Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome (SAPT-ACS)

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).

• 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.

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

A coronary revascularization procedure may be either a CABG or a PCI.

• Target Vessel: The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion including upstream and downstream branches and the target lesion itself All revascularization events will be adjudicated as either ischemia-driven or non-ischemia-driven. Revascularization will be considered ischemia-driven if the diameter stenosis of the revascularized coronary segment is ≥50% by QCA and any of the following criteria for ischemia are met: a) History of angina pectoris, presumably related to the target vessel, b) Objective signs of ischemia at rest (electrocardiographic changes) or during exercise test (or equivalent), presumably related to the target vessel c) Abnormal results of any invasive functional diagnostic test (e.g., CFR or FFR).

• Definite stent thrombosis: defined as occurring when clinical presentation is consistent with acute coronary syndrome and angiography or autopsy examination confirm stent occlusion or thrombus.
• Probable stent thrombosis: defined as death occurring within 30 days that cannot be attributed to another cause or when myocardial infarction occurs at any time point and is attributable to the target vessel in the absence of angiography confirming another culprit lesion.
• Possible stent thrombosis: defined as occurring when the patient dies after >30 days and death is not explained by another cause.