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Apixaban vs Aspirin in Patients With Cancer and Cryptogenic Stroke : A Post Hoc Analysis of the ARCADIA Randomized Clinical Trial

Babak B. Navi, MD, MS; Cenai Zhang, MS; Benjamin Miller, MD; et al

2024년 8월 12일

JAMA Neurology. 2024;81(9):958-965.
doi:10.1001/jamaneurol.2024.2404

Abstract

Importance 

Approximately 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.


Objective 

To compare apixaban vs aspirin for the prevention of adverse clinical outcomes in patients with history of cancer and cryptogenic stroke.


Design, Setting, and Participants 

Post 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.


Exposures 

Oral 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 Measures 

The 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.


Results 

Among 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 Relevance 

Among 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.


Meaning

Among ARCADIA trial participants with history of cancer, the risk of major ischemic or hemorrhagic events did not differ significantly with apixaban vs aspirin, but a clinically important benefit of apixaban could not be ruled out.



요약

  • 소개 : 본 연구는 ARCADIA(Atrial Cardiopathy and Antithrombotic Drugs in Prevention After Cryptogenic Stroke) 임상연구의 사후검증 연구로, 암 과거력이 있는 환자군에서 아픽사반과 아스피린의 부정적인 임상 결과(adverse clinical outcome)에 대한 예방 능력을 비교하기 위한 연구이다.


  • 결과 : 1) 암 과거력이 있는 환자들은 암 과거력이 없는 환자들에 비해 주요 허혈성 및 출혈성 사건 발생의 위험이 높았다. 2) 암 과거력이 있는 ARCADIA 임상시험 피험자 그룹에서 아픽사반을 사용할 경우 아스피린에 비해 주요 허혈성 혹은 출혈성 사건 발생의 위험이 낮았지만, 통계적으로 유의한 수준은 아니었다. (여기에서 주요 허혈성 사건이란 재발성 허혈성 뇌졸중, 심근경색, 전신색전증, 정맥혈전증, 폐색전증을 말하고, 주요 출혈성 사건이란 뇌내출혈 및 그 외 주요 출혈들을 의미한다.)


  • 의의 : 암 관련 특발성 뇌졸중에 관한 최적의 항혈전 전략을 찾고자 한 연구로, 본 연구에서 아픽사반과 아스피린 간의 주요 뇌졸중 위험의 차이는 유의미하지 않았지만, 아픽사반이 아스피린에 비해 뇌졸중 예방 측면에서 열등하지 않음을 보여준다. 그렇지만 아픽사반의 임상적 이점을 배제할 수는 없다.


#Stroke, #Cryptogenic stroke

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