A Clinical Trial of Vena Caval Filters in the Prevention of Pulmonary Embolism in Patients with Proximal Deep-Vein Thrombosis

Autor: Bernard Tardy, Fabrice-Guy Barral, Silvy Laporte, Y. Page, Bernard Charbonnier, Hervé Decousus, Gérald Simonneau, Philippe Girard, René Faivre, Florence Parent, Yann Huet, Alain Leizorovicz
Rok vydání: 1998
Předmět:
Zdroj: New England Journal of Medicine. 338:409-416
ISSN: 1533-4406
0028-4793
DOI: 10.1056/nejm199802123380701
Popis: Background The efficacy and safety of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis are still a matter of debate. Methods Using a two-by-two factorial design, we randomly assigned 400 patients with proximal deep-vein thrombosis who were at risk for pulmonary embolism to receive a vena caval filter (200 patients) or no filter (200 patients), and to receive low-molecular-weight heparin (enoxaparin, 195 patients) or unfractionated heparin (205 patients). The rates of recurrent venous thromboembolism, death, and major bleeding were analyzed at day 12 and at two years. Results At day 12, two patients assigned to receive filters (1.1 percent), as compared with nine patients assigned to receive no filters (4.8 percent), had had symptomatic or asymptomatic pulmonary embolism (odds ratio, 0.22; 95 percent confidence interval, 0.05 to 0.90). At two years, 37 patients assigned to the filter group (20.8 percent), as compared with 21 patients assigned to the ...
Databáze: OpenAIRE