TY - JOUR
TI - Long-term treatment of deep venous thrombosis with a low molecular
weight heparin (Tinzaparin): A prospective randomized trial
AU - Daskalopoulos, ME
AU - Daskalopoulou, SS
AU - Tzortzis, E
AU - Sfiridis, P
AU - and Nikolaou, A
AU - Dimitroulis, D
AU - Kakissis, I
AU - Liapis, CD
JO - European Journal of Vascular and Endovascular Surgery
PY - 2005
VL - 29
TODO - 6
SP - 638-650
PB - W B SAUNDERS CO LTD
SN - 1078-5884, 1532-2165
TODO - 10.1016/j.ejvs.2004.02.029
TODO - venous thromboembolism; low molecular weight heparin; oral
anticoagulants; duplex scanning; recanalization; reflux
TODO - Objectives. 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).
Design. Prospective, randomized clinical trial.
Material and methods. 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.
Results. 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 < 0.02). Thrombus regression was
equivalent or in favor of tinzaparin in the different DVT subgroups and
venous segments, but the statistical significance varied. Reflux showed
non-significant differences overall or in subgroups. A cost-analysis
resulted infavor of LMWH.
Conclusions. A fixed daily dose of tinzaparin for 6 months was at least
as effective and safe as UFH and acenocoumarol. Regarding major events
and recanalization, there was a significant benefit infavor of
tinzaparin. Long-term DVT treatment with tinzaparin could represent an
alternative to conventional treatment.
ER -