AIMS:Metabolic dysfunction-associated steatotic liver disease (MASLD) is increasingly linked to cognitive decline, yet the hepatic factors associated with imaging-derived neurovascular coupling (NVC) remain unclear. This study aimed to investigate whether liver stiffness or liver fat content was more closely associated with resting-state CBF-ReHo surrogate measures. MATERIALS AND METHODS:A total of 130 participants including 98 MASLD patients and 32 age- and education-matched healthy controls (HCs) underwent clinical assessment, neuropsychological testing, and multi-modal MRI. Liver stiffness and fat content were quantified using MR elastography (MRE) and MRI-proton density fat fraction (PDFF). Imaging-derived NVC was assessed using global cerebral blood flow (CBF)-regional homogeneity (ReHo) coupling and voxel-wise CBF/ReHo ratios, interpreted as resting-state surrogates rather than direct stimulus-evoked NVC. Multivariable regression and exploratory mediation analyses were employed. RESULTS:Compared to HCs and patients with lower liver stiffness (MASLD_low), those with higher liver stiffness (MASLD_high) showed reduced global CBF-ReHo coupling and altered CBF/ReHo ratios, primarily localized to the bilateral superior temporal pole/superior temporal gyrus (TPOsup). In multivariable regression, liver stiffness remained independently associated with TPOsup CBF/ReHo ratios (p < 0.001). Exploratory mediation analysis showed a statistically significant indirect association between hepatocellular injury markers and TPOsup CBF/ReHo ratios involving MRE-derived liver stiffness (95% CI: 0.0795-0.2790). CONCLUSIONS:Within this cohort and the observed PDFF range, MRE-derived liver stiffness was more closely associated with imaging-derived NVC surrogate measures than liver fat content in MASLD. These findings are hypothesis-generating and require validation in longitudinal studies.
Background Restenosis is a major cause of stroke recurrence after bare-metal stent (BMS) placement in patients with symptomatic intracranial atherosclerotic disease (ICAD). Observational studies have shown that drug-coated balloon (DCB) angioplasty can reduce restenosis rates. Purpose To compare the efficacy and safety of DCB angioplasty with that of BMS placement in individuals with symptomatic ICAD with high-grade stenosis. Materials and Methods Eligible patients with symptomatic ICAD at 14 Chinese tertiary hospitals were prospectively and randomly assigned (1:1 ratio) to the DCB and BMS groups. The primary outcome was 6-month restenosis assessed with digital subtraction angiography. Secondary and safety outcomes included 6-month symptomatic restenosis, 30-day to 1-year recurrent ischemic event, and 30-day stroke or death. Between-group differences in outcomes were tested using generalized linear and Cox regression models. Results Between July 2021 and March 2023, 209 participants (median age, 59 years [IQR, 52-66 years]; 157 men), 103 and 106 in the DCB and BMS groups, respectively, were included in the intention-to-treat analysis. A total of 164 participants completed the 6-month digital subtraction angiography follow-up, and 203 participants completed the 1-year clinical follow-up. The 6-month angiographic restenosis rate was lower in the DCB group than in the BMS group (11% vs 29%; risk ratio, 0.38 [95% CI: 0.19, 0.78]; P = .006). The DCB group also had a lower 6-month symptomatic restenosis rate (1% vs 10%; risk ratio, 0.13 [95% CI: 0.02, 0.96]; P = .02) and lower 30-day to 1-year recurrent ischemic event rate (4% vs 13%; hazard ratio, 0.31 [95% CI: 0.10, 0.94]; P = .04). The 30-day stroke or death rate was similar in the DCB and BMS groups (6% vs 5%; hazard ratio, 1.24 [95% CI: 0.38, 4.05]; P = .73). Conclusion In individuals with symptomatic ICAD with high-grade stenosis, DCB angioplasty reduced the 6-month risks of angiographic restenosis and symptomatic restenosis and 30-day to 1-year recurrent ischemic event rate compared with BMS placement. Chinese Clinical Trial Registry no. ChiCTR2100046829 © RSNA, 2026 Supplemental material is available for this article. See also the editorial by Wojak in this issue.
