Enoxaparin Versus Unfractionated Heparin in Elective Percutaneous Coronary Intervention. 1-Year Results From the STEEPLE (SafeTy and Efficacy of Enoxaparin in Percutaneous coronary intervention patients, an internationaL randomized Evaluation) Trial

Gilles Montalescot, Richard Gallo, Harvey D. White, Marc Cohen, Ph Gabriel Steg, Philip E.G. Aylward, Christoph Bode, Massimo Chiariello, Spencer B. King, Robert A. Harrington, Walter J. Desmet, Carlos Macaya, Steven R. Steinhubl

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Objectives: Our purpose was to evaluate long-term mortality and identify factors associated with 1-year mortality in patients who underwent elective percutaneous coronary intervention (PCI). Background: While long-term outcomes in PCI patients have been reported previously, limited data are currently available regarding the comparative long-term outcomes in PCI patients who receive enoxaparin versus intravenous unfractionated heparin (UFH). Methods: We conducted a follow-up analysis of clinical outcomes at 1 year in patients enrolled in the STEEPLE (SafeTy and Efficacy of Enoxaparin in Percutaneous coronary intervention patients, an internationaL randomized Evaluation) trial of 3,528 patients undergoing elective PCI. Patients were randomized to receive either intravenous 0.50-mg/kg or 0.75-mg/kg enoxaparin or intravenous UFH during elective PCI procedures. All-cause mortality at 1 year after index PCI was the main outcome measure. Results: Mortality rates were 1.4%, 2.0%, and 1.5% from 1 month to 1 year, and 2.3%, 2.2%, and 1.9% from randomization to 1 year, after index PCI in patients receiving 0.50 mg/kg enoxaparin, 0.75 mg/kg enoxaparin, and UFH, respectively. Multivariate analysis identified nonfatal myocardial infarction and/or urgent target vessel revascularization up to 30 days after index PCI (hazard ratio: 3.5, 95% confidence interval: 1.7 to 7.3; p < 0.001), and major bleeding within 48 h (hazard ratio: 3.0, 95% confidence interval: 1.1 to 8.5; p = 0.04) as the strongest independent risk factors for 1-year mortality. Conclusions: The 1-year mortality rates were low and comparable between patients receiving enoxaparin and UFH during elective PCI. Periprocedural ischemic or bleeding events were the strongest independent predictors of 1-year mortality. (The STEEPLE Trial; NCT00077844).

Original languageEnglish
Pages (from-to)1083-1091
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume2
Issue number11
DOIs
Publication statusPublished - 1 Nov 2009
Externally publishedYes

Keywords

  • enoxaparin
  • percutaneous coronary intervention
  • STEEPLE
  • unfractionated heparin

Fingerprint Dive into the research topics of 'Enoxaparin Versus Unfractionated Heparin in Elective Percutaneous Coronary Intervention. 1-Year Results From the STEEPLE (SafeTy and Efficacy of Enoxaparin in Percutaneous coronary intervention patients, an internationaL randomized Evaluation) Trial'. Together they form a unique fingerprint.

  • Cite this