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Question clinique
Is ticagrelor plus aspirin superior to aspirin alone for decreasing the risk of subsequent stroke or death in patients with acute ischemic stroke?
L’Essentiel
For patients presenting with mild-to-moderate acute nonembolic ischemic stroke, treatment with ticagrelor plus aspirin for 30 days resulted in fewer subsequent strokes, but similar overall disability and an increase in severe bleeding, than with aspirin alone (number needed to treat [NNT] to prevent one event of the composite outcome of stroke or death = 92; number needed to treat to harm [NNTH] to cause one episode of severe bleeding = 263). 1b
Référence
Plan de l'etude: Randomized controlled trial (double-blinded)
Financement: Industry
Cadre: Inpatient (any location) with outpatient follow-up
Sommaire
Although a previous study of ticagrelor did not show a benefit over aspirin in patients with acute ischemic stroke, the effect of ticagrelor plus aspirin is not known. Using concealed allocation, these investigators randomized patients with mild-to-moderate acute nonembolic ischemic strokes (National Institutes of Health Stroke Scale score < 5) or high-risk transient ischemic attacks to receive ticagrelor plus aspirin (n = 5523) or matching placebo plus aspirin (n = 5493). Patients receiving thrombolysis or thrombectomy and those who had intracranial bleeding were excluded. Ticagrelor (or matching placebo) was given at a loading dose of 180 mg, followed by a maintenance dose of 90 mg twice daily for 30 days. Aspirin was given at a loading dose of 300 mg to 325 mg, followed by a dose of 75 mg to 100 mg daily. The 2 groups were balanced at baseline: mean age was 65 years, 39% were women, and 91% presented with ischemic stroke. The primary outcome, a composite of subsequent stroke or death at 30 days, occurred less frequently in the ticagrelor plus aspirin group than in the aspirin-only group (5.5% vs 6.6%; hazard ratio [HR] 0.83; 95% CI 0.71 - 0.96; P = .02). The secondary outcome of subsequent strokes was decreased from 6.3% to 5.0% in the ticagrelor plus aspirin group (HR 0.79; 0.68 - 0.93; P = .004). Overall, disability at the end of the treatment period did not differ significantly between the 2 groups. Severe bleeding was rare but more frequent in the ticagrelor plus aspirin group (0.5% vs 0.1%; HR 3.99; 1.74 - 9.14; P =.001). Overall, 2.8% of patients in the ticagrelor plus aspirin group discontinued treatment because of bleeding (0.6% in the aspirin group).
Reviewer
Nita Shrikant Kulkarni, MD
Assistant Professor in Hospital Medicine
Northwestern University
Chicago, IL
Commentaires
Excellent POEM
Excellent POEM
length of study
30 days is a short time in my opinion to achieve a meaningful outcome