This randomized clinical trial investigates if intra-arterial alteplase improves clinical outcomes in patients with acute ischemic stroke (AIS) of the posterior circulation within 24 hours of symptom onset and after successful mechanical recanalization. QuestionAmong patients with acute basilar artery occlusion treated within 24 hours of symptom onset and achieving successful mechanical recanalization, does intra-arterial alteplase improve clinical outcomes?FindingsIn this randomized clinical trial including 246 patients, functional independence at 90 days was achieved in approximately half of patients in both the intra-arterial alteplase and control groups. Rates of symptomatic intracranial hemorrhage were similar across groups.MeaningStudy results show that adjunctive intra-arterial alteplase after successful endovascular recanalization for acute stroke due to basilar artery occlusion seems safe but did not improve functional outcomes at 90 days. ImportanceThe impact of adjunctive intra-arterial alteplase after successful endovascular thrombectomy (EVT) in patients with acute ischemic stroke due to large-vessel occlusion (AIS-LVO) in the posterior circulation requires further investigation.ObjectiveTo assess the efficacy and safety of intra-arterial alteplase after successful EVT for AIS-LVO in the posterior circulation.Design, Setting, and ParticipantsThis was a multicenter, prospective, randomized, open-label, blinded-end point (PROBE design) clinical trial. The study was conducted between September 5, 2023, and November 29, 2024, with the 3-month follow-up completed on February 18, 2025. The trial was conducted in 37 comprehensive stroke centers in China. Patients in China with acute basilar artery occlusion presenting within 24 hours of the time last known well were randomly assigned to the treatment group or control group. Eligible participants were adults who achieved successful recanalization after EVT.InterventionsEligible patients were randomly assigned to the intra-arterial alteplase group (0.225 mg/kg, maximum dose limit 22.5 mg infused at a concentration of 1.0 mg/mL within 15 minutes distal to the origin of posterior inferior cerebellar artery) or control group (no intra-arterial thrombolysis).Main Outcomes and MeasuresThe primary efficacy outcome was the proportion of patients achieving functional independence (modified Rankin Scale score of 0-2) at 90 days. The primary safety outcomes were mortality at 90 days and incidence of symptomatic intracranial hemorrhage within 48 hours.ResultsA total of 247 patients were enrolled, and 1 patient was excluded from the full analysis set due to basilar artery reocclusion before intra-arterial alteplase. The remaining 246 patients (median [IQR] age, 65.0 [56.0-72.0] years; 176 male [71.5%]) were included in this analysis, 124 (50.4%) in the treatment group and 122 (49.6%) in the control group. Among the patients recruited and followed up, functional independence at 90 days was achieved in 52 (41.9%) in the intra-arterial alteplase group and 57 (46.7%) in the control group (adjusted risk ratio, 0.93; 95% CI, 0.73-1.18; P = .55). Mortality at 90 days (29.6% vs 27.0%, respectively; adjusted hazard ratio, 1.07; 95% CI, 0.71-1.61; P = .75) and incidence of symptomatic intracranial hemorrhage (2.4% vs 2.5%, respectively; unadjusted risk ratio, 0.98; 95% CI, 0.20-4.74; P = .97) were similar across groups.Conclusions and RelevanceResults of this randomized clinical trial reveal that in patients with posterior circulation stroke due to acute basilar artery occlusion, intra-arterial alteplase after successful endovascular recanalization appeared to be safe but was not associated with improvement of functional outcomes at 90 days.Trial RegistrationClinicalTrials.gov Identifier: NCT05897554
BACKGROUND:The high incidence of in-stent restenosis (ISR) associated with bare-metal stents (BMS) undermines the viability of endovascular treatment as a treatment option for patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS). The study aimed to evaluate whether durable fluoropolymer drug-eluting stents (DES) reduce the incidence of ISR compared with BMS in the treatment of severe ICAS. METHODS:This prospective, multicentre, open-label, blinded outcome clinical trial was conducted at 16 centres in China, enrolling patients with ischaemic stroke or transient ischaemic attack (<90 days) attributed to 70%-99% stenosis of an intracranial major artery. Eligible patients were randomly assigned to receive durable fluoropolymer DES or BMS for stenosis treatment. The primary outcome was ISR at 1 year postprocedure, which was defined as a stenosis rate of ≥50% occurring within or immediately adjacent to (within 5 mm) the stent. Secondary outcomes included symptomatic ISR and stroke or death within 30 days or stroke in the target vessel territory between 31 days and 1 year. RESULTS:Between 20 February 2023 and 10 April 2024, 156 patients were enrolled and assigned to receive DES (n=78) or BMS (n=78). The median age was 61 years (IQR 54-67), and 129 (82.7%) of 156 patients were male. At 1 year, the primary outcome occurred in 2.9% in the DES group versus 27.9% in the BMS group (risk difference -0.25, 95% CI -0.37 to -0.13, p<0.001). No significant differences were observed between the DES and BMS groups in symptomatic ISR (0% vs 2.9%, p=0.20) or in stroke or death within 30 days or stroke in the target vessel territory between 31 days and 1 year (7.7% vs 12.3%, p=0.45). CONCLUSIONS:Among patients with severe ICAS, treatment with durable fluoropolymer DES resulted in a lower 1-year ISR compared with BMS. TRIAL REGISTRATION NUMBER:NCT05719883.
