title: Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent.
abstract: OBJECTIVE
  This study sought to compare the safety and efficacy of 2 dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) (Boston Scientific Corp., Natick, Massachusetts) compared with the durable polymer PROMUS Element EES (Boston Scientific Corp.).
  
  
  BACKGROUND
  Durable polymer coatings on drug-eluting stents have been associated with chronic inflammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy.
  
  
  METHODS
  A total of 291 patients with a de novo lesion ≤28 mm in length, in a coronary artery of ≥2.25 to ≤3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography.
  
  
  RESULTS
  The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half dose groups, respectively. The 6-month in-stent late loss was 0.15 ± 0.34 mm for PROMUS Element, 0.10 ± 0.25 mm for SYNERGY, and 0.13 ± 0.26 mm for SYNERGY half dose (SYNERGY, difference -0.06, upper 95.2% confidence limit: 0.02, p for noninferiority <0.001; SYNERGY half dose, difference -0.03, upper 95.2% confidence limit: 0.05, p for noninferiority <0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months.
  
  
  CONCLUSIONS
  The EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent. (A Prospective Randomized Multicenter Single-Blind Noninferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De Novo Atherosclerotic Lesion [EVOLVE]; NCT01135225).
authors.affiliation: MonashHeart, Clayton, Melbourne, Australia. ian.meredith@myheart.id.au
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: Christophe L
authors.initials: CL
authors.lastname: Dubois
authors.forename: Joseph
authors.initials: J
authors.lastname: Dens
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.forename: Didier
authors.initials: D
authors.lastname: Carrié
authors.forename: Simon
authors.initials: S
authors.lastname: Walsh
authors.forename: Keith G
authors.initials: KG
authors.lastname: Oldroyd
authors.forename: Olivier
authors.initials: O
authors.lastname: Varenne
authors.forename: Seif
authors.initials: S
authors.lastname: El-Jack
authors.forename: Raul
authors.initials: R
authors.lastname: Moreno
authors.forename: Anita A
authors.initials: AA
authors.lastname: Joshi
authors.forename: Dominic J
authors.initials: DJ
authors.lastname: Allocco
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
mesh_terms: D020341:Absorbable Implants; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000601:surgery*; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D011108:Polymers; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus