Summary of study definitions
| Studies (Year) | Major bleeding definition | Minor bleeding definition | Access site complications | Primary end point |
| TEMPURA (2003) | Bleeding requiring blood transfusion and/or surgical repair or cerebral bleeding | Not defined | Not defined | MACE: TLR, repeat AMI or death |
| RADIAL-AMI (2005) | Intracranial or retroperitoneal bleeding, a drop in haemoglobin level >5 g/dl or haematocrit >15%, whole blood or packed red cell transfusions | Not defined | Haematoma >5 cm, pseudoaneurysm, arteriovenous fistula, access site rebleeding after initial haemostasis | Primary efficacy end point: reperfusion time. Primary safety end point: major bleeding |
| FARMI (2007) | TIMI major bleeding involving a haemoglobin drop of >5 g/dl or intracranial haemorrhage or cardiac tamponade | TIMI minor bleeding: haemoglobin drop >3 g/dl but <5 g/dl, with bleeding from a known site or spontaneous gross haematuria, haemoptysis or haematemesis | False aneurysm, haematoma (defined as local induration of >4 cm diameter) and ecchymosis (defined as cutaneous bruise or induration of <4 cm) | Peripheral vascular complication rates and PCI efficiency and tolerance of the procedure |
| Yan et al (2008) | Haemoglobin loss of at least 2 mmol/l, the administration of a blood transfusion, vascular repair, or prolonged hospitalisation | Haematoma formation not requiring specific treatment | Haematoma, pseudoaneurysm and arterial occlusion | Vascular access site complications including minor bleeding (haematoma), major bleeding, pseudoaneurysm and artery occlusion. MACE defined as death, recurrent AMI and repeat target vascular revascularisation |
| RADIAMI (2009) | Fatal bleeding, bleeding requiring blood transfusion, operation or resulting in a drop of haemoglobin count of >3 g/dl as well as any intracranial haemorrhage | All bleeding complications that did not fulfil criterion for major bleeding complications defined as minor | Not defined | Primary end point not defined |
| Gan et al (2009) | Not defined, although data presented for major bleeding | Not defined | Not defined, although data presented for presence of and type of vascular access site complications | Major adverse cardiac events, including death, CABG, myocardial infarction and target lesion revascularisation |
| Hou et al (2010) | Haemoglobin loss of ≥2 mmol/l or administration of blood transfusions | Haematoma formation not requiring specific treatment | Not defined | MACE defined as death, recurrent myocardial infarction, or target vessel revascularisation |
| RIVAL (2011) | Fatal bleeding, transfusion of two or more units of red blood cells or equivalent whole blood, bleeding causing substantial hypotension with the need for inotropes, surgical intervention (only if there has been substantial hypotension or transfusion of at least two units of blood), bleeding causing severely disabling sequelae, intracranial bleeding and symptomatic or intraocular leading to significant visual loss | Bleeding events that did not meet the criteria for a major bleed and required transfusion of one unit of blood or modification of the drug regimen (ie, cessation of antiplatelet or antithrombotic treatment) | Pseudoaneurysm needing closure, large haematoma (as judged by investigator), arteriovenous fistula, or an ischaemic limb needing surgery | Primary end point composite of death, AMI, stroke, or non-CABG-related major bleeding at 30 days |
| RADIAMI II (2011) | Fatal bleeding, bleeding requiring blood transfusion, operation or resulting in a drop of haemoglobin count of >3 g/dl or any intracranial haemorrhage | Bleeding events that did not meet the criteria for a major bleed | Not defined | Serious cardiac events including repeat cardiac revascularisation in the infarct-related artery, new CABG, new MI occurrence and death from any cause |
AMI, acute myocardial infarction; CABG, coronary artery bypass grafting; MACE, major adverse cardiac event; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation.