Key PointsQuestion
Does intravenous tirofiban reduce early neurological deterioration in patients with acute noncardioembolic stroke?
Findings
In this randomized clinical trial including 425 patients, the
proportion of patients who experienced neurological deterioration within
72 hours was significantly lower in the tirofiban group compared with
the aspirin group. The safety profiles of tirofan and aspirin were
similar.
Meaning
Given the safety and efficacy profiles of intravenous
tirofiban in patients with acute noncardioembolic stroke, tirofiban
could be used as a first-line antiplatelet drug to prevent early
neurological deterioration.
Importance
Evidence supports using antiplatelet therapy in patients with
acute ischemic stroke. However, neurological deterioration remains
common under the currently recommended antiplatelet regimen, leading to
poor clinical outcomes.
Objective
To determine whether intravenous tirofiban administered within
24 hours of stroke onset prevents early neurological deterioration in
patients with acute noncardioembolic stroke compared with oral aspirin.
Design, Setting, and Participants
This investigator-initiated, multicenter, open-label,
randomized clinical trial with blinded end-point assessment was
conducted at 10 comprehensive stroke centers in China between September
2020 and March 2023. Eligible patients were aged 18 to 80 years with
acute noncardioembolic stroke within 24 hours of onset and had a
National Institutes of Health Stroke Scale (NIHSS) score of 4 to 20.
Intervention
Patients were assigned randomly (1:1) to receive intravenous
tirofiban or oral aspirin for 72 hours using a central, web-based,
computer-generated randomization schedule; all patients then received
oral aspirin.
Main Outcome
The primary efficacy outcome was early neurological
deterioration (increase in NIHSS score ≥4 points) within 72 hours after
randomization. The primary safety outcome was symptomatic intracerebral
hemorrhage within 72 hours after randomization.
Results
A total of 425 patients were included in the intravenous
tirofiban (n = 213) or oral aspirin (n = 212) groups. Median (IQR) age
was 64.0 years (56.0-71.0); 124 patients (29.2%) were female, and 301
(70.8%) were male. Early neurological deterioration occurred in 9
patients (4.2%) in the tirofiban group and 28 patients (13.2%) in the
aspirin group (adjusted relative risk, 0.32; 95% CI, 0.16-0.65; P = .002).
No patients in the tirofiban group experienced intracerebral
hemorrhage. At 90-day follow-up, 3 patients (1.3%) in the tirofiban
group and 3 (1.5%) in the aspirin group died (adjusted RR, 1.15; 95% CI,
0.27-8.54; P = .63), and the median (IQR) modified Rankin scale
scores were 1.0 (0-1.25) and 1.0 (0-2), respectively (adjusted odds
ratio, 1.28; 95% CI, 0.90-1.83; P = .17).
Conclusions and Relevance
In patients with noncardioembolic stroke who were seen within
24 hours of symptom onset, tirofiban decreased the risk of early
neurological deterioration but did not increase the risk of symptomatic
intracerebral hemorrhage or systematic bleeding.
Trial Registration
ClinicalTrials.gov Identifier: NCT04491695
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