Importance:The impact of adjunctive intra-arterial alteplase after successful endovascular thrombectomy (EVT) in patients with acute ischemic stroke due to large-vessel occlusion (AIS-LVO) in the posterior circulation requires further investigation. Objective:To assess the efficacy and safety of intra-arterial alteplase after successful EVT for AIS-LVO in the posterior circulation. Design, Setting, and Participants:This was a multicenter, prospective, randomized, open-label, blinded-end point (PROBE design) clinical trial. The study was conducted between September 5, 2023, and November 29, 2024, with the 3-month follow-up completed on February 18, 2025. The trial was conducted in 37 comprehensive stroke centers in China. Patients in China with acute basilar artery occlusion presenting within 24 hours of the time last known well were randomly assigned to the treatment group or control group. Eligible participants were adults who achieved successful recanalization after EVT. Interventions:Eligible patients were randomly assigned to the intra-arterial alteplase group (0.225 mg/kg, maximum dose limit 22.5 mg infused at a concentration of 1.0 mg/mL within 15 minutes distal to the origin of posterior inferior cerebellar artery) or control group (no intra-arterial thrombolysis). Main Outcomes and Measures:The primary efficacy outcome was the proportion of patients achieving functional independence (modified Rankin Scale score of 0-2) at 90 days. The primary safety outcomes were mortality at 90 days and incidence of symptomatic intracranial hemorrhage within 48 hours. Results:A total of 247 patients were enrolled, and 1 patient was excluded from the full analysis set due to basilar artery reocclusion before intra-arterial alteplase. The remaining 246 patients (median [IQR] age, 65.0 [56.0-72.0] years; 176 male [71.5%]) were included in this analysis, 124 (50.4%) in the treatment group and 122 (49.6%) in the control group. Among the patients recruited and followed up, functional independence at 90 days was achieved in 52 (41.9%) in the intra-arterial alteplase group and 57 (46.7%) in the control group (adjusted risk ratio, 0.93; 95% CI, 0.73-1.18; P = .55). Mortality at 90 days (29.6% vs 27.0%, respectively; adjusted hazard ratio, 1.07; 95% CI, 0.71-1.61; P = .75) and incidence of symptomatic intracranial hemorrhage (2.4% vs 2.5%, respectively; unadjusted risk ratio, 0.98; 95% CI, 0.20-4.74; P = .97) were similar across groups. Conclusions and Relevance:Results of this randomized clinical trial reveal that in patients with posterior circulation stroke due to acute basilar artery occlusion, intra-arterial alteplase after successful endovascular recanalization appeared to be safe but was not associated with improvement of functional outcomes at 90 days. Trial Registration:ClinicalTrials.gov Identifier: NCT05897554.
ABSTRACT:The contribution of immune cells to thrombus architecture and mechanical properties in acute ischemic stroke (AIS) remains poorly understood. Using 3-dimensional imaging and multiplex staining, we mapped immune cells in human stroke thrombi and identified neutrophils as the dominant population. Analysis of 19 thrombi confirmed their positive correlation with collagen, increased stiffness, and poorer clinical outcomes. To preserve spatial context, we developed a laser capture-based proteomic workflow and analyzed thrombus neutrophils from 34 patients with AIS stratified by 90-day outcomes, followed by validation in an independent cohort of 22 patients. Proteomic analysis revealed serpin B3 as a neutrophil-enriched protein strongly correlated with poor prognosis. In murine models of ferric chloride-induced carotid artery thrombosis and middle cerebral artery occlusion, experiments using wild-type, neutrophil-depleted, and Serpinb3a knockout mice demonstrated that neutrophil-derived serpin B3 promotes early thrombus formation, enhances collagen deposition, and contributes to progressive thrombus stiffening. Mechanistically, serpin B3 secreted by neutrophils amplifies thrombus stiffness through upregulation of transforming growth factor β1, neutrophil extracellular traps, and COL1A1. Targeted Serpinb3a knockdown delayed vascular occlusion, improved thrombolysis efficiency, and resulted in better neurological recovery. Collectively, these findings identify a neutrophil-driven mechanism underlying thrombus stiffening and establish SERPINB3 as both a prognostic biomarker and a promising therapeutic target in AIS. This project has been registered with the Chinese Clinical Trial Registration Platform (https://www.chictr.org.cn/index.html) and has successfully passed the review process (registration number: ChiCTR2300077911).
