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OBJECTIVE: The aim of this study was to investigate the factors influencing good outcomes in patients receiving only intravenous tirofiban with endovascular thrombectomy for large vessel occlusion stroke. METHODS: Post hoc exploratory analysis using the RESCUE BT trial identified consecutive patients who received intravenous tirofiban with endovascular thrombectomy for large vessel occlusion stroke in 55 comprehensive stroke centers from October 2018 to January 2022 in China. RESULTS: A total of 521 patients received intravenous tirofiban, 253 of whom achieved a good 90-day outcome (modified Rankin Scale [mRS] 0-2). Younger age (adjusted odds ratio [aOR]: 0.965, 95% confidence interval [CI]: 0.947-0.982; p < 0.001), lower serum glucose (aOR: 0.865, 95%CI: 0.807-0.928; p < 0.001), lower baseline National Institutes of Health Stroke Scale (NIHSS) score (aOR: 0.907, 95%CI: 0.869-0.947; p < 0.001), fewer total passes (aOR: 0.791, 95%CI: 0.665-0.939; p = 0.008), shorter punctures to recanalization time (aOR: 0.995, 95%CI:0.991-0.999; p = 0.017), and modified Thrombolysis in Cerebral Infarction (mTICI) score 2b to 3 (aOR: 8.330, 95%CI: 2.705-25.653; p < 0.001) were independent predictors of good outcomes after intravenous tirofiban with endovascular thrombectomy for large vessel occlusion stroke. CONCLUSION: Younger age, lower serum glucose level, lower baseline NIHSS score, fewer total passes, shorter punctures to recanalization time, and mTICI scores of 2b to 3 were independent predictors of good outcomes after intravenous tirofiban with endovascular thrombectomy for large vessel occlusion stroke. CHINESE CLINICAL TRIAL REGISTRY IDENTIFIER: ChiCTR-IOR-17014167.
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Trombectomía , Tirofibán , Humanos , Tirofibán/administración & dosificación , Tirofibán/uso terapéutico , Masculino , Femenino , Persona de Mediana Edad , Anciano , Trombectomía/métodos , Resultado del Tratamiento , Accidente Cerebrovascular Isquémico/tratamiento farmacológico , Procedimientos Endovasculares/métodos , Administración Intravenosa , Accidente Cerebrovascular/tratamiento farmacológico , Fibrinolíticos/administración & dosificación , Fibrinolíticos/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/uso terapéuticoRESUMEN
BACKGROUND: Stress hyperglycemia ratio (SHR) reflects a true acute hyperglycemic state during acute basilar artery occlusion (ABAO). We aimed to investigate the association between SHR and short-term and long-term outcomes in patients with ABAO receiving endovascular treatment (EVT). METHODS: We selected patients treated with EVT from the BASILAR study, a nationwide prospective registry. A total 250 patients with documented glucose and glycated hemoglobin (HbA1C) values at admission were included. SHR was calculated as the ratio of glucose/HbA1C. All 250 patients completed 90 days of follow-up and 234 patients (93.6%) completed 1 year of follow-up. The primary outcome was the favorable outcome defined as modified Rankin Scale (mRS) score ≤ 3 at 90 days. Safety outcomes included mortality at 90 days and 1 year, and intracranial hemorrhage. RESULTS: Among the 250 patients included, patients with higher tertiles of SHR were associated with decreased odds of a favorable functional outcome at 90 days (adjusted OR, 0.26; 95% CI, 0.12-0.56; P = 0.001 and adjusted OR, 0.37; 95% CI, 0.18-0.80; P = 0.01; respectively) and 1 year (adjusted OR, 0.34; 95% CI, 0.16-0.73; P = 0.006 and adjusted OR, 0.38; 95% CI, 0.18-0.82; P = 0.01; respectively) after adjusting for confounding covariates. The mortality was comparable across tertiles of SHR groups at 90 days and 1 year. CONCLUSIONS: Our study showed that SHR was associated with a decreased probability of favorable functional outcome both at 90 days and 1 year after EVT in patients with ABAO. The relationship was more pronounced in non-diabetes patients. TRIAL REGISTRATION: Clinical Trial Registry Identifier: ChiCTR1800014759 (November 12, 2013).
