The safety and efficacy of albumin combined with endovascular therapy for participants with acute ischemic stroke is unknown. This randomized, double blinded, multicenter study was conducted in China and completed in 2025. Eligible participants were randomly assigned in a 1:1 ratio to albumin group (0.5 g/kg; maximum dose 150 mL; intravenously infusion once daily for 4 days) or placebo group (equivalent volume of placebo). The primary endpoint was the change in infarct volume from baseline to day 5. A total of 134 patients were randomized (66 in albumin group and 68 in placebo group) and 134 patients were included in the final analysis. Albumin reduced infarct volume growth from baseline to day 5 compared with placebo (median growth 7.5 mL vs 16.5 mL, adjusted median difference -8.63, 95%CI (-13.85 to -5.07); P = 0.003). The safety outcomes did not differ between the two groups. This work suggests that albumin plus endovascular therapy could significantly reduce infarct volume growth compared with the placebo group, without raising safety concerns. (Funded by the National Natural Science Foundation of China and others; ClinicalTrials.gov registration: NCT06538844.).
Importance:Endovascular thrombectomy (EVT) has been established as an effective treatment for acute basilar artery occlusion (BAO) in the short term. However, the durability of these benefits over the long term has not been well characterized. Objective:To determine whether the clinical benefits of EVT for acute BAO are sustained at 3 years, with a primary focus on functional outcomes and mortality compared with best medical management alone. Design, Setting, and Participants:This study is a 3-year follow-up extension of a multicenter randomized clinical trial conducted between February 2021 and January 2022, with follow-up data collected through January 2025. The study was designed as an open-label, assessor-blinded trial to evaluate the long-term efficacy of EVT. The trial was conducted at 36 comprehensive stroke centers across China, representing a diverse, population-based setting that enhances the generalizability of the results. A total of 340 patients with acute BAO within 12 hours of estimated symptom onset were randomly assigned to the thrombectomy or control group. Eligible participants were adults with imaging-confirmed BAO and without contraindications to endovascular therapy. Of the randomized patients, 307 (90.3%) completed 3-year follow-up-203 in the thrombectomy group and 104 in the control group. Interventions:Participants in the thrombectomy group received EVT in combination with best medical management, while the control group received best medical management alone. EVT procedures were performed according to institutional protocols using stent retrievers, aspiration devices, balloon angioplasty, stent deployment, intra-arterial thrombolysis, or combinations of these approaches that were left to the discretion of the treating team. Main Outcomes and Measures:The primary outcome was a modified Rankin Scale (mRS) score of 0 to 3 at 3 years, representing the ability to walk and perform self-care. Secondary outcomes included a mRS score of 0 to 2, distribution across the mRS score categories, and quality of life. These outcomes were prespecified prior to data analysis. Results:Among 307 patients (median [IQR] age, 68 [59-75]; 211 [69%] male) with available data, an mRS score of 0 to 3 at 3 years was observed in 78 patients (38.4%) in the thrombectomy group and in 19 patients (18.3%) in the control group (adjusted risk ratio, 2.05; 95% CI, 1.35-3.11; P = .001). The distribution of mRS scores favored the thrombectomy group over the control group (adjusted common odds ratio, 2.60; 95% CI, 1.53-4.43). The cumulative 3-year mortality increased from 36.7% (n = 83) at 90 days to 55.7% (n = 113) in the thrombectomy group and 55.3% (n = 63) to 73.1% (n = 76) in the control group (adjusted risk ratio, 0.76; 95% CI, 0.65-0.89). On prespecified subgroup analysis, benefit was observed in patients younger than 70 years; a treatment effect was not demonstrated in patients aged 70 years and older. Conclusions and Relevance:At 3 years, the clinical benefit of EVT in patients with acute BAO was durable, with substantially better functional outcomes and reduced mortality compared with medical management. These results reinforce EVT as the standard of care for BAO and support broader implementation and timely access to thrombectomy services. Trial Registration:ChiCTR.org.cn Identifier: ChiCTR2400082236.
