This study aimed to evaluate whether replacing clopidogrel with ticagrelor in CYP2C19 loss-of-function (LOF) carriers can reduce the incidence of perioperative ischemic events in endovascular treatment for unruptured intracranial aneurysms (IAs). A retrospective cohort of 654 patients was divided into three groups based on their CYP2C19 genotype and P2Y12 antagonist regimen: the non-LOF group (n=240, using clopidogrel), the LOF-Clopidogrel group (n=309, using clopidogrel), and the LOF-Ticagrelor group (n=105, using ticagrelor). The primary endpoint was ischemic events within 30 days postoperatively, and the safety endpoint was bleeding events within 30 days postoperatively. Compared with the non-LOF group (3.3%), the risk of ischemic events was significantly higher in the LOF-Clopidogrel group (7.8%; OR 2.442, 95% CI 1.072 to 5.248, P=0.028). For LOF carriers, after replacing clopidogrel with ticagrelor, the incidence of ischemic events decreased to 1.9%, which was lower than that of the LOF-Clopidogrel group (1.9% vs 7.8%; OR 0.231, 95% CI 0.053 to 0.866, P=0.032), and there was no significant difference between the two groups in the overall incidence of bleeding (2.9% vs 1.3%, P=0.377). Increasing age (OR 1.043, P=0.028), non-saccular aneurysm (OR 3.196, P=0.012), and clopidogrel use in LOF carriers (OR 2.437, P=0.035) were independent risk factors for ischemic events. CYP2C19 LOF alleles significantly increase ischemic risks following IA stenting. Implementing a ticagrelor alternative strategy for LOF carriers can significantly reduce the risk of ischemic events without increasing the risk of perioperative bleeding events.
The different pathophysiological mechanisms leading to tandem occlusion (TO), namely arterial dissection or atherosclerosis, may have an impact on the outcome of patients with acute ischemic stroke (AIS) undergoing endovascular thrombectomy (EVT). Consecutive AIS patients with occlusion of the cervical internal carotid artery and concomitant intracranial large vessel occlusion who received EVT between 2011 and 2023 as part of the Italian Registry of Endovascular Treatment in Acute Stroke (IRETAS) were deemed eligible. We compared clinical and radiological outcomes of patients with dissecting TO versus atherosclerotic TO by the propensity score matching approach. Overall, 2148 patients (mean age 69.3±12.8 years; males 64.5%) qualified for the analysis. Of these, 236 (10.9%) had dissecting TO, and 1912 (89.1%) atherosclerotic TO. As expected, patients with dissecting TO stroke were younger and had a lower burden of major cardiovascular risk factors. In the matched cohort, we observed no difference between the two groups in either 90-day functional independence (OR 1.33; 95% CI 0.94 to 1.83; p=0.115) or in any of the secondary endpoints, except for a reduced risk of parenchymal hematoma type 2 (OR 0.37; 95% CI 0.14 to 0.98; p=0.046) in the group of patients with dissecting TO stroke, which, however, did not affect patient outcome. The outcome of patients undergoing EVT because of dissecting TO stroke does not differ from that of patients with atherosclerotic TO stroke. The etiology of the underlying vascular lesion should not be regarded as a contraindication to EVT procedures in these cases.
The Woven EndoBridge (WEB) Embolization System is the first intrasaccular device developed for the treatment of wide-necked bifurcation aneurysms (WNBAs). Here we report the 1-year outcomes for the unruptured aneurysm cohort of the WISE Study (WEB Implant Safety and long-term Effectiveness) database, a pooled analysis of subject-level data from seven prospective WEB trials. Individual subject-level data from seven prospective, multicenter, core laboratory adjudicated, externally monitored studies evaluating the WEB device for the treatment of unruptured WNBAs were pooled. The included aneurysms had a mean dome width of 6.5 mm. All studies shared the same core laboratory, and five of the seven shared the same clinical events committee. Subject demographic and aneurysm characteristics, procedural data, and effectiveness and safety outcomes were combined and evaluated as a single population. Adequate occlusion was defined as complete occlusion or residual neck on core laboratory assessment. A total of 449 unruptured aneurysms were successfully treated within WISE. The 1-year rates of complete occlusion and adequate occlusion were 54.7% (223/408) and 82.8% (338/408), respectively. Aneurysm recurrence was 6.4% (19/298) and the retreatment rate was 2.5% (11/449). All-cause morbidity was 1.2% (5/416) and treatment-related morbidity (device- and/or procedure-related) was 0.5% (2/416) at 12 months. No ruptures were observed after WEB treatment through 1 year. Complete occlusion was less likely for anterior circulation aneurysms, larger aneurysm height and width, and wider neck. Complete occlusion was less likely for anterior circulation aneurysms and for aneurysms with larger height, width, and neck size (all p<0.05). Greater WEB lateral compression was associated with higher rates of complete occlusion (OR 1.289 for absolute difference and OR 7.042 for ratio, p≤0.0066), and with higher rates of adequate occlusion (OR 1.288 and 8.846, respectively). Retreatment was associated with larger aneurysm height and width, and smoking history. The WEB device is safe and effective for the treatment of unruptured intracranial aneurysms with high rates of adequate occlusion, low rates of recurrence and retreatment, and reliable protection from rupture.
