January 24, 2011 – Patient enrollment was completed in the EVOLVE clinical trial, which is designed to assess the safety and performance of the Boston Scientific's fourth-generation Synergy coronary stent, which uses a bioabsorbable drug-eluting polymer.
The randomized, single-blind, non-inferiority trial will compare the stent to the 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, and completed enrollment four months ahead of schedule.
The Synergy stent uses a bioabsorbable PLGA polymer and everolimus drug combination to create a thin, uniform coating confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating resorbs in three to six 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. This could potentially reduce the duration of required antiplatelet therapies.
The stent features the same proprietary platinum chromium alloy and stent design used in the Promus Element, which enables thinner struts, increased flexibility and a lower profile, while reducing recoil and improving radial strength and visibility.
"We are pleased to complete the enrollment phase of the EVOLVE clinical trial well ahead of schedule," said professor Ian Meredith, MBBS, Ph.D., director of MonashHeart, Monash Medical Centre, Melbourne, Australia, and principal investigator of the trial. "The brisk pace of enrollment reflects the strong interest in this innovative drug-eluting stent technology that could play an important role in helping reduce adverse events including late stent thrombosis."
The stent will reduce the amount of polymer and drug to which the vessel wall is exposed, while eliminating the coating on the inner surface of the stent where endothelial cell growth is required for healing.
The EVOLVE trial compares two doses of everolimus on the Synergy Stent (a Promus Element equivalent dose and a dose half that amount) randomized against a commercially available 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 six months as measured by quantitative coronary angiography (QCA). Patients will also be assessed by intravascular ultrasound (IVUS) at the time of initial procedure and at six months. Data from the trial will be used to support CE mark approval for the SYNERGY stent.
In the United States, the Synergy stent and the Promus Element 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 in October 2009.
For more information: www.bostonscientific.com