BACKGROUND:Endovascular thrombectomy for acute ischemic stroke due to medium-vessel occlusion has had varying results across trials. Whether thrombectomy improves functional outcomes in patients with medium-vessel occlusion and moderate-to-severe deficits is unclear. METHODS:We conducted an open-label, randomized trial with blinded outcome assessment at 48 centers in China. Eligible patients were adults who presented within 24 hours after the onset of a moderate-to-severe stroke (National Institutes of Health Stroke Scale [NIHSS] score, ≥6; scale, 0 to 42, with higher scores indicating greater neurologic deficits) due to occlusion of a medium vessel. Patients were assigned in a 1:1 ratio to thrombectomy plus medical management (thrombectomy group) or medical management alone (control group). The primary outcome was functional disability as measured by the shift in the modified Rankin scale score (scale, 0 [no disability] to 6 [death]) at 90 days. Violation of the proportional-odds assumption precluded the use of shift in the modified Rankin scale score, so as prespecified, functional independence (modified Rankin scale score of 0, 1, or 2) at 90 days was used as the primary outcome. Safety outcomes were symptomatic intracranial hemorrhage and 90-day mortality. RESULTS:Among 280 patients in the thrombectomy group and 283 in the control group, the median age was 71 years, the median NIHSS score was 10 (range, 3 to 36), and 42.8% were women; 36.6% received intravenous thrombolysis. Functional independence at 90 days was seen in 58.6% of the patients in the thrombectomy group and in 46.6% of those in the control group (adjusted rate ratio, 1.24; 95% confidence interval, 1.07 to 1.44; P = 0.004). The incidence of symptomatic intracranial hemorrhage was 4.7% in the thrombectomy group and 2.2% in the control group; 90-day mortality was 11.1% and 10.2%, respectively. CONCLUSIONS:Among patients with acute ischemic stroke due to medium-vessel occlusion and moderate-to-severe deficits, thrombectomy led to a greater likelihood of functional independence than medical management alone but also to a higher risk of symptomatic intracranial hemorrhage. (Funded by the National Natural Science Foundation of China and the Noncommunicable Chronic Diseases-National Science and Technology Major Project; ORIENTAL-MeVO ClinicalTrials.gov number, NCT06146790.).
BackgroundStroke remains a major cause of death, disability, and long-term care burden in China. National policy has expanded from disease-specific prevention and treatment to broader arrangements involving chronic disease governance, emergency care, hierarchical services, rehabilitation, and medical quality improvement. However, the policy design and governance structure remain underexamined.MethodsWe conducted a multidimensional national policy text analysis of stroke prevention and stroke center development in China. The final corpus comprised 33 national policies issued between 2009 and 2026, including 11 Main policies and 22 Extended policies. Policies were classified by document function, and 1,739 atomic meaning units were coded for policy instruments, governance tasks, strict and contextual actors, policy objects, and policy integration. A stratified sample of 348 units was independently coded, followed by consensus adjudication.ResultsThe corpus showed a descriptive three-stage progression from early disease-specific screening and quality-control arrangements, through system expansion, to system-embedded and quality-oriented governance. The final adjudicated dataset contained 16,882 code assignments. Among 5,263 policy-instrument assignments, environment-side instruments accounted for 47.0%, supply-side instruments for 32.2%, and demand-side instruments for 20.7%. Standardized diagnosis, treatment, and acute care was the most frequent governance task, followed by quality improvement, system coordination, and risk-factor control. Hospitals, medical institutions, and stroke centers were the most frequently specified strict actors, while other actor groups showed differentiated task profiles. Policy integration connected stroke governance with medical quality and safety, specialty capacity, chronic disease governance, public health, emergency care, rehabilitation, referral, and financing. Cohen’s kappa across the six coding dimensions ranged from 0.595 to 0.746.ConclusionChina’s national stroke policy has evolved toward system-embedded, task-differentiated, and quality-oriented governance. Future policy design may benefit from stronger demand-side and continuity-oriented instruments, clearer cross-setting responsibilities, and closer alignment between stroke-specific policies and wider health-system arrangements.
