Risk factors for the primary effectiveness endpoint in secondary prevention of acute coronary syndrome with antiplatelet agents: A cohort in the nationwide French claims and hospitalisation database

Abstract

The French HTA agency requested a real-life benefit-risk study of ticagrelor (T) compared to clopidogrel (C) and prasugrel (P) in the secondary prevention of acute coronary syndrome (ACS) (EUPAS5987). This study aimed to identify the risk factors associated with the primary effectiveness endpoint for patients with antiplatelet agents after a hospitalisation for ACS. Patients hospitalised in 2013 for STEMI, NSTEMI or unstable angina, with intensive care unit (ICU) stay, and followed for 1 year in the nationwide French claims and hospitalisation database, SNIIRAM. Treatment group (T, C, or P ± aspirin) was defined by the first drug dispensed in the month after discharge. The primary effectiveness endpoint was a composite of the first event of ACS with ICU stay, stroke, or all-cause death. Hazard ratios were estimated with Cox proportional hazard risk model (multivariate analysis). A total of 41,954 patients were included (19,796 C, 13,916 T, 8242 P) with different characteristics: mean age of 72, 63, 58 years, respectively; 68%, 76%, 86% male; 42%, 55%, 72% STEMI. A Charlson comorbidity index > 5 was associated with a risk increased by at least 50% for the primary effectiveness endpoint; age, a poverty index, ICU stay duration > 5 days and no PCI during index hospitalisation, and congestive heart failure, peripheral arterial disease, ischemic stroke, abnormal renal function, C and P before index hospitalisation were associated with a risk increased by 20–50%; diabetes, hypertension, aspirin before index hospitalisation, and C in the month after discharge (versus T) were associated with a risk increased by 10–20%. In this nationwide real-life study, the risk factor most associated with the primary effectiveness endpoint was a Charlson comorbidity index > 5.