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.

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.

• Authors: A Romera, M A Cairols, R Vila-Coll, X Martí, E Colomé, A Bonell, O Lapiedra
• Journal: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery (Eur J Vasc Endovasc Surg) Vol. 37 Issue 3 Pg. 349-56 (Mar 2009) ISSN: 1532-2165 [Electronic] England
• PMID: 19121589 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anticoagulants
• Fibrin Fibrinogen Degradation Products
• Fibrinolytic Agents
• Heparin, Low-Molecular-Weight
• fibrin fragment D
• Tinzaparin
• Acenocoumarol

Topics

• Acenocoumarol (therapeutic use)
• Administration, Oral
• Age Factors
• Anticoagulants (therapeutic use)
• Female
• Fibrin Fibrinogen Degradation Products (analysis)
• Fibrinolytic Agents (therapeutic use)
• Heparin, Low-Molecular-Weight (therapeutic use)
• Humans
• Injections, Subcutaneous
• International Normalized Ratio
• Male
• Middle Aged
• Neoplasms (epidemiology)
• Prospective Studies
• Recurrence
• Risk Factors
• Tinzaparin
• Ultrasonography, Doppler, Duplex
• Venous Thrombosis (diagnostic imaging, drug therapy)