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Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Tia of Atherosclerotic Origin

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Author Block: Pierre Amarenco, Paris Univ, Paris, France; Hans Denison, AstraZeneca, Gothenburg, Sweden; Scott R Evans, George Washington Univ, Washington, DC; Anders Himmelmann, AstraZeneca, Gothenburg, Sweden; Stefan James, Uppsala Univ, Uppsala, Sweden; Mikael Knutsson, Per Ladenvall, AstraZeneca, Gothenburg, Sweden; Carlos Molina, Barcelona; Yongjun Wang, Capital Medical Univ, Beijing, China; Claiborne Johnston, Univ of Texas, Austin, TX
Disclosure Block: P.Amarenco: Honoraria; Modest; Amgen, Kowa, Shing Poon, Honoraria; Significant; Bayer, GSK, Fibrogen, Research Grant; Significant; Pfizer, AstraZeneca, Sanofi, BMS, Merck, Boston Scientific. C.Johnston: n/a. H.Denison: Employment; Significant; AstraZeneca . S.R.Evans: Other; Significant; Astrazenica. A.Himmelmann: Employment; Significant; AstraZeneca. S.James: Research Grant; Modest; The Medicines Company, Medtronic, Research Grant; Significant; Astra Zeneca. M.Knutsson: Employment; Significant; AstraZeneca. P.Ladenvall: Employment; Significant; AstraZeneca R&D. C.Molina: None. Y.Wang: n/a.
BACKGROUND: Among patients with a transient ischemic attack (TIA) or minor ischemic strokes, those with ipsilateral atherosclerotic stenosis of cervicocranial vasculature have the highest risk of recurrent vascular events.METHODS: In the THALES trial we randomized patients with a non-cardioembolic, non-severe ischemic stroke or high-risk TIA to ticagrelor (180 mg loading dose on day 1 followed by 90 mg twice daily for days 2-30) or placebo added to aspirin (300-325 mg on day 1 followed by 75-100 mg daily for days 2-30) within 24 hours of symptom onset. The present paper reports a prespecified subgroup of patients with ipsilateral, potentially causal atherosclerotic stenosis ≥30% of cervicocranial vasculature. The primary endpoint was time to the occurrence of stroke or death within 30 days.RESULTS: Of 11,016 randomized patients, 2351 (21.3%) patients had an ipsilateral atherosclerotic stenosis. After 30 days, a primary end-point occurred in 92/1136 (8.1%) patients with ipsilateral stenosis randomized to ticagrelor and in 132/1215 (10.9%) randomized to placebo (HR 0.73; 95% CI 0.56 to 0.96, P=0.023) resulting in a number needed to treat of 34. In patients without ipsilateral stenosis, the corresponding event rate was 211/4387 (4.8%) and 230/4278 (5.4%), respectively (HR 0.89; 95% CI 0.74 to 1.08; P=0.23, Pinteraction =0.245). Severe bleeding occurred in 4 (0.4%) and 3 (0.2%) patients on ticagrelor and on placebo, respectively (P=NS) with ipsilateral atherosclerotic stenosis, and in 24 (0.5%) and 4 (0.1%), respectively in 8665 patients without (HR= 5.87; 95% CI 2.04 to 16.9, P=0.001).CONCLUSIONS: In patients with TIA and minor ischemic stroke with ipsilateral stenosis of cervicocranial vasculature, ticagrelor added to aspirin was superior to aspirin alone in preventing stroke or death at 30 days. In this easily identified population ticagrelor added to aspirin provided a clinically meaningful benefit with a number needed to treat of 34. (ClinicalTrials.gov number, NCT03354429)Funding: AstraZeneca.