Lansberg Maarten G, Wintermark Max, Chen Hui, Howard George, Cassarly Christy, Pauls Qi, Kemp Stephanie, Harris Tashia L, Krishnaiah Balaji, Stanton Robert J, Lyerly Michael J, Miller Benjamin R, Smith Eric E, Tirschwell David L, Sheth Kevin N, Kamel Hooman, Longstreth William T, Elkind Mitchell S V, Broderick Joseph P, Lazar Ronald M
Stanford Stroke Center, Center for Academic Medicine, Stanford University School of Medicine, Palo Alto, California.
Department of Neuroradiology, MD Anderson Cancer Center, The University of Texas, Houston.
JAMA Neurol. 2025 Mar 1;82(3):220-227. doi: 10.1001/jamaneurol.2024.4838.
In the Atrial Cardiopathy and Antithrombotic Drugs in Prevention After Cryptogenic Stroke (ARCADIA) randomized clinical trial, anticoagulation did not prevent recurrent stroke among patients with a recent cryptogenic stroke and atrial cardiopathy. It is unknown whether anticoagulation prevents covert infarcts in this population.
To test the use of apixaban vs aspirin for prevention of nonlacunar covert infarcts after cryptogenic stroke in patients with atrial cardiopathy.
DESIGN, SETTING, AND PARTICIPANTS: ARCADIA-MRI, an ancillary study to the ARCADIA trial with a median follow-up period of 27 months, enrolled participants from 75 sites in the US from November 14, 2019, until December 2, 2022. Participants in ARCADIA were invited to coenroll in ARCADIA-MRI if they had not permanently discontinued the study drug and had no contraindications on magnetic resonance imaging (MRI). A total of 310 (31%) of the 1015 ARCADIA participants enrolled in ARCADIA-MRI and of those 174 (56%) with adequate quality baseline and follow-up MRI were included in the present analyses.
MRI performed at the time of the index stroke served as the baseline image unless it was unavailable or of insufficient quality, in which case a new research MRI was obtained. A follow-up research MRI was performed upon each participant's completion of participation in the ARCADIA parent study.
The primary outcome was incident nonlacunar covert infarct on the follow-up MRI assessed by 2 independent raters who were masked to treatment assignment.
Baseline characteristics were balanced between the apixaban (n = 79) and aspirin (n = 95) arms. The mean (SD) age was 66 (10.6) years, and the median (IQR) modified Rankin Scale (mRS) score 1 (0-2). Ninety-one participants (52.3%) were male. During the median (IQR) follow-up of 811 (487-1288) days, the risk of incident nonlacunar covert infarcts was lower in the apixaban group (5.1%) than the aspirin group (17.9%) (weighted relative risk, 0.29; 95% CI, 0.10-0.83).
Apixaban compared to aspirin was associated with fewer incident nonlacunar covert infarcts among a subset of patients with a recent cryptogenic ischemic stroke and atrial cardiopathy who were enrolled in ARCADIA.
ClinicalTrials.gov Identifier: NCT03192215.
在隐源性卒中后心房心肌病与抗栓药物预防(ARCADIA)随机临床试验中,抗凝治疗并不能预防近期发生隐源性卒中且患有心房心肌病患者的复发性卒中。目前尚不清楚抗凝治疗能否预防该人群中的隐匿性梗死。
比较阿哌沙班与阿司匹林预防心房心肌病患者隐源性卒中后非腔隙性隐匿性梗死的效果。
设计、地点和参与者:ARCADIA-MRI是ARCADIA试验的一项辅助研究,中位随访期为27个月,从2019年11月14日至2022年12月2日在美国75个地点招募参与者。如果ARCADIA试验的参与者没有永久停用研究药物且没有磁共振成像(MRI)禁忌证,则邀请他们共同参与ARCADIA-MRI研究。1015名ARCADIA试验参与者中共有310名(31%)参与了ARCADIA-MRI研究,其中174名(56%)具有质量合格的基线和随访MRI数据,纳入了本分析。
除非首次卒中时的MRI不可用或质量不佳,否则将其作为基线图像,在这种情况下需获取新的研究性MRI。每位参与者完成ARCADIA母研究后进行随访研究性MRI检查。
主要结局是由2名对治疗分配不知情的独立评估者在随访MRI上评估的非腔隙性隐匿性梗死的发生情况。
阿哌沙班组(n = 79)和阿司匹林组(n = 95)的基线特征均衡。平均(标准差)年龄为66(10.6)岁,改良Rankin量表(mRS)评分中位数(四分位间距)为1(0 - 2)。91名参与者(52.3%)为男性。在811(487 - 1288)天的中位(四分位间距)随访期内,阿哌沙班组非腔隙性隐匿性梗死的发生风险(5.1%)低于阿司匹林组(17.9%)(加权相对风险,0.29;95%置信区间,0.10 - 0.83)。
在参与ARCADIA试验的近期发生隐源性缺血性卒中和心房心肌病患者亚组中,与阿司匹林相比,阿哌沙班与较少的非腔隙性隐匿性梗死发生相关。
ClinicalTrials.gov标识符:NCT03192215。