Abstract W P3: Clinical Outcomes and Safety of Endovascular Therapy for IV tpa Ineligible Patients Who Present Within the IV tpa Time Window

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Amin Aghaebrahim ◽  
Srikant Rangaraju ◽  
Christopher Streib ◽  
Ramesh Grandhi ◽  
Michael Reznik ◽  
...  

Background and Purpose: Outcomes in patients treated with endovascular therapy who present within the time window for IV tPA, but do not receive IV tPA, are poorly characterized. This information may be necessary in the planning of randomized trials. Methods: A retrospective analysis of a prospectively collected endovascular stroke database was performed to identify all patients who arrived within the time window for IV tPA (≤4.5 hours) who had significant neurologic deficits, but were not treated with IV tPA due to contraindications. Procedural, safety and clinical outcomes were assessed by determining rates of recanalization, hemorrhagic transformation and 90-day independent outcome (mRS 0-2). Results: Out of 961 patients entered in our endovascular stroke database, we identified 163 {mean age 69±1 years; median baseline NIH Stroke Scale 17 IQR 14-21; occlusion site: MCA-M1 82 (50%); MCA-M2 18 (11 %), ICA-T 33 (20 %), Basilar artery 15 (9 %), ACA-A1 2 (1%), ICA-intracranial 8 (5%)}. The main contraindications to IV tPA were elevated INR or PTT (25%), recent surgeries (34%), previous intracerebral hemorrhage (4%), recent stroke (7%), recent bleeding (5%) and others (25%). Following endovascular treatment, the symptomatic hemorrhage (sICH) rate was 11% and recanalization rates (TICI 2b or 3) was 74.7% (56/75). The rate of good functional outcomes at 90 days (mRS 0-2) was 40% (59/149). The 90-day mortality rate was 34.2% (51/149). There was no significant difference for 90-day good outcome, mortality or sICH with respect to the specific contraindication for IV tPA, but there was trend toward worse outcome and higher mortality rate for patients with elevated INR or PTT compared to other groups (good outcome: 29% vs. 38%, p=0.32, mortality rate: 44% vs. 33%, p=0.24) . Conclusion: This dataset provides an estimate of outcomes obtained with intra-arterial therapy in IV tPA ineligible patients over a 12 year period and may serve as preliminary data that can be used for sample size estimation in planned randomized trials. Our outcomes are comparable to patients treated with IV tPA in the IMS III trial and are superior to the natural history of this disease.

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Alejandro Magadan ◽  
Marie Luby ◽  
Steven Warach

Introduction: Because IV tPA treatment initiated within 4.5 hours is the only acute stroke therapy of proven clinical efficacy, this population offers the greatest validity for determining imaging markers that optimally would differentiate clinical outcomes in treated vs. placebo patients in later time-window clinical trials. The Perfusion Diffusion Mismatch (PDM) approximates the ischemic penumbra, but there is no consensus on the optimal definition or threshold to be used in trials. We assessed the relationship of mismatch size to clinical outcome of an IV tPA treated sample compared with an untreated cohort. Methods: We selected patients from the NINDS Lesion Evolution of Stroke and Ischemia On Neuroimaging (LESION) database who met the following criteria: 1) treated with standard IV tPA 2) received multimodal MRI pre-treatment including diffusion (DWI) and perfusion imaging (PWI), 3) had interpretable MRI imaging showing 4) non-lacunar infarcts or lesions less than 100 ml volumes on DWI and 5) follow-up modified Rankin Score (mRS). We also selected 23 acute stroke patients who did not receive treatment but otherwise met the same criteria. Volumes were measured from the DWI and Mean Transit Time (MTT) images. PDM was defined as either a volume (MTT-DWI) or a percentage (MTT-DWI/MTT). Good outcome was defined as mRS of 0-1. Logistic regression was performed to predict good outcome with covariates of age, initial NIHSS, PDM size, tPA treatment, and tPA treatment by PDM size interaction. Result: Ninety-six patients were treated with IV tPA, 23 patients had no treatment. The figures , showing the unadjusted proportions of patients achieving good outcome as a function of minimum PDM size, suggest greater separation of treated and untreated patients at larger PDM sizes. For percentage PDM a significant interaction of tPA treatment by PDM size was observed at ≥ 80% (p=0.029), indicating that the benefit of tPA treatment is greater for PDM ≥ 80%. For volume PDM, the interaction of tPA treatment by PDM size trended positive at ≥ 50 ml (p=0.058). Conclusion: Greater differences in clinical outcomes with IV tPA versus untreated patients were evident with PDM ≥ 80% or ≥ 50 ml. These minimums of PDM size suggest an optimal target for thrombolytic trials.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Amrou Sarraj ◽  
Navdeep Sangha ◽  
Muhammad Shazam Hussain ◽  
Dolora Wisco ◽  
Nirav Vora ◽  
...  

