Impact of Intracranial Hemorrhage After Endovascular Treatment for Medium Vessel Occlusion.

BACKGROUND AND OBJECTIVES: Endovascular treatment (EVT) for medium vessel occlusion (MeVO) raises concern about hemorrhagic complications; however, its clinical impact has not been elucidated. Therefore, we investigated the association between intracranial hemorrhage (ICH) after EVT for MeVO and functional outcomes. METHODS: We conducted a post hoc analysis of the Japan Registry of NeuroEndovascular Therapy 4, a nationwide registry in Japan from 2015 to 2019 including 13 479 patients who underwent EVT for acute ischemic stroke. This study included 2465 patients with MeVO from 166 participating centers in Japan. We compared patients who underwent EVT for MeVO according to their hemorrhagic complication after EVT (no ICH, asymptomatic ICH, and symptomatic ICH). Outcomes included a modified Rankin scale (mRS) score at 30 days and all-cause mortality within 30 days. We estimated the odds ratios (ORs) and their CIs using a multivariable logistic regression model. RESULTS: Among 2394 patients analyzed, 302 (12.6%) developed ICH, with 95 (31.5%) being symptomatic. Compared with the no-ICH group (n = 2092), the asymptomatic and symptomatic ICH groups had a lower proportion of patients with an mRS score of 0 to 2 at 30 days (41% vs 34%, vs 7.4%, P for trend <.001), with an adjusted ORs of 0.77 (95% CI, 0.53-1.12) and 0.12 (95% CI, 0.05-0.30) in the asymptomatic and symptomatic ICH groups, respectively. The adjusted common ORs of one-point shift of mRS score at 30 days in the asymptomatic ICH group was 0.76 (95% CI, 0.57-0.99) and that of the symptomatic ICH group was 0.13 (0.07-0.23), compared with the no-ICH group. CONCLUSION: ICH after EVT for MeVO was associated with worse outcomes, whether they were symptomatic or not. The optimal treatment devices or techniques to reduce ICH after EVT for MeVO are crucial.

Preoperative Simulation of Intraoperative Findings in Surgical Clipping of Posterior Communicating Artery Aneurysms Using T2-Weighted 3D Images.

BACKGROUND: Tentorium resection and detachment from the oculomotor nerve are sometimes required for surgical clipping of unruptured posterior communicating artery (PCoA) aneurysms. Using T2-weighted 3D images, we aimed to identify the preoperative radiological features required to determine the necessity of these additional procedures. METHODS: We reviewed 30 patients with unruptured PCoA aneurysms who underwent surgical clipping and preoperative simulation using T2-weighted 3D images for measurement of the distance between the tentorium and aneurysm. Aneurysms were classified into superior type (superior to the tentorium) and inferior type (inferior to the tentorium). RESULTS: Seven patients (23%) underwent tentorium resection; all had the inferior type (superior vs. inferior, 0% vs. 33%, p = 0.071). In the 21 patients with the inferior type, the distance from the tentorium to the aneurysmal neck was 2.2 ± 1.1 mm and 0.0 ± 0.5 mm without and with tentorium resection (p < 0.01), respectively. An optimal cutoff value of ≤ +0.84 mm was identified for tentorium resection (area under the curve (AUC) = 0.96). Furthermore, 17 patients (57%) showed tight aneurysm attachment to the oculomotor nerve; all had the inferior type (0% vs. 81%, p < 0.01). The distance from the aneurysm tip to the tentorium was 1.1 ± 1.2 mm and -1.7 ± 1.4 mm without and with attachment (p < 0.01). The optimal cutoff value was ≤ +0.45 mm (AUC = 0.92). CONCLUSIONS: Measurement of the distance between the tentorium and aneurysmal neck or tip with T2-weighted 3D images is effective for preoperative simulation for surgical clipping of PCoA aneurysms.

Hemodynamic differences determining rupture and non-rupture in middle cerebral aneurysms after growth.

