2.5. Outcome Assessments
stroke, myocardial infarction, CHD
MYOCARDIAL INFARCTION, CVD, STROKE, EVENT, SECONDARY, EVENTS
Our proposed primary hierarchical composite outcome was a composite of major CVD events consisting of fatal CHD, other fatal CVD including stroke, non-fatal MI, and non-fatal stroke in this priority modeled with the win ratio method. A secondary hierarchical composite outcome included the above major CVD event composite as well as non-fatal coronary revascularization procedures, specifically, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), with the lowest priority. As sensitivity analyses, we changed the priority between non-fatal MI and non-fatal stroke because non-fatal stroke could potentially lead to more severe functional decline than non-fatal MI events.As additional secondary hierarchical composite outcomes, the present analyses considered the components of the above primary and secondary composite outcomes, namely (1) fatal MI and non-fatal MI, (2) fatal stroke and non-fatal stroke, and (3) fatal CHD, non-fatal MI, and non-fatal coronary revascularization procedures in this priority, separately, modeled with the win ratio method. To ascertain the occurrence of the specified end points, the medical records of participants who experienced any of the end points were meticulously reviewed by an independent committee of physicians who were unaware of the trial-group assignments. The confirmation of myocardial infarction and stroke cases relied on established diagnostic criteria [