Extended prophylaxis of venous thromboembolism with idraparinux.

Non Renseigné Harry R Buller Ander T Cohen 1 Bruce Davidson Hervé Decousus 2 Alex S Gallus Michael Gent Gerard Pillion Franco Piovella Martin H Prins 3 Gary E Raskob
1 ALCHEMY - Architectures, Languages and Compilers to Harness the End of Moore Years
LRI - Laboratoire de Recherche en Informatique, UP11 - Université Paris-Sud - Paris 11, Inria Saclay - Ile de France, CNRS - Centre National de la Recherche Scientifique : UMR8623
2 GRT (EA 3065) - Groupe de recherche sur la thrombose
3 Cluster Infectious Diseases
Abstract : BACKGROUND: The extended use of vitamin K antagonists for prophylaxis against venous thromboembolism is often constrained by risk-benefit limitations and inconvenience. We evaluated the efficacy and safety of a 6-month extension of prophylaxis against recurrent venous thromboembolism with idraparinux in patients who had initially received 6 months of prophylaxis with an anticoagulant. METHODS: We randomly assigned patients who had completed 6 months of prophylaxis with idraparinux or a vitamin K antagonist and in whom extended anticoagulation was warranted to receive once-weekly injections of 2.5 mg of idraparinux or placebo for 6 months without monitoring. The primary efficacy and safety outcomes were recurrent venous thromboembolism and major bleeding. RESULTS: Of 1215 patients, 6 of 594 (1.0%) in the idraparinux group and 23 of 621 (3.7%) in the placebo group had recurrent venous thromboembolism (P=0.002). Major bleeding occurred in 11 patients (1.9%) in the idraparinux group and in none in the placebo group (P<0.001). Of these 11 episodes, 3 were fatal intracranial hemorrhages. As compared with patients whose initial treatment was a vitamin K antagonist, patients whose initial treatment was idraparinux who were assigned to 6 months in the placebo group had a lower incidence of recurrent thromboembolism (0.7% vs. 5.9%); patients who received 6 additional months of idraparinux therapy had a higher incidence of major bleeding (3.1% vs. 0.9%). CONCLUSIONS: During a 6-month extension of thromboprophylaxis, idraparinux was effective in preventing recurrent thromboembolism but was associated with an increased risk of a major hemorrhage. (ClinicalTrials.gov number, NCT00071279 [ClinicalTrials.gov].).
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Submitted on : Wednesday, December 9, 2009 - 11:25:01 AM
Last modification on : Thursday, April 5, 2018 - 12:30:12 PM

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UNIV-ST-ETIENNE | INRIA | UMR8623

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Non Renseigné, Harry R Buller, Ander T Cohen, Bruce Davidson, Hervé Decousus, et al.. Extended prophylaxis of venous thromboembolism with idraparinux.. New England Journal of Medicine, Massachusetts Medical Society, 2007, 357 (11), pp.1105-12. ⟨10.1056/NEJMoa067703⟩. ⟨ujm-00440045⟩

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