Table 2

Summary of study definitions

Studies (Year)Major bleeding definitionMinor bleeding definitionAccess site complicationsPrimary end point
TEMPURA (2003)Bleeding requiring blood transfusion and/or surgical repair or cerebral bleedingNot definedNot definedMACE: 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 transfusionsNot definedHaematoma >5 cm, pseudoaneurysm, arteriovenous fistula, access site rebleeding after initial haemostasisPrimary 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 tamponadeTIMI minor bleeding: haemoglobin drop >3 g/dl but <5 g/dl, with bleeding from a known site or spontaneous gross haematuria, haemoptysis or haematemesisFalse 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 hospitalisationHaematoma formation not requiring specific treatmentHaematoma, pseudoaneurysm and arterial occlusionVascular 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 haemorrhageAll bleeding complications that did not fulfil criterion for major bleeding complications defined as minorNot definedPrimary end point not defined
Gan et al (2009)Not defined, although data presented for major bleedingNot definedNot defined, although data presented for presence of and type of vascular access site complicationsMajor 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 transfusionsHaematoma formation not requiring specific treatmentNot definedMACE 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 lossBleeding 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 surgeryPrimary 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 haemorrhageBleeding events that did not meet the criteria for a major bleedNot definedSerious 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.