Long term data from EVOLVE trial of Synergy everolimus eluting bioabsorbable coronary stent- Boston Scientific

Boston Scientific reported positive, long-term data from the EVOLVE Trial of the Synergy Everolimus-Eluting Bioabsorbable Polymer Platinum Chromium Coronary Stent System, with no new major adverse cardiac events reported between years three and four. The study results were presented for the first time at EuroPCR 2015 by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia.

Findings from year four of the EVOLVE Trial include the following key performance measures: the target lesion revascularization (TLR) rate was 1.1 percent compared to 6.1 percent for the Promus Element Plus Stent System (p=0.07); and no definite or probable stent thrombosis (ST) was observed. The EVOLVE Trial is the first human use, prospective, randomized, single-blind study evaluating the non-inferiority of the Synergy Stent, which employs an ultrathin bioabsorbable polymer coating applied to the abluminal (outer) surface of the stent. The comparator, the Boston Scientific Promus Element Plus Stent System, utilizes a durable polymer coating applied to the entire stent (inner and outer) surface. EVOLVE is the first in a continuing cadence of clinical trials evaluating the performance of the Synergy Stent in a range of patients.

Comment: Synergy Stent has CE Mark and is in clinical trials prior to application for FDA approval.