Introduction: Five RCTs demonstrated the superiority of endovascular therapy (EVT) over best medical management (MM) for acute ischemic strokes (AIS) with large vessel occlusion (LVO) in the anterior circulation. Patients with M2 occlusions, however, were underrepresented (95 randomized; 51 EVT treated). Evidence from RCTs of the benefit of EVT for M2 occlusions is lacking, as reflected in the recent AHA guidelines. Methods: A retrospective cohort was pooled from 10 academic centers from 1/12 to 4/15 of AIS patients with LVO isolated to M2 presenting within 8 hours from last known normal (LKN). Patients were divided into EVT and MM groups. Primary outcome was 90 day mRS (good outcome 0-2); secondary outcome was sICH. Logistic regression compared the 2 groups. Univariate and multivariate analyses evaluated predictors of good outcome in the EVT group. Results: Figure 1 shows participating centers, 522 patients (288 EVT and 234 MM) were identified. Table (1) shows baseline characteristics. MM treated patients were older and had higher IV tPA treatment rates, otherwise the 2 groups were balanced. 62.7 % EVT patients had mRS 0-2 at 90 days compared to 35.4 % MM (figure 2). EVT patients had 3 times the odds of good outcome as compared to MM patients (OR: 3.1, 95% CI:2.1-4.4, P <0.001) even after adjustment for age, NIHSS, ASPECTS, IV tPA and LKN to door time (OR: 3.2, 95%CI: 2-5.2, P<0.001). sICH rate was 5.6 %, which was not statistically different than the MM group (table 1, P=0.1). Age, NIHSS, good ASPECTS, LKN to reperfusion time and successful reperfusion mTICI ≥ 2b were independent predictors of good outcome in EVT patients. There was a linear relationship between good outcome and time LKN to reperfusion (Figure 3). Conclusion: Despite inherent limitations of its retrospective design, our study suggests that EVT may be effective and safe for distal LVO (M2) relative to best MM. A trial randomizing M2 occlusions to EVT vs. MM is warranted to confirm these findings.


Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Kenichi Todo ◽  
Nobuyuki Sakai ◽  
Tomoyuki Kono ◽  
Taku Hoshi ◽  
Hirotoshi Imamura ◽  
...  

