scholarly journals Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke

Stroke ◽  
2021 ◽  
Author(s):  
Jie Xu ◽  
Anxin Wang ◽  
Xia Meng ◽  
Gulbahram Yalkun ◽  
Anding Xu ◽  
...  

Background and Purpose: Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The present clinical trial aimed at testing the effects of edaravone dexborneol versus edaravone on 90-day functional outcome in patients with acute ischemic stroke (AIS). Methods: A multicenter, randomized, double-blind, comparative, phase III clinical trial was conducted at 48 hospitals in China between May 2015 and December 2016. Inclusion criteria included patients diagnosed as AIS, 35 to 80 years of age, National Institutes of Health Stroke Scale Score between 4 and 24, and within 48 hours of AIS onset. AIS patients were randomized in 1:1 ratio into 2 treatment arms: 14-day infusion of edaravone dexborneol or edaravone injection. The primary end point was the proportion of patients with modified Rankin Scale score ≤1 on day 90 after randomization. Results: One thousand one hundred sixty-five AIS patients were randomly allocated to the edaravone dexborneol group (n=585) or the edaravone group (n=580). The edaravone dexborneol group showed significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization, compared with the edaravone group (modified Rankin Scale score ≤1, 67.18% versus 58.97%; odds ratio, 1.42 [95% CI, 1.12–1.81]; P =0.004). The prespecified subgroup analyses indicated that a greater benefit was observed in female patients than their male counterparts (2.26, 1.49–3.43 versus 1.14, 0.85–1.52). Conclusions: When edaravone dexborneol versus edaravone was administered within 48 hours after AIS, 90-day good functional outcomes favored the edaravone dexborneol group, especially in female patients. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02430350.

Stroke ◽  
2021 ◽  
Vol 52 (1) ◽  
pp. 144-151
Author(s):  
Zuolu Liu ◽  
Nerses Sanossian ◽  
Sidney Starkman ◽  
Gilda Avila-Rinek ◽  
Marc Eckstein ◽  
...  

Background and Purpose: A survival advantage among individuals with higher body mass index (BMI) has been observed for diverse acute illnesses, including stroke, and termed the obesity paradox. However, prior ischemic stroke studies have generally tested only for linear rather than nonlinear relations between body mass and outcome, and few studies have investigated poststroke functional outcomes in addition to mortality. Methods: We analyzed consecutive patients with acute ischemic stroke enrolled in a 60-center acute treatment trial, the NIH FAST-MAG acute stroke trial. Outcomes at 3 months analyzed were (1) death; (2) disability or death (modified Rankin Scale score, 2–6); and (3) low stroke-related quality of life (Stroke Impact Scale<median). Relations with BMI were analyzed univariately and in multivariate models adjusting for 14 additional prognostic variables. Results: Among 1033 patients with acute ischemic stroke, average age was 71 years (±13), 45.1% female, National Institutes of Health Stroke Scale 10.6 (±8.3), and BMI 27.5 (±5.6). In both unadjusted and adjusted analysis, increasing BMI was linearly associated with improved 3-month survival ( P =0.01) odds ratios in adjusted analysis for mortality declined across the BMI categories of underweight (odds ratio, 1.7 [CI, 0.6–4.9]), normal (odds ratio, 1), overweight (0.9 [CI, 0.5–1.4]), obese (0.5, [CI, 0.3–1.0]), and severely obese (0.4 [CI, 0.2–0.9]). In unadjusted analysis, increasing BMI showed a U-shaped relation to poststroke disability or death (modified Rankin Scale score, 2–6), with odds ratios of modified Rankin Scale score, 2 to 6 for underweight, overweight, and obese declined initially when compared with normal weight patients, but then increased again in severely obese patients, suggesting a U-shaped or J-shaped relation. After adjustment, including for baseline National Institutes of Health Stroke Scale, modified Rankin Scale score 2 to 6 was no longer related to adiposity. Conclusions: Mortality and functional outcomes after acute ischemic stroke have disparate relations with patients’ adiposity. Higher BMI is linearly associated with increased survival; and BMI has a U-shaped or J-shaped relation to disability and stroke-related quality of life. Potential mechanisms including nutritional reserve aiding survival during recovery and greater frequency of atherosclerotic than thromboembolic infarcts in individuals with higher BMI.


