Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial
Kereiakes, Dean J × Meredith, Ian T Windecker, Stephan Lee Jobe, R Mehta, Shamir R Sarembock, Ian J Feldman, Robert L Stein, Bernardo Dubois, Christophe Grady, Timothy Saito, Shigeru Kimura, Takeshi Christen, Thomas Allocco, Dominic J Dawkins, Keith D #
Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent.