Background Low-molecular-weight heparin appears to be at leastas effective and safe as standard, unfractionated heparin forthe treatment of deep-vein thrombosis, but only limited dataare available on the use of low-molecular-weight heparin totreat acute symptomatic pulmonary embolism.
Methods We randomly assigned 612 patients with symptomatic pulmonaryembolism who did not require thrombolytic therapy or embolectomyto either subcutaneous low-molecular-weight heparin (tinzaparin)given once daily in a fixed dose or adjusted-dose, intravenousunfractionated heparin. Oral anticoagulant therapy was begunbetween the first and the third day and was given for at leastthree months. We compared the treatments at day 8 and day 90with respect to a combined end point of recurrent thromboembolism,major bleeding, and death.
Results In the first eight days of treatment, 9 of 308 patientsassigned to receive unfractionated heparin (2.9 percent) reachedat least one of the end points, as compared with 9 of 304 patientsassigned to low-molecular-weight heparin (3.0 percent; absolutedifference, 0.1 percentage point; 95 percent confidence interval,-2.7 to 2.6). By day 90, 22 patients assigned to unfractionatedheparin (7.1 percent) and 18 patients assigned to low-molecular-weightheparin (5.9 percent) had reached at least one end point (P= 0.54; absolute difference, 1.2 percentage points; 95 percentconfidence interval, -2.7 to 5.1). The risk of major bleedingwas similar in the two treatment groups throughout the study.
Conclusions Under the conditions of this study, initial subcutaneoustherapy with the low-molecular-weight heparin tinzaparin appearedto be as effective and safe as intravenous unfractionated heparinin patients with acute pulmonary embolism.
Source Information
From Hôpital Antoine Béclère, Clamart (G.S.); Hôpital Laennec, Paris (H.S.); Hôpital Trousseau, Tours (B.C.); Hôpital Bellevue, St. Etienne (Y.P.); Hôpital Hôtel Dieu, Paris (J.-P.L.); Hôpital André Mignot, Versailles (R.A.); Hôpital Hôtel Dieu, Rennes (M.L.); Hôpital Henri Duffaut, Avignon (J.-L.H.); Hôpital Pasteur, Nice (E.F.); Hôpital Universitaire, Grenoble (J.-L.B.); Hôpital de la Cavale Blanche, Brest (D.M.); and Leo Pharmaceuticals, St. Quentin en Yvelines (B.B.) — all in France.
Address reprint requests to Dr. Simonneau at the Service de Pneumologie et Réanimation, Hôpital Antoine Béclère, 157 rue de la Porte de Trivaux, 92141 Clamart, France.
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