TRIAL 2

1. 1. Inclusion criteria: The trial used an “all-comers” design.
2. Exclusion criteria
• Previous intervention
• Acute myocardial infarction
• Concomitant surgery.
Patients meeting either of the first two exclusion criteria were, according to the trial design, excluded
without consultation of the local interventional cardiologist and cardiac surgeon.
The need for concomitant surgery was discussed with the local interventional cardiologist and cardiac
surgeon.
Data for patients who were assigned to one treatment but underwent the other and for those who did
not undergo either revascularization procedure were analyzed in an intention-to-treat manner.

2. Registries Objective
• Patients were identified who were not candidates for randomization
based on clinical or anatomical characteristics and formed the basis
for the registry experience:
• Who were not candidates for CABG (inoperable patients)
• Who were not candidates for PCI (technically not feasible)

3. Reasons for Registry Allocation
PCI Registry- CABG ineligible due to:
• Co-morbidities (70.7%)
• No graft material (9.1%)
• Small or poor quality of distal
vessel (1.5%)
• Patient refused CABG (5.6%)
• Other (13.1%)
CABG Registry- PCI ineligible due to:
• Complex anatomy (70.9%)
• Untreatable CTO (22.0%)
• Unable to take anti-platelet medications (0.9%)
• Patient refused PCI (0.5%) Other (5.7%)

4. PRIMARY END POINT
• The primary clinical end point was a composite of major adverse cardiac and
cerebrovascular events (i.e., death from any cause, stroke, myocardial infarction, or
repeat revascularization) throughout the 12-month period after randomization.
• An independent clinical events committee (including cardiologists, cardiac surgeons, and
a neurologist;)
• Adjudicated all primary clinical end points, staged procedures, and cases in which the
sternum was reopened.