Abstract 60: Outcomes Following Sonothrombolysis in Severe Acute Ischemic Stroke

Background&Purpose: A recent meta-analysis showed that sonothrombolysis is safe and can double the rate of early recanalization in acute ischemic stroke (AIS). We sought to explore whether patients with severe strokes could clinically benefit from ultrasound amplification of tPA-induced recanalization. Subjects&Methods: We compared functional outcomes at 3 months among randomized AIS patients with pre-treatment NIHSS scores >=10 in the Combined Lysis of Thrombus in Brain Ischemia (CLOTBUST), Transcranial Ultrasound in Clinical Sonothrombolysis (TUCSON) and pilot randomized clinical safety study of sonothrombolysis with microspheres (Definity study). Patients had proximal arterial occlusions identified by baseline TCD and received intravenous (IV) tPA or IV tPA plus continuous 2-hour TCD ultrasound monitoring (=sonothrombolysis). Favorable outcome was defined as modified Rankin Scale (mRS) 0-1 at 3 months. Sustained complete recanalization was defined as Thrombolysis in Brain Ischemia (TIBI) flow grades 4-5 assessed by TCD at 2 hours after tPA bolus. Symptomatic intracranial hemorrhage (sICH) was defined using ECASS-2 definition as imaging evidence of ICH with clinical worsening (NIHSS >=4) within 72 hours from stroke onset. Results: A total of 139 AIS patients with severe stroke due to proximal arterial occlusions (mean age 69±13years, 56% men, median NIHSS 17, interquartile range 14-21, range 10-34) were randomized in CLOTBUST (n=105), TUCSON (n=21) and Definity (n=13). A total of 60 (43%) and 79 (57%) patients were randomized to IV tPA and sonothrombolysis, respectively. Patients treated with IV tPA and sonothrombolysis did not differ in terms of age, baseline stroke severity, baseline TIBI grades and onset-to-treatment time. Symptomatic ICH rates were similar in patients treated with IV tPA and sonothrombolysis (5.0% vs. 5.1%; p=0.987). More patients achieved sustained complete recanalization in the sonothrombolysis than in the IV tPA group (38.0% vs. 18.3%; p=0.012). Favorable outcome (mRS 0-1) tended to be more prevalent in the sonothrombolysis than in the IV tPA group (36.6% vs. 23.2%; p=0.104). Conclusions: Our data point to a signal-of-efficacy and provide basis to determine the sample size of a phase 3 randomized trial of sonothrombolysis in patients with severe strokes ( NCT01098981 ).

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Abstract 3275: Early Neurological Improvement After Intravenous Thrombolysis in Acute Stroke Predicts Long-Term Functional Outcome

Stroke ◽

10.1161/str.43.suppl_1.a3275 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Leonard L Yeo ◽

Liang Shen ◽

Ben Wakerley ◽

Aftab Ahmad ◽

Kay W Ng ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Functional Outcome ◽

Symptom Onset ◽

Functional Outcomes ◽

Treatment Time ◽

Favorable Outcome ◽

Stroke Patients ◽

Neurological Improvement ◽

Iv Tpa

Background: Intravenously administered tissue plasminogen activator (IV-TPA) remains the only approved therapeutic agent for arterial recanalization in acute ischemic stroke (AIS). Wide variations in the rates and timing of neurological recovery are observed in thrombolyzed patients. While all IV-TPA treated patients are routinely evaluated for neurological recovery at 24-hours, considerable improvement occurs in some cases within 2-hours of treatment initiation. We evaluated whether early neurological improvement at 2-hours after IV-TPA bolus (ENI-2) can predict functional outcomes in thrombolyzed AIS patients at 3-months. Methods: Data for consecutive stroke patients treated with IV-TPA within 4.5 hours of symptom-onset during 2007-2010 were prospectively entered in the thrombolyzed registry maintained at our tertiary care center. Data were collected for demographic characteristics, vascular risk factors, stroke subtypes and blood pressure levels before IV-TPA bolus. National Institute of Health Stroke Scale (NIHSS) scores were obtained before IV-TPA bolus and at 2-hours. ENI-2 was defined as a reduction in NIHSS score by more than 10-points from baseline score or an absolute score of 4-points or less at 2-hours after IV-TPA bolus. Functional outcomes at 3-months were determined by modified Rankin scale (mRS). Data were analyzed by SPSS 19.0. Results: Of the 2238 AIS patients admitted during the study period, 240 (11%) received IV-TPA within 4.5-hours of symptom-onset. Median age was 65yrs (range 19-92), 63% males, median NIHSS 17points (range 3-35) and median onset-to-treatment time 149 minutes. Overall, 122 (50.8%) patients achieved favorable functional outcome (mRS 0-1) at 3-months. Factors associated with favorable outcome at 3-months on univariable analysis were younger age, female gender, presence of atrial fibrillation, baseline NIHSS, onset-to-treatment time (OTT) and ENI-2. However, multivariable analysis demonstrated NIHSS at onset (OR per 1-point increase 0.907, 95%CI 0.848-0.969) and ENI-2 (OR 4.926 95%CI 1.66-15.15) as independent predictors of favorable outcome at 3-months. Conclusion: Early Neurological improvement at 2-hours after IV-TPA bolus is a strong predictor of the functional outcome at 3-months in acute ischemic stroke patients.

