August 3, 2010 — Patient enrollment began in the EVOLVE clinical trial, which is designed to assess the safety and performance of the Boston Scientific Synergy Coronary Stent (previously referred to as the Evolution stent). It uses a bioabsorbable polymer and everolimus drug formulation to create a thin, uniform coating confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating resorbs into the body, leaving behind only a bare-metal stent.
The bioabsorbable polymer technology provides the same degree of restenosis reduction as a conventional drug-eluting stent, while offering faster and more complete vessel healing after stent implantation. The Synergy features the same proprietary platinum chromium alloy and stent design used in the Promus Element stent to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility.
EVOLVE is a randomized, single-blind, noninferiority clinical trial that will enroll 291 patients at up to 35 sites in Europe, Australia and New Zealand. The trial will compare the Synergy stent to the Promus Element everolimus-eluting coronary stent in patients with a single de novo native coronary artery lesion.
Two drug doses will be evaluated with the stent, including an everolimus dose approximately equal to that of the Promus and a dose equivalent to half that amount. 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).
Clinical follow-up will occur at 30 days, six months, nine months, and every 12 months out to five years. In addition, all patients will undergo intravascular ultrasound at the time of initial procedure and at six months. Patient enrollment in the trial is scheduled to be completed by mid-2011. Data from the trial will be used to support CE mark approval in Europe.
The principal investigators for the trial are Ian Meredith, MBBS, Ph.D., professor and director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, and Stefan Verheye, M.D., Ph.D., department of interventional cardiology, Middelheim Hospital in Antwerp, Belgium. The first patient was enrolled by Meredith.
“We are pleased to enroll the first patient in the EVOLVE trial to evaluate this innovative new coronary stent technology,” Meredith said. “I am enthusiastic about the possibility of having an everolimus stent that minimizes the initial polymer coating, provides a bare luminal surface, and becomes a bare-metal stent after a few months once drug delivery is complete. This type of treatment option could play an important role in helping reduce adverse events such as late stent thrombosis.”
This is Boston’s fourth-generation stent. The Synergy is designed to significantly 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.
In the United States, the Synergy Stent and the Promus Element are investigational devices and are limited to investigational use only and are not available for sale.
For more information: www.bostonscientific.com