title: Major bleedings in the comparisons between low-molecular weight heparin versus oral anticoagulant therapy for venous thromboembolism.
abstract: To evaluate the safety (major bleedings) of long-term treatment of symptomatic venous thromboembolism (VTE) using low molecular weight heparin (LMWH) compared with oral anticoagulant therapy (OAT) given for at least 3 months, we analyzed 10 randomized clinical trials enrolling a total of 2817 patients with objectively diagnosed symptomatic deep vein thrombosis, pulmonary embolism or both. The relative risk (RR, incidence of recurrent symptomatic VTE) was combined across the studies, using the inverse variance and the Mantel-Haenszel method. During treatment, major bleeding complications occurred in 2.8% of the patients in the LMWH arm versus 4% in the OAT arm: no statistically significant difference was observed (p=0.31). No differences in major bleeding were registered in the additional 3-9 months of follow-up (p=0.98). Long-term treatment with LMWH does not seem to be significantly safer than OAT. However, no conclusive interpretation from different studies with different designs is possible.
authors.affiliation: Department of Medical Oncology, Regina Elena Cancer Institute, Rome, Italy. gia.fer@flashnet.it
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Ferretti
authors.forename: Emilio
authors.initials: E
authors.lastname: Bria
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.forename: Paolo
authors.initials: P
authors.lastname: Carlini
authors.forename: Alessandra
authors.initials: A
authors.lastname: Felici
authors.forename: Mario
authors.initials: M
authors.lastname: Mandalà
authors.forename: Mariangela
authors.initials: M
authors.lastname: Ciccarese
authors.forename: Paola
authors.initials: P
authors.lastname: Papaldo
authors.forename: Alessandra
authors.initials: A
authors.lastname: Fabi
authors.forename: Francesco
authors.initials: F
authors.lastname: Cognetti
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D006470:Hemorrhage / Q000150:complications*; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D013923:Thromboembolism / Q000175:diagnosis / Q000188:drug therapy*; D013927:Thrombosis / Q000517:prevention & control*; D013997:Time Factors
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight