Optimum therapy for those with Atrial Fibrillation aFtEr Completing miTral valve repair surgery - The AFFECT trial
Patients with a history of atrial fibrillation undergoing mitral valve repair surgery for mitral regurgitation, requiring anti-coagulation after surgery
Intervention arm: Direct Oral Anti-Coagulants (DOACs) Participants allocated to the intervention arm will be prescribed any commercially available DOAC (e.g., apixaban, edoxaban, dabigatran, rivaroxaban). The DOACs are all oral medications and dosing should be prescribed in accordance with the label guidance. Control arm: Vitamin K Antagonists (VKAs) Participants allocated to the control arm will be prescribed any commercially available VKA (e.g., warfarin, phenindione, acenocoumarol). The VKAs are oral medications and dosing should be prescribed in accordance with the label guidance and local practice. Participants are required to remain on the allocated treatment arm for at least 12 months and the duration of their active participation in the study, which could be for up to 4 years. Participants will be followed up at 3 months and 12 months after their allocation, and thereafter annually for the duration of the trial. All participants should receive their randomised strategy medication before discharge and within 7 days of the date of index surgery. Once eligibility has been confirmed, randomisation will be undertaken by the research team using a validated web-based system. The randomisation system will use permuted random blocks of variable length and will allocate participants on a 1:1 ratio to either of the two arms. Randomisation will be stratified by (1) whether the participant has undergone any ablation surgery, (2) a participant’s stroke risk score, and (3) whether the participant has undergone any other concomitant surgery.
1. Adults aged 18 years old or over 2. Confirmed pre-op Atrial Fibrillation (AF) which should be persistent or permanent 3. Undergone Mitral Valve repair surgery* 4. Require prolonged anticoagulation after MVr surgery e.g. for permanent or persistent AF 5. Provided written informed consent
1. Received a mitral valve replacement or any other valve replacement. 2. Anticoagulation contraindicated 3. Already taking long-term anticoagulation unrelated to an atrial arrhythmia 4. Antiphospholipid syndrome with triple positive antibodies 5. Patients who are pregnant or breastfeeding at the time eligibility is confirmed. 6. Patients with severe renal impairment (defined as creatinine clearance <15 ml/min)