BACKGROUND AND PURPOSE: Intracranial aneurysm growth is a significant risk factor for rupture; however, a few aneurysms remain unruptured for long periods, even after growth. Here, we identified hemodynamic features associated with aneurysmal rupture after growth. MATERIALS AND METHODS: We analyzed nine middle cerebral artery aneurysms that grew during the follow-up period using computational fluid dynamics analysis. Growth patterns of the middle cerebral artery aneurysms were divided into homothetic growth (Type 1), de novo bleb formation (Type 2), and bleb enlargement (Type 3). Hemodynamic parameters of the four ruptured aneurysms after growth were compared with those of the five unruptured aneurysms. RESULTS: Among nine aneurysms (78%), seven were Type 1, one was Type 2, and one was Type 3. Three (43%) Type 1 aneurysms ruptured after growth. Maximum oscillatory shear index after aneurysmal growth was significantly higher in ruptured Type 1 cases than in unruptured Type 1 cases (ruptured vs. unruptured: 0.455 ± 0.007 vs. 0.319 ± 0.042, p = 0.003). In Type 1 cases, a newly emerged high-oscillatory shear index area was frequently associated with rupture, indicating a rupture point. Aneurysm growth was observed in the direction of the high-pressure difference area before enlargement. In Types 2 and 3 aneurysms, the maximum oscillatory shear index decreased slightly, however, the pressure difference values remain unchanged. In Type 3 aneruysm, the maximum OSI and PD values remained unchanged. CONCLUSIONS: This study suggests that hemodynamic variations and growth pattern changes are crucial in rupture risk determination using computational fluid dynamics analysis. High-pressure difference areas may predict aneurysm enlargement direction. Additionally, high maximum oscillatory shear index values after enlargement in cases with homothetic growth patterns were potential rupture risk factors.

Comparative analysis of peri-nidal cerebral blood flow and metabolism using a novel quantitative 15O-PET method in patients with arteriovenous malformations.

To effectively treat cerebral arteriovenous malformations (AVMs), peri-nidal flow regulation and metabolic status must be understood. In this study, we used 15O-oxygen positron emission tomography (PET) post-processing analysis to investigate vascular radioactivity in the nidal region of AVMs. Single-dynamic PET imaging was performed on seven unruptured AVM patients during the sequential inhalation of 15O2 and C15O2. A previously validated dual-tracer basis function method (DBFM) was employed to calculate parametric images. The results of our study were as follows. First, in remote and contralateral AVM regions, DBFM and a previous approach of dual-tracer autoradiography (DARG) showed strong positive correlations in cerebral blood flow (CBF), cerebral oxygen metabolism rate (CMRO2), and oxygen extraction fraction. Second, peri-nidal CBF and CMRO2 correlation was lower, and overestimation occurred with DARG compared to with DBFM. Third, on comparing DBFM to quantitative 123I-iodoamphetamine single-photon emission computed tomography (SPECT), CBF correlated significantly. In contrast, the correlation between DARG and quantitative 123I-iodoamphetamine-SPECT was weaker in the peri-nidal regions. Fourth, analysis of tissue time-activity curves demonstrated good reproducibility using the novel formulation in the control, peri-nidus, and core nidal regions, indicating the adequacy of this approach. Overall, the DBFM approach holds promise for assessing haemodynamic alterations in patients with AVMs.

Trends and Progress in Neuroendovascular Treatment in Japan: Japanese Registry of Neuroendovascular Therapy (JR-NET) 4. Main Report.

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.

Ulceration location is associated with clinical course in carotid stenosis.