Background Restenosis after stenting with a standard bare-metal stent (BMS) is the main cause of stroke recurrence for symptomatic intracranial atherosclerotic stenosis (sICAS). Whether a drug-coated balloon (DCB) could reduce the risk of restenosis for such patients is unknown. We aimed to investigate the efficacy and safety of DCB in reducing 6 month restenosis in patients with sICAS. Methods A prospective, multicenter, randomized, open-label, blinded endpoint clinical trial was conducted at 13 stroke centers across China. Eligible patients aged 18–80 years with sICAS defined as a recent transient ischemic attack (<180 days) or ischemic stroke (14–180 days) before enrollment attributed to a 70–99% atherosclerotic stenosis of a major intracranial artery were recruited between June 4, 2021 and September 15, 2022 (final follow-up: April 13, 2023). Patients were randomly assigned to receive a DCB (n=90) or BMS at a 1:1 ratio. The primary outcome was the post-procedure incidence of restenosis in the target lesion at 6 months (165–225 days). The safety outcome was post-procedure target vessel-related stroke (hemorrhage or ischemia) or death at 30 days. Results Among 201 randomized patients, 180 were confirmed eligible (mean age 58 years) and completed the trial. Compared with BMS, DCB was associated with a lower rate of post-procedure incidence of restenosis in the target lesion at 6 months (6.9% vs 32.9%, OR 0.15, 95% CI 0.05 to 0.42, P=0.0003). Regarding the safety outcome, post-procedure target vessel-related stroke (hemorrhage or ischemia) or death at 30 days did not differ between the two groups (4.4% vs 5.6%, OR 0.79, 95%CI 0.21 to 3.05, P=0.73). Conclusion DCB was superior to BMS in reducing the incidence of restenosis without increasing the risk of target vessel-related stroke or death within 6 months. Further trials comparing the outcomes of DCB with medical management for sICAS are warranted. Trial registration number ClinicalTrials.gov Identifier: NCT04631055 .
BACKGROUND:The long-term benefits of bailout intracranial angioplasty or stenting (BAOS) after thrombectomy in patients with acute large vessel occlusion remain unclear. This study compared BAOS with standard therapy in patients with large vessel occlusion with unsuccessful recanalization (expanded Thrombolysis In Cerebral Infarction score 0-2a) or >70% residual stenosis after thrombectomy. METHODS:ANGEL-REBOOT (Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion) was a multicenter, open-label, blinded-end point, randomized trial conducted across 36 Chinese hospitals. Patients ≥18 years of age with anterior or posterior circulation large vessel occlusion within 24 hours of stroke onset were enrolled. After identification of thrombectomy failure or high-grade residual stenosis, patients were randomly assigned to the BAOS group (intervention) or the standard therapy group (control), in which thrombectomy was continued or terminated. The use of tirofiban was permitted in both groups during and after the procedure. In the intention-to-treat population, the primary outcome was analyzed using an assumption-free ordinal analysis (Wilcoxon-Mann-Whitney test) to compare the modified Rankin Scale scores (ordinal variable ranging from 0 to 6) between groups at 1-year follow-up, from which the generalized odds ratio was derived. Secondary outcomes included stroke recurrence in the treated artery and all-cause mortality within 1 year, analyzed using Cox proportional hazards models. RESULTS:A total of 348 patients were randomly assigned (176 to the BAOS group and 172 to the standard therapy group) and followed for 90 days, from December 19, 2021, to June 2, 2023. Of these, 326 patients (166 in the BAOS group and 160 in the standard therapy group) completed the 1-year follow-up. Compared with standard therapy, BAOS significantly improved the 1-year modified Rankin Scale score distribution (generalized odds ratio, 1.34 [95% CI, 1.05-1.73]; P=0.02). Fewer stroke recurrences in the treated artery occurred in the BAOS group than in the standard therapy group (7 of 166 [4%] versus 21 of 160 [13%]; hazard ratio, 0.30 [95% CI, 0.13-0.71]; P=0.006). One-year mortality rates were similar between groups (25 of 166 [15%] versus 27 of 160 [17%]; hazard ratio, 0.87 [95% CI, 0.50-1.50]). CONCLUSIONS:Among Chinese patients with large vessel occlusion with unsuccessful recanalization or high-grade residual stenosis after thrombectomy, BAOS was associated with reduced disability and stroke recurrence after 1 year compared with standard therapy. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT05122286.
