Table 2:
RCT of DOAC vs VKA in dialysis patients with AF.
| Study [Ref] | Design | Patients | Age | Intervention | Duration | Primary endpoint | Further endpoints (selection) | Mortality |
|---|---|---|---|---|---|---|---|---|
| VALKYRIE, 2020–2021 [2, 3] | Open label, N = 132 | Incident or prevalent, HD pat., CHA2DS2-VASc ≥2 (median 5) | 80 years (median) | VKA (INR 2–3; TTR 48% in Months 1–6) vs rivaroxaban 10 mg vs rivaroxaban 10 mg plus Menaquinone-7 (‘Riva + Vit K2’) | Median 1.88 years | Cardiovascular events including stroke: 63.8/100 PY (VKA), 26.2/100 PY (Riva), 21.4/100 PY (Riva + Vit K2)d | Life-threatening/severe bleeding, VKA: 17 pat. (30 events), Riva: 8 pat. (11 events), Riva + Vit K2: 9 pat. (12 events) | 33.7/100 PY (VKA), 28.3/100 PY (Riva), 30.2/100 PY (Riva + Vit K2) |
| RENAL-AF, 2022, [1] | Open label, N = 154 | Prevalent HD pat.c, CHA2DS2-VASc ≥2 | Median (IQR) 68 (61–75) years | VKA (INR 2–3; TTR 44 %) vs apixaban 5 mg bida | Median 330 days (apixaban) 340 days (VKA) | Major bleeding or CRNMB (ISTH definition), 31.5 1-year incidence (apixaban), 25.5 1-year incidence (VKA) (including intracranial bleeding: 1 pat. in both groups) | Ischemic stroke/systemic embolism, apixaban: 1 (1%), VKA: 2 (3%) | Apixaban: 21 (26%), VKA: 13 (18%) |
| AXADIA, 2023 [4] | Open label, N = 97 | Prevalent HD pat.b, CHA2DS2-VASc ≥2 (median 4.5) | 74.7 ± 7.9 years | VKA (INR 2–3; TTR 50.7%) vs apixaban 2.5 mg bid | Median 429 days (apixaban) 506 days (VKA) | All-cause death, major bleeding, CRNMB (ISTH definition), 36.1/100 PY (apixaban), 36.6/100 PY (VKA) | Thromboembolic events (AMI, ischemic stroke, all-cause death, VTE), apixaban 16.4/100 PY, VKA 22.0 PY | Apixaban 14.8/100 PY, VKA 17.6/100 PY |
Two times 2.5 mg for patients with target weight ≤60 kg and/or age ≥80 years.
bInitial target: 222 patients.
cInitial target: 760 patients.
In initial publication: primary endpoint: “Change of coronary artery calcification, thoracic aorta calcification, and PWV over 18 months.”
AMI: acute myocardial infarction; CRNMB: clinically relevant nonmajor bleeding; IQR: interquartile range; ISTH: International Society on Thrombosis and Hemostasis; PY: patient years; Riva: rivaroxaban; TIA: transient ischemic attack; TTR: time in therapeutic range; VALKYRIE: Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial; VTE: venous thromboembolism (deep vein thrombosis, pulmonary embolism).