Key result
Discharge on warfarin alone after left atrial appendage occlusion was associated with a significantly lower risk of any adverse event at 45 days compared with warfarin and aspirin (HR 0.692).
Why the study?
Pivotal trials of percutaneous LAAO used specific post-procedure protocols, but clinical practice patterns and adverse event risks across different discharge antithrombotic strategies were uncharacterized.
Does discharge on alternative antithrombotic strategies (warfarin alone, DOAC alone, DOAC plus aspirin, or DAPT) reduce adverse events compared to warfarin plus aspirin in patients undergoing left atrial appendage occlusion?
Cohort (n=31,994)
Yes
Does discharge on alternative antithrombotic strategies (warfarin alone, DOAC alone, DOAC plus aspirin, or DAPT) reduce adverse events compared to warfarin plus aspirin in patients undergoing left atrial appendage occlusion?
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Of the 31,994 patients undergoing successful left atrial appendage closure with the initial WATCHMAN device, only 12.2% received the full postprocedure treatment protocol studied in the pivotal trials, which included the timing of subsequent studies and the treatment of residual leak, and then longer follow-up.”
In real-world practice, discharging LAAO patients on warfarin or a DOAC without concomitant aspirin reduces adverse events (primarily bleeding) compared to the trial-mandated warfarin plus aspirin regimen, without increasing ischemic risk.
Background: Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific post-procedure treatment protocols. Objectives: This study sought to evaluate patterns of post-procedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies. Methods: We evaluated patients in the NCDR LAAO Registry who underwent LAAO with this device between 2016 and 2018. We assessed adherence to the full post-procedure trial protocol including standardized follow-up, imaging and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and odds of adverse events at 45 days and 6 months using multivariable logistic regression. Results: Among 31,994 patients undergoing successful LAAO, only 12.2% received the full post-procedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), DOAC and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and DAPT (5.0%). In multivariable logistic regression, the adjusted odds of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (odds ratio [OR]: 0.637, 95% CI: 0.525–0.774) and DOAC alone (OR: 0.734; 95% CI: 0.579–0.931) compared with warfarin and aspirin. Warfarin alone remained lower risk at the 6-month follow-up. Conclusions: In contemporary US practice, practitioners rarely used the full Food and Drug Administration–approved post-procedure treatment protocols studied in pivotal trials of this LAAO device. Discharge post-implantation on warfarin or a DOAC without concomitant aspirin was associated with lower risk of adverse outcomes.
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Freeman et al. (2022) conducted a cohort in Atrial Fibrillation (n=31,994). Warfarin alone vs. Warfarin and aspirin was evaluated on Any adverse event through the 45-day follow-up visit (HR 0.692, 95% CI 0.569-0.841). Discharge on warfarin alone after left atrial appendage occlusion was associated with a significantly lower risk of any adverse event at 45 days compared with warfarin and aspirin (HR 0.692).
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