Extended treatment with edoxaban in cancer patients with venous thromboembolism: a post-hoc analysis of the Hokusai-VTE Cancer study.
J Thromb Haemost. 2019 Jul 04;:
Authors: Di Nisio M, van Es N, Carrier M, Wang TF, Garcia D, Segers A, Weitz J, Buller H, Raskob G
BACKGROUND: Patients with active cancer and venous thromboembolism (VTE) are at high risk of recurrence. Therefore, continued anticoagulant therapy beyond the initial 6 months is suggested in this patient population, but evidence supporting this approach is limited.
METHODS: The Hokusai VTE Cancer trial compared edoxaban with dalteparin for VTE treatment in patients with active cancer. This post-hoc analysis focused on the follow-up period from 6 to 12 months. The primary outcome was the composite of adjudicated first recurrent VTE or major bleeding. Secondary outcomes included recurrent VTE, major bleeding, and clinically relevant bleeding.
RESULTS: Of the 522 and 524 patients randomized to edoxaban or dalteparin, 294 (56%) received edoxaban and 273 (52%) received dalteparin for more than 6 months (median duration of 318 and 211 days, respectively). Between 6 and 12 months, the primary outcome during study treatment occurred in 7 patients (2.4%) in the edoxaban group and 6 patients (2.2%) in the dalteparin group (unadjusted hazard ratio 1.05; 95% CI, 0.36 to 3.05). Recurrent VTE occurred in 2 patients (0.7%) in the edoxaban group and in 3 patients (1.1%) in the dalteparin group, whereas major bleeding occurred in 5 (1.7%) and 3 patients (1.1%), respectively.
CONCLUSIONS: The rates of recurrent VTE or major bleeding are relatively low among patients with active cancer receiving extended anticoagulant therapy beyond 6 months. Extended treatment with oral edoxaban appears as effective and safe as subcutaneous dalteparin. This article is protected by copyright. All rights reserved.
PMID: 31271705 [PubMed - as supplied by publisher]