Stroke, Volume 53, Issue Suppl_1, Page A40-A40, February 1, 2022. Background and Purpose:It remains controversial if endovascular treatment (EVT) can improve the outcome of patients with acute basilar artery occlusion (BAO). This study aims to compare the functional outcomes between EVT with and without intravenous thrombolysis (IVT) first in patients with acute ischemic stroke (AIS) caused by BAO.Methods:AIS patients with BAO who underwent EVT within 24 hours of onset were enrolled in this multicenter cohort study, and the efficacy and safety were compared between the IVT+EVT and direct EVT. The primary outcome was the 90-day functional independence (modified Rankin Scale of 0-2). All outcomes were assessed with adjusted odds ratio (aOR) from the multivariable logistic regression. In addition, a meta-analysis was performed on all recently published pivotal studies and incorporating these studies on functional independence after EVT in BAO patients.Results:Of 310 BAO patients enrolled, 241 (78%) were treated with direct EVT and 69 (22%) with IVT+EVT. Direct EVT was associated with a worse functional outcome (aOR, 0.46 [95% CI, 0.25-0.87]; P =0.02). IVT+EVT was associated with a lower percentage of patients who needed ≥ 3 passes of the stent retriever (10.14% vs 20.75%). The meta-analysis regression revealed a potential positive correlation between bridging with IVT first and functional independence (r, 0.14 [95% CI: 0.05-0.24]; P
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Abstract WMP5: Non-invasive Vagus Nerve Stimulation For The Acute Treatment Of Ischemic Or Hemorrhagic Stroke
Stroke, Volume 53, Issue Suppl_1, Page AWMP5-AWMP5, February 1, 2022. Background:This first-in-human randomized, blinded, sham-controlled, multicenter study assessed the safety and feasibility of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of ischemic and hemorrhagic stroke. Potential efficacy was also assessed.Methods:Eligible participants admitted to nine clinical sites received standard care for acute stroke and were randomly assigned to low-dose nVNS, sham (2-minute stimulation applied to the skin overlying the vagus nerve every 10 minutes for an hour; 7 stimulations) or high-dose nVNS (2-minute stimulation every 10 minutes during hour 1 and hour 5; 14 stimulations) within 6 hours of stroke onset. Safety endpoints included severe bradycardia (≤50 beats/min) or significant hypotension (≥20-mm Hg reduction in arterial blood pressure) evaluated at 2 and 5 minutes after each stimulation and 30 minutes after the final stimulation. Feasibility was measured as the proportion of eligible patients in whom nVNS could be initiated within 6 hours of stroke onset and the ability to deliver scheduled stimulations per protocol. Efficacy measurements included absolute and relative infarct growth 24 hours poststroke compared to baseline and the proportion of patients with an NIH Stroke Scale (NIHSS) score of ≤4 or a ≥8-point improvement at 24 hours.Results:Sixty-eight patients with ischemic (n=60) or hemorrhagic (n=8) stroke completed the study. Baseline characteristics did not differ between sham (n=24) and nVNS (n=44). No significant bradycardia (2.9% of sham vs 3.1% of nVNS;p=0.965) or hypotension (1.1% of sham vs 2.5% of nVNS;p=0.145) occurred with nVNS. No deaths, acute coronary syndrome, symptomatic intracerebral hemorrhage, or stimulation site reactions were noted. All patients received 100% of intended stimulations per protocol. Clinical efficacy measures were similar between sham and total nVNS. Relative infarct growth, measured by diffusion weighted imaging, in the high dose nVNS group (63.3%) was lower than in the sham group (185.8%;p=0.05).Conclusions:This study suggests that nVNS is safe and feasible for the acute treatment for ischemic and hemorrhagic stroke. Possible efficacy is suggested by a decrease in relative infarct growth.
