Objectives 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). Methods 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. Results 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. Conclusions 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.
BackgroundDistal intracranial aneurysms are relatively rare in clinical practice and are characterized by distal location, smaller parent vessels, and fragile surrounding brain tissue, which are associated with a relatively higher risk of treatment-related complications such as ischemia and rebleeding. Traditional flow diverter stents have a thin tip, delivery wire can cause intraparenchymal hemorrhage or distal vessel perforation, particularly when attempting to navigate through complex, narrow, or fragile arteries. Therefore, the use of flow diverter devices in the treatment of distal intracranial aneurysms remains technically challenging. Flow diverter devices have been widely used for the treatment of wide-neck intracranial aneurysms; however, comparative data between the domestically developed Lattice device (Accu Medical, China) and the Pipeline Embolization Device remain limited. In this study, we compared the efficacy and safety of these two flow diverters in the treatment of unruptured distal intracranial aneurysms, based on scheduled postoperative imaging follow-up using computed tomography angiography (CTA) and digital subtraction angiography (DSA), focusing on aneurysm occlusion, complications, and branch vessel occlusion.MethodsThis retrospective study included 47 patients with distal intracranial aneurysms treated with flow diverter devices between January 2020 and July 2025, who underwent implantation of either the Lattice or Pipeline stent. All patients underwent imaging follow-up at 6 months postoperatively using either computed tomography angiography (CTA) or digital subtraction angiography (DSA). Inverse probability weighting (IPTW) was performed to balance baseline characteristics between the two groups. Baseline characteristics before and after IPTW are presented in Table 1. After adjusting for age, sex, hypertension, diabetes, preoperative mRS, aneurysm location, aneurysm morphology (saccular vs. fusiform), neck type (wide vs. narrow), maximum aneurysm diameter, neck size, dome-to-neck ratio, the inflow angle of the aneurysm (IFAA), branch vessel diameter, branch vessel origin, and mean parent vessel diameter, propensity scores were calculated for inverse probability of treatment weighting (IPTW). We applied 1/PS as a weight for the Lattice group and 1/(1 − PS) for the Pipeline group. Inverse probability weighting was applied, and logistic regression analysis was performed to identify factors potentially associated with aneurysm occlusion. Aneurysm healing was assessed using the OKM grading scale, with grades 0–2 defined as poor occlusion and grades 3–4 defined as favorable occlusion.ResultsCompared with the Pipeline group, no statistically significant differences were observed in aneurysm occlusion rates or branch vessel occlusion rates in the Lattice group at a median follow-up duration of 179 days (77.8% vs. 75.9%, p = 0.586). Among 18 patients treated with the Lattice device, 14 achieved favorable occlusion on follow-up imaging (14/18, 77.8%), whereas 22 of 29 patients treated with the Pipeline device demonstrated favorable occlusion (22/29, 75.9%). Branch vessel occlusion covered by the stent occurred in 3 patients in the Lattice group (3/18, 16.7%), which was slightly higher than that in the Pipeline group (2/29, 6.9%); however, this difference was not statistically significant (p = 0.317). Logistic regression analysis identified the IFAA as a potential factor associated with delayed or incomplete aneurysm healing. Specifically, for each 1-degree increase in this angle, the odds of aneurysm occlusion decreased by 3.5% (OR = 0.965, 95% CI: 0.933–0.998, p = 0.037). In addition, IPTW-adjusted univariate weighted logistic regression showed that larger aneurysm neck diameter (OR 0.685, 95% CI 0.505–0.929, p = 0.016), presence of branch vessel origin from aneurysms (OR 0.065, 95% CI 0.011–0.364, p = 0.003) were also associated with unfavorable OKM outcomes.ConclusionAfter IPTW adjustment, Lattice and Pipeline devices demonstrated comparable efficacy and safety in the treatment of distal cerebral aneurysms. Aneurysm geometric and anatomical factors, including the inflow angle (IFAA), aneurysm neck diameter and branch vessel origin, were independently associated with incomplete or delayed aneurysm occlusion.
