Definitions and assessment of major vascular events
pulmonary emboli, nonfatal strokes, cerebral venous thromboses, unstable angina or cardiac insufficiency, stroke, claudication, neurological deficit, coronary arterial disease
THROMBOEMBOLIC EVENT, MYOCARDIAL INFARCTION, CARDIAC EVENTS, STROKE, EPILEPTIC SEIZURE, CARDIAC ARREST, EVENTS
For this study, major vascular events included fatal or nonfatal cardiac events, fatal or nonfatal strokes, and fatal or nonfatal major peripheral arterial or thromboembolic events. Cardiac events included myocardial infarction, resuscitation after cardiac arrest, and hospitalization for unstable angina or cardiac insufficiency. Major peripheral events included all events not related to coronary arterial disease leading to hospitalization or revascularization (e.g., new or worsening of claudication leading to revascularization). Major thromboembolic events included pulmonary emboli or cerebral venous thromboses.We defined a recurrent stroke as a stroke which (1) there was clinical evidence of the sudden onset of a new focal neurological deficit with no apparent cause other than a vascular origin (i.e., the deficit could not be ascribed to an intercurrent acute illness, epileptic seizure, or toxic effect) occurring at any time after the index stroke or (2) clinical evidence of the sudden onset of an exacerbation of a previous focal neurological deficit with no apparent cause other than a vascular origin [Reported events were confirmed by contacting treating physicians, hospitals, and/or general practitioners. All events were centrally reviewed by two investigators who are blinded to treatment allocation.