In CHAMPION-AF, 3,000 patients with non-valvular AF were randomized to WATCHMAN FLX LAA closure or NOAC therapy. At 36 months, the device was noninferior for the primary efficacy endpoint (stroke, CV death, systemic embolism: 5.7% vs 4.8%; P<0.001 for noninferiority) and superior for non-procedural bleeding (45% reduction: 10.9% vs 19.0%; P<0.001). This contrasts with the negative CLOSURE-AF trial and establishes WATCHMAN FLX as the first LAA closure device to demonstrate noninferiority vs NOACs as first-line therapy.
New England Journal of Medicine, Ahead of Print.