NeoCastTM is a solvent-free, non-adhesive biomaterial engineered to achieve microvascular occlusion. EMBO-01 is the first-in-human trial of NeoCast for the pre-surgical embolization of hypervascular brain tumors supplied by the middle meningeal artery (MMA). EMBO-01 was an open-label, multicenter, prospective, externally monitored, and core lab adjudicated clinical trial. The primary safety endpoint was freedom from device-related disabling stroke or neurological death within 30 days of embolization. The primary effectiveness endpoint was successful injection of NeoCast into targeted vessel(s), resulting in complete occlusion at or distal to the point of embolysate injection. Additional assessments included occurrence of microcatheter adhesion and non-target embolization, percent tumor devascularization, extent of resection, estimated intraoperative blood loss, and surgical time. Five subjects were enrolled with an average tumor size of 5.0±1.2 cm. NeoCast achieved occlusion in all targeted vessels for all subjects. There were no adverse events or device deficiencies during embolization. The average NeoCast injection volume was 0.68±0.28 mL with an average injection time of 7.8±6.4 min. There was no microcatheter entrapment or non-target embolization. The average percent tumor devascularization was 89±7%. Tumor resection was complete in all subjects, with an average estimated blood loss of 240±164 mL and average total surgery time of 167±75 min. All subjects successfully met both the primary feasibility and safety endpoints. This first-in-human study provides evidence that NeoCast can be used to reproducibly and safely achieve substantial preoperative devascularization of brain tumors supplied by the MMA.
More high-quality evidence for stent-assisted coiling (SAC) of cerebral aneurysms is needed. Randomized controlled trials have shown lower recurrence with the HydroCoil Embolic System (HES) compared with bare platinum coils, and self-adjudicated LVIS Evo SAC studies have demonstrated favorable safety and technical success. The objective of the SEALANT study is to investigate the safety and effectiveness of this device combination. SEALANT is an open-label, prospective, single-arm, multicenter study including patients with aneurysms up to a maximum size of 12 mm. The primary effectiveness endpoint was complete occlusion on digital subtraction angiography (DSA), and the primary safety endpoint was major ipsilateral stroke or neurological death. Adverse events and imaging were independently adjudicated. 206 patients were enrolled; 193 had follow-up imaging for outcome assessment; and 164 satisfied all criteria, were treated with both study devices (including ≥90% HES), and had DSA follow-up. The participants' mean age was 56.8±11.6 years; 65% were female. Of 212 aneurysms, 86.3% were bifurcation and 13.2% sidewall; 25.0% were previously treated and 17.9% previously ruptured; 89.6% were anterior circulation, 34.0% at the anterior communicating artery, and 30.7% at the middle cerebral artery; and 84.9% were wide-necked (neck ≥4 mm or dome/neck ratio <2). The primary effectiveness endpoint of complete occlusion was achieved in 82.1% (95% CI 76.4% to 87.9%) of aneurysms. 2.4% (95% CI 0.3% to 4.5%) of patients met the primary safety endpoint of major ipsilateral stroke or neurological death. The primary safety endpoint was significantly associated with baseline modified Rankin Scale and history of previous stroke. 1-year SEALANT results confirm the safety and effectiveness of SAC using LVIS Evo and HES. NCT04999423.
