scholarly journals Enrollment bias: frequency and impact on patient selection in endovascular stroke trials

2015 ◽  
Vol 8 (4) ◽  
pp. 353-359 ◽  
Author(s):  
Sunil A Sheth ◽  
Jeffrey L Saver ◽  
Sidney Starkman ◽  
Ileana D Grunberg ◽  
Judy Guzy ◽  
...  
Keyword(s):  
First Generation ◽  
National Institutes Of Health ◽  
Stroke Therapy ◽  
Tertiary Referral Center ◽  
Prognostic Features ◽  
Intravenous Tissue Plasminogen Activator ◽  
Acute Cerebral Ischemia ◽  
Tissue Plasminogen ◽  
Scale Scores ◽  
Angiographic Data

BackgroundSelection bias may have affected enrollment in first generation endovascular stroke trials. We investigate, evaluate, and quantify such bias for these trials at our institution.MethodsDemographic, clinical, imaging, and angiographic data were prospectively collected on a consecutive cohort of patients with acute ischemic stroke who were enrolled in formal trials of endovascular stroke therapy (EST) or received EST in clinical practice outside of a randomized trial for acute cerebral ischemia at a single tertiary referral center from September 2004 to December 2012.ResultsAmong patients considered appropriate for EST in practice, 47% were eligible for trials, with rates for individual trials ranging from 17% to 70%. Compared with trial ineligible patients treated with EST, trial eligible patients were younger (67 vs 74 years; p<0.05), more often treated with intravenous tissue plasminogen activator (53% vs 34%; p<0.01), and had shorter last known well to puncture times (328 vs 367 min; p<0.05). Focusing on the largest trial with a non-interventional control arm, compared with trial eligible patients treated with EST outside the trial, enrolled patients presented later (274 vs 163 min; p<0.001), had higher National Institutes of Health Stroke Scale scores (20 vs 17; p<0.05), and larger strokes (diffusion weighted imaging volumes 49 vs 18; p<0.001).ConclusionsThe majority of patients felt suitable for EST at our institution were excluded from recent trials. Formal entry criteria succeeded in selecting patients with better prognostic features, although many of these patients were treated outside of trials. Acknowledging and mitigating these biases will be crucial to ongoing investigations.

scholarly journals Comparison of outcome of patients with acute minor ischaemic stroke treated with intravenous t-PA, DAPT or aspirin

2020 ◽  
pp. svn-2019-000319
Author(s):  
Peng Wang ◽  
Mengyuan Zhou ◽  
Yuesong Pan ◽  
Xia Meng ◽  
Xingquan Zhao ◽  
...  
Keyword(s):  
Functional Outcome ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
National Institutes Of Health ◽  
Minor Stroke ◽  
Post Hoc Analysis ◽  
Intravenous Tissue Plasminogen Activator ◽  
Tissue Plasminogen ◽  
Ischemic Attack ◽  
Post Hoc

BackgroundWhether to treat minor stroke with intravenous tissue plasminogen activator (t-PA) treatment or antiplatelet therapy is a dilemma. Our study aimed to explore whether intravenous t-PA treatment, dual antiplatelet therapy (DAPT) and aspirin have different efficacies on outcomes in patients with minor stroke.MethodsA post hoc analysis of patients with acute minor stroke treated with intravenous t-PA within 4.5 hours from a nationwide multicentric electronic medical record and patients with acute minor stroke treated with DAPT and aspirin from the Clopidogrel with Aspirin in Acute Minor Stroke or Transient Ischemic Attack Database. Minor stroke was defined by a score of 0–3 on the National Institutes of Health Stroke Scale at randomisation. Favourable functional outcome (defined as modified Rankin Scale (mRS) score of 0–1 or 0–2 at 3 months).ResultsCompared with those treated with intravenous t-PA, no significant association with 3-month favourable functional outcome (defined as mRS score of 0–1) was found neither in patients treated with aspirin (87.8% vs 89.4%; OR, 0.83; 95% CI, 0.46 to 1.50; p=0.53) nor those treated with DAPT (87.4% vs 89.4%; OR, 0.84; 95% CI, 0.46 to 1.52; p=0.56). Similar results were observed for the favourable functional outcome defined as mRS score of 0–2 at 3 months.ConclusionsIn our study, no significant advantage of intravenous t-PA over DAPT or aspirin was found. Due to insufficient sample size, our study is probably unable to draw such a conclusion that that intravenous t-PA was superior or non-superior to DAPT.

