Extended prophylaxis of venous thromboembolism with idraparinux.

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].).

• Authors: van Gogh Investigators, Harry R Buller, Ander T Cohen, Bruce Davidson, Hervé Decousus, Alex S Gallus, Michael Gent, Gerard Pillion, Franco Piovella, Martin H Prins, Gary E Raskob
• Journal: The New England journal of medicine (N Engl J Med) Vol. 357 Issue 11 Pg. 1105-12 (Sep 13 2007) ISSN: 1533-4406 [Electronic] United States
• PMID: 17855671 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2007 Massachusetts Medical Society.

Chemical References

• Anticoagulants
• Factor Xa Inhibitors
• Oligosaccharides
• Vitamin K
• idraparinux

Topics

• Aged
• Anticoagulants (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Factor Xa Inhibitors
• Female
• Follow-Up Studies
• Hemorrhage (chemically induced)
• Humans
• Injections, Subcutaneous
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Oligosaccharides (administration & dosage, adverse effects, therapeutic use)
• Pulmonary Embolism (drug therapy, mortality)
• Secondary Prevention
• Treatment Outcome
• Venous Thrombosis (drug therapy, mortality)
• Vitamin K (antagonists & inhibitors)