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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.

Author information

1
Department of Emergency, CHU Clermont-Ferrand, Université Clermont Auvergne, Clermont-Ferrand, France.
2
Department of Medicine-DIMED, 2nd Chair of Internal Medicine, University of Padua, Padua, Italy.
3
Department of Internal Medicine and Emergency Room, Ospedale Buon Consiglio Fatebenefratelli, Naples, Italy.
4
Department of Internal Medicine, ALTAHAIA, Xarxa Assistencial de Manresa, Barcelona, Spain.
5
Department of Medicine 3, Azienda Ospedaliera Universitaria, Parma, Italy.
6
Department of Internal Medicine, Consorcio Hospitalario Provincial de Castellón, Ceu Cardenal Herrera University, Castellón, Spain.
7
Department of Internal Medicine, Hospital Universitario Joan XXIII de Tarragona, Tarragona, Spain.
8
Department of Internal Medicine, CHU de Dijon, Hôpital du Bocage, Dijon, France.
9
Department of Internal Medicine, Hospital de Can Misses, Ibiza, Spain.
10
Department of Internal Medicine, Hospital Universitario Germans Trias i Pujol de Badalona, Barcelona, Universidad Católica de Murcia, Spain.

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.

PMID:
28675460
DOI:
10.1002/cpt.781

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