Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)

A Randomized Clinical Trial Comparing Three Anti-Thrombotic Strategies for Patients with Atrial Fibrillation and Severe Chronic Kidney Dysfunction

VISIONAIRE (Vitamin K AntagonISt, Factor Xa Inhibitor Or Nothing In Atrial Fibrillation And DIalytic End-stage Renal DiseasE) trial will be a prospective randomized open-label with blinded endpoint adjudication trial including 1500 patients with atrial fibrillation or atrial flutter and advanced chronic kidney disease

Inclusion Criteria:

• Patients with clinical atrial fibrillation or flutter (persistent, paroxysmal or permanent);
• CHA2DS2-Vasc ≥ 2 points (≥ 3 if female);
• Chronic kidney disease with estimated glomerular filtration rate (eGFR) ≤ 15 ml/min/1.73 m2 by the CKD-EPI equation (confirmed by two lab results at least 3 months apart) or on chronic renal replacement therapy (Of note: number of patients included in no renal replacement therapy stratum will be capped at around 30% from the total study population).

Exclusion Criteria:

• Active bleeding or severe bleeding < 1 month;
• Prior kidney transplantation;
• Refusal de provide consent
• Severe chronic liver disease (Child C);
• Other indication of oral anticoagulation (e.g.,: venous thromboembolism or pulmonary embolism);
• Prior intracranial hemorrhage;
• Bleeding disorder (other than uremia);
• Platelet count < 50,000 / mm3 ;
• Pregnancy or breastfeeding;
• Mechanical valvar prosthesis;
• Moderate to severe mitral stenosis;
• Need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an ADP receptor blocker;
• Any comorbidity beyond CKD and CV disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months.