Author(s):  
Ganesh Asaithambi ◽  
Amy L Castle ◽  
Emily H Marino ◽  
Bridget M Ho ◽  
Sandra K Hanson

Background: It has been suggested that there is a “weekend effect” resulting in higher mortality rates for stroke patients admitted on weekends. We examine this phenomenon for acute ischemic stroke (AIS) patients presenting to telestroke (TS) sites to determine its effect on stroke code process times and outcomes. Methods: From October 2015-June 2017, we reviewed consecutive AIS patients receiving IV alteplase within our TS network who then were transferred to our CSC. We compared patients presenting to TS sites on weekdays (Monday 0700 to Friday 1859) to patients presenting on weekends (Friday 1900 to Monday 0659). We analyzed door to code activation, code activation to TS evaluation, door to imaging, and door to needle times. Rates of favorable outcome (modified Rankin Scale score ≤2) and death at 90 days were compared. Results: We identified 89 (54 weekday, 35 weekend) patients (mean age 71.8±13.3 years, 47.2% women) during the study period. Median door to code activation (15 [5, 27] vs 8 [1, 17] mins, p=0.01) and door to needle (61 [49, 73] vs 47 [35, 59] mins, p=0.003) times were significantly longer for patients presenting on weekends compared to weekdays. There were no significant differences in median door to imaging (weekend 17 [7, 30] vs weekday 11 [6, 21], p=0.1) and code activation to TS evaluation (weekend 7 [6, 10] vs weekday 5 [4, 9], p=0.14) times. The rates of favorable outcome (weekend 50% vs weekday 66.7%, p=0.18) and death (weekend 8.3% vs weekday 4.8%, p=0.56) at 90 days were not significantly different. Conclusion: While there were no significant differences in outcomes, the “weekend effect” results in slower door to code activation and door to needle times. Efforts to improve methods in increasing efficiency of care on weekends should be considered.


2019 ◽  
Vol 10 (2) ◽  
pp. 115-117
Author(s):  
Ganesh Asaithambi ◽  
Amy L. Castle ◽  
Megan E. Tipps ◽  
Bridget M. Ho ◽  
Emily H. Marino ◽  
...  

A “weekend effect” resulting in higher mortality rates for patients with stroke admitted on weekends has been reported. We examine this phenomenon for patients with acute ischemic stroke (AIS) presenting to telestroke (TS) sites to determine its effect on stroke alert process times and outcomes. From October 2015 to June 2017, we reviewed patients with AIS receiving intravenous alteplase within our TS network. We compared patients presenting to TS sites on weekdays (Monday 07:00 to Friday 18:59) to those presenting on weekends (Friday 19:00 to Monday 06:59). We analyzed door-to-alert activation, alert activation-to-TS evaluation, door-to-imaging, and door-to-needle times. Rates of favorable outcome (modified Rankin Scale score ≤2) and death at 90 days were compared. We identified 89 (54 weekday and 35 weekend) patients (mean age: 71.8 ± 13.3 years, 47.2% women) during the study period. Median door-to-alert activation ( P = .01) and door-to-needle ( P = .004) times were significantly longer for patients presenting on weekends compared to weekdays. There were no significant differences in median door-to-imaging ( P = .1) and alert activation-to-TS evaluation ( P = .07) times. Rates of favorable outcome ( P = .19) and death ( P = .56) at 90 days did not differ. While there were no significant differences in outcomes, patients presenting on weekends had longer door-to-alert activation and door-to-needle times. Efforts to improve methods in efficiency of care on weekends should be considered.


Hypertension ◽  
2021 ◽  
Vol 78 (Suppl_1) ◽  
Author(s):  
Jie Xu ◽  
Yongjun Wang

Background and Aims: Evidenced by TASTE phase III trial, 90-day good functional outcomes favored the edaravone dexborneol group versus edaravone group when administered within 48 hours after Acute Ischemic Stroke (AIS). The present study aimed to investigate the effects of edaravone dexborneol versus edaravone in AIS patients with hypertension medical history. Methods: This study was a subgroup analysis of the TASTE trial with hypertension medical history. The primary outcome was the proportion of patients with modified Rankin Scale (mRS) score ≤1 on day 90 after randomization. The secondary outcome was the mRS score on day 90. The safety endpoints were the incidences of adverse events, serious adverse events and deaths. Analyses were by intention to treat. Results: We included 767 AIS patients with hypertension (390 in edaravone dexborneol group, 377 in edaravone group) in this analysis. Among them, 252 (64.62%) in edaravone dexborneol group versus 199 (52.79%) in edaravone group reached mRS score ≤1 on D90, revealing significantly higher proportion of mRS score ≤1 on D90 in edaravone dexborneol group (OR 1.63 [95% CI, 1.22-2.18]; P<0.001). Significant differences occurred between two groups in mRS score on D90 ([OR 1.32 [95% CI, 1.02-1.72]; P=0.038). The safety outcomes indicated that the two groups were similar in incidences of adverse events (366 [93.85%] versus 352 [93.37%], p=0.787), serious adverse events (48 [12.31%] versus 34 [9.02%], p=0.1405) and number of deaths (6 [1.54%] versus 4 [1.06%], p=0.56). Conclusion: This analysis demonstrated that AIS patients with hypertension receiving edaravone dexborneol had better functional outcomes than those with edaravone, which provided evidences for the clinical application of edaravone dexborneol in AIS patients with hypertension. Keywords: Edaravone dexborneol, Acute ischemic stroke, Hypertension, mRS score


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Jay Chol Choi ◽  
Man-Seok Park ◽  
Ji Sung Lee ◽  
Tai Hwan Park ◽  
Yong-Jin Cho ◽  
...  

