Rivaroxaban or apixaban in fragile patients with acute venous thromboembolism. Issue 193 (September 2020)

• Record Type: Journal Article
• Authors: Trujillo-Santos, Javier; Beroiz, Patricia; Moustafa, Farès; Alonso, Alicia; Morejon, Estrella; López-Reyes, Raquel; Casado, Ignacio; Porras, José Antonio; Flores, Katia; López-Núñez, Juan J.; Monreal, Manuel
• Is Part Of: Thrombosis research. Issue 193(2020)
• Page Start: 160
• Page End: 165
• Publication Date: 2020-09
• Subjects: Fragile -- Venous thromboembolism -- Anticoagulant therapy -- Apixaban -- Rivaroxaban; Thrombosis -- Periodicals; 616.135
• DOI: 10.1016/j.thromres.2020.06.035
• Languages: English
• ISSNs: 0049-3848

Abstract

Abstract: Introduction: The efficacy and safety of the direct oral anticoagulants (DOACs) in fragile patients (age ≥ 75 years and/or creatinine clearance [CrCl] levels ≤50 mL/min and/or body weight ≤50kg) with venous thromboembolism (VTE) have not been consistently compared. Material and methods: We used the RIETE database to compare the rates of the composite of VTE recurrences or major bleeding during anticoagulation in fragile patients with VTE, according to the use of rivaroxaban or apixaban for initial and long-term therapy. Results: From January 2013 to October 2019, 36, 889 patients were recruited, of whom 14, 831 (40%) were fragile. Overall, 999 fragile patients (15%) received DOACs starting within the first 48 h: rivaroxaban 711 and apixaban 288. Median duration of therapy was: 113 vs. 111 days. A substantial amount of patients in both subgroups (25% vs. 40%) received non-recommended doses of DOACs. During anticoagulation, 13 patients developed VTE recurrences, 18 had major bleeding and 36 died. When only considering patients receiving recommended doses (n = 705), there were no differences between drugs in the rate of the composite outcome (rate ratio [RR]: 1.08; 95%CI: 0.35–3.30) or all-cause death (RR: 0.99; 95%CI: 0.32–3.08). On multivariable analysis, patients receiving rivaroxaban or apixaban at recommended doses had a similar risk for the composite outcome (hazard ratio: 1.34; 95%CI: 0.35–5.06). Conclusion: The use of rivaroxaban or apixaban at recommended doses in fragile patients with VTE was associated with a similar risk for VTE recurrences or major bleeding. Highlights: Fragile patients with VTE are at increased risk for bleeding during anticoagulation. The use of DOACs in fragile patients with VTE is associated with better outcomes than standard therapy. Rivaroxaban or apixaban at recommended doses was associated with a similar risk for VTE recurrences or major bleeding. A substantial amount of patients using DOACs were prescribed non-recommended doses.