A Randomised Open-Label Trial Comparing Long-term Sub-Cutaneous Low-Molecular-weight Heparin Compared with Oral-Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis

Objective: To evaluate whether low-molecular-weight heparin (LMWH) could be equally (or more) effective than oral anti-vitamin-K agents (AVK) in the long-term treatment of deep venous thrombosis (DVT). Design: A randomised, open-Label trial. Material and methods: In this trial, 241 patients with symptomatic proximal DVT of the tower limbs confirmed by duplex ultrasound scan were included. After initial LMWH, patients received 6 months of treatment with full therapeutic dosage of tinzaparin or acenocoumarol. The primary outcome was the 12-month incidence of symptomatic recurrent venous thromboembolism (VTE). Duplex scans were performed at 6 and 12 months. Results: During the 12-month period, six patients (5%) of 119 who received LMWH and 13 (10.7%) of 122 who received AVK had recurrent VTE (p = 0.11). In patients with cancer, recurrent VTE tended to be lower in the LMWH group (two of 36 [5.5%]) vs. seven of 33 [21.2%]; p = 0.06). One major bleeding occurred in the LMWH group and three in the AVK group. Venous re-canalisation increased significantly at 6 months (73.1% vs. 47.5%) and at 12 months (91.5% vs. 69.2%) in the LMWH group. Conclusions: Tinzaparin was more effective than AVK in achieving re-canalisation of leg thrombi. Long-term tinzaparin was at least as efficacious and safe as AVK for preventing recurrent VTE, especially in patients with cancer. Crown Copyright (C) 2008 Published by Elsevier Ltd on behalf of European Society for Vascular Surgery. All rights reserved.