Obstructive sleep apnea (OSA) is prevalent in patients with cardiovascular disease (CVD), and is linked to worsened outcomes. Screening tools are essential for early detection and intervention. We aimed to investigate the role of ascending aorta diameter (AAD) obtained from echocardiography in identifying OSA in CVD patients. We examined the correlation between AAD and sleep apnea test parameters in 721 hospitalized CVD (including hypertension, coronary artery disease, chronic heart failure, atrial fibrillation, and pulmonary hypertension) patients. Multivariate analyses were performed on all findings. Receiver operator characteristic curve (ROC) analyses were used to determine the role of AAD in detecting OSA. AAD was significantly higher in patients with OSA than those without OSA. AAD significantly correlated with apnea-hypopnea index (AHI) and saturation-related parameters. In comparison, pulmonary artery diameter did not correlate with AHI but had significant negative correlations with the saturation-related parameters. The area under the ROC of AAD for detecting OSA in CVD patients was 0.70 (95
Background First‐pass successful reperfusion (FPSR), defined as a successful/complete reperfusion achieved after a single thrombectomy pass, is predictive of favorable outcome in patients with acute ischemic stroke with large‐vessel occlusion. It is unknown whether intravenous tirofiban is effective in increasing the rate of FPSR in acute anterior large‐vessel occlusion stroke. Methods and Results Patients who had acute large‐vessel occlusion stroke presenting within 24 hours and underwent endovascular thrombectomy were analyzed from the RESCUE BT (Intravenous Tirofiban for Patients With Large Vessel Occlusion Stroke) clinical trial, of which the main analysis was neutral. The RESCUE BT trial randomized patients to receive either intravenous tirofiban or placebo before endovascular thrombectomy. The primary end point was FPSR, defined as successful reperfusion (extended thrombolysis in cerebral infarction scale 2b50, 2c, or 3) at first thrombectomy attempt. A modified Poisson regression analysis assessed the association between intravenous tirofiban treatment and FPSR. Of 948 enrolled patients, 463 patients were randomized to the tirofiban group and 485 to the placebo group. The mean age was 67 years, and 41.0% of the patients were women. FPSR was achieved more often in the tirofiban group (30.5% versus 23.5%; adjusted risk ratio, 1.24 [95% CI, 1.01–1.51]; P =0.04). FPSR was associated with a favorable shift to lower modified Rankin Scale disability levels at 90 days (common odds ratio, 1.42 [95% CI, 1.08–1.86]; P =0.01). Conclusions In this post hoc analysis of the RESCUE BT trial, treatment with intravenous tirofiban before endovascular thrombectomy was associated with increased FPSR in patients with acute ischemic stroke due to large‐vessel occlusion in the anterior circulation. FPSR was associated with reduced 90‐day levels of disability. Registration URL: http://chictr.org ; Unique Identifier: ChiCTR‐INR‐17014167.
Rationale Unsuccessful thrombectomy of acute large vessel occlusions (LVOs) has been associated with unfavourable outcomes. Multiple randomised controlled trials (RCTs) have reported a failure rate of 12%–41% for thrombectomy procedures. Various factors contribute to failed thrombectomy, including technical difficulties in accessing the occlusion, unsuccessful thrombus retrieval, thrombotic reocclusion and pre-existing intracranial atherosclerotic stenosis. Although some studies have explored balloon dilation or permanent stenting as rescue intracranial angioplasty for failed thrombectomy in individual cases, there is currently no evidence from RCTs on this specific topic. Aim To evaluate the potential superiority of bailout angioplasty over standard treatment in cases of unsuccessful recanalisation (eTICI 0 to 2a) or residual severe stenosis (>70%) after thrombectomy in acute LVO patients within 24 hours of stroke onset. Design This study is a multicentre, prospective, randomised, controlled clinical trial designed by investigators. It compares bailout angioplasty with standard therapy and follows an open-label treatment approach while maintaining a blinded outcome assessment (PROBE design). Our objective is to allocate 348 patients in a 1:1 ratio to either receive bailout angioplasty as an intervention or standard therapy as a control, following unsuccessful thrombectomy. Outcome The main measure of interest is the modified Rankin Scale (mRS) Score, which will be assessed in a blinded manner at 90 (±14) days following randomisation. The primary effect size will be determined using ordered logistic regression to calculate the common OR, representing the shift on the six-category mRS Scale at the 90-day mark. Additionally, the safety outcomes will be evaluated, including symptomatic intracranial haemorrhage within 18–36 hours, severe procedure-related complications and mortality within 90 (±14) days, among others. Discussion The ANGEL-REBOOT study aims to generate substantial evidence regarding the efficacy and safety of bailout intracranial angioplasty as a treatment option for patients with LVO who have experienced unsuccessful thrombectomy. Trial registration number NCT05122286 .
