Left atrial appendage closure was noninferior to DOACs for preventing major cardiovascular, neurological, and bleeding events (sHR 0.84; 95% CI 0.53-1.31; p=0.004 for noninferiority).
RCT (n=402)
Yes
Does percutaneous left atrial appendage closure (LAAC) prevent major cardiovascular, neurological, and bleeding events compared to direct oral anticoagulants (DOACs) in high-risk patients with nonvalvular atrial fibrillation?
In high-risk patients with nonvalvular atrial fibrillation, percutaneous left atrial appendage closure was noninferior to direct oral anticoagulants for preventing major cardiovascular, neurological, and bleeding events.
Effect estimate: sHR 0.84 (95% CI 0.53-1.31)
Absolute Event Rate: 10.99% vs 13.42%
p-value: p=0.004 for noninferiority
BACKGROUND Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio sHR: 0.84; 95% confidence interval CI: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation PRAGUE-17; NCT02426944).
“From a clinical perspective, CLOSURE-AF reinforces the importance of careful patient selection for LAAO and highlights the continued central role of DOAC therapy in eligible patients.”
Osmančík et al. (Mon,) conducted a rct in Atrial Fibrillation (n=402). Left atrial appendage closure (LAAC) vs. Direct oral anticoagulants (DOACs) was evaluated on stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications (sHR 0.84, 95% CI 0.53-1.31, p=0.004 for noninferiority). Left atrial appendage closure was noninferior to DOACs for preventing major cardiovascular, neurological, and bleeding events (sHR 0.84; 95% CI 0.53-1.31; p=0.004 for noninferiority).