Real-life use of anticoagulants in venous thromboembolism with focus on patients with exclusion criteria for direct oral anticoagulants.

Identifier:  imarina:2931427

Handle: https://hdl.handle.net/20.500.11797/imarina2931427

Authors:  Moustafa, Fares; Pesavento, Raffaele; di Micco, Pierpaolo; Gonzalez-Martinez, Jose; Quintavalla, Roberto; Peris, Maria-Luisa; Antonio Porras, Jose; Falvo, Nicolas; Banos, Pilar; Monreal, Manuel

Abstract:
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.© 2017 American Society for Clinical Pharmacology and Therapeutics.