Current liquid embolic agents (LEAs) often suffer from unpredictable polymerization and risks of microcatheter entrapment, reflux, or non-target embolization. NVS-Gel1 is a novel photoactivated LEA designed to decouple delivery from solidification, enabling externally triggered, operator-directed control over the timing and location of embolic polymerization. This study evaluates its in vivo technical feasibility and embolic control characteristics. NVS-Gel1, a novel polymer-based hydrogel with photo-initiator, was evaluated as a proof of concept in a large-animal tumor embolization model. Following selective catheter delivery under fluoroscopic guidance, solidification was initiated using 405 nm light delivered via a microcatheter-integrated optical fiber. Assessments focused on qualitative procedural and technical endpoints, including delivery behavior, fluoroscopic visibility, spatial confinement of polymerization, and the presence of reflux or non-target embolization. NVS-Gel1 demonstrated fluoroscopic visibility and microcatheter compatibility. Precise spatial and temporal control of polymerization was demonstrated, with solidification occurring exclusively on photoactivation. Angiography confirmed consistent distal penetration with complete occlusion of the target vasculature. No reflux or non-target embolization was observed in this limited series. NVS-Gel1 introduces a photo-triggered, operator-controlled polymerization mechanism that enables on-demand solidification following delivery. In this preliminary in vivo study, the technique was feasible and demonstrated controlled embolic behavior under experimental conditions. Given the small sample size and absence of comparator data, further studies are required to evaluate safety, efficacy, and potential advantages over existing embolic agents. The underlying principles of externally activated embolization support the potential for future translation to neurovascular applications.
FDSS, DIANES, 4F-FPS, and ABC are scoring models developed to predict incomplete occlusion of intracranial aneurysms after treatment with flow diverters (FDs). We retrospectively included consecutive patients with intracranial aneurysms treated with FDs at our center between January 2020 and December 2025 with at least 6 months of angiographic follow-up. Predictors of incomplete occlusion were analyzed by univariable analysis followed by multivariable Firth penalized logistic regression. The predictive performance of the four scores was evaluated. Modified scores (mFDSS, mDIANES, and mABC) were generated by excluding the ophthalmic artery (OphA) and adult-type posterior communicating artery (aPComA) from the variable 'side branch arising from the aneurysm neck/dome' and were compared with the original scores. The study included 152 patients harboring 185 aneurysms, 86.49% of which were located in the internal carotid artery (ICA), with an incomplete occlusion rate of 13.51%. Male sex and branch involvement were independent predictors of incomplete occlusion (aOR, 3.67 and 3.81, respectively). Area under the curve (AUC) for FDSS, DIANES, 4F-FPS, and ABC were 0.715, 0.741, 0.539, and 0.732, respectively. Excluding the OphA and aPComA from branch involvement improved the accuracy of mFDSS, mDIANES, and mABC compared with the original scores. FDSS, DIANES, and ABC showed fair predictive performance, whereas 4F-FPS had limited predictive value in this predominantly ICA saccular aneurysm cohort. Branch involvement was the strongest predictor of incomplete occlusion. The exploratory refinement of branch involvement by excluding the OphA and aPComA improved score accuracy. The rich collateral circulation of these branches could be the potential explanation but this theory requires further verification.
Unintended device movement during carotid artery stenting (CAS) may lead to procedural complications. Our previous preliminary single-center study using a real-time artificial intelligence (AI) assistance system suggested that AI may help detect such movements and offer potential clinical usefulness; however, the small sample size limited the strength of the findings. In this multicenter study, we aimed to validate the accuracy and clinical utility of this real-time AI system in a diverse cohort. A total of 53 consecutive CAS procedures with distal filter protection were performed at three institutions under real-time AI monitoring. The AI system continuously analyzed fluoroscopic images and issued notifications when filter devices, guiding catheters, or guidewires moved outside predefined areas or went off-screen. Two types of distal filter protection devices were used. The participating institutions used two angiography systems. The efficacy, safety, and accuracy of the software were evaluated. Subgroup analyses were performed by filter type and operator experience. On average, there were 13.1 AI notifications per case, including 11.4 true positives and 1.7 false positives. The overall precision and recall were 87% and 98%, respectively. In 32% of true positive notifications, the operator adjusted the inappropriate device position after the notification. No significant differences were observed across filter types or operator experience. No AI-related complications were observed. This multicenter study demonstrated consistent performance of real-time AI-assisted notifications of device movement during CAS across multiple institutions and operators. The system showed high accuracy and supports its integration into standard neuroendovascular workflows.
