P94 LOWER RATE OF MAJOR BLEEDING IN HIGH–RISK PATIENTS UNDERGOING LEFT ATRIAL APPENDAGE OCCLUSION: A PROPENSITY MATCHED COMPARISON WITH DIRECT ORAL ANTICOAGULATION

Abstract

Abstract Background Stroke prophylaxis in very high risk (CHA2DS2–VASc ≥ 5) patients with atrial fibrillation (AF) is one of the major challenges faced by physicians. Specifically, initiating direct oral anticoagulants (DOACs) in these patients poses a therapeutic conundrum due to the concomitant high risk of bleeding. Left atrial appendage occlusion (LAAO) might be a potential alternative for thromboembolic (TE) prevention; however, there are no studies comparing these two strategies in very high–risk patients. Objective To evaluate the efficacy of LAAO versus DOACs in AF patients at very high TE risk. Methods Data were extracted from two prospective databases including 1053 Watchman and 1328 DOAC patients. Watchman patients with a CHA2DS2–VASc ≥ 5 accounted for 26.3% (n = 277). In order to attenuate the imbalance in covariates, a 1:1 propensity score matching technique was used (co–variates: age, sex, CHA2DS2–VASc and HAS–BLED scores). This method resulted in 554 matched patients (277 patients per group; mean age: 79±7y; 57.4% F; CHA2DS2–VASc: 5.8±0.9). The primary endpoint was a composite of cardiovascular (CV) death, TE events (Stroke/TIA/peripheral embolism) and clinically significant bleeding. The annual TE and major bleeding risks were estimated based on the CHA2DS2–VASc score and compared with the annualized observed risk. Results After a mean follow–up of 26±7 months, total events were 55 (9.4 event rates per 100 patient–years) in LAAO group vs. 78 (14.9 event rates per 100 patient–years) in DOAC group. DOACs had a significantly higher risk of the primary endpoint (hazard ratio [HR]: 1.30; 95% confidence interval [CI]: 1.08 to 1.56; p = 0.03). TE events (HR: 1.15; 95% CI: 0.84 to 1.57; p = 0.63) and CV death (HR: 1.13; 95% CI: 0.84 to 1.54; p = 0.63) did not differ between groups. Major bleeding events were significantly lower in LAAO patients (HR: 0.75; 95% CI: 0.51 to 0.82; p = 0.04). The unadjusted estimated risk of TE events was 12.3% with LAAO and 12.4% with DOACs. The annualized incidence of TE was 3.2% with LAAO and 4.1% with DOACs, which led to a risk reduction of 74% and 67%, respectively. Conclusion In a large cohort of AF patients at very high TE risk (CHA2DS2–VASc ≥ 5), LAAO showed similar stroke prevention but a significantly lower risk of major bleeding than DOACs during a > 2year follow–up.