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Abstract 3290: Timing Of Recanalization After Intravenous Thrombolysis Determines The Functional Outcomes In Acute Ischemic Stroke

Stroke ◽

10.1161/str.43.suppl_1.a3290 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Leonard L Yeo ◽

Ben Wakerley ◽

Liang Shen ◽

Prakash R Paliwal ◽

Aftab Ahmad ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Symptom Onset ◽

Functional Outcomes ◽

Treatment Time ◽

Tertiary Care ◽

Favorable Outcome ◽

Arterial Recanalization ◽

Arterial Patency ◽

Iv Tpa

Background and Purpose: Intravenously administered tissue plasminogen activator (IV-TPA) is the only approved therapeutic agent for arterial recanalization in acute ischemic stroke (AIS). Wide variations in rates and timing of neurological recovery are observed in thrombolyzed patients. Although, recanalization of acutely occluded intracranial artery remains the major aim IV-TPA, timing and impact of this phenomenon on functional outcomes has not been evaluated properly. We evaluated the relationship between the arterial patency and timing of recanalization with functional outcomes at 3-months in AIS. Methods: Data for consecutive AIS patients treated with IV-TPA within 4.5 hours of symptom-onset during 2007-2010 were prospectively entered in the thrombolysis registry maintained at our tertiary care center. Data were collected for demographic characteristics, vascular risk factors, stroke subtypes and blood pressure before IV-TPA bolus. National Institute of Health Stroke Scale (NIHSS) scores were obtained before IV-TPA, at 2-hours and at 24-hours. Patients were continuously monitored with 2-MHz pulsed wave diagnostic transcranial Doppler (TCD) for 2-hours after IV-TPA bolus for early recanalization (ER). ER was assessed using the Thrombolysis in Brain Ischemia grading TCD system. Arterial patency was assessed on day 2 in patients who underwent CT angiography or magnetic resonance angiography, labeled as delayed recanalization (DR). Absence of recanalization on early TCD or imaging on day 2 was called persistent arterial occlusion (PAO). Favorable functional outcomes at 3 months were determined by modified Rankin scale (mRS) of 0-1. Results: Of the 2238 AIS patients admitted during the study period, 240 (11%) received IV-TPA within 4.5-hours of symptom-onset. Median age was 65yrs (range 19-92), 63% males, median NIHSS 17points (range 3-35) and median onset-to-treatment time 149 minutes. Overall, 122 (50.8%) patients achieved favorable functional outcome at 3-months. Information about ER, DR and PAO was available for 160 patients- ER in 55(34.4%), DR in 44(27.5%) and PAO in 61(38.1%) patients. Timing of recanalization was associated with favorable outcome (ER 72.7%, DR 63.6% and PAO 31.1%; p<0.005). Factors associated with favorable outcome at 3-months on univariable analysis were younger age, female gender, atrial fibrillation, baseline NIHSS, onset-to-treatment time and timing of recanalization. However, on multivariable analysis, NIHSS at onset (OR per 1-point increase 0.907, 95%CI 0.848-0.969), ER (OR 3.32, 95%CI 1.295-9.474) and DR (OR 3.021 95%CI 1.197-7.634) were found as independent predictors of favorable outcome at 3-months. Conclusions: Timing of arterial recanalization induced by IV-TPA in acute ischemic stroke is a strong predictor of favorable outcome at 3-months.

