Table 2.
Definitions of outcome measurements
| References | Study | MACEa | MBb | MALEc |
|---|---|---|---|---|
| [36] | Becquemin | 1, 3, 4 | – | – |
| [15] | BOA | 2, 3, 4, 6 | 1, 2, 3 | – |
| [37] | CABBAGE | 1, 3, 4 | 1, 2, 3, 4 | 1, 2, 3 |
| [13] | CAPRIE | 2, 3, 4 | – | – |
| [38] | CASPAR | – | GUSTO | 1, 3, 4 |
| [39] | CHARISMA | 1, 3, 4 | GUSTO | – |
| [40] | CLIPS | 1, 3, 4 | – | – |
| [16, 41] | COMPASS | 2, 3, 4 | Modified ISTH | 1, 3, 5 |
| [42] | COOPER | 2, 3, 4 | – | – |
| [43] | CREDO | 1, 3, 4 | – | – |
| [44] | ePAD | 2, 3, 4 | TIMI | – |
| [35] | EUCLID | 2, 3, 5 | TIMI | 1, 5 |
| [45] | Gresele | 2, 3, 4 | – | – |
| [46] | Johnson | – | 1, 2, 3, 5, 6 | – |
| [47] | Li | 1, 3, 4 | 1, 2, 5, 6, 7, 8 | – |
| [48] | MIRROR | NS | – | – |
| [49] | Monaco | 2, 3, 4, 7 | 1, 2, 3, 6 | – |
| [50] | PEGASUS TIMI 54 | 2, 3, 4 | TIMI | 1, 5 |
| [51] | PLATO | 2, 3, 4 | TIMI | – |
| [52] | RIVAL-PAD | – | TIMI | – |
| [53] | Soga | 1, 3, 4 | 5, 6, 9 | – |
| [54] | STOP-IC | 1, 3, 4 | – | 3, 4, 5, 6 |
| [17] | VOYAGER-PAD | 1, 3, 4, 6, 8 | ISTH | 1, 3, 5 |
| [55] | WAVE | 2, 3, 4 | 1, 2, 5, 6, 10 | – |
GUSTO Global Use of Strategies to Open Occluded Arteries,ISTH International Society on Thrombosis and Haemostasis, MACE major adverse cardiovascular events, MALE major adverse limb events, MB major bleeding, NS not specified, TIMI Thrombolysis In Myocardial Infarction,
aMACE: 1 = death; 2 = cardiovascular death; 3 = myocardial infarction; 4 = stroke; 5 = ischaemic stroke; 6 = amputation; 7 = urgent revascularization; 8 = acute limb event
bMB: 1 = fatal bleeding; 2 = intracranial haemorrhage; 3 = bleeding requiring hospitalization; 4 = gastro-intestinal haemorrhage; 5 = bleeding requiring intervention; 6 = bleeding requiring blood product transfusion; 7 = hematoma with diameter > 5 cm; 8 = haemoglobin reduction of > 4 g/dL; 9 = hypotension requiring inotropic support; 10 = intraocular haemorrhage. GUSTO = major bleeding defined as intracranial haemorrhage and/or haemodynamic compromise. ISTH = major bleeding including (1) fatal bleeding, (2) symptomatic bleeding into a critical organ, or (3) bleeding causing a fall in haemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. Modified ISTH = major bleeding including (1) symptomatic bleeding into a critical organ, (2) surgical site bleeding requiring reoperation, or (3) any bleeding requiring hospitalization (including presentation to an acute care facility without an overnight stay). TIMI = major bleeding including (1) any intracranial bleeding, (2) clinically overt signs of haemorrhage associated with a drop in haemoglobin of ≥ 5 g/dL or a ≥ 15% absolute decrease in haematocrit, and (3) fatal bleeding
cMALE: 1 = peripheral revascularization; 2 = any revascularization; 3 = major amputation; 4 =re-occlusion/revascularization of target lesion after intervention; 5 = acute limb event; 6 = death