Long-term Treatment of Deep Venous Thrombosis with a Low Molecular Weight Heparin (Tinzaparin): A Prospective Randomized Trial

Evaluation of the effectiveness and safety of the low molecular weight heparin (LMWH) tinzaparin versus unfractionated heparin (UFH) followed by acenocoumarol in proximal deep venous thrombosis (DVT). Prospective, randomized clinical trial. Consecutive patients ( n=108) with acute leg DVT, confirmed...

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Bibliographic Details
Published in:European journal of vascular and endovascular surgery 2005-06, Vol.29 (6), p.638-650
Main Authors: Daskalopoulos, M.E., Daskalopoulou, S.S., Tzortzis, E., Sfiridis, P., Nikolaou, A., Dimitroulis, D., Kakissis, I., Liapis, C.D.
Format: Article
Language:English
Subjects:
Acenocoumarol - administration & dosage
Acenocoumarol - adverse effects
Administration, Oral
Adult
Aged
Aged, 80 and over
Drug Therapy, Combination
Duplex scanning
Female
Follow-Up Studies
Heparin - administration & dosage
Heparin - adverse effects
Heparin, Low-Molecular-Weight - administration & dosage
Heparin, Low-Molecular-Weight - adverse effects
Humans
Infusions, Intravenous
Injections, Subcutaneous
Long-Term Care
Low molecular weight heparin
Male
Middle Aged
Oral anticoagulants
Partial Thromboplastin Time
Pulmonary Embolism - diagnostic imaging
Pulmonary Embolism - drug therapy
Recanalization
Recurrence
Reflux
Ultrasonography, Doppler, Duplex
Vascular Patency - drug effects
Venous thromboembolism
Venous Thrombosis - diagnostic imaging
Venous Thrombosis - drug therapy
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Summary:Evaluation of the effectiveness and safety of the low molecular weight heparin (LMWH) tinzaparin versus unfractionated heparin (UFH) followed by acenocoumarol in proximal deep venous thrombosis (DVT). Prospective, randomized clinical trial. Consecutive patients ( n=108) with acute leg DVT, confirmed by duplex, were randomized to either tinzaparin alone or UFH and acenocoumarol for 6 months. Patients were evaluated ultrasonographically at entry, 1, 3, 6 and 12 months. Thrombus regression, reflux distribution and the incidence of complications were studied. A cost-analysis, comparing the two treatments, was performed. The overall incidence of major events (mortality, DVT recurrence, pulmonary embolism, major bleeding, heparin-induced thrombocytopenia) was significantly different ( p=0.035) in favor of tinzaparin (7 versus 17 events). The ultrasonographic clot volume score (an index of recanalization) decreased significantly in both treatment groups. However, tinzaparin produced significantly more extended overall recanalization from 3 months onwards ( p
ISSN:1078-5884
1532-2165
DOI:10.1016/j.ejvs.2004.02.029