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Table 2 Definitions of registry outcome measures

From: A novel endothelial damage inhibitor for the treatment of vascular conduits in coronary artery bypass grafting: protocol and rationale for the European, multicentre, prospective, observational DuraGraft registry

Outcome Definition
Mortality
 Cardiovascular Any of the following criteria:
• Death due to proximate cardiac cause (eg, myocardial infarction, cardiac tamponade, worsening heart failure)
• Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease
• All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure
• All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events
• Sudden or unwitnessed death
• Arrhythmia or cardiac arrest
• Death of unknown cause
 Non-cardiovascular Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)
Myocardial infarction
 Periprocedural ≤48 h after the index procedure: absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit plus ≥1 of the following criteria:
• New significant Q waves or equivalent
• Flow-limiting angiographic complications
• New “substantial” loss of myocardium on imaging
 Spontaneous > 48 h after the index procedure: detection of rise and/or fall in cardiac biomarkers with ≥1 value above the 99th percentile upper reference limit, together with the evidence of myocardial ischaemia with ≥1 of the following present:
• Symptoms of ischaemia
• Electrocardiographic changes indicative of new ischaemia (new ST-T changes or new left bundle branch block
• New pathological Q-waves in ≥2 contiguous leads
• Imaging evidence of a new loss of viable myocardium or new wall motion abnormality
• Sudden, unexpected cardiac death, involving cardiac arrest, often with symptoms suggestive of myocardial ischaemia, and accompanied by presumably new ST elevation, or new left bundle branch block, and/or evidence of fresh thrombus by coronary angiography and/or at autopsy, but death occurring before blood samples could be obtained, or at a time before the appearance of cardiac biomarkers in the blood
• Pathological findings of an acute myocardial infarction
 Revascularisation Endovascular or surgical procedure performed on the DuraGraft-treated venous or arterial graft(s) because of loss of graft patency
 Stroke Neurological deficit documented by physical examination or some form of imaging