OBJECTIVES

The THEMIS trial (NCT01991795) will compare ticagrelor + ASA vs placebo + ASA for prevention of CV events in patients with coronary artery disease (CAD) and type 2 diabetes (T2D) without prior MI or stroke. We assessed healthcare resource utilization (HCRU) and cost in patients similar to those eligible for enrollment in THEMIS (THEMIS-like) and in a broader population (T2D-CAD) to inform the generalizability of THEMIS results to routine practice.

METHODS

This retrospective, observational study encompassed two real-world T2D populations at high risk for CV events, 95% of whom were aged >65 years. Data were collected for 2013-14 from the Diabetes Collaborative Registry linked to Medicare administrative claims. The THEMIS-like cohort included patients with T2D plus either revascularization or angina and excluded MI and ischemic stroke. The broader T2D-CAD cohort additionally included hemorrhagic stroke and patients with prescriptions for antiplatelet therapy. HCRU, costs, and persistence with secondary prevention medications (antiplatelets, statins, ACE inhibitors, ARBs, beta-blockers) were analyzed.

RESULTS

Baseline characteristics were similar between cohorts. Men constituted 63% of the THEMIS-like cohort (N=56,040) and 61% of the T2D-CAD cohort (N=69,790). Mean ±SD age in both cohorts was 74 ±7 years. Mean all-cause total costs for the study period in the THEMIS-like and T2D-CAD cohorts were $11,626 and $11,803, respectively. Inpatient costs were 43% and CV-related costs were 22% of the total in both cohorts. Incidence rate for ED visits and inpatient admissions for nontraumatic bleeding was 0.13 per 100 person-years in both cohorts. Persistence with statin and beta-blocker therapy was 58%, and <40% for the other therapies.

CONCLUSIONS

Substantial healthcare costs but low bleeding risks were observed in a THEMIS-like and a similar cohort of patients aged >65 years from a large US registry. These findings identify a unique patient population that may benefit from better preventive measures.