BACKGROUND:New ischemic cerebral infarction (NICI) on diffusion-weighted imaging (DWI) is frequently observed after stent-assisted coiling. OBJECTIVE:To investigate whether preoperative statin use reduces NICI volume and whether the effect depends on baseline low-density lipoprotein cholesterol (LDL-C). METHODS:We retrospectively analyzed 490 patients with intracranial aneurysms who underwent stent-assisted treatment at multiple centers. Based on preoperative statin use, patients were classified into statin (n=269) and non-statin (n=221) groups. NICI volume was quantified on postoperative DWI. Multivariable linear regression was used to identify predictors of log-transformed NICI volume, including an interaction term between statin use and LDL-C >3.4 mmol/L. RESULTS:Median infarct volume was significantly lower in the statin group (1.39 (IQR 0.87-1.92)) than in the non-statin group (1.83 (IQR 1.48-2.47); P<0.001). After multivariable adjustment, statin use remained independently associated with smaller NICI volume (B = -0.382; 95% CI -0.488 to -0.277; P<0.001). Subgroup analysis showed consistent reductions in both statin+normal LDL-C and statin+high LDL-C subgroups (both P<0.001). No interaction was observed between statin use and LDL-C level (P=0.147), suggesting consistent protection regardless of lipid status. Smoking (B=0.407; P<0.001), higher body mass index (B=0.040; P<0.001), and female sex (B=0.130; P=0.033) were independent predictors of larger infarct volume. CONCLUSIONS:Preoperative statin therapy significantly reduced NICI volume after stent-assisted aneurysm treatment, independently of LDL-C, suggesting possible neurovascular protection through pleiotropic mechanisms beyond lipid lowering.
[This corrects the article DOI: 10.3389/fneur.2026.1851112.].
Background:Stent-assisted coiling (SAC) is widely used for wide-necked intracranial aneurysms. Limited studies have compared new generation Neuroform Atlas and Enterprise 2 (EP2) stents. This study compared the two in terms of efficacy, safety, and cost implications. Methods:Data from 572 patients with anterior circulation aneurysms treated with SAC using either Atlas or EP2 stents were retrospectively analyzed. Propensity score matching (PSM) was applied to balance patient and aneurysm characteristics between the groups. Results:The Atlas group had a higher prevalence of male patients, smokers, drinkers, hypertensives, and distal carotid artery aneurysms. The dome-to-neck ratio was larger in the EP2 group. After PSM (147 matched pairs), there were no significant differences in occlusion rates (89.1% vs. 87.1%, P=0.719), perioperative ischemic (6.8% vs. 10.2%, P=0.403) and hemorrhagic complications (2.0% vs. 2.0%, P=0.999), or favorable outcomes (98.6% vs. 96.6%, P=0.444). The EP2 stent was associated with lower hospital costs ($25,235.9±6,484.2 vs. $27,540.5±7125.9, P=0.004). Subgroup analysis revealed that the Atlas group had more advantages in preventing ischemic complications for bifurcation aneurysms, aneurysms with smaller parent vessel diameter, and aneurysms with larger dome-to-neck ratio; but these differences were not significant after PSM. Conclusions:Atlas and EP2 stents are effective for anterior circulation aneurysms. EP2 stent offers economic benefits, whereas Atlas stent was more commonly used for aneurysms with smaller parent artery diameters and bifurcation aneurysms and ischemic complications were less frequent with the Neuroform Atlas compared to EP2 in these aneurysm types.
BackgroundFlow diverters (FDs) are increasingly applied for intracranial aneurysms, but their high metal coverage raises thromboembolic risk. Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is standard, yet clopidogrel resistance, especially in Asian populations, reduces efficacy. Tirofiban, a glycoprotein IIb/IIIa inhibitor, may enhance perioperative protection. This study evaluated the safety and efficacy of adding short-term tirofiban to DAPT after FDs treatment and developed a model to predict thromboembolic events (TEEs).MethodsWe retrospectively analyzed 319 patients with unruptured aneurysms treated with FDs across multiple centers (2018–2022). Patients received either DAPT alone (group 1) or DAPT plus tirofiban (group 2). After propensity score matching (140 per group), ischemic and hemorrhagic complications were compared. Predictive factors for TEEs were identified using Lasso-logistic regression, and a nomogram was constructed.ResultsA total of 389 aneurysms in 319 patients were included in the statistical analysis. There were no statistically significant differences in the baseline characteristics of the patients and aneurysms between the groups, indicating comparability. After PSM, 140 patients were included in each group for comparison. The group 1 vs. the group 2 (Early postoperative complications): TEEs (3.6% vs. 5.0%, p = 0.768), intracranial hemorrhage (0% vs. 0.7%, p = 0.390); The group 1 vs. the group 2 (Long-term postoperative complications): TEEs (3.3% vs. 5.7%, p = 0.370), intracranial hemorrhage (3.6% vs. 1.4%, p = 0.444), and peripheral bleeding events (2.9% vs. 6.5%, p = 0.256) showed no statistically significant differences. Multivariable logistic regression identified maximum aneurysm diameter (OR = 1.153, 95% CI: 1.087–1.223, p < 0.0001) as significant risk factor for TEEs, while diameter of the feeding artery (OR = 0.442, 95% CI: 0.286–0.682, p = 0.0003) was protective factor. A nomogram based on these factors achieved a C-index of 0.723.ConclusionTirofiban combined with DAPT in flow diverter treatment for intracranial aneurysms demonstrated good safety without increasing bleeding risk, though its efficacy advantage over DAPT alone was not evident. The proposed nomogram enables individualized TEE risk prediction and supports personalized antiplatelet management.
