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Tirofiban improves outcomes in patients with small vessel occlusion strokes who are not eligible for thrombolysis
Question clinique
For stroke patients who are ineligible for or fail thrombolysis, can tirofiban improve outcomes?
L’Essentiel
In a population of patients with acute ischemic stroke and no large or medium-sized vessel occlusion who were either not eligible for or failed thrombolysis, tirofiban improves the likelihood of achieving an excellent neurological outcome at 90 days when compared with aspirin. Although tirofiban presented a higher risk of symptomatic intracranial hemorrhage, the incidence of these bleeds was low. Of note, this study was performed on a primarily Chinese population, so results may not be generalizable to other groups. 1b
Référence
Plan de l'etude: Randomized controlled trial (double-blinded)
Financement: Government
Cadre: Inpatient (any location) with outpatient follow-up
Sommaire
This study from China included patients with acute ischemic stroke without large or medium-sized vessel occlusion who (1) presented within 24 hours of stroke onset, but were ineligible for thrombolysis or thrombectomy, (2) had progression of stroke symptoms 24 hours to 96 hours after stroke onset, or (3) deteriorated or failed to improve after thrombolysis. Study patients also had a National Institutes of Health Stroke Scale (NIHSS) score of at least 5 upon trial entry and a motor deficit in at least one limb. Using concealed allocation, investigators randomized these patients to receive tirofiban or aspirin. In the tirofiban group (n = 606), patients received intravenous tirofiban at a dose of 0.4 mcg/kg/min for 30 minutes, followed by 0.1 mcg/kg/min for up to 48 hours, along with oral placebo for 2 days. In the aspirin group (n = 571), patients received oral aspirin 100 mg daily for 2 days, along with intravenous placebo for up to 48 hours. Patients in both groups then received aspirin 100 mg daily until day 90. The 2 groups were similar at baseline with a median age of 68 years and a median NIHSS score of 9. The majority of patients were presumed to have strokes due to atherosclerosis. The primary efficacy end point was an "excellent" outcome at 90 days, defined as a modified Rankin scale score of 0 or 1. Patients in the tirofiban group fared better overall, with 29.1% achieving an excellent outcome compared with 22.2% in the aspirin group (adjusted risk ratio 1.26; 95% CI 1.04 - 1.53; P = .02; number needed to treat = 15). For safety end points, there was no significant difference in death at 90 days between the 2 groups (3.8% in tirofiban group vs 2.6% in aspirin group; P = .12). However, 6 patients in the tirofiban group experienced symptomatic intracranial hemorrhages compared with 0 patients in the aspirin group (1% vs 0%; P = .03).
Reviewer
Nita Shrikant Kulkarni, MD
Assistant Professor in Hospital Medicine
Northwestern University
Chicago, IL
Commentaires
Lack of sex disaggregated information
The information is not sex-disaggregated, and is therefore useless information. We know that men and women have different risk factors for stroke, different responses to ASA, as well as different risk reduction with the uses of ASA, so this research actually tells us nothing useful.
Impact assessment
Excellent
tirofiban
good information
Further commentary useful
It would have been nice to see what kind of outcome the "less than excellent" patients had and if the if the 1% risk of symptomatic ICH is worth taking. A cost comparison would also have been useful.