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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 18  |  Issue : 4  |  Page : 385-388

Intravenous thrombolysis with rt-plasminogen activator in patients with acute ischemic stroke: clinical experience from two Egyptian centers


1 Department of Neurology, Faculty of Medicine, Al-Azhar University, Egypt
2 Department of Neurology, Maadi Military Hospital, Cairo, Egypt

Date of Submission16-Jan-2020
Date of Decision18-Feb-2020
Date of Acceptance14-May-2020
Date of Web Publication29-Dec-2020

Correspondence Address:
Ahmed Essmat
Department of Neurology, Faculty of Medicine, Al-Azhar University, Cairo, 11765
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/AZMJ.AZMJ_7_20

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  Abstract 


Objective Stroke is one of the leading causes of disability and death worldwide. Intravenous thrombolytic therapy has been widely recommended as a standard treatment for acute ischemic stroke in most clinical practice guidelines. The authors aimed to report on the efficacy and safety of rt-plasminogen activator (PA) in the management of acute ischemic stroke in a sample of Egyptian patients.
Patients and methods There were 58 patients treated with IV rt-PA within 4.5 h of stroke onset during the study period between 2014 and 2018 at the Stroke Units of Al-Azhar University Hospitals and Al-Maadi Military Hospital.
Results The studied patients had an age of 62.55±9.94 years and comprised 36 men and 22 women. Treatment window was within the first 3 h of stroke onset in 24 (41.3%) patients, while it was within 3–4.5 h in 34 (58.7%) patients. Forty-six (79.3%) patients had an early improvement and the remaining 12 (20.7%) patients experienced early deterioration. Treatment complications included symptomatic intracranial hemorrhage (10.3%), asymptomatic intracranial hemorrhage (3.4%), and hematuria (3.4%). The in-hospital mortality rate was 10.3%. Comparison between patients with early improvement and those with early deterioration shows significant association between treatment within the first 3 h of stroke onset and early improvement.
Conclusions The authors have been able to show that IV thrombolysis is feasible and safe in our hospitals. However, the number of stroke patients receiving rt-PA in the developing world is relatively low.

Keywords: intravenous thrombolysis, ischemic stroke, rt-plasminogen activator


How to cite this article:
Mohamed N, Nemr A, ElGharieb H, Essmat A, Ahmed E. Intravenous thrombolysis with rt-plasminogen activator in patients with acute ischemic stroke: clinical experience from two Egyptian centers. Al-Azhar Assiut Med J 2020;18:385-8

How to cite this URL:
Mohamed N, Nemr A, ElGharieb H, Essmat A, Ahmed E. Intravenous thrombolysis with rt-plasminogen activator in patients with acute ischemic stroke: clinical experience from two Egyptian centers. Al-Azhar Assiut Med J [serial online] 2020 [cited 2021 May 8];18:385-8. Available from: http://www.azmj.eg.net/text.asp?2020/18/4/385/305220




  Introduction Top


Acute ischemic stroke (AIS) is one of the leading causes of mortality and long-term morbidity worldwide. Treatment strategies include reperfusion therapy with intravenous tissue plasminogen activator (tPA) and/or endovascular thrombectomy. If administered within the critical window of 4.5 h from symptom onset, tPA significantly improves outcome in stroke patients [1]. While the use of low and standard doses of tPA was associated with comparable functional neurological outcome and mortality rates, low-dose tPA can reduce the incidence of symptomatic intracranial hemorrhage (ICH) [2]. Moreover, it was found that in patients with mild AIS, the advantage of tPA is limited to improving the functional outcome rather than reducing the mortality rate [3]. In developing countries including Egypt, the clinical experience on the use of tPA is limited by the small number of stroke centers with adequate infrastructure. The situation is worsened by the inefficient transportation system particularly in overcrowded cities [4]. The present study aimed to report the clinical experience with the use of tPA in two Egyptian stroke centers.


  Patients and methods Top


This retrospective study was conducted on 58 patients admitted to the Stroke Unit at Al-Azhar University Hospitals and Al-Maadi Military Hospital in the period extending from 2014 through 2018. The study protocol was approved by the Local Ethics Committees at both centers and informed consent was obtained from the legal guardians of the studied patients before initiation of treatment. Patients were included in the study if they were diagnosed with AIS and eligible for thrombolytic treatment using IV rt-PA. Patients were excluded from the study if they had uncontrolled hypertension. The local Ethics Research and Review Committee approved the study protocol and informed consent was obtained from all participants.

On admission, all patients were submitted to careful history taking, thorough clinical examination, and non-contrast brain computed tomography scans. Initial severity of the stroke and evolution after thrombolysis was evaluated using the National Institute of Health Stroke Scale (NIHSS). The dose of administered rt-PA was 0.9 mg/kg body weight with a maximum of 90 mg. According to protocol, 1/10 of total dose of rt-PA was given IV in a bolus and the remaining 9/10 were infused over 1 h.

