Contrast-induced nephropathy
A rise in creatinine levels of > 25% or 44.2 µmol/l within 48 hours after angiography and persisting for at least 48 hours.
Death
Death from any cause classified as cardiovascular or non-cardiovascular.
Causes of cardiovascular deaths include, but are not limited to, deaths resulting from atherosclerotic vascular disease (excluding coronary), congestive heart failure, cardiogenic shock, during or immediately following a CABG procedure, during or immediately following a PCI procedure, dysrhythmia, pulmonary embolism, MI, sudden cardiac death, intracranial haemorrhage, non-haemorrhagic stroke and other cardiovascular causes. Cardiovascular death includes any cardiac causes, or other vascular causes (e.g. pulmonary embolism, aortic dissection).
Non-cardiovascular death includes accidental death, trauma, haemorrhage (not intracranial), infection, malignancy, suicide and other.
Myocardial infarction (new)
Hospital admission (or in hospital) with:
Type 1: spontaneous re-MI: recurrent angina symptoms or new ECG changes occurring before PCI or < 48 hours from PCI that is compatible with re-MI associated with an elevation of creatine kinase MB isoenzyme (CK-MB), troponin, or total CK levels beyond the upper limit of normal (ULN) and 20% or more above the previous value.
Type 4b: stent thrombosis documented by coronary angiography and/or autopsy AND fulfilling the criteria of spontaneous MI (type 1).
Type 4a: CK-MB or total CK levels more than three times the ULN within 48 hours following PCI. If the pre-PCI CK-MB or total CK level is higher than the ULN, there also needs to be:
either the demonstration of a falling CK-MB or total CK level prior to the onset of the suspected event
or a subsequent peak of the cardiac biomarker of at least 20% above the previous value obtained prior to the onset of the suspected event
with either an appropriate clinical presentation or new ischaemic ECG changes (ST-segment depression or ST-segment elevation or development of new pathological Q-waves/LBBB).
Transient ischaemic attack/cerebrovascular event
Defined as the presence of a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting more than 24 hours. It is strongly recommended (but not required) that an imaging procedure, such as a computed tomography scan or MRI, be performed. Stroke will be further classified as ischaemic, haemorrhagic or type uncertain.
Major bleed
Cumulative occurrence of intracranial or intraocular bleeding.
Haemorrhage at the vascular access site requiring intervention.
Reduction in haemoglobin levels of at least 5 g/dl.
Reoperation for bleeding or transfusion of a blood product (at least 2 units).
Bleeding causing substantial hypotension requiring the use of inotropic agents.
All other bleeding events were considered as minor (i.e. epistaxis, blood traces in the stool, etc.).
Planned or repeat coronary artery bypass graft or percutaneous coronary intervention
IRA target lesion re-interventions (TLRs) inside the implanted stent or within 5-mm proximally or distally or repeated interventions in the same vessel (target vessel revascularisation; TVR) PCIs or by CABG surgery.
Non-IRA TVR.
IRA TLR (i.e. lesions within the index IRA, but not the IRA culprit lesion).
Non-IRA TLR.
PCI to lesions not identified previously.
CABG for new symptoms or complications of PCI. Discussions in a cardiosurgical multidisciplinary team (MDT) forum must be recorded (MDT yes/no with result of discussion).
Heart failure
Any hospital admission with any of the following symptoms and signs:
Confirmation of heart failure according to local expert judgement and evidence of impaired LV function will be required for the event to be classified as heart failure.
Other serious adverse events
Any event requiring hospitalisation or prolonging length of stay during hospitalisation at time of index procedure.