Abstract TMP68: Underlying Intracranial Atherosclerosis Disease Is Associated With Worse Outcome In Acute Large Vessel Occlusion Undergoing Endovascular Therapy
Stroke, Volume 53, Issue Suppl_1, Page ATMP68-ATMP68, February 1, 2022. Introduction:Acute large vessel occlusion (LVO) can be secondary to thromboembolism or underlying intracranial atherosclerotic disease (ICAD). Data on the management of LVO due to underlying ICAD are scarce.Hypothesis:We hypothesized that patients with ICAD would have worse clinical outcomes following mechanical thrombectomy (MT) than those without ICAD.Methods:We performed a retrospective analysis of consecutive patients who underwent MT for LVO in a large academic comprehensive stroke center between 01/2018 and 05/2021. Presence of underlying ICAD at the site of LVO was determined by the treating interventionalist. We compared outcomes including in-hospital mortality and 90-day modified Rankin Scale (mRS) between those with and without underlying ICAD, adjusting for relevant covariates using logistic regression.Results:Among 195 patients (mean age 67.4+15.1 years, 56.9% female, 81% black, median NIHSS score 15), underlying ICAD was present in 39 (20.0%). Stent-retrievers were used 196 patients with only 3 having rescue stent placement. There were no significant differences in baseline factors amongst the two groups except diabetes was more common (69.2% vs. 49.7%, p=0.028) and intravenous thrombolysis provided less often (17.9% vs. 36.5%, p=0.027) in those with ICAD. TICI 2B or higher was achieved in 82.1% of ICAD compared with 94.3% of non-ICAD patients (p=0.012). Mortality was more common (50.0% vs. 30.8%, p=0.025) and good functional outcome (mRS 0-2) at 90 days was less common (10.8% vs. 30.0%, p=0.002) in the ICAD group. Adjusting for age, diabetes, intravenous thrombolysis, baseline NIHSS score, and final TICI score, underlying ICAD was an independent predictor of mRS 0-2 at 90 days (OR 4.5, 95% CI 1.4-14.2, p=0.010).Conclusion:Underlying ICAD is associated with 4.5-fold increase in poor functional outcome in patients with LVO undergoing traditional MT. Further research is needed to understand factors associated with poor outcomes investigate alternative interventional approaches and medical management in this high-risk population.
Abstract WP6: Recovery To Baseline Function In Patients With Acute Stroke And Pre-existing Disability: A Natural History Study
Stroke, Volume 53, Issue Suppl_1, Page AWP6-AWP6, February 1, 2022. Introduction:One in 3 strokes occur in patients with pre-stroke disability. This excludes many from acute treatment trials, but whether these patients benefit from aggressive treatment is unknown.Methods:A prospective stroke center registry (10/2019-04/2021) of consecutive adult patients with acute stroke was queried for patients with pre-stroke modified Rankin Scale (mRS) of 0-4. Multivariable logistic regression was used to estimate odds of full functional recovery (FFR) at 90 days (mRS 0-2 or return to pre-stroke mRS), comparing those with significant pre-stroke disability (mRS 3, 4) to those without (mRS 0-2).Results:Of 1228 patients, 1190 (97%) had pre-stroke mRS 0-4, with 856 (70%) included patients also having 90d follow-up mRS. The median age was 68y (IQR 59-78), with a median NIH Stroke Scale (NIHSS) of 5 (IQR 2-17). Compared to those with mRS 0-2 (n=722), patients with a pre-stroke mRS of 3 (n=96) or 4 (n=38) had more frequent comorbidities and were less likely to achieve FFR (Table). After multivariable adjustment, the odds of FFR was no less for patients with prestroke mRS of 3 (ORadj 1.37, 95%CI 0.80-2.34) or 4 (ORadj 0.59, 95%CI 0.25-1.39). In that model, FFR was less likely among the elderly (ORadj per year 0.96, 95%CI 0.95-0.97) and higher NIHSS (ORadj per point 0.89, 95%CI 0.88-0.91). Thrombolysis was strongly associated with FFR (ORadj 2.70, 95%CI 1.59-4.60).Conclusions:In this single center analysis, stroke recovery in the setting of pre-existing disability was driven by age and stroke severity. Thrombolysis remained predictive of FFR irrespective of age and stroke severity, but was underutilized in patients with pre-stroke disability.
