ATRİYAL FİBRİLASYONLU HASTALARDA SOL ATRİYAL APENDİKS KAPAMA İLE VİTAMİN K ANTAGONİSTİ DIŞI ORAL ANTİKOAGÜLAN KULLANIMININ KARŞILAŞTIRILMASI

Abstract

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in adults and is a significant cause of morbidity and mortality. Oral anticoagulant (OAC) drugs are commonly used to prevent thromboembolic events in AF patients. However, in patients with a high risk of bleeding who cannot tolerate OAC therapy, left atrial appendage (LAA) closure is an alternative treatment option. The aim of this study is to retrospectively compare the clinical outcomes of patients with atrial fibrillation (AF) who do not have a mechanical heart valve or moderate-to-severe mitral stenosis, between those who underwent left atrial appendage (LAA) closure and those using non-vitamin K antagonist oral anticoagulants (NOACs). Patients who were initiated on NOAC therapy for the first time or underwent LAA closure between 01.09.2015 and 12.04.2023 at Hacettepe University Faculty of Medicine Hospital were retrospectively analyzed. Baseline demographic data, medications, laboratory and echocardiography findings, and data related to the LAA closure procedure were recorded. A total of 119 patients were included in the LAA closure group and 168 in the NOAC group. The median CHA2DS2-VASc and HAS-BLED scores in the LAA closure group were 4 (3-5) and 2 (2-3), respectively, while the median CHA2DS2-VASc and HAS-BLED scores in the NOAC group were similarly 4 (3-5) and 2 (2-3). Patients with a history of stroke or transient ischemic attack (TIA) were more common in the NOAC group, whereas the LAA closure group had a significantly higher number of patients with a history of bleeding. Other baseline characteristics were similar between the two groups. In the LAA closure group, 81.5% of patients underwent the procedure with an Amulet device, and the implantation success rate was 99.2%. The procedure was performed primarily due to bleeding in 78.2% of cases, and the most frequent complication was device-related issues at the access site (8.4%). The primary endpoint was defined as the occurrence of any of the following: stroke, systemic embolic event, bleeding, all-cause mortality, or procedure-related complications. Patients were followed for an average of 4.9 years. The primary endpoint occurred at a rate of 12.3 events per 100 patient-years in the NOAC group and 17 events per 100 patient-years in the LAA closure group, with no statistically significant difference between the groups (p=0.082). All-cause mortality occurred at rates of 8.4 per 100 patient-years in the NOAC group and 12.2 per 100 patient-years in the LAA closure group, with no statistically significant difference (p=0.073). Ischemic stroke, TIA, or systemic embolic events occurred at rates of 1.2 per 100 patient-years in the NOAC group and 0.64 per 100 patient-years in the LAA closure group, with no statistically significant difference (p=0.466). Clinically significant bleeding occurred at rates of 4.2 per 100 patient-years in the NOAC group and 3.8 per 100 patient-years in the LAA closure group, with no statistically significant difference (p=0.617). In the LAA closure group, 1.6 significant procedure and device-related complications per 100 patient-years were reported. In conclusion, LAA closure demonstrated similar efficacy and safety to NOAC therapy in preventing AF-related complications in patients with high risks of bleeding and stroke. LAA closure may be considered an effective alternative treatment option for managing these patients.