Subjects undergoing major orthopedic surgery and acutely ill hospitalized medical patients represent a population at medium–high risk for venous thromboembolism (VTE). They are treated with low molecular weight heparin (LMWH) and direct oral anticoagulants [DOACs] for VTE prevention. We conducted a meta-analysis of phase III randomized clinical trials evaluating LMWH enoxaparin versus DOACs for prophylaxis of VTE by combining studies including patients undergoing elective total hip and knee replacement surgery, and acutely ill hospitalized medical subjects. Studies were searched using PubMed, MEDLINE, and EMBASE databases until December 2016. Differences in clinical outcomes for efficacy and safety endpoints between treatment groups were expressed as risk differences with 95% confidence intervals (95% CI), using random effects regression models. Fourteen RCTs were considered (60,467 subjects). Overall mortality, symptomatic deep venous thrombosis, non-fatal pulmonary embolism (PE) major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) are not different between treatment regimens. Treatment with LMWH enoxaparin is associated with a lower risk of fatal PE plus VTE-related death compared therapy with DOACs (RD = 0.040%, 95% CI 0.001–0.080%, p = 0.0434). Subgroup analysis shows an incidence of MB (RD = 0.181%, 95% CI 0.029–0.332%, p = 0.0033) and CRNMB (RD = 0.546%, 95% CI 0.009–1.082%, p = 0.0462) in patients treated with 40 mg OD enoxaparincompared to DOACs. In major orthopedic surgery and acutely ill hospitalized medical patients, DOACs do not offer clear advantages in terms of clinical efficacy compared to enoxaparin. The advantage of the latter in terms of major and CRNMB, when used at a dose of 40 mg, is statistically significant, but small in terms of clinical relevance

Thromboprophylaxis with enoxaparin and direct oral anticoagulants in major orthopedic surgery and acutely ill medical patients : a meta-analysis / C. Cimminiello, P. Prandoni, G. Agnelli, G. Di Minno, H. Polo Friz, F. Scaglione, P. Boracchi, G. Marano, J. Harenberg. - In: INTERNAL AND EMERGENCY MEDICINE. - ISSN 1828-0447. - (2017 Jul 29). [Epub ahead of print] [10.1007/s11739-017-1714-9]

Thromboprophylaxis with enoxaparin and direct oral anticoagulants in major orthopedic surgery and acutely ill medical patients : a meta-analysis

F. Scaglione;P. Boracchi;G. Marano
Penultimo
;
2017

Abstract

Subjects undergoing major orthopedic surgery and acutely ill hospitalized medical patients represent a population at medium–high risk for venous thromboembolism (VTE). They are treated with low molecular weight heparin (LMWH) and direct oral anticoagulants [DOACs] for VTE prevention. We conducted a meta-analysis of phase III randomized clinical trials evaluating LMWH enoxaparin versus DOACs for prophylaxis of VTE by combining studies including patients undergoing elective total hip and knee replacement surgery, and acutely ill hospitalized medical subjects. Studies were searched using PubMed, MEDLINE, and EMBASE databases until December 2016. Differences in clinical outcomes for efficacy and safety endpoints between treatment groups were expressed as risk differences with 95% confidence intervals (95% CI), using random effects regression models. Fourteen RCTs were considered (60,467 subjects). Overall mortality, symptomatic deep venous thrombosis, non-fatal pulmonary embolism (PE) major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) are not different between treatment regimens. Treatment with LMWH enoxaparin is associated with a lower risk of fatal PE plus VTE-related death compared therapy with DOACs (RD = 0.040%, 95% CI 0.001–0.080%, p = 0.0434). Subgroup analysis shows an incidence of MB (RD = 0.181%, 95% CI 0.029–0.332%, p = 0.0033) and CRNMB (RD = 0.546%, 95% CI 0.009–1.082%, p = 0.0462) in patients treated with 40 mg OD enoxaparincompared to DOACs. In major orthopedic surgery and acutely ill hospitalized medical patients, DOACs do not offer clear advantages in terms of clinical efficacy compared to enoxaparin. The advantage of the latter in terms of major and CRNMB, when used at a dose of 40 mg, is statistically significant, but small in terms of clinical relevance
anticoagulants; low molecular weight; heparin; venous thromboembolism; evidence-based practice; meta-analysis
Settore BIO/14 - Farmacologia
29-lug-2017
29-lug-2017
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/519605
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