Introduction: The utilization of drip-and-ship thrombolysis paradigm, clinical characteristics and outcomes of patients treated with the paradigm could vary with regional stroke care system. Hypothesis: We hypothesized that clinical characteristics and functional outcomes of patients treated with drip-and-ship paradigm would be different from those of patients treated via direct visit. Methods: From a multicenter stroke registry, we identified acute ischemic stroke patients treated with tPA who arrived hospital within 6 hours from the symptom onset. Functional outcomes at three months after the stroke were classified as favorable (modified Rankin Scale score [mRS] 0 to 1) or unfavorable (mRS 2-6). Using multivariable analysis, we compared the modified Rankin scale (mRS) score at 3 months and symptomatic intracranial hemorrhages (SICH) between patients treated with drip-and-ship paradigm and those treated via direct visit. Results: Among 1,843 patients who met the eligible criteria, 244 patients (13.2%; 95% CI, 11.7-14.9) were treated using drip-and-ship paradigm. Patients treated with drip-and-ship paradigm had shorter onset to needle time compared with patients treated via direct visit (median[IQR], 110 minutes[79-150] vs 126 minutes[90-173], p<0.001). After multivariable analysis, patients treated with drip-and-ship paradigm had significantly greater risk of unfavorable functional outcome (mRS 2-6) at 3 months after the stroke compared with patients treated via direct visit (OR 2.15; 95% CI, 1.50-3.08; p < 0.001). SICH also occurred more frequently in patients treated with drip-and-ship paradigm (OR 1.78; 95% CI, 1.02-3.12; p =0.04). Of 1,843 patients, 509 patients (27.6%, 71 patients with drip-and-ship paradigm and 438 patients via direct visit) received subsequent endovascular recanalization therapy. The use of drip-and-ship paradigm caused approximately 105 minute delay in onset to groin puncture time compared with those treated via direct visit (305 minutes[260-345] vs 200 minutes[155-245], p<0.001). Conclusions: Drip-and-ship thrombolysis paradigm was used in less than 15% of patients treated with tPA, and use of the paradigm caused a significant delay in onset to groin puncture time for endovascular therapy.


Neurology ◽  
2017 ◽  
Vol 89 (18) ◽  
pp. 1860-1868 ◽  
Author(s):  
Eva Zupanic ◽  
Mia von Euler ◽  
Ingemar Kåreholt ◽  
Beatriz Contreras Escamez ◽  
Johan Fastbom ◽  
...  

Objective:To compare access to intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) and its outcomes in patients with and without dementia.Methods:This was a longitudinal cohort study of the Swedish dementia and stroke registries. Patients with preexisting dementia who had AIS from 2010 to 2014 (n = 1,356) were compared with matched patients without dementia (n = 6,755). We examined access to thrombolysis and its outcomes at 3 months (death, residency, and modified Rankin Scale [mRS] score). Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated with logistic and ordinal logistic regression.Results:The median age at stroke onset was 83 years in both groups. IVT was administered to 94 (7.0%) patients with dementia and 639 (9.5%) patients without dementia. The OR of receiving IVT was 0.68 (95% CI 0.54–0.86) for patients with dementia. When the analysis was repeated exclusively among patients independent in everyday activities, dementia status was no longer significant (OR 0.79, 95% CI 0.60–1.06). However, differences persisted in patients ≤80 years of age (OR 0.58, 95% CI 0.36–0.94). In patients who received thrombolysis, the incidence of symptomatic intracerebral hemorrhage (sICH; 7.4% vs 7.3%) and death at 3 months (22.0% vs 18.8%) did not differ significantly between the 2 groups. However, mRS score and accommodation status were worse among patients with dementia after 3 months in adjusted analyses (both p < 0.001). Unfavorable outcomes with an mRS score of 5 to 6 were doubled in patients with dementia (56.1% vs 28.1%).Conclusions:Younger patients with dementia and AIS are less likely to receive IVT. Among patients receiving thrombolysis, there are no differences in sICH or death, although patients with dementia have worse accommodation and functional outcomes at 3 months.


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