The WISE (WEB Implant Safety and long term Efficacy: A pooled analysis of seven clinical trials) study combines data from seven fully adjudicated clinical trials totaling 601 enrolled patients, of which 143 were ruptured aneurysms. This analysis evaluates the safety and effectiveness of the Woven EndoBridge (WEB) device for the treatment of wide neck bifurcation aneurysms in the ruptured aneurysm cohort. WISE is a pooled analysis that combined patient level data from seven prospective multicenter WEB studies, each conducted with independent core laboratory review of imaging and independent adjudication of adverse events. Patients treated for ruptured aneurysms were identified, and baseline characteristics, procedural details, and 12 month clinical and angiographic outcomes were evaluated. Safety events, including thromboembolic and hemorrhagic complications, vasospasm, and hydrocephalus were assessed. Among 143 patients with ruptured aneurysms, technical success was achieved in 97.2% of cases. Adequate occlusion was achieved in 87.5% of patients with available imaging, including 60.0% with complete occlusion. Retreatment up to 12 months occurred in 6.5% of patients. No rebleeding of WEB treated aneurysms was reported. Safety events up to 12 months included procedural thromboembolic events in 13.3% and stroke events in 8.4% of patients, with low 12 month mortality (1.4%) and morbidity (6.4%), mostly related to the initial aneurysm rupture. WEB treatment provided complete protection against rebleeding and is a safe and effective option for patients with ruptured wide neck bifurcation aneurysms.
Balloon guide catheters (BGCs) are used during mechanical thrombectomy to arrest or reverse blood flow in order to improve revascularization results. STRAIT was an early post-market study of the new generation BOBBY BGC to evaluate performance and safety in the treatment of anterior circulation large vessel occlusion (LVO). This prospective, core lab-controlled multicenter study was conducted across nine sites in Germany and Switzerland. Key inclusion criteria were LVO at the distal internal carotid article through proximal M2, symptom onset to treatment initiation within 8 hours, National Institute of Health Stroke Scale (NIHSS) ≥5, and Alberta Stroke Program Early CT Score (ASPECTS) ≥6. After having reached the primary endpoint in the planned interim analysis, enrollment was stopped early. Therefore, STRAIT enrolled 171 subjects from April 2022 to September 2023. Included patients were 49.7% female, median age was 73 years, and median NIHSS was 15. The primary endpoint of successful final reperfusion, as defined by Thrombolysis In Cerebral Infarction (TICI) 2b-3, was achieved in 94.7% of cases (n=161), and modified first pass effect (FPE) was 63.1%, with a median procedure time of 51 min. There were no device malfunction-related serious adverse events or adverse events. At final follow-up, 107/171 subjects (65.2%) had good neurological function (modified Rankin Scale ≤2) and an overall mortality of 8.5%. Mechanical thrombectomy using BOBBY BGC demonstrates high rates of FPE and overall success with a good safety profile, further supporting the additional benefit of the new generation BGCs in interventional stroke treatment. NCT05361187.
To develop and validate a novel scoring system for predicting successful endovascular recanalization in patients with non-acute symptomatic carotid artery occlusion (NASCAO). We analyzed consecutive patients from a nationwide prospective registry who underwent endovascular treatment for NASCAO. Patients were divided into derivation and validation cohorts based on the enrolling centers. Technical success was defined as Thrombolysis in Cerebral Infarction score 3 and <50% residual stenosis. A NASCAO score was developed using stepwise logistic regression based on the Bayesian information criterion. The performance of the score was examined in terms of discrimination and calibration. Among the 511 included patients, successful recanalization was achieved in 61.3% (192/313) of the derivation cohort and 54.5% (108/198) of the validation cohort. Four independent predictors of technical success were used to construct a 6-point NASCAO score: ischemic stroke (1 point), time from last event to intervention within 1-30 days (1 point), tapered proximal stump (1 point), and number of occluded segments (1-2: 3 points, 3-4: 2 points, 5-7: 0 points). The area under the receiver operating curve (AUC) of the NASCAO score was 0.780 (95% CI 0.729 to 0.832) in the derivation cohort and 0.758 (95% CI 0.692 to 0.824) in the validation cohort. Patients with a score of 4-6 had 6.3 times higher odds of successful recanalization than those with a score of 0-3 (95% CI 4.29 to 9.38, P<0.001). The NASCAO score is a reliable tool for predicting successful endovascular recanalization in patients with NASCAO.
