International Stroke Conference 2025  /  Closing Main Event  /  A randomized controlled trial of antithrombotic therapy in ischemic stroke patients with non-valvular atrial fibrillation and atherosclerosis: The ATIS-NVAF trial
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American Heart Association

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Final ID: LB43

A randomized controlled trial of antithrombotic therapy in ischemic stroke patients with non-valvular atrial fibrillation and atherosclerosis: The ATIS-NVAF trial

Abstract Body: Background: The addition of antiplatelet therapy to anticoagulant therapy in patients with stroke with non-valvular atrial fibrillation (NVAF) and atherosclerotic cardiovascular disease (ASCVD) may increase bleeding risk without reducing recurrent stroke risk, while it may provide enhanced protection against ischemic events compared to anticoagulant monotherapy. We aimed to evaluate the clinical benefits of anticoagulant monotherapy compared to combination therapy with anticoagulants and antiplatelet agents.
Methods: The optimal antithrombotic therapy in ischemic stroke patients with NVAF and atherothrombosis (ATIS-NVAF) trial is a multicenter, open-label, randomized clinical trial in Japan, enrolling patients with NVAF and ASCVD. Participants were randomized in a 1:1 ratio to receive either anticoagulant monotherapy or combination therapy with anticoagulants and antiplatelet agents. The primary outcome was a composite of cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization, and major bleeding events within 2 years. Secondary outcomes included ischemic cardiovascular events, and safety outcomes included major and clinically relevant non-major bleeding events.
Results: Participants were recruited from May 2017 to April 2022, and the trial was terminated after the first planned interim analysis because of futility. Although the initial sample size target was 400 patients (200 per group), 316 patients (mean age 77.2 years, 226 men, 157 in the anticoagulant monotherapy and 159 in the combination therapy group) were included in the primary analysis. The cumulative incidence of the primary outcome was 19.6% in the monotherapy group and 17.8% in the combination therapy group (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.64 to 1.89; P=0.64). Whereas the incidence of ischemic cardiovascular events was similar between groups (14.2% vs 11.1%, HR, 1.32: 95% 0.68 to 2.58), monotherapy was associated with a remarkable lower risk of major and clinically relevant non-major bleeding (HR 0.41; 95%CI, 0.21 to 0.81; unadjusted P=0.008).
Conclusion: In ischemic stroke patients with NVAF and ASCVD, anticoagulant monotherapy demonstrated lower bleeding risk than combination therapy with antiplatelets despite no superiority in primary outcome.

