Table 2.

Definitions of Primary and Secondary Study Endpoints

Primary endpoints
Cardiovascular mortality: Death due to AMI, SCD, HF or cardiogenic shock, stroke, or other cardiovascular causes, including arrhythmias unrelated to SCD, aortic aneurysm rupture, PE, PAD, or complications of cardiovascular intervention, including cardiac surgery and nonsurgical revascularization.
MI: Based on an evidence of myocardial necrosis (cardiac biomarkers) in combination of a clinical setting consistent with MI (ECG, symptoms).
Unplanned revascularization: An unforeseen repeat PCI or bypass graft placement in any coronary vessel (ie, either at the lesion treated during the index PCI, in another segment of the vessel treated at the index PCI, or in another vessel other than the vessel treated at index PCI).
Stroke/TIA: Stroke is defined as global or focal cerebral, spinal cord, or retinal injury resulting in acute neurological dysfunction and is further classified into ischemic, hemorrhagic, or undetermined stroke. TIA is defined as a transient episode of neurological dysfunction due to focal temporary cerebral, spinal cord, or retinal ischemia without acute infarction.
Secondary endpoints
All‐cause mortality: Death due to any cause.
TVR (all and ischemia‐driven): An unforeseen repeat PCI or bypass graft placement for any segment of the vessel treated during the index PCI.
ST: Based on the level of evidence (definite, probable, or possible ST) and the elapsed time since stent implantation (acute, subacute, late, or very late ST).
Hospitalization for HF: The presence of CHF being the primary disease process accounting for clinical and physical signs of HF, with a need for additional or increased HF therapy, requiring at least a 24‐hour stay in an inpatient unit or ED.

Abbreviations: AMI, acute myocardial infarction; CHF, congestive heart failure; ECG, electrocardiogram; ED, emergency department; HF, heart failure; MI, myocardial infarction; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; PE, pulmonary embolism; SCD, sudden cardiac death; ST, stent thrombosis; TIA, transient ischemic attack; TVR, target‐vessel revascularization.