This systematic review and diagnostic test accuracy meta-analysis aimed to evaluate the diagnostic performance of flat-panel computed tomography (FPCT) for acute stroke-related findings, particularly intracranial hemorrhage and ischemic events, in comparison with standard CT or MRI. A systematic review and meta-analysis were conducted following PRISMA-DTA guidelines. PubMed, Scopus, and Embase were searched through September 2024 for diagnostic accuracy studies comparing FPCT with CT or MRI in acute stroke settings. Pooled sensitivity, specificity, and diagnostic odds ratio (DOR) were calculated using random-effects and bivariate models. Subgroup analyses and sensitivity analyses addressed heterogeneity. Thirteen studies were included in the meta-analysis. Pooled univariate estimates showed a sensitivity of 82.2% (95% CI: 75.1-87.7), specificity of 93.1% (95% CI: 88.5-96.0), and DOR of 78.6 (95% CI: 40.3-153.4). Bivariate analysis demonstrated improved diagnostic performance with a sensitivity of 86.5%, specificity of 96.7%, and DOR of 187.3. Subgroup analysis revealed higher sensitivity for intracerebral hemorrhage (92.6%) than ischemic stroke (62.3%, p=0.003). Specificity was highest for intraventricular hemorrhage (98.8%). While significant heterogeneity and publication bias were detected, results remained robust after exclusion of outliers. FPCT demonstrates high specificity and moderate-to-high sensitivity for stroke-related findings, with strongest performance for intracranial hemorrhage. These findings support consideration of FPCT as a complementary in-suite imaging tool in selected direct-to-angiosuite workflows, particularly for rapid hemorrhage exclusion. However, its lower sensitivity for ischemic changes and susceptibility to contrast-related artifacts indicate that FPCT should complement, rather than replace, standard CT/MRI-based evaluation.
Super-large-bore aspiration catheters are designed to improve clot engagement and aspiration efficiency during mechanical thrombectomy. However, multiple 0.088-inch platforms are now available, and device-specific clinical performance cannot be inferred from catheter size alone. We report the first multicenter real-world experience with SOFIA 88. This retrospective multicenter European registry included consecutive patients treated with SOFIA 88 for anterior circulation large vessel occlusion involving the internal carotid artery or M1. The primary outcome was successful catheter advancement to the thrombus-vessel interface. Angiographic outcomes included first-pass effect (extended Thrombolysis in Cerebral Infarction (eTICI)≥2c after one pass), final complete reperfusion (eTICI 2c-3), and final successful reperfusion (eTICI≥2b). Safety outcomes included procedural complications, embolization to new territory, intracranial hemorrhage, and symptomatic intracranial hemorrhage. Eighty-one patients from eight centers were included. SOFIA 88 reached the thrombus-vessel interface in 67/81 cases (82.7%), most often using smaller-catheter support (57/81, 70.4%). SOFIA 88 standalone first-pass effect occurred in 32/81 patients (39.5%) using the full real-world cohort denominator and in 32/67 patients (47.8%) among cases with successful SOFIA 88 target access. Final complete and successful reperfusion was achieved in 67/81 (82.7%) and 79/81 (97.5%) patients, respectively. Procedural adverse events occurred in 3/81 (3.7%), embolization to new territory in 1/81 (1.2%), and symptomatic intracranial hemorrhage in 5/81 (6.2%). No device-related adverse events occurred. SOFIA 88 showed feasible target access, high final reperfusion, favorable standalone first-pass performance after successful target access, and acceptable early safety. Further prospective studies are warranted to define optimal patient selection, delivery strategies, and the role of SOFIA 88 in contemporary thrombectomy practice.
Predictors of endovascular treatment failure in high-grade dural arteriovenous fistulas (DAVFs) with cortical venous drainage (CVD) remain insufficiently characterized. This study aimed to identify angioarchitectural factors associated with failed endovascular treatment in DAVFs with CVD. Patients with angiographically confirmed DAVFs with CVD who underwent first-line endovascular embolization in the DREAM-INI (Dural Arteriovenous Fistula Research and Management in China) database were retrospectively analyzed. Successful endovascular treatment was defined as durable complete obliteration without the need for additional surgery or radiosurgery. Baseline clinical and angioarchitectural characteristics were compared between successful and unsuccessful treatment groups. Logistic regression was used to identify predictors of treatment success. A total of 415 patients were included. Successful endovascular treatment was achieved in 302 patients (72.8%), whereas 113 patients (27.2%) were classified as having unsuccessful treatment. On multivariable analysis, the presence of a middle meningeal artery feeder was independently associated with successful endovascular treatment. In contrast, pial arterial supply, venous congestion, and multiple fistulas were associated with lower odds of treatment success. In DAVFs with CVD, specific angioarchitectural features are associated with the likelihood of durable cure after endovascular treatment. Middle meningeal artery feeders may facilitate successful embolization, whereas pial arterial supply, venous congestion, and multiple fistulas suggest more complex lesions that may require careful treatment planning and earlier consideration of multimodal strategies.
