The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
External applicability of the ISCHEMIA trial: an analysis of a prospective, nationwide registry of patients with stable coronary artery disease
Leonardo De Luca1; Massimo Uguccioni2; Jennifer Meessen3; Pier Luigi Temporelli4; Fabrizio Tomai5; Francesco Mario De Rosa6; Enrico Passamonti7; Dario Formigli8; Carmine Riccio9; Domenico Gabrielli10; Furio Colivicchi11; Michele Massimo Gulizia12; Gian Piero Perna13;
1. Division of Cardiology, A.O. San Camillo-Forlanini, Roma, Italy, Italy 2. Division of Cardiology, A. O. San Camillo-Forlanini, Roma, Italy 3. Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano 4. Division of Cardiology, Istituti Clinici Scientifici Maugeri, IRCCS, Gattico-Veruno (Novara) 5. Division of Cardiology, European Hospital/Aurelia Hospital, Roma 6. Division of Cardiology, P.O. dell'Annunziata, Cosenza 7. Division of Cardiology, Istituti Ospedalieri, Cremona 8. Division of Cardiology, A. O. G. Rummo, Benevento 9. Division of Cardiology, Azienda Ospedaliera Sant'Anna e San Sebastiano, Caserta 10. Division of Cardiology, A. Murri Hospital, Fermo 11. Division of Cardiology, S. Filippo Neri Hospital, Roma 12. Division of Cardiology, Garibaldi-Nesima Hospital, Catania 13. Division of Cardiology, Azienda Ospedaliero-Universitaria Ospedali Riuniti, Ancona, Italy
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Aim. 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 or -Unclassifiable), 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.