Table III.
Primary end points |
30-d MACCE: |
Cardiac death |
Myocardial re-infarction |
Emergency coronary revascularization, including PCI, thrombolysis, and CABG |
Stroke |
Secondary end points |
1. Each component of the primary end point |
2. 30-d severe STEMI complications: |
Cardiogenic shock (Killip IV) |
Acute left heart failure (Killip II, III) |
Mechanical complications: including interventricular septum perforation, papillary muscle dysfunction, ruptured left ventricular free walls |
Malignant arrhythmia: including ventricular fibrillation, ventricular flutter, ventricular tachycardia, ventricular premature contraction (frequent, polymorphic, multifocal, or R on T) |
3. BARC type III and V major bleeding: |
BARC IIIa: overt bleeding with hemoglobin drop of 3 to <5 g/dL or any transfusion with overt bleeding |
BARC IIIb: overt bleeding with hemoglobin drop >5 g/dL, cardiac tamponade, bleeding that requires surgical intervention to control (excluding dental, nasal, skin, or hemorrhoid), or bleeding that requires intravenous vasoactive agents |
BARC IIIc: intracranial hemorrhage (including intraspinal bleeding, excluding microbleeds or hemorrhagic transformation), subcategories confirmed by autopsy/imaging/lumbar puncture, or intraocular bleeding comprising vision |
BARC V: fatal bleeding |
4. 1-y MACCE |
Cardiac death |
Myocardial reinfarction |
Emergency coronary revascularization, including PCI, thrombolysis, and CABG |
Stroke |
5. 1-y rehospitalization due to heart failure |
6. 1-y all-cause death |
7. In-stent thrombosis: |
Acute: <24 h |
Subacute: 1-30 d |
Late: 1-12 m |
8. ECG evaluation of myocardial reperfusion and no-reflow: ST-segment resolution and occurrence of no-reflow in ECG at 2 h, 24 h, and 7 d after revascularization therapy |
CABG, coronary artery bypass grafting.