Boston Scientific announced the completion of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of the fourth generation Synergy coronary stent. The randomised, single-blind, non-inferiority 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. 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, which could potentially reduce the duration of required adjunctive medical therapies.
The Synergy stent features the same proprietary platinum chromium alloy and innovative 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 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,” said Ian Meredith, director of MonashHeart, Monash Medical Centre, Melbourne, Australia, and principal investigator of the trial.
“We believe this technology will represent a significant advance for drug-eluting stents by reducing 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.” said Keith D. Dawkins, senior vice president and chief medical officer of Boston Scientific’s Cardiology, Rhythm and Vascular Group.
The EVOLVE trial compares two doses of everolimus on the Synergy stent (a Promus element equivalent dose and a dose half that amount) randomised 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 revascularisation. The primary angiographic endpoint is in-stent late loss at six months as measured by quantitative coronary angiography. Patients will also be assessed by intravascular ultrasound at the time of initial procedure and at six months. Data from the trial will be used to support CE mark approval for Synergy.
“Completion of enrollment brings our fourth generation drug-eluting stent platform another step closer to commercialisation,” said Hank Kucheman, executive vice president and president of Boston Scientific’s Cardiology, Rhythm and Vascular Group. “We are confident that the Synergy stent will enhance our leading drug-eluting stent portfolio.”
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 in the USA. The Promus element stent received CE mark approval in October 2009.