External applicability of the ISCHEMIA trial: an analysis of a prospective, nationwide registry of patients with stable coronary artery disease.

Aims We sought to assess the proportion of patients eligible for the ISCHEMIA trial and to compare the characteristics and outcome of these patients with those without ISCHEMIA inclusion or with ISCHEMIA exclusion criteria in a contemporary, nationwide cohort of patients with stable coronary artery disease (CAD). Methods and results Among the 5070 consecutive patients enrolled in the START registry, 4295 (84.7%) did not fulfill the inclusion criteria (ISCHEMIA-Not Included), 582 (11.5%) had exclusion criteria (ISCHEMIA-Excluded), and the remaining 193 (3.8%) were classified as ISCHEMIA-Like. At 1 year, the incidence of the primary outcome, a composite of death from cardiovascular (CV) causes, myocardial infarction (MI), or hospitalization for unstable angina and heart failure, was 0.5% in the ISCHEMIA-Like vs 3.3% in other patients (p=0.03). The composite secondary outcome of CV mortality and MI occurred in 0.5% of the ISCHEMIA-Like and 1.4%in the remaining patients (p=0.1). Conclusions In a contemporary real-world cohort of stable CAD, only 4% of patients resulted as eligible for the ISCHEMIA. These patients presented an extremely low annual risk of adverse events, especially when compared with other groups of stable CAD patients.