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. European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery [Eur J Vasc Endovasc Surg] Journal article | | Title | 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. | | Author(s) | Romera A, Cairols MA, Vila-Coll R, Martí X, Colomé E, Bonell A, Lapiedra O | | Institution | Department of Vascular Surgery, Hospital Universitari de Bellvitge, Feixa Llarga, s/n 08907, LHospitalet de Llobregat, Barcelona, Spain. aromera@csub.scs.es | | Source | Eur J Vasc Endovasc Surg 2009 Mar; 37(3):349-56. | | MeSH | Acenocoumarol
Administration, Oral
Age Factors
Anticoagulants
Female
Fibrin Fibrinogen Degradation Products
Fibrinolytic Agents
Heparin, Low-Molecular-Weight
Humans
Injections, Subcutaneous
International Normalized Ratio
Male
Middle Aged
Neoplasms
Prospective Studies
Recurrence
Risk Factors
Ultrasonography, Doppler, Duplex
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. | | Language | eng | | Pub Type(s) | Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 19121589 |
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