Photo Credit: Rasi Bhadramani
Edoxaban is not inferior to warfarin in preventing worsening pulmonary hemodynamics for patients with chronic thromboembolic pulmonary hypertension.
In patients with chronic thromboembolic pulmonary hypertension (CTEPH) who had received a re-perfusion treatment, edoxaban showed non-inferiority to warfarin for preventing the worsening of pulmonary hemodynamics. Also, symptomatic venous thromboembolism (VTE) and bleeding rates were comparably low in edoxaban receivers and warfarin-treated patients.
The multicentre, single-blind, non-inferiority, warfarin-controlled, phase 3 KABUKI trial (NCT04730037) compared edoxaban with warfarin in patients with CTEPH (n=74). Participants were randomized 1:1, and the primary endpoint was the week 48 pulmonary vascular resistance (PVR) ratio to baseline PVR. Kazuya Hosokawa, MD, PhD (Kyushu University, Japan), presented the results at AHA Scientific Sessions 2023.1
The PVR ratio was numerically in favor of edoxaban (treatment effect 0.92; 95% CI 0.82–1.03), reaching the non-inferiority threshold, which was an upper limit of the confidence interval of 1.19 (Pnon-inferiority<0.001). Clinically relevant bleeding occurred in 2.7% of the edoxaban-treated patients and 5.4% of the warfarin-treated patients (P=1.00). Finally, 1 serious adverse event (AE) was observed in the edoxaban arm, a case of worsening pulmonary hypertension, and 3 serious AEs were reported in the warfarin arm, being 1 tooth extraction, a hemorrhagic duodenal ulcer, and a case of urothelial transitional cell carcinoma.
Medical writing support was provided by Robert van den Heuvel.
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