Table 2 Outcomes collected and associated definitions
From: Rationale and design of the Chinese Atrial Fibrillation Registry Study
Outcomes | Definitions |
|---|---|
Primary outcome | |
Composite outcome of any of the following events: all-cause mortality, non-fatal ischemic stroke and peripheral embolism. | All-cause mortality: All deaths regardless of etiology |
Non-fatal Ischemic stroke: Documented stroke or cerebrovascular accident consisting of acute loss of neurological function caused by an ischemic event with residual symptoms at least 24 hours after onset. | |
Peripheral embolism: Abrupt vascular insufficiency associated with clinical and radiological evidence of arterial occlusion in a vascular bed other than the cerebrovascular system in the absence of other likely mechanisms (e.g., atherosclerosis). | |
Secondary outcomes | |
Component of the primary composite outcome including: 1) all-cause mortality; 2) non-fatal stroke or peripheral embolism. | As above |
Intracranial hemorrhages | Bleeding into or around the brain, including 1) Hemorrhagic conversion of a primary ischemic stroke; 2) Subarachnoid hemorrhage; 3) Intra-cerebral hemorrhage; 4) Other (including subdural and epidural hematomas); |
Major bleeding | Bleeding leads to 1) Transfusion of at least 2 units of whole blood or erythrocytes; 2) Requiring hospitalization or surgery; 3) Resulting in permanent disability; 4) Involving a critical anatomic site (retroperitoneal, pericardial, intra-spinal, intracranial, non-traumatic intra-articular, or intra-ocular bleeding associated with abrupt deterioration of visual acuity). |