Table 3 Definitions of adverse events
Adverse event | Definition |
|---|---|
Cardiogenic shock | Systolic blood pressure <90 mmHg for at least 30 min (or the need for supportive measures to maintain a systolic blood pressure of >90 mmHg) in the presence of a heart rate of >60 beat/min in association with signs of end-organ hypoperfusion (cold extremities, low urinary output <30 mL/h and/or mental confusion) |
Myocardial infarction (MI) | MI will be defined differently in specific clinical situations in this trial. The European Society of Cardiology (ESC) and American College of Cardiology (ACC) criteria for acute, evolving or recent MI will apply |
Re-infarction | Further chest pain during the index admission lasting >20 min accompanied by new electrocardiographic changes (new Q waves >0.04 s or ST-segment elevation >0.1 mV in two leads for >30 min), further enzyme rise or both |
Recurrent MI | A ≥20% rise in the value of the biomarker measured serially 6 to 12 h apart, provided the absolute value is greater than the 99% percentile upper reference limit. For patients who die and for whom no cardiac markers were obtained, the presence of new ST segment elevation and new chest pain would meet criteria for MI |
Contrast-induced nephropathy | 25% increase in serum creatinine concentration from the baseline value, or absolute increase of at least 0.5 mg/dL (44.2 μmol/L), appearing within 48 h of administration of contrast media, and maintained for 2 to 5 days [94–96] |
Cerebrovascular events | Stroke is defined as a new focal neurological deficit of presumed vascular aetiology persisting >24 h combined with a neurological imaging study that does not indicate a different aetiology. Transient ischaemic attack (TIA) is any focal ischaemic neurological deficit of abrupt onset, which resolves completely within 24 h |
Severe heart failure | Early heart failure: any new onset cardiogenic shock or heart failure occurring after randomisation and during the index admission with radiographic evidence of pulmonary oedema requiring intravenous diuretic therapy |
Late heart failure: admission to hospital for treatment for documented New York Heart Association (NYHA) class III or IV heart failure | |
Major bleeding | Defined according to the TIMI criteria as fatal bleeding, any intracranial bleeding or clinically overt signs of haemorrhage associated with a drop in haemoglobin (Hb) of ≥ 50 g/L |