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.
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;
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;
The study population comprises adults with documented non-valvular atrial fibrillation who require stroke prevention therapy. Two distinct cohorts will be enrolled: Cohort 1 (LAAC group): Patients with non-valvular atrial fibrillation and elevated thromboembolic risk who have relative or absolute contraindications to long-term oral anticoagulation, history of bleeding complications on anticoagulation, or patient preference for a non-pharmacological stroke prevention strategy. These patients will undergo percutaneous left atrial appendage closure. Cohort 2 (Control group): Patients with non-valvular atrial fibrillation and elevated thromboembolic risk who are appropriate candidates for and willing to continue long-term standard-dose direct oral anticoagulant therapy. Both cohorts will be recruited from the same institution during the same time period to minimize selection bias related to temporal trends in clinical practice.
Cohort
Prospective
Left Atrial Appendage Closure
DevicePercutaneous left atrial appendage closure using Watchman FLX (Boston Scientific) or Amplatzer Amulet (Abbott) devices
Apixaban 2.5 mg BID
DrugReduced-dose apixaban 2.5 mg BID for 3 months post-LAAC, followed by complete withdrawal of antithrombotic therapy
Standard-dose DOAC
DrugStandard-dose DOAC therapy (e.g., apixaban 5 mg BID, rivaroxaban 20 mg daily, or other DOAC per physician discretion) continued for the duration of follow-up
Composite of major adverse events
Composite endpoint including: bleeding events (BARC type ≥3), all-cause death, ischemic stroke, systemic embolism, device-related thrombosis (DRT), and peri-device leak (\>3 mm)
Major bleeding events
Incidence of bleeding events classified as BARC type 3 or higher
All-cause mortality
Incidence of death from any cause
Ischemic stroke
Incidence of ischemic cerebrovascular events confirmed by imaging
Systemic embolism
Incidence of systemic embolic events excluding stroke
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