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Procedimientos Endovasculares , Hiperglucemia , Accidente Cerebrovascular , Humanos , Arteria Basilar , Hemoglobina Glucada , Glucosa , Hospitalización , Resultado del Tratamiento , TrombectomíaRESUMEN
Importance: It is uncertain whether intravenous methylprednisolone improves outcomes for patients with acute ischemic stroke due to large-vessel occlusion (LVO) undergoing endovascular thrombectomy. Objective: To assess the efficacy and adverse events of adjunctive intravenous low-dose methylprednisolone to endovascular thrombectomy for acute ischemic stroke secondary to LVO. Design, Setting, and Participants: This investigator-initiated, randomized, double-blind, placebo-controlled trial was implemented at 82 hospitals in China, enrolling 1680 patients with stroke and proximal intracranial LVO presenting within 24 hours of time last known to be well. Recruitment took place between February 9, 2022, and June 30, 2023, with a final follow-up on September 30, 2023. Interventions: Eligible patients were randomly assigned to intravenous methylprednisolone (n = 839) at 2 mg/kg/d or placebo (n = 841) for 3 days adjunctive to endovascular thrombectomy. Main Outcomes and Measures: The primary efficacy outcome was disability level at 90 days as measured by the overall distribution of the modified Rankin Scale scores (range, 0 [no symptoms] to 6 [death]). The primary safety outcomes included mortality at 90 days and the incidence of symptomatic intracranial hemorrhage within 48 hours. Results: Among 1680 patients randomized (median age, 69 years; 727 female [43.3%]), 1673 (99.6%) completed the trial. The median 90-day modified Rankin Scale score was 3 (IQR, 1-5) in the methylprednisolone group vs 3 (IQR, 1-6) in the placebo group (adjusted generalized odds ratio for a lower level of disability, 1.10 [95% CI, 0.96-1.25]; P = .17). In the methylprednisolone group, there was a lower mortality rate (23.2% vs 28.5%; adjusted risk ratio, 0.84 [95% CI, 0.71-0.98]; P = .03) and a lower rate of symptomatic intracranial hemorrhage (8.6% vs 11.7%; adjusted risk ratio, 0.74 [95% CI, 0.55-0.99]; P = .04) compared with placebo. Conclusions and Relevance: Among patients with acute ischemic stroke due to LVO undergoing endovascular thrombectomy, adjunctive methylprednisolone added to endovascular thrombectomy did not significantly improve the degree of overall disability. Trial Registration: ChiCTR.org.cn Identifier: ChiCTR2100051729.
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Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Femenino , Humanos , Anciano , Método Doble Ciego , Trombectomía/efectos adversos , Hemorragias Intracraneales , Metilprednisolona/efectos adversosRESUMEN
Importance: The benefit of intravenous thrombolysis (IVT) for acute ischemic stroke declines with longer time from symptom onset, but it is not known whether a similar time dependency exists for IVT followed by thrombectomy. Objective: To determine whether the benefit associated with IVT plus thrombectomy vs thrombectomy alone decreases with treatment time from symptom onset. Design, Setting, and Participants: Individual participant data meta-analysis from 6 randomized clinical trials comparing IVT plus thrombectomy vs thrombectomy alone. Enrollment was between January 2017 and July 2021 at 190 sites in 15 countries. All participants were eligible for IVT and thrombectomy and presented directly at thrombectomy-capable stroke centers (n = 2334). For this meta-analysis, only patients with an anterior circulation large-vessel occlusion were included (n = 2313). Exposure: Interval from stroke symptom onset to expected administration of IVT and treatment with IVT plus thrombectomy vs thrombectomy alone. Main Outcomes and Measures: The primary outcome analysis tested whether the association between the allocated treatment (IVT plus thrombectomy vs thrombectomy alone) and disability at 90 days (7-level modified Rankin Scale [mRS] score range, 0 [no symptoms] to 6 [death]; minimal clinically important difference for the rates of mRS scores of 0-2: 1.3%) varied with times from symptom onset to expected administration of IVT. Results: In 2313 participants (1160 in IVT plus thrombectomy group vs 1153 in thrombectomy alone group; median age, 71 [IQR, 62 to 78] years; 44.3% were female), the median time from symptom onset to expected administration of IVT was 2 hours 28 minutes (IQR, 1 hour 46 minutes to 3 hours 17 minutes). There was a statistically significant interaction between the time from symptom onset to expected administration of IVT and the association of allocated treatment with functional outcomes (ratio of adjusted common odds ratio [OR] per 1-hour delay, 0.84 [95% CI, 0.72 to 0.97], P = .02 for interaction). The benefit of IVT plus thrombectomy decreased with longer times from symptom onset to expected administration of IVT (adjusted common OR for a 1-step mRS score shift toward improvement, 1.49 [95% CI, 1.13 to 1.96] at 1 hour, 1.25 [95% CI, 1.04 to 1.49] at 2 hours, and 1.04 [95% CI, 0.88 to 1.23] at 3 hours). For a mRS score of 0, 1, or 2, the predicted absolute risk difference was 9% (95% CI, 3% to 16%) at 1 hour, 5% (95% CI, 1% to 9%) at 2 hours, and 1% (95% CI, -3% to 5%) at 3 hours. After 2 hours 20 minutes, the benefit associated with IVT plus thrombectomy was not statistically significant and the point estimate crossed the null association at 3 hours 14 minutes. Conclusions and Relevance: In patients presenting at thrombectomy-capable stroke centers, the benefit associated with IVT plus thrombectomy vs thrombectomy alone was time dependent and statistically significant only if the time from symptom onset to expected administration of IVT was short.
