Can left atrial appendage closure challenge anticoagulation as the standard of care in atrial fibrillation?
Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with a high risk of cardioembolic stroke. Anticoagulation with NOACs is the standard treatment, although limited by bleeding risk. Percutaneous left atrial appendage closure is an alternative in patients with contraindications, but its role in those eligible for anticoagulation had not been clearly defined. The CHAMPION-AF study, a prospective, international, randomized trial conducted in 141 centers across 16 countries, was designed to answer a clinically impactful question: whether percutaneous left atrial appendage closure could directly compete with anticoagulation in patients eligible to receive it.
A total of 3,000 patients with non-valvular AF and increased stroke risk—defined as CHA₂DS₂-VASc ≥2 in men and ≥3 in women—were randomized 1:1 to left atrial appendage closure with the Watchman FLX device (n=1499) or treatment with an approved NOAC (n=1501). The mean age was 71.7±7.5 years, 31.9% were women, the mean CHA₂DS₂-VASc score was 3.5±1.3, and the HAS-BLED score was low (1.3±0.8), confirming that this was not a population selected for high bleeding risk.
In the device group, after the procedure, patients received for 3 months: NOAC plus aspirin (85%), NOAC monotherapy or dual antiplatelet therapy (12%), followed by single antiplatelet therapy with aspirin or a P2Y12 inhibitor. In the medical therapy group, all patients received a NOAC (the specific agent was not specified).
From a technical standpoint, procedural success was 98.8%, with a total procedure time of 37.6±20.7 minutes and a mean fluoroscopy time of 8.4±6.8 minutes. Periprocedural complication rates were low (stroke 0.1%, pericardial effusion 0.6%, major bleeding 0.4%), with no procedure-related mortality. During follow-up, device-related thrombus was detected at 4 months in 63 patients (4.8%), being clinically relevant in 24 (1.8%) and associated with stroke in 2 cases. Effective left atrial appendage closure (leak ≤3 mm) was achieved in 98.6%.
The primary efficacy endpoint (cardiovascular death, stroke, or systemic embolism) at 3 years occurred in 5.7% of the appendage closure group versus 4.8% in the NOAC group (absolute difference 0.9%; 95% CI −0.8 to 2.6), meeting the non-inferiority criterion (p<0.001). When analyzing individual components, cardiovascular death was identical in both groups (2.7% vs 2.7%, HR 1.01). Total stroke was more frequent in the device group (3.6% vs 2.5%; HR 1.46), mainly driven by ischemic stroke (3.2% vs 2.0%; HR 1.61), with no differences in hemorrhagic stroke (0.4% vs 0.4%). Systemic embolism was infrequent (<0.1% in both groups).
Regarding the safety endpoint, non-procedural bleeding occurred in 154 patients in the device group (10.9%) versus 260 patients in the anticoagulation group (19.0%), with a hazard ratio of 0.55 (95% CI 0.45–0.67; p<0.001), demonstrating superiority of left atrial appendage closure. This benefit was not driven by a reduction in major bleeding (5.1% vs 6.4%, HR 0.78), but by a reduction in non-major bleeding (7.0% vs 14.2%, HR 0.48).
Left atrial appendage closure: non-inferior to NOACs for embolic events with lower overall bleeding
In summary, CHAMPION-AF shows that left atrial appendage closure is non-inferior to NOAC anticoagulation for major embolic events and significantly reduces overall bleeding, mainly driven by non-major events, with a signal of increased ischemic stroke. These findings position left atrial appendage closure as a valid and competitive alternative in patients eligible for anticoagulation, within an individualized treatment strategy.
Título Original: Can Left Atrial Appendage Closure Challenge Anticoagulation as Standard Therapy in Atrial Fibrillation? Insights from CHAMPION-AF.
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