Left atrial appendage closure with the Watchman device resulted in similar rates of all-cause stroke or systemic embolism compared to warfarin (HR 1.02; 95% CI 0.62-1.7; p=0.94).
Meta-Analysis (n=2,406)
Yes
Does left atrial appendage closure (LAAC) with the Watchman device reduce stroke, systemic embolism, and cardiovascular death in patients with nonvalvular atrial fibrillation compared to warfarin?
In patients with nonvalvular atrial fibrillation, LAAC with the Watchman device provides similar overall stroke prevention to warfarin but significantly reduces hemorrhagic stroke, cardiovascular death, and nonprocedural bleeding.
Hazard Ratio: 1.02 (95% CI 0.62–1.7)
Absolute Event Rate: 1.75% vs 1.87%
p-value: p=0.94
BACKGROUND: The risk-benefit ratio of left atrial appendage closure (LAAC) versus systemic therapy (warfarin) for prevention of stroke, systemic embolism, and cardiovascular death in nonvalvular atrial fibrillation (NVAF) requires continued evaluation. OBJECTIVES: This study sought to assess composite data regarding left atrial appendage closure (LAAC) in 2 randomized trials compared to warfarin for prevention of stroke, systemic embolism, and cardiovascular death in patients with nonvalvular AF. METHODS: Our meta-analysis included 2,406 patients with 5,931 patient-years (PY) of follow-up from the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman LAA Closure Device In Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trials, and their respective registries (Continued Access to PROTECT AF registry and Continued Access to PREVAIL registry). RESULTS: With mean follow-up of 2.69 years, patients receiving LAAC with the Watchman device had significantly fewer hemorrhagic strokes (0.15 vs. 0.96 events/100 patient-years PY; hazard ratio HR: 0.22; p = 0.004), cardiovascular/unexplained death (1.1 vs. 2.3 events/100 PY; HR: 0.48; p = 0.006), and nonprocedural bleeding (6.0% vs. 11.3%; HR: 0.51; p = 0.006) compared with warfarin. All-cause stroke or systemic embolism was similar between both strategies (1.75 vs. 1.87 events/100 PY; HR: 1.02; 95% CI: 0.62 to 1.7; p = 0.94). There were more ischemic strokes in the device group (1.6 vs. 0.9 and 0.2 vs. 1.0 events/100 PY; HR: 1.95 and 0.22, respectively; p = 0.05 and 0.004, respectively). Both trials and registries identified similar event rates and consistent device effect in multiple subsets. CONCLUSIONS: In patients with NVAF at increased risk for stroke or bleeding who are candidates for chronic anticoagulation, LAAC resulted in improved rates of hemorrhagic stroke, cardiovascular/unexplained death, and nonprocedural bleeding compared to warfarin.
“These cardioembolic strokes are associated with the highest morbidity and mortality as well as an increased rate of recurrence and hemorrhagic transformation.”
Holmes et al. (Mon,) conducted a meta-analysis in nonvalvular atrial fibrillation (n=2,406). Left atrial appendage closure (LAAC) vs. Warfarin was evaluated on All-cause stroke or systemic embolism (HR 1.02, 95% CI 0.62 to 1.7, p=0.94). Left atrial appendage closure with the Watchman device resulted in similar rates of all-cause stroke or systemic embolism compared to warfarin (HR 1.02; 95% CI 0.62-1.7; p=0.94).