Synergy clears noninferiority bar in EVOLVE II

An everolimus-eluting stent with a bioresorbable coating held its own clinically against a durable polymer drug-eluting stent in the pivotal EVOLVE II trial, findings that may be used to determine regulatory approval of the bioresorbable device.

The first EVOLVE trial (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) compared Boston Scientific’s Synergy stent with its durable polymer Promus Element everolimus-eluting stent. The Synergy stent is a thin-strut platinum chromium metal alloy stent with an ultrathin everolimus-eluting polymer applied to an abluminal stent surface that is resorbed in three to four months. EVOLVE found Synergy to be noninferior to Promus at six months for the angiographic endpoint of in-stent late lumen loss.

EVOLVE II took it further, with a clinical endpoint of target lesion failure at 12 months, in an international, randomized clinical trial designed to evaluate Synergy’s clinical efficacy and safety. Dean J. Kereiakes, MD, of the Christ Hospital Heart and Vascular Center in Cincinnati, and other EVOLVE II researchers reported their results in the April issue of Circulation: Cardiovascular Interventions.

EVOLVE II enrolled 1,684 patients in 2012 and 2013 with non-STEMI or stable coronary artery disease who were to undergo PCI. They were randomized to be treated with either a Synergy or Promus Element Plus stent. Baseline characteristics were similar between the two groups.

Target lesion failure occurred in 6.7 percent of the Synergy group vs. 6.5 percent of the Promus group at one year in an intention-to-treat analysis and 6.4 percent for both groups in a per protocol analysis. The researchers defined target lesion failure as ischemia-driven revascularization of the target lesion, MI related to the target vessel or cardiac death. Rates for revascularization and definite/probable stent thrombosis were similar between the groups, too.

EVOLVE II met the noninferiority criteria, Kereiakes et al wrote, and showed Synergy to be as safe and effective as Promus. They added that they would continue to study Synergy’s long-term safety and efficacy through five years.

Boston Scientific funded the trial. Synergy received CE mark in Europe in 2012 but it remains an investigational only device in the U.S.