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

• Published in: European journal of vascular and endovascular surgery 2009-03, Vol.37 (3), p.349-356
• Main Authors: Romera, A, Cairols, M.A, Vila-Coll, R, Martí, X, Colomé, E, Bonell, A, Lapiedra, O
• Format: Article
• Language: English
• Subjects: Acenocoumarol - therapeutic use; Administration, Oral; Age Factors; Anticoagulants - therapeutic use; Duplex scan; Female; Fibrin Fibrinogen Degradation Products - analysis; Fibrinolytic Agents - therapeutic use; Heparin, Low-Molecular-Weight - therapeutic use; Humans; Injections, Subcutaneous; International Normalized Ratio; Long term; Low-molecular-weight heparin; Male; Middle Aged; Neoplasms - epidemiology; Prospective Studies; Recurrence; Risk Factors; Surgery; Ultrasonography, Doppler, Duplex; Venous thrombo-embolism; Venous Thrombosis - diagnostic imaging; Venous Thrombosis - drug therapy; Vitamin-K antagonist
• ISSN: 1078-5884; 1532-2165
• DOI: 10.1016/j.ejvs.2008.11.030

Abstract 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 lower 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 thrombo-embolism (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.