Background and purpose: The outcome after endovascular therapy in acute ischemic stroke is associated with onset-to-reperfusion time (ORT). The Totaled Health Risks in Vascular Events (THRIVE) score is also an important pre-thrapeutic predictor of outcome. We hypothesized that the therapeutic time window is narrower in patients with the higher THRIVE score. Methods: We retrospectively studied consecutive 109 ischemic stroke patients with successful reperfusion after endovascular therapy between October 2005 and March 2014 at a single institute (Kobe City Medical Center General Hospital). Inclusion criteria was as follows: National Institutes of Health Stroke Scale (NIHSS) score ≥8, stroke symptom duration ≤8 h, premorbid modified Rankin Scale (mRS) score ≤2, and thrombolysis myocardial infarction score 2-3. We analyzed the relationships of ORT, THRIVE score, and THRIVE+ORT score with good outcome (mRS ≤2 at 3 months). The THRIVE+ORT score was defined as the sum of the THRIVE score and ORT (h). Results: Median ORT was 5.5 h (IQR; 4.4-7.1 h), median THRIVE score was 5 (IQR; 4-6), and median THRIVE+ORT score was 10.8 (IQR; 9.2-12.5). Good outcome rates for patients with ORT ≤4 h, >4 and ≤6 h, >6 and ≤8 h, and >8h were 50.0%, 45.8%, 37.0%, and 21.4%, respectively (p=0.3), those with THRIVE score ≤3, >3 and ≤5, >5 and ≤7, and >7 were 57.1%, 51.4%, 28.3%, and 20.0%, respectively (p9 and ≤11, >11 and ≤13, and >13 were 64.0%, 44.1%, 34.4%, and 16.7%, respectively (p<0.05). Multivariate logistic regression analysis revealed that THRIVE+ORT score was an independent predictor of good outcome after adjusted for THRIVE score (odds ratio [OR], 1.367; 95% confidence interval [CI], 1.082-1.728) or after adjusted for ORT (OR, 1.517: 95% CI, 1.160-1.983). Conclusion: Our study showed that THRIVE+ORT score was associated with outcome that was independent from THRIVE score or ORT. This is the first report to suggest that patients with the higher THRIVE score require the shorter ORT for good outcome.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Tomohide Yoshie ◽  
Toshihiro Ueda ◽  
Tatsuro Takada ◽  
Shinji Nogoshi ◽  
Satoshi Takaishi ◽  
...  

Introduction: Previous studies suggested that low cerebral blood volume (CBV) lesion predicts hemorrhagic transformation after endovascular therapy. Hypothesis: We assessed the hypothesis that delays in time to reperfusion lead to hemorrhagic transformation on T2*-weighted MRI after endovascular therapy in patients with low CBV obtained from pre-treatment CT perfusion (CTP). Methods: We retrospectively analyzed 62 consecutive patients with acute ischemic stroke who were obtained successful reperfusion (TICI 2A-3) by endovascular thrombectomy for internal carotid artery or M1 occlusion. CTP maps were assessed for relative CBV (rCBV) values obtained separately for cortical and basal ganglia regions in the MCA territory. The presence of cortical and basal ganglia hemorrhage (either HI or PH) was assessed on T2*-weighted MRI after endovascular therapy. We analyzed the influence of rCBV in each region, CTP-to-reperfusion time and degree of reperfusion on cortical and basal ganglia hemorrhage. Results: Forty patients developed hemorrhagic transformation. HIs occurred in 16, PH1s in 21, PH2s in 3 and symptomatic hemorrhage in 1 of the patients. rCBV of the cortical region (0.77 versus 0.98, P=0.002) and basal ganglia region (0.64 versus 0.88, P<0.001) were significantly lower in the patients with hemorrhage than in those without. There was no significant difference in CTP-to-reperfusion time between cortical hemorrhage and no cortical hemorrhage groups. However, in the patients with low cortical rCBV (rCBV <0.8) and TICI ≥2b, mean CTP-to-reperfusion time was significantly shorter (70 versus 108 minutes, p=0.021) in the non-cortical hemorrhage group. There was no significant difference in CTP-to-reperfusion time between basal ganglia hemorrhage and non-basal ganglia hemorrhage groups. Conclusions: Early reperfusion decreases risk of cortical hemorrhage in patients with low cortical rCBV. Low rCBV in basal ganglia region is more predictive of basal ganglia hemorrhage than time to reperfusion.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Alex Abou-Chebl ◽  
Michael D Hill ◽  
Bernard Yan ◽  
Kevin Cockroft ◽  
Pooja Khatri ◽  
...  

