Real-world Data of Antithrombotic Therapy in Neuroendovascular Therapy: Analysis of JR-NET 4.

As the number of neuroendovascular therapies in Japan increases, the current trends in periprocedural antithrombotic therapy must be understood.We retrospectively analyzed data on periprocedural antithrombotic therapy in the Japanese Registry of Neuroendovascular Therapy (JR-NET) 4, a nationwide survey carried out in Japan between January 2015 and December 2019. Details on antithrombotic therapy in neuroendovascular therapy for ruptured cerebral aneurysms, unruptured cerebral aneurysms, and percutaneous transluminal angioplasty or stenting were collected from the JR-NET 4 database. These data were analyzed and compared with those from the JR-NET 2 (January 2008 to December 2009) and JR-NET 3 (January 2010 to December 2014). A total of 36,560 cases were analyzed in the JR-NET 4. The frequency of preprocedural dual antiplatelet therapy (DAPT) significantly increased from the JR-NET 2 to 4 (48.1%, 53.4%, and 62.3%, respectively; P < 0.001), whereas the frequency of monotherapy significantly decreased (15.7%, 13.9%, and 8%, respectively; P < 0.001). Postprocedural antiplatelet therapy exhibited similar trends, and postprocedural anticoagulant therapy was discontinued. Particularly, heparin use significantly decreased from the JR-NET 2 to 4 (23.4% vs. 12.7% vs. 7.9%, respectively; P < 0.001). In terms of periprocedural complications, the incidence of ischemic complications increased from the JR-NET 3 to 4 (5.8% vs. 6.2%; P = 0.05). In the JR-NET 4, severe adverse events and hemorrhagic and all complications were significantly more frequent in the preprocedural triple or more therapy group.The rate of postprocedural anticoagulant therapy decreased, whereas that of antiplatelet therapy increased. Overall, in Japan, periprocedural DAPT has become increasingly common.

Efforts toward Gender Equality and Diversity in the Japanese Society for Neuroendovascular Therapy.

The Japanese Society for Neuroendovascular Therapy (JSNET) is a diverse subspecialty society based on four basic fields and is continuously growing with the advancement of neuroendovascular therapy. Despite a recent increase in the proportion of female members, awareness of diversity within JSNET remains inadequate. To foster a more mature and inclusive society, we established the JSNET-Diversity Promotion Committee in 2021, which has actively engaged in various initiatives aimed at promoting the inclusion of minorities such as female physicians as well as minority fields. Our objective is to continue in our initiative, anticipating that JSNET will evolve into an even more ideal organization in the future.

Multicenter clinical trial evaluating the safety and efficacy of mechanical thrombectomy using the Versi Retriever.

BACKGROUND: This study aimed to elucidate the safety and efficacy of mechanical thrombectomy using the Versi Retriever in patients with acute ischemic stroke (AIS). METHODS: This was a prospective, multicenter, single-arm study conducted at 10 institutes in Japan from December 2018 to March 2021 on mechanical thrombectomy using the Versi Retriever in patients with AIS. The primary efficacy outcome was the modified Rankin scale (mRS) 0-2 at 90 days after the procedure. The primary safety outcome was mortality within 90 days after the procedure. RESULTS: Fifty-eight patients with a mean age of 72.7 years were enrolled in the study. The primary efficacy outcome of mRS 0-2 at 90 days was 62.0% (95% CI 47.2-75.3%) in patients within 8 hours of stroke onset. The rate of immediate reperfusion of Thrombolysis in Cerebral Infarction (TICI) grade 2b-3 using the Versi Retriever in three passes was 78.0% (64.0-88.5%). The rate of final reperfusion of TICI 2b-3 was 100% (92.9-100%). The primary safety outcome of mortality within 90 days was 8.0% (2.2-19.2%) in patients within 8 hours of AIS onset. The incidence of intracranial hemorrhage within 24 hours was 12.0% (4.5-24.3%) for symptomatic cases and 32.0% (19.5-46.7%) for asymptomatic cases. CONCLUSION: The Versi Retriever proved to be a safe and effective option for mechanical thrombectomy in patients with AIS.

The Current Status of Endovascular Treatment for Extracranial Vertebral Artery Stenosis in Japan: A Subanalysis of the Japanese Registry of Neuroendovascular Therapy 4.