OBJECTIVE: Plaque ulceration in carotid artery stenosis is a risk factor for cerebral ischemic events; however, the characteristics that determine plaque vulnerability are not fully understood. We thus assessed the association between plaque ulceration sites and cerebrovascular ischemic attack. METHODS: We retrospectively collected the clinical data of 72 consecutive patients diagnosed with carotid artery stenosis with plaque ulcers. After excluding patients with pseudo-occlusion, a history of previous carotid endarterectomy or carotid artery stenting before the ulcer was first discovered, follow-up data of less than 1 month, or carotid endarterectomy or carotid artery stenting performed within 1 month after the ulcer was first discovered, 60 patients were ultimately included. Patients were divided into proximal and distal groups based on the ulcer location relative to the most stenotic point. The primary endpoints were ipsilateral cerebrovascular ischemic events ("ischemic events"), such as amaurosis fugax, transient ischemic attack, or ischemic stroke due to carotid artery stenosis with plaque ulceration. The association between ulcer location and ischemic events was also assessed. RESULTS: In the patients with plaque ulcer, more patients had proximal than distal plaque ulcers (39 vs 21; P = .028). The median follow-up duration was 3.8 years (interquartile range, 1.5-6.2 years). Nineteen patients (32%) experienced ischemic event. Ischemic events occurred more frequently in the distal than in the proximal group (18% vs 59%; P = .005). Kaplan-Meier curves demonstrated a significantly shorter event-free time in the distal group (log-rank P = .021). In univariate analysis, distal ulcer location was associated with ischemic events (odds ratio [OR], 2.94; 95% confidence interval [CI], 1.13-7.65; P = .03). Multivariate analysis using two different models also showed that distal ulcer location was independently associated with ischemic events (Model 1: OR, 3.85; 95% CI, 1.26-11.78; P = .03; Model 2: OR, 4.31; 95% CI, 1.49-12.49; P = .009). CONCLUSIONS: Patients with carotid artery stenosis and plaque ulcers located distal to the most stenotic point are more likely to experience cerebrovascular ischemic attacks. Therefore, carotid plaques with ulcers located distal to the most stenotic point may be a potential indication for surgical treatment.

Real-World Outcomes of Carotid Artery Stenting in Symptomatic and Asymptomatic Patients With Carotid Artery Stenosis.

BACKGROUND: The effectiveness and safety of carotid artery stenting (CAS) are comparable to those of carotid endarterectomy in both symptomatic and asymptomatic patients with carotid artery stenosis, but real-world outcomes are not well-known. OBJECTIVES: The purpose of this study was to investigate the real-world clinical outcomes of CAS in symptomatic and asymptomatic patients with carotid artery stenosis. METHODS: We conducted a nationwide retrospective registry study of 156 centers between January 2015 and December 2019. We enrolled consecutive patients with CAS managed by certified specialists from the Japanese Society of Neuroendovascular Therapy. Outcomes between symptomatic and asymptomatic patients were compared. The primary outcome was a composite of ischemic stroke and all-cause death at 30 days after CAS. Secondary outcomes were ischemic stroke, all-cause death, intracranial hemorrhage (ICH), and procedural complications. RESULTS: We analyzed 9,792 patients (symptomatic, n = 5,351; asymptomatic, n = 4,441). The mean age was 73.5 years, and men were dominant (86.4%). Embolism protection devices were used in 99% of patients. The primary outcome was not significantly different between the symptomatic and asymptomatic groups (120 [2.2%] vs 65 [1.5%]; adjusted OR: 1.30; 95% CI: 0.92-1.83). The incidences of symptomatic ICH, any ICH, acute in-stent occlusion, and hyperperfusion syndrome were significantly more prevalent in the symptomatic group (47 [0.9%] vs 8 [0.2%], aOR: 4.41 [95% CI: 1.68-11.6]; 73 [1.4%] vs 12 [0.3%], aOR: 3.56 [95% CI: 1.71-7.39]; 45 [0.8%] vs 19 [0.4%], aOR: 2.18 [95% CI: 1.08-4.40]; and 102 [1.9%] vs 36 [0.8%], aOR: 1.78 [95% CI: 1.17-2.71], respectively). Other secondary outcomes were not significantly different between the 2 groups. CONCLUSIONS: The complication rate after specialist-involved CAS at 30 days was low in real-world practice.

Sex differences in outcomes of carotid artery stenting.

OBJECTIVE: Existing evidence is inconclusive on whether women after carotid artery stenting (CAS) experience worse outcomes than men. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

One-Stage Combined Open and Endovascular Treatment Using a Hybrid Operating Room is Safe and Effective for Distal Middle Cerebral Artery Aneurysms.

