Primary and Secondary Outcomes
The primary outcomes in this study were re-hospitalization and major
adverse cardiovascular events (MACE), a composite of cardiovascular
death, reinfarction, cerebrovascular events, major bleeding, target
vessel revascularization (TVR), and target lesion revascularization
(TLR).
Major bleeding based on the standardized definitions of bleeding for
cardiovascular clinical trials includes: fatal bleeding that leads to
death within 7 days, intracranial or retroperitoneal bleeding, bleeding
that is accompanied by a drop of at least 3-5 units of hemoglobin or
need to inject at least 2-4 units of blood, bleedings that lead to
hemodynamic disorders and require intervention, access site bleedings
that require intervention, and hematoma with a size of 5 cm or more
(17).
TVR was defined as unplanned repeat PCI or bypass graft placement for a
stenosis in another part of the vessel treated at the index PCI (ie,
exclusive of TLR events). TLR was defined as repeat PCI or bypass graft
placement for restenosis at the lesion treated during index PCI or
occurring within 5 mm of the PCI site (18).
Secondary outcomes include separate examination of in-hospital and
out-of-hospital death due to cardiovascular diseases, re-infarction,
cerebrovascular events, major bleeding, minor bleeding, TVR and TLR.