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

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Daniel Korya ◽  
Mohammad Moussavi ◽  
Siddhart Mehta ◽  
Jaskiran Brar ◽  
Harina Chahal ◽  
...  

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.

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Janhavi M Modak ◽  
Syed Daniyal Asad ◽  
Jussie Lima ◽  
Amre Nouh ◽  
Ilene Staff ◽  
...  

Introduction: Acute ischemic stroke treatment has undergone a paradigm shift, with patients being treated in the extended time window (6-24 hours post symptom onset). The purpose of this study is to assess outcomes in stroke patients above 80 years of age undergoing endovascular treatment (EVT) in the extended time window. Methods: Acute ischemic stroke patients presenting to Hartford Hospital between January 2017 to June 2019 were considered for the study. Stroke outcomes in patients above 80 years of age with anterior circulation ischemic strokes presenting in the extended time window (Group A, n=30) were compared to a younger cohort of patients below 80 years (Group B, n=31). Patients over 80 years treated in the traditional time window (within 6 hours of symptom onset) served as a second set of controls (Group C, n=40). Statistical analysis was performed with a significance level of 0.05 Results: For angiographic results, there were no statistically significant differences in terms of good outcomes (TICI 2b-3) among patients of Group A, when compared to Groups B or C (p>0.05). For the endovascular procedures, no significant differences were noted in the total fluoroscopy time (Median Group A 44.05, Group B 38.1, Group C 35.25 min), total intra-procedure time (Median Group A 144, Group B 143, Group C 126 min) or total radiation exposure (Median Group A 8308, Group B 8960, Group C 8318 uGy-m 2 ). For stroke outcomes, a good clinical outcome was defined as modified Rankin score of 0-2 at discharge. Significantly better outcomes were noted in the younger patients in Group B - 35.4%, when compared to 13.3% in Group A (p=0.03). Comparative outcomes differed in the elderly patients above 80 years, Group A -13.3% vs Group C - 25%, although not statistically significant (p=0.23). There was a significant difference in mortality in patients of Group A - 40% as compared to 12% in the younger cohort, Group B (p= 0.01). Conclusions: In the extended time window, patients above 80 years of age were noted to have a higher mortality, morbidity compared to the younger cohort of patients. No significant differences were noted in the stroke outcomes in patients above 80 years of age when comparing the traditional and the extended time window for stroke treatment.


Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Javaad Ahmad ◽  
Mohammed Hussain ◽  
Siddhart Mehta ◽  
Jaskiran Brar ◽  
Harina Chahal ◽  
...  

Background and Objective: It is considered unconventional to initiate antiplatelet regimen within 24 hours of IV tPa administration in acute ischemic strokes. There has been an increasing amount of literature assessing combination therapy of IV r- tPA and IV Eptifibatide in acute ischemic stroke. Our objectives were to evaluate the safety (hemorrhagic complications) and efficacy (discharge mRS) of administering IV Eptifibatide within the first 24 hours of receiving full dose IV r-tPA respectively. Materials and Methods: All patients that presented to our university affiliated stroke center from 2010-13 with an acute ischemic stroke were included and retrospectively classified into two groups. Group A underwent full dose IV r- tPa (.9 mg/kg) (+/- Endovascular intervention). Group B underwent full dose IV r-tPa (.9mg/kg) and IV Eptifibatide (+/- Endovascular intervention). Epitafibide was administered as a bolus of 135 mcg/kg IV followed by .5 mcg/kg/min for 20 hours. The primary endpoint of bleeding is classified as major (symptomatic intracranial hemorrhage or hemoglobin decrease by >5 mg/dl), minor (asymptomatic intracranial hemorrhage or hemoglobin decrease by 3-5 mg/dl) and insignificant as proposed by TIMI score. The efficacy endpoint was discharge mRS of 0-1 as favorable, with 2 and above being unfavorable. Results: We reviewed 2,016 patients with ischemic stroke, of which 170 received IV tPA. Among the group, 118 received IV r-tPa alone and 52 received combined modalities of IV r-tPa and IV Eptifibatide. In group A, there were 7 patients who had a major complication of symptomatic intracranial hemorrhage, while 1 patient had a minor complication of asymptomatic intracranial hemorrhage. In group B, there were 3 patients who had major complication of symptomatic intracranial hemorrhage and 5 with minor complications of asymptomatic intracranial hemorrhage. In group A , 9% (n=4) had a favorable outcome (OR=2.389, 95% CI 0.6645 to 8.589, p= 0.2217). Of the 52 patients in group B, 18% (n=8) had a favorable outcome. Conclusion: IV Eptifibatide, within the first 24 hours of ischemic stroke in combination with full dose IV r-tPA was found to be safe and efficacious. Further, larger prospective trials are needed to corroborate our findings.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Zhen Jing ◽  
Hao Li ◽  
Shengming Huang ◽  
Min Guan ◽  
Yongxin Li ◽  
...  

