Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report From the COMPARE II Trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent)

Georgios J Vlachojannis, Pieter C Smits, Sjoerd H Hofma, Mario Togni, Nicolás Vázquez, Mariano Valdés, Vassilis Voudris, Ton Slagboom, Jean-Jaques Goy, Peter den Heijer, Martin van der Ent

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

OBJECTIVES: This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention.

BACKGROUND: Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce.

METHODS: The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization.

RESULTS: Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17).

CONCLUSIONS: The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population.

Original languageEnglish
Pages (from-to)1215-1221
Number of pages7
JournalJACC. Cardiovascular Interventions
Volume10
Issue number12
DOIs
Publication statusPublished - 26 Jun 2017
Externally publishedYes

Keywords

  • Absorbable Implants
  • Aged
  • Cardiovascular Agents/administration & dosage
  • Coronary Artery Disease/diagnosis
  • Coronary Thrombosis/etiology
  • Drug-Eluting Stents
  • Everolimus/administration & dosage
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Myocardial Infarction/etiology
  • Percutaneous Coronary Intervention/adverse effects
  • Polymers/chemistry
  • Prospective Studies
  • Prosthesis Design
  • Risk Factors
  • Sirolimus/administration & dosage
  • Time Factors
  • Treatment Outcome

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