Table 3.

Inclusion and Exclusion Criteria^*

Inclusion Criteria (at enrollment) 1. At least moderate ischemia on a qualifying stress test 2. Participant is willing to give informed consent 3. Age ≥ 21 years

Exclusion Criteria 1. LVEF <35% 2. History of unprotected left main stenosis ≥50% on prior CCTA or prior cardiac catheterization (if available) 3. Finding of “no obstructive coronary artery disease” (<50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months 4. Coronary anatomy unsuitable for either PCI or CABG 5. Unacceptable level of angina despite maximal medical therapy 6. Very dissatisfied with medical management of angina 7. History of noncompliance with medical therapy 8. Acute coronary syndrome within the previous 2 months 9. PCI within the previous 12 months 10. Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time 11. History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia not due to a transient reversible cause 12. NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months 13. Non-ischemic dilated cardiomyopathy or hypertrophic cardiomyopathy 14. End stage renal disease on dialysis or estimated glomerular filtration rate <30 ml/min (not an exclusion criterion for CKD ancillary trial, see CKD ancillary trial) 15. Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial 16. Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast 17. Planned major surgery necessitating interruption of dual antiplatelet therapy (note that patients may be eligible after planned surgery) 18. Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity 19. Pregnancy (known to be pregnant; to be confirmed pre-CCTA and/or randomization, if applicable) 20. Patient who, in the judgment of the patient’s physician, is likely to have significant unprotected left main stenosis (those who are able to undergo CCTA will have visual assessment of the left main coronary artery by the CCTA core laboratory) 21. Enrolled in a competing trial that involves a non-approved cardiac drug or device 22. Inability to comply with the protocol 23. Exceeds the weight or size limit for CCTA or cardiac catheterization at the site 24. Canadian Cardiovascular Society Class III angina of recent onset, or angina of any class with a rapidly progressive or accelerating pattern 25. Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina 26. High risk of bleeding which would contraindicate the use of dual antiplatelet therapy 27. Cardiac transplant recipient 28. Prior CABG, unless CABG was performed more than 12 months ago and coronary anatomy has been demonstrated to be suitable for PCI or CABG to accomplish complete revascularization of ischemic areas (CCC approval required)

^*ISCHEMIA Protocol Version 2.0

LVEF = left ventricular ejection fraction; CCTA = coronary computed tomography angiography; PCI = percutaneous coronary intervention; CABG = coronary artery bypass graft surgery; NYHA = New York Heart Association; CKD = chronic kidney disease; CCC = Clinical Coordinating Center.