux, Hélène Villeneuve, Estelle Boute, Jean-Christophe Stauffer, Jean-Jacques Goy, Stéphane Cook

Published in: Trials | Issue 1/2014

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Abstract

Background

Second-generation everolimus-eluting stents (EES) and third generation biolimus-eluting stents (BES) have been shown to be superior to first-generation paclitaxel-eluting stents (PES) and second-generation sirolimus-eluting stents (SES). However, neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent (DES) implantation overall. The Absorb™ (Abbott Vascular, Abbott Park, IL, USA) is the first CE approved DES with a bioresorbable vascular scaffold (BVS) thought to reduce long-term complication rates. The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion.

Methods/Design

The EVERBIO II trial is a single-center, assessor-blinded, randomized trial. The study population consists of all patients aged ≥18 years old undergoing percutaneous coronary intervention. Exclusion criterion is where the lesion cannot be treated with BVS (reference vessel diameter >4.0 mm). A total of 240 patients will be enrolled and randomly assigned into 3 groups of 80 with either BVS, EES or BES implantation. All patients will undergo a follow-up angiography study at 9 months. Clinical follow-up for up to 5 years will be conducted by telephone. The primary endpoint is in-segment late lumen loss at 9 months measured by quantitative coronary angiography. Secondary endpoints are patient-oriented major adverse cardiac event (MACE) (death, myocardial infarction and target-vessel revascularization), device-oriented MACE (cardiac death, myocardial infarction and target-lesion revascularization), stent thrombosis according to ARC and binary restenosis at follow-up 12 months angiography.

Discussion

EVERBIO II is an independent, randomized study, aiming to compare the clinical efficacy, angiographic outcomes and safety of BVS, EES and BES in all comer patients.

