Table 1. Main Clinical Trials of Intra-arterial Thrombolysis before New Era of Endovascular Therapy in Acute Ischemic Stroke.
PROACT II | IMS III | SYNTHESIS | MR RESCUE | |
---|---|---|---|---|
Study period | 1996~1998 | 2006~2012 | 2008~2012 | 2004~2011 |
Subject number | 180 | 656 (early termination) | 362 | 118 |
Intervention | IA r-proUK plus heparin vs. heparin | EVT plus IV rtPA vs IV rtPA | EVT vs. IV rtPA | EVT vs. standard care |
Used devices | Non applicable | Merci, Penumbra, EKOS, Solitaire | Solitaire, Penumbra, Trevo, Merci | Merci, Penumbra |
Patients included | Patients with occlusion of MCA <6 h | Patients with IV rtPA <3 h | Patients eligible for IV rtPA (<4.5 h) and EVT (<6 h) | Patients with LAO (anterior circulation) < 8 h |
Imaging at baseline | CT | CT, CT angiography | CT | Multimodal CT/MR |
Primary endpoint | mRS 0, 1, 2 | mRS 0, 1, 2 | mRS 0, 1, 2 | Shift in mRS |
Time to endovascular treatment | 5.3 h | 249 min (122+127) | 3.45 h | > 6 h |
Recanalization rate | 66% (TIMI 2, 3) | 40% (TICI2b/3) | Not reported | 27% (TICI2b/3) |
Clinical outcome | 40% vs. 25% (p=0.04) | 40.8% vs. 38.7% | 30.4% vs. 34.8% | No difference |
Symptomatic ICH | 10% vs. 2% | 6.2% vs. 5.9% | 6% vs. 6% | 9% vs. 6% (penumbral pattern) |
Abbreviations: EVT, endovascular treatment; MCA, middle cerebral artery; LAO, large artery occlusion; mRS, modified Rankin Scale, ICH, intracerebral hemorrhage
Definition of symptomatic ICH; PROACT, ICH with neurological deterioration within 24 hours; IMS III, neurological worsening within 24 hours; SYNTHESIS, SICH within 7 days; MRRESCUE, 4 or more point worsening of NIHSS (associated with a parenchymal hematoma type 2)