Figure 3.

Stratified analysis of major adverse cardiac events (MACE) plus myocardial injury at 30 d across subgroups. A 5P-MACE is defined as a composite of death from cardiovascular causes, nonfatal myocardial infarction (MI), nonfatal stroke, recurrent ischemia with hospitalization, or urgent coronary revascularization. Myocardial injury is defined as an elevation of cTnI (cardiac troponin I) of >5×99% URL (>0.14 ng/mL) in patients with a normal baseline cTnI (<0.028 ng/mL) or >20% increase above an elevated baseline cTnI according to the Third Universal Definition of Myocardial Infarction. Analysis was performed in a modified intent-to-treat population which comprised randomized patients who underwent cardiac catheterization ± percutaneous coronary intervention (PCI) and received any amount of investigational product and had adequate cTnI research biomarker data available for evaluation (n=95). Solid box width is proportional to number of patients in subgroup. Adjusted relative risk (RR) with 95% CI and P values adjusted for age and total coronary atherosclerotic burden (29-segment CASS [Coronary Artery Surgery Study]) using logistic regression (LR). Prior MI did not regress by LR, and χ² analysis was used instead. P value for age ≥75 was adjusted only for CASS score in the LR model. Diabetes includes prediabetes. Smoking includes former and current. Elevated cTnI patients were those patients with a diagnosis of NSTEMI (non–ST-segment–elevation myocardial infarction) determined by the clinical site before randomization and index catheterization plus additional patients whose elevated cTnI levels were identified from the central research lab baseline sample in the absence of local clinical biomarker assessment. ACS indicates acute coronary syndromes; and CAD, coronary artery disease.