Table 3.

Clinical endpoints.

Clinical endpoint	Advantages	Disadvantages
MACE rate or TVF Rate	Highly relevant for reimbursement	In observational studies, MACE/TVF may be difficult to determine Larger population >500 patients
TLR (Re-PCI + CABG) rate or TVR (Re-PCI, CABG) in target vessel	Highly relevant for reimbursement	In observational studies, target lesion re-PCI may be difficult to determine
Cardiac death rate	Highly relevant for reimbursement	Meaningful test hypotheses require patient numbers >1000 patients per group Cause of death sometimes unclear
MI rate	Should be associated with TLR	Not always attributable to the treated target lesion or vessel
ST rate	Highly desirable for interdevice comparisons, e.g. DES	Meaningful test hypotheses require patient numbers >5000 patients per group
Stroke rate	Highly relevant for reimbursement	Meaningful test hypotheses require patient numbers >2000 patients per group May not be an outcome of the coronary revascularization procedure

CABG, coronary-artery bypass graft; DES, drug-eluting stents; MACE, major adverse cardiac event; TLR, target-lesion revascularization; Re-PCI, repeat percutaneous coronary intervention; TVR, target-vessel revascularization; TVF, target-vessel failure; MI, myocardial infarction; ST, stent thrombosis.