scholarly journals Treating ischaemic stroke with intravenous tPA beyond 4.5 hours under the guidance of a MRI DWI/T2WI mismatch was safe and effective

2019 ◽  
Vol 4 (1) ◽  
pp. 8-13 ◽  
Author(s):  
Qing-ke Bai ◽  
Zhen-guo Zhao ◽  
Lian-jun Lu ◽  
Jian Shen ◽  
Jian-ying Zhang ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Contrast Material ◽  
Final Analysis ◽  
National Institutes Of Health ◽  
Haemorrhagic Transformation ◽  
Intravenous Tissue Plasminogen Activator ◽  
Hyperintense Signal ◽  
Rapid Sequence ◽  
Tissue Plasminogen ◽  
Sequence Study

PurposeClinical trials have provided evidence that treating patients with acute ischaemic stroke (AIS) beyond 4.5 hours was feasible. Among them using MRI diffusion-weighted imaging/fluid attenuation inversion response (DWI/FLAIR) mismatch to guide intravenous tissue plasminogen activator (tPA) was successful. Our study explored the outcome and safety of using DWI/T2-weighted imaging (T2WI) mismatch to guide intravenous tPA therapy for patients with AIS between 4.5 hours and 12 hours of onset.MethodThis was a retrospective study. Records of 1462 AIS patients with the time of onset of <12 hours were reviewed. Those had MRI rapid sequence study and had hyperintense signal on DWI but normal T2WI and received intravenous tPA up to 12 hours of onset were included in the analysis. Their demographics, risk factors, post-tPA complications, National Institutes of Health Stroke Scale (NIHSS) scores and outcome were recorded and analyse. χ2 was used to compare the intergroup variables. SAS was used to perform statistical calculation. A p<0.05 was considered statistically significant.ResultsOf 1462 identified, 601 (41%) patients were entered into the final analysis. Among them, 327 (54%) had intravenous tPA within 4.5 hours of onset and 274 (46%) were treated between 4.5–12 hours. After intravenous tPA, 426 cases (71%) had >4 pints of improvement on NIHSS score within 24 hours. Postintravenous tPA, 32 (5.32%) cases had haemorrhagic transformation. 26 (4.33%) were asymptomatic ICH and 4 (0.67%) died. At 90 days, 523 (87%) achieved a modified Rankin scale of 0–2.ConclusionUsing MRI DWI/T2WI mismatch to identify patients with AIS for intravenous tPA between 4.5 hours and 12 hours was safe and effective. The outcome was similar to those used DWI/PWI or DWI/FLAIR mismatch as the screening tool. However, obtaining DWI/T2WI was faster and avoided the need of contrast material.

Thrombolytic treatment in stroke mimic, inevitable but fortunately safe: An observational study from Iran

2020 ◽  
Author(s):  
Sara Esmaeili ◽  
Motahareh Afrakhteh ◽  
Maryam Bahadori ◽  
Seyedeh Fahimeh Shojaei ◽  
Rezan Ashayeri ◽  
...  
Keyword(s):  
Alcohol Intoxication ◽  
Intravenous Thrombolysis ◽  
Treatment Decision ◽  
National Institutes Of Health ◽  
Nihss Score ◽  
Number Of Patients ◽  
Acute Cerebral Ischemia ◽  
Tissue Plasminogen ◽  
Baseline Characteristics ◽  
Stroke Mimic

