• Dean J Kereiakes, Ian T Meredith, Stephan Windecker, R Lee Jobe, Shamir R Mehta, Ian J Sarembock, Robert L Feldman, Bernardo Stein, Christophe Dubois, Timothy Grady, Shigeru Saito, Takeshi Kimura, Thomas Christen, Dominic J Allocco, and Keith D Dawkins.
• From the Heart and Vascular Center/The Lindner Research Center, Christ Hospital, Cincinnati, OH (D.J.K., I.J.S.); Department of Medicine, MonashHEART, Southern Health, Monash Medical Centre, Clayton, Victoria, Australia (I.T.M.); Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.); Department of Invasive Cardiology, Wake Medical Center, Raleigh, NC (R.L.J.); Department of Medicine, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada (S.R.M.); Invasive/Interventional Cardiology, Mediquest Research at Munroe Regional Medical Center, Ocala, FL (R.L.F.); Interventional Cardiology, Morton Plant Mease Healthcare System, Clearwater, FL (B.S.); Department of Cardiology, University Hospital Leuven, Leuven, Belgium (C.D.); Research and Education, Aspirus Heart and Vascular Institute-Research and Education, Wausau, WI (T.G.); Division of Cardiology and Catherization Laboratories Heart Center, Shonan Kamakura General Hospital, Kanagawa, Japan (S.S.); Department of Cardiovascular Medicine, Kyoto University Hospital, Kyoto, Japan (T.K.); and Clinical Sciences, Boston Scientific Corporation, Marlborough, MA (T.C., D.J.A., K.D.D.). lindner@thechristhospital.com.
• Circ Cardiovasc Interv. 2015 Apr 1; 8 (4).

BackgroundDrug 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.Methods And ResultsPatients (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 (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively.ConclusionsIn 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.Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.© 2015 American Heart Association, Inc.

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