Background and purposeTo evaluate the efficacy and safety of endovascular treatment (EVT) versus standard medical therapy (SMT) in patients with progressive large vessel occlusion (LVO) presenting 24–72 h after onset.MethodsWe retrospectively analyzed patients with progressive LVO and perfusion mismatch (tissue window) between 24 and 72 h after onset. Propensity score matching (PSM) was performed to balance baseline characteristics. The primary outcome was functional independence (modified Rankin Scale [mRS] 0–2) at 90 days. Secondary outcomes included 90-day mortality and symptomatic intracranial hemorrhage (sICH).ResultsA total of 164 patients were included (EVT, n = 48; SMT, n = 116). The EVT group showed significantly better 90-day functional outcomes (median mRS: 3 [IQR 2–4] vs. 4 [IQR 3–6]; OR 1.86, 95% CI 1.13–5.25; p = 0.018) and higher functional independence rates (43.8% vs. 12.9%; OR 5.24, 95% CI 2.73–10.05; p < 0.001) compared with the SMT group. EVT was also associated with reduced severe disability or death (18.8% vs. 47.4%; OR 0.26, 95% CI 0.12–0.56; p < 0.001) and lower all-cause mortality (12.5% vs. 37.9%; OR 0.23, 95% CI 0.09–0.51; p = 0.001). The incidence of sICH did not differ significantly between groups (10.4% vs. 6.0%; OR 1.81, 95% CI 0.65–5.08; p = 0.409). These findings remained consistent after PSM and in sensitivity analyses excluding non-witnessed strokes. Subgroup analysis indicated that good collateral circulation (Tan 2–3) significantly predicted functional independence (73.1% vs. 9.1%; OR 27.14, 95% CI 4.83–152.45; p < 0.001).ConclusionFor progressive LVO patients presenting 24–72 h after onset with favorable perfusion imaging, EVT was associated with improved functional outcomes and lower mortality, without a significant increase in hemorrhage risk. Furthermore, good collateral circulation is a statistically significant factor associated with EVT benefit.
Background and purpose One clinical trial demonstrated the beneficial effect of intravenous tenecteplase for large vessel occlusion patients not undergoing endovascular thrombectomy (EVT) within 4.5–24 hours. However, for those with acute basilar artery occlusion (BAO) presenting beyond the 4.5-hour therapeutic window, it remains unknown whether intravenous thrombolysis before EVT is beneficial. This study hypothesised that treatment of acute BAO patients with intravenous tenecteplase before EVT will result in better clinical outcomes vs EVT alone within 4.5–24 hours.Methods and design ATTENTION LATE is a prospective, multicentre, randomised, controlled, open-label trial with blinded endpoint assessment. This study will enrol patients with acute BAO who present within 4.5–24 hours of symptom onset. These patients will be randomised 1:1 to either intravenous tenecteplase bridging to EVT or EVT alone.Study outcomes A score of 0–2 on the modified Rankin Scale at 90 days will serve as the primary endpoint.Discussion The ATTENTION LATE trial evaluates whether administering intravenous tenecteplase is safe and effective for acute BAO patients prior to EVT beyond the 4.5-hour time frame. This trial could establish the basis for expanding the eligible patient population to receive intravenous thrombolysis and extending the time window for acute BAO.Trial registration number NCT05701956.
