Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial.
Abstract | CONTEXT: OBJECTIVES: To compare the outcomes of patients treated with enoxaparin vs unfractionated heparin and to define the role of enoxaparin in patients with non-ST-segment elevation ACS at high risk for ischemic cardiac complications managed with an early invasive approach. DESIGN, SETTING, AND PARTICIPANTS: The Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial was a prospective, randomized, open-label, multicenter, international trial conducted between August 2001 and December 2003. A total of 10 027 high-risk patients with non-ST-segment elevation ACS to be treated with an intended early invasive strategy were recruited. INTERVENTIONS: Subcutaneous enoxaparin (n = 4993) or intravenous unfractionated heparin (n = 4985) was to be administered immediately after enrollment and continued until the patient required no further anticoagulation, as judged by the treating physician. MAIN OUTCOME MEASURES: The primary efficacy outcome was the composite clinical end point of all-cause death or nonfatal myocardial infarction during the first 30 days after randomization. The primary safety outcome was major bleeding or stroke. RESULTS: The primary end point occurred in 14.0% (696/4993) of patients assigned to enoxaparin and 14.5% (722/4985) of patients assigned to unfractionated heparin (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.86-1.06). No differences in ischemic events during percutaneous coronary intervention (PCI) were observed between enoxaparin and unfractionated heparin groups, respectively, including similar rates of abrupt closure (31/2321 [1.3%] vs 40/2364 [1.7%]), threatened abrupt closure (25/2321 [1.1%] vs 24/2363 [1.0%]), unsuccessful PCI (81/2281 [3.6%] vs 79/2328 [3.4%]), or emergency coronary artery bypass graft surgery (6/2323 [0.3%] vs 8/2363 [0.3%]). More bleeding was observed with enoxaparin, with a statistically significant increase in TIMI (Thrombolysis in Myocardial Infarction) major bleeding (9.1% vs 7.6%, P =.008) but nonsignificant excess in GUSTO (Global Utilization of Streptokinase and t-PA for Occluded Arteries) severe bleeding (2.7% vs 2.2%, P =.08) and transfusions (17.0% vs 16.0%, P =.16). CONCLUSIONS:
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Authors | James J Ferguson, Robert M Califf, Elliott M Antman, Marc Cohen, Cindy L Grines, Shaun Goodman, Dean J Kereiakes, Anatoly Langer, Kenneth W Mahaffey, Christopher C Nessel, Paul W Armstrong, Alvaro Avezum, Phil Aylward, Richard C Becker, Luigi Biasucci, Steven Borzak, Jacques Col, Marty J Frey, Ed Fry, Dietrich C Gulba, Sema Guneri, Enrique Gurfinkel, Robert Harrington, Judith S Hochman, Neal S Kleiman, Martin B Leon, Jose Luis Lopez-Sendon, Carl J Pepine, Witold Ruzyllo, Steven R Steinhubl, Paul S Teirstein, Luis Toro-Figueroa, Harvey White, SYNERGY Trial Investigators |
Journal | JAMA
(JAMA)
Vol. 292
Issue 1
Pg. 45-54
(Jul 07 2004)
ISSN: 1538-3598 [Electronic] United States |
PMID | 15238590
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Enoxaparin
- Fibrinolytic Agents
- Heparin
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Topics |
- Aged
- Angina Pectoris
(drug therapy, mortality, therapy)
- Angioplasty, Balloon, Coronary
- Enoxaparin
(therapeutic use)
- Female
- Fibrinolytic Agents
(therapeutic use)
- Hemorrhage
(epidemiology)
- Heparin
(therapeutic use)
- Humans
- Male
- Middle Aged
- Myocardial Infarction
(epidemiology)
- Stroke
(epidemiology)
- Survival Analysis
- Treatment Outcome
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