Abstract WMP3: Hyperglycemic Control In Acute Ischemic Stroke Patients Undergoing Endovascular Treatment: Post-hoc Analysis Of Stroke Hyperglycemia Insulin Network Effort Trial
Stroke, Volume 53, Issue Suppl_1, Page AWMP3-AWMP3, February 1, 2022. Background and Purpose:Hyperglycemia has been associated with higher rates of death or disability in acute ischemic stroke patients undergoing endovascular treatment. However, it remains unclear whether intensive serum glucose reduction can reduce the rates of death or disability in patients undergoing endovascular treatment.Methods:We analyzed the effect of intensive (serum glucose
Abstract WP89: Evaluating Age, Sex, And Racial / Ethnic Representation In Acute Ischemic Stroke Trials, 2010-2020: A Systematic Review And Meta-Analysis
Stroke, Volume 53, Issue Suppl_1, Page AWP89-AWP89, February 1, 2022. Introduction:Enrollment of populations that bear the real-world burden of ischemic strokes is critical to development of generalizable and clinically relevant randomized clinical trials (RCTs). Despite well-recognized historical patterns of underrepresentation for women, older adults, and certain racial/ethnic minorities, major knowledge gaps remain regarding representation in modern trials. We aimed to determine representativeness by age, sex, and race/ethnicity of participants in acute ischemic stroke RCTs performed in the US or CanadaMethods:We conducted a systematic review and meta-analysis in accordance with PRISMA, and prospectively registered with PROSPERO (CRD42021247730). ClincalTrials.gov was searched for ischemic stroke RCTs with acute interventions (
Abstract WMP35: Assessment Of Spatial Neglect In Acute Stroke Patients: Results Of A Cross-country Pilot Study To Validate A Simplified Version Of The Catherine Bergego Scale
Stroke, Volume 53, Issue Suppl_1, Page AWMP35-AWMP35, February 1, 2022. Background:Spatial neglect (SN) is present in about 20% patients in acute stroke units. If left unidentified SN may obstruct rehabilitation. The 10-item Catherine Bergego Scale (CBS) is increasingly recommended for SN assessment and has excellent psychometric properties. However, a standardized assessment with the CBS takes around 30-40 minutes to complete, making it rather unrealistic for nurses and physicians to use in the fast pace of the stroke unit.Objectives:To test a revised protocol for the CBS to make its routine use feasible in acute stroke units. We will: a). Compare the time used to administer the original version of the CBS with the simplified version of the CBS (sCBS), b). evaluate the agreement between the results of the CBS and sCBS, c). establish the interrater agreement between two rates, R1+R2, when scoring the sCBS, and d). correlate the sCBS with stroke severity and disability.Methods:Out of 98 consecutive stroke patients from the stroke units in Kaunas and Reykjavik, 15 with right-sided SN were included within five days following stroke. A structured assessment with the CBS established the presence and severity of SN. Patients identified with SN using the original structured assessment underwent a replicated evaluation with a simplified version of the sCBS. Two raters assessed the participants with the sCBS while they were blinded to the other rater’s scores. Stroke severity was assessed with NIHSS and disability with smRS.Results:There was a positive correlation between the NIHSS and the severity of SN r(13) = .78, p = .001. and the smRS and SN r(13) = .72, p =.002. On average it took 42 minutes to assess patients with mild/moderate SN with the CBS versus 14 minutes with the sCBS. Patients with very severe SN took
Abstract WP93: An Internet Of Things Based Real Time Location System With Machine Learning For Coordination Of Acute Stroke Endovascular Intervention: A Proof-of-concept Study
Stroke, Volume 53, Issue Suppl_1, Page AWP93-AWP93, February 1, 2022. Introduction:The delivery of mechanical thrombectomy in acute stroke can be challenging because it requires coordination between patient travel and multiple stroke team members across different locations in the hospital. A Real Time Location System (RTLS) can facilitate a streamlined workflow by determining a patient’s location, but the required infrastructure can be costly to set up. We investigated the feasibility of a machine learning based RTLS using an Internet Of Things (IOT) device prototype to coordinate acute stroke endovascular intervention.Methods:In this proof-of-concept study, study investigators programmed an IOT device to collect WiFi signals from different hospital zones relevant to the mechanical thrombectomy workflow. Different machine learning (ML) algorithms were trained on location labelled training WiFi signals to predict location. The accuracies of the different ML algorithms to predict unlabeled testing WiFi signals collected on a separate day were measured, in percentages.Results:The training and testing datasets contained 1,179 and 293 samples respectively, with 2,516 and 2,618 unique WiFi signals detected in each dataset. The trained neural network, random forest, support vector machine, K-nearest neighbors, decision tree and ensemble classifiers achieved accuracies of 96.6%, 96.2%, 97.3%, 97.3%, 83.6% and 97.3% on the testing dataset respectively. Additionally, the neural network model produced estimates of uncertainty, which were significantly associated with the correctness of predictions based on logistic regression analysis (p < 0.001).Conclusions:An IOT based real time location system with machine learning can accurately predict locations within the hospital, demonstrating immense potential for the future applications of streamlining delivery of acute stroke endovascular intervention.
