The Treatment of Proximal Vein Thrombosis with Subcutaneous Low-Mole Molecular-Weight Heparin Compared with Continuous Intravenous Heparin

Abstract

Low-molecular-weight heparin, compared with unfractionated heparin, has a higher bioavailability and a more prolonged half-life. There are limited data comparing the use of low-molecular-weight heparin with unfractionated heparin for the treatment of deep vein thrombosis. We have compared fixed-dose, subcutaneous low-molecular-weight heparin given once daily with adjusted-dose intravenous heparin given by continuous infusion in a multicenter double-blind clinical trial for the initial treatment of patients with proximal vein thrombosis. Clinical outcomes were objectively documented. Six of 213 patients receiving low-molecular-weight heparin (2.8%) and 15 of 219 patients receiving intravenous heparin (6.9%) developed new episodes of venous thromboembolism (p = 0.07; 95% confidence interval for the difference, 0.02%-8.1%). During initial therapy, major bleeding occurred in one patient receiving low-molecular-weight heparin (0.5%) and in 11 patients receiving intravenous heparin (5.0%), a risk reduction of 91% (p = 0.006). This apparent protection against major bleeding was lost during long-term therapy. Minor bleeding complications were rare. During the period of the study, 10 patients receiving low-molecular-weight heparin (4.7%) died, as compared with 21 patients receiving intravenous heparin (9.6%), a risk reduction of 51%(p = 0.049). This study shows that low-molecular-weight heparin is at least as effective as classic intravenous heparin therapy and that there was a reduction in deaths and bleeding complications. Furthermore, low-molecular-weight heparin was more convenient to administer. The simplified therapy with low-molecular-weight heparin given by once-daily subcutaneous injection without monitoring may allow patients with uncomplicated proximal deep vein thrombosis to be cared for as outpatients. Key Words: Low-molecular-weight heparin—Unfractionated heparin—Deep vein thrombosis—Deaths—Bleeding complications.