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Isquemia Encefálica , Fibrinolíticos , Accidente Cerebrovascular Isquémico , Trombectomía , Terapia Trombolítica , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Administración Intravenosa , Isquemia Encefálica/tratamiento farmacológico , Isquemia Encefálica/cirugía , Fibrinolíticos/administración & dosificación , Fibrinolíticos/uso terapéutico , Accidente Cerebrovascular Isquémico/tratamiento farmacológico , Accidente Cerebrovascular Isquémico/cirugía , Ensayos Clínicos Controlados Aleatorios como Asunto , Recuperación de la Función , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/complicaciones , Terapia Trombolítica/métodos , Tiempo de Tratamiento , Resultado del TratamientoRESUMEN
Purpose: Acute ischemic stroke (AIS) stands as the primary cause of mortality and extended disability globally. While prior studies have examined the connection between stroke and local weather, they have produced conflicting results. Our goal was to examine the correlation between temperature and functional prognosis in patients with large vessel occlusion (LVO) undergoing endovascular therapy (EVT). Patients and methods: This study included a total of 1809 patients. Temperatures from stroke onset to groin puncture were categorized into Cold (10th percentile of temperature), Cool (10th-50th percentile of temperature), Warm (50th-90th percentile of temperature), and Hot (90th percentile of temperature) groups. The primary efficacy result was the modified Rankin Scale (mRS) score at 90 days. Safety outcomes included mortality, symptomatic intracranial hemorrhage (sICH) and complications after cerebral infarction. Results: The primary efficacy results demonstrated a statistical enhancement in functional outcomes at 90 days for patients in the Warm group compared to the Cold group (adjusted common odds ratio [OR]: 1.386; 95% confidence interval [CI]: 1.024-1.878, P=0.035). Secondary efficacy results showed that temperature was associated with a higher rate of 90-day functional independence (adjusted OR: 1.016; 95% CI: 1.004-1.029; P=0.009), which was higher in the Warm group compared with patients in the Cold group (adjusted OR: 1.646; 95% CI: 1.107-2.448, P=0.014). There were no significant differences between groups in terms of sICH, 90-day mortality, and post-infarction complications. Conclusion: Compared with Cold temperature, Warm temperature is associated with better functional outcomes and reduced mortality risk without increasing the risk of sICH.
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Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Humanos , Masculino , Femenino , Anciano , Procedimientos Endovasculares/métodos , Persona de Mediana Edad , Anciano de 80 o más Años , Temperatura , Resultado del Tratamiento , Estudios Retrospectivos , Hemorragias Intracraneales/etiologíaRESUMEN
The effectiveness and safety of human urinary kallidinogenase (HUK) in acute ischemic stroke (AIS) patients undergoing endovascular therapy (EVT) due to large vessel occlusion (LVO) was unclear. A pooled analysis was performed using individual data from the DEVT and RESCUE BT trials. Patients were divided into two groups based on HUK treatment. The primary outcome was the 90-day modified Rankin Scale (mRS) score. Safety outcomes included 90-day mortality and symptomatic intracranial hemorrhage (sICH) within 48 hours. A total of 1174 patients were included in the study. Of these, 150 (12.8%) patients received HUK. The adjusted common odds ratio (OR) of the mRS score was 1.458 (95% confidence interval [CI] = 1.072-1.983; p = 0.016) favoring HUK. The incidence of sICH (2.0% vs. 8.6%; adjusted OR: 0.198; 95% CI: 0.061-0.638; p = 0.007) and mortality (11.3% vs.18.5%; adjusted OR: 0.496; 95% CI: 0.286-0.862; p = 0.013) was lower in HUK group than non-HUK group. This association was consistent with propensity score-matching and the inverse probability of treatment weighting analysis. In conclusion, HUK was safe and associated with a preferable prognosis in AIS patients due to LVO in the anterior circulation.
