Aernoud Fiolet

149 Colchicine in Patients with Chronic Coronary Disease B: Primary and Secondary End Point Definitions Ischemic stroke Stroke is defined as symptoms of acute focal cerebral, spinal, or retinal dysfunction due to a vascular cause with other non-vascular etiologies excluded. The symptoms must last > 24 hours in the absence of brain imaging. The symptoms may last < 24 hours in the presence of pathological, imaging or other objective evidence of acute, focal cerebral, spinal, or retinal ischemia or hemorrhage. Ischemic stroke requires pathological, imaging, or other objective evidence of acute, focal cerebral, spinal, or retinal ischemic injury in a defined vascular distribution; or clinical evidence of acute, focal cerebral spinal cord, or retinal ischemic injury based on symptoms persisting > 24 hours or until death, and other etiologies excluded. Ischemic stroke includes hemorrhagic infarction but not intra-cerebral or subarachnoid hemorrhage. Ischemia‑driven coronary revascularization The end point “Ischemia-driven Coronary Revascularization” includes all coronary revascularization that were performed in the context of myocardial infarction and those for worsening symptoms in combination with evidence of myocardial ischemia. The definition of the latter required the following: 1. A history of new or worsening symptoms consistent with myocardial ischemia that is not provoked by factors such as anemia, tachyarrhythmia, cold, unusual effort, sepsis or non-compliance with anti-anginal medication, 2. No documented rise in serum troponin suggestive of myocardial infarction, 3. Angiographic evidence of a culprit lesion 4. Revascularization. C: Adverse events of special interest Adverse events of special interest Definition Neutropenia Investigator‑reported and defined as an absolute neutrophil count <1500/µL (<1.5 x 109/L). Dysesthesia Investigator-reported and defined as numbness, paraesthesia or allodynia in any dermatome. Queried at every clinical visit in the cohort from The Netherlands only. Myalgia Investigator-reported and defined as muscle complaints without elevated biomarkers. Queried at every clinical visit in the cohort from The Netherlands only. Myotoxicity Evaluated by a blinded, independent physician who assessed severity and relation to trial medication. It was classified as myalgia, myopathy, myositis or rhabdomyolysis, according to the European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management of Statin-associated muscle symptoms from 2015. 4 Cancer Evaluated by a blinded, independent physician of the End Point Adjudication Committee. Classified according to anatomic site of origin and whether it concerns a suspected relapse or new occurrence.