PMID- 19926048
OWN - NLM
STAT- MEDLINE
DCOM- 20100127
LR  - 20220321
IS  - 1876-7605 (Electronic)
IS  - 1936-8798 (Linking)
VI  - 2
IP  - 11
DP  - 2009 Nov
TI  - 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.
PG  - 1083-91
LID - 10.1016/j.jcin.2009.08.016 [doi]
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).
FAU - Montalescot, Gilles
AU  - Montalescot G
AD  - Institut du Coeur, Centre Hospitalier Universitaire Pitie-Salpetriere, Paris, 
      France. gilles.montalescot@psl.aphp.fr
FAU - Gallo, Richard
AU  - Gallo R
FAU - White, Harvey D
AU  - White HD
FAU - Cohen, Marc
AU  - Cohen M
FAU - Steg, Ph Gabriel
AU  - Steg PG
FAU - Aylward, Philip E G
AU  - Aylward PE
FAU - Bode, Christoph
AU  - Bode C
FAU - Chiariello, Massimo
AU  - Chiariello M
FAU - King, Spencer B 3rd
AU  - King SB 3rd
FAU - Harrington, Robert A
AU  - Harrington RA
FAU - Desmet, Walter J
AU  - Desmet WJ
FAU - Macaya, Carlos
AU  - Macaya C
FAU - Steinhubl, Steven R
AU  - Steinhubl SR
CN  - STEEPLE Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00077844
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JACC Cardiovasc Interv
JT  - JACC. Cardiovascular interventions
JID - 101467004
RN  - 0 (Anticoagulants)
RN  - 0 (Enoxaparin)
RN  - 0 (Fibrinolytic Agents)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 9005-49-6 (Heparin)
SB  - IM
CIN - JACC Cardiovasc Interv. 2009 Nov;2(11):1092-4. PMID: 19926049
MH  - Aged
MH  - *Angioplasty, Balloon, Coronary/adverse effects/mortality
MH  - Anticoagulants/*administration & dosage/adverse effects
MH  - Australia
MH  - Canada
MH  - Enoxaparin/*administration & dosage/adverse effects
MH  - Europe
MH  - Female
MH  - Fibrinolytic Agents/*administration & dosage/adverse effects
MH  - Hemorrhage/etiology/mortality
MH  - Heparin/*administration & dosage/adverse effects
MH  - Humans
MH  - Injections, Intravenous
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Myocardial Infarction/etiology/mortality
MH  - New Zealand
MH  - Platelet Aggregation Inhibitors/therapeutic use
MH  - Proportional Hazards Models
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
EDAT- 2009/11/21 06:00
MHDA- 2010/01/28 06:00
CRDT- 2009/11/21 06:00
PHST- 2009/04/07 00:00 [received]
PHST- 2009/08/07 00:00 [revised]
PHST- 2009/08/10 00:00 [accepted]
PHST- 2009/11/21 06:00 [entrez]
PHST- 2009/11/21 06:00 [pubmed]
PHST- 2010/01/28 06:00 [medline]
AID - S1936-8798(09)00581-0 [pii]
AID - 10.1016/j.jcin.2009.08.016 [doi]
PST - ppublish
SO  - JACC Cardiovasc Interv. 2009 Nov;2(11):1083-91. doi: 10.1016/j.jcin.2009.08.016.