Clinical Trial Registration
ClinicalTrials.gov: NCT03062319; UMIN-CTR: UMIN000025392; Japan Registry of Clinical Trials: jRCTs051180202
  • Okazaki, Shuhei  ( NHO Osaka National Hospital , Osaka , Japan )
  • Tanaka, Kanta  ( Kindai University Hospital , Osaka-sayama , Japan )
  • Yazawa, Yukako  ( Kohnan Hospital , Sendai , Japan )
  • Doijiri, Ryosuke  ( Akita Cerebrospinal and Cardiovascular Center , Akita , Japan )
  • Koga, Masatoshi  ( National Cerebral and Cardiovascular Center , Suita , Japan )
  • Ihara, Masafumi  ( National Cerebral and Cardiovascular Center , Suita , Japan )
  • Yamamoto, Shiro  ( NHO Osaka Minami Medical Center , Kawachinagano , Japan )
  • Kamiyama, Kenji  ( Nakamura Memorial Hospital , Sapporo , Japan )
  • Honda, Yuko  ( Kyorin University , Mitaka , Japan )
  • Uchida, Kazutaka  ( Hyogo Medical University , Nishinomiya , Japan )
  • Asakura, Koko  ( National Cerebral and Cardiovascular Center , Suita , Japan )
  • Omae, Katsuhiro  ( National Cerebral and Cardiovascular Center , Suita , Japan )
  • Yamamoto, Haruko  ( National Cerebral and Cardiovascular Center , Suita , Japan )
  • Hirano, Teruyuki  ( Kyorin University , Mitaka , Japan )
  • Toyoda, Kazunori  ( National Cerebral and Cardiovascular Center , Suita , Japan )
  • Iguchi, Yasuyuki  ( Jikei University , Tokyo , Japan )
  • Noguchi, Teruo  ( National Cerebral and Cardiovascular Center , Suita , Japan )
  • Okada, Yasushi  ( NHO Kyushu Medical Center , Fukuoka , Japan )
  • Kitagawa, Kazuo  ( Suita Municipal Hospital , Suita , Japan )
  • Sakai, Nobuyuki  ( Seijinkai Shimizu Hospital , Kyoto , Japan )
  • Yamagami, Hiroshi  ( University of Tsukuba , Tsukuba , Japan )
    • Author Disclosures:
    Shuhei Okazaki: DO NOT have relevant financial relationships | Kazutaka Uchida: DO have relevant financial relationships ; Speaker:Hyogo Medical University:Past (completed) ; Speaker:Stryker:Past (completed) | Koko Asakura: DO NOT have relevant financial relationships | Katsuhiro Omae: No Answer | Haruko Yamamoto: DO NOT have relevant financial relationships | Teruyuki Hirano: DO NOT have relevant financial relationships | Kazunori Toyoda: DO have relevant financial relationships ; Speaker:BMS:Active (exists now) ; Speaker:Bayer:Active (exists now) ; Speaker:Daiichi-Sankyo:Active (exists now) ; Speaker:Otsuka:Active (exists now) ; Advisor:Janssen:Active (exists now) | Yasuyuki Iguchi: DO have relevant financial relationships ; Speaker:Daiichi-Sankyo:Active (exists now) ; Speaker:Alexion:Active (exists now) ; Speaker:Amagen Biogen:Active (exists now) ; Speaker:Takeda:Active (exists now) ; Speaker:Sumitomo Dainippon:Active (exists now) ; Speaker:Pfizer:Active (exists now) ; Speaker:Otsuka:Active (exists now) ; Speaker:Novartis:Active (exists now) ; Speaker:Mitsubishi-Tanabe:Active (exists now) ; Speaker:JB:Active (exists now) ; Speaker:Eisai:Active (exists now) ; Speaker:CSL-Behring:Active (exists now) ; Speaker:Chugai:Active (exists now) | Teruo Noguchi: No Answer | Yasushi Okada: DO NOT have relevant financial relationships | Kazuo Kitagawa: DO NOT have relevant financial relationships | Kanta Tanaka: DO NOT have relevant financial relationships | Nobuyuki Sakai: DO NOT have relevant financial relationships | Hiroshi Yamagami: DO NOT have relevant financial relationships | Yukako Yazawa: DO NOT have relevant financial relationships | Ryosuke Doijiri: DO have relevant financial relationships ; Speaker:Otsuka Pharmaceutical:Past (completed) ; Speaker:Abbott:Past (completed) ; Speaker:Medtronic:Past (completed) | Masatoshi Koga: DO have relevant financial relationships ; Research Funding (PI or named investigator):Nippon Boehringer Ingelheim:Past (completed) ; Research Funding (PI or named investigator):Daiichi-Sankyo:Active (exists now) ; Research Funding (PI or named investigator):Boston Scientific:Expected (by end of conference) ; Speaker:Otsuka Pharmaceutical:Past (completed) ; Speaker:BMS/Pfizer:Past (completed) ; Speaker:Mitsubishi Tanabe Pharma Corporation:Past (completed) ; Speaker:Bayer Yakuhin:Past (completed) ; Speaker:AstraZeneca:Past (completed) ; Speaker:Daiichi-Sankyo:Active (exists now) ; Advisor:BMS/Janssen Pharmaceuticals:Active (exists now) | Masafumi Ihara: DO NOT have relevant financial relationships | Shiro Yamamoto: No Answer | Kenji Kamiyama: DO NOT have relevant financial relationships | Yuko Honda: No Answer
Meeting Info:

International Stroke Conference 2025

2025

Los Angeles, CA

Session Info:

Closing Main Event

Friday, 02/07/2025 , 11:00AM - 01:05PM

ISC Invited Symposium

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