Sirolimus-eluting stents versus bare-metal stents in routine clinical use: a nonrandomized comparison

Tex Heart Inst J. 2011;38(5):508-15.

Abstract

Conflicting patient outcomes have been reported after the use of sirolimus-eluting stents or bare-metal stents. In this nonrandomized study, we examine the outcomes after placement of sirolimus-eluting versus bare-metal stents in an unselected population of patients who underwent percutaneous coronary revascularization.We used THIRD-base, a longitudinal data registry of patients who underwent revascularization at our institution, to compare demographics and outcomes in patients treated with a sirolimus-eluting or bare-metal stent from January 2001 through June 2006. Outcome measures included major acute coronary and cerebral events at 30 days, target-vessel failure at 9 months and at 3 years, and stent thrombosis. Target-vessel failure was defined as the composite of all-cause death, recurrent myocardial infarction in the treated vessel distribution, and target-vessel revascularization. Logistic regression and Cox proportional regression models were used to determine the predictors of outcome.Of the 6,425 patients analyzed, 2,581 patients (40.2%) received only sirolimus-eluting stents, and 3,844 patients (59.8%) received only bare-metal stents. Early major acute coronary and cerebral events and stent thrombosis at 30 days and 9 months were similar in both groups. Target-vessel failure was less frequent in sirolimus-eluting stent patients than in bare-metal stent patients at 9 months (4.84% vs 11.81%, P < 0.0001) and at 3 years (29% vs 32%, P < 0.0001).Use of sirolimus-eluting stents improved target-vessel failure survival at 9 months and at 3 years. Late adverse events were determined by known risk factors for atherosclerosis, not by stent type.

Keywords: Angioplasty, balloon, coronary; bare-metal stents/statistics & numerical data; coronary restenosis/prevention & control; drug delivery systems; drug-eluting stents/statistics & numerical data; hyperplasia/prevention & control; immunosuppressive agents; sirolimus/therapeutic use; thrombosis/prevention & control.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Cardiovascular Agents / administration & dosage*
  • Cerebrovascular Disorders / etiology
  • Chi-Square Distribution
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Logistic Models
  • Male
  • Metals*
  • Middle Aged
  • Myocardial Infarction / etiology
  • Patient Selection
  • Propensity Score
  • Proportional Hazards Models
  • Prosthesis Design
  • Registries
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Sirolimus / administration & dosage*
  • Stents*
  • Texas
  • Thrombosis / etiology
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Metals
  • Sirolimus