scholarly journals Dose optimization study for recombinant tissue plasminogen activator in acute ischemic stroke: A study from Middle-East

2021 ◽  
Vol 26 (3) ◽  
pp. 465-469
Author(s):  
Helia Hemasian ◽  
Erfan Sheikhbahaei ◽  
Arvin Shahzamani ◽  
Faribourz Khorvash ◽  
Mohammad Saadatnia ◽  
...  

Background: Variable intravenous recombinant tissue-plasminogen activator (rt-PA) dosages are used for ischemic stroke. We aimed to report our experience from administering different rt-PA doses in a tertiary referral center in Middle-East. Method: Medical documents of ischemic stroke patients who received rt-PA were retrospectively reviewed and analyzed. Patients were grouped into three categories based on the received total amount of rt-PA and their body weight: 0.6 mg/kg (low-dose), 0.75 mg/kg (intermediate-dose), and 0.9 mg/kg (high-dose). During the hospitalization period, patients were under full surveillance for rt-PA complications. The validated format of the National Institutes of Health stroke scale (NIHSS) and the modified Rankin scale (mRS) were used at the baseline, at the time of being discharged, and after 3 months. Chi-square, ANOVA, and ANCOVA were used for statistical analysis. Results: 602 patients were evaluated and grouped as follow: 187 (31.06%) in 0.6 mg/kg group (61% male) with mean age of 68±15 years, 217 (36.04%) in 0.75 mg/kg group (59% male) with mean age of 67±13 years, and 198 (32.89%) in 0.9 mg/kg group (50% male) with mean age of 69±17 years. There was no significant difference between the three groups regarding their demographics, comorbidities, and the distribution of stroke risk factors. No significant difference was seen between the three groups regarding in-hospital death and intracranial hemorrhage (p=0.07 and 0.09, respectively). In terms of NIHSS, no significant difference was observed between the three groups at the time of admission, discharge, and follow-up (p=0.98, 0.85, and 0.47, respectively). At the time of discharge, the mRS of 0.6 mg/kg group was significantly higher than the other two groups (p=0.04), which decreased in the 3-month follow-up and did not make significant differences (p=0.38). Conclusions: According to the in-hospital mortality, intracranial hemorrhage, mRS, and NIHSS scores, we recommend 0.75 mg/kg as our safe, beneficial, and cost-effective dosage.

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.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Alfonso Ciccone ◽  
Luca Valvassori ◽  
Edoardo Boccardi ◽  
Roberto Sterzi ◽  

Background: As compared with systemic i.v. thrombolytic therapy, primary endovascular treatment results in a higher rate of patency of the ischemic stroke-related cerebral artery. However, the comparative clinical efficacy of the two approaches has not been carefully studied. Methods: We randomly assigned a total of 362 patients with acute ischemic stroke seen within 4.5 h from symptoms onset to endovascular treatment (i.e., intra-arterial thrombolysis with recombinant tissue plasminogen activator - t-PA - if necessary, associated to or substituted by mechanical clot disruption and/or retrieval) or i.v. t-PA administered according to EU labeling. The purpose of the study was to determine the proportion of independent survivors at three months. Safety endpoints included symptomatic intracranial hemorrhage, death and other serious adverse events. Results: A total of 181 patients were assigned to undergo endovascular treatment, and 181 to receive i.v. t-PA. Median time from stroke onset to start to treatment was 3 h 45 min for endovascular treatment (range: 1 h 30 min to 5 h 55 min) and 2 h 45 min (range: 55 min to 4 h 30 min) for i.v. t-PA (p=0.002). All the randomized patients were assessed at 3 months and analyzed. We will present analyses comparing the effect of endovascular treatment with i.v. t-PA on a) the primary outcome (proportion of patients alive and independent at 3 months as assessed by the modified Rankin scale) adjusted for key covariates, b) death from any cause within 3 months, c) events within 7 days: fatal and non fatal symptomatic intracranial hemorrhages, fatal and non fatal neurological deterioration attributed to brain swelling from the initial ischemic stroke, fatal and non fatal neurological deterioration not attributed to swelling or intracranial hemorrhage, fatal and non fatal recurrent ischemic stroke, death from any cause. Conclusions: Data from the trial will provide new evidence on the balance of risk and benefit of endovascular treatment, as compared to systemic thrombolysis, among patients with acute 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.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Guijing Wang ◽  
Heesoo Joo ◽  
Mary G George

Introduction: Intravenous recombinant tissue plasminogen activator (IV rtPA) is recommended treatment for acute ischemic stroke patients, but the cost-effectiveness of IV rtPA within different time windows after the onset of acute ischemic stroke is not well reviewed. Objectives: We conducted a literature review of the cost-effectiveness studies about IV rtPA. Methods: A literature search was conducted using PubMed, MEDLINE, and EconLit, with the key words stroke, cost, economic benefit, saving, cost-effectiveness, tissue plasminogen activator, and rtPA. The review is limited to original research articles published during 1995–2014 in English-language peer-reviewed journals. Results: We found 15 studies meeting our criteria for this review. Nine of them were cost-effectiveness studies of IV rtPA treatment within 0-3 hours after stroke onset, 2 studies within 3-4.5 hours, 3 studies within 0-4.5 hours, and 1 study within 0-6 hours. IV rtPA is a cost-saving or a cost-effectiveness strategy from most of the study results. Only one study showed incremental cost-effectiveness ratio of IV rtPA within one year was marginally above $50,000 per QALY threshold. IV rtPA within 0-3 hours after stroke led to cost savings for lifetime or 30 years, and IV rtPA within 3-4.5 hours after stroke increased costs but still was cost-effective. Conclusions: The literature generally showed that intravenous IV rtPA was a dominant or a cost-effective strategy compared to traditional treatment for acute ischemic stroke patients without IV rtPA. The findings from the literature lacked generalizability because of limited data and various assumptions.


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