BACKGROUND: Aneurysms located in the distal middle cerebral artery (DMCA) are relatively rare and lack an established treatment strategy. For DMCA aneurysms, we performed a one-stage combined procedure of endovascular parent artery occlusion (PAO) with coils and superficial temporal artery to middle cerebral artery (STA-MCA) bypass in a hybrid operating room (HOR). The aim of this study was to evaluate the safety and efficacy of this procedure. METHODS: Cases of unruptured DMCA aneurysms treated with the one-stage combined PAO and STA-MCA bypass in HOR were retrospectively examined, and patients' and aneurysmal backgrounds, surgical procedures, and treatment outcomes were analyzed. RESULTS: Six patients were included in the study. The average maximum diameter of the aneurysms was 14.4 mm. One aneurysm was located at M2 and five at M3. All aneurysms had a fusiform shape. No cases were associated with infection, trauma, or malignant tumors. In all 6 cases, the combined PAO and STA-MCA bypass was successfully completed. No postoperative hemorrhagic complications occurred. A symptomatic ischemic complication occurred in 1 case whose symptom disappeared in a week. Three months after surgery, complete obliteration of the aneurysm and patency of the bypass was confirmed in all cases. CONCLUSIONS: The one-stage combined PAO and STA-MCA bypass in the HOR is safe and effective for DMCA aneurysms, potentially serving as a treatment option for this complex aneurysm.

A Review of Current Flow Diverters.

Flow diverter (FD) devices are new-generation stents placed in the parent artery at the aneurysmal neck to obstruct intra-aneurysmal blood flow, thus favoring intra-aneurysmal thrombosis. In Japan, about eight years have passed since health insurance approval was granted for FD devices, and FD placement to treat aneurysms has become widespread. Treatment indications have also been expanded with the introduction of novel devices. At present, three types of FD (Pipeline, FRED, and Surpass Streamline) are available in Japan. This report represents a compilation of available FD technologies and describes the current consensus on this treatment.

Early neurological changes following endovascular therapy for acute stroke due to intracranial atherosclerotic disease.

BACKGROUND: Endovascular therapy (EVT) reduces functional disability in patients with acute large vessel occlusion (LVO). However, the early neurological change after EVT may be limited in patients with intracranial atherosclerotic disease (ICAD). METHODS: We analyzed the Japanese Registry of NeuroEndovascular Therapy (JR-NET) 4 which was a retrospective, nationwide, multicenter registry of patients with LVO between 2015 and 2019. We compared the early neurological change, efficacy and safety of EVT for acute LVO in ICAD and other etiologies. The primary outcome was NIHSS improvement ≥10 points, and secondary outcome were NIHSS worsening ≥4 points 7 days after EVT, effective reperfusion rate, 30-day functional outcomes, and safety outcomes. RESULTS: Among the 6710 enrolled patients, 610 (9.1%) had ICAD. The ICAD group was younger (mean 72.0 vs. 75.8 years) and predominantly male (63.4% vs. 56.0%), had lower NIHSS scores before EVT (median 16 vs. 18), and underwent percutaneous transluminal angioplasty and stenting more frequently (43.0% vs. 4.4%, 12.3% vs. 4.4%). In the ICAD group, NIHSS improvement was significantly lower (adjusted odds ratio (aOR) [95% confidence interval (95%CI)] 0.52 [0.41-0.65]), NIHSS worsening was significantly higher (aOR [95%CI] 1.76 [1.31-2.34]), and effective reperfusion was significantly lower (aOR [95%CI] 0.47 [0.36-0.60]). Fewer patients with ICAD had modified Rankin scale 0-2 at 30 days (aOR [95%CI] 0.60 [0.47-0.77]). The risk of acute reocclusion was more prominent in the ICAD group (aOR [95%CI] 4.03 [1.98-8.21]). CONCLUSIONS: Improvement in neurological severity after EVT was lower in patients with LVO and ICAD.

[Japanese National Plan for Promotion of Measures against Stroke and Cardiovascular Diseases and Data-Based Health Management Initiatives].

