Table 2.
Definitions of Main Composite Primary End Points
| Cardiovascular death | Cardiovascular mortality is included in the composite primary end point. Cardiovascular death includes fatal myocardial infarction, sudden death, untreated heart failure, fatal cerebral infarction, and hemorrhage and procedure-related fatal bleeding. |
| Cerebrovascular accident | Patients with a focal neurological deficit of central origin lasting more than 72 hours, or a focal neurological deficit of central origin lasting more than 24 hours with imaging evidence of cerebral infarction or intracerebral hemorrhage, or a nonfocal encephalopathy lasting more than 24 hours with imaging evidence of cerebral infarction or hemorrhage adequate to account for the clinical state. Retinal arterial ischemia or hemorrhage is also included. To fulfill the definitions of stroke, the deficit must be new, sudden in conset, and not attributable to any more likely alternative cause. |
| Myocardial infarction | Elevation of specific cardiac enzymes within 14 days of a revascularization procedure and presence of new Q waves in at least 2 or more contiguous leads and CK-MB elevation 5 × normal (see Appendix). |
| Further revascularization | The initial revascularization is considered completed when the patient is transferred from the operating room to bed. Refractory angina requiring revascularization was considered an end point. |