Twelve-Month EVOLVE II Data Published for Boston Scientific's Synergy Bioabsorbable EES

April 8, 2015—The 12-month data from the EVOLVE II were published by Dean J. Kereiakes, MD, et al online ahead of print in Circulation: Cardiovascular Interventions. EVOLVE II is a randomized trial evaluating the efficacy and safety of the Synergy (Boston Scientific Corporation) bioabsorbable polymer-coated, everolimus-eluting coronary stent.

The study showed that the Synergy device was noninferior to Boston Scientific’s 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, concluded the investigators in Circulation: Cardiovascular Interventions. Dr. Kereiakes, who serves as principal investigator for EVOLVE II, presented the results in November 2014 at the American Heart Association Scientific Session in Chicago, Illinois.

The investigators noted that the background of the study is that bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety, whereas drug-eluting stents with durable polymer 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.

As summarized in Circulation: Cardiovascular Interventions, 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.

The EVOLVE II investigators 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. Patients (n = 1,684) 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 endpoint 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 and 6.4% in both the groups by per-protocol analysis. Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% and 0.4% versus 0.6% of Synergy versus Promus Element Plus–treated patients, respectively, reported the investigators in Circulation: Cardiovascular Interventions.