Clinical Study
Intravenous alteplase for Chinese patients with stroke and borderline eligibility

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Abstract

Lack of efficacy and safety data among Chinese patients with stroke have contributed to the slow development of stroke thrombolysis as standard-of-care for these patients. We examined a retrospective cohort of 57 patients who received intravenous alteplase for acute ischemic stroke to identify predictors of outcome, including age, stroke severity, onset-to-treatment time, and early ischemic changes on brain CT scan. Overall, the mean National Institute of Health Stroke Scale (NIHSS) score was 15.7 and the mean onset-to-treatment time was 142 minutes. Twenty-nine (51%) patients had a favorable outcome with modified Rankin Scale (mRS) score of ⩽2 at three months. Ten (17.5%) patients were deceased at three months. Four (7%) patients developed symptomatic intracranial hemorrhage (sICH). For patients aged >80 years (n = 18), five (28%) achieved favorable outcome, six (33%) were deceased at three months and three (17%) had sICH. Prognosis was worst for patients with NIHSS score >25 (n = 5); one (20%) was dependent (mRS 4) and the other four (80%) were deceased. Multivariate analysis found that the Alberta Stroke Program Early CT Score (ASPECTS) was associated with favorable outcome (odds ratio [OR] 1.8, 95% confidence interval [CI] 1.1–3.0), and mortality (OR 0.5, 95% CI 0.3–0.9). Our findings showed advanced age and severe stroke were associated with less favorable outcome in Chinese patients receiving intravenous alteplase, ASPECTS can be used reliably to identify patients at risk of poor outcomes. Further studies are warranted.

Introduction

Updated meta-analysis has affirmed the efficacy and safety of intravenous thrombolysis for patients with acute ischemic stroke, and ongoing efforts are being devoted to improve penetrance of stroke thrombolysis worldwide.1, 2 Since the approval of the recombinant tissue plasminogen activator, alteplase, for stroke thrombolysis in 2006, major hospitals in Hong Kong have been developing a 24 hour/day stroke thrombolysis service amid conservatism and resource constraints.3 Meanwhile there is variability in the relative contraindications employed for alteplase in acute stroke, including maximum age (⩽80 years) and appropriate stroke severity, usually determined using a National Institute of Health Stroke Scale (NIHSS) score greater than 4 and less than 25. There are yet inadequate data to support or refute treatment in patients outside of these relative exclusion criteria.4 As a result, hospitals usually develop local treatment guidelines for stroke thrombolysis with selection criteria based on published guidelines, randomized trials, and their own experience.

A validated and pragmatic assessment system for outcome and complication prediction after intravenous alteplase is lacking for Chinese patients, but is essential for efficient thrombolysis triage. We therefore undertook this study to report the outcomes of intravenous thrombolysis in our stroke unit, and examine whether borderline-eligible patients, defined as age >80 years, severe stroke with NIHSS score >25, or extensive ischemic changes on brain CT scan with Alberta Stroke Program Early CT Score (ASPECTS) ⩽7, were associated with poor outcome after intravenous thrombolysis.

Section snippets

Methods

We performed a retrospective cohort study of consecutive patients with ischemic stroke who received intravenous alteplase from January 2007 to May 2011 at a university teaching hospital in Hong Kong. The study was approved by the local Ethics Committee. The stroke thrombolysis triage algorithm has been described previously.3 The inclusion criteria were largely adopted from the National Institute of Neurological Disorders and Stroke (NINDS) trial,5 with the treatment window extended to 4.5 hours

Results

Table 1 shows the baseline characteristics of 57 patients who received intravenous alteplase during the study period. The mean age was 74.6 years and there were 25 (44%) male patients. The most common risk factor was hypertension (n = 46, 81%), and the most common stroke mechanism was cardioembolism (n = 30, 53%). The mean NIHSS was 15.7 and the mean OTT was 142 minutes. A total of 29 (51%) patients had a favorable outcome with mRS ⩽2 at three months. Ten (17.5%) patients were dead at three months,

Discussion

In a cohort of Chinese patients who received intravenous alteplase for acute ischemic stroke, those with advanced age, severe stroke, and significant early ischemic changes on brain CT scans had less favorable outcomes and higher mortality rates.

A recent review concluded that elderly patients (age >80 years) have a lower probability of achieving favorable outcome and higher mortality rate after intravenous thrombolysis.8 A less favorable outcome (only 28% with mRS 0–2) among our elderly patients

Disclosures and Conflicts of interest

The authors report no disclosures or conflicts of interest.

Acknowledgements

The authors would like to thank all stroke team members in Accident and Emergency Department, Department of Medicine and Therapeutics, and Department of Imaging and Interventional Radiology of the Prince of Wales Hospital, Hong Kong.

References (12)

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    The multivariate analysis revealed that age, admission NIHSS score and onset to treatment time were independently associated with favorable clinical outcome in stroke patients. There is evidence that advanced age and high NIHSS score are independent predictors of IV rt-PA treated AIS poor outcome [18,19]. The time-dependent nature of treatment benefit has been appreciated for some years [20].

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