Abstract WP7: Critical Importance Of Enrollment Hours For Successful Recruitment In Acute Stroke Trials
Stroke, Volume 53, Issue Suppl_1, Page AWP7-AWP7, February 1, 2022. Introduction:Recruitment into hyperacute stroke trials is challenging but ultimately depends on on-call availability of treating investigators, study coordinators, and pharmacists. These data may not be considered in initial decision-making for site selection and estimates of site recruitment are frequently based upon registry data from sites that includes all clinical cases.Hypothesis:Site recruitment on a per month basis is associated with time open for enrollment.Methods:We surveyed all Multi-arm Optimization of Stroke (MOST) trial centers open for enrollment to determine which were open for trial recruitment during business hours during Monday through Friday only, business hours 7 days a week, extended hours beyond business hours, or 24 hours/7 days a week. We also surveyed about pharmacy availability. Descriptive statistics were used to compare the average monthly enrollment by survey responses.Results:Sites open for enrollment only during business hours, Monday through Friday recruited at a rate of 0.14 participants per month compared to 0.36 per month for sites that enroll 7 days a week (see graphic). Restriction of pharmacy availability to business hours Monday through Friday was associated with decreased recruitment rate as well.Conclusions:Ability to recruit trial participants 7 days a week should be the standard for site selection, successful acute stroke trial recruitment, and estimates of needed sites. Methods to increase financial support for hours outside of week-day business hours is a potential method to enhance recruitment into acute stroke trials.
Abstract TP95: Characterization And Comparison Of Hospitalization Outcomes Between Symptomatic And Asymptomatic Urinary Tract Infection In Acute Ischemic Stroke Patients
Stroke, Volume 53, Issue Suppl_1, Page ATP95-ATP95, February 1, 2022. Background:Urinary Tract Infection (UTI) has been associated with increased cost of care and poor outcomes in stroke patients. Guidelines from the Infectious Disease Society of America do not support treating asymptomatic UTI in the absence of objective markers of infection.Aims:Characterize demographics and hospitalization outcomes of symptomatic (sUTI) and asymptomatic (aUTI) in stroke patients compared to a control group without infectious complication.Method:This is a single center retrospective cohort study using the 2019 ischemic stroke database at the University of Kentucky. Cases were defined as patients with confirmed UTI on urine culture or urinalysis, and without other infections. Cases were subdivided into sUTI (subjectively endorsing UTI symptoms or objective vitals suggestive of infection) and aUTI group (reason for urine studies being encephalopathy or leukocytosis without fever). Controls were defined as patients without evidence of infection, and matched to the case group by age and sex. Demographics (age, sex, and stroke mechanism) were compared using Chi-squared analysis. Outcomes included length of stay (LOS), change in pre-hospital to discharge modified Rankin Scale (delta mRS), delta NIHSS (difference between admission and discharge NIHSS), and % change in NIHSS ((highest NIHSS -lowest NIHSS)/admission NIHSS)). Mean and standard deviation between the 3 groups were compared using ANOVA.Results:A total of 120 cases were identified as having UTI (sUTI = 35; aUTI = 85), with nearly all receiving antimicrobials. No difference in demographics was observed between sUTI and aUTI, except for stroke mechanism (p=0.007 for chi-squared comparison of TOAST classification). Both sUTI and aUTI had greater morbidity as defined by delta mRS compared to control (p=0.0066; p=0.0001 respectively), but not to each other (p=0.0625). Only sUTI resulted in longer LOS compared to control (p=0). No difference in delta or % change NIHSS was observed between the 3 groups.Conclusion:Both sUTI and aUTI were associated with poor outcome in mRS, which may suggest impaired stroke recovery. Withholding antibiotic treatment in aUTI, as suggested by IDSA guidelines, may lead to worse outcomes. Further study is needed to determine the impact of non-treatment.