Endovascular treatment (EVT) is a potential therapeutic option for extracranial vertebral artery (VA) stenosis; however, its efficacy or optimal procedures remain unknown. This study aimed to investigate the recent status of EVT for extracranial VA stenosis in Japan using a nationwide registry. We conducted a post hoc analysis of the Japanese Registry of Neuroendovascular Therapy 4 that enrolled patients who underwent EVT at 166 hospitals in Japan from 2015 to 2019. The outcomes of this study were as follows: procedural success indicating that the planned procedure was completed, modified Rankin Scale (mRS) score at 30 days, and procedure-related complications evaluated according to the procedure during EVT (percutaneous transluminal angioplasty vs. stenting and with or without the use of embolic protection devices [EPDs]). Of 308 eligible patients, 301 (95%) were treated for atherosclerotic stenosis, predominantly by stenting (74%). EPDs were used in 43%, primarily with the distal balloon (63%). The proportion of procedural success was 98%. Functional independence (mRS of 0-2) at 30 days was achieved in 80% of the total cohort, and there were no differences between patients treated with or without stenting or EPDs (74% vs. 82%, p = 0.12, and 80% vs. 80%, p = 0.93). Procedural complications occurred in 28 (9.1%) patients similarly in each group, with distal embolism and vessel dissection being common. In conclusion, EVT is a reasonable option for extracranial VA stenosis as a daily clinical practice. This study emphasizes the potential of EVT in managing extracranial VA stenosis and the need for further research to refine treatment strategies.

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.

Investigator-initiated clinical trial of stabilizer device: A novel intracranial exchange guidewire for neuroendovascular treatments.

BACKGROUND: Neuroendovascular procedures, especially those involving significant vessel tortuosity, giant intracranial aneurysms, or distally located lesions, frequently necessitate exchange methods. However, exchange maneuvers pose a risk of inadvertent vessel injury. To address these challenges, a Stabilizer device was developed and evaluated for its efficacy and safety. This clinical trial aimed to assess the efficacy and safety of the Stabilizer device in facilitating the navigation of neuroendovascular devices to target lesions in cases where the exchange technique was necessary. METHODS: This was a single-arm, prospective, open-label, multicenter clinical trial performed at nine different sites. It focused on investigating the use of the Stabilizer device for treating intracranial aneurysms and atherosclerosis. RESULTS: A total of 31 patients were enrolled across nine centers in Japan from July 21, 2022, to March 10, 2023. The study enrolled 24 (77.4%) patients with intracranial aneurysms and seven (22.6%) patients with intracranial artery stenosis. Majority of the target lesions were in the middle cerebral artery territory (83.9%). The Stabilizer device was used to exchange for 0.027-inch catheters, intermediate catheters, PTA balloons, and Wingspan stent system. The Stabilizer device demonstrated 100% technical success rate. While three complications related to the treatment were noted, there were no complications related to the device, including any vascular damage. CONCLUSIONS: This is the first multicenter clinical trial that investigated and demonstrated technical efficacy as well as overall safety profile of the Stabilizer device in neuroendovascular procedures where the use of an exchange method was necessary.

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.

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.

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.

Treatment Results of Carotid Artery Stenting with an Open-Cell Stent: Analysis of 734 Consecutive Cases at a Single Center.

OBJECTIVE: In carotid artery stenting (CAS) for internal carotid artery stenosis, the stent is often selected according to the plaque properties and arterial tortuosity. In our institute, an open-cell stent is used as the first-line stent regardless of the characteristics of the lesion. This study was performed to examine the outcome of CAS with an open-cell stent as the real-world results. METHODS: In total, 811 CAS procedures using open-cell stents were performed for internal carotid artery stenosis from April 2002 to December 2019. Of these patients, we excluded those with hyperacute conditions for which CAS was performed within 3 days of onset, those in whom acute mechanical thrombectomy was performed simultaneously with CAS, and those with stenosis due to arterial dissection. Thus, 734 patients were retrospectively analyzed. Perioperative and long-term outcomes and risk factors for perioperative infarction were investigated. RESULTS: The periprocedural stroke rate and mortality rate were 3.7% (27/734) and 0.4% (3/734), respectively. Low-echoic plaque was a significant risk factor for periprocedural stroke in both univariate (P < 0.03) and multivariate (odds ratio, 2.69; 95% confidence interval, 1.14-6.66; P = 0.02) analyses. Cerebral infarction and high grade restenosis were observed in 15 (2.0%) and 17 (2.3%) patients during a median 50-month follow-up. CONCLUSIONS: CAS with open-cell stents showed good results in terms of both the postoperative stroke incidence and long-term severe restenosis rate. However, low-echoic plaque was a risk factor for perioperative stroke incidence, which should be considered when deciding on the indication for CAS with an open-cell stent.

Novel use of a closed-tip stent retriever to prevent distal embolism in the posterior circulation: illustrative case.

