Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome

Major Adverse Cardiovascular Events

Major adverse cardiovascular events are defined as a composite of all-cause death, myocardial infarction, ischemia-driven target vessel revascularization, and definite or probable stent thrombosis occurring up to 12 months after randomization.

Clinically Relevant Bleeding

Clinically relevant bleeding is defined as the incidence of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding events occurring up to 12 months after randomization.

Incidence of Major and Minor Bleeding According to TIMI Criteria

TIMI bleeding definitions: • Major: Any intracranial bleeding (excluding microhemorrhages 10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of 5 g/dL, Fatal bleeding (bleeding that directly results in death within 7 d) • Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to 5 g/dL, requiring medical attention, any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above, requiring intervention (medical practitioner-guided medical or surgical treatment to stop or treat bleeding, including, temporarily or permanently discontinuing or changing the dose of a medication or study drug), leading to or prolonging hospitalization, prompting evaluation (leading to an unscheduled visit to a healthcare professional and diagnostic testing, either laboratory or imaging).

Incidence of Major and Minor Bleeding According to ISTH Criteria

* Major: 1. Fatal bleeding and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. * Minor: All non-major bleeds will be considered minor bleeds. Minor bleeds will be further divided into those that are clinically relevant and those that are not.

Incidence of All-Cause Death

All-cause mortality was used rather than cardiac mortality to eliminate the need for possibly difficult adjudication of causes of death, especially given the relatively low mortality expected. In addition, the cause of death will be adjudicated as being due to cardiovascular causes, non-cardiovascular causes, or undetermined causes. * Cardiovascular death includes sudden cardiac death, death due to acute MI, heart failure or cardiogenic shock, stroke, other cardiovascular causes, or bleeding * Non-cardiovascular death is defined as any death with known cause not of cardiac or vascular causes * Undetermined cause of death refers to a death not attributable to one of the above categories of cardiovascular death or to a noncardiovascular cause. For this trial all deaths of undetermined cause will be included in the cardiovascular category

Incidence of Myocardial Infarction

The definition of MI is based on the SCAI definition of clinically relevant MI. MI is defined as an abnormal cardiac biomarker level above the institutional upper limit of normal (either cardiac troponin or CK-MB), and either at least 1 of the following: a) Symptoms of myocardial ischemia, b) New or presumed new significant ST-segment-T wave (ST-T) changes or new LBBB on the ECG, c) Development of pathological Q waves on the ECG, d) Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, e) Identification of an intracoronary thrombus by angiography or autopsy.