Boston Scientific Completes EVOLVE Enrollment

January 24, 2011—Boston Scientific Corporation (Natick, MA) announced the completion of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of the company’s fourth-generation Synergy coronary stent. EVOLVE is a randomized, single-blind, noninferiority trial comparing the Synergy stent to the company’s third-generation Promus Element everolimus-eluting coronary stent in patients with a single de novo native coronary artery lesion. The trial enrolled 291 patients at 29 sites in Europe, Australia, and New Zealand. Professor Ian Meredith, MBBS, is the principal investigator of the trial, which completed enrollment 4 months ahead of schedule, the company noted.

According to Boston Scientific, the EVOLVE trial compares two doses of everolimus on the Synergy stent (equivalent to a Promus Element dose and a dose half that amount) randomized against the Promus Element stent. The primary clinical endpoint is target lesion failure at 30 days, a composite measure of cardiac death, myocardial infarction, and target lesion revascularization. The primary angiographic endpoint is in-stent late loss at 6 months as measured by quantitative coronary angiography. Patients will also be assessed by intravascular ultrasound at the time of initial procedure and at 6 months. The company stated that data from the trial will be used to support CE Mark approval for the Synergy stent.

Boston Scientific advised that in the United States, the Synergy stent and the Promus Element stent are investigational devices and are limited by applicable law to investigational use only and are not available for sale. The company received CE Mark approval for the Promus Element stent in October 2009.

Boston Scientific’s Synergy stent uses a bioabsorbable polylactic-coglycolic acid polymer combined with an everolimus drug to create a thin, uniform coating that is confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating resorbs in 3 to 6 months, leaving behind only a bare-metal stent. This technology is designed to provide the same degree of restenosis reduction as a conventional drug-eluting stent while offering faster and more complete vessel healing after stent implantation. According to Boston Scientific, this could potentially reduce the duration of required adjunctive medical therapies. The Synergy stent features the same platinum chromium alloy and stent design used in the Promus Element stent to enable thinner struts, increased flexibility, and a lower profile while reducing recoil and improving radial strength and visibility, the company stated.