Abstract | BACKGROUND: METHODS: RESULTS: The number of patients with primary-outcome events was similar in the two groups (579 with fondaparinux [5.8 percent] vs. 573 with enoxaparin [5.7 percent]; hazard ratio in the fondaparinux group, 1.01; 95 percent confidence interval, 0.90 to 1.13), satisfying the noninferiority criteria. The number of events meeting this combined outcome showed a nonsignificant trend toward a lower value in the fondaparinux group at 30 days (805 vs. 864, P=0.13) and at the end of the study (1222 vs. 1308, P=0.06). The rate of major bleeding at nine days was markedly lower with fondaparinux than with enoxaparin (217 events [2.2 percent] vs. 412 events [4.1 percent]; hazard ratio, 0.52; P<0.001). The composite of the primary outcome and major bleeding at nine days favored fondaparinux (737 events [7.3 percent] vs. 905 events [9.0 percent]; hazard ratio, 0.81; P<0.001). Fondaparinux was associated with a significantly reduced number of deaths at 30 days (295 vs. 352, P=0.02) and at 180 days (574 vs. 638, P=0.05). CONCLUSIONS:
Fondaparinux is similar to enoxaparin in reducing the risk of ischemic events at nine days, but it substantially reduces major bleeding and improves long term mortality and morbidity. (ClinicalTrials.gov number, NCT00139815.).
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Authors | Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators, Salim Yusuf, Shamir R Mehta, Susan Chrolavicius, Rizwan Afzal, Janice Pogue, Christopher B Granger, Andrzej Budaj, Ron J G Peters, Jean-Pierre Bassand, Lars Wallentin, Campbell Joyner, Keith A A Fox |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 354
Issue 14
Pg. 1464-76
(Apr 06 2006)
ISSN: 1533-4406 [Electronic] United States |
PMID | 16537663
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2006 Massachusetts Medical Society. |
Chemical References |
- Anticoagulants
- Enoxaparin
- Polysaccharides
- Fondaparinux
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Topics |
- Aged
- Angina, Unstable
(drug therapy, mortality, therapy)
- Angioplasty, Balloon, Coronary
- Anticoagulants
(adverse effects, therapeutic use)
- Enoxaparin
(adverse effects, therapeutic use)
- Female
- Fondaparinux
- Hemorrhage
(chemically induced)
- Humans
- Male
- Middle Aged
- Myocardial Infarction
(drug therapy, mortality, therapy)
- Polysaccharides
(adverse effects, therapeutic use)
- Recurrence
- Stroke
- Survival Analysis
- Treatment Outcome
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