DAPT with P2Y12-inhibitor lowers CV events in T2DM patients with established CAD
The Phase III THEMIS trial met its primary endpoint and demonstrated that ticagrelor, taken in conjunction with aspirin, showed a statistically significant reduction in a composite of major adverse cardiovascular events (MACE) compared to aspirin alone, in patients with coronary artery disease (CAD) and type-2 diabetes (T2DM) with no prior myocardial infarction (MI) or stroke.
THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) was a multi-national, randomized, double‑blinded trial conducted in over 19,000 patients with T2DM and CAD. CAD was defined as a prior percutaneous coronary intervention, bypass surgery or at least a 50% narrowing of a coronary artery.
THEMIS was designed to test the hypothesis that ticagrelor plus aspirin would reduce MACE, a composite of CV death, MI or stroke, in patients with CAD and T2DM with no prior MI or stroke, vs. aspirin alone. Ticagrelor is an oral, reversible, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. Ticagrelor, together with aspirin, has been shown to significantly reduce the risk of MACE in patients with acute coronary syndrome or a history of MI.
Preliminary safety results were consistent with the known profile of ticagrelor. A full evaluation of the THEMIS data will be presented at a forthcoming medical meeting.
Deepak L. Bhatt, MD, MPH, THEMIS co-Chair and Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and a Professor at Harvard Medical School said: “The THEMIS trial is the largest randomised trial of patients with type-2 diabetes performed to date and was designed to evaluate whether more-intense antiplatelet therapy is a promising approach. The results could help us refine our understanding of the role of dual antiplatelet therapy in patients across the atherothrombotic spectrum.”