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Effect of Extended-Duration Thromboprophylaxis on Venous Thromboembolism and Major Bleeding Among Acutely Ill Hospitalized Medical Patients: A Bivariate Analysis.
J Thromb Haemost. 2017 Aug 01;:
Authors: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM
Abstract
BACKGROUND: Among acutely ill hospitalized medical patients, extended-duration thromboprophylaxis reduces venous thromboembolism (VTE), but some pharmacologic strategies have been associated with greater risks of major bleeding, thereby offsetting the net clinical benefit (NCB).
METHODS: To assess the risk-benefit profile of anticoagulation regimens, a previously described bivariate method that does not assume a linear risk-benefit tradeoff and can accommodate different margins for efficacy and safety was performed to simultaneously assess efficacy (symptomatic VTE) and safety (major bleeding) based on data from four randomized controlled trials of extended-duration (30 to 46 days) versus standard-duration (6 to 14 days) thromboprophylaxis among 28,227 patients (EXCLAIM, ADOPT, MAGELLAN, and APEX trials).
RESULTS: Extended thromboprophylaxis with full-dose betrixaban (80 mg once daily) was superior in efficacy and non-inferior in safety compared to standard-duration enoxaparin, and demonstrated a significantly favorable NCB with a risk difference of -0.51% (-0.89% to -0.10%) in the bivariate outcome. Extended enoxaparin was superior in efficacy and inferior in safety (bivariate outcome: 0.03% [-0.37% to 0.43%]), whereas apixaban and rivaroxaban were non-inferior in efficacy and inferior in safety (-0.20% [-0.49% to 0.17%] and 0.23% [-0.16% to 0.69%], respectively). Reduced-dose betrixaban did not show a significant difference in either efficacy or safety (0.41% [-0.85% to 1.94%]).
CONCLUSIONS: In a bivariate analysis that assumes non-linear risk-benefit tradeoffs, extended prophylaxis with full-dose betrixaban was favorable over standard-duration enoxaparin, while other regimens failed to simultaneously achieve both superiority and non-inferiority with respect to symptomatic VTE and major bleeding in the management of acutely ill hospitalized medical patients. This article is protected by copyright. All rights reserved.
PMID: 28762617 [PubMed - as supplied by publisher]