This review outlines the recent advances in stroke and cardiovascular diseases control and direction of national data health reform. Since the enactment of the Basic Act on Countermeasures against Cardiovascular Diseases, the national government and related academic societies have collaborated to promote countermeasures based on five key pillars; medical systems development, registration projects promotion, human resource development, public awareness, and research promotion. Simultaneously, the government is intensively promoting data health reform to compensate for the delay in digital medicine that became evident in the new coronary infection. Data health reform has four major pillars; promotion of using genomic medicine and artificial intelligence(AI), promotion of personal health records(PHR), promotion of information utilization in medical and nursing care settings, and promotion of effective database utilization. Five years have passed since the Basic Act on Countermeasures for Cardiovascular Diseases was enacted, and it is important that the Japanese Stroke Association, Japanese Cardiovascular Society and other related academic societies, government, prefectures, and National Cardiovascular Center collaborate to vigorously promote the cardiovascular disease countermeasures.

Pathological changes in the lenticulostriate artery indicate the mechanisms leading to intracranial hemorrhage in Moyamoya disease: a case report.

This case report details the pathological findings of a vessel wall identified as the bleeding point for intracranial hemorrhage associated with Moyamoya disease. A 29-year-old woman experienced intracranial hemorrhage unrelated to hyperperfusion following superficial temporal artery-middle cerebral artery bypass surgery. A pseudoaneurysm on the lenticulostriate artery (LSA) was identified as the causative vessel and subsequently excised. Examination of the excised pseudoaneurysm revealed a fragment of the LSA, with a disrupted internal elastic lamina and media degeneration. These pathological findings in a perforating artery, akin to the circle of Willis, provide insights into the underlying mechanisms of hemorrhage in Moyamoya disease.

Ten-year national trends in in-hospital mortality and functional outcomes after intracerebral hemorrhage by age in Japan: J-ASPECT study.

INTRODUCTION: National-level data on trends in the prognosis of age-stratified patients with intracerebral hemorrhage (ICH) are lacking. This study aimed to assess time trends in in-hospital mortality and functional outcomes of ICH patients by sex and age, and to explore factors associated with changes in in-hospital mortality trend. PATIENTS AND METHODS: Using the largest nationwide, J-ASPECT stroke database in Japan, this serial cross-sectional study included ICH patients aged ⩾18 years who were hospitalized for non-traumatic ICH from April 2010 to March 2020. We examined trends in in-hospital mortality and functional outcomes using the modified Rankin Scale at discharge, as well as differences in in-hospital mortality change between age groups. RESULTS: Among 262,399 ICH patients from 934 hospitals, crude in-hospital mortality showed a significant decreasing time trend (from 19.5% to 16.7%), and this trend was consistent across sex and age groups. In addition, differences in in-hospital mortality change over the 10-year study period were significant between male patients aged ⩾75 years and those aged ⩽64 years (-3.9% [95% confidence interval, -5.4 to -2.4] for 75-84 years; -4.1% [-6.3 to -1.9] for ⩾85 years). On the other hand, the proportion of dependent patients (mRS 3-5) at discharge increased from 52.0% to 54.9% over the 10-year study period. CONCLUSION: The in-hospital mortality of ICH patients improved, whereas the proportion of patients with dependent functional outcome at discharge increased, over the 10-year study period. Elucidating the mechanism underlying differences in in-hospital mortality reduction in men may provide insights into effective interventions in the future.

Plaque Ulcerations are Associated with Recurrence in Symptomatic Low-Grade Carotid Stenosis.

OBJECTIVE: Surgical indications for low-grade carotid stenosis have not yet been established. This study aimed to clarify the characteristics of low-grade carotid stenosis refractory to medical treatment. METHODS: We retrospectively analyzed 48 patients with symptomatic low-grade carotid stenosis (<50%). Recurrence was defined as an ipsilateral ischemic event in the symptomatic lesions during the follow-up period. Patient demographics and imaging findings were compared between the recurrence and nonrecurrence groups to investigate risk factors associated with medical treatment. RESULTS: The mean age was 74.1 (58-90 years), and the mean follow-up period was 35.4 months (2.0-97 months). Recurrence occurred in 15 of the symptomatic patients. Ulceration was significantly associated with recurrence under medical treatment (P = 0.001). The median time to recurrence was 26.1 months in patients with ulcers and 54.3 months in those without ulcers (P = 0.04). Pathological study with recurrence showed plaque rupture with multilayered lesions, indicating lesions refractory to medical treatment. CONCLUSIONS: In cases of low-grade carotid stenosis, lesions with ulcerations are likely refractory to medical therapy. Consideration of the indications for surgical treatment may be warranted for lesions with ulceration, even if the degree of stenosis is low.

