Edoxaban use in patients with acute VTE in South Korea and Taiwan demonstrated an overall annual VTE recurrence rate of 3.9%/y over 12 months.
Observational (n=277)
Yes
Does edoxaban prevent recurrent VTE and maintain safety in patients with acute VTE in a real-world setting?
In a real-world registry of patients from South Korea and Taiwan, edoxaban demonstrated low 12-month VTE recurrence and major bleeding rates, consistent with previous randomized controlled trials.
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. 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. Of 352 patients enrolled, 277 met inclusion criteria for the 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. Rates of VTE recurrence, bleeding complications, and deaths in patients from South Korea and Taiwan were low and consistent with RCTs. • Edoxaban is effective in preventing recurrent VTE in a real-world setting • Low 12-month VTE recurrence rates were reported from South Korea and Taiwan • ETNA-VTE-KOR-TWN supports the favourable risk-benefit profile for edoxaban • The findings of this study align with previous reports from RCTs
Choi et al. (Wed,) conducted a observational in acute venous thromboembolism (VTE) (n=277). edoxaban was evaluated on VTE recurrence. Edoxaban use in patients with acute VTE in South Korea and Taiwan demonstrated an overall annual VTE recurrence rate of 3.9%/y over 12 months.