https://doi.org/10.55788/c719228c
“Direct oral anticoagulants (DOACs) are first-line anticoagulants for the treatment of acute pulmonary embolism and the prevention of recurrent pulmonary embolism,” said Dr Kazuya Hosokawa (Kyushu University, Japan) [1,2]. “It has, however, not been established whether DOACs are safe and effective in patients with CTEPH.”
The multicentre, single-blind, non-inferiority, warfarin-controlled, phase 3 KABUKI trial (NCT04730037) compared edoxaban with warfarin in patients with CTEPH [2]. Participants (n=74) were randomised 1:1 and the primary endpoint was the ratio of pulmonary vascular resistance (PVR) at 48 weeks to the PVR at baseline.
The PVR ratio was non-inferior with 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 participants and in 5.4% of the warfarin-treated participants (P=1.00).
One serious adverse event was observed in the edoxaban arm, a case of worsening pulmonary hypertension, and 3 serious adverse events were reported in the warfarin arm, being 1 tooth extraction, a haemorrhagic duodenal ulcer, and a case of urothelial transitional cell carcinoma.
“The trial was not designed to assess the effects of edoxaban on clinical outcomes,” Dr Hosokawa mentioned as a study limitation. “Also, the small sample size and single-country design limit the generalisability of the findings.” According to Dr Teresa Carman (University Hospitals, OH, USA), a discussant of the trial, some questions remain: “Will DOACs do as well in patients prior to reperfusion or in patients with underlying chronic vascular changes?” she wondered. “And can we extrapolate these findings to patients with more severe WHO class III disease?” Further studies are needed to address these issues.
- Stevens SM, et al. Chest. 2021;160(6):e545–e608.
- 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, 11–13 November, Philadelphia, USA.
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Table of Contents: AHA 2023
Featured articles
Abelacimab substantially lowers bleeding risk compared with rivaroxaban
Hot Topics in CAD/PAD
MINT: Liberal or restrictive transfusion strategy in MI with anaemia?
ORBITA-2 confirms PCI effective for symptom relief in patients with stable angina
Nicotinamide riboside shows promising trend for walking function in PAD
Pemafibrate reduces microvascular complications of PAD and T2D
Dapagliflozin improves cardiometabolic outcomes in myocardial infarction
Optimising Hypertension Outcomes
Edoxaban versus warfarin in chronic thromboembolic pulmonary hypertension
Sodium intake and blood pressure: new insights
Post-partum intervention lowers BP after hypertensive pregnancy
Biannual zilebesiran associated with substantial BP reductions
Future of Lipid-Lowering Therapies
Encouraging data for lepodisiran as Lp(a) lowering therapy
Gene editing may change the treatment landscape of hypercholesterolaemia
REPRIEVE: Mechanisms behind MACE reduction in HIV population on pitavastatin
Recaticimab may offer a solution for uncontrolled hypercholesterolaemia
Atrial Fibrillation and Sudden Cardiac Death
Abelacimab substantially lowers bleeding risk compared with rivaroxaban
Liraglutide may improve post-ablation outcomes in obese patients with AF
Single or dual cardioversion in patients with obesity and AF?
NOAH-AFNET 6: Does the duration of AHRE influence response to edoxaban?
ARTESIA: How useful is anticoagulation in subclinical AF?
Jewel IDE: High compliance rates for novel patch wearable cardioverter defibrillator
Sudden cardiac death in athletes: incidence, causes, and trends over 20 years
Miscellaneous Trials
Successful results for semaglutide in the highly anticipated SELECT trial
Can a walking intervention improve functional status and quality of life in HFrEF?
Head-to-head: Surgical embolectomy versus ultrasound-assisted thrombolysis in high-risk pulmonary embolism
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