scholarly journals Age differences in utilization and outcomes of tissue-plasminogen activator and mechanical thrombectomy in acute ischemic stroke

2021 ◽  
Vol 420 ◽  
pp. 117262
Author(s):  
Nandakumar Nagaraja ◽  
Urvish K. Patel ◽  
Seemant Chaturvedi
2017 ◽  
Vol 12 (6) ◽  
pp. 659-666 ◽  
Author(s):  
Susanne Siemonsen ◽  
Nils D Forkert ◽  
Martina Bernhardt ◽  
Götz Thomalla ◽  
Martin Bendszus ◽  
...  

Aim and hypothesis Using a new study design, we investigate whether next-generation mechanical thrombectomy devices improve clinical outcomes in ischemic stroke patients. We hypothesize that this new methodology is superior to intravenous tissue plasminogen activator therapy alone. Methods and design ERic Acute StrokE Recanalization is an investigator-initiated prospective single-arm, multicenter, controlled, open label study to compare the safety and effectiveness of a new recanalization device and distal access catheter in acute ischemic stroke patients with symptoms attributable to acute ischemic stroke and vessel occlusion of the internal cerebral artery or middle cerebral artery. Study outcome The primary effectiveness endpoint is the volume of saved tissue. Volume of saved tissue is defined as difference of the actual infarct volume and the brain volume that is predicted to develop infarction by using an optimized high-level machine learning model that is trained on data from a historical cohort treated with IV tissue plasminogen activator. Sample size estimates Based on own preliminary data, 45 patients fulfilling all inclusion criteria need to complete the study to show an efficacy >38% with a power of 80% and a one-sided alpha error risk of 0.05 (based on a one sample t-test). Discussion ERic Acute StrokE Recanalization is the first prospective study in interventional stroke therapy to use predictive analytics as primary and secondary endpoint. Such trial design cannot replace randomized controlled trials with clinical endpoints. However, ERic Acute StrokE Recanalization could serve as an exemplary trial design for evaluating nonpivotal neurovascular interventions.


2009 ◽  
Vol 110 (3) ◽  
pp. 508-513 ◽  
Author(s):  
Chirag G. Patil ◽  
Elisa F. Long ◽  
Maarten G. Lansberg

Object Mechanical thrombectomy is increasingly being used for the treatment of large-vessel ischemic stroke in patients who arrive outside of the 3-hour tissue plasminogen activator time window. In this study, the authors evaluated the cost and effectiveness of mechanical thrombectomy compared with standard medical therapy in patients who are ineligible to receive tissue plasminogen activator. Methods Clinical outcomes of an open-label study of mechanical thrombectomy were compared with a hypothetical control group with a lower recanalization rate (18 vs 60%) and a lower rate of symptomatic intracranial hemorrhage (0.6 vs 7.8%) than the active treatment group. A Markov cost-effectiveness model was built to compare the health benefits and costs associated with mechanical thrombectomy compared with standard medical therapy. All probabilities, quality-of-life factors, and costs were estimated from the published literature. Univariate sensitivity analyses were performed to assess how variations in model parameters affect health and economic outcomes. Results Treatment of acute ischemic stroke with mechanical thrombectomy increased survival time by 0.54 quality-adjusted life years (QALYs), compared with standard medical therapy (2.37 vs 1.83 QALYs), at an increased cost of $6600. This yielded an incremental cost-effectiveness ratio (ICER) of $12,120 per QALY gained, a value generally considered cost-effective. Sensitivity analysis showed that mechanical thrombectomy remained cost-effective (ICER < $50,000 per QALY gained) for all model inputs varied over a reasonable range, except for age at stroke treatment. For patients older than 82 years of age, the treatment was only borderline cost-effective (ICER of $50,000–100,000 per QALY gained). Conclusions The treatment of large-vessel ischemic stroke with mechanical thrombectomy appears to be costeffective. These results require validation when data from a randomized, controlled trial of mechanical thrombectomy become available.


