(252) Percutaneous Left Atrial Appendage Occlusion and Risk of Stroke, Hospitalized Bleeding and Death in Medicare Beneficiaries with Atrial Fibrillation
Postdoctoral Fellow University of Minnesota School of Public Health Minneapolis, United States
Background: Atrial fibrillation (AF) is a significant stroke risk factor, with oral anticoagulants (OACs) recommended for stroke prevention; however, a nonpharmacologic option is needed for patients with OAC contraindications. Recently, percutaneous left atrial appendage occlusion (LAAO) has emerged as an alternative treatment option. Clinical trials have shown that percutaneous LAAO is non-inferior to warfarin and direct OACs, but few studies have evaluated the effectiveness and safety of LAAO using real-world data.
Objectives: To assess the association between percutaneous LAAO vs. OAC use and risk of all stroke, death, and hospitalized bleeding among patients with AF who had an elevated CHA2DS2-VASc score
Methods: Using data from the Medicare 20% sample databases (2015-18), patients undergoing percutaneous LAAO were matched with up to 5 patients who were taking OACs by sex, age, date of enrollment, index date, and CHA2DS2-VASc score. A total of 17,514 patients with AF (2,927 with percutaneous LAAO) were matched (average [SD] 78 [6] years, 44% female). Cox proportional hazards model adjusting for CHA2DS2-VASc and HAS-BLED variables was used. For hospitalized bleeding, we also conducted analyses stratified by time since LAAO procedure date, since postoperative guidelines suggest concomitant OAC therapy days 8-45, and dual antiplatelet therapy days 46-179.
Results: Over a median follow-up of 10.3 months, 293 strokes, 1,925 deaths and 618 major bleeding events occurred. After multivariable adjustments, no significant difference for risk of stroke or death was noted when patients with percutaneous LAAO was compared to OAC users (HRs [95% CIs]: 1.25 [0.94, 1.66] and 0.96 [0.85, 1.08], respectively). However, there was a 3.33-fold (95% CI: 2.83, 3.92) higher risk for hospitalized bleeding after percutaneous LAAO compared to OAC. When stratified by time, patients with percutaneous LAAO had a higher risk of bleeding in the periprocedural period (0-7 days; HR [95% CI]: 6.20 [2.38, 16.17]), the period when concomitant OAC therapy is required (HR [95% CI]: 11.49 [7.80, 16.94]) and the period when dual antiplatelet therapy is taken (HR [95% CI]: 4.44 [3.37, 5.86]) compared to OAC users. However, after 180 days from the index date, there was no longer a significant association (HR [95% CI]: 1.29 [0.96, 1.74]).
Conclusions: No significant difference in risk of stroke or death were noted when percutaneous LAAO was compared to OAC users. However, there was a higher risk for bleeding. Our results confirm the results of randomized trials that among older patients with AF and a high-risk for stroke, percutaneous LAAO may be an alternative to OAC use, though a higher risk of bleeding in the post-procedural period in those with an implanted LAAO device was observed.
