Table 1 Guidelines for adjudication of potential events of MI and stroke in the ADDITION-study

MYOCARDIAL INFARCTION (MI)

Fatal

Death from a new (within 30 days) acute myocardial infarction (MI)

Confirmed in hospital by appropriate biochemistry, ECG or imaging test or

Confirmed by autopsy showing a recent MI or recent occluding coronary thrombus, whether or not the patient was in hospital

Non-fatal

The term MI should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Under these conditions, any one of the following criteria meets the diagnosis of MI:

• Detection of rise/fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit (URL) together with evidence of myocardial ischemia with at least one of the following:

• Symptoms of ischemia

• ECG changes indicative of new ischemia (new ST-, T- 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.

STROKE

Fatal

Death occurring within 30 days from the onset of symptoms suspected to be due to a cerebrovascular event, including athero/thrombotic infarction, embolism or haemorrhage, assuming no other more relevant intervening event. In the absence of other obvious causes for the sudden onset of neurological signs and symptoms, the endpoint committee should presume a vascular cause. Death due to subarachnoid or subdural haemorrhage should be included in this category. A stroke may also be defined by autopsy findings showing a recent cerebrovascular event, including athero/thrombotic infarction, embolism or haemorrhage, whether or not the patient was in hospital

Non-fatal

The diagnosis of stroke requires evidence of a neurological deficit, usually localised, lasting 24 h or more, usually confirmed by diagnostic testing (e.g. CT scan). The clinical characteristics of stroke include sudden onset of a neurological deficit, typically manifested as:

• Depression of state of consciousness

• Disturbance of vision

• Paresis of paralysis of one or more extremities

• Sensory impairment

• Speech impairment

• Central cranial nerve dysfunction

• Memory defect

• Ataxia

• Movement disorder

Confirmed diagnoses of stroke will be categorised into the following:

1. Definite ischemic stroke: verified by CT or MRI scanning carried out within 2 weeks after the stroke (focal neurological deficit of more than 24 h of duration) or by autopsy.

2. Definite hemorrhagic stroke: primary intracerabral, subarachnoidal or secondary to ischemic stroke verified by CT or MRI scanning within 2 weeks after the stroke (focal neurological deficit of more than 24 h of duration) or by autopsy or lumbar puncture.

3. Not classifiable