AbstractEndovascular treatment (EVT) has been accepted as the standard of care for patients with acute ischemic stroke. The aim of the present study was to compare clinical outcomes of patients who received EVT within and beyond 6 h from symptom onset to groin puncture without perfusion software in Guangdong district, China. Between March 2017 and May 2018, acute ischemic stroke patients who received EVT from 6 comprehensive stroke centers, were enrolled into the registry study. In this subgroup study, we included all patients who had acute proximal large vessel occlusion in the anterior circulation. The demographic, clinical and neuroimaging data were collected from each center. A total of 192 patients were included in this subgroup study. They were divided into two groups: group A (n = 125), within 6 h; group B (n = 67), 6–24 h from symptom onset to groin puncture. There were no substantial differences between these two groups in terms of 90 days favorable outcome (modified Rankin scale [mRS] ≤ 2, P = 0.051) and mortality (P = 0.083), and the risk of symptomatic intracranial hemorrhage at 24 h (P = 0.425). The NIHSS (median 16, IQR12-20, group A; median 12, IQR8-18, group B; P = 0.009) and ASPECTS (median 10, IQR8-10, group A; median 9, IQR8-10, group B; P = 0.034) at baseline were higher in group A. The anesthesia method (general anesthesia, 21.3%, group A vs. 1.5% group B, P = 0.001) were also statistically different between the two groups. The NIHSS and ASPECTS were higher, and general anesthesia was also more widely used in group A. Clinical outcomes were not significantly different within 6 h versus 6–24 h from symptom onset to groin puncture in this real world study.


Author(s):  
Elisabeth B Marsh ◽  
Erin Lawrence ◽  
Rafael H Llinas

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.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Yazan J Alderazi ◽  
Niravkumar V Barot ◽  
Vivek Misra ◽  
James C Grotta ◽  
Sean I Savitz

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.


Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Deborah Camp ◽  
Katja Bryant ◽  
Susan Zimmermann ◽  
Cynthia. Brasher ◽  
Kerrin M Connelly ◽  
...  

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.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Michelle Provencher ◽  
Ashley Scherman ◽  
Elizabeth Baraban ◽  
Robert Jackson ◽  
Tamela L Stuchiner ◽  
...  

Previous studies have shown that faster Door to Needle (DTN) treatment times are associated with better outcomes for acute ischemic stroke patients. With the continued push for faster times, we aimed to determine if DTN treatment times in the 30- vs 45-minute time window yielded statistically significant differences in outcomes or complications. Data obtained from a multi-state stroke registry included acute ischemic stroke patients ≥18 years of age discharged between January 2017 and April 2020, and treated with IV alteplase with DTN times between 25-30 or 40-45 minutes. Outcomes were 90-day Modified Rankin Score (mRS) (0-2 vs 3-6), discharge disposition [home or inpatient rehabilitation facility (IRF) vs other location], complications (any treatment-related complication vs none), and hospital length of stay (LOS). Patients with a documented reason for delay or who received thrombectomy were excluded. Outcomes of patients with 25- to 30-minute DTN times were compared to those with 40- to 45-minute DTN times using generalized linear models and multiple linear regression, adjusting for admission NIHSS, age, gender, race/ethnicity, and medical history. Compared to the 20-25 minute group, patients treated in the 40-45 minute window had higher odds of a documented 90-day mRS of 3 or more (Adjusted Odds Ratio (AOR)=1.19, p=0.253, n=201 ) and treatment-related complication (AOR=1.35, p=0.569) and lower odds of discharge to home or IRF (AOR=0.846, p=0.359). There was little difference in LOS (β=-0.008, p=0.847). None of the outcomes reached statistical significance. Administering alteplase in the 25- to 30-minute window is safe and did not result in an increase in bleeding complications. Although faster treatment times trended toward better outcomes, there was no statistically significant difference between the 25-30 and 40-45 minute DTN treatment times.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Ashish Kulhari ◽  
Daniel Ro ◽  
Amrinder Singh ◽  
Farah Fourcand ◽  
Gurneel Kaur Dhanesar ◽  
...  

Background: Multiple recent positive endovascular trials have proven mechanical thrombectomy as standard of care for large vessel occlusion (LVO) of the Anterior Circulation (AC). Post-thrombectomy subarachnoid hemorrhage (PT-SAH) is a known complication of this procedure. The aim of this study was to compare the incidence of SAH in proximal (ICA terminus and MCA M1) versus distal (MCA M2 and beyond) LVOs with use of stentrievers. Methods: Retrospective analysis of patients who underwent anterior circulation acute ischemic stroke interventions (AISI) at a community based, university affiliated comprehensive stroke center during a 5 year period (2014-2019) was done. AISI using stentrievers were separated in 2 groups based on location of LVO (Proximal and Distal). Post procedure CT heads were reviewed for SAH in location of stent deployment. Results: 2980 patients presented with acute ischemic stroke during the pre-specified time period. Of those, 2,682 were anterior circulation strokes. Of those, 373 received AISI. Stentrievers were used in 193 patients. Proximal occlusions (ICA terminus and MCA M1) were placed into Group A (n=150). Distal occlusions (MCA M2 and beyond) were placed into Group B (n=43). Group A had 6% SAH (n=9); Group B had 16% SAH (n=7) (p value <0.05). Conclusion: This study reveals an increased incidence of PT-SAH for distal LVOs. Main limitation of the study is the small sample size. Next generation stentrievers with smaller stent size and different design may decrease incidence of PT-SAH. Larger prospective RCTs are warranted to validate these results.


Circulation ◽  
2013 ◽  
Vol 127 (suppl_12) ◽  
Author(s):  
Amelia K Boehme ◽  
James E Siegler ◽  
Karen C Albright ◽  
Dominique J Monlezun ◽  
Erica M Jones ◽  
...  

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.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Kristian Barlinn ◽  
Georgios Tsivgoulis ◽  
Andrew D Barreto ◽  
Robert Mikulik ◽  
Maher Saqqur ◽  
...  

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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