IMPORTANCEFor patients with large vessel occlusion strokes, it is unknown whether endovascular treatment alone compared with intravenous thrombolysis plus endovascular treatment (standard treatment) can achieve similar functional outcomes. OBJECTIVE To investigate whether endovascular thrombectomy alone is noninferior to intravenous alteplase followed by endovascular thrombectomy for achieving functional independence at 90 days among patients with large vessel occlusion stroke.DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized, noninferiority trial conducted at 33 stroke centers in China. Patients (n = 234) were 18 years or older with proximal anterior circulation intracranial occlusion strokes within 4.5 hours from symptoms onset and eligible for intravenous thrombolysis. Enrollment took place from May 20, 2018, to May 2, 2020. Patients were enrolled and followed up for 90 days (final follow-up was July 22, 2020).INTERVENTIONS A total of 116 patients were randomized to the endovascular thrombectomy alone group and 118 patients to combined intravenous thrombolysis and endovascular thrombectomy group. MAIN OUTCOMES AND MEASURESThe primary end point was the proportion of patients achieving functional independence at 90 days (defined as score 0-2 on the modified Rankin Scale; range, 0 [no symptoms] to 6 [death]). The noninferiority margin was −10%. Safety outcomes included the incidence of symptomatic intracerebral hemorrhage within 48 hours and 90-day mortality. RESULTSThe trial was stopped early because of efficacy when 234 of a planned 970 patients had undergone randomization. All 234 patients who were randomized (mean age, 68 years; 102 women [43.6%]) completed the trial. At the 90-day follow-up, 63 patients (54.3%) in the endovascular thrombectomy alone group vs 55 (46.6%) in the combined treatment group achieved functional independence at the 90-day follow-up (difference, 7.7%, 1-sided 97.5% CI, −5.1% to ϱ)P for noninferiority = .003). No significant between-group differences were detected in symptomatic intracerebral hemorrhage (6.1% vs 6.8%; difference, −0.8%; 95% CI, −7.1% to 5.6%) and 90-day mortality (17.2% vs 17.8%; difference, −0.5%; 95% CI, −10.3% to 9.2%).CONCLUSIONS AND RELEVANCE Among patients with ischemic stroke due to proximal anterior circulation occlusion within 4.5 hours from onset, endovascular treatment alone, compared with intravenous alteplase plus endovascular treatment, met the prespecified statistical threshold for noninferiority for the outcome of 90-day functional independence. These findings should be interpreted in the context of the clinical acceptability of the selected noninferiority threshold.
Writing Group for the BASILAR Group IMPORTANCE Several randomized clinical trials have recently established the safety and efficacy of endovascular treatment (EVT) of acute ischemic stroke in the anterior circulation. However, it remains uncertain whether patients with acute basilar artery occlusion (BAO) benefit from EVT.OBJECTIVE To evaluate the association between EVT and clinical outcomes of patients with acute BAO. DESIGN, SETTING, AND PARTICIPANTSThis nonrandomized cohort study, the EVT for Acute Basilar Artery Occlusion Study (BASILAR) study, was a nationwide prospective registry of consecutive patients presenting with an acute, symptomatic, radiologically confirmed BAO to 47 comprehensive stroke centers across 15 provinces in China between January 2014 and May 2019. Patients with acute BAO within 24 hours of estimated occlusion time were divided into groups receiving standard medical treatment plus EVT or standard medical treatment alone. MAIN OUTCOMES AND MEASURESThe primary outcome was the improvement in modified Rankin Scale scores (range, 0 to 6 points, with higher scores indicating greater disability) at 90 days across the 2 groups assessed as a common odds ratio using ordinal logistic regression shift analysis, adjusted for prespecified prognostic factors. The secondary efficacy outcome was the rate of favorable functional outcomes defined as modified Rankin Scale scores of 3 or less (indicating an ability to walk unassisted) at 90 days. Safety outcomes included symptomatic intracerebral hemorrhage and 90-day mortality.RESULTS A total of 1254 patients were assessed, and 829 patients (of whom 612 were men [73.8%]; median [interquartile] age, 65 [57-74] years) were recruited into the study. Of these, 647 were treated with standard medical treatment plus EVT and 182 with standard medical treatment alone. Ninety-day functional outcomes were substantially improved by EVT (adjusted common odds ratio, 3.08 [95% CI, 2.09-4.55]; P < .001). Moreover, EVT was associated with a significantly higher rate of 90-day modified Rankin Scale scores of 3 or less (adjusted odds ratio, 4.70 [95% CI,; P < .001) and a lower rate of 90-day mortality (adjusted odds ratio, 2.93 [95% CI, 1.95-4.40]; P < .001) despite an increase in symptomatic intracerebral hemorrhage (45 of 636 patients [7.1%] vs 1 of 182 patients [0.5%]; P < .001).CONCLUSIONS AND RELEVANCE Among patients with acute BAO, EVT administered within 24 hours of estimated occlusion time is associated with better functional outcomes and reduced mortality.
