PMID- 37068941 OWN - NLM STAT- MEDLINE DCOM- 20240115 LR - 20240210 IS - 1759-8486 (Electronic) IS - 1759-8478 (Print) IS - 1759-8478 (Linking) VI - 16 IP - 2 DP - 2024 Jan 12 TI - Short- versus long-term Dual AntiPlatelet Therapy for Stent-Assisted treatment of CErebral aneurysm (DAPTS ACE): a multicenter, open-label, randomized clinical trial. PG - 171-176 LID - 10.1136/jnis-2022-019867 [doi] AB - BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after stent-assisted coil embolization (SACE) for cerebral aneurysm remains uncertain. This randomized trial of short- versus long-term Dual AntiPlatelet Therapy for Stent-Assisted treatment of CErebral aneurysm (DAPTS ACE) aimed to clarify whether long-term DAPT can reduce the occurrence of ischemic stroke in patients with cerebral aneurysms treated by SACE compared with short-term DAPT. METHODS: Patients treated for cerebral aneurysm with SACE were enrolled from 17 hospitals in Japan. Patients were enrolled within 30 days after SACE and assigned in a 1:1 ratio to receive long-term (12 months) or short-term (3 months) DAPT with aspirin and clopidogrel. Randomization was performed centrally through a web-based system. The primary outcome was the time to ischemic stroke event during 3 to 12 months after SACE. This trial was registered with the Japan Registry of Clinical Trials (jRCTs051180141). RESULTS: A total of 142 patients were recruited from November 4, 2016 to January 7, 2019. Among them, 65 and 68 patients assigned to the long- and short-term DAPT groups, respectively, were included in the full analysis set. Ischemic stroke occurred in no patients in the long-term DAPT group and in one patient in the short-term DAPT group. The incidence rate did not differ between the groups (0.0 vs 2.1/100 person-years; log rank test, P=0.33). CONCLUSIONS: In this multicenter randomized controlled trial, there was not a statistically significant difference in the rate of ischemic strokes between long- and short-term DAPT. CI - (c) Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Ozaki, Tomohiko AU - Ozaki T AUID- ORCID: 0000-0003-1558-4785 AD - Neurosurgery, National Hospital Organization Osaka National Hospital, Osaka, Japan. FAU - Yamagami, Hiroshi AU - Yamagami H AD - Stroke Neurology, National Hospital Organization Osaka National Hospital, Osaka, Japan yamagami.brain@outlook.com. FAU - Morimoto, Masafumi AU - Morimoto M AD - Neurosurgery, Yokohama Shintoshi Neurosurgical Hospital, Yokohama, Kanagawa, Japan. FAU - Hatano, Taketo AU - Hatano T AD - Neurosurgery, Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan. FAU - Oishi, Hidenori AU - Oishi H AD - Neurosurgery, Juntendo University, Faculty of Medicine, Tokyo, Japan. AD - Neuroendovascular Therapy, Juntendo University, Faculty of Medicine, Tokyo, Japan. FAU - Haraguchi, Koichi AU - Haraguchi K AD - Neurosurgery, Hakodate Shintoshi Hospital, Hakodate, Japan. FAU - Yoshimura, Shinichi AU - Yoshimura S AD - Neurosurgery, Hyogo Medical University, Nishinomiya, Hyogo, Japan. FAU - Sugiu, Kenji AU - Sugiu K AD - Neurosurgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Okayama, Japan. FAU - Iihara, Koji AU - Iihara K AD - Neurosurgery, National Cerebral and Cardiovascular Center Hospital, Suita, Osaka, Japan. FAU - Matsumaru, Yuji AU - Matsumaru Y AD - Division of Stroke Prevention and Treatment, Department of Neurosurgery, University of Tsukuba Faculty of Medicine, Tsukuba, Ibaraki, Japan. FAU - Matsumoto, Yasushi AU - Matsumoto Y AD - Division of Development and Discovery