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Abstract TMP2: Is Eptifibatide a Viable and Safe Option as Stand-alone Therapy for Acute Ischemic Stroke Patients?

Stroke ◽

10.1161/str.47.suppl_1.tmp2 ◽

2016 ◽

Vol 47 (suppl_1) ◽

Author(s):

Daniel Korya ◽

Mohammad Moussavi ◽

Siddhart Mehta ◽

Jaskiran Brar ◽

Harina Chahal ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Time Window ◽

T Test ◽

Bleeding Complications ◽

Stroke Severity ◽

Paired Samples ◽

Group A ◽

Group B ◽

Iv Tpa

Introduction: The list of contraindications for IV tPA in acute ischemic stroke (AIS) is often too long and may lead to physicians opting to offer no treatment for certain strokes. An alternative treatment is proposed in cases where IV tPA is not an option due to time-window restrictions or contraindications. We compared the stroke severity, outcomes and safety of IV eptifibatide when compared with IV tPA. Methods: Patients who presented to a community based university affiliated comprehensive stroke center from 2012-15 with AIS over a two-year period were included in the study. Those who qualified for IV tPA, and were treated, were compared with patients who only received IV eptifibatide. The initial NIH Stroke Score (NIHSS), 24-hour NIHSS, discharge NIHSS (DCNIHSS), discharge mRS (DCmRS) and symptomatic ICH rates were compared with a paired samples t-test to determine significance of difference between the means. SPSS Version 22 was used for all data analysis. Results: A total of 864 patients presented with AIS in the evaluated time period and of those 166 met study criteria. There were 119 patients who received IV tPA alone (group A) and 47 patients received eptifibatide (group B). The mean initial NIHSS, 24-NIHSS, DCNIHSS, DCmRS and percent bleeding complications for group A were: 11.2, 10.8, 8.6, 3.1 and 6%. For group B the figures were: 6.7, 4.8, 4.3, 1.7 and 0%, respectively. Group A was compared with group B in a paired samples T-test and yielded -4.3, -6.2, -6, -1.5 (p=.0001 to .04) for initial, 24-hour, discharge NIHSS and discharge mRS, respectively. The difference between initial and discharge NIHSS between the two groups was -2.7 (p=.009), favoring IV tPA. Conclusion: In patients who are either outside the time-window or with contraindications to IV tPA, eptifibatide may be a safe alternative and appears to be efficacious. None of the patients who were started on eptifibatide had bleeding complications and they had a statistically significant improvement in their level of disability and stroke severity at discharge. A limitation of this study is that patients in group A had significantly worse initial NIHSS compared with group B. To better evaluate the efficacy of eptifibatide, a larger, prospective study should be initiated.

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Abstract 202: The NIH Stroke Scale Can Miss Improvement After IV tPA For Acute Ischemic Stroke

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.8.suppl_2.202 ◽

2015 ◽

Vol 8 (suppl_2) ◽

Author(s):

Elisabeth B Marsh ◽

Erin Lawrence ◽

Rafael H Llinas

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Post Treatment ◽

Functional Improvement ◽

Stroke Severity ◽

Post Discharge ◽

Significant Difference ◽

The Mean ◽

Iv Tpa

Background and Objective: The National Institute of Health Stroke Scale (NIHSS) is the most commonly used metric to evaluate stroke severity and improvement following intervention. Despite its advantages as a rapid, reproducible screening tool, it may be too insensitive to adequately capture functional improvement following treatment. We evaluated the difference in rate of improvement by previously accepted criteria (change of ≥4 NIHSS points) versus physician documentation in patients receiving IV tissue plasminogen activator (tPA) for acute ischemic stroke. Methods: Prospectively collected data on all patients receiving IV tPA over a 15 month period were retrospectively reviewed. NIHSS 24 hours post-treatment and on discharge were extrapolated based on examination and compared to NIHSS on presentation. NIHSS scores at post-discharge follow-up were also recorded. Two reviewers evaluated the medical record and determined improvement based on physician documentation. Using tests of proportion, ‘significant improvement’ by NIHSS was compared to physician documentation at each time point. Results: Forty-one patients were treated with IV tPA. The mean admission NIHSS was 8.6 and improved to 6.4 24 hours post-tPA. Twenty-nine of 41 patients (79%) were “better” by documentation; however only 11/41 (27%) met NIHSS criteria for improvement (p compared to documentation <0.001). On discharge, 20/41 patients (49%) met NIHSS criteria for improvement; however a significant difference between physician documentation remained (p=0.04). The mean post-discharge follow-up NIHSS score was 2.0. 20/21 patients (95%) were “better” compared to 16/21 (76%) meeting NIHSS criteria (p=0.08). Conclusion: The NIHSS may inadequately capture functional improvement post-treatment, especially in the days immediately following intervention.

