Primary Endpoint Results of the EVOLVE Trial

• Published in: Journal of the American College of Cardiology 2012-04, Vol.59 (15), p.1362-1370
• Main Authors: Meredith, Ian T., MBBS, PhD, Verheye, Stefan, MD, PhD, Dubois, Christophe L., MD, Dens, Joseph, MD, Fajadet, Jean, MD, Carrié, Didier, MD, Walsh, Simon, MD, Oldroyd, Keith G., MD, Varenne, Olivier, MD, El-Jack, Seif, MD, Moreno, Raul, MD, Joshi, Anita A., PhD, Allocco, Dominic J., MD, Dawkins, Keith D., MD
• Format: Article
• Language: English
• Subjects: bioabsorbable polymer; Cardiology; Cardiovascular; Clinical outcomes; Coronary vessels; Drug therapy; everolimus-eluting stents; Heart attacks; Internal Medicine; PROMUS Element; Stents; SYNERGY
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2011.12.016

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