FDA Approves Ticagrelor for Stroke Risk Reduction in Patients With Coronary Artery Disease

June 1, 2020

This is the first regulatory approval for aspirin plus ticagrelor dual antiplatelet therapy in patients who have a high cardiovascular event risk, but without a history of heart attack or stroke.

Deepak Bhatt, MD, MPH

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The FDA has approved ticagrelor (Brilinta; AstraZenica) for the reduction of risk for first heart attack or stroke in patients with coronary artery disease (CAD).

This is the first regulatory approval for aspirin plus ticagrelor dual antiplatelet therapy in those who are high-risk but have no history of heart attack or stroke, AstraZeneca said in a statement.

“Coronary artery disease is a potentially life-threatening condition that causes significant morbidity in many people. 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,” said Deepak Bhatt, MD, MPH, THEMIS trial Co-Chair and executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, in a statement.

READ MORE: Poorer Cognitive Performance Post-Stroke Observed in Patients With Diabetes

The oral, reversibly binding, direct-acting P2Y12 receptor antagonist was approved as a blood-thinning agent in 2011 and again in 2015 for an expanded indication for reducing cardiovascular risk in patients with a history of cardiovascular disease. The latest approval for patients without a history of cardiovascular disease is backed by data from the multinational phase 3 THEMIS trial. The largest trial in diabetes ever at the time, THEMIS randomized more than 19,000 patients and, over almost 40 months of follow-up, examined the impact of dual antiplatelet therapy with ticagrelor and aspirin against placebo and aspirin.

Results of the trial indicated use of dual antiplatelet therapy with ticagrelor resulted in a relative risk reduction of 10% for a composite of heart attack, stroke, and cardiovascular disease compared with placebo plus aspirin (absolute risk reduction; 0.8%, 7.7% vs 8.5%). The statement announcing this most recent expanded indication approval also noted results from the phase 3 THALES trial indicated ticagrelor with aspirin decreased risk of stroke and death at 30 days after an acute ischemic stroke or transient ischemic attack compared to aspirin alone.

"Today’s approval of Brilinta is important news for patients with coronary artery disease who will now have a new therapy option to reduce the risk of a first heart attack or stroke. This new indication is a further testament to the overwhelming science supporting Brilinta in the management of patients with coronary artery disease at high risk for cardiovascular events,” said Ruud Dobber, executive vice president of BioPharmaceuticals Business Unit at AstraZeneca.

Label information for ticagrelor highlights an increased bleeding risk, similar to other antiplatelet agents, that can result in significant and sometimes fatal bleeding. Ticagrelor is also contraindicated in those with active pathological bleeding or history of intracranial hemorrhage. Labeling information also recommends against initiating therapy in those undergoing urgent coronary artery bypass graft surgery.

REFERENCE

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. AstraZenica. June 1, 2020. Accessed June 1, 2020. https://www.businesswire.com/news/home/20200601005200/en/BRILINTA-Approved-Reduce-Risk-Heart-Attack-Stroke