Aernoud Fiolet

148 Chapter 5 B: Primary and Secondary End Point Definitions Cardiovascular death Cardiovascular death is defined as any death with a clear relationship to underlying cardiovascular disease, including death secondary to acute myocardial infarction causing sudden death, or acute heart failure, a complication of a coronary revascularization procedure where the cause of death is clearly related to the procedure, death due to cardiovascular hemorrhage and death due to other cardiovascular causes. Myocardial infarction The term myocardial infarction implies (biochemical) evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Myocardial typing is defined by the ACC/AHA/ESC 3rd universal definition of (acute) myocardial infarction. Myocardial infarction in the primary endpoint will include all non-procedural MI’s. i.e. Type 1, 2 and 4b myocardial infarction and type 3 as part of cardiovascular death. Type 1 myocardial infarction is a spontaneous myocardial infarction related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection with resulting intraluminal thrombus in one or more of the coronary arteries leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis. Type 2 myocardial infarction is myocardial infarction secondary to an ischemic imbalance. In instances of myocardial injury with necrosis, where a condition other than coronary artery disease contributes to an imbalance between myocardial oxygen supply and/or demand, the term ‘MI type 2’ is used. In critically ill patients, or in patients undergoing major (non-cardiac) surgery, elevated values of cardiac biomarkers may appear. Type 3 myocardial infarction is death due to myocardial infarction. This concerns patients with symptoms or clinical features of myocardial ischemia prior to their death. Type 4a myocardial infarction is myocardial infarction related to percutaneous coronary intervention (PCI). Myocardial infarction associated with PCI is arbitrarily defined by elevation of cardiac troponin values >5 x 99th percentile upper reference limit in patients with normal baseline values or a rise of cardiac troponin values >20% if the baseline values are elevated and are stable or falling. Type 4b myocardial infarction is associated with stent thrombosis detected by coronary angiography or at autopsy. Type 5 myocardial infarction is associated with coronary artery bypass grafting and is arbitrarily defined by elevation of cardiac biomarker values >10 x 99th percentile upper reference limit in patients with normal baseline cardiac troponin values (≤99th percentile upper reference limit).