Assessment of the High Risk and Unmet Need in Patients With Coronary Artery Disease and Type 2 Diabetes: A Descriptive Retrospective Cohort Study (ATHENA)

Abstract Objective: Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) filled an important data gap by showing a significant reduction of ischemic cardiovascular events in a ticagrelor plus aspirin cohort compared with placebo plus aspirin cohort among patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) but without a history of myocardial infarction. This study aims to evaluate the applicability of the THEMIS results in a real-world clinical setting in China. Methods: This retrospective, observational cohort study used data from the Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease (OPT-CAD) study which enrolled participants who were hospitalized between November 2012 and December 2013. The 24-month cumulative incidence of major adverse cardiovascular event (MACE), major bleeding, and all-cause death in patients with T2DM and CAD (T2DM-CAD), T2DM and stable CAD (SCAD)(T2DM-SCAD), and T2DM and SCAD without prior myocardial infarction or stroke (THEMIS-like) were analyzed. Results: Data from 13,296 patients with CAD were included; the T2DM-CAD, T2DM-SCAD, and THEMIS-like cohorts comprised 3,344 (25.2%), 949 (7.1%), and 509 (3.8%) patients, respectively. The corresponding 24-month cumulative incidence of major bleeding was 38 (1.1%), 16 (1.7%), and 8 (1.6%), and that of MACEs was 250 (7.5%), 87 (9.2%), and 29 (5.7%), and all-cause death was 181 (5.4%), 84 (8.9%), 29 (5.7%), respectively. The risk of MACE in the THEMIS-like cohort was approximate to that in the THEMIS trial (7.7% vs. 8.5% in ticagrelor and placebo group, respectively). Conclusion: The incidence of MACE was substantial in the THEMIS-like cohort, suggesting that cardiovascular risk for future events correlates with the presence of cardiovascular disease across the CAD risk continuum.