of Interventional Therapy, Tohoku University Hospital, Sendai, Miyagi, Japan. FAU - Satow, Tetsu AU - Satow T AD - Neurosurgery, Kindai University, Osaka-Sayama, Osaka, Japan. FAU - Hayakawa, Mikito AU - Hayakawa M AD - Division of Stroke Prevention and Treatment, Department of Neurosurgery, University of Tsukuba Faculty of Medicine, Tsukuba, Ibaraki, Japan. FAU - Sakai, Chiaki AU - Sakai C AD - Neurosurgery, Kobe City Medical Center General Hospital, Kobe-city, Japan. FAU - Miyamoto, Susumu AU - Miyamoto S AD - Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan. FAU - Kitagawa, Kazuo AU - Kitagawa K AD - Neurology, Tokyo Women's Medical University School of Medicine, Shinjuku-ku, Tokyo, Japan. FAU - Daimon, Takashi AU - Daimon T AD - Biostatistics, Hyogo Medical University, Nishinomiya, Hyogo, Japan. FAU - Kagimura, Tatsuo AU - Kagimura T AD - Foundation for Biomedical Research and Innovation at Kobe, Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. FAU - Sakai, Nobuyuki AU - Sakai N AD - Neurosurgery, Kobe City Medical Center General Hospital, Kobe-city, Hyogo, Japan. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20240112 PL - England TA - J Neurointerv Surg JT - Journal of neurointerventional surgery JID - 101517079 RN - 0 (Platelet Aggregation Inhibitors) RN - R16CO5Y76E (Aspirin) SB - IM MH - Humans MH - Platelet Aggregation Inhibitors MH - *Intracranial Aneurysm/diagnostic imaging/drug therapy MH - Aspirin MH - Stents MH - Drug Therapy, Combination MH - *Ischemic Stroke/etiology MH - *Percutaneous Coronary Intervention MH - Treatment Outcome PMC - PMC10850618 OTO - NOTNLM OT - Aneurysm OT - Drug OT - Intervention COIS- Competing interests: HY reports research grants from Bristol-Myers Squibb; lecturer's fees from Stryker, Medtronic, Terumo, Johnson & Johnson, Biomedical Solutions, Bristol-Myers Squibb, Daiichi Sankyo, and Medico's Hirata. 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. YuM reports lecturer's fees from Daiichi Sakyo, Otsuka Pharmaceutical, Medtronic, Stryker, Terumo, Johnson & Johnson, Kaneka, and Medicos Hirata. KK reports lecturer's fee from Kyowa Kirin and Daiichi Sankyo. YaM reports advisory role for GE Health Care, Fuji Systems, Medicos Hirata, and Stryker; patents and royalties from Sumitomo Bakelite; lecturer's fee 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. TD reports consultant fees from Ajinomoto, Astellas Pharma, Daiichi Sankyo, Eisai, Ferring Pharmaceuticals, Healios, Integral Geometry Science, Ono Pharmaceutical, Periotherapia, and Terumo; lecturer's fee from Bayer, Chugai Pharmaceutical, Daiichi Sankyo, Ono Pharmaceutical, and Takeda Pharmaceutical Company; participation fees on Data Safety Monitoring Boards or Advisory Boards from Astellas Pharma, Eisai, and Terumo Corporation, outside of the submitted work. NS reports a research grant from Biomedical Solutions, Medtronic and Terumo; lecturer's fees from Asahi-Intec, Biomedical Solutions, Medtronic, and Terumo; membership on the advisory boards for Johnson&Johnson, Medtronic and Terumo outside the submitted work. EDAT- 2023/04/18 06:00 MHDA- 2024/01/15 12:42 PMCR- 2024/02/08 CRDT- 2023/04/17 21:41 PHST- 2022/11/12 00:00 [received] PHST- 2023/04/02 00:00 [accepted] PHST- 2024/01/15 12:42 [medline] PHST- 2023/04/18 06:00 [pubmed] PHST- 2023/04/17 21:41 [entrez] PHST- 2024/02/08 00:00 [pmc-release] AID - jnis-2022-019867 [pii] AID - 10.1136/jnis-2022-019867 [doi] PST - epublish SO - J Neurointerv Surg. 2024 Jan 12;16(2):171-176. doi: 10.1136/jnis-2022-019867.