For participants with intracranial aneurysm who underwent stent treatment, light transmission aggregation–guided antiplatelet therapy helped reduce ischemic events without increasing bleeding risks.
INTRODUCTION:Flow diverters (FD) have gradually become the preferred treatment option for complex and large intracranial aneurysms. Postoperative thromboembolic events (TEEs) are among the most common complications associated with endovascular treatment. However, widely applicable predictive tools for the occurrence of TEEs are currently lacking. METHODS:This retrospective study included clinical data from 377 patients (a total of 451 aneurysms) treated with flow diverters at two neurointerventional centers between June 2018 and September 2022. Thirty-nine baseline patient characteristics were included as clinical variables. The primary endpoint was the occurrence of postoperative ischemic events. The dataset was randomly divided into a training set (80%) and a testing set (20%). We performed fivefold cross-validation and applied Lasso regression to the training set to identify the most informative features. Multiple machine learning (ML) algorithms were employed to construct predictive models. Model performance was evaluated on the testing set using the area under the receiver operating characteristic curve (AUC-ROC), the area under the precision-recall curve (AUC-PR), and calibration plots. SHapley Additive exPlanations (SHAP) analysis was used to visualize feature contributions and to interpret individual case predictions. RESULTS:Among 377 patients, 21 (5.6%) experienced TEEs. A machine learning model incorporating 10 variables was developed, with the support vector machine (SVM) model demonstrating the best performance-achieving an AUC-ROC of 0.96 and an AUC-PR of 0.88 in validation. The key predictive factors included aneurysm width, low-density lipoprotein (LDL) levels, hypertension, aneurysm location, triglycerides (TG), and diabetes. Additionally, a web-based tool was developed to assist clinicians in applying the model in practice. CONCLUSIONS:We developed a machine learning model to predict the risk of TEEs following FD implantation for intracranial aneurysms, and demonstrated its clinical potential through internal validation. This tool can assist neurointerventionalists in estimating the probability of TEE occurrence based on patient clinical data and aneurysm characteristics, enabling the development of personalized treatment strategies.
BackgroundAlthough calcium channel blockers (CCBs) are useful in stroke prevention, their specific role in preventing stroke in hypertensive patients with intracranial aneurysms undergoing endovascular stent placement remains unclear.MethodsWe retrospectively examined 458 hypertensive patients with intracranial aneurysms who underwent stent treatment, drawn from a larger multicenter cohort comprising 1326 patients across eight centers. Patients were dichotomized into two groups according to use of a CCB. Propensity score matching (PSM) was performed to balance group differences in patient and aneurysm characteristics. We conducted a comparison of patient and aneurysm characteristics, ischemic complications, and clinical outcomes between the two groups.ResultsThe CCB and non-CCB groups comprised 279 and 179 patients, respectively. PSM resulted in 165 matched pairs. After PSM, the incidence of ischemic events within 1 month of the procedure (4.2% vs 10.9%; P=0.022) and proportion of patients with modified Rankin Scale score >2 at last follow-up (1.5% vs 7.8%; P=0.013) were significantly lower in the CCB group. Among patients treated with combination therapy, inclusion of a CCB was associated with a lower incidence of ischemic events (1.5% vs 13.3%; P=0.345), but the difference was not statistically significant after correction.ConclusionsCCB use in hypertensive patients undergoing endovascular stenting for treatment of intracranial aneurysms is associated with a lower incidence of ischemic events and a lower incidence of unfavorable neurological outcomes, especially when used in combination therapy.