Background: A number of patients with symptoms of acute cerebral ischemia may have other causes called stroke mimics (SM). The prevalence of SM can be as high as 31% in some reports, and these patients are potentially at the risk of intravenous thrombolysis (IVT) therapy and its complications. This study was designed to determine the prevalence of our center’s SM (Firoozgar Hospital) among patients who received IVT, their baseline characteristics, final diagnoses, and outcomes. Methods: We reviewed the medical records of all patients who received IVT between June 2015 and May 2018. The following variables were collected: demographic characteristics, past medical history, onset-to-needle (OTN) time, door-to-needle (DTN) time, National Institutes of Health Stroke Scale (NIHSS) score at admission, brain imaging, and all paraclinic findings. Functional outcome at discharge based on modified Rankin Scale (mRS) was also assessed. Results: 10 out of 165 (6.0%) patients including 8 men and 4 women were finally diagnosed with SM. The median age and NIHSS score at presentation were 60 years and 7, respectively. Final diagnoses were seizure (n = 6), hemiplegic migraine (n = 2), conversion (n = 1), and alcohol intoxication (n = 1). All patients were discharged with a mRS score of 0 and 1 without experiencing any thrombolytic adverse effects. Conclusion: None of the patients with SM experienced any adverse effect of tissue plasminogen activator (tPA) including hemorrhage and all of them reached good mRS score. This shows that tPA is generally safe and the risk of treating patients with SM is very low and making a vital treatment decision may outweigh the risk of neglected cases in a time-sensitive setting.

Treatment of Acute Right-Sided Weakness

2016 ◽  
Author(s):  
Ji Y. Chong ◽  
Michael P. Lerario
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Symptom Onset ◽  
Randomized Trials ◽  
Stroke Therapy ◽  
Eligibility Criteria ◽  
Off Label ◽  
Intravenous Tissue Plasminogen Activator ◽  
Tissue Plasminogen ◽  
Iv Tpa

Intravenous tissue plasminogen activator (IV tPA) is the mainstay of stroke therapy and is US Food and Drug Administration-approved for the treatment of acute ischemic stroke. Its benefit on functional outcome has been established in multiple randomized trials when administered within 3 hours. Select patients may be treated off-label up to 4.5 hours from symptom onset. Eligibility criteria need to be reviewed carefully to optimize benefit and to minimize complications, namely reperfusion hemorrhage.

Abstract WP40: CT-based Evaluation is Faster and as Precise as MRI in Acute Stroke Evaluation

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Christine K Hansen ◽  
Anders Christensen ◽  
Inger Havsteen ◽  
Hanne Christensen
Keyword(s):  
Acute Stroke ◽  
Diagnostic Quality ◽  
Additional Information ◽  
Intravenous Tissue Plasminogen Activator ◽  
Acute Cerebral Ischemia ◽  
Tissue Plasminogen ◽  
Magnetic Resonance Imaging Mri ◽  
Oncological Pathology ◽  
Iv Tpa ◽  
Ct And Mri

Introduction: The issue if Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) are ‘best’ in evaluation of patients with symptoms of acute stroke prior to intravenous-tissue-plasminogen-activator treatment (iv-tPA) has been widely discussed; CT-based door-to-needle-times of 20 minutes are feasible and motivated by time-dependent efficacy of iv-tPA, but the more time consuming MRI-based evaluation likely provides additional information on hyper-acute cerebral ischemia and iv-tPA-contraindicating stroke mimicking pathology. Aim: The aim of this study was to compare the delay of iv-tPA-treatment and the level of diagnostic information obtained for patients randomized to CT and MRI-based acute stroke evaluation. Method: Three-hundred-sixty-nine consecutive patients admitted with symptoms of stroke within 4.5 hours from symptom-onset were quasi-randomized to CT or MRI-based evaluation as part of an ongoing single-center trial and treated with iv-tPA if eligible. Door-to-needle-times for patients, allocated to CT and MRI, were compared. Imaging of diagnostic quality and stroke mimicking detected pathology were registered for the two modalities. Results: Door-to-needle-times for CT evaluated patients (median 26 (7-55) min) were significantly faster than for MRI-examined patients (median 36 (11-71) min), p=0.007. Imaging of adequate diagnostic quality was acquired for all patients examined with CT and for 96.4% of patients, without inherent MRI-contraindications, examined with MRI. All patients with discharge diagnoses of intracerebral hemorrhage and intracerebral oncological pathology were identified by the primary scan at admission, regardless if CT or MRI were performed. Conclusion: CT-based evaluation prior to iv-tPA-treatment is faster and as presice as MRI-based evaluation of patients with acute stroke.

