Boston Scientific Corporation today announced the start of patient enrolment in the Evolve clinical trial, designed to assess the safety and performance of its fourth-generation Synergy Coronary Stent. The first patient was enrolled by Dr Ian Meredith, professor and director of MonashHeart, at Monash Medical Centre in Melbourne, Australia.
Formerly known as the Evolution Stent, it uses a bioabsorbable PLGA 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. 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. The stent’s design is modelled on the Promus Element Stent to enable various benefits in operational procedure, such as thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. Hank Kucheman, Executive Vice President, believes it is this combination that will help to strengthen Boston’s global leadership position in the drug-eluting stent market. He said, “the Synergy Stent is designed to combine the acute performance advantages of the platinum chromium PROMUS Element Stent with an innovative bioabsorbable polymer.”
The qualities of both drug-eluting stents’ qualities will be pitted against each other during Evolve, a randomized, single-blind, non-inferiority clinical trial that will enrol 291 patients at up to 35 sites in Europe, Australia and New Zealand with a single de novo native coronary artery lesion. The primary clinical endpoint is target lesion failure at 30 days, a composite measure of cardiac death, myocardial infarction and target lesion revascularisation, supported by follow-up at 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 enrolment in the trial is scheduled to be completed by mid-2011. The trial data will be used to support CE Mark approval for the Synergy Stent.
One of the trial’s principal investigators, professor Meredith Verheye from the Department of Interventional Cardiology, Middelheim Hospital in Antwerp, Belgium, believes the outcome may have a greatly beneficial effect on drug-eluting stent technology. “This type of treatment option could play an important role in helping reduce adverse events such as late stent thrombosis,” she said.