Ticagrelor gains FDA approval for secondary stroke prevention
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AstraZeneca announced the FDA approved its P2Y12 inhibitor ticagrelor for the reduction of stroke risk among patients with acute ischemic stroke or high-risk transient ischemic attack.
The new indication for ticagrelor (Brilinta) was granted based on positive results from the THALES phase 3 trial, according to a press release from the company.
As Healio previously reported, compared with placebo, ticagrelor 90 mg used twice daily and taken with daily aspirin for 30 days lowered the risk for stroke or death among patients with acute ischemic stroke or TIA who did not undergo IV or endovascular thrombolysis.
“One in four patients who have had a stroke will experience a second one, with the risk particularly high within the first 30 days,” S. Claiborne Johnston, MD, dean of the Dell Medical School at the University of Texas at Austin and lead investigator for the THALES trial, said in the release. “The approval of Brilinta in combination with aspirin is an important advancement to reduce the risk of recurrent stroke and much-awaited good news for physicians and patients.”
In the U.S., ticagrelor is also indicated for risk reduction of first MI or stroke among high-risk patients with CAD.
“In the U.S., someone has a stroke every 40 seconds and the impact on a person’s life can be truly devastating,” Sir Mene Pangalos, PhD, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in the release. “Brilinta is a well-established medicine across patients with coronary artery disease and with today’s approval, we can now expand its potential to patients with an acute ischemic stroke or transient ischemic attack.”
Perspective
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Larry B. Goldstein, MD, FAAN, FANA, FAHA
The SOCRATES trial (Johnston SC, et al. N Engl J Med. 2016;doi:375:35-43.) found that ticagrelor was not superior to aspirin in reducing the rate of stroke, MI or death at 90 days in patients who had a non-disabling ischemic stroke or TIA.
The THALES trial (Johnston SC, et al. N Engl J Med. 2020;doi:383:207-217.) found that in patients with a mild-to-moderate acute non-cardioembolic ischemic stroke or TIA, stroke or death within 30 days was lower with ticagrelor plus aspirin than with aspirin alone, but the incidence of disability did not differ significantly between the two groups and the risk of bleeding was higher with the combination.
PLATO (Wallentin L, et al. N Engl J Med. 2009;doi:361:1045-57.), comparing ticagrelor with clopidogrel in patients with ACS, reported no difference in the primary endpoint (death from vascular causes, MI or stroke) for those with or without a history of prior nonhemorrhagic stroke or TIA. A subsequent analysis (DiNicolantonio JJ, et al. Stroke. 2012;doi:43:3409-3410.), including the FDA PLATO complete response review, suggested that there could be a twofold increased risk for a recurrent stroke or TIA, a twofold increased risk for an intracranial hemorrhage, and a 10-fold increased risk for a fatal intracranial hemorrhage among PLATO participants with prior stroke or TIA treated with ticagrelor compared with clopidogrel.
Given all of these data, ticagrelor might be a reasonable alternative for patients with ischemic stroke or TIA who were allergic to or had another contraindication for aspirin. I am not aware of persuasive evidence suggesting benefit of ticagrelor compared to clopidogrel in this patient population.
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