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

Moustafa, F.; Pesavento, R.; di Micco, P.; Gonzalez-Martinez, J.; Quintavalla, R.; Peris, M. -L.; Porras, J. A.; Falvo, N.; Banos, P.; Monreal, M.; Adarraga, M. D.; Aibar, M. A.; Alfonso, M.; Arcelus, J. I.; Ballaz, A.; Banos, P.; Barba, R.; Barron, M.; Barron-Andres, B.; Bascunana, J.; Blanco-Molina, A.; Camon, A. M.; Chasco, L.; del Pozo, R.; de Miguel, J.; del Toro, J.; Diaz-Pedroche, M. C.; Diaz-Peromingo, J. A.; Falga, C.; Fernandez-Aracil, C.; Fernandez-Capitan, C.; Fidalgo, M. A.; Font, C.; Font, L.; Gallego, P.; Garcia, M. A.; Garcia-Bragado, M. F.; Garcia-Morillo, M.; Garcia-Raso, A.; Gavin, O.; Gil, F.; Gomez, C.; Gomez, V.; Gonzalez, J.; Grau, E.; Grimon, A.; Guijarro, R.; Gutierrez, J.; Hernandez-Comes, H.; Hernandez-Blasco, G.; Hernando, E.; Jara-Palomares, L.; Jaras, M. J.; Jimenez, D.; Joya, M. D.; Llamas, P.; Lobo, J. L.; Lopez-Jimenez, L.; Lopez-Reyes, R.; Lopez-Saez, J. B.; Lorente, M. A.; Lorenzo, A.; Lumbierres, M.; Madridano, O.; Maestre, A.; Marchena, P. J.; Martin-Asenjo, M.; Martin-Martos, F.; Martin-Romero, M.; Miralles, M.; Monreal, M.; Morales, M. V.; Moya, E. M.; Munoz, C.; Nieto, J. A.; Nieto, S.; Nunez, A.; Nunez, M. J.; Odriozola, M.; Otalora, S.; Otero, R.; Pedrajas, J. M.; Pellejero, G.; Perez-Ductor, C.; Peris, M. L.; Pons, I.; Porras, J. A.; Ramirez, L.; Riera-Mestre, A.; Riesco, D.; Rivas, A.; Rodriguez, M.; Rodriguez-Davila, M. A.; Rosa, V.; Rosillo-Hernandez, E. M.; Ruiz-Artacho, P.; Sahuquillo, J. C.; Sala-Sainz, M. C.; Samperiz, A.; Sanchez-Martinez, R.; Soler, S.; Surinach, J. M.; Tolosa, C.; Torres, M. I.; Trujillo-Santos, J.; Uresandi, F.; Usandizaga, E.; Valero, B.; Valle, R.; Vela, J.; Vela, L.; Vidal, G.; Villalobos, A.; Vanassche, T.; Verhamme, P.; Yoo, H. H. B.; Wells, P.; Hirmerova, J.; Maly, R.; Salgado, E.; Bertoletti, L.; Bura-Riviere, A.; Falvo, N.; Farge-Bancel, D.; Hij, A.; Mahe, I.; Merah, A.; Moustafa, F.; Quere, I.; Braester, A.; Brenner, B.; Ellis, M.; Tzoran, I.; Andriulli, M.; Antonucci, G.; Barillari, G.; Bortoluzzi, C.; Brandolin, B.; Bucherini, E.; Cattabiani, C.; Ciammaichella, M.; Dentali, F.; Di Micco, P.; Duce, R.; Giorgipierfranceschi, M.; Grandone, E.; Imbalzano, E.; Lessiani, G.; Maida, R.; Mastroiacovo, D.; Pace, F.; Pesavento, R.; Pinelli, M.; Poggio, R.; Prandoni, P.; Quintavalla, R.; Rocci, A.; Siniscalchi, C.; Tiraferri, E.; Visona, A.; Zalunardo, B.; Gibietis, V.; Skride, A.; Vitola, B.; Zdraveska, M.; Bounameaux, H.; Mazzolai, L.

doi:10.1002/cpt.781

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.