A Clinical Trial of Vena Caval Filters in the Prevention of Pulmonary Embolism in Patients with Proximal Deep-Vein Thrombosis
Hervé Decousus, M.D., Alain Leizorovicz, M.D., Florence Parent, M.D., Yves Page, M.D., Bernard Tardy, M.D., Philippe Girard, M.D., Silvy Laporte, B.S., René Faivre, M.D., Bernard Charbonnier, M.D., Fabrice-Guy Barral, M.D., Yann Huet, M.D., Gérald Simonneau, M.D., for The Prévention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group
Background The efficacy and safety of vena caval filters inthe prevention of pulmonary embolism in patients with proximaldeep-vein thrombosis are still a matter of debate.
Methods Using a two-by-two factorial design, we randomly assigned400 patients with proximal deep-vein thrombosis who were atrisk for pulmonary embolism to receive a vena caval filter (200patients) or no filter (200 patients), and to receive low-molecular-weightheparin (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 twoyears.
Results At day 12, two patients assigned to receive filters(1.1 percent), as compared with nine patients assigned to receiveno filters (4.8 percent), had had symptomatic or asymptomaticpulmonary embolism (odds ratio, 0.22; 95 percent confidenceinterval, 0.05 to 0.90). At two years, 37 patients assignedto the filter group (20.8 percent), as compared with 21 patientsassigned to the no-filter group (11.6 percent), had had recurrentdeep-vein thrombosis (odds ratio, 1.87; 95 percent confidenceinterval, 1.10 to 3.20). There were no significant differencesin mortality or the other outcomes. At day 12, three patientsassigned to low-molecular-weight heparin (1.6 percent), as comparedwith eight patients assigned to unfractionated heparin (4.2percent), had had symptomatic or asymptomatic pulmonary embolism(odds ratio, 0.38; 95 percent confidence interval, 0.10 to 1.38).
Conclusions In high-risk patients with proximal deep-vein thrombosis,the initial beneficial effect of vena caval filters for theprevention of pulmonary embolism was counterbalanced by an excessof recurrent deep-vein thrombosis, without any difference inmortality. Our data also confirmed that low-molecular-weightheparin was as effective and safe as unfractionated heparinfor the prevention of pulmonary embolism.
Source Information
From the Thrombosis Research Group, Clinical Pharmacology Unit (H.D., S.L.), Intensive Care Unit (Y.P., B.T.), and Department of Radiology (F.-G.B.), Bellevue Hospital, Saint-Etienne; the Clinical Pharmacology Unit, Cardiological Hospital, Lyons (A.L.); the Respiratory Unit, Antoine Béclère Hospital, Clamart (F.P., G.S.); the Institut Mutualiste Montsouris, Paris (P.G.); the Cardiology Unit, Clinique Saint-Vincent, Besançon (R.F.); the Cardiology Unit, Trousseau Hospital, Tours (B.C.); and RhônePoulenc Rorer, Paris (Y.H.) all in France.
Address reprint requests to Dr. Decousus at the Thrombosis Research Group, Clinical Pharmacology Unit, Hôpital Bellevue, CHU Saint-Etienne, 42055 Saint-Etienne CEDEX 2, France.
Vena Caval Filters for the Prevention of Pulmonary Embolism
Chuu W.-M., Wang N.-Y., Perry D., Murphy T. P., Trerotola S. O., Vogelzang R. L., Greenfield L. J., Proctor M. C., Decousus H., Mismetti P., Tardy B., The Prevention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group
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N Engl J Med 1998;
339:46-48, Jul 2, 1998.
Correspondence
Pulmonary Embolism
Schrijvers D., Van den Brande J., Vermorken J. B., Corbanese U., Possamai C., Blatt P. M., Marlar R. A., Joist J. H., Fink L. M., Goldhaber S. Z.
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N Engl J Med 1998;
339:1555-1557, Nov 19, 1998.
Correspondence
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