As endovascular thrombectomy has become the standard of care for patients with large-vessel occlusion stroke, interest in intra-arterial (IA) selective brain cooling as a method of delivering therapeutic hypothermia has emerged. However, the impact of catheter configuration and competing warm blood flow on IA cooling efficiency is not well understood. We constructed a closed-loop circulatory system to perform in vitro experiments of IA cooling and tested the impact of seven catheter configurations on cooling efficiency, including single and co-axial catheter setups, non-insulated and insulated catheters, and proximal blood flow control (using balloon guide catheter (BGC) inflation) versus no flow control. Thermal modeling was performed to assess the relationship between catheter and internal carotid artery (ICA) flow rates and predicted brain temperature. After 10 min of delivering chilled infusate, the least effective cooling configuration was administering coolant directly through a non-inflated BGC, achieving a 1.2°C reduction in predicted brain temperature. The most effective cooling configuration was the co-axial combination of an insulated catheter and a fully inflated BGC, achieving a 7.8°C reduction in predicted brain temperature. Without proximal blood flow control (BGC inflation), high catheter flow rates were required to overcome rewarming from native ICA flow. These findings emphasize the impacts of catheter flow rate, catheter insulation, and competing warm blood flow on cooling efficiency.
Cerebral perfusion imaging may help detect the presence of, and infer vessel occlusion location in, anterior circulation stroke, but its value in posterior circulation large vessel occlusion (PC-LVO) is less well defined. We evaluated the accuracy and inter-reader reliability of CT and MR perfusion imaging for occlusion classification and posterior circulation vessel localization. We performed a retrospective multicenter diagnostic accuracy study from 11 centers that underwent perfusion imaging for stroke evaluation. The cohort was enriched for posterior circulation stroke. Four blinded readers assigned each case to one of five categories: no occlusion, anterior circulation large vessel occlusion (AC-LVO), basilar artery, posterior cerebral artery (PCA), or vertebral/posterior inferior cerebellar artery (vert/PICA) occlusion. Final classification was determined by majority vote. 184 patients were included. Perfusion imaging correctly classified 150/184 cases on the 5-class task (81.5%, 95% CI 75.1% to 86.9%). Across the 3-class task of LVO(-), AC-LVO, and PC-LVO, accuracy was 163/184 (88.6%, 95% CI 83.1% to 92.8%), with sensitivity of 100% for LVO(-), 100% for AC-LVO, and 84.4% for PC-LVO. Within the posterior circulation subgroup, perfusion imaging correctly localized basilar, PCA, and vert/PICA occlusions in 101/135 cases (74.8%, 95% CI 66.6% to 81.9%), including 82/107 basilar (76.6%), 10/12 PCA (83.3%), and 9/16 vert/PICA (56.3%). Fleiss κ was 0.889 for the 3-class task, 0.742 for the 5-class task, and 0.604 for posterior localization. Perfusion imaging is moderately accurate for the detection and localization of PC-LVO, but performs less well compared with the detection of AC-LVO.