Background Although flow diverter device (FDD) has brought revolutionized advances in endovascular treatment of intracranial aneurysms, it also presents considerable drawbacks as well, as the innovation for novel device has never stopped. This preclinical research aims to evaluate the safety and efficacy of a newly developed FDD, the EMBOPIPE, through in vivo and in vitro experiments. Methods Aneurysms were induced in 20 New Zealand white rabbits which were randomized to three follow-up groups according to the time elapsed after EMBOPIPE implantation (28, 90, and 180 days). Additional EMBOPIPEs were implanted in the abdominal aorta to cover the renal artery in nine rabbits. Angiography was performed immediately after device placement in all groups. Aneurysm occlusion, patency of renal arteries, and pathological outcomes were assessed. For the in vitro experiments, we measured the thrombogenic potential of EMBOPIPEs ( n = 5) compared with bare stents ( n = 5) using the Chandler loop model. Evaluation indicators were the platelet counts, macroscopic observations and scanning electron microscopy. Results EMBOPIPEs were successfully deployed in 19 of 20 rabbit aneurysms (95.0%). The rates of complete or near-complete aneurysm occlusion were 73.3%, 83.3%, and 100% in the 28-, 90-, and 180-day groups, respectively. All renal arteries covered by EMBOPIPEs remained patent, and the mean difference in renal artery diameter before and after the device placement in the three groups was 0.07 mm, 0.10 mm, and 0.10 mm, respectively ( p = 0.77). Renal pathology was normal in all cases. The pathological findings of the aneurysms were as follows: thickened and adequate neointimal coverage at the aneurysm neck, minimal inflammatory response, near-complete smooth muscle cell layer, and endothelialization along the device. In vitro experiments showed that the platelet counts were significantly higher in EMBOPIPE blood samples than in bare stent samples and that platelet adhesion to the device was lower in the EMBOPIPE stent struts compared with bare stent struts through macroscopic observations and scanning electron microscopy. Conclusions The EMBOPIPE can achieve high rates of aneurysm occlusion while maintaining excellent branch artery patency. It exhibited wonderful pathological results. This novel device with phosphorylcholine surface modification could reduce platelet thrombus attached to the stent struts.
Importance:Previous randomized clinical trials did not demonstrate the superiority of endovascular stenting over aggressive medical management for patients with symptomatic intracranial atherosclerotic stenosis (sICAS). However, balloon angioplasty has not been investigated in a randomized clinical trial. Objective:To determine whether balloon angioplasty plus aggressive medical management is superior to aggressive medical management alone for patients with sICAS. Design, Setting, and Participants:A randomized, open-label, blinded end point clinical trial at 31 centers across China. Eligible patients aged 35 to 80 years with sICAS defined as recent transient ischemic attack (<90 days) or ischemic stroke (14-90 days) before enrollment attributed to a 70% to 99% atherosclerotic stenosis of a major intracranial artery receiving treatment with at least 1 antithrombotic drug and/or standard risk factor management were recruited between November 8, 2018, and April 2, 2022 (final follow-up: April 3, 2023). Interventions:Submaximal balloon angioplasty plus aggressive medical management (n = 249) or aggressive medical management alone (n = 252). Aggressive medical management included dual antiplatelet therapy for the first 90 days and risk factor control. Main Outcomes and Measures:The primary outcome was a composite of any stroke or death within 30 days after enrollment or after balloon angioplasty of the qualifying lesion or any ischemic stroke in the qualifying artery territory or revascularization of the qualifying artery after 30 days through 12 months after enrollment. Results:Among 512 randomized patients, 501 were confirmed eligible (mean age, 58.0 years; 158 [31.5%] women) and completed the trial. The incidence of the primary outcome was lower in the balloon angioplasty group than the medical management group (4.4% vs 13.5%; hazard ratio, 0.32 [95% CI, 0.16-0.63]; P < .001). The respective rates of any stroke or all-cause death within 30 days were 3.2% and 1.6%. Beyond 30 days through 1 year after enrollment, the rates of any ischemic stroke in the qualifying artery territory were 0.4% and 7.5%, respectively, and revascularization of the qualifying artery occurred in 1.2% and 8.3%, respectively. The rate of symptomatic intracranial hemorrhage in the balloon angioplasty and medical management groups was 1.2% and 0.4%, respectively. In the balloon angioplasty group, procedural complications occurred in 17.4% of patients and arterial dissection occurred in 14.5% of patients. Conclusions and Relevance:In patients with sICAS, balloon angioplasty plus aggressive medical management, compared with aggressive medical management alone, statistically significantly lowered the risk of a composite outcome of any stroke or death within 30 days or an ischemic stroke or revascularization of the qualifying artery after 30 days through 12 months. The findings suggest that balloon angioplasty plus aggressive medical management may be an effective treatment for sICAS, although the risk of stroke or death within 30 days of balloon angioplasty should be considered in clinical practice. Trial Registration:ClinicalTrials.gov Identifier: NCT03703635.
