Short- versus long-term Dual AntiPlatelet Therapy for Stent-Assisted treatment of CErebral aneurysm (DAPTS ACE): a multicenter, open-label, randomized clinical trial.

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.

Informations de copyright

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

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.