Background and Purpose—
Thrombolysis
with alteplase has beneficial effect on outcome and is safe within 4.5
hours. The present study compares the efficacy and safety of
tenecteplase and alteplase in patients treated 3 to 4.5 hours after
ischemic stroke.
Methods—
The
data are from a prespecified substudy of patients included in The
NOR-TEST (Norwegian Tenecteplase Stroke Trial), a randomized control
trial comparing tenecteplase with alteplase.
Results—
The
median admission National Institutes of Health Stroke Scale for this
study population was 3 (interquartile range, 2–6). In the
intention-to-treat analysis, 57% of patients that received tenecteplase
and 53% of patients that received alteplase reached good functional
outcome (modified Rankin scale score of 0–1) at 3 months (odds ratio,
1.19; 95% CI, 0.68–2.10). The rates of intracranial hemorrhage in the
first 48 hours were 5.7% in the tenecteplase group and 6.7% in the
alteplase group (odds ratio, 0.84; 95% CI, 0.26–2.70). At 3 months,
mortality was 5.7% and 4.5%, respectively. After excluding stroke mimics
and patients with modified Rankin scale score of >1 before stroke,
the proportion of patients with
good functional outcome was 61% in the
tenecteplase group and 57% in the alteplase group (odds ratio, 1.24; 95%
CI, 0.65–2.37).
Conclusions—
Tenecteplase
is at least as effective as alteplase to achieve a
good clinical
outcome in patients with mild stroke treated between 3 and 4.5 hours
after ischemic stroke.
Clinical Trial Registration—
URL:
https://www.clinicaltrials.gov. Unique identifier: NCT01949948.
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