Abstract WP61: Volumetric DWI Malignant Profile Assessment in Acute Ischemic Patients With Reperfusion Therapy.

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Manabu Inoue ◽  
Shinichi Wada ◽  
Kazutaka Sonoda ◽  
Sohei Yoshimura ◽  
Shoichiro Sato ◽  
...  
Keyword(s):  
Endovascular Therapy ◽  
Reperfusion Therapy ◽  
National Institutes Of Health ◽  
Roc Curve Analysis ◽  
Poor Outcome ◽  
Intravenous Tissue Plasminogen Activator ◽  
Tissue Plasminogen ◽  
Magnetic Resonance Imaging Mri ◽  
Poor Outcomes ◽  
Iv Tpa

Background: The efficacy of endovascular therapy (EVT) in acute stroke has been established but the imaging criteria have not yet been assessed. Malignant profile is a magnetic resonance imaging (MRI) pattern that is associated with poor outcomes. We estimated this profile by volumetrically assessing diffusion weighted image (DWI) in patients treated with reperfusion therapy including intravenous tissue plasminogen activator (IV tPA) and endovascular therapy (EVT). Methods: Acute anterior ischemic stroke patients with baseline DWI before reperfusion therapy were included. Outcome was assessed by modified Rankin Scale (mRS) at discharge. DWI volume was measured by semi-automated software.Receiver operating characteristic (ROC) curve analysis was performed to identify optimal DWI volumes with poor outcome (mRS 5-6). Results: Total of 96 patients (43% women, mean age 72±13 years) were included in this study. Median (interquartile range: IQR) National Institutes of Health Stroke Scale was 9 (5-12) and median onset to MRI time was 108.5 (70-217) minutes. Median DWI volume was 4.4 (1.3-17) mL for overall patients. Median onset to IV tPA time for 60 (63%) patients were 120 (65-177) minutes. Median onset to puncture time for 36 (38%) EVT-treated patients was 208 (121.0-474.3) minutes; 29 of these 36 patients (81%) had Thrombolysis in Cerebral Infarction (TICI) score of 2B/3. Median discharge mRS was 2 (1-3) for overall and 6 cases (6%) had mRS 5-6. ROC analysis determined DWI volume with poor outcome as 49.5 mL (92.2% specificity and 50% sensitivity, AUC 0.75, p<0.001). Conclusion: Our study suggests the optimal volume of the malignant profile on DWI was approximately 50mL in reperfusion therapy eligible patients. Clinical outcome of patients exceeding the cutoff volume were very poor. The imaging criteria for reperfusion therapy including EVT should be well considered to achieve better outcomes.

scholarly journals Initial Stroke Severity Is the Major Outcome Predictor for Patients Who Do Not Receive Intravenous Thrombolysis due to Mild or Rapidly Improving Symptoms

2011 ◽  
Vol 2011 ◽  
pp. 1-3 ◽  
Author(s):  
Mu-Chien Sun ◽  
Tien-Bao Lai
Keyword(s):  
Independent Predictor ◽  
Intravenous Thrombolysis ◽  
National Institutes Of Health ◽  
Unfavorable Outcome ◽  
Stroke Severity ◽  
Outcome Predictor ◽  
Nihss Score ◽  
Intravenous Tissue Plasminogen Activator ◽  
Tissue Plasminogen ◽  
Favorable Group