Irreversible postoperative cognitive impairment after unruptured intracranial aneurysm treatment in the elderly.

PURPOSE: Postoperative cognitive dysfunction and recovery remain unclear in older patients undergoing interventional therapies for unruptured intracranial aneurysms (UIAs). This study aimed to compare changes in postoperative cognitive function between younger and older patients and to detect factors associated with non-recovery from postoperative cognitive dysfunction. METHODS: This study reviewed 59 consecutive patients with UIAs who underwent interventional therapies, including microsurgical clipping or endovascular treatment, from 2021 to 2022. All patients were divided into the older (aged ≥ 70 years) and younger (aged < 70 years) groups. Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB) were performed within 2 months before interventions, at 1 week postoperatively (POW1), and 3-6 months postoperatively (POM3-6). RESULTS: MMSE and FAB scores decreased more frequently in the older group than in the younger group at POW1 (older vs. younger: MMSE: 48% vs. 21%, p < 0.05; FAB: 56% vs. 18%, p < 0.01). In the older group, the FAB Z-score decreased in POW1 and recovered by POM3-6 (p < 0.01), while the MMSE Z-score continued to decrease (p = 0.04). Age and the preoperative MSME Z-score were significantly associated with non-recovery from decreased MMSE score at POM3-6 (recovery vs. non-recovery, age: 62 years old vs. 72 years old, p = 0.03, preoperative MMSE Z-score: 0.16 vs. - 0.90, p < 0.01). CONCLUSIONS: This retrospective study found that older patients were more likely to have a postoperative cognitive decline after UIA treatment and implicated that global cognitive function tended to decline more than executive function in the long term. In addition, this study demonstrated that lower preoperative cognitive function was associated with inadequate postoperative cognitive recovery. The findings potentially contribute to the establishment of indications for treating UIAs in older patients.

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.

Japanese nationwide questionnaire survey on delayed cerebral infarction due to vasospasm after subarachnoid hemorrhage.

Background and purpose: Various prophylactic drugs for cerebral vasospasm and delayed cerebral infarction (DCI) after subarachnoid hemorrhage (SAH) have been used in Japan. To investigate the treatment trends for cerebral vasospasm and frequency of DCI after SAH throughout Japan in 2021. Methods: In 2021 we conducted an anonymous questionnaire survey on management for preventing cerebral vasospasm after aneurysmal SAH, and the frequency of DCI. The questionnaire was emailed to 955 certified neurosurgeons at 553 hospitals in Japan. Of them, 162 hospitals (29% response rate) responded to the questionnaire. Of these, 158 were included in this study, while four hospitals that responded insufficiently were excluded. The efficacy of treatments for reducing DCI were examined through a logistic regression analysis. Results: Among 3,093 patients treated with aneurysmal SAH, 281 patients (9.1%) were diagnosed with DCI related to cerebral vasospasm. Coil embolization had significantly lower DCI frequency (6.9%), compared to microsurgical clipping (11.8%, odds ratio, 0.90; 95% confidential intervals, 0.84-0.96; P, 0.007). In addition, cilostazol administration was associated with significantly lower DCI frequency (0.48; 0.27-0.82; 0.026). The efficacy of cilostazol in reducing DCI remained unchanged after adjustment for covariates. The most effective combination of multiple prophylactic drugs in reducing DCI related to cerebral vasospasm was cilostazol, fasudil, and statin (0.38; 0.22-0.67; 0.005). Conclusions: This study elucidated the trends in prophylactic drugs to prevent cerebral vasospasm and frequency of DCI after aneurysmal SAH in Japan. Coil embolization and cilostazol administration showed effectiveness in reducing DCI related to cerebral vasospasm in 2021.