拜瑞妥
蒙特利尔认知评估
医学
阿司匹林
冲程(发动机)
认知
曼惠特尼U检验
内科学
日常生活活动
随机对照试验
物理疗法
心理干预
认知障碍
精神科
心房颤动
华法林
工程类
机械工程
作者
Jackie Bosch,Lesly A. Pearce,Mukul Sharma,Michelle Canavan,William Whiteley,Robert Mikulík,Hardi Mundl,Salim Yusuf,Robert G. Hart,Martin O’Donnell
标识
DOI:10.1016/j.jstrokecerebrovasdis.2022.106404
摘要
Background The effect of interventions on functional impairment is an important outcome in stroke prevention trials and should be considered as an adjunct to counting discrete events. In the NAVIGATE-ESUS trial, 7213 patients with recent embolic strokes of undetermined source were randomized to rivaroxaban (15 mg once daily) or aspirin (100 mg daily). After 11 months there was no effect on the prevention of recurrent stroke. Aims To determine the effect of rivaroxaban compared to aspirin on functional and cognitive outcomes. Methods Function and cognition were measured at baseline, 1 year, and study end using the Standard Assessment of Global Everyday Activities (SAGEA), a 15-item scale assessing cognitive, instrumental, and basic activities of daily living as well as mobility, and the Montreal Cognitive Assessment (MoCA). Changes in scores were calculated by subtracting either study end or 1-year scores from baseline, and differences in distributions were compared using the Mann-Whitney U test. SAGEA and MoCA scores were also correlated with recurrent stroke. Results Follow-up SAGEA scores were available in 6378 (88%) participants. There was no difference in change in function for those allocated to rivaroxaban compared to aspirin (Mann-Whitney U test, p = 0.8), with both distributions having a median (25p,75p) change of 0 (-2,1). Overall, more of those who experienced a recurrent stroke (n=247; mostly minor ischemic), reported functional difficulty at study end versus entry, compared with those who did not (51% versus 30%, chi-square test, p< 0.001), and this was consistent across global regions. There was no difference in the change in cognition by treatment group, nor were recurrent strokes associated with a change in cognition. Conclusions Rivaroxaban, compared to aspirin, was not associated with changes in functional or cognitive status in patients with recent ESUS. The SAGEA scale detected changes in functional status associated with recurrent strokes in an international stroke population.
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