Discharge on warfarin alone (OR 0.637; 95% CI 0.525-0.774) or DOAC alone after LAAO was associated with lower odds of adverse events at 45 days compared with warfarin plus aspirin.
Observational (n=31,994)
Yes
Does discharge on warfarin or DOAC alone reduce adverse events compared to warfarin and aspirin in patients after successful LAAO?
In contemporary US practice, discharging patients on warfarin or a DOAC without aspirin after LAAO is associated with a lower risk of adverse events compared to the traditional warfarin plus aspirin regimen.
Odds Ratio: 0.637 (95% CI 0.525–0.774)
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.
“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.”
Freeman et al. (Sun,) conducted a observational 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 (OR 0.637, 95% CI 0.525-0.774). Discharge on warfarin alone (OR 0.637; 95% CI 0.525-0.774) or DOAC alone after LAAO was associated with lower odds of adverse events at 45 days compared with warfarin plus aspirin.
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