BACKGROUND:Tocilizumab, an interleukin-6 receptor inhibitor, is a promising cytoprotective agent selected by the Stroke Preclinical Assessment Network. It showed a protective effect on infarct volume and functional outcomes in animal stroke models. METHODS:In this investigator-initiated, multicentre, randomised, double-blind, placebo-controlled trial, patients with acute ischaemic stroke undergoing EVT were recruited. Eligible patients were randomly assigned (1:1) to receive tocilizumab or placebo treatment. Both patients and investigators were blinded to the treatment assignments. A single dose of tocilizumab (240 mg) or placebo was administered intravenously as soon as possible within 24 h after stroke onset and within 1 h after randomisation. The primary efficacy outcome was the change in infarct volume from baseline (before EVT and start of study drug) to 72 h. Primary and safety analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT06238024. FINDINGS:A total of 108 patients were enrolled (n placebo = 57; n tocilizumab = 51). The median change in infarct core volume between baseline and 72 h was 27.0 mL (7.6-62.4) in the placebo group and 8.8 mL (IQR 3.4-20.6) in the tocilizumab group (adjusted mean difference in cubic root volume [ml1/3] -0.41, 95% CI -0.79 to -0.03, P = 0.04, wald-type test). Symptomatic intracranial haemorrhage occurred in 7 (12%) patients in the placebo group and 3 (6%) patients in the tocilizumab group. The incidence of all-cause death and serious adverse events were similar between the two groups. INTERPRETATION:Among patients with acute ischaemic stroke undergoing endovascular treatment, tocilizumab tended to reduce infarct volume growth at 72 h post-treatment and is well tolerated. Future trials are necessary to confirm the beneficial effect of tocilizumab on long-term functional outcome following stroke. FUNDING:Noncommunicable Chronic Diseases-National Science and Technology Major Project, Beijing Nova Program, National Natural Science Foundation of China, Beijing Natural Science Foundation.
BACKGROUND:The Neuroform Atlas stent is increasingly used in the management of ruptured intracranial aneurysms (RIAs). However, its safety and efficacy in RIAs remain to be fully established. This study aimed to assess the safety and efficacy of Neuroform Atlas stent-assisted coiling (SAC) for the treatment of RIAs. METHODS:We conducted a multicenter retrospective cohort study of patients with RIAs treated with Neuroform Atlas SAC between January 2020 and May 2023. Clinical characteristics, angiographic outcomes, and follow-up data were analyzed. RESULTS:A total of 101 patients with 101 RIAs were included. All aneurysms were treated using Neuroform Atlas SAC. The mean aneurysm size was 4.9 mm, and the average neck width was 3.3 mm. Immediate Raymond-Roy occlusion class I was achieved in 59.4% of patients and increased to 87.7% at the latest follow-up. The mean follow-up duration was 257.9 days. Favorable clinical outcomes were observed in 92.1% of surviving patients with available follow-up. CONCLUSIONS:Our study demonstrated the safety and efficacy of Neuroform Atlas SAC in the treatment of RIAs.
INTRODUCTION:This study aimed to investigate how diabetes mellitus (DM) influences the efficacy of early tirofiban administration after intravenous thrombolysis in patients with acute ischaemic noncardioembolic stroke. PATIENTS AND METHODS:This was a post-hoc analysis of the ASSET-IT (Advancing Stroke Safety and Efficacy through Early Tirofiban Administration after Intravenous Thrombolysis) trial. Patients were categorised into DM and non-DM groups based on baseline diabetes history. The primary efficacy outcome was an excellent functional outcome at 90 days, defined as an mRS score of 0-1. Safety outcomes included sICH within 36 h, any ICH and all-cause mortality within 90 days. The effect of diabetes on treatment outcomes was assessed using multivariable regression models adjusting for relevant confounders. RESULTS:A total of 832 patients at 38 centres were randomised in the ASSET-IT trial (414 to tirofiban, 418 to placebo). The median age was 69 years (IQR, 59-76); 301 (36.2%) were women. Overall, 191 patients (23.0%) had diabetes mellitus. Among patients without diabetes, an excellent functional outcome at 90 days occurred in 69.0% of patients in the tirofiban group and 55.8% in the placebo group, whereas among patients with diabetes, the corresponding rates were 55.0% and 52.0%, respectively. The nominal P value for the treatment-by-diabetes interaction was .009. The 90-day mortality was higher in the DM group receiving tirofiban (6.6% vs 2.0%; RR, 3.79; 95% CI, 0.84-17.05; P = .082) but not in the non-DM group (3.4% vs 4.4%; RR, 0.82; 95% CI, 0.40-1.70; P = .597). CONCLUSION:Exploratory post-hoc findings from the ASSET-IT trial suggest that the association between early tirofiban administration after intravenous thrombolysis and 90-day functional outcomes may differ according to diabetes status. These hypothesis-generating observations require confirmation in prospective studies with pre-specified subgroup analyses.