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BACKGROUND: Despite the remarkable effectiveness of endovascular treatment (EVT), recent randomized controlled trials indicate that up to half of patients with large core infarction have a very poor outcome (modified Rankin Scale score 5-6 at 90 days). This study investigates the combined effect of Alberta Stroke Program Early CT Score (ASPECTS) and age on very poor outcome in patients with large core infarction treated with EVT. METHODS: This subanalysis of the MAGIC registry, which is a prospective, multicenter cohort study of early treatment in acute stroke, focused on patients with ASPECTS ≤5 presenting within 24 hours of stroke onset and receiving CT followed by EVT from November 1, 2021 to February 8, 2023. Multivariable logistic regression was used to investigate the independent and joint association of ASPECTS and age with very poor outcome. RESULTS: Among the 490 patients (57.3% men; median (IQR) age 69 (59-78) years), very poor outcome occurred more frequently in those with lower ASPECTS (65.2% in ASPECTS 0-2 vs 43.4% in ASPECTS 3-5; P<0.001). The predictive value of successful recanalization for very poor outcome was significant in patients with ASPECTS 3-5 (P=0.010), but it diminished in those with ASPECTS 0-2 (P=0.547). Compared with patients with ASPECTS 3-5 and age ≤69 years, the risk of a very poor outcome increased incrementally in those with lower ASPECTS, advanced age, or both (P<0.05). Graphical plot analysis showed a significantly lower probability of very poor outcome in younger patients (≤69 years) compared with older patients (>69 years) across all ASPECTS points. CONCLUSION: These findings suggest prioritizing young patients as candidates for EVT in those with ASPECTS 0-2.
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INTRODUCTION: This study aimed to analyze the association between baseline National Institutes of Health Stroke Scale (NIHSS) scores and clinical outcomes in patients with large core infarctions undergoing endovascular treatment (EVT), a relationship that remains unclear. METHODS: Data were obtained from the MAGIC study, a prospective multicenter cohort study focusing on patients with acute large core ischemic stroke. This analysis evaluated the impact of NIHSS scores on EVT outcomes in patients with large core infarctions. Primary outcome metrics included favorable outcomes (modified Rankin Scale [mRS] of 0-3 at 90 days), while secondary outcomes encompassed shifts in mRS scores, functional independence (mRS score of 0-2), mRS score of 0-4, and successful recanalization rates. Adverse events considered were symptomatic intracranial hemorrhage (sICH) and mortality. RESULTS: A total of 490 patients were enrolled in this study. Higher baseline NIHSS scores were inversely correlated with favorable outcomes (adjusted odds ratio [OR] in model 3, 0.848 [0.797-0.903], P < 0.001), particularly in patients with NIHSS scores above 20 (adjusted OR in model 3, 0.518 [0.306-0.878] vs. 0.290 [0.161-0.523]). Regarding adverse events, higher baseline NIHSS scores significantly correlated with increased 90-day mortality rates (adjusted OR in model 3, 1.129 [1.072-1.189], P < 0.001). This correlation became insignificant when baseline NIHSS scores exceeded 22. Additionally, baseline NIHSS scores partially mediated the association between age (indirect effect = - 0.0005, 19.39% mediated) and sex (indirect effect = 0.0457, 25.08% mediated) with the primary outcome. CONCLUSIONS: The findings indicate that higher baseline NIHSS scores correlate with poorer outcomes and increased mortality, particularly when scores exceed 20. Moreover, age and sex indirectly influence favorable outcomes through their association with baseline NIHSS scores.