Combined Approach to Eptifibatide and Thrombectomy in Acute Ischemic Stroke Because of Large Vessel Occlusion: A Matched-Control Analysis
Stroke, Ahead of Print. Background:In patients undergoing mechanical thrombectomy (MT), adjunctive antithrombotic might improve angiographic reperfusion, reduce the risk of distal emboli and reocclusion but possibly expose patients to a higher intracranial hemorrhage risk. This study evaluated the safety and efficacy of combined MT plus eptifibatide for acute ischemic stroke.Methods:This was a propensity-matched analysis of data from 2 prospective trials in Chinese populations: the ANGEL-ACT trial (Endovascular Treatment Key Technique and Emergency Workflow Improvement of Acute Ischemic Stroke) in 111 hospitals between November 2017 and March 2019, and the EPOCH trial (Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke) in 15 hospitals between April 2019 and March 2020. The primary efficacy outcome was good outcome (modified Rankin Scale score 0–2) at 3 months. Secondary efficacy outcomes included the distribution of 3-month modified Rankin Scale scores and poor outcome (modified Rankin Scale score 5–6) and successful recanalization. The safety outcomes included any intracranial hemorrhage, symptomatic intracranial hemorrhage, and 3-month mortality. Mixed-effects logistic regression models were used to account for within-hospital clustering in adjusted analyses.Results:Eighty-one combination arm EPOCH subjects were matched with 81 ANGEL-ACT noneptifibatide patients. Compared with the no eptifibatide group, the eptifibatide group had significantly higher rates of successful recanalization (91.3% versus 81.5%;P=0.043) and 3-month good outcomes (53.1% versus 33.3%;P=0.016). No significant difference was found in the remaining outcome measures between the 2 groups. All outcome measures of propensity score matching were consistent with mixed-effects logistic regression models in the total population.Conclusions:This matched-control study demonstrated that MT combined with eptifibatide did not raise major safety concerns and showed a trend of better efficacy outcomes compared with MT alone. Overall, eptifibatide shows potential as a periprocedural adjunctive antithrombotic therapy when combined with MT. Further randomized controlled trials of MT plus eptifibatide should be prioritized.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03844594 (EPOCH), NCT03370939 (ANGEL-ACT).
