15 #AHA24 ScientificSessions.org OPTION randomized 1,600 patients across 114 global sites, 803 patients to LAAC and 797 to OAC. Patients were 69.6 years old and had a mean CHA2DS2-VASc score of 3.5. LAAC was performed in combination with (40.8%) or sequentially after (59.2%) catheter ablation for AFib. The primary safety endpoint was nonprocedural major or clinically relevant nonmajor bleeding at 36 months. Major bleeding, including procedural bleeding, through 36 months, was a secondary endpoint. LAAC was successful in 99% of patients, Wazni reported. The rates of major bleeding were comparable, 3.9% for LAAC versus 5.0% for OAC, p for noninferiority < 0.0001, with a numerical trend favoring LAAC. “For all intents and purposes in patients who undergo an ablation for AFib and have a moderate to high risk for stroke, most of them are probably going to end up with left atrial appendage closure,” he said. OPTION was published simultaneously in the New England Journal of Medicine. BRAIN-AF halted early The BRAIN-AF trial of anticoagulation to prevent ischemic stroke and neurocognitive impairment in low-risk individuals with AFib was halted early for lack of benefit. Anticoagulation with rivaroxaban 15 mg/day did not reduce the incidence of cognitive decline, stroke or TIA in patients in their 50s who had AFib but no conventional risk factors for stroke. Rivard “We have been seeing reports for the last 10-15 years showing a link between atrial fibrillation and cognitive decline and dementia. Whether the link is causal or due to shared risk factors remains unknown. But cerebral emboli damaging the brain is one of the main hypothesis, said Lena Rivard, MD, MSc, Montreal Heart Institute in Montreal, Canada. “And in our own clinical practice, we have been seeing patients in their 50s, very young, without any stroke risk but who had both atrial fibrillation and cognitive decline.” BRAIN-AF followed 1,235 patients with atrial fibrillation and low risk for stroke, no congestive heart failure, hypertension, diabetes, prior stroke/TIA or age ≥65 years. Patients were randomized to rivaroxaban 15 mg/day or standard care, either placebo or aspirin, depending on vascular status. Median age was 53.4 years and 25.6% were female. Patient underwent yearly cognitive testing. More than 5,500 Montreal Cognitive Assessment (MoCA) tests were performed during the trial. The primary outcome was a composite of stroke, TIA or cognitive decline as measured by a decline in MoCA score ≥2. The trial was planned to continue until 410 primary events occurred but was halted for futility after 205 events following a planned interim analysis. Median follow-up was 3.7 years. In intention-to-treat analysis, the composite primary event was observed in 130 patients in the rivaroxaban group, 7% per year, versus 126 in the usual care group, 6.4% per year, p=0.46 (95% CI 0.861.40). There were no differences in the primary outcome components. The study was not powered to test anticoagulation therapy in stroke, TIA and systemic embolism. The combined secondary outcome of stroke, TIA or systemic embolism occurred in 2.5% of patients randomized to rivaroxaban and 2.7% of patients randomized to placebo (HR 0.92; 95% CI 0.50-1.84). “We didn’t have any safety issues, which is very reassuring,” Rivard said. “Major bleeding occurred in just two patients on rivaroxaban (0.03%) and five on standard care (0.08%). Biomarker, cerebral MRI and genetic testing results will be presented later.” In the U.S. 3-6 million people have atrial fibrillation (AFib), the most common form of arrhythmia. Individuals with AFib have stroke, acute coronary syndrome, heart failure, and cardiovascular death at approximately 5% per year. American Heart Association® Lifelong LearningTM Improving Outcomes in Patients with Atrial Fibrillation Education on your time. CE and MOC Available. This activity is supported by an independent medical education grant from Sanofi US VIDEOS ON DEMAND A series of videos covering topics on lifestyle modifications, rate control, anticoagulation therapy and more. NAME THAT BEAT: AN AFIB CHALLENGE Do you know the prevalence of AFib or the clinical significance and associated risks with AFib or the benefits of rhythm control vs. rate control? Test your knowledge with this fun and engaging game. GUIDELINES AND ARTICLES Access the latest guidelines, articles and toolkit resources © Copyright 2024 American Heart Association, Inc., a 501(c)(3) not-for-profit. All rights reserved. Unauthorized use prohibited. WF_668006 10/24 Access these resources and learn more! Paid Advertisement WF_668006 AFib Sessions 2024 Junior Ad.indd 1 10/4/24 12:14 PM ARRHYTHMIA continued from page 5
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