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THUNDER (Acute Ischemic Stroke Study With the Penumbra System Including Thunderbolt Aspiration Tubing) was the first study to evaluate the safety and effectiveness of a proprietary computer assisted vacuum thrombectomy (CAVT) system including modulated aspiration (Penumbra System with Thunderbolt; Penumbra, California, USA) in patients with emergent large vessel occlusion (ELVO). THUNDER was a single arm, prospective, multicenter study with core laboratory adjudication and oversight by a Clinical Events Committee and Data Safety Monitoring Board. The primary endpoint was post-Thunderbolt successful revascularization (modified Treatment in Cerebral Infarction (mTICI) 2b-3). Secondary endpoints included first pass mTICI 2b-3, post-Thunderbolt mTICI 2c-3, time to revascularization, symptomatic intracranial hemorrhages (sICH), device/procedure related serious adverse events (SAEs) within 24 hours, 90- day modified Rankin Score (mRS) 0-2, and all cause mortality. 216 patients were enrolled across 29 US centers (mean age 64.8 years, 45.4% women, median National Institutes of Health Stroke Scale score 15.0). The predefined performance goal was met, with post-Thunderbolt mTICI 2b-3 revascularization achieved in 87.5% (95% CI 82.3% to 91.6%; P<0.001). First pass mTICI 2b-3 was 64.8%. Post-Thunderbolt mTICI 2c-3 was 70.4%. Median time to revascularization was 20 min. Post-procedure, 83.0% of visualized clots were characterized as ingested. At 90 days, mRS 0-2 was 55.4%. Device/procedure related SAEs occurred in 2.8%, sICH in 0.9%, and the rate of all cause mortality at 90 days was 11.7%. The Thunderbolt system was safe and effective for the treatment of ELVO, achieving high revascularization and clot ingestion rates, short procedure times, and low complication rates. The first pass effect rate was numerically higher than those previously reported for large bore catheters and approximated those of ultra bore/super large bore devices. ClinicalTrials.gov NCT05437055.
Intravenous thrombolysis (IVT) has been the mainstay of acute ischemic stroke (AIS) treatment for over three decades. Recently, several studies have evaluated the safety and efficacy of IVT in certain complex clinical scenarios such as bridging IVT with mechanical thrombectomy (MT) versus direct MT, MT in distal medium vessel occlusions (DMVOs), and extended time window reperfusion. Many of these scenarios overlap with neurointerventional treatment strategies. This updated evidence has uncovered certain nuances in AIS treatment (transfer vs non-transfer patients, degree of disability, feasibility of MT) that warrant consideration in medical decision-making in addition to the conventional risks-versus-benefits discussion. Furthermore, as an increasing number of neurologists with diverse subspecialty interests are involved in AIS triage and treatment decision-making across various patient-care models (telestroke, spoke and hub systems, etc), variability in data interpretation may lead to inconsistencies in the administration of these time-sensitive therapies. In this vignette-based narrative review, we focus on evolving 'gray zones' of AIS reperfusion therapy that are particularly relevant to neurointerventional practice: (1) bridging IVT before MT, and (2) reperfusion strategies for DMVOs, with the role of IVT in the extended time window primarily discussed within the second vignette and, to a lesser extent, in the first. This paper is not meant to be a treatment guideline but rather a case-based exercise to provide a better understanding of the new data in this area.
To evaluate the safety and efficacy of clopidogrel versus ticagrelor in patients undergoing flow diverting stent (FDS) placement for unruptured intracranial aneurysms (UIAs). The Neurovascular Quality Initiative-Quality Outcomes Database (NVQI-QOD) Cerebral Aneurysm Registry was queried for patients who underwent FDS placement for UIAs treated with clopidogrel or ticagrelor. Propensity score matching (1:1) was performed to balance demographics, comorbidities, and aneurysm characteristics. Primary outcomes were intraoperative thrombus formation and postoperative symptomatic intracranial hemorrhage (sICH). Secondary outcomes included modified Rankin Scale (mRS), aneurysm occlusion at discharge, and parent vessel stenosis or occlusion on long-term follow-up. 1387 patients (1088 clopidogrel, 299 ticagrelor) were analyzed. Ticagrelor was more frequently used in posterior circulation aneurysms (7.8% clopidogrel vs. 14.4% ticagrelor, P=0.0008) and cases requiring multiple FDS (8.7% clopidogrel vs. 28.2% ticagrelor, P<0.0001). Rates of intraoperative thrombus formation (0.5% clopidogrel vs 0.3% ticagrelor, P=1) and postoperative sICH (0.3% clopidogrel vs 0.5% ticagrelor, P=1) were similar, as were discharge mRS, aneurysm occlusion at discharge, last follow-up mRS, and rates of parent vessel occlusion or stenosis. After matching (180 per group), there were similar rates of intraoperative thrombus formation (0% clopidogrel vs 0.6% ticagrelor, P=1) and postoperative sICH (0.6% clopidogrel vs 0.6% ticagrelor, P=1). Functional outcomes, aneurysm occlusion at discharge, and rates of parent vessel stenosis or occlusion also remained similar. No significant differences in safety or efficacy were detected between clopidogrel and ticagrelor in patients undergoing FDS placement for UIAs.