Objectives: Use of general anesthesia (GA) during endovascular therapy (ET) of AIS patients is controversial with some suggestion of worse outcomes and death. The IMS III trial permitted the study of the effect of GA in a prospectively collected data set to test two hypotheses: (1) intubation is associated with poorer outcomes and (2) there is no increase in the risk of SAH or sICH with local anesthesia (LA). Methods: IMS III was a randomized trial of IV tPA +/- ET in patients presenting within 3hrs of AIS onset. In addition to demographic and outcomes data (mRS, ICH, etc.), information was collected on GA use or not within 7hrs of stroke onset. A good outcome was defined as mRS≤2 at 90 days. A multivariable analysis adjusting for dichotomized NIHSS (8-19 vs. ≥20), age and time from onset to groin puncture was performed. Additional analyses of reasons for intubation are ongoing and will be part of the presentation. Results: Four-hundred-thirty-four patients were randomized to ET, 269(62%) with LA and 147(33.9%) with GA. They were evenly matched in demographics, medical comorbidities, time to tPA, time to groin puncture, 40minute post IV tPA bolus SBP and occlusion location/side. The baseline NIHSS were slightly lower in the LA group (median 16 vs. 18). The GA group was less likely to achieve a good outcome (RR 0.64, CI 0.49-0.84, p=0.001) and had a greater risk of in-hospital death (RR 3.11, CI 1.86-5.20, p<0.0001). There was an increased risk of SAH in the GA group (RR 1.79, CI 1.04-3.08, p=0.0364) but no statistically significant difference in sICH (RR 1.69, CI 0.79-3.61, p=0.18). The multivariable analysis confirmed the negative association between GA and good outcomes (RR 0.68, CI 0.52-0.90, p=0.0027). Conclusions: In the IMS III trial there was an association with worse neurological outcomes and increased mortality with ET under GA. Also, there was an association between GA and an increased risk of SAH. Although the reasons for these associations are not clear, these data support the use of LA when possible during ET.


2020 ◽  
Vol 64 (7) ◽  
Author(s):  
Dokyun Kim ◽  
Eun-Jeong Yoon ◽  
Jun Sung Hong ◽  
Hyukmin Lee ◽  
Kyeong Seob Shin ◽  
...  

ABSTRACT This study was performed to evaluate the impacts of vanA positivity of Enterococcus faecium exhibiting diverse susceptibility phenotypes to glycopeptides on clinical outcomes in patients with a bloodstream infection (BSI) through a prospective, multicenter, observational study. A total of 509 patients with E. faecium BSI from eight sentinel hospitals in South Korea during a 2-year period were enrolled in this study. Risk factors of the hosts and causative E. faecium isolates were assessed to determine associations with the 30-day mortality of E. faecium BSI patients via multivariable logistic regression analyses. The vanA gene was detected in 35.2% (179/509) of E. faecium isolates; 131 E. faecium isolates exhibited typical VanA phenotypes (group vanA-VanA), while the remaining 48 E. faecium isolates exhibited atypical phenotypes (group vanA-atypical), which included VanD (n = 43) and vancomycin-variable phenotypes (n = 5). A multivariable logistic regression indicated that vanA positivity of causative pathogens was independently associated with the increased 30-day mortality rate in the patients with E. faecium BSI; however, there was no significant difference in survival rates between the patients of the vanA-VanA and vanA-atypical groups (log rank test, P = 0.904). A high 30-day mortality rate was observed in patients with vanA-positive E. faecium BSIs, and vanA positivity of causative E. faecium isolates was an independent risk factor for early mortality irrespective of the susceptibility phenotypes to glycopeptides; thus, intensified antimicrobial stewardship is needed to improve the clinical outcomes of patients with vanA-positive E. faecium BSI.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Sameer Sharma ◽  
Umair Afzal ◽  
Mubashir Pervez ◽  
Rochele Clark ◽  
Julius G Latorre ◽  
...  