Acute Ischemic Stroke, Depressed Left Ventricular Ejection Fraction, and Sinus Rhythm: Prevalence and Practice Patterns
Stroke, Ahead of Print. Background:There are limited data about the epidemiology and secondary stroke prevention strategies used for patients with depressed left ventricular ejection fraction (LVEF) and sinus rhythm following an acute ischemic stroke (AIS). We sought to describe the prevalence of LVEF ≤40% and sinus rhythm among patients with AIS and antithrombotic treatment practice in a multi-center cohort from 2002 to 2018.Methods:This was a multi-center, retrospective cohort study comprised of patients with AIS hospitalized in the Greater Cincinnati Northern Kentucky Stroke Study and 4 academic, hospital-based cohorts in the United States. A 1-stage meta-analysis of proportions was undertaken to calculate a pooled prevalence. Univariate analyses and an adjusted multivariable logistic regression model were performed to identify demographic, clinical, and echocardiographic characteristics associated with being prescribed an anticoagulant upon AIS hospitalization discharge.Results:Among 14 338 patients with AIS with documented LVEF during the stroke hospitalization, the weighted pooled prevalence of LVEF ≤40% and sinus rhythm was 5.0% (95% CI, 4.1–6.0%;I2, 84.4%). Of 524 patients with no cardiac thrombus and no prior indication for anticoagulant who survived postdischarge, 200 (38%) were discharged on anticoagulant, 289 (55%) were discharged on antiplatelet therapy only, and 35 (7%) on neither. There was heterogeneity by site in the proportion discharged with an anticoagulant (22% to 45%,P8 (odds ratio, 2.0 [95% CI, 1.1–3.8]) were significant, independent predictors of being discharged with an anticoagulant in an adjusted analysis.Conclusions:Nearly 5% of patients with AIS have a depressed LVEF and are in sinus rhythm. There is significant variation in the clinical practice of antithrombotic therapy prescription by site and stroke severity. Given this clinical equipoise, further study is needed to define optimal antithrombotic treatment regimens for secondary stroke prevention in this patient population.
Inpatient Management of Acute Stroke of Unknown Type in Resource-Limited Settings
Stroke, Ahead of Print. Stroke is the second leading cause of death and disability worldwide, with a disproportionate burden on low- and middle-income countries. Critical elements of guideline-based stroke care developed in high-income countries are not applicable to resource-limited settings, where lack of access to neuroimaging prevents clinicians from distinguishing between ischemic stroke and intracranial hemorrhage, requiring challenging clinical decision-making, particularly in the acute setting. We discuss strategies for acute inpatient management of stroke of unknown type with a focus on blood pressure management and antiplatelet therapy when neuroimaging is unavailable, and review some of the challenges and strategies for successfully implementing stroke unit care in resource-limited health care settings.
Endogenous Deoxyribonuclease Activity and Cell-Free Deoxyribonucleic Acid in Acute Ischemic Stroke: A Cohort Study
Stroke, Ahead of Print. Background and Purpose:Cell-free DNA (cfDNA) and endogenous deoxyribonuclease activity are opposing mediators and might influence the inflammatory response following acute ischemic stroke. In this cohort study, we investigated the relation between these markers, circulating inflammatory mediators and clinical course including occurrence of stroke-associated infections (SAI) in patients with acute stroke.Methods:Ninety-two patients with stroke due to large vessel occlusion undergoing mechanical thrombectomy were prospectively recruited at Hannover Medical School from March 2018 to August 2019. Deoxyribonuclease activity, cfDNA, damage-associated molecular patterns, and circulating cytokines were measured in venous blood collected immediately before mechanical thrombectomy and 7 days later. Reperfusion status was categorized (sufficient/insufficient). Clinical outcome was evaluated using the modified Rankin Scale after 90 days, where a score of 3 to 6 was considered unfavorable. To validate findings regarding SAI, another stroke cohort (n=92) was considered with blood taken within 24 hours after stroke onset.Results:Patients with unfavorable clinical outcome had higher cfDNA concentrations. After adjustment for confounders (Essen Stroke Risk Score, National Institutes of Health Stroke Scale, and sex), 7-day cfDNA was independently associated with clinical outcome and especially mortality (adjusted odds ratio: 3.485 [95% CI, 1.001–12.134] and adjusted odds ratio: 9.585 [95% CI, 2.006–45.790]). No association was found between reperfusion status and cfDNA or deoxyribonuclease activity. While cfDNA concentrations correlated positively, deoxyribonuclease activity inversely correlated with distinct biomarkers. Baseline deoxyribonuclease activity was lower in patients who developed SAI compared with patients without SAI. This association was confirmed after adjustment for confounding factors (adjusted odds ratio: 0.447 [95% CI, 0.237–0.844]). In cohort 2, differences of deoxyribonuclease activity between patients with and without SAI tended to be higher with higher stroke severity.Conclusions:The interplay of endogenous deoxyribonuclease activity and cfDNA in acute stroke entails interesting novel diagnostic and potential therapeutic approaches. We confirm an independent association of cfDNA with a detrimental clinical course after stroke due to large vessel occlusion. This study provides first evidence for lower endogenous deoxyribonuclease activity as risk factor for SAI after severe stroke.
