The primary clinical endpoint was the occurrence of major adverse cardiac events (MACE), which was a composite of cardiac death (CD), MI, revascularization, and re-admission due to HF during the 2-year follow-up period. Although the recurrence of MI was the main focus, it was a secondary endpoint in this study because the primary endpoint of the KAMIR-NIH study was defined as MACE [10 (
link)]. Other secondary endpoints were CD, revascularization, re-admission due to HF, all-cause death, stroke, stent thrombosis, 2-year major adverse cardiac and cerebrovascular events (MACCE) which was a composite of the primary endpoint and stroke, and 2-year MACE with non-cardiac death (NCD).
All deaths were considered to be associated with cardiac problems, unless a definite non-cardiac cause was established. Revascularization included repeated PCI or CABG on either target or non-target vessels. The staged PCI was excluded from revascularization.
The clinical follow-ups were routinely performed by visiting the hospital at 6-, 12-, 24-, and 36-month and whenever any clinical events occurred. If patients did not visit the hospitals, the outcome data were assessed by telephone interview. Clinical events were not centrally adjudicated. The physician identified all events and the principal investigator of each hospital confirmed them.