AstraZeneca Announced Brilinta Reduced the Composite of Stroke and Death in Patients With Head and Neck Artery Atherosclerosis Who Had an Acute Ischaemic Stroke or Transient Ischaemic Attack
Detailed results from a prespecified subgroup (n=2,351) analysis of the positive THALES Phase III trial showed AstraZeneca's Brilinta (ticagrelor) 90mg used twice daily and taken with daily aspirin for 30 days reduced the rate of the composite of stroke and death by 27% (absolute risk reduction 3%, HR 0.73 [95% CI 0.56, 0.96], nominal p=0.023) compared to aspirin alone in patients who had an acute
· 11/17/2020 05:14
Detailed results from a prespecified subgroup (n=2,351) analysis of the positive THALES Phase III trial showed AstraZeneca's Brilinta (ticagrelor) 90mg used twice daily and taken with daily aspirin for 30 days reduced the rate of the composite of stroke and death by 27% (absolute risk reduction 3%, HR 0.73 [95% CI 0.56, 0.96], nominal p=0.023) compared to aspirin alone in patients who had an acute ischaemic stroke or a transient ischaemic attack (TIA) and had ipsilateral atherosclerotic stenosis in the head and neck (cervicocranial) arteries.1 This means that the number needed to treat (NNT) was 34 in this sub-group of patients compared to a NNT of 92 in the overall THALES population.1,2 This represents a consistent reduction in an easily identifiable patient population. In the subgroup of patients without ipsilateral stenosis at baseline, the rate of the primary composite endpoint of stroke or death was 4.8% for the aspirin and ticagrelor group versus 5.3% for the aspirin alone group (HR 0.89 [95% CI 0.74, 1.08]).1 Furthermore, aspirin plus ticagrelor also reduced the rate of the first secondary endpoint of ischaemic stroke by 28% (absolute risk reduction 2.9%, HR 0.72 [95 % CI 0.55, 0.95], nominal p=0.02) compared to aspirin alone up to day 30 in this sub-group.1 Atherosclerotic stroke or TIA can occur when a lipid-rich plaque ruptures in head and neck arteries leading to the formation of blood clots that may obstruct the blood flow to the brain. About 40 per cent of patients with ischaemic stroke have an ipsilateral (on the same side as the symptomatic cerebral ischaemia) atherosclerotic stenosis (narrowing of the arteries due to plaque formation), which may cause a stroke.1 Dr Pierre Amarenco, International Coordinating Investigator and Vice-Chair of the THALES Executive Committee and Professor of Neurology at Paris University, said: "A body of scientific evidence, including our own analysis, shows that patients with ipsilateral atherosclerotic disease experience a much higher risk of ischaemic stroke than patients with other subtypes.1 This new data from the THALES trial indicates that ticagrelor offers protection in this patient population, which is easily identified in clinical practice." Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "Patients who had an acute ischaemic stroke or a transient ischaemic attack are at high risk for recurrent, potentially disabling or fatal events.3 Given this and the established heritage of ticagrelor in the prevention of atherothrombotic events, we are pleased to see that aspirin plus ticagrelor has the potential to be an effective preventive treatment for subsequent stroke in patients with cervicocranial atherosclerosis." Key efficacy and safety data from the subgroup analysis of the THALES trial Key efficacy and safety data from the subgroup analysis of the THALES trial table i. Amarenco P et al. Ticagrelor added to aspirin in acute non-severe ischemic stroke or TIA of atherosclerotic origin. Stroke; doi: 10.1161/STROKEAHA.120.032239. * By GUSTO (Global Utilization of Streptokinase and Tissue-type plasminogen activator for Occluded coronary arteries trial) definition; CI=confidence interval; KM=Kaplan-Meier The risk of severe bleeding events in the atherosclerotic subgroup was 0.4% in the aspirin plus ticagrelor arm and 0.2% in the placebo arm.1 The results were in line with the known safety profile of ticagrelor. Results from the subgroup analysis of the THALES trial were presented on 16 November at the American Heart Association Scientific Sessions 2020 and simultaneously published in Stroke. Earlier this month, AstraZeneca announced that the US Food and Drug Administration (FDA) approved ticagrelor to reduce the risk of stroke in patients with an acute ischaemic stroke (National Institutes of Health Stroke Scale score ≤5) or high-risk TIA.