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Abstract 159: Current Treatment with Clotting Factors Does not Improve Outcome from Intracranial Hemorrhage After Thrombolysis for Acute Ischemic Stroke

Stroke ◽

10.1161/str.43.suppl_1.a159 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Yazan J Alderazi ◽

Niravkumar V Barot ◽

Vivek Misra ◽

James C Grotta ◽

Sean I Savitz

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Intracranial Hemorrhage ◽

Conservative Management ◽

Small Sample ◽

Stroke Severity ◽

Clotting Factors ◽

Prognostic Variables ◽

Before And After ◽

Iv Tpa

Objective & Background: Significant intracranial hemorrhage (sigICH), defined as either symptomatic intracerebral hemorrhage SICH or parenchymal hematoma type 2 (PH2), is a concerning complication of thrombolysis for acute ischemic stroke (AIS). While clotting factors have been incorporated into clinical protocols, the effectiveness of such treatment for sigICH has not been evaluated. We investigated the effects of clotting factors, fresh frozen plasma FFP and cryoprecipitate, in patients with sigICH post thrombolysis. Methods: We retrospectively evaluated all patients with sigICH after TPA for AIS in the prospective University of Texas at Houston Stroke registry; January 2007 - July 2011. We included all patients who received TPA for AIS and subsequently developed sigICH. Patients either received clotting factors (FFP or cryoprecipitate) or conservative management. The primary outcome measure was modified Rankin scale at discharge. The other outcome was death. We collected data on confounding variables: Stroke risk factors, infarct prognostic variables and intracerebral hematoma prognostic variables. Statistical analysis was by Fisher-exact, Chi-square and Mann-Whitney-U tests. Results: Out of 921 patients receiving TPA, sigICH occurred in 50. We excluded 3 because of enrollment in clinical trials. Out of 47 patients, 37 received IV TPA alone and 10 received IV TPA with subsequent intra-arterial therapy. Clotting factors were given in 22/47 (46.8%) patients; 18 received FFP & 9 received cryoprecipitate. The rest received no specific therapies for hemorrhage. There was no difference in stroke severity between groups before and after TPA. The incidence of hydrocephalus was higher in patients receiving clotting factors. There were no differences in outcomes at discharge in either group; the majority of patients in both groups had poor outcomes (mRS was >3). Mortality was high and not different between the two groups. Fibrinogen levels before and after clotting factors did not significantly differ from the patients who received only conservative management. Table 1. Conclusions: We found that clinical outcome of sigICH post TPA is poor. Furthermore, our data suggest that clotting factors do not improve the poor outcome associated with sigICH after t-PA. Our study is limited by small sample size, and the higher incidence of hydrocephalus in those receiving clotting factors may have influenced the outcomes. Nevertheless, our data suggest that new therapies are urgently needed for t-PA associated intracranial hemorrhage.

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Abstract NS7: Presenting Symptoms and Response to Dysphagia Screen Predict Unfavorable Outcome in Acute Ischemic Stroke Patients Who Do Not Receive IV tPA Due to Mild and Rapidly Improving Stroke Symptoms

Stroke ◽

10.1161/str.46.suppl_1.ns7 ◽

2015 ◽

Vol 46 (suppl_1) ◽

Author(s):

Deborah Camp ◽

Katja Bryant ◽

Susan Zimmermann ◽

Cynthia. Brasher ◽

Kerrin M Connelly ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Time Window ◽