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BACKGROUND: In the RESCUE BT (Endovascular Treatment With versus Without Tirofiban for Stroke Patients with Large Vessel Occlusion) trial, enrollment in extended time window was based on non-contrast computed tomography. To assess whether perioperative intravenous tirofiban would further enhance the clinical benefit of endovascular therapy in the RESCUE BT trial according to advanced imaging criteria based on current American Heart Association/American Stroke Association (AHA/ASA) guidelines. METHODS: This is a secondary analysis of the RESCUE BT trial. Patients who were eligible for endovascular thrombectomy in the 6-hour window and met the criteria of the DAWN or DEFUSE 3 trials in the extended window according to the AHA/ASA guidelines were analyzed. The primary outcome was the distribution of the 90-day modified Rankin Scale (mRS) scores. Safety outcomes included the incidence of symptomatic intracranial hemorrhage (sICH) within 48 hours and 90-day mortality. RESULTS: A total of 652 patients (319 in tirofiban group and 333 in placebo group) who meeting the AHA/ASA guidelines were included in this analysis, with median (IQR) age of 68 (58-75) years, 278 (42.6%) were women. The median 90-day mRS score was 3 (IQR, 1-4) in the tirofiban group, and 3 (IQR, 1-4) in the placebo group. The adjusted common odds ratio (OR) for a lower level of disability with tirofiban than with placebo was 1.08 (95% confidence interval [CI], 0.83-1.42). The incidence of sICH (10.1% versus 6.3%; adjusted OR 1.70; [95% CI, 0.95-3.04]) was not significantly different between groups. However, intravenous tirofiban might be associated with lower disability level (adjusted common OR, 1.74 [95% CI, 1.14-2.65]; P=0.01) in patients with large artery atherosclerosis. CONCLUSIONS: There was no significant difference in the severity of disability at 90 days with intravenous tirofiban compared to placebo in patients who underwent endovascular therapy according to AHA/ASA guidelines. We observed potential benefits of tirofiban in patients with large artery atherosclerosis, but there was an increased risk of sICH in patients with cardioembolism stroke.
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OBJECTIVE: Renal function can modify the outcomes of large vessel occlusion (LVO) stroke across stroke etiologies in disparate degrees. The presence of renal function deficit can also impair the pharmacokinetics of tirofiban. Hence, this study aimed to investigate the roles of renal function in determining efficacy and safety of intravenous tirofiban before endovascular treatment (EVT) for acute ischemic stroke patients with large vessel occlusion (LVO). METHODS: This study was a post hoc exploratory analysis of the RESCUE-BT trial. The primary outcome was the proportion of patients achieving functional independence (modified Rankin scale 0-2) at 90 days, and the primary safety outcome was the rate of symptomatic intracranial hemorrhage (sICH). RESULTS: Among 908 individuals with available serum creatinine, decreased estimated glomerular filtration rate (eGFR) status was noted more commonly in patients with cardioembolic stroke (CE), while large artery atherosclerosis (LAA) was predominant in patients with normal renal function. In LAA with normal renal function, tirofiban was associated with higher rates of functional independence at 90 days (41.67% vs 59.80%, p = 0.003). However, for LVO patients with renal dysfunction, tirofiban did not improve functional outcomes for any of the etiologies (LAA, p = 0.876; CE, p = 0.662; others, p = 0.894) and significantly increased the risk of sICH among non-LAA patients (p = 0.020). Mediation analysis showed tirofiban reduced thrombectomy passes (12.27%) and drug/placebo to recanalization time (14.25%) mediated its effects on functional independence. CONCLUSION: This present study demonstrated the importance of evaluating renal function before administering intravenous tirofiban among patients with LVO who are planned to undergo EVT.
