TY - JOUR
T1 - Real-life Use of Anticoagulants in Venous Thromboembolism With a Focus on Patients With Exclusion Criteria for Direct Oral Anticoagulants
AU - The Riete Investigators
AU - Moustafa, Farès
AU - Pesavento, Raffaele
AU - di Micco, Pierpaolo
AU - González-Martínez, José
AU - Quintavalla, Roberto
AU - Peris, Maria Luisa
AU - Porras, José Antonio
AU - Falvo, Nicolas
AU - Baños, Pilar
AU - Monreal, Manuel
AU - Adarraga, M. D.
AU - Aibar, M. A.
AU - Alfonso, M.
AU - Arcelus, J. I.
AU - Ballaz, A.
AU - Baños, P.
AU - Barba, R.
AU - Barrón, M.
AU - Barrón-Andrés, B.
AU - Bascuñana, J.
AU - Blanco-Molina, A.
AU - Camón, A. M.
AU - Chasco, L.
AU - del Pozo, R.
AU - de Miguel, J.
AU - del Toro, J.
AU - Díaz-Pedroche, M. C.
AU - Díaz-Peromingo, J. A.
AU - Falgá, C.
AU - Fernández-Aracil, C.
AU - Fernández-Capitán, C.
AU - Fidalgo, M. A.
AU - Font, C.
AU - Font, L.
AU - Gallego, P.
AU - García, M. A.
AU - García-Bragado, M. F.
AU - García-Morillo, M.
AU - Garcıa-Raso, A.
AU - Gavín, O.
AU - Gil, F.
AU - Gómez, C.
AU - Gómez, V.
AU - González, J.
AU - Grau, E.
AU - Grimón, A.
AU - Guijarro, R.
AU - Gutiérrez, J.
AU - Hernández-Comes, H.
AU - Hernández-Blasco, G.
N1 - Publisher Copyright:
© 2017 American Society for Clinical Pharmacology and Therapeutics
PY - 2018/4/1
Y1 - 2018/4/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85043466147&partnerID=8YFLogxK
U2 - 10.1002/cpt.781
DO - 10.1002/cpt.781
M3 - Article
C2 - 28675460
AN - SCOPUS:85043466147
SN - 0009-9236
VL - 103
SP - 684
EP - 691
JO - Clinical Pharmacology and Therapeutics
JF - Clinical Pharmacology and Therapeutics
IS - 4
ER -