Abstract
Abstract Introduction The modified Rankin Scale (mRS) is usually used to evaluate the degree of disability in patients who have suffered a stroke. Some data suggest that pre-stroke mRS may be associated with clinical outcomes. No data exist about atrial fibrillation (AF) patients. Purpose To evaluate if baseline level of disability, evaluated as mRS, is associated with major adverse outcomes in patients with AF Methods Data from the SPORTIF III and V trials were used to evaluate study aims. mRS was categorized as follows: i) mRS 0 = No Disability; ii) mRS 1 = Operational Limitation; iii) mRS ≥2 = Disability. Stroke/systemic embolism (SE), death and composite of stroke/SE/acute myocardial infarction (AMI)/death were considered as major adverse outcomes. Results Among 7329 patients enrolled in SPORTIF trials, 7325 (99.9%) had data about baseline mRS, with 5587 (76.3%) with mRS 0, 1156 (15.8%) with mRS 1 and 582 (7.9%) with mRS ≥2. Mean (SD) and median [IQR] CHA2DS2-VASc was progressively higher across the three mRS categories (both p<0.001). An adjusted linear regression analysis confirmed that mRS was associated with an increasing CHA2DS2-VASc (unstandardized B: 0.354, 95% confidence interval [CI]: 0.317–0.390, p<0.001]. After a mean (SD) 1.55 (0.40) years of follow-up 184 (2.5%) stroke/SE, 392 (5.4%) death and 597 (8.2%) composite events were recorded. Log-rank test showed that cumulative risk of stroke/SE (p=0.005), death (p<0.001) and composite outcome (p<0.001) was progressively higher across the mRS categories [Figure]. Cox adjusted regression analysis found no independent association between mRS categories and stroke/SE occurrence, but baseline disability (mRS ≥2) was independently associated with death (hazard ratio [HR]: 2.17, 95% CI: 1.65–2.86 compared with no disability). Both operational limitation (mRS 1) and disability (mRS ≥2) were associated with the composite outcome (HR: 1.28, 95% CI: 1.04–1.59 and HR: 1.91, 95% CI: 1.51–2.42, respectively) compared to no disability. Kaplan-Meier curves Conclusions In a large cohort of AF patients derived from a randomized controlled trial, baseline disability was associated with an increased risk of death and composite outcome of stroke/SEAMI/death. Acknowledgement/Funding None
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