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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, 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^¶¶,## for the STEEPLE Investigators

^_* Institut du Cœur, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France
The Montreal Heart Institute, University of Montreal, Montreal, Canada
Auckland City Hospital, Auckland, New Zealand
Division of Cardiology, Newark Beth Israel Medical Center, Newark, New Jersey
^|| INSERM U-698, Université Paris 7 and AP-HP, Paris, France
^¶ Cardiology Research, Flinders Medical Centre, South Australia, Australia
^# Abteilung Innere Medizin III, Universitätsklinikum Freiburg, Freiburg, Germany
^_** Division of Cardiology, Federico 2nd University, Naples, Italy
St Joseph's Heart and Vascular Institute, Atlanta, Georgia
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
University Hospital Gasthuisberg, Leuven, Belgium
^|||| Servicio de Cardiología, Hospital Universitario, Madrid, Spain
^¶¶ Geisinger Clinic, Geisinger Center for Health Research, Danville, Pennsylvania
^## The Medicines Company, Zurich, Switzerland

^_* 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 (Email: gilles.montalescot{at}psl.aphp.fr).

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)

Key Words: percutaneous coronary intervention • enoxaparin • STEEPLE • unfractionated heparin

Abbreviations and Acronyms   ACS = acute coronary syndromes   ACT = activated clotting time   CI = confidence interval   CK = creatine kinase   CK-MB = creatine kinase-myocardial/brain mass   HR = hazard ratio   LMWH = low-molecular-weight heparin   MI = myocardial infarction   PCI = percutaneous coronary intervention   UFH = unfractionated heparin   ULNR = upper limit of the normal range   UTVR = urgent target vessel revascularization

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