BACKGROUND: In mechanical thrombectomy for tandem occlusions in vertebrobasilar stroke, distal emboli from the vertebral artery lesion should be prevented. However, no suitable embolic protection devices are currently available in the posterior circulation. Here, the authors describe the case of a vertebral artery lesion effectively treated with a closed-tip stent retriever as an embolic protection device in the posterior circulation. OBSERVATIONS: A 65-year-old male underwent mechanical thrombectomy for basilar artery occlusion, with tandem occlusion of the proximal vertebral artery. After basilar artery recanalization via the nonoccluded vertebral artery, a subsequent mechanical thrombectomy was performed for the occluded proximal vertebral artery. To prevent distal embolization of the basilar artery, an EmboTrap III stent retriever was deployed as an embolic protection device within the basilar artery to successfully capture the thrombus. LESSONS: A stent retriever with a closed-tip structure can effectively capture thrombi, making it a suitable distal embolic protection device in the posterior circulation.

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.

Pipeline embolization device dynamics: prediction of incomplete occlusion by elongation from nominal length.

OBJECTIVE: According to benchtop studies, the oversizing of a Pipeline embolization device (PED) relative to the parent artery leads to a significant increase in porosity and potentially compromises aneurysm occlusion as well as transitional zone (TZ) formation around the neck of aneurysms. However, no clinical assessment has been reported. Here this potential was studied by measuring the dynamic changes of PEDs in the clinical time course. METHODS: The authors retrospectively examined 124 anterior circulation unruptured aneurysms in 114 consecutive patients treated with a PED between July 2015 and December 2020 at their institution. The authors excluded 77 cases of 68 patients with adjunctive coil embolization or multiple stents that could affect the PED dynamics and measurements, and 47 aneurysms in 46 patients were included. Measurements were performed before, immediately after, and 6 months after treatment, and then at intervals of 6 months to 1 year after that for nonocclusion cases. RESULTS: Complete occlusion was achieved in 79.0% and incomplete occlusion in 21.0% at last follow-up. The PED length immediately after deployment was 136% nominal length. A multivariable regression analysis revealed that age (OR 1.11/year; p = 0.02) and PED elongation from nominal length (OR 1.31/mm; p = 0.012) were independently associated with a higher rate of incomplete occlusion at the last follow-up. TZ formation did not affect the occlusion rate. CONCLUSIONS: PED elongation from the nominal length is a new predictor of incomplete aneurysm occlusion. The PED showed vascular remodeling by changing its diameter and length in the clinical course. TZ formation was remodeled and did not affect the occlusion rate.

First-in-human trial of a self-expandable, temporary dilation system for intracranial atherosclerotic disease in patients presenting with acute ischemic stroke.

BACKGROUND: Intracranial atherosclerotic disease (ICAD) significantly contributes to ischemic stroke, especially among Asian populations. Large vessel occlusion (LVO) due to underlying ICAD accounts for 15-35% of acute ischemic stroke cases requiring endovascular therapy. However, the successful recanalization rate of ICAD-related LVO remains lower. The TG dilator is a self-expandable device, temporarily dilating ICAD-related blocked blood vessels. OBJECTIVE: To demonstrate TG dilator safety and efficacy for ICAD-related acute ischemic stroke. METHODS: This was a single-arm, open-label, non-randomized, prospective, multicenter, and investigator-initiated trial that involved patients undergoing TG dilator application for acute ischemic stroke caused by ICAD-related LVO or severe stenosis. RESULTS: We enrolled 10 patients in this trial between November 2022 and April 2023. The median (IQR) age was 68 (59.3-75.3) years. Before using the dilator, seven patients received stent retriever treatment. All 10 patients were prescribed a loading dose of aspirin with prasugrel. The median application time was 10 (10-12) min. At the end of the procedure, we achieved significant recanalization immediately in all patients. The stenosis/occlusion decreased from 100% (100-100) to 68% (56.3-75.3). No patient experienced recurrent ischemic stroke or reocclusion within 90 days. We achieved a modified Rankin scale score of 0-2 in 8 patients by day 90. We detected no cases of intracranial hemorrhage, equipment failure, distal embolism, vasospasm, dissection, or perforation requiring intervention. CONCLUSIONS: Acute revascularization using the TG dilator on patients with ICAD-related LVO or severe stenosis did not cause any significant adverse event, and consistently improved blood flow at 90 days.

Incidence and Outcomes of Aneurysmal Subarachnoid Hemorrhage: A Multicenter Retrospective Registry-based Descriptive Trial in Kobe City.

