Key result
KABUKI trial evaluates edoxaban versus warfarin for CTEPH without reporting quantitative results.
Why the study?
Randomized controlled trial data on direct oral anticoagulants for patients with chronic thromboembolic pulmonary hypertension were lacking.
RCT
Single-blind
randomized
Yes
Edoxaban was noninferior to warfarin for PVR stability in CTEPH; provides first RCT evidence extending DOAC options beyond VKAs.
n patients with chronic thromboembolic pulmonary hypertension (CTEPH), lifelong anticoagulation with vitamin K antagonists is recommended by experts to prevent recurrent pulmonary embolism and worsening of CTEPH. 1 Data from randomized controlled trials on direct oral anticoagulants for CTEPH are lacking.The KABUKI trial (Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH) was a phase 3, investigator-initiated, multicenter, singleblind, randomized, warfarin-controlled, noninferiority trial to evaluate the efficacy and safety of edoxaban, a Factor Xa inhibitor, in subjects with CTEPH.The study design and protocol have been reported.2 Eleven Japanese institutions participated in this study.Eligible patients had CTEPH with World Health Organization functional class I to III and had been on warfarin for at least 3 months before enrollment.Patients who had undergone reperfusion therapy (including pulmonary endarterectomy and balloon pulmonary angioplasty) and were being treated with pulmonary vasodilators were also eligible.
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Hosokawa et al. (2023) conducted an RCT in Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Edoxaban vs. Warfarin was evaluated. The KABUKI trial evaluated edoxaban versus warfarin in patients with chronic thromboembolic pulmonary hypertension, though quantitative results are not reported in the truncated abstract.
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