Unfavorable Outcome ◽

Favorable Outcome ◽

Nihss Score ◽

Factors Associated ◽

Presenting Symptoms ◽

Lower Likelihood ◽

Iv Tpa

Background & Purpose: Studies have shown that patients who do not receive IV t-PA due to mild and rapidly improving stroke symptoms (MaRISS) are often not discharged home. The purpose of this study was to identify whether presenting symptoms and response to initial dysphagia screen can predict which patients not treated with IV tPA due to MaRISS have an unfavorable outcome. Methods: Acute ischemic stroke (AIS) patients presenting to hospitals participating in the Georgia Coverdell Acute Stroke Registry and not treated with IV t-PA due to MaRISS alone from January 1, 2009 through December 31, 2013 were included in this analysis. Patients who were unable to ambulate or needed assistance to ambulate prior to admission were excluded. Presenting symptoms and response to dysphagia screen were collected from retrospective chart review at participating hospitals. Multivariable regression analysis was used to identify factors associated with a lower likelihood of favorable outcome, defined as discharge to home. During the study period, < 1% of patients presenting to participating hospitals with MaRISS within the 3 hour time window received IV t-PA. Results: Of 841 AIS patients who did not receive IV-tPA due to MaRISS [median NIHSS 1 (Q1-Q3: 0-3)], 160 (19%) did not have a favorable outcome. Factors associated with lower likelihood of a favorable outcome included increasing NIHSS score (per unit OR 0.89, 95% CI 0.84 to 0.93), weakness as the presenting symptom (OR 0.50, 95% CI 0.30 to 0.84), and a failed dysphagia screen (OR 0.43, 95% CI 0.23 to 0.80). Conclusion: Nearly 1 in 5 AIS patients presenting with MaRISS were not discharged to home. Among AIS patients who present with MaRISS and do not receive IV thrombolytic therapy, baseline characteristics including increasing NIHSS score and weakness as a presenting symptom, and a failed dysphagia screen were all associated with a lower likelihood of discharge to home. Given the low rate of patients presenting during the study period, a prospective randomized trial to evaluate IV t-PA treatment focusing on this subgroup of patients is warranted.

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Embolus Retriever with Interlinked Cages versus other stent retrievers in acute ischemic stroke: an observational comparative study

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-013838 ◽

2018 ◽

Vol 10 (12) ◽

pp. e31-e31 ◽

Cited By ~ 6

Author(s):

Philipp Gruber ◽

Salome Zeller ◽

Carlos Garcia-Esperon ◽

Jatta Berberat ◽

Javier Anon ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Multiple Logistic Regression Analysis ◽

Case Series ◽

Favorable Outcome ◽

Stroke Severity ◽

Anterior Circulation ◽

Vessel Occlusion ◽

Stent Retrievers ◽

Favorable Clinical Outcome

Background and purposeGiven the promising performance of the new Embolus Retriever with Interlinked Cages (ERIC) in smaller case series, we sought to assess the efficacy and safety of mechanical thrombectomy (MT) with ERIC compared with other stent retrievers (SRs) in acute ischemic stroke due to large vessel occlusion (LVO).MethodsWe reviewed the databases of two comprehensive stroke centers in in Germany and Switzerland for MT due to LVO in the anterior circulation with either ERIC or another SR as a first device. Co-primary outcome was defined as successful recanalization (Thrombolysis in Cerebral Infarction 2b/3) after the first device and favorable outcome (modified Rankin Scale score 0–2) at 90 days' follow-up. Multiple logistic regression analysis was applied to adjust for potential confounders.Results183 consecutive patients with stroke were treated with either ERIC (49%) or a SR (51%) as the first device and successful recanalization was seen in 82% and 57%, respectively (P<0.001). Adding SR to futile ERIC recanalization or vice versa increased final recanalization rates (ERIC: 87%, SR: 79%). The use of ERIC as a first device resulted in favorable clinical outcome in 50% compared with 35% when a SR was used (P=0.038), an effect driven by age, stroke severity, presence of carotid-T-occlusion, and general anesthesia and not by the device deployed.ConclusionThe use of ERIC as a first device appeared to be associated with higher rates of successful recanalization and resulted in better functional outcome. However, favorable outcome was not attributable to ERIC. Most importantly, both device types complemented one another and improved final recanalization rates when used successively.

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Abstract P208: Racial Differences in Stroke Severity and Outcomes in Female Acute Ischemic Stroke Patients

Circulation ◽

10.1161/circ.127.suppl_12.ap208 ◽

2013 ◽

Vol 127 (suppl_12) ◽

Author(s):

Amelia K Boehme ◽

James E Siegler ◽

Karen C Albright ◽

Dominique J Monlezun ◽

Erica M Jones ◽

...