Clinical and Imaging Indicators of Hemorrhagic Transformation in Acute Ischemic Stroke After Endovascular Thrombectomy
Stroke, Ahead of Print. Background and Purpose:Prior studies have investigated the clinical and imaging factors for hemorrhagic transformation (HT), especially symptomatic intracranial hemorrhage (sICH); however, whether alteplase increases the risk of HT after endovascular thrombectomy (EVT) is unknown. This study aimed to assess clinical and imaging features associated with HT, sICH, and parenchymal hematoma (PH) in patients with acute ischemic stroke after EVT, with and without intravenous alteplase in DIRECT-MT (Direct Intraarterial Thrombectomy to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals: a Multicenter Randomized Clinical Trial).Methods:The DIRECT-MT trial is a randomized trial of EVT alone versus intravenous thrombolysis combined with EVT. HT, sICH, and PH was evaluated on follow-up computed tomography. Multivariable ordinal logistic regression analysis was used to test the association of stepwise selected determinants with HT, sICH, and PH.Results:In total, 633 patients were analyzed; 261 (41.2%) had HT; 34 (5.4%) had sICH; and 85 (13.4%) had PH. The median age was 69, and 56.7% were men. The median National Institutes of Health Stroke Scale score was 18, and 320 patients were in combination-therapy group. Symptomatic intracranial hemorrhage was associated with higher baseline National Institutes of Health Stroke Scale score (adjusted odds ratio [OR], 1.06 [95% CI, 1.10–1.12]) and higher glucose level at hospital arrival (adjusted OR, 1.14 [95% CI, 1.00–1.29]). No association was found between alteplase treatment and HT, sICH, or PH. The independent predictor of sICH was higher baseline National Institutes of Health Stroke Scale score (adjusted OR, 1.09 [95% CI, 1.01–1.18]) in EVT alone group, and history of anticoagulant drugs (adjusted OR, 3.75 [95% CI, 1.07–13.06]), higher glucose level at hospital arrival (adjusted OR, 1.19 [95% CI, 1.03–1.38]), >3 passes of device (adjusted OR, 4.42 [95% CI, 1.36–14.32]) in combination-therapy group.Conclusions:In DIRECT-MT, independent predictors of sICH were baseline National Institutes of Health Stroke Scale score and glucose level at hospital arrival. Alteplase treatment did not increase the risk of HT, sICH, or PH after EVT. The independent predictor of sICH was different in EVT alone group and combination-therapy group.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03469206.
Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial
Stroke, Ahead of Print. Background and Purpose:Seeking consent rapidly in acute stroke trials is crucial as interventions are time sensitive. We explored the association between consent pathways and time to enrollment in the TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) randomized controlled trial.Methods:Consent was provided by patients or by a relative or an independent doctor in incapacitated patients, using a 1-stage (full written consent) or 2-stage (initial brief consent followed by full written consent post-randomization) approach. The computed tomography-to-randomization time according to consent pathways was compared using the Kruskal-Wallis test. Multivariable logistic regression was performed to identify variables associated with onset-to-randomization time of ≤3 hours.Results:Of 2325 patients, 817 (35%) gave self-consent using 1-stage (557; 68%) or 2-stage consent (260; 32%). For 1507 (65%), consent was provided by a relative (1 stage, 996 [66%]; 2 stage, 323 [21%]) or a doctor (all 2-stage, 188 [12%]). One patient did not record prerandomization consent, with written consent obtained subsequently. The median (interquartile range) computed tomography-to-randomization time was 55 (38–93) minutes for doctor consent, 55 (37–95) minutes for 2-stage patient, 69 (43–110) minutes for 2-stage relative, 75 (48–124) minutes for 1-stage patient, and 90 (56–155) minutes for 1-stage relative consents (P