Trial | SYNTHESIS EXPANSION [6] | MR RESCUE [20] | IMS III [4] | MR CLEAN [7] | ESCAPE [8] | EXTEND-IA [9] | SWIFT PRIME [10] | REVASCAT [11] |
---|---|---|---|---|---|---|---|---|
Publication year | 2013 | 2013 | 2013 | 2014 | 2015 | 2015 | 2015 | 2015 |
Countries | Italy | North America | International | Netherlands | International | Australia and New Zealand | USA and Europe | Spain |
Participants (n) | 362 | 118 | 656 | 500 | 315 | 70 | 196 | 206 |
Age (year) | 66.5 | 65.5 | 68.7 | 65.7 | 71.5 | 69.4 | 65.6 | 66.5 |
Female (%) | 42.3 | 51.7 | 48.2 | 41.6 | 52.4 | 51.0 | 49.0 | 47.1 |
Baseline NIHSS (active/control) | 13/13 | 17.4/17.7 | 17/16 | 17/18 | 16/17 | 17/13 | 17/17 | 17/17 |
Time window (hour) | 4.5 | 8.0 | 5.0 | 6.0 | 12.0 | 6.0 | 6.0 | 8.0 |
Anterior circulation stroke (%) | 92.0 | 100.0 | 97.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
LAO confirmation before randomization (confirmation, %) | No (NA) | Yes (100.0) | No (43.0) | Yes (100.0) | Yes (100.0) | Yes (100.0) | Yes (100.0) | Yes (100.0) |
ICA occlusion (%) | NA | 16.9 | 22.1 (ERT arm only) | 27.6 | 26.7 | 31.4 | 16.3 | 26.2 |
M1 occlusion (%) | NA | 66.1 | 41.1 (ERT arm only) | 63.8 | 68.6 | 54.3 | 68.4 | 63.6 |
Infarct core or penumbral selection | None | Infarct core ≤90 mL on CT or MRI | CT hypointensity <1/3 MCA territory or ASPECTS ≥4 | None | ASPECTS ≥6 and moderate-to-good collaterals | Infarct core ≤70 mL and Mismatch on CT/MRI | CT/MRI ASPECTS ≥6* | CT ASPECTS ≥7 or DWI ASPECTS ≥6 |
Onset to randomization/groin puncture/first reperfusion (minute) | 146/NA/225 | 330/381/NA | 146/208/244 | 200/260/NA | 170/185/241 | 169/210/NA | 185/224/252 | 225/269/355 |
ERT arm | IA only | IA with standard care | IA with IV-TPA | IA with standard care | IA with standard care | IA with IV-TPA | IA with IV-TPA | IA with standard care |
Control arm | IV-TPA | Standard care | IV-TPA | Standard care | Standard care | IV-TPA | IV-TPA | Standard care |
IV-TPA (active/control) (%) | 0/98.3 | 43.8/29.6 | 100/100 | 87.1/90.6 | 72.7/78.7 | 100/100 | 100/100 | 68.0/77.0 |
ERT performed in ERT arm (%) | 91.2 | 95.3 | 77.0 | 83.7 | 91.5 | 85.7 | 88.8 | 95.1 |
Stent-Retriever thrombectomy in active arm (%) | 12.7 | 0.0 | 0.9 | 81.5 | 78.8 | 77.1 | 88.8 | 95.1 |
mTICI 2b-3 in active arm (%) | NA | 25.0 | 41.0 | 58.7 | 72.4 | 86.2 | 88.0 | 65.7 |
Outcome assessment (day) | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 |
Imaging entry criteria were changed from original criteria (Infarct core ≤50 mL, severe hypoperfusion ≤100 mL, ischemic penumbra <15 mL and mismatch ratio ≤1.8).
ERT, endovascular recanalization therapy; NA, not assessed; LAO, large artery occlusion; ICA, internal carotid artery; BA, basilar artery; VA, vertebral artery; UK, urokinase; IV, intravenous; mTICI, modified Thrombolysis in Cerebral Infarction; mRS, modified Rankin Scale; OR, odds ratio; CI, confidence interval; SICH, symptomatic intracranial hemorrhage; IA, intra-arterial; TPA, tissue type plasminogen activator; MCA, middle cerebral artery; ASPECTS, Alberta Stroke Program Early CT Score; NA, not available.