本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2023.27188

摘要内容如下：

重要性

在临床上没有明显的心房颤动的情况下，心房性心脏病与中风有关。目前尚不清楚抗凝治疗（已证实对房颤有益）是否能预防房性心脏病患者和无房颤患者的卒中。

目的

比较抗凝治疗与抗血小板治疗对有心房性心脏病证据的不明原因卒中患者的二级卒中预防作用。

设计、设置和参与者

多中心、双盲、3期随机临床试验纳入了1015名患有隐源性卒中且有心房性心脏病证据的参与者，心房性心脏病的定义为心电图V1导联P波终末力大于5000μV×ms，血清N末端B型利钠肽前体水平大于250 PG/mL，或超声心动图左心房直径指数为3 cm/m2或更大。参与者在随机分组时没有房颤的证据。从2018年2月1日到2023年2月28日，在美国国立卫生研究院中风网络和加拿大中风协会的185个站点进行了招募和随访。

干预措施

阿哌沙班，5 mg或2.5 mg，每日两次（n=507）vs阿司匹林，81 mg，每日一次（n=508）。

主要成果和措施

时间-事件分析中的主要疗效转归为复发性卒中。所有参与者，包括随机分组后诊断为房颤的参与者，根据他们被随机分组的组别进行分析。主要安全性转归为症状性颅内出血和其他严重出血。

结果

目标1100名参与者中有1015名入组，平均随访1.8年，在计划的中期分析后，该试验因无效而终止。参与者的平均（SD）年龄为68.0（11.0）岁，54.3%为女性，87.5%完成了全部随访。阿哌沙班组和阿司匹林组分别有40例（年发生率为4.4%）和40例（年发生率为4.4%）患者发生复发性卒中（风险比为1.00[95%CI为0.64-1.55]）。服用阿哌沙班的患者中有0例出现症状性颅内出血，服用阿司匹林的患者中有7例出现症状性颅内出血（年发生率为1.1%）。5名服用阿哌沙班的患者（年发生率0.7%）和5名服用阿司匹林的患者（年发生率0.8%）发生其他严重出血（风险比，1.02[95%CI，0.29-3.52]）。

结论和相关性

与阿司匹林相比，阿哌沙班并不能显著降低隐源性卒中和无房颤的房性心脏病患者的卒中复发风险。

试用注册

ClinicalTrials.gov标识符：NCT03192215。

英文原文如下：

Abstracts

Importance  Atrial cardiopathy is associated with stroke in the absence of clinically apparent atrial fibrillation. It is unknown whether anticoagulation, which has proven benefit in atrial fibrillation, prevents stroke in patients with atrial cardiopathy and no atrial fibrillation.

Objective  To compare anticoagulation vs antiplatelet therapy for secondary stroke prevention in patients with cryptogenic stroke and evidence of atrial cardiopathy.

Design, Setting, and Participants  Multicenter, double-blind, phase 3 randomized clinical trial of 1015 participants with cryptogenic stroke and evidence of atrial cardiopathy, defined as P-wave terminal force greater than 5000 μV × ms in electrocardiogram lead V1, serum N-terminal pro-B-type natriuretic peptide level greater than 250 pg/mL, or left atrial diameter index of 3 cm/m2 or greater on echocardiogram. Participants had no evidence of atrial fibrillation at the time of randomization. Enrollment and follow-up occurred from February 1, 2018, through February 28, 2023, at 185 sites in the National Institutes of Health StrokeNet and the Canadian Stroke Consortium.

Interventions  Apixaban, 5 mg or 2.5 mg, twice daily (n = 507) vs aspirin, 81 mg, once daily (n = 508).

Main Outcomes and Measures  The primary efficacy outcome in a time-to-event analysis was recurrent stroke. All participants, including those diagnosed with atrial fibrillation after randomization, were analyzed according to the groups to which they were randomized. The primary safety outcomes were symptomatic intracranial hemorrhage and other major hemorrhage.

Results  With 1015 of the target 1100 participants enrolled and mean follow-up of 1.8 years, the trial was stopped for futility after a planned interim analysis. The mean (SD) age of participants was 68.0 (11.0) years, 54.3% were female, and 87.5% completed the full duration of follow-up. Recurrent stroke occurred in 40 patients in the apixaban group (annualized rate, 4.4%) and 40 patients in the aspirin group (annualized rate, 4.4%) (hazard ratio, 1.00 [95% CI, 0.64-1.55]). Symptomatic intracranial hemorrhage occurred in 0 patients taking apixaban and 7 patients taking aspirin (annualized rate, 1.1%). Other major hemorrhages occurred in 5 patients taking apixaban (annualized rate, 0.7%) and 5 patients taking aspirin (annualized rate, 0.8%) (hazard ratio, 1.02 [95% CI, 0.29-3.52]).

Conclusions and Relevance  In patients with cryptogenic stroke and evidence of atrial cardiopathy without atrial fibrillation, apixaban did not significantly reduce recurrent stroke risk compared with aspirin.

Trial Registration  ClinicalTrials.gov Identifier: NCT03192215.

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