Efficacy and Safety of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent. (April 2015)

• Record Type: Journal Article
• Authors: Kereiakes, Dean J.; Meredith, Ian T.; Windecker, Stephan; Jobe, R. Lee; 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.
• Is Part Of: Circulation. Volume 8:Number 4(2015)
• Publication Date: 2015-04
• Subjects: Cardiovascular system -- Surgery -- Periodicals; Cardiovascular system -- Diseases -- Treatment -- Periodicals; 616.105
• DOI: 10.1161/CIRCINTERVENTIONS.114.002372
• Languages: English
• ISSNs: 1941-7640

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <sec> <title>Background—</title> <p>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.</p> </sec> <sec> <title>Methods and Results—</title> <p>Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non–ST-segment–elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (<italic>P</italic>=0.83 for difference; <italic>P</italic>=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (<italic>P</italic>=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (<italic>P</italic>=0.21) and 0.4% versus 0.6% (<italic>P</italic>=0.50) of SYNERGY versus PROMUS Element Plus–treated subjects, respectively.</p> </sec> <sec> <title>Conclusions—</title> <p>In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention.</p> </sec> <sec> <title>Clinical Trial Registration—</title> <p>URL: <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">http://www.clinicaltrials.gov</ext-link>. Unique identifier: NCT01665053.</p> </sec> </abstract>