Introduction: Minor acute stroke (NIHSS≤4) within 4.5 hours from symptom onset is a common reason for withholding intravenous (iv) Thrombolysis (TPA), due to potential risk of major bleeding with such treatment and assumed good outcome without intervention. This subgroup of patients was excluded from the landmark NINDS iv tPA trial as per the prespecified protocol and also from various recent clinical trials involving acute stroke. In a recent study of patients with Rapid Improving symptoms and Minor stroke who did not receive IV tPA, 28.3% could not be discharged home and 28.5% could not ambulate independently at the time of discharge (Smith et al 2011). The efficacy of iv TPA in Minor stroke has not been previously studied. Method: Retrospective review of consecutive patients with Minor stroke (NIHSS ≤4) arriving within 4.5 hours between January 2009-July 2013 was done. Outcome in patients who received IV TPA was compared with patients who did not receive any IV tPA. Good outcome was defined as mRS ≤2. Results: 186 patients were identified out of which 20 received iv tPA. The baseline median NIHSS was 2 in the non-intervention group vs 3 in the intervention group (p =0.001), more cardioembolic, cryptogenic and lacunar stroke in tPA group (40% vs 35.53%, 20% vs 14.46% and 30% vs 22.89% respectively) there was no other statistically significant difference between the baseline characteristics of the two groups. Median change in NIHSS from admission to discharge was 1 for non-tPA vs 2.5 for tPA(p<0.001) and good outcome at discharge was seen in 80% patients in tPA vs 69.28% in non-tpa group (p =0.321). 8-12 week follow up data was available for 100 patients (12 tPA patients). Mean mRS was 1.34 in non-tPA vs 1 in tPA group (p=0.430) Conclusion: Acute intervention in Minor stroke appears to be safe. We did not find any statistically significant difference in clinical outcome between the two groups; this is likely due to small sample size, short follow-up period, and other confounding factors that we cannot fully account for in a retrospective study. A prospective randomized control study is warranted to clearly delineate the effect of iv TPA in patients with Minor stroke.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Srikant Rangaraju ◽  
Amin Aghaebrahim ◽  
Christopher Streib ◽  
Ashutosh P Jadhav ◽  
Tudor G Jovin

Introduction: Successful recanalization independently predicts good outcome following endovascular therapy for acute large vessel occlusions. Thrombolysis In Cerebral Infarction (TICI) status 2B (near-complete revascularization) and 3 (complete revascularization) are routinely combined to reflect successful recanalization. Whether outcomes in these two groups are truly comparable, has not been demonstrated. Methods: In a retrospective analysis of a prospectively collected patient cohort at our center (2008-2013), we identified adults with intracranial internal carotid and middle cerebral artery M1 occlusions who underwent endovascular therapy within 8 hours from symptom onset, achieved operator-measured TICI2B or TICI3 status and had a documented 90 day modified Rankin Score (mRS). Baseline characteristics (age, NIHSS score, time to groin puncture, ASPECTS, risk factors), final infarct volume, rate of good outcome (mRS 0-2), intracranial hemorrhage and mortality were assessed. Results: 99 patients (TICI2B:N=64, TICI 3:N=35, Median NIHSS 16, median ASPECTS 9) were included. No differences in baseline characteristics were identified (Figure A). Patients with TICI3 status had smaller final infarct volume (6.2cc vs. 22.5cc, p=0.007, Figure B), higher rate of good outcome (74.3% vs 45.3%, p=0.006), lower mortality (5.7% vs. 28.1%, p=0.008, Figure C) and similar hemorrhage rates (p=0.2) as compared to TICI2B. After controlling for age, NIHSS and ASPECTS, TICI3 status independently predicted good outcomes (OR 4.74 95%CI 1.53-14.67, p=0.007). Conclusions: Patients with TICI3 recanalization have smaller infarct volumes and better clinical outcomes as compared to TICI2B. With the improving efficiency of mechanical thrombectomy, future thrombectomy stroke trials should report TICI2B and TICI3 status separately.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Wenjun Deng ◽  
Bo Song ◽  
Sherry H-Y Chou ◽  
Lindsay Fisher ◽  
Maxwell Oyer ◽  
...  