RESCUE BT Trial Investigators E ndovascular treatment has been shown to significantly increase the reperfusion rate and improve the functional outcomes of patients with acute ischemic stroke due to large vessel occlusion. [1][2][3][4] However, endovascular thrombectomy has historically failed to yield successful reperfusion in approximately 30% of patients. 5 Unsuccessful reperfusion likely arises in part from mechanical thrombectomy devices causing traumatic damage to the vascular endothelium with subendothelial matrix exposure, leading to platelet activation, adhesion, and aggregation and potentially resulting in reocclusion and thromboembolic complications. 6,7 Tirofiban, a highly selective nonpeptide platelet glycoprotein IIb/IIIa inhibitor with a relatively short half-life that can reversibly prevent platelet aggregation, has been proven to reduce the risk of thrombotic complications during percutaneous coronary intervention. [8][9][10] Given the benefit of treatment of acute coronary syndromes, a growing number of studies have evaluated tirofiban as an adjunctive treatment in patients with large vessel occlusion ischemic stroke 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.
Background and Purpose: This study aimed to analyze the impact of baseline posterior circulation Acute Stroke Prognosis Early Computed Tomography Score (pc-ASPECTS) on the efficacy and safety of endovascular therapy (EVT) for patients with acute basilar artery occlusion. Methods: The BASILAR was a nationwide prospective registry of consecutive patients with a symptomatic and radiologically confirmed acute basilar artery occlusion within 24 hours of symptom onset. We estimated the effect of standard medical therapy alone (SMT group) versus SMT plus EVT (EVT group) for patients with documented pc-ASPECTS on noncontrast CT, both as a categorical (0–4 versus 5–7 versus 8–10) and as a continuous variable. The primary outcomes included favorable functional outcomes (modified Rankin Scale ≤3) at 90 days and mortality within 90 days. Results: In total, 823 cases were included: 468 with pc-ASPECTS 8 to 10 (SMT: 71; EVT: 397), 317 with pc-ASPECTS 5 to 7 (SMT: 85; EVT: 232), and 38 with pc-ASPECTS 0 to 4 (SMT: 13; EVT: 25). EVT was associated with higher rate of favorable outcomes (adjusted relative risk with 95% CI, 4.35 [1.30–14.48] and 3.20 [1.68–6.09]; respectively) and lower mortality (60.8% versus 77.6%, P =0.005 and 35.0% versus 66.2%, P< 0.001; respectively) than SMT in the pc-ASPECTS 5 to 7 and 8 to 10 subgroups. Continuous benefit curves also showed the superior efficacy and safety of EVT over SMT in patients with pc-ASPECTS ≥5. Furthermore, the prognostic effect of onset to puncture time on favorable outcome with EVT was not significant after adjustment for pc-ASPECTS (adjusted odds ratio, 0.98 [95% CI, 0.94–1.02]). Conclusions: Patients of basilar artery occlusion with pc-ASPECTS ≥5 could benefit from EVT. The baseline pc-ASPECTS appears more important for decision making and predicting prognosis than time to EVT. REGISTRATION: URL: http://www.chictr.org.cn . Unique identifier: ChiCTR1800014759.
