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Previous Volume 334:682-687 March 14, 1996 Number 11 Next

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ABSTRACT

Background An intravenous course of standard (unfractionated) heparin with the dose adjusted to prolong the activated partial-thromboplastin time to a desired length is the standard initial in-hospital treatment for patients with deep-vein thrombosis, but fixed-dose subcutaneous low-molecular-weight heparin appears to be as effective and safe. Because the latter treatment can be given on an outpatient basis, we compared the two treatments in symptomatic outpatients with proximal-vein thrombosis but no signs of pulmonary embolism.

Methods We randomly assigned patients to adjusted-dose intravenous standard heparin administered in the hospital (198 patients) or fixed-dose subcutaneous low-molecular-weight heparin administered at home, when feasible (202 patients). We compared the treatments with respect to recurrent venous thromboembolism, major bleeding, quality of life, and costs.

Results Seventeen of the 198 patients who received standard heparin (8.6 percent) and 14 of the 202 patients who received low-molecular-weight heparin (6.9 percent) had recurrent thromboembolism (difference, 1.7 percentage points; 95 percent confidence interval, -3.6 to 6.9). Major bleeding occurred in four patients assigned to standard heparin (2.0 percent) and one patient assigned to low-molecular-weight heparin (0.5 percent; difference, 1.5 percentage points; 95 percent confidence interval, -0.7 to 2.7). Quality of life improved in both groups. Physical activity and social functioning were better in the patients assigned to low-molecular-weight heparin. Among the patients in that group, 36 percent were never admitted to the hospital at all, and 40 percent were discharged early. This treatment was associated with a mean reduction in hospital days of 67 percent, ranging from 29 percent to 86 percent in the various study centers.

Conclusions In patients with proximal-vein thrombosis, treatment with low-molecular-weight heparin at home is feasible, effective, and safe.

Source Information

From the Academic Medical Center, Amsterdam (M.M.W.K., M.H.P., P.M.M.B., H.H., A.G.M.B., H.R.B.); Slotervaart Hospital, Amsterdam (D.P.M.B.); the Istituto di Semeiotica Medica, Padua, Italy (P.P.); Medicina Interna e Oncologica Medica, Pavia, Italy (F.P.); Auckland Hospital, Auckland, New Zealand (P.A.O.); Academic Hospital Groningen, Groningen, the Netherlands (J.M.); Flinders Medical Center, Adelaide, Australia (A.S.G.); Prince of Wales Hospital, Sydney, Australia (C.H.C.); Hôpital Clamart, Paris (G.S.).; and Sanofi Winthrop, Paris (L.S., P.A.).

Address reprint requests to Dr. Koopman at the Academic Medical Center, University of Amsterdam, Center for Hemostasis, Thrombosis, Atherosclerosis, and Inflammation Research, Rm. F4-133, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.

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