Keyword(s):

Ischemic Stroke ◽

Black Women ◽

Acute Ischemic Stroke ◽

Racial Differences ◽

White Women ◽

Lower Percentage ◽

Stroke Severity ◽

Discharge Disposition ◽

Significant Difference ◽

Iv Tpa

Background: Previous research has indicated that women and Blacks have worse outcomes following acute ischemic stroke (AIS). Little research has been done to investigate the influence of race in the presentation and outcome specifically among women with AIS. Methods: AIS patients presenting to two centers in the Stroke Belt (2004-2011) were identified by prospective registries. Men, women who did not identify as Black or White, and in-hospital strokes were excluded. Patient demographics, clinical characteristics, admission National Institutes of Health Stroke Scale (NIHSS) scores, favorable discharge disposition (home or inpatient rehab), time from last seen normal to ED arrival, and functional discharge outcome as measured by the modified Rankin Scale (mRS) were investigated. Patients were divided into 3 groups: (1) not treated with IV t-PA, (2) treated with IV t-PA within 3 hours of symptom onset, and (3) treated with IV t-PA beyond 3 hours. Results: Of the 8763 patients screened, 2217 women met the study criteria (59% White). White women were older (72 vs. 64; p<0.0001), had higher percentage of atrial fibrillation (24% vs. 11%; p<0.0001), lower percentage of diabetes (30% vs. 40%, p<0.0001), lower percentage of hypertension (73% vs. 84%; p<0.0001) and had a higher baseline NIHSS (9 vs. 7; p=0.0045) Administration of tPA was significantly less among Black women (36% Whites vs. 27% Blacks, p<0.0001). White women are at increased odds of receiving tPA treatment (OR=1.43, 95%CI 1.17-1.75, p=0.0005), and remain at increased odds after adjusting for age, baseline NIHSS, time from last seen normal and glucose (OR 1.42, 95% CI 1.11-1.81, p=00044). Despite the significant difference in treatment with IV tPA, White women had increased odds of having a poor functional outcome (OR=1.2, 95% CI 1.02-1.439,p=0.0250) and unfavorable discharge disposition (OR 1.4, 95% CI 1.18-1.67, p=0.0001), but stratifying by tPA treatment groups, race was not found to be predictive of outcome after adjusting for known confounders (i.e., age, glucose, baseline NIHSS, time from last seen normal). Discussion: Unlike data from previous studies, Black women who presented to these two centers with AIS had less severe neurologic deficits on presentation compared to their White counterparts. Despite differences in the proportion of Blacks and Whites treated with IV tPA, race was not significantly associated with outcome. In our study, age and stroke severity_not race_were the primary predictors for poor outcome.

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Abstract 158: Persisting Arterial Occlusion And Risk Of Symptomatic Intracranial Hemorrhage In Systemic Thrombolysis: A Pooled Analysis Of Randomized Sonothrombolysis Studies

Stroke ◽

10.1161/str.43.suppl_1.a158 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Georgios Tsivgoulis ◽

Kristian Barlinn ◽

Maher Saqqur ◽

Robert Mikulik ◽

Andrew M Demchuk ◽

...

Keyword(s):

