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Clin Pharmacol Ther. 2018 Apr;103(4):684-691. doi: 10.1002/cpt.781. Epub 2017 Aug 7.

Real-life Use of Anticoagulants in Venous Thromboembolism With a Focus on Patients With Exclusion Criteria for Direct Oral Anticoagulants.

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Department of Emergency, CHU Clermont-Ferrand, Université Clermont Auvergne, Clermont-Ferrand, France.
Department of Medicine-DIMED, 2nd Chair of Internal Medicine, University of Padua, Padua, Italy.
Department of Internal Medicine and Emergency Room, Ospedale Buon Consiglio Fatebenefratelli, Naples, Italy.
Department of Internal Medicine, ALTAHAIA, Xarxa Assistencial de Manresa, Barcelona, Spain.
Department of Medicine 3, Azienda Ospedaliera Universitaria, Parma, Italy.
Department of Internal Medicine, Consorcio Hospitalario Provincial de Castellón, Ceu Cardenal Herrera University, Castellón, Spain.
Department of Internal Medicine, Hospital Universitario Joan XXIII de Tarragona, Tarragona, Spain.
Department of Internal Medicine, CHU de Dijon, Hôpital du Bocage, Dijon, France.
Department of Internal Medicine, Hospital de Can Misses, Ibiza, Spain.
Department of Internal Medicine, Hospital Universitario Germans Trias i Pujol de Badalona, Barcelona, Universidad Católica de Murcia, Spain.


We assessed the real-life use of direct oral anticoagulants (DOACs) in patients with venous thromboembolism (VTE) and exclusion criteria for randomized trials. From 2013 to 2016, 3,578 of 18,853 patients (19%) had exclusion criteria. Irrespective of which anticoagulant was chosen, they had more VTE recurrences (hazard ratio (HR): 3.10; 95% confidence interval (CI): 2.47-3.88), major bleeds (HR: 4.10; 95% CI: 3.38-4.96), and deaths (HR: 9.47; 95% CI: 8.46-10.6) than those without exclusion criteria. During initial therapy, no patient with exclusion criteria on DOACs (n = 115) recurred, but those on rivaroxaban bled less often (adjusted HR: 0.18; 95% CI: 0.04-0.79) than those on unfractionated heparin (n = 224) and similar to those (n = 3,172) on low-molecular-weight (LMWH) heparin. For long-term therapy, patients on rivaroxaban (n = 151) had nonsignificantly fewer VTE recurrences (adjusted HR: 0.74; 95% CI: 0.08-1.32) and major bleeds (adjusted HR: 0.41; 95% CI: 0.15-1.15) than those on LMWH (n = 2,071). The efficacy and safety of DOACs were similar to standard therapy.


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