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Vascular neurology
Relation between duration of dual antiplatelet therapy and risk of ischemic stroke after stent-assisted treatment of cerebral aneurysm (DAPTS ACE-registry)
  1. Tomohiko Ozaki1,
  2. Hiroshi Yamagami2,
  3. Masafumi Morimoto3,
  4. Hirotoshi Imamura4,
  5. Taketo Hatano5,
  6. Hidenori Oishi6,
  7. Koichi Haraguchi7,
  8. Shinichi Yoshimura8,
  9. Tetsu Satow9,
  10. Kenji Sugiu10,
  11. Koji Iihara11,
  12. Yuji Matsumaru12,
  13. Mikito Hayakawa12,
  14. Yasushi Matsumoto13,
  15. Chiaki Sakai4,
  16. Susumu Miyamoto14,
  17. Kazuo Kitagawa15,
  18. Tatsuo Kagimura16,
  19. Nobuyuki Sakai4
  1. 1Neurosurgery, National Hospital Organization Osaka National Hospital, Osaka, Japan
  2. 2Stroke Neurology, National Hospital Organization Osaka National Hospital, Osaka, Japan
  3. 3Neurosurgery, Yokohama Shintoshi Neurosurgical Hospital, Yokohama, Kanagawa, Japan
  4. 4Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
  5. 5Neurosurgery, Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan
  6. 6Department of Neurosurgery, Juntendo University, Faculty of Medicine, Tokyo, Japan
  7. 7Neurosurgery, Hakodate Shintoshi Hospital, Hakodate, Japan
  8. 8Neurosurgery, Hyogo College of Medicine, Nishinomiya city, Japan
  9. 9Department of Neurosurgery, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan
  10. 10Department of Neurological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Kita-ku, Okayama, Japan
  11. 11Neurosurgery, National Cerebral and Cardiovascular Center Hospital, Suita, Osaka, Japan
  12. 12Department of Neurology, Institute of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan
  13. 13Division of Development and Discovery of Interventional Therapy, Tohoku University Hospital, Sendai, Miyagi, Japan
  14. 14Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan
  15. 15Neurology, Tokyo Women's Medical University School of Medicine, Shinjuku-ku, Tokyo, Japan
  16. 16Foundation for Biomedical Research and Innovation at Kobe, Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
  1. Correspondence to Dr Hiroshi Yamagami, Stroke Neurology, National Hospital Organization Osaka National Hospital, Osaka, Osaka, Japan; yamagami.brain{at}outlook.com

Abstract

Background The optimal duration of dual antiplatelet therapy (DAPT) in patients with cerebral aneurysm who undergo stent-assisted coil embolization (SACE) has not been established. We aimed to clarify the association between duration of DAPT and incidence of ischemic stroke in patients with cerebral aneurysm.

Methods We registered patients with cerebral aneurysm who underwent SACE in 27 hospitals in Japan. Those treated with DAPT (aspirin and clopidogrel) were eligible for inclusion in a previously reported randomized control trial (RCT). Patients who were ineligible or refused to participate to the RCT were followed-up for 15 months after SACE as the non-RCT cohort. Our study examined both the RCT and non-RCT cohorts. The primary and secondary outcomes were ischemic stroke and hemorrhagic events.

Results Among the 313 patients registered, 296 were included for analysis (of these, 136 were RCT patients and 160 were non-RCT patients). Patients who were treated with DAPT for more than 6 months (n=191) were classified as the long-term DAPT group. Those treated less than 6 months (n=105) were classified as the short-term group. The incidence of ischemic stroke did not significantly differ between the long-term group (2.5 per 100 person-years) and the short-term group (3.2 per 100 person-years); nor did incidence of hemorrhagic events (0.8 and 3.2 per 100 person-years, respectively). The period of DAPT was not significantly associated with incidence rates of ischemic stroke or hemorrhagic events.

Conclusions Duration of DAPT was not associated with the incidence of ischemic stroke in the first 15 months after SACE.

  • Intervention
  • Aneurysm

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/jnis-2023-020495

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Contributors TO performed the data analysis and drafted the manuscript. HY and NS conceptualized and designed the study. HY is responsible for over all content as guatantor. HY accepts full responsibility for the finished work and/or the conduct of the study, had access to the data, and controlled the decision to publish. MM, HI, TH, HO, KH, SY, TS, KS, YuM, YaM, and MH acquired the data. HY, HO, SY, KS, KI, YuM, and YaM comprised the Steering Committee. TS, MH, and CS assisted in devising the study protocol. SM and KK comprised the independent Event Evaluation Committee. TK contributed to the statistical analyses. All authors reviewed the manuscript and approved the final version.

    • Funding DAPTS ACE was funded by a public interest foundation. The foundation raised financial resources for performing this research, and this research was funded by Daiichi Sankyo Co., Ltd. Daiichi Sankyo Co., Ltd. had no role in study design, data collection, data analysis, data interpretation, or manuscript writing. Some of the investigators have received compensation from Daiichi Sankyo Co., Ltd. for work not related to the present study.

    • Competing interests HY reports research grants from Bristol-Myers Squibb and lecturer’s fees from Stryker, Medtronic, Terumo, Johnson & Johnson, Bristol-Myers Squibb, Daiichi Sankyo, Otsuka Pharmaceutical. and Medico's Hirata. HI reports lecture's fee from Medtronic Japan, Daiichi Sankyo, Johnson & Johnson, Stryker Jaoan, Terumo, and Asahi Intecc. HO reports research grants from Terumo, Stryker, Medtronic, Medikit, and Kaneka and consulting fees from Medtronic, Stryker, Kaneka, and Asahi Intec. KS reports lecturer’s fees from Medtronic Japan, Kaneka Medix, and Terumo. YM reports lecturer’s fees from Daiichi Sakyo, Otsuka Pharmaceutical, Medtronic, Stryker, Terumo, Johnson &Johnson, Kaneka, and Medico’s Hirata. KK reports lecturer’s fees from Kyowa Kirin and Daiichi Sankyo. YM serves in an advisory role for GE Healthcare, Fuji Systems, Medico’s Hirata, and Stryker; he reports patents and royalties from Sumitomo Bakelite and lecturer’s fees from GE Healthcare, Stryker, Medtronic, Medico’s Hirata, Century Medical, Takeda Pharmaceutical Company, Otsuka Pharmaceutical, Kaneka, and Fuji Systems. TS reports research grants from CANON medical systems, lecturer’s fees from Medtronic, and consulting fees from Kaneka Medix. CS reports research grants from Biomedical Solutions, Medtronic, and Terumo and lecturer’s fees from Asahi-Intec, Biomedical Solutions, Medtronic, and Terumo; he is also a member of the advisory boards of Johnson & Johnson, Medtronic, and Terumo.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.