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).


METHODS
A randomised, open-label trial.


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.
Romera
A
A
Department of Vascular Surgery, Hospital Universitari de Bellvitge, Feixa Llarga, s/n 08907, LHospitalet de Llobregat, Barcelona, Spain. aromera@csub.scs.es
Cairols
M A
MA
Vila-Coll
R
R
Martí
X
X
Colomé
E
E
Bonell
A
A
Lapiedra
O
O
D000074:Acenocoumarol / Q000627:therapeutic use*; D000284:Administration, Oral; D000367:Age Factors; D000925:Anticoagulants / Q000627:therapeutic use*; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D007279:Injections, Subcutaneous; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology; D011446:Prospective Studies; D012008:Recurrence; D012307:Risk Factors; D000078222:Tinzaparin; D018616:Ultrasonography, Doppler, Duplex; D020246:Venous Thrombosis / Q000000981:diagnostic imaging / Q000188:drug therapy*
D000925:Anticoagulants; D005338:Fibrin Fibrinogen Degradation Products; D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; C036309:fibrin fragment D; D000078222:Tinzaparin; D000074:Acenocoumarol