Background The Catfish stent retriever is a newly developed mechanical thrombectomy device for rapid recanalisation in emergent large vessel occlusion (ELVO) stroke. The current trial aimed to assess whether the Catfish stent retriever is non-inferior to the Solitaire stent retriever in terms of outcomes in ELVO stroke. Methods This was a randomised, prospective, parallel-group, multicentre, open-label, non-inferiority study conducted at 18 sites in China. The primary outcome was the proportion of cases with successful recanalisation (modified thrombolysis in cerebral infarction score of 2b or 3) following the procedure. Secondary efficacy outcomes included the National Institutes of Health Stroke Scale scores at 24 hours and 7 days or discharge if earlier, time from artery puncture to successful recanalisation and good clinical outcome (modified Rankin scale score ≤2) at 90 days. Safety outcomes included symptomatic intracranial haemorrhage, all cause-death and severe adverse events at 90 days. Results Between 3 March 2019 and 5 June 2021, 118 and 120 patients were randomly allocated to the Catfish and Solitaire groups, respectively. The primary endpoint after all endovascular procedures was non-inferior in the Catfish group (88.5%, 100/113) than in the Solitaire group (87.7%, 100/114), with a rate difference (RD) of 0.78% (95% CI –7.64 to –9.20; p=0.001). Sensitivity analysis only considering the per-protocol set also yielded similar results, with an RD of 0.83% (95% CI –7.03 to –8.70; p<0.001). Additionally, the proportions of cases with good clinical outcomes (47.8% vs 50.0%, p=0.739) and all-cause death rates (17.7% vs 18.8%, p=0.700) were similar in both groups at 90 days. Conclusions The Catfish stent retriever is an effective and safe device for endovascular recanalisation in ELVO stroke. Trial registration number NCT03820882 .
BACKGROUND The effects and risks of endovascular thrombectomy 6 to 24 hours after stroke onset due to basilar-artery occlusion have not been extensively studied. METHODS In a trial conducted over a 5-year period in China, we randomly assigned, in a 1:1 ratio, patients with basilar-artery stroke who presented between 6 to 24 hours after symptom onset to receive either medical therapy plus thrombectomy or medical therapy only (control). The original primary outcome, a score of 0 to 4 on the modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 4 moderately severe disability, and 6 death) at 90 days, was changed to a good functional status (a modified Rankin scale score of 0 to 3, with a score of 3 indicating moderate disability). Primary safety outcomes were symptomatic intracranial hemorrhage at 24 hours and 90-day mortality. RESULTS A total of 217 patients (110 in the thrombectomy group and 107 in the control group) were included in the analysis; randomization occurred at a median of 663 minutes after symptom onset. Enrollment was halted at a prespecified interim analysis because of the superiority of thrombectomy. Thrombolysis was used in 14% of the patients in the thrombectomy group and in 21% of those in the control group. A modified Rankin scale score of 0 to 3 (primary outcome) occurred in 51 patients (46%) in the thrombectomy group and in 26 (24%) in the control group (adjusted rate ratio, 1.81; 95% confidence interval [CI], 1.26 to 2.60; P<0.001). The results for the original primary outcome of a modified Rankin scale score of 0 to 4 were 55% and 43%, respectively (adjusted rate ratio, 1.21; 95% CI, 0.95 to 1.54). Symptomatic intracranial hemorrhage occurred in 6 of 102 patients (6%) in the thrombectomy group and in 1 of 88 (1%) in the control group (risk ratio, 5.18; 95% CI, 0.64 to 42.18). Mortality at 90 days was 31% in the thrombectomy group and 42% in the control group (adjusted risk ratio, 0.75; 95% CI, 0.54 to 1.04). Procedural complications occurred in 11% of the patients who underwent thrombectomy. CONCLUSIONS Among patients with stroke due to basilar-artery occlusion who presented 6 to 24 hours after symptom onset, thrombectomy led to a higher percentage with good functional status at 90 days than medical therapy but was associated with procedural complications and more cerebral hemorrhages. (Funded by the Chinese National Ministry of Science and Technology; BAOCHE ClinicalTrials.gov number, NCT02737189.).
