Device-based left atrial appendage closure was noninferior to NOAC therapy for cardiovascular death, stroke, or systemic embolism and superior for non-procedure-related bleeding at 3 years.
RCT
Does device-based left atrial appendage closure reduce a composite of death from cardiovascular causes, stroke, or systemic embolism compared to NOAC therapy in patients with atrial fibrillation who are candidates for anticoagulation?
Device-based left atrial appendage closure is a noninferior alternative to NOAC therapy for stroke prevention in atrial fibrillation, offering superior protection against non-procedure-related bleeding at 3 years.
BACKGROUND: For patients with atrial fibrillation, the use of oral anticoagulant therapy to prevent stroke is limited by the risk of bleeding. Left atrial appendage closure is considered for patients who are unsuitable candidates for long-term anticoagulation, but its role in patients who are eligible for anticoagulants has not been established. METHODS: In this ongoing, prospective, international, randomized trial involving patients with atrial fibrillation who were suitable candidates for anticoagulation, we randomly assigned patients in a 1:1 ratio to receive either device-based left atrial appendage closure (device group) or non-vitamin K antagonist oral anticoagulant (NOAC) therapy (anticoagulation group). The primary efficacy end point - a composite of death from cardiovascular causes, stroke, or systemic embolism - was tested for noninferiority (noninferiority margin, 4.8 percentage points) after 3 years of follow-up. The primary safety end point, non-procedure-related bleeding, was tested for superiority. RESULTS: Of the 3000 patients who underwent randomization, 1499 were assigned to the device group and 1501 to the anticoagulation group. The mean (±SD) age of the patients was 71.7±7.5 years, 31.9% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3. At 3 years, a primary efficacy end-point event had occurred in 81 patients (Kaplan-Meier estimate, 5.7%) in the device group and in 65 patients (Kaplan-Meier estimate, 4.8%) in the anticoagulation group (difference, 0.9 percentage points; 95% confidence interval CI, -0.8 to 2.6; P<0.001 for noninferiority). Non-procedure-related bleeding occurred in 154 patients (Kaplan-Meier estimate, 10.9%) in the device group and in 260 patients (Kaplan-Meier estimate, 19.0%) in the anticoagulation group (hazard ratio, 0.55; 95% CI, 0.45 to 0.67; P<0.001 for superiority). CONCLUSIONS: Among patients with atrial fibrillation who were candidates for anticoagulation, device-based left atrial appendage closure was noninferior to NOAC therapy with respect to a composite of death from cardiovascular causes, stroke, or systemic embolism and was superior to NOAC therapy for non-procedure-related bleeding at 3 years. (Funded by Boston Scientific; CHAMPION-AF ClinicalTrials.gov number, NCT04394546.).
“In patients with nonvalvular atrial fibrillation suitable for anticoagulation, left atrial appendage closure using the Watchman FLX device, at 3 years was noninferior to NOACs for the composite primary endpoint [of] cardiovascular death, stroke, and systemic embolization, and significantly reduced clinically relevant nonprocedural bleeding.”
Major ACC.26 LBCT with extensive coverage (NEJM publication, Boston Scientific press release, 600+ X discussions); expert debate on stroke signal and generalizability; sustained interest in device vs drug strategy for AF.
Doshi et al. (Sat,) conducted a rct in Atrial fibrillation. Device-based left atrial appendage closure vs. NOAC therapy was evaluated on Composite of death from cardiovascular causes, stroke, or systemic embolism. Device-based left atrial appendage closure was noninferior to NOAC therapy for cardiovascular death, stroke, or systemic embolism and superior for non-procedure-related bleeding at 3 years.