ImportancePrevious randomized clinical trials did not demonstrate the superiority of endovascular stenting over aggressive medical management for patients with symptomatic intracranial atherosclerotic stenosis (sICAS). However, balloon angioplasty has not been investigated in a randomized clinical trial.ObjectiveTo determine whether balloon angioplasty plus aggressive medical management is superior to aggressive medical management alone for patients with sICAS.Design, Setting, and ParticipantsA randomized, open-label, blinded end point clinical trial at 31 centers across China. Eligible patients aged 35 to 80 years with sICAS defined as recent transient ischemic attack (<90 days) or ischemic stroke (14-90 days) before enrollment attributed to a 70% to 99% atherosclerotic stenosis of a major intracranial artery receiving treatment with at least 1 antithrombotic drug and/or standard risk factor management were recruited between November 8, 2018, and April 2, 2022 (final follow-up: April 3, 2023).InterventionsSubmaximal balloon angioplasty plus aggressive medical management (n = 249) or aggressive medical management alone (n = 252). Aggressive medical management included dual antiplatelet therapy for the first 90 days and risk factor control.Main Outcomes and MeasuresThe primary outcome was a composite of any stroke or death within 30 days after enrollment or after balloon angioplasty of the qualifying lesion or any ischemic stroke in the qualifying artery territory or revascularization of the qualifying artery after 30 days through 12 months after enrollment.ResultsAmong 512 randomized patients, 501 were confirmed eligible (mean age, 58.0 years; 158 [31.5%] women) and completed the trial. The incidence of the primary outcome was lower in the balloon angioplasty group than the medical management group (4.4% vs 13.5%; hazard ratio, 0.32 [95% CI, 0.16-0.63]; P < .001). The respective rates of any stroke or all-cause death within 30 days were 3.2% and 1.6%. Beyond 30 days through 1 year after enrollment, the rates of any ischemic stroke in the qualifying artery territory were 0.4% and 7.5%, respectively, and revascularization of the qualifying artery occurred in 1.2% and 8.3%, respectively. The rate of symptomatic intracranial hemorrhage in the balloon angioplasty and medical management groups was 1.2% and 0.4%, respectively. In the balloon angioplasty group, procedural complications occurred in 17.4% of patients and arterial dissection occurred in 14.5% of patients.Conclusions and RelevanceIn patients with sICAS, balloon angioplasty plus aggressive medical management, compared with aggressive medical management alone, statistically significantly lowered the risk of a composite outcome of any stroke or death within 30 days or an ischemic stroke or revascularization of the qualifying artery after 30 days through 12 months. The findings suggest that balloon angioplasty plus aggressive medical management may be an effective treatment for sICAS, although the risk of stroke or death within 30 days of balloon angioplasty should be considered in clinical practice.Trial RegistrationClinicalTrials.gov Identifier: NCT03703635
Background and purpose Light transmission aggregometry (LTA) and CYP2C19 genotype analysis are commonly used to evaluate the antiplatelet effects of clopidogrel during the interventional treatment of intracranial aneurysms. The aim of this study was to determine which test can predict ischaemic events during these treatments. Methods Patient demographic information, imaging data, laboratory data and ischaemic complications were recorded. LTA and CYP2C19 genotype results were compared, and multiple linear regression was performed to examine factors related to platelet reactivity. Multivariate regression analysis was performed to determine whether LTA and CYP2C19 could predict ischaemic complications and to identify other clinical risk factors. Receiver operating characteristic curve analysis was conducted to calculate the cut-off value for predicting ischaemic complications. A subgroup analysis was also performed for different CYP2C19 genotype metabolisers, as well as for patients with flow diverters and traditional stents. Results A total of 379 patients were included, of which 22 developed ischaemic events. Maximum platelet aggregation induced by ADP (ADP-MPA) could predict ischaemic events (p<0.001; area under the curve, 0.752 (95% CI 0.663 to 0.842)), and its cut-off value was 41.5%. ADP-MPA (p=0.001) and hypertension duration >10 years (p=0.022) were independent risk factors for ischaemic events, while the CYP2C19 genotype was not associated with ischaemic events. In the subgroup analysis, ADP-MPA could predict ischaemic events in fast metabolisers (p=0.004) and intermediate metabolisers (p=0.003). The cut-off value for ischaemic events was lower in patients with flow diverters (ADP-MPA=36.4%) than in patients with traditional stents (ADP-MPA=42.9%). Conclusions ADP-MPA can predict ischaemic complications during endovascular treatment of intracranial aneurysms. Patients with flow diverters require stronger antiplatelet medication than patients with traditional stents.
