Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
van Gogh Investigators (with Pilger, E); Buller, HR; Cohen, AT; Davidson, B; Decousus, H; Gallus, AS; Gent, M; Pillion, G; Piovella, F; Prins, MH; Raskob, GE.
Extended prophylaxis of venous thromboembolism with idraparinux.
N Engl J Med. 2007; 357(11): 1105-1112.
Doi: 10.1056/NEJMoa067703
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- Study Group Members Med Uni Graz:
- Pilger Ernst
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- 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].).
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Anticoagulants - administration and dosage
- Double-Blind Method - administration and dosage
- Drug Administration Schedule - administration and dosage
- Factor Xa - antagonists and inhibitors
- Female - antagonists and inhibitors
- Follow-Up Studies - antagonists and inhibitors
- Hemorrhage - chemically induced
- Humans - chemically induced
- Injections, Subcutaneous - chemically induced
- Kaplan-Meiers Estimate - chemically induced
- Male - chemically induced
- Middle Aged - chemically induced
- Oligosaccharides - administration and dosage
- Pulmonary Embolism - drug therapy
- Recurrence - prevention and control
- Treatment Outcome - prevention and control
- Venous Thrombosis - drug therapy
- Vitamin K - antagonists and inhibitors