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THEMIS top-line results announced: Ticagrelor reduces major adverse CV events

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Deepak L. Bhatt

AstraZeneca announced today top-line results from the THEMIS trial, showing that the trial met its primary endpoint and demonstrated a statistically significant reduction in a composite of major adverse CV events in patients with CAD and type 2 diabetes without a history of MI or stroke who were treated with ticagrelor and aspirin compared with aspirin alone.

“The THEMIS trial is the largest randomized trial of patients with type 2 diabetes performed to date and was designed to evaluate whether more intense antiplatelet therapy is a promising approach,” Cardiology Today’s Intervention Chief Medical Editor Deepak L. Bhatt, MD, MPH, professor of medicine at Harvard Medical School, executive director of interventional cardiovascular programs in the Heart and Vascular Center at Brigham and Women’s hospital, and co-chair of the THEMIS trial, said in a press release. “The results could help us refine our understanding of the role of dual antiplatelet therapy in patients across the atherothrombotic spectrum.”

The THEMIS trial assessed data from more than 19,000 patients with CAD and type 2 diabetes without previous MI or stroke. Patients were assigned either ticagrelor (Brilinta, AstraZeneca) with aspirin or aspirin alone. The primary endpoint was major adverse CV events, defined as a composite of MI, CV death or stroke.

“Patients who have both stable coronary artery disease and diabetes are a sizable group which remains at particularly high risk of major adverse cardiac events,” Gabriel Steg, MD, professor at Université Paris-Diderot and at the National Heart and Lung Institute at Imperial College in London, and co-chair of the THEMIS trial, said in the press release. “The optimal long-term antiplatelet therapy in that group is not fully established. We look forward to presenting the full results from the THEMIS trial later this year.”

Gabriel Steg

Disclosures: The THEMIS trial is sponsored by AstraZeneca. Bhatt and Steg are co-chairs of the THEMIS trial.