Introduction The DEVT and DIRECT-MT trials showed that endovascular thrombectomy (EVT) alone is non-inferior to intravenous thrombolysis (IVT) followed by EVT in achieving 90-day functional independence for stroke patients with large-vessel occlusion (LVO). However, it is unclear whether EVT alone is non-inferior to IVT followed by EVT among patients with acute basilar artery occlusion (BAO). Therefore, additional studies are needed to explore the potential benefits of EVT alone in these patients. Methods and analysis The ATTENTION IV trial is a prospective, multicentre, non-inferiority, blinded endpoint assessment, randomised controlled clinical trial to assess the effect of EVT alone compared with IVT plus EVT in acute BAO patients within 4.5 hours of symptom onset. Patients will be randomised in a 1:1 ratio to either the EVT-alone group or the IVT-plus-EVT group. A score of 0–2 on the 90-day modified Rankin Scale (mRS) was designated as the primary outcome for this study. Primary analysis will follow the intention-to-treat principle with a 15% non-inferiority margin. Secondary outcomes encompass functional status (mRS shift, excellent/good/fair outcomes), quality of life, early neurological recovery and radiological outcomes alongside safety endpoints of intracerebral haemorrhage and mortality. Ethics and dissemination This study has been approved by the Ethics Committee of the First Affiliated Hospital of the University of Science and Technology of China (2023KY-055) and will be conducted following the Declaration of Helsinki. Study results will be published in peer-reviewed academic journals. Trial registration number ClinicalTrials.gov ( NCT05827042 ).
Background The TRACE III trial showed that for patients with large arterial occlusion presenting 4.5–24 hours of symptom occurrence and a salvageable penumbra on perfusion imaging, intravenous tenecteplase (TNK) thrombolysis is safe and can significantly improve patient outcomes in cases where endovascular thrombectomy is not feasible. However, it is currently unknown whether intravenous TNK thrombolysis beyond 4.5 hours can improve the outcomes of subjects with distal medium vessel occlusion (MeVO).Objective To determine the safety and effectiveness of extended window TNK thrombolysis for MeVO stroke.Methods and design Extending the Time Window for Intravenous TNK in Patients with Distal Medium Vessel Occlusions Stroke (TNK-MeVO) is a prospective, randomised, controlled, multicentre and open-label study with blinded outcome assessment. Up to 560 eligible subjects will be randomised 1:1 to receive TNK thrombolysis or standard medical management in over 40 comprehensive stroke centres across China.Outcomes The primary endpoint is the rates of modified Rankin Scale score of 0–1 at 90 days. Safety endpoints include symptomatic intracerebral haemorrhage within 24 hours and mortality at 90 days.Conclusions TNK-MeVO trial is designed to provide robust evidence on whether TNK thrombolysis is safe and effective for acute MeVO stroke presenting 4.5–24 hours of symptom onset.Trial registration number NCT06559436.
