Table 3 Event definitions
Ischaemic stroke | Clinical evidence of the sudden onset of a new neurological deficit, or an increase in an existing deficit, persisting for more than 24 hours, without evidence of a intracerebral haemorrhage on a CT or MRI scan or at post-mortem investigation |
Intracerebral haemorrhage | Clinical evidence of the sudden onset of a new neurological deficit, or an increase in an existing deficit, persisting for more than 24 hours, with a corresponding intracerebral haemorrhage on a CT or MRI scan or at post-mortem investigation |
Unclassified stroke | Clinical evidence of the sudden onset of a new neurological deficit, or an increase in an existing deficit, persisting for more than 24 hours, without imaging or post-mortem investigations performed |
Subarachnoid haemorrhage | Subarachnoid haemorrhage (SAH) demonstrated by CT, lumbar puncture, or at post-mortem investigation |
Myocardial infarction | Evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Under these conditions any one of the following criteria meets the diagnosis for MI [51]: |
● Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit and with at least one of the following: | |
○ Symptoms of ischemia | |
○ New or presumed new significant ST-segment-T wave changes or new left bundle branch block (LBBB) | |
○ Development of pathological Q waves in the ECG | |
○ Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality | |
○ Identification of an intracoronary thrombus by angiography or autopsy | |
● Cardiac death with symptoms suggestive of myocardial ischemia and presumed new ischemic ECG changes or new LBBB, but death occurred before cardiac biomarkers | |
Vascular death | Death from cerebral infarction; intracerebral, subarachnoid, epidural, or subdural haemorrhage; unclassified stroke; myocardial infarction; extracranial haemorrhage; or systemic embolism, fatal arterial or gastric bleeding, terminal heart failure, fatal pulmonary embolism, and sudden death, defined as death within 1 hour after onset of symptoms |
Major extracranial haemorrhage | Major extracranial bleeding will be defined using the ISTH criteria [52]; |
1) Fatal bleeding, and/or | |
2) Symptomatic bleeding in a critical area or organ, such as intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or | |
3) Bleeding causing a fall in haemoglobin level of 1.24 mmol L−1 or more, or leading to transfusion of 2 or more units of whole blood or red cells | |
Clinically relevant non-major bleeding | Clinically relevant non-major bleeding will be defined as acute clinically overt bleeding that does not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least one of the following criteria [53]: |
● Hospital admission for bleeding | |
● Physician-guided medical or surgical treatment for bleeding | |
● Change in antithrombotic (anticoagulant or antiplatelet) therapy | |
Intracranial haemorrhage | Intracerebral haemorrhage (see above), SAH (see above), subdural haemorrhage: evidence of a subdural haematoma on a CT or MRI scan or at post-mortem investigations; epidural haematoma: evidence of an epidural haematoma on a CT or MRI scan or at post-mortem investigations |
Systemic embolism | The diagnosis of systemic embolism requires a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries) supported by evidence of embolism from surgical specimens, post-mortem investigations, angiography, vascular imaging, or other objective testing |