Three-Year EVOLVE Data Support Boston Scientific's Synergy Stent System

May 21, 2014—Boston Scientific Corporation announced that Professor Ian Meredith, MD, presented 3-year follow-up data from the EVOLVE clinical trial at the EuroPCR 2014 congress being held May 20–23, in Paris, France. The EVOLVE study compares the safety and performance of Boston Scientific’s Synergy platinum chromium coronary stent system with everolimus-eluting bioabsorbable polymer versus the Promus Element stent system. The primary clinical and angiographic endpoints of this noninferiority study have already been published, noted the company.

In Boston Scientific’s press release, Prof. Meredith commented, “The Synergy stent 3-year results from the EVOLVE trial continue to show promise with respect to safety and efficacy. Target lesion revascularization remains very low, at a rate of 1.1%, while there is no stent thrombosis in the Synergy full-dose arm at 3 years. The EVOLVE clinical data support the hypothesis that this novel bioabsorbable polymer stent technology could allow for improved healing over durable polymer DES.”

The device is composed of an ultrathin abluminal bioabsorbable drug/polymer coating technology that eliminates long-term polymer exposure. In addition to reducing restenosis, the Synergy system may also offer faster and more complete vessel healing after stent implantation, potentially reducing the duration of postprocedure dual-antiplatelet therapy.

The company advised that it has expanded its commercial launch of the Synergy stent system in Europe and in select markets in Asia. The system is an investigational device in the United States and Japan and is not available for sale in those countries. 

The EVOLVE II trial is being conducted to support US Food and Drug Administration and Japanese Ministry of Health, Labor, and Welfare approval of the Synergy stent system. EVOLVE II, which completed enrollment in August 2013, is a global, multicenter, pivotal, randomized controlled trial that enrolled 1,684 patients at 125 sites worldwide, including the United States, Canada, Europe, Australia, New Zealand, Japan, and Singapore.