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

Abstract

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.