2021 ◽  
pp. 251660852110162
Author(s):  
Elanagan Nagarajan ◽  
Lakshmi P. Digala ◽  
Anudeep Yelam ◽  
Pradeep C. Bollu ◽  
Premkumar C. Nattanmai

Background and Purpose: Intravenous recombinant tissue plasminogen activator (IV rt-PA) is an effective treatment of acute ischemic stroke. The safety and efficacy of IV rt-PA were extensively studied in adults, including both octogenarians and nonagenarians.This study provides safety outcome of exclusive nursing home (NH) residents (dependent on activities of daily living [ADLs]) , who received IV rt-PA. Not much literature or studies are available exclusively on the NH residents. Aim: To assess the safety and outcome of IV rt-PA in patients from NHs who were admitted to our university-based tertiary care hospital, using data from a prospective stroke registry. Methods: Our study is a retrospective review of patients living in nursing facilities, admitted to our neuroscience intensive care unit after receiving IV rt-PA, from January 2010 to June 2018. We reviewed the clinical symptoms, comorbid conditions, medications, diagnostic evaluation, complications, and functional outcomes. The functional outcome was assessed based on the modified Rankin Scale (mRS) at the time of discharge, and 1- and 3-month follow-up. Results: Twenty-eight NH residents (20 [71.4%] were female with a mean age of 80.96 +/− 12.43 years) were identified who had received IV rt-PA for symptoms of acute ischemic stroke. The median mRS on admission was 3, and all of them were dependent on ADL. Twenty-seven (96.5%) patients were treated within the window (≤3 h) for IV rt-PA. There were no IV rt-PA-related violations from both our hospital and outside hospital treatment protocols. The initial computed tomographic (CT) scan of 8 (28.5%) patients revealed evidence of infarction. CT angiogram of head and neck revealed an acute intracranial blood vessel occlusion in 13 (46.4%) patients, and asymptomatic stenosis of intracranial and extracranial blood vessels in 4 (14.2%) patients. Mechanical thrombectomy was attempted in 6 (21.4%) patients and among them, the procedure was unsuccessful in 2 (7.1%) patients due to severe stenosis. One (1/21; 16.6%) patient received an intra-arterial rt-PA, and 5 (5/6;83.3%) patients developed symptomatic intracranial hemorrhage within 24 h following the procedure. Families of 9/28 (32.1%) patients decided to withdraw care. The median mRS on 30 and 90 days follow-up was 4 (interquartile range: 3-6). Conclusion: In this population, mechanical thrombectomy has a high risk for hemorrhagic conversion. IV rt-PA treatment in the NH residents may not improve the outcome of ischemic stroke.


2020 ◽  
Vol 17 ◽  
Author(s):  
Jie Chen ◽  
Fu-Liang Zhang ◽  
Shan Lv ◽  
Hang Jin ◽  
Yun Luo ◽  
...  

Objective:: Increased leukocyte count are positively associated with poor outcomes and all-cause mortality in coronary heart disease, cancer, and ischemic stroke. The role of leukocyte count in acute ischemic stroke (AIS) remains important. We aimed to investigate the association between admission leukocyte count before thrombolysis with recombinant tissue plasminogen activator (rt-PA) and 3-month outcomes in AIS patients. Methods:: This retrospective study included consecutive AIS patients who received intravenous (IV) rt-PA within 4.5 h of symptom onset between January 2016 and December 2018. We assessed outcomes including short-term hemorrhagic transformation (HT), 3-month mortality, and functional independence (modified Rankin Scale [mRS] score of 0–2 or 0–1). Results:: Among 579 patients who received IV rt-PA, 77 (13.3%) exhibited HT at 24 h, 43 (7.4%) died within 3 months, and 211 (36.4%) exhibited functional independence (mRS score: 0–2). Multivariable logistic regression revealed admission leukocyte count as an independent predictor of good and excellent outcomes at 3 months. Each 1-point increase in admission leukocyte count increased the odds of poor outcomes at 3 months by 7.6% (mRS score: 3–6, odds ratio (OR): 1.076, 95% confidence interval (CI): 1.003–1.154, p=0.041) and 7.8% (mRS score: 2–6, OR: 1.078, 95% CI: 1.006–1.154, p=0.033). Multivariable regression analysis revealed no association between HT and 3-month mortality. Admission neutrophil and lymphocyte count were not associated with 3-month functional outcomes or 3-month mortality. Conclusion:: Lower admission leukocyte count independently predicts good and excellent outcomes at 3 months in AIS patients undergoing rt-PA treatment.


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