Device-based LAAC noninferior to NOAC therapy in AF patients

In the prevention of stroke in patients with atrial fibrillation (AF), device-based left atrial appendage closure (LAAC) compares favourably with non–vitamin K antagonist oral anticoagulant (NOAC) therapy, with the added advantage of reduced non–procedure-related bleeding, according to the CHAMPION-AF trial.

CHAMPION-AF included 3,000 AF patients (mean age 71.7 years, 31.9 percent female, mean CHA2DS2-VASc score 3.5) who were suitable candidates for anticoagulation. These patients were randomly assigned to either undergo device-based LAAC (device group, n=1,499) or receive NOAC therapy (anticoagulation group, n=1,501).

The primary efficacy endpoint of a composite of death from cardiovascular causes, stroke, or systemic embolism after 3 years of follow-up was tested for noninferiority. The prespecified noninferiority margin was 4.8 percentage points. On the other hand, the primary safety endpoint of non–procedure-related bleeding was tested for superiority.

At 3 years, the composite efficacy endpoint event had occurred more frequently in the device group than in the anticoagulation group (5.7 percent vs 4.8 percent; difference, 0.9 percentage points, 95 percent confidence interval [CI], −0.8 to 2.6), establishing the noninferiority of device-based LAAC (p<0.001).

The proportion of patients who had non–procedure-related bleeding was 10.9 percent in the device group vs 19 percent in the anticoagulation group, meeting the criteria for superiority (hazard ratio, 0.55, 95 percent CI, 0.45–0.67; p<0.001).