Table 3.

Secondary end points.

Patient-Related End Points

The following end points will be reported at all time points, unless otherwise specified: •MACE at all time points not included in the primary end point •Major adverse cardiovascular and cerebrovascular events (MACCE), defined as MACE and/or any stroke (NeuroARC definition) •All-cause, cardiovascular, and noncardiovascular mortality •Myocardial infarction (Fourth Universal Definition) •Stroke (NeuroARC definition) •Revascularization (PCI or CABG) •Hospitalization for cardiovascular causes •Hospitalization for heart failure •Repeat coronary angiography •Progression to obstructive CAD by core laboratory analysis (subject level) •Progression to obstructive CAD by core laboratory analysis (lesion level) •Major bleeding (BARC definition 3-5) •Major vascular complications •Composite of death, myocardial infarction, and stroke •Angina severity assessed by Canadian Cardiovascular Society class or Braunwald Unstable Angina classification •Seattle Angina Questionnaire as a change from baseline •Quality of life assessed by EQ-5D-5L (at 30 d, 6 mo, and 1-5 y) as a change from baseline •Depression assessed by the PHQ-8 questionnaire (at 30 d, 6 mo, and 1-5 y) as a change from baseline •Anxiety assessed by the GAD-7 questionnaire (at 30 d, 6 mo, and 1-5 y) as a change from baseline

Procedural End Points

The following end points will be reported in-hospital (or within 48 h of the index procedure): •Reclassification from preprocedure diagnosis (including noncardiac chest pain) •Completion of the interventional diagnostic procedure without device-related serious adverse events or major angiographic complications •Frequency of major angiographic complications (device-related coronary artery dissection [greater than type C], slow or no flow, or perforation)

BARC, Bleeding Academic Research Consortium; CABG, coronary artery bypass grafting; CAD, coronary artery disease; EQ-5D-5L, EuroQol 5 Dimensions – 5 Levels; GAD, Generalized Anxiety Disorder; MACCE, major adverse cardiovascular and cerebrovascular events; MACE, major adverse cardiovascular events (composite of cardiovascular death, myocardial infarction, hospitalization for cardiovascular causes, or coronary revascularization); NeuroARC, Neurologic Academic Research Consortium; PHQ, Patient Health Questionnaire; PCI, percutaneous coronary intervention.