About this trial
This is a prospective, non-randomized, observational cohort study conducted at the FSBI "NMRC TPM" of the Ministry of Healthcare of the Russian Federation. Left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation for preventing cardioembolic events in patients with atrial fibrillation. However, the optimal post-procedural antithrombotic regimen following LAAC remains unclear, with no consensus on evidence-based therapy. Given current trends in cardiology favoring reduced-intensity antithrombotic strategies, this study aims to contribute to the evidence base by evaluating whether LAAC followed by reduced-dose apixaban (2.5 mg BID) for 3 months with subsequent complete withdrawal of antithrombotic therapy is superior to long-term standard-dose DOAC therapy in patients with non-valvular atrial fibrillation.
Eligibility criteria
Qualifiers
Age ≥18 years;
Documented nonvalvular AF (≥30 seconds on ECG within previous 12 months);
CHA2DS2-VASc score ≥3 for women and ≥2 for men;
Signed informed consent to participate in the study;
Disqualifiers
Active indication for anticoagulation OTHER than atrial fibrillation at the time of enrollment and/or the predicted/unpredicted occurrence of such indications during the entire study period (e.g., mechanical valve, acute VTE, recent PE requiring >3 months anticoagulation);
Inability to tolerate at least 3 months of apixaban therapy (for LAAC arm);
Indications for antiplatelet therapy or therapy with P2Y12 inhibitors at the time of inclusion and/or the predicted/unpredicted occurrence of such indications during the entire study period;
The presence of mechanical prosthetic heart valves, mitral stenosis of severe or moderate degree;
Trial design
Treatments tested in this trial
- Left Atrial Appendage Closure
- Apixaban 2.5 mg BID
- Standard-dose DOAC