ImportanceApproximately 10% to 15% of ischemic strokes are associated with cancer; cancer-associated stroke, particularly when cryptogenic, is associated with high rates of recurrent stroke and major bleeding. Limited data exist on the safety and efficacy of different antithrombotic strategies in patients with cancer and cryptogenic stroke.ObjectiveTo compare apixaban vs aspirin for the prevention of adverse clinical outcomes in patients with history of cancer and cryptogenic stroke.Design, Setting, and ParticipantsPost hoc analysis of data from 1015 patients with a recent cryptogenic stroke and biomarker evidence of atrial cardiopathy in the Atrial Cardiopathy and Antithrombotic Drugs in Prevention After Cryptogenic Stroke (ARCADIA) trial, a multicenter, randomized, double-blind clinical trial conducted from 2018 to 2023 at 185 stroke centers in North America. Data analysis was performed from October 15, 2023, to May 23, 2024.ExposuresOral apixaban, 5 mg (or 2.5 mg if criteria met), twice daily vs oral aspirin, 81 mg, once daily. Subgroups of patients with and without cancer at baseline were examined.Main Outcomes and MeasuresThe primary outcome for this post hoc analysis was a composite of major ischemic or major hemorrhagic events. Major ischemic events were recurrent ischemic stroke, myocardial infarction, systemic embolism, and symptomatic deep vein thrombosis or pulmonary embolism. Major hemorrhagic events included symptomatic intracranial hemorrhage and any major extracranial hemorrhage.ResultsAmong 1015 participants (median [IQR] age, 68 [60-76] years; 551 [54.3%] female), 137 (13.5%) had a history of cancer. The median (IQR) follow-up was 1.5 (0.6-2.5) years for patients with history of cancer and 1.5 (0.6-3.0) years for those without history of cancer. Participants with history of cancer, compared with those without history of cancer, had a higher risk of major ischemic or major hemorrhagic events (hazard ratio [HR], 1.73; 95% CI, 1.10-2.71). Among those with history of cancer, 8 of 61 participants (13.1%) randomized to apixaban and 16 of 76 participants (21.1%) randomized to aspirin had a major ischemic or major hemorrhagic event; however, the risk was not significantly different between groups (HR, 0.61; 95% CI, 0.26-1.43). Comparing participants randomized to apixaban vs aspirin among those with cancer, events included recurrent stroke (5 [8.2%] vs 9 [11.8%]), major ischemic events (7 [11.5%] vs 14 [18.4%]), and major hemorrhagic events (1 [1.6%] vs 2 [2.6%]).Conclusions and RelevanceAmong participants in the ARCADIA trial with history of cancer, the risk of major ischemic and hemorrhagic events did not differ significantly with apixaban compared with aspirin.Trial RegistrationClinicalTrials.gov Identifier: NCT03192215

中文翻译：

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阿哌沙班与阿司匹林在癌症和隐源性中风患者中的疗效


重要性大约 10% 至 15% 的缺血性卒中与癌症有关;癌症相关卒中，尤其是隐源性卒中，与高复发性卒中和大出血率相关。关于不同抗血栓治疗策略对癌症和隐源性卒中患者的安全性和有效性的数据有限。目的比较阿哌沙班与阿司匹林预防癌症和隐源性卒中患者不良临床结局的效果。设计、设置和参与者对 1015 名近期隐源性中风患者的数据和心房心脏病的生物标志物证据进行事后分析隐源性中风和隐源性中风后预防药物 （ARCADIA） 试验，这是一项多中心、随机、双盲临床试验，于 2018 年至 2023 年在北美的 185 个中风中心进行。数据分析于 2023 年 10 月 15 日至 2024 年 5 月 23 日进行。检查基线时患有癌症和无癌症的患者亚组。主要结局和措施该事后分析的主要结局是主要缺血或主要出血事件的复合。主要的缺血事件是复发性缺血性卒中、心肌梗死、全身性栓塞和症状性深静脉血栓形成或肺栓塞。主要出血事件包括有症状的颅内出血和任何严重的颅外出血。结果在 1015 名参与者 （中位 [IQR] 年龄，68 [60-76] 岁;551 名 [54.3%] 女性）中，137 名 （13.5%） 有癌症病史。有癌症病史患者的中位 （IQR） 随访时间为 1.5 （0.6-2.5） 年，无癌症病史患者的中位 （IQR） 随访时间为 1.5 （0.6-3.0） 年。 与无癌症病史的参与者相比，有癌症病史的参与者发生严重缺血或严重出血事件的风险更高 （风险比 [HR]，1.73;95% CI，1.10-2.71）。在有癌症病史的患者中，61 名参与者中有 8 名 （13.1%） 被随机分配到阿哌沙班组，76 名参与者中有 16 名 （21.1%） 被随机分配到阿司匹林组，患有严重缺血或严重出血事件;然而，两组间风险无显著差异 （HR， 0.61;95% CI， 0.26-1.43）。比较随机分配到阿哌沙班组与阿司匹林组的癌症参与者，事件包括复发性中风 （5 例 [8.2%] 对 9 例 [11.8%]）、严重缺血事件 （7 例 [11.5%] 对 14 例 [18.4%]）和主要出血事件 （1 例 [1.6%] 对 2 例 [2.6%]）。结论和相关性在有癌症病史的 ARCADIA 试验参与者中，与阿司匹林相比，阿哌沙班组发生严重缺血和出血事件的风险没有显著差异。试验注册临床试验。gov 标识符： NCT03192215