Table 3. Clinical cardiovascular outcomes

“Definite” cardiovascular outcomes:
    • Cardiovascular death; or
    • Cardiac revascularization procedure; or
    • Nonfatal myocardial infarction, defined as a clinical report of myocardial infarction from the investigator and the presence of one of the following:
        • Elevation of CPK >twice the upper limit of normal for the given hospital supported by the elevation of cardiac specific enzyme above the normal range such as MB fraction or cardiac troponin, OR
        • In the absence of cardiac specific enzymes, determination of a typical evolutionary pattern defined as an elevation of CPK to twice the upper limit of normal for the given hospital followed by a fall of at least 50% or the appearance of new pathological Q-waves in two or more contiguous leads, or
        • The appearance of a R-wave with R/S ratio in lead V1 >1.0 in the absence of another explanation or a loss of progression of R-waves V2 through V5.
    • Heart failure requiring hospitalization and therapy with an inotropic agent, vasodilator ACE inhibitor, increased diuretic dose, ultra filtration, or dialysis: or
    • Stroke, defined as a permanent neurological deficit of at least 24 h, attributed to stroke by the personal physician, requiring hospitalization and confirmation by radiographic imaging.
“Probable” cardiovascular outcome:
    • Nonfatal myocardial infarction, defined by a clinical report from the investigator but lacking confirmation of elevated enzymes or ECG changes: or
    • Nonfatal myocardial infarction, defined by centrally read ECG that documents a new myocardial infarction in comparison with the baseline ECG but without clinical event: or
    • Stroke, defined as above but lacking confirmation by radiographic imaging.