This randomized study was designed to compare two antithrombotic regimens (long-term half-dose apixaban vs long-term aspirin after 45-days of full-dose apixaban) after successful Watchman implantation.
• Men and women ≥18 years of age;
Patients who underwent a clinically successful LAA closure procedure with a Watchman device (device implanted without procedural or bleeding complication) within a day or are scheduled to undergo the LAAO procedure
Paroxysmal, persistent, or permanent AF patients irrespective of prior antithrombotic treatment are eligible for randomization,
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Two or more clinical characteristics at baseline (age≥80 years, body weight ≤60 kg, serum creatinine ≥1.5 mg/dL) requiring apixaban dosage adjustment;
Mechanical heart valves or valvular disease requiring surgery or interventional procedure;
Mandatory indication for dual antiplatelet therapy (e.g. recent stent) or single anti-platelet treatment (SAPT) (e.g. high coronary risk);
Any contra-indication or known allergy to aspirin or clopidogrel or apixaban;
Parallel
Half-Dose of novel OAC
DrugPatients randomized to long-term half-dose apixaban (Group hdNOAC) will receive half-dose (2.5mg BID) apixaban monotherapy throughout the study period
Low-dose ASA
DrugIn the low-dose ASA group, patients will receive full-dose of apixaban for 45 days followed by the low-dose aspirin
Composite endpoint of DRT, TE and major bleeding events
Composite endpoint of device-related thrombosis, TE and major bleeding events
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