Late-breaking at ACC.26 with simultaneous NEJM publication; extensive ACC coverage, Boston Scientific press release, expert analyses noting 'uneasy win' due to numerical increase in ischemic stroke; high social buzz among electrophysiologists and interventionalists; multiple podcasts and threads debating first-line use (~40+ professional discussions post-ACC).
Device-based left atrial appendage closure was noninferior to NOAC therapy for cardiovascular death, stroke, or systemic embolism (difference 0.9%; 95% CI -0.8 to 2.6; P<0.001 for noninferiority).
RCT
1:1
Yes
Does device-based left atrial appendage closure prevent a composite of cardiovascular death, stroke, or systemic embolism compared to NOAC therapy in patients with atrial fibrillation who are suitable candidates for anticoagulation?
3000 patients with atrial fibrillation who were suitable candidates for anticoagulation, mean age 71.7±7.5 years, 31.9% women, mean CHA2DS2-VASc score 3.5±1.3, international.
Device-based left atrial appendage closure
Non-vitamin K antagonist oral anticoagulant (NOAC) therapy
Composite of death from cardiovascular causes, stroke, or systemic embolism at 3 years of follow-upcomposite
In patients with atrial fibrillation eligible for anticoagulation, device-based left atrial appendage closure was noninferior to NOAC therapy for preventing cardiovascular death, stroke, or systemic embolism, and superior for reducing 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.”
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Shephal K. Doshi
Saibal Kar
Devi G. Nair
New England Journal of Medicine
Massachusetts General Hospital
Duke University
Mayo Clinic
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Doshi et al. (Sat,) conducted a rct in Atrial fibrillation (n=3,000). Device-based left atrial appendage closure vs. Non-vitamin K antagonist oral anticoagulant (NOAC) therapy was evaluated on Composite of death from cardiovascular causes, stroke, or systemic embolism (Difference 0.9 percentage points, 95% CI -0.8 to 2.6, p=<0.001 for noninferiority). Device-based left atrial appendage closure was noninferior to NOAC therapy for cardiovascular death, stroke, or systemic embolism (difference 0.9%; 95% CI -0.8 to 2.6; P<0.001 for noninferiority).
www.synapsesocial.com/papers/69ccb55116edfba7beb8740e — DOI: https://doi.org/10.1056/nejmoa2517213
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