After treatment, the patients were continuously monitored for pulse and blood pressure. After 24 h of treatment, computed tomography scan was repeated. The primary study outcome was early improvement or deterioration. Early improvement was defined as a four-point improvement in the NIHSS score from baseline values or complete resolution of neurological deficit. Significant clinical deterioration was defined as a two-point NIHSS deterioration or new headache and vomiting developed within 24 h post rt-PA infusion. Symptomatic ICH was defined according to the European Cooperative Acute Stroke Study III as any hemorrhage with neurological deterioration combined with an NIHSS score four points greater than either the baseline value or the lowest value in the first 7 days, or death [2].

Results obtained from this study were statistically analyzed using SPSS 25 (IBM-SPSS Inc., Chicago, USA). Numerical variables were expressed as mean±SD or median and interquartile range while categorical data were presented as number and percentage. Comparison between categorical variables was achieved using the χ2-test with a P value of less than 0.05 indicating significant results.


  Results Top


The present study included 58 patients subjected to IV rt-PA treatment. They had an age of 62.55±9.94 years and comprised 36 men and 22 women. The associated morbidities are shown in [Table 1].
Table 1 Clinical data in the studied patients (N=58)

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Treatment parameters and treatment outcome are illustrated in [Table 2]. Treatment window was within the first 3 h of stroke onset in 24 (41.3%) patients, while it was within 3–4.5 h in 34 (58.7%) patients. Forty-six (79.3%) patients had early improvement and the remaining 12 (20.7%) patients experienced early deterioration. The reported treatment complications included symptomatic ICH (10.3%), asymptomatic ICH (3.4%), and hematuria (3.4%). The in-hospital mortality rate was 10.3%.
Table 2 Treatment parameters and outcome in the studied patients

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Comparison between patients with early improvement and those with early deterioration shows significant association between treatment within the first 3 h of stroke onset and early improvement ([Table 3]).
Table 3 Relation between treatment outcome at 24 h and treatment window

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  Discussion Top


In this study, we analyzed the data of 58 thrombolyzed patients gathered over a 4-year period. In developing countries like Egypt, only a small proportion of patients with ischemic stroke currently receive thrombolytic therapy with IV rt-PA. The most important reasons for low usage rates of I.V rt-PA as in our study are related to structural/logistic factors such as referral-triage-treatment system, difficulties in patient recognition of stroke symptoms, delays in seeking appropriate emergency care, delays in obtaining urgent brain imaging scan, and also cost constraint. Of note, the rt-PA is not covered by medical insurance in Egypt. An evidence of these limitations provided by this study is the longer mean time required from stroke onset to emergency room (ER) presentation and subsequently the high percentage of patients treated in the critical window of 3–4.5 h of stroke onset in comparison to other studies [5],[6]. Even in the same country, logistic and financial limitations can affect using rt-PA as shown by the Indian study by Venugopalan et al. [7].

In our study, patients with good outcome had significantly higher frequency of cases treated in the first 3 h after onset of AIS. This is in line with the study of Xu et al. [8], who concluded that the shorter the time to initiation of treatment, the better the functional outcome in AIS patients treated with IV rt-PA. Similar findings were reported by the study of Chtaou et al. [4], who highlighted the significant influence of early administration of rt-PA on treatment outcome. Also, the study of Dorado et al. [9] noted that patients treated within 4.5 h showed better functional outcome when compared with patients submitted to later treatment. These conclusions were also confirmed by the recent study of Ringleb et al. [10], who found that extending the therapeutic window of IV rt-PA to 4.5–9 h after onset of symptoms did not produce significant benefits.

In this study, the reported treatment complications included symptomatic ICH (10.3%), asymptomatic ICH (3.4%), and hematuria (3.4%). However, in the study of Kutluk et al. [11], the prevalence of symptomatic hemorrhage was 4.9%. Also, in the study of Soto et al. [12] on 106 consecutive patients treated with IV rt-PA, symptomatic intracerebral hemorrhage was reported in 5.7% of patients. Moreover, the rate of intracerebral hemorrhage was 4.9% in the study of Merkler et al. [13]. In comparison to our findings, the study of Xu [14] found no cases of hematuria in their study that aimed to assess the effect of different doses of IV rt-PA on AISThe reported mortality rate in this study is 10.3%. This figure is comparable to the 7.2% mortality rate reported by the study of Tong et al. [15] on 7193 patients treated with treated with IV rt-PA within 4.5 h of time while the mortality rate was 10.7% in the study of Merkler et al. [13] and 13.1% in the study of Soto et al. [12].

