Abstract | BACKGROUND: METHODS: SYNERGY was an international, multicenter, randomized, open-label trial that compared enoxaparin with UFH in high-risk NSTE ACS patients managed with an early invasive strategy. For enrollment, 2 out of 3 high-risk features were required: age > or =60 years, elevated cardiac biomarkers, or ST-segment changes. The primary efficacy end point was death/ myocardial infarction (MI) at 30 days. The primary safety end point was inhospital major bleeding or stroke through 30 days. RESULTS: The incidence of death/MI at 30 days was 14.0% in the enoxaparin group and 14.5% in the UFH group (hazard ratio 0.96, 95% CI 0.86-1.06), demonstrating noninferiority of enoxaparin relative to UFH. Enoxaparin was associated with a small but significant excess of Thrombolysis In Myocardial Infarction (TIMI) major bleeding, but there was no statistically significant increase in Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding or the rate of transfusion. There was no difference in complications of percutaneous coronary intervention. Interpretation of trial results was complicated by widespread use of enoxaparin or UFH before randomization, and by postrandomization crossover to the nonrandomized agent. CONCLUSIONS: In patients with NSTE ACS, including high-risk patients proceeding rapidly to catheterization, enoxaparin is an effective and safe alternative to UFH.
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Authors | Kenneth W Mahaffey, James J Ferguson |
Journal | American heart journal
(Am Heart J)
Vol. 149
Issue 4 Suppl
Pg. S81-90
(Apr 2005)
ISSN: 1097-6744 [Electronic] United States |
PMID | 16124952
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticoagulants
- Enoxaparin
- Platelet Glycoprotein GPIIb-IIIa Complex
- Heparin
- Aspirin
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Topics |
- Aged
- Anticoagulants
(adverse effects, therapeutic use)
- Aspirin
(therapeutic use)
- Cardiac Catheterization
- Enoxaparin
(adverse effects, therapeutic use)
- Female
- Hemorrhage
(chemically induced)
- Heparin
(adverse effects, therapeutic use)
- Humans
- Male
- Middle Aged
- Multicenter Studies as Topic
- Myocardial Infarction
(mortality, prevention & control)
- Myocardial Ischemia
(drug therapy)
- Myocardial Revascularization
- Platelet Glycoprotein GPIIb-IIIa Complex
(antagonists & inhibitors)
- Randomized Controlled Trials as Topic
- Syndrome
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