Author + information
- Received April 7, 2009
- Revision received August 7, 2009
- Accepted August 10, 2009
- Published online November 1, 2009.
- Gilles Montalescot, MD, PhD⁎,⁎ (, )
- Richard Gallo, MD†,
- Harvey D. White, MB, ChB, DSc‡,
- Marc Cohen, MD§,
- Ph. Gabriel Steg, MD∥,
- Philip E.G. Aylward, MB, ChB, PhD¶,
- Christoph Bode, MD, PhD#,
- Massimo Chiariello, MD⁎⁎,
- Spencer B. King III, MD††,
- Robert A. Harrington, MD‡‡,
- Walter J. Desmet, MD§§,
- Carlos Macaya, MD, PhD∥∥,
- Steven R. Steinhubl, MD¶¶,##,
- STEEPLE Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Gilles Montalescot, Institut du Cœur, Bureau 2-236, Centre Hospitalier Universitaire Pitié-Salpêtrière, 47 Boulevard de l'Hôpital, 75013 Paris, France
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)
The STEEPLE trial was funded by sanofi-aventis. The authors received editorial support in the preparation of this manuscript, funded by sanofi-aventis. The authors, however, were fully responsible for content and editorial decisions for this manuscript. For full author disclosures, please see the end of this article.
- Received April 7, 2009.
- Revision received August 7, 2009.
- Accepted August 10, 2009.
- American College of Cardiology Foundation