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.

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

Dentali F.;
2018-01-01

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.
2018
Moustafa, F.; Pesavento, R.; di Micco, P.; Gonzalez-Martinez, J.; Quintavalla, R.; Peris, M. -L.; Porras, J. A.; Falvo, N.; Banos, P.; Monreal, M.; Ad...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11383/2123964
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