title: Efficacy and safety of extended thromboprophylaxis for medically ill patients. A meta-analysis of randomised controlled trials.
abstract: Compelling evidence suggests that the risk of pulmonary embolism (PE) and deep-vein thrombosis (DVT) persists after hospital discharge in acutely-ill medical patients. However, no studies consistently supported the routine use of extended-duration thromboprophylaxis (ET) in this setting. We performed a meta-analysis to assess efficacy and safety of ET in acutely-ill medical patients. Efficacy outcome was defined by the prevention of symptomatic DVT, PE, venous thromboembolism (VTE) and VTE-related mortality. Safety outcome was the occurrence of major bleeding (MB) and fatal bleeding (FB). Pooled odds ratios (ORs) and 95 % confidence intervals (95 %CI) were calculated for each outcome using a random effects model. Four RCTs for a total of 28,105 acutely-ill medical patients were included. ET was associated with a significantly lower risk of DVT (0.3 % vs 0.6 %, OR 0.504, 95 %CI: 0.287-0.885) and VTE (0.5 % vs 1.0 %, OR: 0.544, 95 %CI: 0.297-0.997); a non-significantly lower risk of PE (0.3 % vs 0.4 %, OR 0.633, 95 %CI: 0.388-1.034) and of VTE-related mortality (0.2 % vs 0.3 %, OR 0.687, 95 %CI: 0.445-1.059) and with a significantly higher risk of MB (0.8 % vs 0.4 %, OR 2.095, 95 %CI: 1.333-3.295). No difference in FB was found (0.06 % vs 0.03 %, OR 1.79, 95 %CI: 0.384-8.325). The risk benefit analysis showed that the NNT for DVT was 339, for VTE was 239, and the NNH for MB was 247. Results of our meta-analyses focused on clinical important outcomes did not support a general use of antithrombotic prophylaxis beyond the period of hospitalization in acutely-ill medical patients.
authors.affiliation: Francesco Dentali, MD, U. O. Medicina Interna, Ospedale di Circolo, Viale Borri 57, 21100 Varese, Italy, Tel.: +39 0332 278594, Fax: +39 0332 278229, E-mail: fdentali@libero.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Dentali
authors.forename: Nicola
authors.initials: N
authors.lastname: Mumoli
authors.forename: Domenico
authors.initials: D
authors.lastname: Prisco
authors.forename: Andrea
authors.initials: A
authors.lastname: Fontanella
authors.forename: Matteo Nicola Dario
authors.initials: MN
authors.lastname: Di Minno
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006470:Hemorrhage / Q000139:chemically induced / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011655:Pulmonary Embolism / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*
chemical_list: D005343:Fibrinolytic Agents
keywords: Pulmonary embolism; antithrombotic prophylaxis; deep-vein thrombosis