Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial

Circ Cardiovasc Interv. 2015 Apr;8(4):e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372.

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.

Methods and 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.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.

Keywords: drug-eluting stent; percutaneous coronary intervention.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorbable Implants / adverse effects
  • Absorbable Implants / statistics & numerical data*
  • Acute Coronary Syndrome / surgery*
  • Aged
  • Biocompatible Materials / administration & dosage*
  • Biocompatible Materials / adverse effects
  • Biocompatible Materials / chemistry
  • Blood Vessel Prosthesis Implantation*
  • Coronary Artery Disease / surgery*
  • Dioxanes
  • Drug-Eluting Stents / statistics & numerical data
  • Everolimus / administration & dosage*
  • Everolimus / adverse effects
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention*
  • Platinum Compounds
  • Polymers / administration & dosage
  • Polymers / adverse effects
  • Treatment Outcome

Substances

  • Biocompatible Materials
  • Dioxanes
  • Platinum Compounds
  • Polymers
  • dilactide
  • Everolimus

Associated data

  • ClinicalTrials.gov/NCT01665053