Intravenous tissue plasminogen activator thrombolysis for stroke is still under use. A substantial proportion of excluded patients for mild or improving symptoms are dependent at discharge. We prospectively recruited 49 patients who did not receive thrombolysis because of mild or improving symptoms. 32 had favorable outcome (mRS ≤ 2) and 17 had unfavorable outcome (mRS > 2) at discharge. Comparisons were made between the two groups. Age was older (72.5 ± 10.0 versus 64.7 ± 13.2 years, P = 0.037), and initial National Institutes of Health Stroke Scale (NIHSS) score (5.7 ± 4.0 versus 2.2 ± 2.1, P < 0.001) was higher in the unfavorable group. Diastolic blood pressure was higher in the favorable group (98 ± 15 versus 86 ± 18  mmHg; P = 0.018). Atrial fibrillation (3.1 versus 23.5%; P = 0.043) and ipsilateral artery stenosis (21.9 versus 58.8%; P = 0.012) were more frequently found in the unfavorable group. Percentage of patients excluded from thrombolysis due to improving symptoms was higher in the unfavorable group (40.6 versus 82.4%; P = 0.005). Initial NIHSS score, but not other factors, was identified by logistic regression analysis as a major independent predictor for unfavorable outcome (OR 1.44; 95%CI, 1.03–2.02).

Abstract 2808: The Prognosis of Intravenous Thrombolysis with Alteplase Relate to Site of Cerebral Artery Occlusion

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Takao Kanzawa ◽  
Ban Mihara ◽  
Tomo horikoshi
Keyword(s):  
Independent Predictor ◽  
Intravenous Thrombolysis ◽  
Artery Occlusion ◽  
National Institutes Of Health ◽  
Intravenous Tissue Plasminogen Activator ◽  
Tissue Plasminogen ◽  
Cerebral Artery Occlusion ◽  
Mean Time ◽  
Time Form ◽  
Iv Tpa

Purpose: The objective of this study was to determine whether the arterial obstruction site is predictive of clinical outcomes in patients receiving intravenous tissue plasminogen activator (IV tPA). Methods: In a retrospective analysis of our stroke database between Nov. 2005 and May. 2011, we identified 91 consecutive patients who were treated with IV tPA within 3 hours after symptom onset of a stroke in the distribution of a documented ICA, proximal M1, distal M1, or M2/M3 occlusion by Magnetic resonance angiography. We analyzed the rate of favorable outcomes at 3 months (modified Rankin Scale 0 or 1) at various occlusion sites, and determined predictors of favorable outcomes. Results: 91 consecutive patients were treated (mean age, 71 +/- 11 yr; 40.9% were women). Median baseline National Institutes of Health Stroke Scale score (NIHSS) was 10 (range, 4 to 32) and mean time form onset to IV tPA was 128+/- 33 minutes. Favorable outcomes were achieved in 55.6% and significantly correlated with age, basal NIHSS and MRI ASPECT score. Based on the occlusion site, M2/M3 occlusion had an OR of 6.4 for favorable outcomes (83.7%, 95% CI: 2.2 to 19.2, P 0.0006), whereas the odds for proximal M1 occlusion was 0.163 (25.9%, 95% CI: 0.059 to 0.447, P 0.0004), ICA occlusion was 0.378 (23.0%, 95% CI: 0.138 to 1.036, P 0.01). After adjusting for age, sex, baseline NIHSS, and MRI ASPECT score, M2/M3 occlusion occlusion were an independent predictor to achieve favorable outcomes (OR: 9.203, 95% CI: 1.896 to 45.443, P 0.006). Conclusions: Clinical outcome in IV tPA depends on the site of occlusion. This is important to make reasonable decisions for identifying which patients benefit in IV tPA and combined IV tPA/ interventional approach.

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