To analyze the effect of tirofiban on ischemic events in CYP2C19 loss-of-function (LOF) allele carriers during pipeline embolization device (PED) implantation. Demographic information, imaging data, ischemic complications, CYP2C19 genotyping, and platelet function test results were collected from patients with PED-treated intracranial aneurysms at three centers. Multivariate logistic regression was used to analyze risk factors for ischemic events. Patients were grouped according to LOF alleles and antiplatelet drugs, the baseline information of LOF allele carriers and non-carriers were compared, and the efficacy of tirofiban was analyzed by comparing the incidence of ischemic events in each group. In total, 278 patients were included in the study, 24 of whom had an ischemic event. 157 (56.5%) patients carried the LOF allele and were more likely to develop resistance to clopidogrel ( P < 0.001) and hypertension ( P = 0.010). Multivariate logistic regression analysis revealed that the independent risk factors for ischemic events were age of > 55 years (OR = 3.308, P = 0.028), LOF alleles (OR = 3.960, P = 0.036), and clopidogrel nonresponsiveness (OR = 3.301, P = 0.014). For LOF allele carriers, prophylactic use of tirofiban after PED implantation helped to reduce ischemic events (4.3% vs. 16.4%, P = 0.039). This study supports CYP2C19 genotyping before flow diversion because LOF alleles increase the risk of ischemic events. Prophylactic use of tirofiban may help reduce ischemic events in LOF allele carriers.
ABSTRACT Background The goal of standard dual antiplatelet therapy (SDAT) in patients undergoing endovascular interventional treatment of intracranial aneurysms is to prevent thrombosis; however, some patients have a poor response to these drugs, which increases the risk of cerebral infarction. This study aims to examine whether adjusting antiplatelet therapy based on light transmission aggregometry (LTA) can reduce the incidence of ischemic events compared with SDAT. Methods We will conduct a cluster randomized controlled trial using 16 treatment teams from eight hospitals in mainland China, enrolling 590 patients with unruptured intracranial aneurysms treated using endovascular stent placement. The treatment teams serving as clusters will be randomly assigned to either the test or control group at a 1:1 ratio. Test group patients will receive an antiplatelet regimen guided by LTA. Control group patients will receive SDAT. Patients will be followed for 1 month after the treatment period. The primary outcome measure is cerebral ischemic events within 30 days of stent placement, including stent thrombosis, ischemic stroke, and transient ischemic attack. The safety measure is all bleeding events within 30 days of treatment. Discussion The trial aims to determine whether LTA-guided antiplatelet therapy reduces the incidence of ischemic events without increasing the risk of bleeding in patients with intracranial aneurysms treated with endovascular stenting. Completion of this clinical trial may provide an individualized safe and effective regimen for antiplatelet therapy. Trial registration ClinicalTrials.gov, NCT05825391 . Registered on April 11, 2023. What is already known on this topic Dual antiplatelet therapy is administered to reduce thrombotic events in neurointerventional therapy of intracranial aneurysms. Platelet function testing is used to evaluate the antiplatelet effect of aspirin and clopidogrel. What this study adds The trial aims to determine whether LTA-guided antiplatelet therapy reduces the incidence of ischemic events without increasing the risk of bleeding in patients with intracranial aneurysms treated with endovascular stenting. How this study might affect research, practice or policy For stent neurointerventional therapy of unruptured intracranial aneurysms, this study could provide a promising method for adjusting appropriate antiplatelet therapy.