Background: IV tissue plasminogen activator (tPA) is an efficacious treatment of acute ischemic stroke. However, the utilization of tPA has been deterred by its hemorrhagic complications. Our previous exploratory study found that following tPA administration, ischemic stroke patients with hemorrhagic transformation (HT) had a significantly longer prothrombin time (PT) than those without HT. Here we aim to study the effect of post-tPA parenchymal hemorrhage on a wide range of coagulation labs in a lager cohort of patients. Method: 308 consecutive ischemic stroke patients with IV tPA were recruited in accordance with IRB approval. Clinical coagulation profiles were analyzed at 6, 12, 24, 36, 48 and 72 hr post IV tPA. Patients on anticoagulants or having other conditions (e.g. liver and kidney dysfunctions) that may affect these labs were excluded. Result: As determined by head CT scan, 16 patients (5.19%) developed post-tPA hemorrhage. Compared to patients without tPA related hemorrhage, patients with hemorrhage had significantly higher levels of PT within the first 24 hr post tPA (Figure 1A), and PT levels at 6 hr have the potential to predict subsequent hemorrhage (Figure 1C, AUC = 0.753, p = 0.003). Moreover, D-Dimer remained at high levels even after 48 hr (Figure 1B), suggesting sustained fibrinolysis abnormality or possibly indicating active bleeding. D-Dimer levels at 24 and 48 hr were also predictive of tPA-induced bleed (Figure 1D, AUC = 0.827, p = 0.007). Conclusion: Our results suggest PT and D-Dimer as early markers of tPA-induced hemorrhage in ischemic stroke patients. Their differential predictive ability at different time points may offer the possibility to monitor the clinical efficacy of tPA over a longer time window to guide adjunct treatment. Studies in additional coagulation factors in an expanded patient cohort are ongoing.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Anat Horev ◽  
David G Romero ◽  
Brian T Jankowitz ◽  
Amin Aghaebrahim ◽  
Cynthia L Kenmuir ◽  
...  

Background: The hyperdense MCA sign (HMCAS) is related to poor clinical outcomes and low recanalization rates after IV TPA. We explored the association between presence of HMCAS and clinical /procedural outcomes in patients with M1 MCA occlusion treated at our institution with endovascular therapy within the last five years. Methods: We retrospectively collected from our mechanical thrombectomy database a total of 193 patients with M1 occlusion, of which 107 patients were found to have HMCAS (55%). Eligible patients were treated with IV TPA prior to the intra-arterial thrombectomy. A blinded stroke neurologist evaluated baseline head CT done for possible HMCAS and measured the MCA Hounsfield Units (HU). Procedure times and other clinical and radiographic parameters were calculated. Results: A positive correlation between presence of HMCAS and procedure duration (mean time with HMCAS 112.3 min versus 89.89 min in the non HMCAS group P<0.05) was found. Intraprocedural perforation was 8% (n=9) in the HMCAS group versus 1% (n=1) in the non HMCAS group (P<0.05).Hounsfield Unit analysis (ratio of ipsilateral side/contralateral side), showed a linear correlation (p<0.05) between this ratio and procedure duration (Graph 1). Conclusions: HMCAS is associated with slower recanalization, higher rate of complications and lack of differences in clinical outcomes possibly explained by low power after endovascular therapy. This association may reflect differences in thrombus composition or thrombus burden which should be taken into account when choosing recanalization strategies.Further studies focused on clot analysis and better understanding of clot's structure, may serve a future role in selecting special treatment options for acute stroke patients.


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