The current study aims to evaluate the incidence and results of aneurysmal subarachnoid hemorrhage (aSAH) throughout Kobe City. Based on a multicenter retrospective registry-based descriptive trial involving all 13 primary stroke centers in Kobe City, patients with aSAH treated between October 2017 and September 2019 were studied. A total of 334 patients were included, with an estimated age-adjusted incidence of 11.12 per 100,000 person-years. Curative treatment was given to 94% of patients, with endovascular treatment (51%) preferred over surgical treatment (43%). Of the patients, 12% were treated by shunt surgery for sequential hydrocephalus with a worse outcome at 30 days or discharge (14% vs. 46%, odds ratio (OR): 0.19, 95% confidence interval (CI): 0.088-0.39, p-value <0.001). As for vasospasm and delayed cerebral ischemia, most patients were given intravenous fasudil infusion (73%), with endovascular treatment for vasospasm in 24 cases (7.2%). The fasudil group had more good outcomes (42% vs. 30%, OR: 1.64, 95% CI: 0.95-2.87, p-value = 0.075) and significantly less death (3.3% vs. 35%, OR: 0.064, 95% CI: 0.024-0.15, p-value <0.001) at 30 days or discharge. Mortality rose from 12% at 30 days or discharge to 17% at 1 year, but neurological function distribution improved over time (modified Rankin Scale 0-2 was 39% at 30 days or discharge, 53% at 60 days, and 63% at 1 year). Our retrospective registered trial presented various statistics on aSAH, summarizing the current treatment status and prognosis.

Relation between duration of dual antiplatelet therapy and risk of ischemic stroke after stent-assisted treatment of cerebral aneurysm (DAPTS ACE-registry).

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.

First-in-human trial of Center Wire for neuroendovascular therapy to avoid guidewire-related complications.

BACKGROUND: An exchange maneuver is useful for the delivery of devices to target vessels. However, hemorrhagic complications can occur due to vessel perforation during an exchange maneuver. In addition, the exchange is often challenging due to unfavorable anatomy. Center Wire is an exchange-length wire with a nondetachable stent that was developed to improve navigation and stability during exchange maneuvers. The aim of this study is to investigate the safety and efficacy of Center Wire of the anchor wire technique during neuroendovascular treatment. METHODS: Ten patients with intracranial aneurysms were treated after signing a Certified Review Board-approved consent. Anchor wire technique was used in all patients to navigate catheters to the target vessel for aneurysm treatment. RESULTS: Anchor wire technique was successfully applied in all 10 cases using Center Wire. One device-related incident of vasospasm occurred which was asymptomatic. No device-related dissection, perforation, or thromboembolic events occurred. One patient had intraoperative aneurysm rupture during coil placement which was treated immediately without clinical consequences. Two patients had postoperative ischemic strokes due to thrombotic occlusion of branches originating from the aneurysm which were unrelated to the device. CONCLUSIONS: This first-in-human trial of Center Wire demonstrated the safety and efficacy of the anchor wire technique for neuroendovascular treatment in a strictly regulated prospective registry trial.

First-in-human trial of Stabilizer device in neuroendovascular therapy.

Objectives: Flow diverter or stent implantation to intracranial target lesion requires large inner diameter microcatheter navigation. The exchange method using stiff long wire is often necessary if it is difficult to navigate over the regular guidewire. However, this method has an intrinsic risk of vessel damage and may cause severe complications. We investigated the safety and efficacy of a new device, the Stabilizer device for navigation in a first-in-human clinical trial under the Certified Review Board agreement. Materials and methods: The Stabilizer is a 320 cm length exchange wire with a stent for anchoring and is compatible with a 0.0165" microcatheter. The trial design is a prospective single-arm open-label registry. Inclusion criteria are elective flow diverter treatment or stent-assisted coiling, expected to be difficult to navigate a microcatheter with a regular micro guidewire, and obtained documented consent. The primary endpoint of the study was a hemorrhagic complication. Results: Five patients were enrolled in this trial. The median age is 52 years, ranges from 41 to 70, and all patients were female. Three aneurysms were located on the internal carotid artery, one on the vertebral artery, and one on the basilar artery. Basilar artery aneurysm was treated by stent-assisted coiling and others were treated by flow diverter deployment. All cases successfully navigate microcatheter for the treatment by the trial method using Stabilizer device without any adverse event. Conclusions: The results from this first-in-human consecutive five cases show the safety of the Stabilizer device in neuro-endovascular therapy for navigation of devices to the intracranial target lesion.

Japanese Postmarket Surveillance of Percutaneous Transluminal Angioplasty and Wingspan Stenting for Intracranial Atherosclerotic Disease.

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.