FDA Approves Ticagrelor (Brilinta) for DAPT in High-risk Patients With CAD

June 01, 2020

The US Food and Drug Administration has approved ticagrelor (Brilinta/Brilique, AstraZeneca) for use with aspirin to cut the risk for a first myocardial infarction (MI) or stroke in high-risk patients with coronary artery disease (CAD) but no history of MI or stroke, AstraZeneca announced today.

The new indication is based on the results of THEMIS, in which such patients with both CAD and type 2 diabetes on dual-antiplatelet therapy (DAPT) that included ticagrelor 60 mg twice-daily showed a 10% drop in risk for major adverse cardiac events compared with aspirin alone over about 3 years. The absolute difference was 0.8% in the 42-country trial with more than 19,000 patients.

Patients falling under the new indication do not need to have diabetes, although THEMIS had entered patients with diabetes and CAD, the latter defined as a 50% or greater narrowing of a coronary artery or a history of coronary revascularization but without a history of MI or stroke.

The trial showed a significant reduction in the rate of the primary efficacy end point (= .04), a composite of cardiovascular (CV) death, MI, and stroke. But the risk of TIMI major bleeding was more than doubled in the ticagrelor group (P < .001) and the risk for intracranial hemorrhage went up 71% (P = .005). Net clinical benefit didn't differ significantly between the groups in an exploratory analysis, as previously reported by theheart.org | Medscape Cardiology.

The benefit of DAPT with ticagrelor for the primary efficacy end point was even more pronounced in a prespecified THEMIS subanalysis of more than 11,000 patients with a history of percutaneous coronary intervention. In this group, the risk for ICH didn't differ significantly between the groups, and the net clinical benefit favored ticagrelor by a significant 15%.

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