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