| Stroke | Defined as a new-onset neurological dysfunction caused by central nervous system injury as a result of haemorrhage or infarction, of at least 24 hours duration (or if symptoms lasted <24 hours a clear matching lesion on CT or MRI), not due to another identifiable nonvascular cause (ie, brain tumour, trauma).
All available data will be considered to support the diagnosis and subclassification of the type of stroke. Strokes will be subclassified as ‘ischaemic’or ‘primary haemorrhagic’ based on imaging data, if available, or ‘undetermined cause’ if imaging data are missing, according to the definitions below.
Ischaemic strokeIschaemic stroke with no haemorrhage: stroke without intracerebral blood on brain imaging Ischaemic stroke with haemorrhagic conversion: presence of blood felt to represent haemorrhagic conversion and not a primary haemorrhage
Primary haemorrhagic strokeA stroke with documentation on imaging (eg, CT scan or MRI) of intracerebral, subdural or subarachnoid haemorrhage. Evidence of haemorrhagic stroke from other sources (lumbar puncture, neurosurgery or autopsy) can also confirm the diagnosis.
Undetermined Stroke |
| Systemic embolism | A history consistent with an acute cessation of blood flow to a peripheral artery (or arteries) or evidence of embolism from other sources (eg, surgical specimens, angiography, vascular imaging), localised to one of the following:Lower or upper limb Intraocular Intra-abdominal viscera Other (to be specified)
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| Pulmonary embolism | Symptoms of PE with one of the following findings:A new intraluminal filling defect in (sub)segmental or more-proximal branches on CTPA, or in vessels more than 2.5 mm in diameter on the pulmonary angiogram. A new perfusion defect of at least 75% of a segment with a local normal ventilation result (high probability) on VQ scan. Inconclusive diagnosis of PE based on CTPA, pulmonary angiography, or VQ scan, but with demonstration of a new or recurrent deep-vein thrombosis in the lower extremities by compression ultrasound or venography.
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| Intracardiac thrombus | Identified by echocardiography or cardiac MRI as a discrete echodense mass with well-defined borders that are distinct from the endocardium and seen throughout systole and diastole, in any of the four cardiac chambers (including atrial appendages) |
Major bleeding
(ISTH) | Defined as clinically overt bleeding that is associated with:A fall in haemoglobin of 2 g/L or more A transfusion of ≥2 units of packed red blood cells or whole blood Bleeding in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal Death (fatal bleeding)
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| Clinically relevant nonmajor bleeding | Defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, an unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or discomfort for the patient, including:Any bleeding compromising haemodynamics Any bleeding leading to hospitalisation Subcutaneous (skin) hematoma if the size is >25 cm2, or >100 cm2 if provoked Intramuscular haematoma Epistaxis lasting for more than 5 min, if the episode was repetitive (ie, two or more episodes of true bleeding, that is, not spots on a handkerchief, within 24 hours), or led to an intervention (packing, electrocoagulation etc) Gingival bleeding if it occurred spontaneously (ie, unrelated to tooth brushing or eating), or if it lasted for more than 5 min Haematuria if it was macroscopic, and either spontaneous or lasting for more than 24 hours after instrumentation (eg, catheter placement or surgery) of the urogenital tract Macroscopic gastrointestinal haemorrhage: at least one episode of melena/hematemesis, if clinically apparent and haemoccult positive Rectal blood loss, if more than a few spots on toilet paper Haemoptysis, if more than a few speckles in the sputum and not occurring within the context of PE Any other bleeding type that was considered to have clinical consequences for a patient
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| Minor bleeding | Defined as other overt bleeding events that do not fulfil the criteria of a major bleeding event or a clinically relevant non-major bleeding event (eg, epistaxis that does not require medical attention). |
| Transient ischaemic attack | Defined as new neurological symptoms or deficit lasting less than 24 hours without acute infarction on CT or MRI (if available). |
Myocardial infarction
(fourth universal definition) | *Detection of a rise and/or fall of cardiac Troponin values with at least one value above the 99th percentile URL and with at least one of the following:Symptoms of acute myocardial ischemia New ischaemic ECG changes Development of pathological Q waves Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology Identification of a coronary thrombus by angiographic methods or autopsy.
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| Death | Cause of death will be classified as follows:
CardiovascularIschaemic stroke Haemorrhagic stroke Systemic or pulmonary embolism Other cardiovascular (ie, myocardial infarction, sudden death, heart failure) and unobserved deaths Unobserved deaths, unless a non-cardiovascular cause can be clearly identified.
Non-cardiovascularBleeding Other non-cardiovascular (ie, malignancy, infection, trauma, pulmonary causes of death) Unknown death: observed deaths of unknown cause
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