medwireNews: Intravenous treatment with the antiplatelet therapy tirofiban decreases the risk for early neurological deterioration (ND) in patients with acute ischemic stroke (AIS) compared with aspirin, the TREND trial has found.
Within 72 hours of treatment, just 4.2% of patients given tirofiban showed early ND compared with 13.2% of those given aspirin, a significant difference. Moreover, there was no increase in the risk for intracerebral hemorrhage (ICH) with the glycoprotein IIb/IIIa inhibitor relative to aspirin.
“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,” write Xunming Ji (Capital Medical University, Beijing, China) and colleagues in JAMA Neurology.
The open-label trial conducted at 10 comprehensive stroke centers in China enrolled participants aged 18 to 64 years who presented with AIS within 24 hours of symptom onset and had scores of between 4 and 20 points on the National Institutes of Health Stroke Scale (NIHSS). The NIHSS ranges from 0 to 42 points, where higher scores indicate more severe stroke symptoms. They also had at least two paralyzed limbs according to the Medical Research Council score.
The patients were randomly assigned to receive intravenous tirofiban (n=213) or aspirin (n=212). Tirofiban was given at a dose of 0.4 μg/kg of body weight per minute for 30 minutes, followed by a continuous infusion of 0.1 μg/kg per minute up to the end of the 72-hour treatment period, after which oral aspirin could be taken. Aspirin was given daily at a dose of 150 to 300 mg during the first 2 weeks after symptom onset followed by 100 to 300 mg daily for secondary prevention.
The median age of the participants was 64 years and 70.8% were men. The median baseline NIHSS score was 5 points in both groups and the median time from symptom onset to randomization was slightly higher in the tirofiban group (12.5 hours) than the aspirin group (10.5 hours).
Most stroke cases involved the anterior circulation (59.2% in the tirofiban group vs 52.8% in the aspirin group), and the most common stroke causes were large artery atherosclerosis (23.0 vs 30.7%) and small vessel occlusion (33.8 vs 24.5%).
Ji et al found that patients given tirofiban were 68% less likely than the aspirin group to experience early ND, defined as a drop of 4 or more points on the NIHSS within 72 hours of treatment, after taking into account age, sex, location of the infarction, baseline NIHSS score, prestroke antiplatelet therapy, and stroke subtype.
When early ND was defined as an NIHSS score increase of 2 or more points within 72 hours of treatment, the risk for early ND was reduced by 50% for patients treated with tirofiban compared with those given aspirin, occurring in 11.7% versus 23.6% of patients.
The researchers note that the subgroups of patients who benefited most from the treatment were those who were older than 60 years of age, who were not taking antiplatelet therapy before the stroke, who had anterior versus posterior circulation stroke, whose baseline NIHSS score was less than 10 points, whose onset to randomization was longer than 12 hours, and whose stroke subtype was large artery atherosclerosis.
Despite the reduction in early ND with tirofiban, there was no significant difference between the two treatment groups in the change in NIHSS score from baseline to 24 or 72 hours nor in functional outcomes at 90 days on the modified Rankin scale, although there was a trend in favor of tirofiban.
None of the patients in either group experienced symptomatic ICH and no patient treated with tirofiban experienced ICH compared with 1.0% of patients taking aspirin. Both groups had a similar rate of serious adverse events (2.2 and 2.0%, respectively), and there was no difference in the incidence of bleeding events. Mortality rates at 90 days were similar between the two groups, at 1.3% in the tirofiban group compared with 1.5% in the aspirin group.
The authors acknowledge that the generalizability of the findings could be limited by the exclusion of patients with severe, minor, and cardioembolic strokes and the fact that it only involved Chinese patients with AIS, who have a high proportion of intracranial artery stenosis.
They therefore call for further randomized trials to “determine the clinical benefit of tirofiban” in patients with AIS.
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