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The following definitions were used in the adjudicated diagnosis of a MACE end point. Acute MI was defined as the presence of two or more of the following criteria: (1) persistent chest pain; (2) cardiac biomarker (myocardial band fraction of creatine phos-phokinase, cardiac troponins) levels above the upper limit of normal if spontaneous or more than three or five times the upper limits of normal if after percutaneous coronary intervention or coronary artery bypass graft surgery, respectively; and (3) myocardial injury pattern or development of Q waves in two contiguous ECG leads. Stroke was defined as ischemic or hemorrhagic with an acute, focal neurologic event lasting > 24 h.
Imaging studies (CT scan or MRI of the brain) were reviewed and nearly always available but were not mandatory for adjudication of the event. If an imaging study demonstrated an acute cerebrovascular injury that was not associated with a clinical neurologic deficit of > 24 h, the event was characterized as a stroke. Cardiovascular death was defined as that caused by MI, stroke, heart failure, arrhythmia, sudden or unexplained death, pulmonary embolism, or vascular emergencies, such as aortic dissection. The definitions of all events used in the adjudication process were well defined and prespecified in a committee charter.
If events adjudicated by the cardiovascular adjudication committee differed in diagnosis from that assigned by the original reporter, the event was reclassified according to the committee determination. If the data available were deemed insufficient by the committee to permit a definitive diagnosis, then the original reporter’s diagnosis was accepted.
All events within 30 days of the last drug exposure were considered as exposure associated and included in the analyses. When two clinically linked events occurred within 2 weeks of each other, the more severe event was included in the analysis; for example, if a patient had a hemorrhagic stroke followed by a cardiovascular Viagra in Australia death 6 days later, cardiovascular death rather than nonfatal stroke would be the event included in the analysis.