Intracranial Hemorrhage ◽

Treatment Time ◽

Arterial Occlusion ◽

Pooled Analysis ◽

Transcranial Ultrasound ◽

Stroke Severity ◽

Clinical Safety ◽

Exact Test ◽

Systemic Thrombolysis ◽

Symptomatic Intracranial Hemorrhage

Background & Purpose: Recent observational data showed that delayed (>6 hours) recanalization in acute ischemic stroke (AIS) patients treated with systemic thrombolysis may be associated with a higher risk of symptomatic intracranial hemorrhage (sICH). We sought to investigate the relationship of persisting occlusion during the first two hours of iv-tPA and the likelihood of sICH using pooled data from three randomized sonothrombolysis studies. Subjects & Methods: We evaluated the risk of sICH among AIS patients randomized in the Combined Lysis of Thrombus in Brain Ischemia (CLOTBUST), Transcranial Ultrasound in Clinical Sonothrombolysis (TUCSON) and a pilot randomized clinical safety study of sonothrombolysis augmentation with ultrasound-activated perflutren-lipid microspheres (Definity study). Acute proximal arterial occlusions were identified in all patients at baseline using Trancranial Doppler (TCD). Patients underwent continuous or intermitted TCD-monitoring for a two-hour period following tPA-bolus. Persisting occlusion was defined as absence of improvement of baseline TIBI flow grade at the end of TCD-monitoring. sICH was defined using ECASS-2 definition as imaging evidence of ICH with clinical worsening (NIHSS≥4) within 72 hours from stroke onset. Results: A total of 176 AIS patients (mean age 68±14years, 57% men, median baseline NIHSS-score 16 points, interquartile range 11-20) were randomized in CLOTBUST (n=126), DEFINITY (n=15) and TUCSON (n=35). A total of 75 (43%) and 101 (57%) individuals were randomized to systemic thrombolysis and sonothrombolysis respectively. Persisting occlusion was identified at the end of TCD-monitoring in 65 patients (37%). Patients with persisting occlusion tended to have higher sICH rates compared to individuals with partial or complete recanalization (9.2% vs. 2.7%; p=0.078 by Fisher’s exact test). After adjusting for demographic characteristics, onset-to-treatment time, baseline stroke severity, baseline TIBI flow grade and treatment (sonothrombolysis vs. systemic thrombolysis) persisting occlusion was independently associated with a higher likelihood of sICH (OR:6.29, 95%CI:1.28-30.85; p=0.024). Conclusions: Failure to recanalize during the first two hours following tPA-bolus appears to increase sICH risk among AIS treated with standard systemic thrombolysis and sonothrombolysis. Possible mechanisms (elevated blood pressure with persistent occlusion and late, potentially harmful recanalization causing reperfusion injury to infracted brain tissue) are now subject of a prospective multicenter study (CLOTBUST-PRO).

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Abstract T P3: Safety of Eptifibatide after Full Dose IV tPA and Endovascular Treatment for Ischemic Stroke

Stroke ◽

10.1161/str.46.suppl_1.tp3 ◽

2015 ◽

Vol 46 (suppl_1) ◽

Author(s):

Jawad F Kirmani ◽

Daniel Korya ◽

Grace Choi ◽

Jaskiran Brar ◽

Harina Chahal ◽

...

Keyword(s):

Ischemic Stroke ◽

Endovascular Treatment ◽

Favorable Outcome ◽

Stroke Severity ◽

Categorical Data Analysis ◽

Exact Test ◽

Full Dose ◽

Comprehensive Stroke Center ◽

Stroke Center ◽

Iv Tpa

Background and Objective: The safety of eptifibatide in combination with IV tPA for ischemic stroke has recently been demonstrated in the CLEAR-ER trial which used .6 mg/kg IV tPA plus eptifibatide (135 mcg/kg bolus and .75mcg/kg/min two-hour infusion) versus standard tPA (.9 mg/kg). Prior studies have also looked into the combination of intra-arterial (IA) tPA and eptifibatide at dosing and duration similar to cardiology literature. Our aim was to compare the safety and efficacy of eptifibatide after full dose IV tPA and endovascular treatment versus full dose IV tPA and endovascular treatment alone. Materials and Methods: We reviewed the records and procedure reports of patients who underwent endovascular treatment for ischemic stroke from 2010-2013 at a university affiliated comprehensive stroke center. Patients who received full dose IV tPA (.9 mg/kg) followed by endovascular treatment were compared with those who had the same treatment, but also received a bolus of 135 mcg/kg of eptifibatide followed by a .5 mcg/kg/min for 20 hours (based on IMPACT-II trial protocol). The initial and discharge NIH Stroke Scale as well as the discharge mRS (DCmRS) were evaluated. A DCmRS of 0 or 1 was considered a favorable outcome, and 2 or more was considered as a unfavorable. Initial stroke severity (NIHSS) was analyzed with logistic regression for baseline comparison and Fisher’s exact test were used for categorical data analysis. Results: We evaluated 2,016 patients with ischemic stroke, of which 230 received IV tPA and 91 (55% female) underwent endovascular treatment, 44 of them also received eptifibatide. Of the 44 patients who received eptifibatide (bolus and 20 hour infusion), 18% (n=8) had a favorable outcome, and in the group that did not receive eptifibatide , 9% (n=4) had a favorable outcome (OR=2.389, 95% CI 0.6645 to 8.589, p= 0.2217). Conclusion: Eptifibatide in combination with full dose IV tPA and endovascular treatment did not increase morbidity in our patient population, and may have improved outcome. Further, larger trials need to be conducted for more definitive results.

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