IMPORTANCEEndovascular therapy (EVT) has been reported to be safe and effective in improving clinical outcomes among patients with acute basilar artery occlusion (ABAO). The benefits associated with EVT remain uncertain for patients with ABAO with severe symptoms (ie, National Institutes of Health Stroke Scale [NIHSS] score Ն 21). OBJECTIVES To assess the outcomes associated with EVT and identify factors associated with outcomes among patients with ABAO and severe symptoms. DESIGN, SETTING, AND PARTICIPANTS This prospective, nationwide cohort study was conducted using data from January 2014 to May 2019 in China from the Endovascular Treatment for Acute Basilar Artery Occlusion Study Registry (BASILAR). Included patients had ABAO and underwent EVT or standard medical treatment (SMT) alone in routine clinical practice. Patients were dichotomized into severe symptoms (ie, NIHSS score Ն 21) and minor to moderate symptoms (NIHSS score < 21) groups. Patients were followed up for 90 days. Data were analyzed from December 2020 through June 2021.EXPOSURES EVT with SMT vs SMT alone. MAIN OUTCOMES AND MEASURES The primary outcome was improvement in modified RankinScale (mRS) score at 90 days, defined as a decrease by 1 grade in mRS score. Secondary outcomes included favorable functional outcome (ie, mRS score, 0-3) and mortality. RESULTS Among 542 patients with ABAO and severe symptoms (median [IQR] age,[65][66][67][68][69][70][71][72][73][74] years; 147 [27.1%] women), 431 patients (79.5%) received EVT and 111 patients (20.5%) received SMT.
BackgroundThe best anesthetic management strategy for patients with acute large vessel occlusion treated with mechanical thrombectomy (MT) remains uncertain. Most studies have focused on anterior–circulation stroke caused by large artery occlusion. Nevertheless, limited data are available on the appropriate choice of anesthetic for acute basilar artery occlusion (BAO). We aimed to investigate the effect of anesthetic method on clinical outcomes in patients with BAO undergoing MT.MethodsPatients undergoing MT for acute BAO in the BASILAR registry (Acute Basilar Artery Occlusion Study) were included. We divided patients into three groups according to the anesthetic technique used during MT: general anesthesia (GA), local anesthesia (LA), and conscious sedation (CS). Propensity score matching was performed to achieve baseline balance.Results639 patients were included. GA was used in 257 patients (40.2%), LA was used in 250 patients (39.1%), and CS was used in 132 patients (20.7%). After 1:1 matching, favorable outcome, mortality, and hemorrhagic transformation rates, as well as modified Rankin Scale (mRS) score at 90 days, did not differ between the GA, LA, and CS groups.ConclusionsThe choice of anesthetic strategy, GA, LA, or CS, did not affect the clinical outcomes of patients with acute BAO treated with MT in the BASILAR registry.
Background: To date, few data have been reported on clinical outcomes following interventions in elderly populations with acute basilar artery occlusion. Using data from the Endovascular Treatment for Acute Basilar Artery Occlusion Study (BASILAR), we evaluated the efficacy and safety of intervention and determined predictors of outcomes among elderly patients in China. Methods: Patients from January 2014 to May 2019 were dichotomized into elderly (75 years or older) and nonelderly patients (under 75 years). Pearson’s Chi-square test and multivariate logistic regression were performed to assess 90-day favorable functional outcome (defined as a modified Rankin scale score of 0–3), mortality and symptomatic intracranial hemorrhage between intervention and conservative cohorts in elderly patients. Results: Among the 829 patients in the BASILAR, 182 patients aged 75 years or older were analyzed. These patients were divided into intervention (127 patients) and conservative (55 patients) cohorts. Compared with the conservative cohort, the intervention cohort presented more frequently with a favorable functional outcome (28.3% versus 12.7%; p = 0.023) and with a decreased mortality (54.3% versus 76.4%; p = 0.005). There was no difference in symptomatic intracranial hemorrhage (4.7% versus 0, p = 0.235). Multivariate analysis indicated that intervention was associated with favorable functional outcome (adjusted odds ratio, 0.262; 95% confidence interval, 0.088–0.778, p = 0.016) and lower mortality (adjusted odds ratio, 0.257; 95% confidence interval, 0.109–0.606, p = 0.002). In the intervention cohort, initial National Institutes of Health Stroke Scale (NIHSS) score and occlusion site were associated with functional outcome, and initial NIHSS score and recanalization were associated with mortality. Conclusions: Although the overall outcome following intervention was worse with age, intervention was more effective and safer than conservative treatment for elderly Chinese patients with basilar artery occlusion. Predictors of desirable outcome in elderly patients undergoing intervention included lower initial NIHSS score, occlusion site and successful recanalization. Clinical Trial Registration-URL: http://www.chictr.org . Unique identifier: ChiCTR-1800014759
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