QuestionDoes endovascular thrombectomy provide sustained clinical benefit at 3 years compared with best medical management alone in patients with acute basilar artery occlusion?FindingsIn this randomized clinical trial involving 303 patients, a significantly higher proportion of patients in the thrombectomy group achieved functional independence at 3 years compared with the control group. The 3-year follow-up also showed lower cumulative mortality in the thrombectomy group.MeaningThese findings support the routine use of endovascular thrombectomy as the standard of care and underscore the need to expand access to thrombectomy services worldwide. This prespecified analysis of a randomized clinical trial evaluates the 3-year benefits of endovascular thrombectomy for basilar artery occlusion. ImportanceEndovascular thrombectomy (EVT) has been established as an effective treatment for acute basilar artery occlusion (BAO) in the short term. However, the durability of these benefits over the long term has not been well characterized.ObjectiveTo determine whether the clinical benefits of EVT for acute BAO are sustained at 3 years, with a primary focus on functional outcomes and mortality compared with best medical management alone.Design, Setting, and ParticipantsThis study is a 3-year follow-up extension of a multicenter randomized clinical trial conducted between February 2021 and January 2022, with follow-up data collected through January 2025. The study was designed as an open-label, assessor-blinded trial to evaluate the long-term efficacy of EVT. The trial was conducted at 36 comprehensive stroke centers across China, representing a diverse, population-based setting that enhances the generalizability of the results. A total of 340 patients with acute BAO within 12 hours of estimated symptom onset were randomly assigned to the thrombectomy or control group. Eligible participants were adults with imaging-confirmed BAO and without contraindications to endovascular therapy. Of the randomized patients, 307 (90.3%) completed 3-year follow-up-203 in the thrombectomy group and 104 in the control group.InterventionsParticipants in the thrombectomy group received EVT in combination with best medical management, while the control group received best medical management alone. EVT procedures were performed according to institutional protocols using stent retrievers, aspiration devices, balloon angioplasty, stent deployment, intra-arterial thrombolysis, or combinations of these approaches that were left to the discretion of the treating team.Main Outcomes and MeasuresThe primary outcome was a modified Rankin Scale (mRS) score of 0 to 3 at 3 years, representing the ability to walk and perform self-care. Secondary outcomes included a mRS score of 0 to 2, distribution across the mRS score categories, and quality of life. These outcomes were prespecified prior to data analysis.ResultsAmong 307 patients (median [IQR] age, 68 [59-75]; 211 [69%] male) with available data, an mRS score of 0 to 3 at 3 years was observed in 78 patients (38.4%) in the thrombectomy group and in 19 patients (18.3%) in the control group (adjusted risk ratio, 2.05; 95% CI, 1.35-3.11; P = .001). The distribution of mRS scores favored the thrombectomy group over the control group (adjusted common odds ratio, 2.60; 95% CI, 1.53-4.43). The cumulative 3-year mortality increased from 36.7% (n = 83) at 90 days to 55.7% (n = 113) in the thrombectomy group and 55.3% (n = 63) to 73.1% (n = 76) in the control group (adjusted risk ratio, 0.76; 95% CI, 0.65-0.89). On prespecified subgroup analysis, benefit was observed in patients younger than 70 years; a treatment effect was not demonstrated in patients aged 70 years and older.Conclusions and RelevanceAt 3 years, the clinical benefit of EVT in patients with acute BAO was durable, with substantially better functional outcomes and reduced mortality compared with medical management. These results reinforce EVT as the standard of care for BAO and support broader implementation and timely access to thrombectomy services.Trial RegistrationChiCTR.org.cn Identifier: ChiCTR2400082236
