Boston Scientific has reported positive three-year follow-up data for the EVOLVE clinical trial, comparing the safety and performance of the Synergy everolimus-eluting bioabsorbable polymer platinum chromium (PtCr) coronary stent system to the Promus element stent system.
The data were presented today at EuroPCR 2014 by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia. The primary clinical and angiographic endpoints of this non-inferiority study have already been published.
Meredith said that the Synergy stent three-year results from the EVOLVE trial continue to show promise with respect to safety and efficacy.
"Target lesion revascularization remains very low, at a rate of 1.1 percent, while there is no stent thrombosis in the SYNERGY full-dose arm at three years. The EVOLVE clinical data support the hypothesis that this novel bioabsorbable polymer stent technology could allow for improved healing over durable polymer DES," Meredith added.
Boston Scientific has expanded its commercial launch of the SYNERGY stent system in Europe and in select markets in Asia. It features an ultrathin abluminal bioabsorbable drug/polymer coating technology which eliminates long-term polymer exposure. In addition to reducing restenosis, the SYNERGY Stent System may also offer faster and more complete vessel healing after stent implantation, potentially reducing the duration of post-procedure dual antiplatelet therapy.
The Synergy stent system is supported by a rigorous clinical program. Beyond the EVOLVE study three-year results, the EVOLVE II clinical trial, which completed enrollment in August 2013, is the pivotal trial designed to support US Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approval of the Synergy stent system.
EVOLVE II is a global, multicenter, randomized, controlled pivotal trial that enrolled 1,684 patients in 125 sites worldwide, including the U.S., Canada, Europe, Australia, New Zealand, Japan and Singapore. Additional studies to assess outcomes, including the potential for reduced dual antiplatelet therapy, will be supported by Boston Scientific.
The Synergy stent system is being investigated in multiple independent, real-world studies across the spectrum of cardiovascular disease complexity.
The Synergy stent system is an investigational device in the US and Japan, and is not available for sale in those countries.