Background: This study examined the safety and efficacy of different anticoagulation regimens in patients with atrial fibrillation (AF) after left atrial appendage occlusion (LAAC) using the Watchman closure device.
Methods: AF patients who underwent LAAC using the Watchman closure device in the Department of Cardiology, Jiangsu Taizhou People's Hospital between March 2018 and November 2019 were retrospectively enrolled in this study. Patients were divided into two groups according to different postoperative anticoagulant regimens. One group was treated with anticoagulant therapy alone [oral anticoagulant (OAC)/new OAC (NOAC) group] and the other was given NOACs combined with single antiplatelet therapy (SPAT) (NOAC + SAPT group). The incidences of ischemic stroke/transient ischemic attack (TIA), major bleeding events, all-cause mortality, and device-related thrombosis (DRT) were recorded. Furthermore, multivariate regression was used to analyze the factors associated with the occurrence of early DRT.
Results: A total of 160 patients, including 42 (51%) females, with a mean age of 69.13±6.14 years were enrolled in this study. The mean CHA2DS2-VASc score was 3.66±1.11 and the mean HAS-BLED score was 4.16±0.82. During the postoperative follow-up period, there were no significant differences in the incidence of ischemic stroke/TIA [hazard ratio (HR) =0.616; 95% confidence interval (CI): 0.056 to 6.818; P=0.693], major bleeding events (HR =0.520; 95% CI: 0.047 to 5.764; P=0.594) nor all-cause mortality (HR =0.579; 95% CI: 0.052 to 6.394; P=0.656) between the two groups. However, the incidence of early DRT was higher in the OAC/NOAC group compared to the NOAC + SAPT group [odds ratio (OR) =0.120; 95% CI: 0.015 to 0.984; P=0.048]. Multivariate regression confirmed that atrial blood stasis (OR =11.367; 95% CI: 1.394 to 92.687; P=0.023) and peri-device leak (OR =9.337; 95% CI: 1.623 to 53.727; P=0.012) were independent predictors of early DRT.
Conclusions: Short-term NOAC + SAPT after LAAC did not significantly increase the incidence of major bleeding events, ischemic stroke/TIA, nor all-cause mortality compared to OAC/NOAC therapy. Not only was NOAC + SAPT therapy found to be safe and effective in short-term follow-up, but it also lowered the risk of early DRT.
Keywords: Atrial fibrillation (AF); anticoagulation therapy; left atrial appendage occlusion (LAAC); safety.