Abstract Background and aims Results from the GALLOP study indicated that semaglutide, a glucagon-like peptide-1 receptor agonist, could potentially improve 90-day functional recovery for large vessel occlusion (LVO) patients who received endovascular thrombectomy (EVT) without intravenous thrombolysis (IVT). Given its potential as a neuroprotective agent, a larger-scale trial (GALLOP-2) was conducted to validate the efficacy and safety of semaglutide treatment in these patients. Methods In this investigator-initiated, multicenter, prospective, randomized, open-label, blinded endpoint assessment (PROBE) trial conducted at 19 centers in China, we assigned patients with acute ischemic LVO who presented within 24 hours after onset and did not receive IVT to two groups: the semaglutide group received subcutaneous semaglutide (0.5 mg) before and 7 days after EVT, while the control group received EVT alone. The primary efficacy outcome was the ordinal shift of modified Rankin Scale (mRS) at 90 days. The safety outcomes were symptomatic intracranial hemorrhage and death at 90 days. Results A total of 195 patients were assigned to semaglutide goup and 195 to control group. At 90 days, semaglutide group had superior functional outcome compared with control group (common odds ratio, 0.67; 95% confidence interval, 0.47 to 0.96; P=0.029). Symptomatic intracranial hemorrhage rates were 10.8% in semaglutide group and 5.7% in the control group (P=0.073), with 90-day mortality were 17.4% vs. 14.4% (P=0.407), respectively. Conclusions In LVO patients who did not receive IVT within 24 hours after onset, subcutaneous semaglutide improved functional outcomes and was well-tolerated with no observed harm. (NCT 06788626.) Conflict of interest
Background Previous clinical trials have supported the use of endovascular therapy (EVT) for basilar artery occlusion (BAO) stroke within 24 hours of symptom onset. However, the safety and effectiveness of EVT in patients with BAO treated beyond 24 hours remains unclear. Purpose To compare clinical outcomes and safety following EVT combined with standard medical care versus medical care alone in patients with acute ischemic stroke due to BAO treated beyond 24 hours from symptom onset. Materials and Methods This multicenter retrospective study enrolled patients between March 2017 and April 2024 across China. Eligible patients had BAO and were treated with EVT or standard medical care beyond 24 hours from symptom onset. The primary outcome was the proportion of patients achieving good functional status (modified Rankin Scale score, 0-3). Primary safety outcomes included 90-day mortality and symptomatic intracranial hemorrhage. Inverse probability-weighted regression was performed to adjust for prespecified clinical characteristics, and instrumental variable analysis was repeated as sensitivity analysis. Results Among 217 patients (median age, 66 years [IQR, 58-73 years]; 160 men), good functional status at 90 days was achieved in 35.7% (46 of 129) of patients who underwent EVT and 26.1% (23 of 88) of controls (inverse probability of treatment weighting [IPTW]-adjusted risk ratio [RR], 1.67; P = .008), which was confirmed by instrument variable analysis (adjusted RR, 2.18; P = .04). There was no evidence of a difference in mortality at 90 days between EVT and control groups (48.1% [62 of 129 patients] vs 54.6% [48 of 88 patients]; IPTW-adjusted RR, 0.80; P = .10). Risk of symptomatic intracranial hemorrhage was higher in EVT compared with control groups (11.9% [15 of 126 patients] vs 1.3% [one of 80 patients]; IPTW-adjusted RR, 11.01; P = .02). Conclusion In this study of patients with BAO treated beyond 24 hours from symptom onset, EVT was associated with higher odds of good functional status at 90 days compared with standard medical care, albeit with increased odds of symptomatic intracranial hemorrhage. Chinese Clinical Trial Registry no. ChiCTR2000041117 © RSNA, 2026 Supplemental material is available for this article.
Abstract Background and aims To investigate how diabetes mellitus influences the efficacy of early tirofiban administration after intravenous thrombolysis in patients with acute ischemic noncardioembolic stroke. Methods This was a post hoc analysis of the ASSET-IT trial. Patients were categorized into DM and non-DM groups based on baseline diabetes history. The primary efficacy outcome was excellent functional outcome at 90 days, defined as an mRS score of 0–1. Safety outcomes included symptomatic intracranial hemorrhage (sICH) within 36 hours, any intracranial hemorrhage, and all-cause mortality within 90 days. The effect of diabetes on treatment outcomes was assessed using multivariable regression models adjusting for relevant