This differences may be explained by the different characteristics of the included patients, variable experience of the managing teams, or other logistic factors.


  Conclusion Top


IV thrombolysis is feasible and safe in our hospitals. However, the number of stroke patients receiving rt-PA in the developing world is low.

Acknowledgements

All authors of this paper have equally contributed to the design, execution, and writing of this paper.

The manuscript has been read and approved by all the authors.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Bevers MB, Kimberly WT. Critical care management of acute ischemic stroke. Curr Treat Options Cardiovasc Med 2017; 19:41.  Back to cited text no. 1
    
2.
Bluhmki E, Chamorro A, Davalos A, Machnig T, Sauce C, Wahlgren N et al. Stroke treatment with alteplase given 3.0-4.5 h after onset of acute ischaemic stroke (ECASS III): additional outcomes and subgroup analysis of a randomised controlled trial. Lancet Neurol 2009; 8:1095–1102.  Back to cited text no. 2
    
3.
You S, Saxena A, Wang X, Tan W, Han Q, Cao Y et al. Efficacy and safety of intravenous recombinant tissue plasminogen activator in mild ischaemic stroke: a meta-analysis, Stroke Vasc Neurol 2018; 3:22–27.  Back to cited text no. 3
    
4.
Chtaou N, Rachdi L, Midaoui AE, Souirti Z, Wahlgren N, Belahsen MF. Intravenous thrombolysis with rt-PA in stroke: experience of the moroccan stroke unit. Pan Afr Med J 2016; 24:207.  Back to cited text no. 4
    
5.
Gurav SK, Zirpe KG, Wadia R, Pathak MK, Deshmukh AM, Sonawane RV et al. Problems and limitations in thrombolysis of acute stroke patients at a tertiary care center. Indian I Crit Care Med 2015; 19:265.  Back to cited text no. 5
    
6.
Sadeghi-Hokmabadi E, Farhoudi M, Taheraghdam A, Hashemilar M, Savadi-Osguei D, Rikhtegar R et al. Intravenous recombinant tissue plasminogen activator for acute ischemic stroke: a feasibility and safety study. Int J Gen Med 2016; 9:361.  Back to cited text no. 6
    
7.
Venugopalan VY, Bhatia R, Pandian J, Khurana D, Kaul S, Sylaja P et al. Regional differences in ischemic stroke in India (north vs. south). 2019; 14:706–714.  Back to cited text no. 7
    
8.
Xu ZP, Li HH, Li YH, Zhang Y, Wu Q, Lin L. Feasibility and outcomes of intravenous thrombolysis 3-4.5 hours after stroke in Chinese patients. J Clin Neurosci 2014; 21:822–826.  Back to cited text no. 8
    
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Dorado L, Ahmed N, Thomalla G, Lozano M, Malojcic B, Wani M et al. Intravenous thrombolysis in unknown-onset stroke: results from the safe implementation of treatment in stroke − International Stroke Thrombolysis Registry. Stroke 2017; 48:720–725.  Back to cited text no. 9
    
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Ringleb P, Bendszus M, Bluhmki E, Donnan G, Eschenfelder C, Fatar M et al. Extending the time window for intravenous thrombolysis in acute ischemic stroke using magnetic resonance imaging-based patient selection. Int J Stroke 2019; 14:483–490.  Back to cited text no. 10
    
11.
Kutluk K, Kaya D, Afsar N, Arsava EM, Ozturk V, Uzuner N et al. Analyses of the Turkish National Intravenous Thrombolysis Registry. J Storke Cerebrovasc Dis 2016; 25:1041–1047.  Back to cited text no. 11
    
12.
Soto ÁV, Morales G, Grandjean M, Pollak D, Del CCC, García P et al. Intravenous thrombolysis for acute ischemic stroke. A four years experience in a Chilean Public Hospital. Neurohospitalist 2017; 145:468–475.  Back to cited text no. 12
    
13.
Merkler AE, Salehi Omran S, Gialdini G, Lerario MP, Yaghi S, Elkind MSV et al. Safety outcomes after thrombolysis for acute ischemic stroke in patients with recent stroke. Stroke 2017; 48:2282–2284.  Back to cited text no. 13
    
14.
Xu H. Efficacy of different doses of alteplase thrombolysis on acute ischemic stroke in patients. Pak J Pharm Sci 2019; 32:2465–2469.  Back to cited text no. 14
    
15.
Tong X, George MG, Yang Q, Gillespie CJIJoS. Predictors of in‐hospital death and symptomatic intracranial hemorrhage in patients with acute ischemic stroke treated with thrombolytic therapy: P aul C overdell A cute S troke R egistry 2008–2012. Int J Stroke 2014; 9:728–734.  Back to cited text no. 15
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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