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Isquemia Encefálica , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Tirofibán/efectos adversos , Accidente Cerebrovascular Isquémico/complicaciones , Isquemia Encefálica/complicaciones , Resultado del Tratamiento , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/tratamiento farmacológico , Hemorragias Intracraneales/inducido químicamente , RiñónRESUMEN
OBJECTIVE: This study assesses the safety and efficacy of tirofiban for patients with large vessel occlusion stroke after intravenous thrombolysis. METHODS: This study data was from SUSTAIN, DEVT, and RESCUE BT trials. According to whether the use of tirofiban who underwent endovascular treatment and preceding intravenous thrombolysis was divided into the tirofiban group and the no-tirofiban group. The safety outcomes were symptomatic intracranial hemorrhage, any intracranial hemorrhage within 48â¯h, and 3-month mortality. The efficacy outcome was defined as a score of 0-2 on the modified Rankin Scale scores at 3 months. RESULTS: A total of 372 patients with intravenous thrombolysis were included in these SUSTAIN, DEVT, and RESCUE BT trials. Adjusted multivariate analysis showed that tirofiban with intravenous thrombolysis was not associated with symptomatic intracranial hemorrhage (aOR, 0.87; 95â¯% CI, 0.49-1.57; P=0.65), any intracranial hemorrhage within 48â¯h (aOR, 1.00; 95â¯% CI, 0.60-1.66; P=1.00), 3-month mortality (aOR, 1.10; 95â¯% CI, 0.56-2.19; P=0.78) and 3-month modified Rankin Scale scores 0-2 (aOR, 0.72; 95â¯% CI, 0.42-1.25; P=0.25) in patients with acute large vessel occlusion. In the subgroup analysis, we found that tirofiban was not recommended for females (aOR, 0.34; 95â¯% CI, 0.12-0.93), baseline Alberta Stroke Program Early CT Score≤9 (aOR, 0.37; 95â¯% CI, 0.18-0.76), and cardiogenic embolism (aOR, 0.36; 95â¯% CI, 0.14-0.97). CONCLUSION: Tirofiban combined with intravenous thrombolysis in patients with acute large vessel occlusion may be safe. Further studies need to confirm the effectiveness of tirofiban after intravenous thrombolysis in different stroke etiology.
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Procedimientos Endovasculares , Fibrinolíticos , Terapia Trombolítica , Tirofibán , Humanos , Tirofibán/uso terapéutico , Tirofibán/administración & dosificación , Femenino , Masculino , Persona de Mediana Edad , Anciano , Procedimientos Endovasculares/métodos , Terapia Trombolítica/métodos , Resultado del Tratamiento , Fibrinolíticos/uso terapéutico , Fibrinolíticos/administración & dosificación , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular Isquémico/tratamiento farmacológico , Anciano de 80 o más Años , Administración Intravenosa , Hemorragias Intracraneales/etiología , Hemorragias Intracraneales/inducido químicamente , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificaciónRESUMEN
OBJECTIVE: The impact of true first-pass effect (T-FPE, achieving substantial recanalization with extended thrombolysis in cerebral infarction; eTICI 3 after 1 thrombectomy) and outcomes on acute ischemic stroke (AIS) with large ischemic core remains uncertain. We aimed to study the association between T-FPE and outcomes in AIS patients with large core infarct through a real-world multicenter study. METHODS: From a prospective multicentric registry, we collected the data of all consecutive acute stroke patients with a large ischemic core who underwent thrombectomy and compared the outcomes of patients who achieved T-FPE and those who did not. In addition, we compared the outcomes of patients with different numbers of thrombectomy pass to identify the effectiveness of T-FPE. Multivariate analysis was performed to determine the predictors of T-FPE. The primary outcome was good functional outcome (modified Rankin Scale score; mRS 0-3) at 90 days. Safety outcomes included a 90-day mortality and symptomatic intracerebral hemorrhage within 48 hours after thrombectomy. RESULTS: Between November 2021 and February 2023, 447 eligible patients at 38 stroke centers were enrolled. Out of 447 thrombectomy patients, T-FPE was achieved in 102 individuals (22.8%). T-FPE was significantly associated with a higher proportion of good functional outcome (mRS 0-3 at 3 months, OR 2.221, 95% CI 1.418-3.479, p < 0.001) and lower mortality than non-T-FPE patients (31.4% vs. 45.5%, p = 0.012). The occlusion sites and lower DBP were strong predictors of T-FPE. INTERPRETATION: T-FPE was associated with favorable outcomes at 90 days in AIS patients with a large ischemic core who underwent EVT.
