title: Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial.
abstract: BACKGROUND
  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.
  
  
  RESULTS
  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 (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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.
authors: 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.
authors: Dean J
authors: DJ
authors: Kereiakes
authors: 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.).
authors: Ian T
authors: IT
authors: Meredith
authors: 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.).
authors: Stephan
authors: S
authors: Windecker
authors: 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.).
authors: R
authors: R
authors: Lee Jobe
authors: 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.).
authors: Shamir R
authors: SR
authors: Mehta
authors: 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.).
authors: Ian J
authors: IJ
authors: Sarembock
authors: 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.).
authors: Robert L
authors: RL
authors: Feldman
authors: 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.).
authors: Bernardo
authors: B
authors: Stein
authors: 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.).
authors: Christophe
authors: C
authors: Dubois
authors: 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.).
authors: Timothy
authors: T
authors: Grady
authors: 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.).
authors: Shigeru
authors: S
authors: Saito
authors: 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.).
authors: Takeshi
authors: T
authors: Kimura
authors: 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.).
authors: Thomas
authors: T
authors: Christen
authors: 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.).
authors: Dominic J
authors: DJ
authors: Allocco
authors: 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.).
authors: Keith D
authors: KD
authors: Dawkins
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects / Q000706:statistics & numerical data*; D054058:Acute Coronary Syndrome / Q000601:surgery*; D000368:Aged; D001672:Biocompatible Materials / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D019917:Blood Vessel Prosthesis Implantation; D003324:Coronary Artery Disease / Q000601:surgery*; D004146:Dioxanes; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D017671:Platinum Compounds; D011108:Polymers / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D004146:Dioxanes; D017671:Platinum Compounds; D011108:Polymers; C091880:dilactide; D000068338:Everolimus
keywords: drug-eluting stent; percutaneous coronary intervention