TY - JOUR
T1 - 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
AU - Montalescot, Gilles
AU - Gallo, Richard
AU - White, Harvey D.
AU - Cohen, Marc
AU - Steg, Ph Gabriel
AU - Aylward, Philip E.G.
AU - Bode, Christoph
AU - Chiariello, Massimo
AU - King, Spencer B.
AU - Harrington, Robert A.
AU - Desmet, Walter J.
AU - Macaya, Carlos
AU - Steinhubl, Steven R.
N1 - Funding Information:
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.
Funding Information:
Dr. Montalescot reports receiving grant support, consulting fees, and lecture fees from sanofi-aventis, Eli Lilly, and Bristol-Myers Squibb, consulting fees from Schering-Plough and The Medicines Company, and lecture fees from GlaxoSmithKline. Dr. Gallo reports having received grant support, consulting fees from AstraZeneca, Biovail Pharmaceuticals, sanofi-aventis, and Schering-Plough, and lecture fees from Abbott Interventional, Biovail Pharmaceuticals, and sanofi-aventis. Dr. White reports receiving grant support, consulting fees, and lecture fees from sanofi-aventis and The Medicines Company, and grant support from Proctor and Gamble, Alexion, Schering-Plough, and Eli Lilly. Dr. Cohen reports receiving grant support from Aventis Pharmaceuticals, consulting fees from sanofi-aventis and AstraZeneca, and lecture fees from sanofi-aventis, Merck, and Schering-Plough. Dr. Steg reports receiving grant support from sanofi-aventis, consulting fees from sanofi-aventis, Takeda, AstraZeneca, Bristol-Myers Squibb, Endotis, Lilly, Merck Sharpe & Dohme, GlaxoSmithKline, Pfizer, Servier, and The Medicines Company, and is on the Speakers' Bureau of AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Merck Sharpe & Dohme, Novartis, Nycomed, sanofi-aventis, Sankyo, Servier, The Medicines Company, and ZLB Behring. Dr. Aylward reports receiving grant support from sanofi-aventis, Proctor and Gamble, Alexion, The Medicines Company, Schering-Plough, and Eli Lilly, as well as consulting fees and lecture fees from sanofi-aventis and Bristol-Myers Squibb. Dr. Bode reports receiving consulting fees and lecture fees from sanofi-aventis, Lilly, and GlaxoSmithKline, as well as consulting fees from Nycomed and lecture fees from AstraZeneca. Dr. Chiariello reports receiving consulting fees from Schering-Plough and Nycomed, and lecture fees from Merck Sharpe & Dohme, GlaxoSmithKline, and IFB Stroder. Dr. King reports receiving grant support from Medtronic, and lecture fees from sanofi-aventis and Bristol-Myers Squibb. Dr. Harrington reports receiving grant support and consulting fees from sanofi-aventis. Dr. Desmet reports having received consulting fees from Nycomed and The Medicines Company. Dr. Steinhubl is currently employed by The Medicines Company. Before this appointment, Dr. Steinhubl reports receiving consulting fees from sanofi-aventis, The Medicines Company, AstraZeneca, Eli Lilly, Cardax Pharmaceuticals, and Daiichi Sankyo.
PY - 2009/11
Y1 - 2009/11
N2 - 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).
AB - 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).
KW - STEEPLE
KW - enoxaparin
KW - percutaneous coronary intervention
KW - unfractionated heparin
UR - http://www.scopus.com/inward/record.url?scp=70449464568&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2009.08.016
DO - 10.1016/j.jcin.2009.08.016
M3 - Article
C2 - 19926048
AN - SCOPUS:70449464568
SN - 1936-8798
VL - 2
SP - 1083
EP - 1091
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 11
ER -