PMID- 15878544 OWN - NLM STAT- MEDLINE DCOM- 20050623 LR - 20220408 IS - 1078-5884 (Print) IS - 1078-5884 (Linking) VI - 29 IP - 6 DP - 2005 Jun TI - Long-term treatment of deep venous thrombosis with a low molecular weight heparin (tinzaparin): a prospective randomized trial. PG - 638-50 AB - 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 in favor 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 in favor of tinzaparin. Long-term DVT treatment with tinzaparin could represent an alternative to conventional treatment. FAU - Daskalopoulos, M E AU - Daskalopoulos ME AD - Department of Vascular Surgery, Athens University Medical School, Athens, Greece. FAU - Daskalopoulou, S S AU - Daskalopoulou SS FAU - Tzortzis, E AU - Tzortzis E FAU - Sfiridis, P AU - Sfiridis P FAU - Nikolaou, A AU - Nikolaou A FAU - Dimitroulis, D AU - Dimitroulis D FAU - Kakissis, I AU - Kakissis I FAU - Liapis, C D AU - Liapis CD LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20050331 PL - England TA - Eur J Vasc Endovasc Surg JT - European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery JID - 9512728 RN - 0 (Heparin, Low-Molecular-Weight) RN - 7UQ7X4Y489 (Tinzaparin) RN - 9005-49-6 (Heparin) RN - I6WP63U32H (Acenocoumarol) SB - IM CIN - Eur J Vasc Endovasc Surg. 2007 Sep;34(3):353-4. PMID: 17574456 MH - Acenocoumarol/administration & dosage/adverse effects MH - Administration, Oral MH - Adult MH - Aged MH - Aged, 80 and over MH - Drug Therapy, Combination MH - Female MH - Follow-Up Studies MH - Heparin/administration & dosage/adverse effects MH - Heparin, Low-Molecular-Weight/*administration & dosage/adverse effects MH - Humans MH - Infusions, Intravenous MH - Injections, Subcutaneous MH - Long-Term Care MH - Male MH - Middle Aged MH - Partial Thromboplastin Time MH - Pulmonary Embolism/diagnostic imaging/drug therapy MH - Recurrence MH - Tinzaparin MH - Ultrasonography, Doppler, Duplex MH - Vascular Patency/drug effects MH - Venous Thrombosis/diagnostic imaging/*drug therapy EDAT- 2005/05/10 09:00 MHDA- 2005/06/24 09:00 CRDT- 2005/05/10 09:00 PHST- 2003/08/19 00:00 [received] PHST- 2004/02/05 00:00 [accepted] PHST- 2005/05/10 09:00 [pubmed] PHST- 2005/06/24 09:00 [medline] PHST- 2005/05/10 09:00 [entrez] AID - S1078-5884(05)00067-5 [pii] AID - 10.1016/j.ejvs.2004.02.029 [doi] PST - ppublish SO - Eur J Vasc Endovasc Surg. 2005 Jun;29(6):638-50. doi: 10.1016/j.ejvs.2004.02.029. Epub 2005 Mar 31.