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We reported the main results of the Japanese Registry of Neuroendovascular Therapy (JR-NET) 4, a nationwide surveillance of therapy (NET) in Japan from January 2015 to December 2019. JR-NET 4 registered consecutive patients who underwent NETs by Japan Society of Neuroendovascular Therapy (JSNET) -certified specialists. The primary endpoint was functional independence (mRS score of 0-2) at 30 days post-NET, with secondary endpoints focusing on technical success and major adverse events within 30 days.A total of 63,230 patients and 60,354 NET procedures from 166 participating centers were analyzed. During the study period, NET cases have consistently increased, with an increase in the proportion of elderly patients. A significant trend shift was observed in the distribution of NET procedures, with endovascular treatment for acute ischemic stroke that showed a dramatic increase in 5 years. This trend aligns with key randomized clinical trials from 2015 that presented the efficacy of this treatment. Clinical outcomes at 30 days posttreatment revealed that endovascular treatment for acute ischemic stroke and other NETs maintained safety and effectiveness despite varying prevalence of functional independence between target diseases. The study also observed a steady increase in emergency treatment cases, reflecting the increase in acute ischemic stroke, a time-sensitive medical condition.This comprehensive surveillance highlights the trend of NET practices in Japan, driven by clinical evidence and advancements in treatment devices. Although these findings were specific to Japan, they offer valuable insights into the broader trends in NETs and acute stroke care.

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., Competing Interests: 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., (© 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.)

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., Competing Interests: 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., (© 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.)

Background: The Wingspan stent system was approved as a rescue device for angioplasty of intracranial atherosclerotic disease (ICAD) in 2012. We conducted the government-recommended Japanese Postmarket Surveillance of Percutaneous Transluminal Angioplasty and Wingspan Stenting for Intracranial Atherosclerotic Disease to monitor Wingspan safety and performance., Methods: In this open-label, single-arm study at 76 centers in Japan, ICAD subjects were treated with the Wingspan stent between 2014 and 2016. Efficacy end points were successful stent deployment and technical success, defined as stenosis improvement to <50%. Safety end points were ischemic stroke, modified Rankin Scale and National Institutes of Health Stroke Scale scores, adverse events, and mortality. Subjects were considered treated outside of current recommendations if not already receiving antithrombotics or if percutaneous transluminal angioplasty and stenting occurred within 7 days of onset., Results: The safety cohort included 305 subjects (mean age: 68.7 + 9.6; 83.3% male). Four subjects were removed due to being out of contract. Therefore, 301 subjects were included (mean age: 68.7 ± 9.7; 84.1% male). Successful stent placement was 96.7%. Technical success was observed in 86.8% of lesions. At 1 year, the rate of restenosis was 15.7%, ischemic stroke was 3.9%, and any stroke was 7.9%. Functionally independent outcome (modified Rankin Scale: 0-2) was 88.9% and mortality 3.0%. Significantly more serious adverse events occurred in subjects treated outside of current recommendations (17.9%) versus subjects treated per current recommendations (8.8%) (P = 0.045)., Conclusions: Endovascular treatment using the Wingspan stent for ICAD is safe and effective in the Japanese population., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: In all of randomized controlled trials of mechanical thrombectomy, the target vessels were proximal. Herein we report a clinical trial of the Tron FX stent retriever, including the smallest size of 2/15 mm for distal intracranial large vessel occlusion (LVO)., Objective: Eligible patients presented within 8 h of onset with proximal or distal LVOs, and the Tron FX 4/20 mm or 2/15 mm were used as the first-line device., Methods: The primary endpoints were rate of modified Thrombolysis in Cerebral Infarction (mTICI) grade 2a-3 immediately after using Tron FX only, and mortality rate 90 d. We compared the outcomes between sizes 4/20 and 2/15 mm., Results: The clinical trial was conducted in 50 cases, of which 44% presented with distal LVO and 15 cases were treated using only Tron FX 2/15 mm. The overall rate of mTICI grade 2a-3 was 80.0% (75.8% with Tron FX 4/20 mm, and 86.7% with 2/15 mm), and a 90-day modified Rankin Scale ≤ 2 or improvement of National Institute of Health Stroke Scale after thrombectomy ≥ 10 was achieved in 66.7% of cases (61.3% with Tron FX 4/20 mm, and 80.0% with 2/15 mm). The overall 90-day mortality rate was 8.0%, and symptomatic intracranial hemorrhage within 24 h occurred in 2.0% of cases., Conclusion: In this clinical trial using the Tron FX, which included the size of 2/15 mm for distal LVO, its efficacy was similar and its safety was superior compared with previous studies., Competing Interests: Declaration of Competing Interest All authors who are members of the Japan Neurosurgical Society (JNS) have registered online self-reported conflicts of interest disclosure statement forms through the website for JNS members. H. Imamura received Speakers’ Bureau/Honoraria from Medtronic Co. N. Sakai received Speakers’ Bureau/Honoraria from JIMRO Co., Johnson & Johnson K.K., Medtronic Co,. Penumbra Co., and Stryker Japan K.K., and research funding from Japanese Ministry of Health, Labour and Welfare and Terumo Co. H. Yamagami received Speakers’ Bureau/Honoraria from Terumo Co., Biomedical Solutions Co., and Otsuka Pharmaceutical Co., and research funding from JIMRO Co. Y. Matsumoto received Speakers’ Bureau/Honoraria from Medtronic Co., Takeda Pharmaceutical Co., Otsuka Pharmaceutical Co., GE Health care Japan Co., Stryker Co., Century Medical Co., Medico's Hirata Co., and Fuji systems Co. S. Yoshimura received Speakers’ Bureau/Honoraria from Boehringer-Ingelheim Co., Daiichi Sankyo Co., Bayer Co., and Bristol-Meyers Squibb Co., and research funding from Otsuka Pharmaceutical Co. and Medtronic Co. Y. Matsumaru received Speakers’ Bureau/Honoraria from Medtronic Co., Stryker Co., Terumo Co., Johnson & Johnson Co., Kaneka Co., JIMRO Co., and Biomedical Solutions Co. Other authors have no conflict of interest related to this manuscript., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Recent studies have demonstrated that endovascular reperfusion therapy improves clinical outcomes at 90 days after ischemic stroke. However, the effects on long-term outcomes are not well known. We hypothesized that successful reperfusion might be associated with long-term improvement beyond 90 days after endovascular therapy. To assess the long-term effects beyond 90 days, we analyzed the association of successful reperfusion with a temporal change in modified Rankin Scale (mRS) score from 90 days to 1 year after endovascular therapy. Methods: We retrospectively analyzed a database of consecutive patients with acute ischemic stroke who received endovascular therapy between April 2006 and March 2016 at 4 centers. We compared the incidences of improvement and deterioration in patients with successful reperfusion (i.e., modified thrombolysis in cerebral infarction score of 2b or 3) with those in patients with unsuccessful reperfusion. We defined improvement and deterioration as decrease and increase on the mRS score by 1 point or more from 90 days to 1 year after endovascular therapy respectively. Results: A total of 268 patients were included in the current study. The rate of patients with improvement tended to be higher in patients with successful reperfusion than in patients with unsuccessful reperfusion (20% [34/167 patients] vs. 12% [12/101], p = 0.07). The rate of patients with deterioration was lower in patients with successful reperfusion than in patients with unsuccessful reperfusion (25% [42/167] vs. 42% [42/101], p < 0.01). After adjustment for confounders, successful reperfusion was associated with improvement (adjusted OR 2.65; 95% CI 1.23–5.73; p < 0.05) and deterioration (adjusted OR 0.33; 95% CI 0.18–0.62; p < 0.01), independent of the 90-day mRS score. Conclusions: Successful reperfusion has further beneficial legacy effects on long-term outcomes beyond 90 days after stroke. [ABSTRACT FROM AUTHOR]

