Edoxaban versus warfarin in CTEPH

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 haemodynamics. Also, symptomatic venous thromboembolism (VTE) and bleeding rates were comparably low in edoxaban receivers and in 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 randomised 1:1 and the primary endpoint was the ratio of week 48 pulmonary vascular resistance (PVR) to baseline PVR. Dr Kazuya Hosokawa (Kyushu University, Japan) presented the results [1].

The PVR ratio was numerically in favour 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 (P_{non-inferiority}<0.001). Clinically relevant bleeding occurred in 2.7% of the edoxaban-treated patients and in 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 haemorrhagic duodenal ulcer, and a case of urothelial transitional cell carcinoma.

1. Hosokawa K, et al. A multicenter, randomised, warfarin-controlled trial of edoxaban in patients with chronic thromboembolic pulmonary hypertension: KABUKI trial. FS07, AHA Scientific Sessions 2023, 10–12 November, Philadelphia, PA, USA.

 

Medical writing support was provided by Robert van den Heuvel.

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Posted on 17 November, 202317 November, 2023