One year prognosis in venous thromboembolism patients treated with direct oral anticoagulants versus standard anticoagulation: Outcomes from the REMOTEV registry

Abstract

In phase 3 clinical trials, direct oral anticoagulants (DOACs) as compared to standard anticoagulation (SACO) showed non-inferiority in terms of efficacy (venous thromboembolism (VTE) recurrence, all-cause death) and significantly reduced major bleeding risk. However, real-life studies remain of paramount importance when extending this observation to the general population. This study aimed to provide safety and efficacy data of DOACs use in routine patient care in a non-selected symptomatic VTE population, from the REMOTEV registry. REMOTEV is a prospective, non-interventional study of patients with acute symptomatic VTE, treated with DOACs (rivaroxaban or apixaban) or SACO (vitamin K antagonists or low molecular weight heparin alone) for at least 3 months with a follow-up of 1 year for VTE recurrence, death and bleeding complications. Patients with active cancer were excluded. From October 23rd, 2013 to December 15th, 2017, among 1159 consecutive patients included in REMOTEV, 908 were cancer-free and had completed the follow-up of 12 months or until death occurred. Among them, 905 received an anticoagulant treatment with DOAC ( n = 724, 80%) or SACO ( n = 181, 20%). The median age was 68 (51–79, 25th–75th percentiles), 88% had PE with (62%) or without (26%) deep vein thrombosis. The major bleeding, VTE recurrence and all-cause death rates were of 3.2%, 3.8%, 4.4% in the DOAC group and, respectively, of 6.6%, 5.5% and 12.1% in the SACO group. Major bleeding (HR 0.47 [95% CI, 0.24–0.94], P < 0.05), all-cause death (HR 0.36 [95% CI, 0.21–0.61], P < 0.001) and the composite of recurrent VTE, major bleeding and all-cause mortality (HR 0.52 [95% CI, 0.36–0.75], P < 0.001), but not VTE recurrence (HR 0.70 [95% CI, 0.34–1.41], P = 0.32) were significantly lower in the DOAC group compared to the SACO group ( Fig. 1 ). In REMOTEV, DOAC treatment was associated with a lower risk of major bleeding and all-cause death after 1-year follow-up.