confounders. Results A total of 832 patients at 38 centers were randomized in the ASSET-IT trial (414 to tirofiban, 418 to placebo). The median age was 69 years (interquartile range, 59 -76); 301 (36.2%) were women. Overall, 191 patients (23.0%) had diabetes mellitus. Among non-DM patients, excellent functional outcome (mRS 0-1) at 90 days was achieved in 69% with tirofiban versus 55.8% with placebo (RR, 1.22; 95% CI, 1.09-1.37; P=0.001); among DM patients, the rates were 55% versus 52% (RR, 1.03; 95% CI, 0.79-1.34; P=0.846). The 90-day mortality was higher in the DM group receiving tirofiban (6.6% vs 2.0%; RR, 3.79; 95% CI, 0.84-17.05; P=0.082) but not in the non-DM group (3.4% vs 4.4%; RR, 0.82; 95% CI, 0.40-1.70; P=0.597). Conclusions Diabetes mellitus was associated with attenuated therapeutic benefit of early tirofiban administration after intravenous thrombolysis in acute ischemic stroke. Prospective studies are warranted to confirm these observations. Conflict of interest all authors,nothing to disclose
BACKGROUND:Distal medium vessel occlusions (MeVOs) account for an estimated 25% to 40% of all acute ischemic strokes. Emerging evidence from non-randomized trials suggest that endovascular thrombectomy (EVT) can achieve high rates of successful reperfusion in MeVO strokes, with a safety profile comparable to EVT for proximal arterial occlusions. These findings underscore the need for a prospective randomized clinical trial to evaluate the safety and efficacy of EVT for MeVO stroke. OBJECTIVE:This trial aims to evaluate the safety and efficacy of EVT for MeVO stroke. METHODS AND DESIGN:Endovascular treatment in acute intracranial distal medium vessel occlusion stroke (ORIENTAL-MeVO) is an investigator-initiated, multicenter, prospective, randomized clinical trial with open-label treatment and blinded endpoint assessment (PROBE). Up to 564 eligible patients will be consecutively randomized in a 1:1 ratio to receive either EVT or standard of care over a period of 2 years in over 50 comprehensive stroke centers in China. OUTCOMES:The primary outcome is a shift in the distribution of the modified Rankin Scale (mRS) at day 90s with levels 5-6 combined (mRS = 0, 1, 2, 3, 4, 5-6). Primary safety endpoints include symptomatic intracerebral hemorrhage at 24 h and mortality at 90 days. TRIAL REGISTRATION:ClinicalTrials.gov NCT06146790.
BACKGROUND:Intravenous thrombolysis remains a standard treatment for acute ischemic stroke within 4.5 hours after onset. Vascular reocclusion may occur after intravenous thrombolysis and may be preventable with an antiplatelet agent within the first 24 hours after thrombolysis. Tirofiban, a platelet glycoprotein IIb-IIIa receptor antagonist, has reduced macrovascular reocclusion in experimental models. METHODS:In this phase 3, multicenter, double-blind, randomized, placebo-controlled trial conducted at 38 centers in China, we assigned patients with acute ischemic noncardioembolic stroke who presented within 4.5 hours after stroke onset and who were not eligible for thrombectomy to receive a 24-hour intravenous infusion of tirofiban or placebo within 60 minutes after intravenous thrombolysis. The primary efficacy outcome was an excellent functional outcome, defined as a score of 0 to 1 on the modified Rankin scale, at 90 days. The safety outcomes were symptomatic intracranial hemorrhage within 36 hours and death at 90 days. RESULTS:A total of 414 patients were assigned to receive tirofiban and 418 to receive placebo. Thrombolytic agents included alteplase (in 75% of the patients) and tenecteplase (in 25%). At 90 days, a score of 0 to 1 on the modified Rankin scale was reported in a higher percentage of patients in the tirofiban group than in the placebo group (65.9% vs. 54.9%; risk ratio, 1.20; 95% confidence interval, 1.07 to 1.34; P = 0.001). Symptomatic intracranial hemorrhage occurred in 1.7% of the patients in the tirofiban group and none in the placebo group. Mortality at 90 days was 4.1% in the tirofiban group and 3.8% in the placebo group. CONCLUSIONS:In patients with acute ischemic noncardioembolic stroke who underwent thrombolysis within 4.5 hours after onset, early tirofiban increased the likelihood of an excellent functional outcome. The incidence of intracranial hemorrhage was low but higher with tirofiban than placebo. (Funded by the Fundamental Research Funds for Central Universities; ASSET-IT ClinicalTrials.gov number, NCT06134622.).