BACKGROUND The role of endovascular therapy for acute stroke with a large infarction has not been extensively studied in differing populations. METHODS We conducted a multicenter, prospective, open-label, randomized trial in China involving patients with acute large-vessel occlusion in the anterior circulation and an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower values indicating larger infarction) or an infarct-core volume of 70 to 100 ml. Patients were randomly assigned in a 1:1 ratio within 24 hours from the time they were last known to be well to undergo endovascular therapy and receive medical management or to receive medical management alone. The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability), and the primary objective was to determine whether a shift in the distribution of the scores on the modified Rankin scale at 90 days had occurred between the two groups. Secondary outcomes included scores of 0 to 2 and 0 to 3 on the modified Rankin scale. The primary safety outcome was symptomatic intracranial hemorrhage within 48 hours after randomization. RESULTS A total of 456 patients were enrolled; 231 were assigned to the endovascular-therapy group and 225 to the medical-management group. Approximately 28% of the patients in both groups received intravenous thrombolysis. The trial was stopped early owing to the efficacy of endovascular therapy after the second interim analysis. At 90 days, a shift in the distribution of scores on the modified Rankin scale toward better outcomes was observed in favor of endovascular therapy over medical management alone (generalized odds ratio, 1.37; 95% confidence interval, 1.11 to 1.69; P = 0.004). Symptomatic intracranial hemorrhage occurred in 14 of 230 patients (6.1%) in the endovascular-therapy group and in 6 of 225 patients (2.7%) in the medical-management group; any intracranial hemorrhage occurred in 113 (49.1%) and 39 (17.3%), respectively. Results for the secondary outcomes generally supported those of the primary analysis. CONCLUSIONS In a trial conducted in China, patients with large cerebral infarctions had better outcomes with endovascular therapy administered within 24 hours than with medical management alone but had more intracranial hemorrhages. (Funded by Covidien Healthcare International Trading [Shanghai] and others; ANGEL-ASPECT ClinicalTrials.gov number, NCT04551664.).
Endothelialization of the aneurysmal neck is essential for aneurysm healing after endovascular treatment. Mesenchymal stem cell (MSC)-seeded stents can promote aneurysm repair. The biological effects of coated and uncoated nitinol intracranial stents seeded with MSCs on vascular cells and macrophage proliferation and inflammation are investigated. Two stent coatings that exert pro-aggregation effects on MSCs via different mechanisms are examined: gelatin/polylysine (G/PLL), which enhances cell adhesion, and silk fibroin/SDF-1α (SF/SDF-1α), which enhances chemotaxis. The aim is to explore the feasibility of MSC-seeded coated stents in the treatment of intracranial aneurysms. The G/PLL coating provides the highest cytocompatibility and blood compatibility substrate for MSCs and vascular cells and promotes cell adhesion and proliferation. Moreover, it enhances MSC secretion and regulation of vascular cell and macrophage proliferation and chemotaxis. Although the SF/SDF-1α coating promotes MSC secretion and vascular cell chemotaxis, it induces a greater degree of macrophage proliferation, chemotaxis, and secretion of pro-inflammatory factors. MSC-seeded stents coated with G/PLL may benefit stent surface endothelialization and reduce the inflammatory response after endovascular treatment of intracranial aneurysm. These effects may improve aneurysm healing and increase the cure rate.
Objective:To preliminarily evaluate the efficacy and safety of Surpass Streamline flow diverting device (FD) in the treatment of intracranial aneurysms.Methods:A retrospective analysis was conducted on the clinical data of 46 patients with intracranial aneurysms treated with Surpass Streamline FD at the Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University from November 2020 to March 2021. There were 57 aneurysms in 46 patients. Among them, there were 28 ophthalmic segment aneurysms, 8 communicating segment aneurysms, 19 cavernous sinus segment aneurysms, 1 carotid segment aneurysm and 1 vertebral V4 segment aneurysm. The O′Kelly-Marotta (OKM) grading scale was used to assess the degree of embolization of aneurysms immediately after surgery and during follow-up. The modified Rankin scale (mRS) was used to evaluate the neurological function of patients during the perioperative period and during follow-up. At 6 months after surgery, digital subtraction angiography (DSA) or CT angiography (CTA) was performed to review the occlusion of the aneurysm.Results:A total of 46 FDs were implanted in 57 intracranial aneurysms in 46 patients. Among them, 42 FDs (91.3%) were successfully released at one time; the other 4 FDs were not successfully released at one time, but after bridging, overlapping and balloon dilation, satisfactory release effects were achieved. Forty-three patients were treated with FD implantation alone, and three patients were treated with FD combined with coiling. The DSA of 57 aneurysms immediately after the operation showed that the contrast agent was well filled in the aneurysm, and the OKM grades were grade A in 30 cases, grade B in 19, grade C in 5, and grade D in 3. After the operation, 43 patients (93.5%) had a good outcome (mRS ≤2 points); the remaining 3 patients (6.5%) had various degrees of ischemic complications. A total of 32 patients (37 aneurysms) underwent DSA or CTA follow-up, the follow-up time was 6.6±1.8 months (3-10 months), and 32 aneurysms (86.5%) were completely occluded (OKM grade D in all). At the last follow-up, 32 patients had no new ischemic or bleeding complications, and their mRS were all ≤2 points.Conclusions:The immediate effect of Surpass Streamline FD in the treatment of intracranial aneurysms is satisfactory. The aneurysm occlusion rate in the mid-term follow-up seems high and the incidence of complications is low. However, the long-term efficacy and safety need to be further observed.