Importance Tirofiban is a highly selective nonpeptide antagonist of glycoprotein IIb/IIIa receptor, which reversibly inhibits platelet aggregation. It remains uncertain whether intravenous tirofiban is effective to improve functional outcomes for patients with large vessel occlusion ischemic stroke undergoing endovascular thrombectomy. Objective To assess the efficacy and adverse events of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke secondary to large vessel occlusion. Design, Setting, and Participants This investigator-initiated, randomized, double-blind, placebo-controlled trial was implemented at 55 hospitals in China, enrolling 948 patients with stroke and proximal intracranial large vessel occlusion presenting within 24 hours of time last known well. Recruitment took place between October 10, 2018, and October 31, 2021, with final follow-up on January 15, 2022. Interventions Participants received intravenous tirofiban (n = 463) or placebo (n = 485) prior to endovascular thrombectomy. Main Outcomes and Measures The primary outcome was disability level at 90 days as measured by overall distribution of the modified Rankin Scale scores from 0 (no symptoms) to 6 (death). The primary safety outcome was the incidence of symptomatic intracranial hemorrhage within 48 hours. Results Among 948 patients randomized (mean age, 67 years; 391 [41.2%] women), 948 (100%) completed the trial. The median (IQR) 90-day modified Rankin Scale score in the tirofiban group vs placebo group was 3 (1-4) vs 3 (1-4). The adjusted common odds ratio for a lower level of disability with tirofiban vs placebo was 1.08 (95% CI, 0.86-1.36). Incidence of symptomatic intracranial hemorrhage was 9.7% in the tirofiban group vs 6.4% in the placebo group (difference, 3.3% [95% CI, -0.2% to 6.8%]). Conclusions and Relevance Among patients with large vessel occlusion acute ischemic stroke undergoing endovascular thrombectomy, treatment with intravenous tirofiban, compared with placebo, before endovascular therapy resulted in no significant difference in disability severity at 90 days. The findings do not support use of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke. Trial Registration Chinese Clinical Trial Registry Identifier: ChiCTR-IOR-17014167.
Abstract Postpartum cerebral arterial dissections are rare, and the clinical features, diagnosis, and treatment approaches are not clear to many physicians. This study was to investigate the clinical features, diagnosis, and treatment of postpartum cerebral arterial dissections. One patient with postpartum cerebral arterial dissections enrolled in our hospital was analyzed. All patients with postpartum cerebral arterial dissections retrieved from the PubMed were also included in this study and analyzed. A total of 45 patients with postpartum cerebral arterial dissections were retrieved including our case, with an age range of 24 to 44 years (mean 34). Thirty-six (80%) patients were older than 30 years of age (mean 35). There were 17 cases of cesarean section, 14 cases of natural labor, and 14 cases whose delivery modes were not reported. The clinical symptoms included headache in 35 cases (78%) and neck pain in 14 (31%). The symptoms occurred at a mean time of 11 days (range 0-53 days) following delivery. Among 45 patients, arterial dissections involved unilateral carotid or vertebral artery in 29 cases (64%), bilateral carotid or vertebral arteries in 8 (18%), 3 arteries in 3 (7%), and all bilateral carotid and vertebral arteries in 5 (11%). Fourteen (31%) patients were treated with antiplatelet agents, 27 (60%) with anticoagulation, 7 (16%) with both antiplatelet and anticoagulation medications, and only 2 (4%) with stent angioplasty. The prognosis was complete recovery in 30 (86%) patients and mild focal neurological symptoms in 5 (14%). Postpartum cerebral arterial dissections are rare, and correct diagnosis relies on imaging examination. Prognosis is usually favorable in patients with early diagnosis and prompt treatment.
Postpartum cerebral arterial dissections are rare, and the clinical features, diagnosis, and treatment approaches are not clear to many physicians. This study was to investigate the clinical features, diagnosis, and treatment of postpartum cerebral arterial dissections. One patient with postpartum cerebral arterial dissections enrolled in our hospital was analyzed. All patients with postpartum cerebral arterial dissections retrieved from the PubMed were also included in this study and analyzed. A total of 45 patients with postpartum cerebral arterial dissections were retrieved including our case, with an age range of 24 to 44 years (mean 34). Thirty-six (80%) patients were older than 30 years of age (mean 35). There were 17 cases of cesarean section, 14 cases of natural labor, and 14 cases whose delivery modes were not reported. The clinical symptoms included headache in 35 cases (78%) and neck pain in 14 (31%). The symptoms occurred at a mean time of 11 days (range 0-53 days) following delivery. Among 45 patients, arterial dissections involved unilateral carotid or vertebral artery in 29 cases (64%), bilateral carotid or vertebral arteries in 8 (18%), 3 arteries in 3 (7%), and all bilateral carotid and vertebral arteries in 5 (11%). Fourteen (31%) patients were treated with antiplatelet agents, 27 (60%) with anticoagulation, 7 (16%) with both antiplatelet and anticoagulation medications, and only 2 (4%) with stent angioplasty. The prognosis was complete recovery in 30 (86%) patients and mild focal neurological symptoms in 5 (14%). Postpartum cerebral arterial dissections are rare, and correct diagnosis relies on imaging examination. Prognosis is usually favorable in patients with early diagnosis and prompt treatment.
