Efficacy and Safety of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent: The EVOLVE II Randomized Trial

• Published in: Circulation. Cardiovascular interventions Vol. 8; no. 4; p. e002372
• Main Authors: Kereiakes, Dean J., Meredith, Ian T., Windecker, Stephan, Jobe, R. Lee, Mehta, Shamir R., Sarembock, Ian J., Feldman, Robert L., Stein, Bernardo, Dubois, Christophe, Grady, Timothy, Saito, Shigeru, Kimura, Takeshi, Christen, Thomas, Allocco, Dominic J., Dawkins, Keith D.
• Format: Journal Article
• Language: English
• Published: United States American Heart Association, Inc 01.04.2015
• Subjects: Absorbable Implants - adverse effects; Absorbable Implants - utilization; Acute Coronary Syndrome - surgery; Aged; Biocompatible Materials - administration & dosage; Biocompatible Materials - adverse effects; Biocompatible Materials - chemistry; Blood Vessel Prosthesis Implantation; Coronary Artery Disease - surgery; Dioxanes; Drug-Eluting Stents - utilization; Everolimus - administration & dosage; Everolimus - adverse effects; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platinum Compounds; Polymers - administration & dosage; Polymers - adverse effects; Treatment Outcome; percutaneous coronary intervention; drug-eluting stent
• ISSN: 1941-7640; 1941-7632; 1941-7632
• DOI: 10.1161/CIRCINTERVENTIONS.114.002372

BACKGROUND—Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent. METHODS AND RESULTS—Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non–ST-segment–elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus–treated subjects, respectively. CONCLUSIONS—In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01665053.