Background:Basilar trunk and vertebrobasilar junction (BTVBJ) aneurysms have a poor prognosis and are challenging to treat.Objective:This study aimed to evaluate the efficacy of reconstructive endovascular treatment for BTVBJ aneurysms and explore a treatment selection paradigm.Methods:Clinical and angiographic data from 77 patients with 80 BTVBJ aneurysms who underwent endovascular treatment with flow diverters (FDs) or conventional stent-assisted coiling between January 2016 and December 2020 were retrospectively analyzed. Aneurysm characteristics and treatment outcomes were compared between treatment groups.Results:Among the 77 study patients, 34 (44.2%) were treated with FDs and 43 (55.8%) with conventional stent-assisted coiling. Overall, 72.7% of patients achieved favorable clinical outcome at follow-up. The rate of procedure-related complications was 23.4%. The aneurysm occlusion rate at last follow-up did not differ between the FD and conventional stent groups (79.2% vs. 77.1%, p = 0.854). Although the occlusion rate immediately after the procedure was lower in the FD group (29.4%), incidence of progressive occlusion was significantly higher (62.5 vs. 5.7%; p < 0.001). The proportion of patients with large and giant aneurysms (≥10 mm) was significantly higher in the FD group (70.6 vs. 34.8%; p = 0.002). In patients with large or giant aneurysms, favorable clinical outcome at last follow-up was achieved in 75% of patients in the FD group but only 43.8% of patients in the conventional stent group (p = 0.046). Moreover, the complication rate was lower in the FD group, but the difference was not significant (20.8 vs. 37.5%; p = 0.247). The same analyses were performed for patients with small aneurysms (<10 mm) but no significant differences between the two groups were observed.Conclusion:Endovascular treatment of small BTVBJ aneurysms using either FDs or conventional stents was feasible and effective. In patients with large or giant aneurysms, treatment using FDs achieved higher rates of occlusion and favorable clinical outcome at last follow-up than conventional stent-assisted coiling.
Background This study analyzed the safety and efficacy of Enterprise 2 stent-assisted coil embolization for wide-necked intracranial aneurysms by examining stent-vessel apposition, operative complications, embolization outcomes, and clinical outcomes. Methods We retrospectively reviewed the medical records of patients with wide-necked intracranial aneurysms who underwent Enterprise 2 stent-assisted coiling in our hospital from November 2018 to October 2019. Intraoperative VasoCT was performed immediately after stent release in a continuous cohort of patients to observe stent-vessel apposition. Patient demographic, clinical, and imaging data were recorded and analyzed. Results A total of 106 wide-necked aneurysms in 106 patients were treated. Stent release was successful in all patients. Twenty-one patients were enrolled consecutively for VasoCT scanning, and incomplete stent apposition was observed in 5 (23.8%). Perioperative complications occurred in 10 patients (9.4%): cerebral infarction in 6, intraoperative coil prolapse in 1, puncture site pseudoaneurysm in 1, deep vein thrombosis at multiple sites in 1, and transient brainstem mass effect in 1. Among the 95 aneurysms with angiographic follow-up, embolization was satisfactory (Raymond–Roy classifications I and II) in 89 (93.7%). Hyperlipidemia was an independent risk factor for incomplete aneurysm occlusion. At the last clinical follow-up, seven patients had a poor clinical outcome (modified Rankin Scale score ≥ 3). Independent risk factors for poor outcomes were preoperative subarachnoid hemorrhage at presentation and cerebral infarction. Conclusion Enterprise 2 stent-assisted coiling for treatment of wide-necked intracranial aneurysms showed good safety and efficacy; however, incomplete stent apposition can still occur in vessels with a large curvature. Preoperative subarachnoid hemorrhage at presentation and cerebral infarction are the main reasons for poor clinical outcomes after stent-assisted coil embolization.