FDA Approves Ticagrelor to Reduce Risk of First Heart Attack, Stroke in Patients with Coronary Artery Disease
This marks the first regulatory approval for aspirin plus ticagrelor dual antiplatelet therapy in patients with a high cardiovascular risk but without a history of heart attack or stroke.
The FDA has approved ticagrelor (Brilinta, AstraZeneca) for high-risk patients with coronary artery disease (CAD). This marks the first regulatory approval for aspirin plus ticagrelor dual antiplatelet therapy in patients with a high cardiovascular risk but without a history of heart attack or stroke.1
The drug is also indicated to reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction. The drug has been shown to be superior to clopidogrel for at least the first 12 months following acute coronary syndrome.1
The FDA approval is based on results from the phase 3 THEMIS trial, which found a statistically significant reduction in major adverse cardiovascular events at 36 months in patients who received aspirin and ticagrelor 60 mg, compared with patients who received aspirin alone.1
The investigators randomized 19,220 patients aged 50 years and older and who had stable CAD and type 2 diabetes to receive either ticagrelor plus aspirin or a placebo plus aspirin. They found that the incidence of ischemic cardiovascular events was lower among the ticagrelor group, whereas the incidence of thrombosis in myocardial infarction (TIMI) major bleeding was higher.2
Although the drugs’ indication is not limited to patients with CAD and type 2 diabetes without a history of heart attack or stroke, the trial also established efficacy in the type 2 diabetes population.1
“Around one-third of patients with coronary artery disease have type 2 diabetes, putting them at higher risk of heart attack or stroke than patients without diabetes,” said Gabriel Steg, MD, co-chair of the THEMIS trial, in a statement. “Today’s approval brings new hope to patients at risk of experiencing a first heart attack or stroke.”1
High-level results from the trial also found that ticagrelor 90 mg and aspirin reduced the risk of the composite of stroke and death at 30 days after an acute ischemic stroke or transient ischemic attack, compared with just aspirin alone. Ticagrelor is not indicated for patients with minor acute ischemic stroke or high-risk transient ischemic attack.1
“Coronary artery disease is a potentially life-threatening condition that causes significant morbidity in many people,” said Deepak L. Bhatt, MD, MPH, a co-chair of the THEMIS trial, in a statement from AstraZeneca. “The addition of ticagrelor to aspirin offers a new therapeutic option to decrease the likelihood of both heart attack and stroke, a significant advance in our ability to treat these high-risk patients.”1
- Brilinta approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease [news release]. AstraZeneca; June 1, 2020. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2020/brilinta-approved-in-the-us-to-reduce-the-risk-of-a-first-heart-attack-or-stroke-in-high-risk-patients-with-coronary-artery-disease-06012020.html. Accessed June 2, 2020.
- Steg G, Bhatt D, Simon T, Fox K, et al. Ticagrelor in Patients with Stable Coronary Disease and Diabetes. New England Journal of Medicine; October 3, 2019. https://www.nejm.org/doi/full/10.1056/NEJMoa1908077. Accessed June 2, 2020.