Abstract
Background: The PROTECT AF study demonstrated that LAA closure with the WATCHMAN device was non-inferior to Warfarin for preventing stroke in non-valvular atrial fibrillation (NV AF) patients; however the last available data presented on device patients were on 1026 patient years of follow-up. Long term 5 year data is available on patients from the randomized study (PROTECT AF) and the CAP registry and taken together constitute the largest cohort of long term follow-up for a LAA closure device. Methods: Roll-in and randomized device patients in the PROTECT AF trial and enrolled patients in the CAP Registry were compared and data were combined for the following outcomes: the composite primary efficacy endpoint (stroke, systemic embolism, and cardiovascular/unknown death), stroke, all-cause mortality and cardiovascular death. The event rates are presented per 100 patient-years of follow-up with 95% confidence intervals for the intent-to-treat group. Results: There were 93 device roll-in patients and 463 patients randomized in the PROTECT AF study and 566 device patients enrolled in CAP Registry. For the combined cohort of 1122 patients, average follow-up was 3.1 years (range = 0 to 6.5 years) with an aggregate 3503 patient-years of follow-up. The average CHADS2 score was 2.3±1.2. The overall rate (95% CI) of the composite efficacy endpoint was 2.21 (1.62, 2.95) in PROTECT AF, 1.96 (1.28, 2.87) in CAP, and the combined study rate was 2.11 (1.65, 2.66). The overall rate of stroke was 1.44 (0.97, 2.05) and 1.13 (0.63, 1.86) respectively for the studies, with a combined study rate of 1.32 (0.96, 1.76). The all-cause mortality rate was 2.88 (2.21, 3.69) and 3.78 (2.81, 4.97) respectively, with a combined study rate of 3.23 (2.66, 3.88). However, the cardiovascular death rate was 0.88 (0.53, 1.38) and 0.81 (0.41, 1.46), respectively, with a combined study rate of 0.86 (0.58, 1.22). Conclusion: Long-term results of the WATCHMAN device with 3503 patient-years of exposure confirm durable efficacy with low rates of stroke, systemic embolism and cardiovascular death. LAA closure with WATCHMAN is an efficacious alternative to long-term anticoagulation for patients with NV AF requiring protection from thromboembolism.
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