Trial registration

The trial listed in clinicaltrials.gov as NCT01711931.
Appendix
Available only for authorised users
Literature
1.
Dibra A, Kastrati A, Alfonso F, Seyfarth M, Pérez-Vizcayno MJ, Mehilli J, Schömig A: Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials. J Am Coll Cardiol. 2007, 49: 616-623. 10.1016/j.jacc.2006.10.049.CrossRefPubMed
2.
Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R: Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006, 48: 193-202. 10.1016/j.jacc.2006.03.042.CrossRefPubMed
3.
4.
Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC: Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010, 375: 201-209. 10.1016/S0140-6736(09)62127-9.CrossRefPubMed
5.
Park KW, Chae IH, Lim DS, Han KR, Yang HM, Lee HY, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Jo SH, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Gwon HC, Jang YS, Kim HS: Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: the EXCELLENT (efficacy of xience/promus versus cypher to reduce late loss after stenting) randomized trial. J Am Coll Cardiol. 2011, 58: 1844-1854. 10.1016/j.jacc.2011.07.031.CrossRefPubMed
6.
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. 10.1056/NEJMoa0910496.CrossRefPubMed
7.
Byrne RA, Kastrati A, Massberg S, Wieczorek A, Laugwitz KL, Hadamitzky M, Schulz S, Pache J, Fusaro M, Hausleiter J, Schömig A, Mehilli J, ISAR-TEST 4 Investigators: Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease: 3-year outcomes from a randomized clinical trial. J Am Coll Cardiol. 2011, 58: 1325-1331. 10.1016/j.jacc.2011.06.027.CrossRefPubMed
8.
Räber L, Jüni P, Nüesch E, Kalesan B, Wenaweser P, Moschovitis A, Khattab AA, Bahlo M, Togni M, Cook S, Vogel R, Seiler C, Meier B, Windecker S: Long-term comparison of everolimus-eluting and sirolimus-eluting stents for coronary revascularization. J Am Coll Cardiol. 2011, 57: 2143-2151. 10.1016/j.jacc.2011.01.023.CrossRefPubMed
9.
Chevalier B, Silber S, Park SJ, Garcia E, Schuler G, Suryapranata H, Koolen J, Hauptmann KE, Wijns W, Morice MC, Carrie D, van Es GA, Nagai H, Detiege D, Paunovic D, Serruys PW, NOBORI 1 Clinical Investigators: Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberte paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial--Phase. Circ Cardiovasc Interv. 2009, 2: 188-195. 10.1161/CIRCINTERVENTIONS.108.823443.CrossRefPubMed
10.
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. 10.1016/S0140-6736(11)61672-3.CrossRefPubMed
11.
Puricel S, Oberhänsli M, Guntern P, Lehmann S, Goy JJ, Arroyo D, Villeneuve H, Baeriswyl G, Stauffer JC, Togni M, Cook S: Long-term comparison of everolimus-eluting and biolimus-eluting stents. Euro Intervention. 2013, 9: 336-344.PubMed
12.
Smits PC, Hofma S, Togni M, Vázquez N, Valdés M, Voudris V, Slagboom T, Goy JJ, Vuillomenet A, Serra A, Nouche RT, den Heijer P, van der Ent M: Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013, 381: 651-660. 10.1016/S0140-6736(12)61852-2.CrossRefPubMed
13.
Jukema JW, Ahmed TA, Verschuren JJ, Quax PH: Restenosis after PCI. Part 2: prevention and therapy. Nat Rev Cardiol. 2012, 9: 79-90.CrossRef
14.
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. 10.1016/S0140-6736(08)60415-8.CrossRefPubMed
15.
Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hébert K, Veldhof S, Webster M, Thuesen L, Dudek D: A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009, 373: 897-910. 10.1016/S0140-6736(09)60325-1.CrossRefPubMed
16.
Okamura T, Garg S, Gutiérrez-Chico JL, Shin ES, Onuma Y, García-García HM, Rapoza RJ, Sudhir K, Regar E, Serruys PW: In vivo evaluation of stent strut distribution patterns in the bioabsorbable everolimus-eluting device: an OCT ad hoc analysis of the revision 1.0 and revision 1.1 stent design in the ABSORB clinical trial. Euro Intervention. 2010, 5: 932-938.PubMed
17.
Rensing BJ, Vos J, Smits PC, Foley DP, van den Brand MJ, van der Giessen WJ, de Feijter PJ, Serruys PW: Coronary restenosis elimination with a sirolimus eluting stent; First European human experience with 6-month angiographic and intravascular ultrasonic follow-up. Eur Heart J. 2001, 22: 2125-2130. 10.1053/euhj.2001.2892.CrossRefPubMed
18.
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. 10.1056/NEJMoa012843.CrossRefPubMed
19.
Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE, SIRIUS Investigators: Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003, 349: 1315-1323. 10.1056/NEJMoa035071.CrossRefPubMed
20.
Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME, TAXUS-IV Investigators: A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004, 350: 221-231. 10.1056/NEJMoa032441.CrossRefPubMed
21.
McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW: Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004, 364: 1519-1521. 10.1016/S0140-6736(04)17275-9.CrossRefPubMed
22.
Ong ATL, McFadden EP, Regar E, de Jaegere PPT, van Domburg RT, Serruys PW: Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol. 2005, 45: 2088-2092. 10.1016/j.jacc.2005.02.086.CrossRefPubMed
23.
Kuchulakanti PK, Chu WW, Torguson R, Ohlmann P, Rha SW, Clavijo LC, Kim SW, Bui A, Gevorkian N, Xue Z, Smith K, Fournadjieva J, Suddath WO, Satler LF, Pichard AD, Kent KM, Waksman R: Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation. 2006, 113: 1108-1113. 10.1161/CIRCULATIONAHA.105.600155.CrossRefPubMed
24.
Cook S, Wenaweser P, Togni M, Billinger M, Morger C, Seiler C, Vogel R, Hess O, Meier B, Windecker S: Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation. Circulation. 2007, 115: 2426-2434. 10.1161/CIRCULATIONAHA.106.658237.CrossRefPubMed
25.
Cook S, Ladich E, Nakazawa G, Eshtehardi P, Neidhart M, Vogel R, Togni M, Wenaweser P, Billinger M, Seiler C, Gay S, Meier B, Pichler WJ, Jüni P, Virmani R, Windecker S: Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation. 2009, 120: 391-399. 10.1161/CIRCULATIONAHA.109.854398.CrossRefPubMed
26.
Onuma Y, Serruys PW: Bioresorbable scaffold: the advent of a new era in percutaneous coronary and peripheral revascularization?. Circulation. 2011, 123: 779-797. 10.1161/CIRCULATIONAHA.110.971606.CrossRefPubMed
27.
Gogas BD, Farooq V, Onuma Y, Serruys PW: The ABSORB bioresorbable vascular scaffold: an evolution or revolution in interventional cardiology?. Hellenic J Cardiol. 2012, 53: 301-309.PubMed
Metadata
Title
Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial
Authors
Diego Arroyo
Mario Togni
Serban Puricel
Baeriswyl Gerard
Lehmann Sonja
Noé Corpataux
Hélène Villeneuve
Estelle Boute
Jean-Christophe Stauffer
Jean-Jacques Goy
Stéphane Cook
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-9

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