Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial

Circ Cardiovasc Interv. 2015 Oct;8(10):e002817. doi: 10.1161/CIRCINTERVENTIONS.115.002817.

Abstract

Background: There is a paucity of data reporting the clinical outcomes of biodegradable polymer biolimus-eluting stent (BP-BES) compared with durable polymer everolimus-eluting stent (DP-EES) beyond 1 year after stent implantation when the polymer is fully degraded.

Methods and results: The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial (NEXT) is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BP-BES with DP-EES in patients scheduled for percutaneous coronary intervention using drug-eluting stent (DES) without any exclusion criteria among 98 participating centers in Japan. The trial was designed to evaluate noninferiority of BP-BES relative to DP-EES in terms of any target-lesion revascularization at 1 year and death or myocardial infarction at 3 years. Between May and October 2011, 3235 patients were randomly assigned to receive either BP-BES (1617 patients) or DP-EES (1618 patients). Complete 3-year follow-up was achieved in 97.6% of patients. At 3 years, the primary safety end point of death or myocardial infarction occurred in 159 patients (9.9%) in the BP-BES group and in 166 patients (10.3%) in the DP-EES group, demonstrating noninferiority of BP-BES relative to DP-EES (P noninferiority<0.0001 and P superiority=0.7). Cumulative incidence of target-lesion revascularization was not significantly different between the 2 groups (7.4% versus 7.1%; P=0.8). By a landmark analysis at 1 year, the cumulative incidences of death or myocardial infarction and target-lesion revascularization were also not significantly different between the 2 groups (4.6% versus 5.2%; P=0.46 and 3.3% versus 2.7%; P=0.39, respectively).

Conclusions: Safety and efficacy outcomes of BP-BES were non inferior to those of DP-EES 3 years after stent implantation.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01303640.

Keywords: coronary artery disease; drug-eluting stents; percutaneous coronary intervention; stents.

Publication types

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

MeSH terms

  • Absorbable Implants / statistics & numerical data
  • Aged
  • Blood Vessel Prosthesis Implantation*
  • Drug-Eluting Stents / statistics & numerical data*
  • Everolimus / administration & dosage*
  • Female
  • Follow-Up Studies
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology*
  • Myocardial Infarction / mortality
  • Percutaneous Coronary Intervention*
  • Postoperative Complications* / mortality
  • Prospective Studies
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives*
  • Survival Analysis
  • Treatment Outcome

Substances

  • Everolimus
  • umirolimus
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT01303640