Final five-year clinical outcomes in the EVOLVE trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent

Affiliation.

  • 1 Boston Scientific Corporation, Marlborough, MA, USA.
  • PMID: 28923786
  • DOI: 10.4244/EIJ-D-17-00529

Aims: Long-term data on bioabsorbable polymer-coated everolimus-eluting stents (BP-EES) are limited. The EVOLVE trial compared the safety and efficacy of two dose formulations of the SYNERGY BP-EES with the permanent polymer-coated PROMUS Element EES (PE).

Methods and results: The EVOLVE study was a prospective, multicentre, non-inferiority trial that randomised 291 patients with de novo coronary lesions (length: ≤28 mm; diameter: ≥2.25 to ≤3.5 mm) to receive PE (n=98), SYNERGY (n=94), or SYNERGY half-dose (n=99). At five years, there were no significant differences in the rates of TLF or individual components between groups. TLR rates trended lower in both SYNERGY arms than in the PE arm (TLR: 1.1% SYNERGY and 1.0% SYNERGY half-dose vs. 6.1% PE; p=0.07 and p=0.06, respectively). TVR was numerically lower in the SYNERGY arms compared to the PE arm (TVR: 3.3% SYNERGY and 4.2% SYNERGY half-dose vs. 10.2% PE; p=0.06 and p=0.11, respectively). No incidence of stent thrombosis was reported in any arm up to five years.

Conclusions: The EVOLVE trial represents the longest-term follow-up of the SYNERGY stent available to date, demonstrating its continued safety and efficacy for the treatment of selected de novo atherosclerotic lesions up to five years.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Absorbable Implants / adverse effects*
  • Coronary Artery Disease* / diagnosis
  • Coronary Artery Disease* / surgery
  • Coronary Restenosis* / diagnosis
  • Coronary Restenosis* / epidemiology
  • Coronary Restenosis* / etiology
  • Drug-Eluting Stents
  • Everolimus / pharmacology*
  • Follow-Up Studies
  • Immunosuppressive Agents / pharmacology
  • Long Term Adverse Effects* / diagnosis
  • Long Term Adverse Effects* / epidemiology
  • Long Term Adverse Effects* / etiology
  • Middle Aged
  • Percutaneous Coronary Intervention* / adverse effects
  • Percutaneous Coronary Intervention* / instrumentation
  • Percutaneous Coronary Intervention* / methods
  • Polymers / pharmacology
  • Prosthesis Design
  • Treatment Outcome
  • Immunosuppressive Agents

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