A strategy involving left atrial appendage occlusion (LAAO) at the same time as TAVR was noninferior to TAVR plus medical therapy for the primary composite endpoint of all-cause mortality, all stroke, and life-threatening and major bleeding in patients with severe aortic stenosis and atrial fibrillation (AFib), based on findings from the WATCH-TAVR trial presented Oct. 24 during TCT 2023 and simultaneously published in Circulation.

The study randomized 349 patients at 34 centers in the U.S. to receive either TAVR plus LAAO (n=177) or TAVR plus medical therapy (n=172). The mean age of participants was 81 years; the mean CHA₂DS₂-VASc and HAS-BLED scores were 4.9 and 3.0, respectively; and 85.4% of patients were taking anticoagulation and 71.3% patients were on antiplatelet therapy at baseline. Researchers noted that WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy until 6 months. Additionally, anticoagulation was based on treating physician preference for those patients randomized to TAVR plus medical therapy. The primary noninferiority endpoint was all-cause mortality, stroke and major bleeding at two years.

Results found 82.5% of patients in the TAVR plus LAAO group were on any antiplatelet therapy at two years, compared with 50.8% of patients in the TAVR plus medical therapy group. Additionally, 13.9% of those in the TAVR plus LAAO group were on any anticoagulation therapy at two years vs. 66.7% of patients in the TAVR plus medical therapy group. For the composite primary endpoint, TAVR plus LAAO was noninferior to TAVR plus medical therapy (22.7 vs. 27.3 events/100 patient years, respectively).

“Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AFib,” said Samir R. Kapadia, MBBS, FACC, et al. However, they added that “the increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AFib undergoing TAVR.” They also noted that the current study “did not capture costs following the index hospitalization including medications and rehospitalizations” and “does not account for differences between therapies beyond two years.”