The Effectiveness and Safety of Thrombolysis with Recombinant Tissue-type Plasminogen Activator for Acute Ischemic Stroke

Main Article Content

Tassanee Jintaganon

Abstract

Background: Intravenous thrombolysis with recombinant tissue-type plasminogen activator (rtPA) is widely accepted as an effective treatment for patients with acute ischemic stroke (AIS) if the treatment can be started within 4.5 hours after stroke onset. The rtPA was first used at Trat Hospital in 2016. At present, there has been no evaluation of the patients' clinical outcomes in our setting.


Objectives: To assess the effectiveness and safety of thrombolysis in the treatment of AIS using the propensity score (PS) as covariate adjusted analysis.


Materials and Methods: This is retrospective cohort study conducted at Trat Hospital between January 2016 and December 2018 with patients over 18 years of age diagnosed with AIS whose scores on the National Institute of Health Stroke Scale–Thai (NIHSS-T) were 4 or higher. These cases were retrospectively reviewed to compare clinical outcomes among patients who were treated with rtPA and those in the non-treated group. The primary outcome was functional independence at 3 months, measured with the modified Rankin Scale (mRS) 0-2 (i.e. favorable outcome). The safety endpoints included death within 3 months and symptomatic intracranial hemorrhage (sICH) within the first 24 hours. PS (the chance of the patients being treated with rtPA) was determined. Multivariate linear regression adjusted for baseline prognostic variables and PS was performed.


Results: Out of 217 patients, 59 (27.2%) were treated with rtPA. Of these, 36 were men (61%); the mean age was 58.1 years, and the median of the index NIHSS-T was 11. It was found that 29 patients (49%) were able to live independently, while 10 patients (17%) died within 3 months. The non-treated group had 91 men (58%) with a mean age of 68.5 years. The median of the index NIHSS-T was 7, while 55 patients (35%) were able to live independently, and 31 patients (20%) died within 3 months. The treated group had a significantly (23%) greater probability of independent living (efficacy outcome) than the non-treated patients [adjusted risk difference (aRD) 0.23; 95% confidence interval (95% CI) 0.05 to 0.41; P = 0.013]. Mortality within 3 months (safety outcome) was not significantly different between the two groups after adjusting for stroke severity and other confounders [aRD -0.02; 95% CI -0.17 to 0.14; P = 0.840]. The risk of sICH in the treated group was insignificantly greater than in the non-treated group [RD 0.03; 95%CI -0.01 to 0.08; P = 0.073].


Conclusion: Thrombolysis for acute ischemic stroke with intravenous rtPA within 4.5 hours after onset is an effective and safe treatment in the Trat Hospital setting.


 

Keywords

Article Details

Section
นิพนธ์ต้นฉบับ (Original article)

References

1. Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, et al. Thrombolysis with
alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-
Monitoring Study (SITS-MOST): an observational study. Lancet 2007; 369:275–82.
2. National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group.
Tissue plasminogen activator for acute ischemic stroke. N Engl J Med 1995; 333:1581–7.
3. Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos A, Guidetti D, et al. Thrombolysis with
alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 2008; 359:1317–29.
4. Wardlaw JM, Murray V, Berge E, del Zoppo GJ. Thrombolysis for acute ischaemic stroke.
Cochrane Database Syst Rev [Internet] 2009[ cited 2018 Oct 28]. Avalable from:
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000213.pub2/full
5. Dirks M, Niessen LW, van Wijngaarden J, Koudstaal PJ, Franke CL, van Oostenbrugge RJ, et
al. The effectiveness of thrombolysis with intravenous alteplase for acute ischemic stroke
in daily practice. Int J Stroke 2012;7:289–92.
6. Stroke-1989. Recommendations on stroke prevention, diagnosis, and therapy. Report on
the WHO Task Force on stroke and other cerebrovascular disorders. Stroke 1989; 20:1407-
31.
7. Weng WC, Huang WY, Chien YY, Wu CL, Su FC, Hsu HJ, et al. The impact of smoking on
the severity of acute ischemic stroke. J Neurol Sci 2011;308: 94-7 .
8. Wilson JT, Hareendran A, Grant M, Baird T, Schulz UG, Muir KW, et al. Improving the
assessment of outcomes in stroke: use of the structured interview to assign grades on the
modified Rankin Scale. Stroke 2002; 33:2243-6.
9. Van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver
agreement for the assessment of handicap in stroke patients. Stroke 1998; 19:604-7.
10. Saebo. What is The NIH Stroke Scale (NIHSS)? [Internet]. 2017 [Cited 2018 Oct 28].
Available from: https://www.saebo.com/nih-stroke-scale-nihss/
11. Dirks M, Niessen LW, Huijsman R , van Wijngaarden J, Minkman MM, Franke CL, et al.
Promoting acute thrombolysis for ischaemic stroke (PRACTISE). Int J Stroke 2007; 2:151–9.
12. Rubin DB. The design versus the analysis of observational studies for causal effects:
parallels with the design of randomized trials. Stat Med 2007;26:20-36.
13. Anaissie JE, Monlezun DJ, Siegler JE, Waring ED, Dowell LN, Samai AA, et al. Intravenous
tissue plasminogen activator for wake-up stroke : A propensity score – matched analysis.
J Stroke Cerebrovasc Dis 2016:25:2603-9.
14. Newgaurd CD, Hedges JR, Arthur M, Mullins RJ. Advanced statistics: the propensity score-a
method for estimating treatment effect in observational research. Acad Emerg Med 2004;
11:953-61.
15. Fitzmaurice G. Confounding: propensity score adjustment. Nutrition 2006; 22: 1214-16.
16. Meschia JF, Miller DA, Brott TG. Thrombolytic treatment of acute ischemic stroke.
Clin Proc 2002;77:542-51.
17. Marler JR, Jones PW, Emr M. Proceedings of a national symposium on rapid
identification and treatment of acute stroke.1. Maryland: National Institutes of Health,
National Institute of Neurological Disorders and Stroke; 1997.