Existing evidence is inconclusive on whether women after carotid artery stenting (CAS) experience worse outcomes than men. The outcomes of women and men were compared using the data from nationwide retrospective registry between 2015 and 2019. The primary outcome was the incidence of ischemic stroke and all-cause death. Secondary outcomes included the incidence of ischemic stroke, all-cause death, acute occlusion, and acute myocardial infarction. Functional outcomes were the achieving an mRS score of 0–1 and 0–2. Outcomes were assessed at 30 days after CAS. In total, 9792 patients (1330 women, 8862 men; mean age, 73.8 vs 73.5 years, p = 0.17) were analyzed. Symptomatic stenosis was common in men (52.0% vs. 55.1%; p = 0.03), while ≥50% stenosis after CAS was common in women (3.2% vs. 2.0%; p = 0.005). The primary outcome was no significantly difference in women and men (2.0% vs. 1.9%; adjusted odds ratio [aOR], 1.19; 95% confidence interval [95%CI], 0.75–1.88).The incidence of all-cause death was higher in women (0.9% vs. 0.5%; aOR, 2.45; 95%CI, 1.11–5.39). Functional outcomes were significantly less common in women than in men (mRS0–1, 72.6% vs. 74.8%; aOR, 0.77; 95%CI, 0.63–0.95; mRS0–2, 82.1% vs. 85.6%; aOR, 0.76; 95%CI, 0.60–0.95). This study suggests that there was no significant sex differences in the incidence of ischemic stroke and all-cause death at 30 days. However, women have higher rate of all-cause death and poorer functional outcomes at 30 days than men. • Whether women after carotid artery stenting (CAS) experience worse outcomes than men are inconclusive. • There was no significant sex difference in the incidence of ischemic stroke and all-cause death at 30 days. • Women have higher rate of all-cause death and poorer functional outcomes at 30 days than men. [ABSTRACT FROM AUTHOR]