Preliminary Findings on the Efficacy and Safety of Early Intravenous Thrombolysis Administration in Acute Ischaemic Stroke Treatment

Abstract

Introduction:

In Malaysia, stroke has remained the third leading cause of death after ischaemic heart disease and pneumonia from 2007 to 2017. We aimed to explore the efficacy, safety, and predictive factors of the functional outcome of early intravenous administration of recombinant tissue plasminogen activator (rt-PA), alteplase for patients who were presented to the hospital within 4.5 hours of the onset of stroke.

Methods:

A longitudinal study was conducted for 36 months from January 2018 to December 2020 at Bintulu Hospital in Sarawak, Malaysia. The primary outcome was defined as the National Institute of Health Stroke Scale (NIHSS) scoring of 0 or 1, or more than an 8-point improvement in the score. The secondary endpoint was disability at 3 months post-discharge assessed using the modified Rankin scale (mRS), whereas safety endpoints were mortality, intracranial haemorrhage, and other serious adverse events. Baseline characteristics included demographics, disease-related characteristics, medication history, time of arrival to the hospital, and onset-to-needle time. Safety and efficacy data were analysed using descriptive analysis. Independent t-tests and the Chi-Square tests were used to determine predictive factors of outcomes after intravenous thrombolysis.

Results:

A total of 20 participants participated in the study. We found out that 9 (45.0%) participants treated with alteplase achieved an NIHSS scoring of 0 or 1, or more than an 8-point improvement in the score at Day 1 post thrombolysis. At 3-month follow-up, a favourable outcome of mRS ≤ 2 was observed in 8 participants (40.0%). Intracranial haemorrhage (ICH) and symptomatic ICH occurred in 3 (15.0%) and 1 (5.0%) participants on alteplase, respectively. Positive smoking history (P=0.01) and age group of more than 65 years old (P=0.02) were associated with poorer functional outcomes after thrombolysis.

Conclusion:

Our preliminary findings showed that not all patients with acute ischemic stroke benefit from intravenous rt-PA. There is a need to identify subgroups of patients who will benefit from rt-PA, especially in resource-limited settings.