Primary Endpoint Results of the EVOLVE Trial A Randomized Evaluation of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:59

Article

Meredith, Ian T.¹  Verheye, Stefan²  Dubois, Christophe L.³  Dens, Joseph⁴  Fajadet, Jean⁵  Carrie, Didier⁶  Walsh, Simon⁷  Oldroyd, Keith G.⁸  Varenne, Olivier⁹  El-Jack, Seif¹⁰  Moreno, Raul¹¹  Joshi, Anita A.¹²  Allocco, Dominic J.¹²  Dawkins, Keith D.¹² 

[1] MonashHeart, So Hlth, Melbourne, Vic, Australia

[2] Ziekenhuisnetwerk Antwerpen Middelheim, Antwerp, Belgium

[3] Univ Ziekenhuizen Leuven, Louvain, Belgium

[4] Ziekenhuis Oost Limburg, Genk, Belgium

[5] Clin Pasteur, Toulouse, France

[6] Hop Rangueil, Toulouse, France

[7] Belfast Hlth & Social Care Trust, Belfast, Antrim, North Ireland

[8] Golden Jubilee Natl Hosp, Glasgow, Lanark, Scotland

[9] Hop Cochin, F-75674 Paris, France

[10] N Shore Hosp, Auckland, New Zealand

[11] Hosp Univ La Paz, Madrid, Spain

[12] Boston Sci Corp, Natick, MA USA

关键词: bioabsorbable polymer;    everolimus-eluting stents;    PROMUS Element;    SYNERGY;   

DOI  :  10.1016/j.jacc.2011.12.016

来源: Elsevier

【 摘 要 】

Objectives This study sought to compare the safety and efficacy of 2 dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) (Boston Scientific Corp., Natick, Massachusetts) compared with the durable polymer PROMUS Element EES (Boston Scientific Corp.). Background Durable polymer coatings on drug-eluting stents have been associated with chronic inflammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy. Methods A total of 291 patients with a de novo lesion <28 mm in length, in a coronary artery of >2.25 to <3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography. Results The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half dose groups, respectively. The 6-month in-stent late loss was 0.15 +/- 0.34 mm for PROMUS Element, 0.10 +/- 0.25 mm for SYNERGY, and 0.13 +/- 0.26 mm for SYNERGY half dose (SYNERGY, difference -0.06, upper 95.2% confidence limit: 0.02, p for noninferiority <0.001; SYNERGY half dose, difference -0.03, upper 95.2% confidence limit: 0.05, p for noninferiority <0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months. Conclusions The EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent. (A Prospective Randomized Multicenter Single-Blind Noninferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De Novo Atherosclerotic Lesion [EVOLVE]; NCT01135225) (J Am Coll Cardiol 2012;59:1362-70) (C) 2012 by the American College of Cardiology Foundation

【 授权许可】

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