This analysis shows that the long-term clinical benefit of left atrial appendage closure with Watchman is superior to warfarin in patients with atrial fibrillation (AF). The initial peri-procedural risks of device implantation are counterbalanced over time, with reduced risk of bleeding and death.
The PROTECT-AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) and the PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) showed the non-inferiority of left atrial appendage closure vs. warfarin for the combined end point of stroke, systemic embolism and cardiovascular death. The present study aims at quantifying the clinical net benefit of left atrial appendage closure vs. Warfarin.
To this end, researchers carried out a post hoc analysis of the above-mentioned randomized studies, which included patients from the US and Europe between 2005 and 2012 with paroxysmal, persistent or permanent atrial fibrillation, with CHADS₂ risk score ≥1.
Of the 1114 patients randomized, the clinical net benefit of left atrial appendage closure was 1.42% per year (p=0.04) and relative risk was 0.74 (CI 95%, 0.56 to 1).
Early in follow up, the clinical net benefit favors warfarin (given the inevitable events of all invasive procedures) but the scales tilt in favor of left atrial appendage closure between the first and second year of follow up.
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The superiority of left atrial appendage closure was observed across all subgroups, but patients with prior stroke and non-diabetic were particularly benefited.
Conclusion
This long-term analysis shows that in patients with atrial fibrillation, the net clinical benefit of left atrial appendage closure is superior to warfarin. The initial risks are compensated by reduced bleeding and death rates between the first and second year.
Original Title: Net Clinical Benefit of Left Atrial Appendage Closure Versus Warfarin in Patients With Atrial Fibrillation: A Pooled Analysis of the Randomized PROTECT-AF and PREVAIL Studies.
Reference: Tom F. Brouwer et al. J Am Heart Assoc. 2019;8:e013525.
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