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Importance: The association of endovascular therapy (EVT) with outcomes is unclear for patients with very low Alberta Stroke Program Early Computed Tomography Score (ASPECTS) within 24 hours of stroke onset. Objective: To explore the association of EVT with functional and safety outcomes among patients with ASPECTS of 0 to 2 scored with noncontrast computed tomography. Design, Setting, and Participants: This cohort study used data from an ongoing, prospective, observational, nationwide registry including all patients treated at 38 stroke centers in China with an occlusion in the internal carotid artery or M1 or M2 segment of the middle cerebral artery within 24 hours of witnessed symptom onset. Patients with ASPECTS of 0 to 2 between November 1, 2021, and February 8, 2023, were included in analysis. Data were analyzed October to November 2023. Exposures: EVT vs standard medical treatment (SMT). Main Outcomes and Measures: The primary outcome was favorable functional outcome, defined as modified Rankin Scale score (mRS) of 0 to 3, at 90 days. Safety outcomes included symptomatic intracerebral hemorrhage (sICH) within 48 hours and mortality at 90 days. Results: A total of 245 patients (median [IQR] age, 71 [63-78] years; 118 [48%] women) with ASPECTS of 0 to 2 were included, of whom 111 patients (45.1%) received SMT and 135 patients (54.9%) received EVT. The EVT group had significantly greater odds of favorable functional outcome at 90 days than the SMT group (30 patients [22.2%] vs 11 patients [9.9%]; P = .01; adjusted odds ratio [aOR], 3.07 [95% CI, 1.29-7.31]; P = .01). Patients in the EVT group, compared with the SMT group, had significantly greater odds of any ICH (56 patients [41.5%] vs 16 patients [11.4%]; P < .001; aOR, 4.27 [95% CI, 2.19-8.35]; P < .001) and sICH (24 patients [17.8%] vs 1 patient [0.9%]; P < .001; aOR, 23.07 [95% CI, 2.99-177.79]; P = .003) within 48 hours. There were no differences between groups for 90-day mortality (80 patients [59.3%] vs 59 patients [53.2%]; P = .34; aOR, 1.38 [95% CI, 0.77-2.47]; P = .28). The results remained robust in the propensity score-matched analysis. Conclusions and Relevance: In this cohort study of patients with very low ASPECTS based on NCCT within 24 hours of stroke onset, those treated with EVT had higher odds of a favorable functional outcome compared with those who received SMT. Randomized clinical trials are needed to assess these findings.
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Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Humanos , Femenino , Masculino , Procedimientos Endovasculares/métodos , Anciano , Persona de Mediana Edad , Accidente Cerebrovascular Isquémico/terapia , Accidente Cerebrovascular Isquémico/mortalidad , Accidente Cerebrovascular Isquémico/cirugía , Estudios Prospectivos , Resultado del Tratamiento , Sistema de Registros , China/epidemiología , Tomografía Computarizada por Rayos X , Estudios de CohortesRESUMEN
BACKGROUND: Previous trials confirmed the benefit of endovascular treatment (EVT) in acute large core stroke, but the effect of EVT on outcomes in these patients based on noncontrast computed tomography (NCCT) in real-world clinical practice was unclear. The aim of this study was to explore the effect of EVT versus standard medical treatment (SMT) in patients with large ischemic core stroke defined as Alberta Stroke Program Early CT Score (ASPECTS) ≤5 based on NCCT alone. MATERIALS AND METHODS: Patients with acute large core stroke at 38 Chinese centers between November 2021 and February 2023 were reviewed from a prospectively maintained database. The primary outcome was favorable functional outcome [modified Rankin Scale score (mRS), 0-3] at 90 days. Safety outcomes included 48 h symptomatic intracerebral hemorrhage (sICH) and 90-day mortality. RESULTS: Of 745 eligible patients recruited at 38 stroke centers between November 2021 and February 2023, 490 were treated with EVT+SMT and 255 with SMT alone. One hundred and eighty-one (36.9%) in the EVT group achieved favorable functional independence versus 48 (18.8%) treated with SMT only [adjusted risk ratio (RR), 1.86; 95% CI: 1.43-2.42, P <0.001; adjusted risk difference (RD), 13.77; 95% CI: 7.40-20.15, P <0.001]. The proportion of sICH was significantly higher in patients undergoing EVT (13.3 vs. 2.4%; adjusted RR, 5.17; 95% CI: 2.17-12.32, P <0.001; adjusted RD, 10.10; 95% CI: 6.12-14.09, P <0.001). No significant difference of mortality between the groups was observed (41.8 vs. 49.0%; adjusted RR, 0.91; 95% CI: 0.77-1.07, P =0.24; adjusted RD, -5.91; 95% CI: -12.91-1.09, P =0.1). CONCLUSION: Among patients with acute large core stroke based on NCCT in real-world, EVT is associated with better functional outcomes at 90 days despite of higher risk of sICH. Rates of procedure-related complications were relatively higher in the EVT+SMT group.