The ETNA-VTE-KOR-TWN study: Real-world outcomes of edoxaban use in patients with venous thromboembolism in South Korea and Taiwan

Abstract

Introduction Long-term (>6 months), real-world evidence on the effectiveness and safety of edoxaban for venous thromboembolism (VTE) management including data from South Korea and Taiwan remain limited. The global ETNA-VTE programme evaluated real-world outcomes of edoxaban-treated patients. Materials and methods ETNA-VTE-KOR-TWN was a multi-centre (20-site), prospective, observational, non-interventional, single-arm registry study (NCT02952599) evaluating edoxaban in patients with acute VTE (initial/recurrent), followed up for 12 months. Effectiveness outcomes—including VTE recurrence—safety, bleeding events, and hospitalisations were analysed and annualised rates (%/year) reported. Results Of 352 patients enrolled, 277 met inclusion criteria for the full analysis set (FAS) (Taiwan: 119/277 [43.0%]; South Korea: 158/277 [57.0%]). The most prevalent index VTE was pulmonary embolism (n = 133), followed by deep vein thrombosis (n = 89) and both (n = 55). Most patients received the 60-mg dose (67.1%), and these patients were younger (median age, 65 vs 76 years), with higher body weight (mean, 71.2 vs 58.3 kg) vs the 30-mg group. The overall annual VTE recurrence rate was 3.9%/y: it was 2.5%/y vs 6.9%/y in the 60-mg vs 30-mg group. None of the all-cause deaths (n = 21) in the overall analysis were due to VTE. Hospitalisations due to cardiovascular-related events occurred in 25/277 patients (11.3%/y). Ischaemic/haemorrhagic stroke occurred in 2/277 patients (0.9%/y); overall bleeding events occurred in 29/277 patients (13.4%/y); and major bleeding events occurred in 3/277 patients (1.3%/y) in the overall analysis. The effectiveness and safety of edoxaban should be interpreted with caution due to the lack of a direct comparator arm including other oral anticoagulants. Conclusions Rates of VTE recurrence, bleeding complications, and deaths in patients from South Korea and Taiwan were low and consistent with those in randomised controlled trials (RCTs).