Background Mechanical thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in the anterior circulation. This trial aimed to indicate whether Skyflow, a new thrombectomy device, could achieve the same safety and efficacy as Solitaire FR in the treatment of AIS. Methods This study was a prospective, multicenter, randomized, single blind, parallel, positive controlled, non-inferiority clinical trial. Patients with intracranial anterior circulation LVO within 8 hours from onset were included to receive thrombectomy treatment with either the Skyflow or Solitaire FR stent retriever. The primary endpoint was the rate of successful reperfusion (modified Treatment In Cerebral Infarction (mTICI) ≥2b) after the operation. The safety endpoints were the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage (SAH) at 24 hours after operation. Results A total of 95 and 97 patients were involved in the Skyflow group and Solitaire FR group, respectively. A successful reperfusion (mTICI ≥2b) was finally achieved in 84 (88.4%) patients in the Skyflow group and 80 (82.5%) patients in the Solitaire FR group. Skyflow was non-inferior to Solitaire FR in regard to the primary outcome, with the criterion of a non-inferiority margin of 12.5% (p=0.0002) after being adjusted for the combined center effect and the National Institutes of Health Stroke Scale (NIHSS) score. The rate of periprocedural sICH and SAH did not differ significantly between the two groups. Conclusion Endovascular thrombectomy with the Skyflow stent retriever was non-inferior to Solitaire FR with regard to successful reperfusion in AIS due to LVO (with a pre-specified non-inferiority margin of 12.5%).
Background and purpose Endovascular treatment could improve functional outcomes and reduce mortality in patients with intracranial large artery occlusion. This registry aims to evaluate the endovascular treatment delivery and to improve endovascular treatment algorithm in clinical practice for patients with stroke in China.Methods and analysis This multicentric, nationwide, prospective registry plans to include 20 stroke centres and recruit 900 consecutive AIS patients with large-artery occlusion under endovascular treatment. This registry will enrol acute large vessel occlusion patients suitable for endovascular treatment and the inclusion and exclusion criteria. In this study, 90 days functional independence (modified Rankin Scale score ≤2) is the primary efficacy endpoint. The procedural efficacy endpoint of this registry is target artery recanalisation defined by modified Thrombolysis in Cerebral Infarction score 2b or 3 after endovascular therapy. Symptomatic intracranial haemorrhage with 24±3 hours after the procedure is the primary safety endpoint of this registry.Ethics and dissemination Beijing Tiantan Hospital’s Ethics committee and all other participating centres approved the protocol and data collection of Acute Ischaemic Stroke Cooperation Group of Endovascular Treatment registry. Each participant or representative had a written informed consent.
OBJECTIVE:To estimate the association of different etiologies of cardioembolism (CE), intracranial arterial stenosis (ICAS), or the combination of these conditions with outcomes of mechanical thrombectomy in acute ischemic stroke. METHODS:Data from the intervention group of the Endovascular therapy for Acute ischemic Stroke Trial (EAST) were analyzed. In 140 patients, the presence of CE, ICAS, neither CE nor ICAS, or both conditions was assessed. The primary outcome was a favorable outcome at 90 days (modified Rankin Scale score 0-2); secondary outcomes included successful reperfusion (modified Thrombolysis In Cerebral Infarction grade 2b-3), symptomatic intracerebral hemorrhage, and 90-day mortality. RESULTS:Of 140 patients, 47 had neither CE nor ICAS, 35 had ICAS but not CE, 46 had CE but not ICAS, and 12 had both CE and ICAS. The rate of favorable outcome was 67.1% in the no CE and no ICAS group, 74.3% in the ICAS without CE group, 41.3% in the CE without ICAS group, and 33.3% in the CE and ICAS group. The CE and ICAS group had poor outcomes (odds ratio = 0.20 after adjusting for age, sex, and National Institutes of Health Stroke Scale score; 95% confidence interval, 0.04-0.95; P = 0.043). No significant differences were observed in secondary outcomes. CONCLUSIONS:The presence of both CE and ICAS was associated with poor outcome in patients with anterior circulation large-vessel occlusion treated with endovascular thrombectomy. Future studies are warranted to further explore this association.