Table 1. Criteria for event inclusion in the study for venous thromboembolism and cerebrovascular events in patients with GCA and non-GCA subjects*.
Deep vein thrombosis(definite) | Verified by venography, ultrasound, or thrombus removedduring surgery or autopsy. |
Deep vein thrombosis(probable) | Confirmatory tests indeterminate or not done but all the following were present: a) physician diagnosis present in medical record, b) signs and symptoms consistent with deep vein thrombosis documented in exam, and c) patient underwent therapy with anticoagulant (heparin, warfarin, or similar agent). |
Pulmonary embolism | Verified by pulmonary angiography, CT/MRI angiography, ventilation-perfusion lung scan (interpreted as high probability), or thrombus removed during surgery or autopsy. |
Ischemic stroke | Focal neurological deficit persisting > 24 hours, compatible with altered circulation to a limited region of brain parenchyma, diagnosed by a neurologist (CT/MRI confirmation optional). |
Hemorrhagic stroke | Acute onset of focal neurologic deficit associated with headache, vomiting, altered level of consciousness, signs of meningeal irritation, and blood stained cerebrospinal fluid. Diagnosis made by neurologist. If done, CT/MRI showed parenchymal hemorrhage. |
Transient ischemic attack | Transient period of ≤ 24 hours of neurologic dysfunction caused by focal brain ischemia without evidence of acute infarction on neuroimaging or clinical evidence of permanent injury or neurologic sequelae. |
Amaurosis fugax | Transient monocular visual disturbance with abrupt onset and rapid resolution, lasting < 24 hours and due to altered circulation to the optic nerve. |
*GCA = giant cell arteritis
CT = computed tomography; MRI = magnetic resonance imaging