Characteristics of included trials
| Characteristic | DIRECT-MT18 | DEVT12 | SKIP17 | MR CLEAN-NO IV19 |
| Treatment | EVT (n=327)/IVT before EVT (n=329) | EVT (n=116)/IVT before EVT (n=118) | EVT (n=101)/IVT before EVT (n=103) | EVT (n=273)/IVT before EVT (n=266) |
| Inclusion criteria | Age ≥18 years, mRS of 0 or 2 before onset ICA, MCA-M1, or M2 occlusion on CTA NIHSS: ≥2 ASPECTS: no limit Onset to IV rt-PA ≤4 hours 30 min | Age ≥18 years, mRS of 0 or 1 before onset ICA or MCA-M1 occlusion on CTA or MRA NIHSS: no limit ASPECTS: no limit Onset to randomization ≤4 hours 15 min | Age ≥18 and <86 years, mRS of 0 or 2 before onset ICA or MCA-M1 occlusion on CTA or MRA NIHSS: ≥6 ASPECTS: DWI ≥5 or CT ≥6 Onset to puncture <4 hours | Age ≥18 years, mRS of 0 or 2 before onset ICA or MCA-M1 or proximal M2 occlusion on CTA or MRA NIHSS: ≥2 ASPECTS: no limit |
| Country | China | China | Japan | European countries |
| Age (years) | 69 (61–76)/69 (61–76) | 70 (60–77)/70 (60–78) | 74 (67–80)/76 (67–80) | 72 (62–80)/69 (61–77) |
| Male | 189 (58%)/181 (55%) | 66 (57%)/66 (56%) | 56 (55%)/72 (70%) | 161 (59%)/144 (54%) |
| NIHSS | 17(12–21)/17(14–22) | 16(12–20)/16(13–20) | 19(13–23)/17(12–22) | 16(10–20)/16(10–20) |
| ASPECT | 9 (7–10)/9 (7–10) | 8 (7–9)/8 (7–9) | 7 (6–9)/8 (6–9) | NA/NA |
| Alteplase dose (mg/kg) | 0.9 | 0.9 | 0.6 | 0.9 |
| Medical history | ||||
| Hypertension | 193 (59%)/201 (61%) | 69 (59%)/74 (62%) | 61 (60%)/61 (59%) | NA/NA |
| AF | 152 (46%)/149 (45%) | 62 (53%)/62 (52%) | 57 (56%)/64 (62%) | 86 (32%)/63 (24%) |
| Smoking | 73 (22%)/68 (20%) | 28 (24%)/29 (24%) | 42 (42%)/54 (52%) | NA/NA |
| Dyslipidemia | 13 (4%)/14 (4%) | 18 (15%)/22 (18%) | 30 (30%)/37 (36%) | NA/NA |
| DM | 59 (18%)/65 (19%) | 25 (21%)/20 (17%) | 16 (16%)/17 (17%) | NA/NA |
| Past stroke | 43 (13%)/47 (14%) | 14 (12%)/19 (16%) | 12 (12%)/14 (14%) | NA/NA |
| Etiology | ||||
| Embolic | 146 (44%)/144 (43%) | 65 (56%)/69 (58%) | 67 (66%)/72 (15%) | NA/NA |
| Atherosclerosis | 26 (8%)/19 (5%)* | 28 (24%)/23 (19%)* | 21 (21%)/15 (15%)† | NA/NA |
| Occlusion site | ||||
| ICA | 112 (35%)/114 (35%) | 18 (15%)/17 (14%) | 41 (41%)/36 (35%) | 68 (25%)/50 (19%) |
| M1 proximal | 161 (50%)/178 (54%) | 95 (81%)/99 (83%) | 19 (19%)/18 (17%) | 156 (57%)/174 (65%) |
| Median duration (min) | ||||
| Onset to randomization | 167/177 | 170/168 | 129/136 | 94/93 |
| IVT to puncture | NA/26 | NA/40 | NA/8 | NA/NA |
| Onset to puncture | 198/213 | 200/210 | 149/158 | 130/135 |
| sICH definition | Heidelberg Bleeding Classification‡ | SITS-MOST§ | SITS-MOST§ | Heidelberg Bleeding Classification‡ |
Trial name: DIRECT-MT: Thrombectomy in Order to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals: a Multicenter Randomized Clinical Trial; DEVT: Direct Endovascular Thrombectomy vs Combined IVT and Endovascular Thrombectomy for Patients With Acute Large Vessel Occlusion in the Anterior Circulation; SKIP: The Direct Mechanical Thrombectomy in Acute LVO Stroke; MR CLEAN-NO IV: The Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands (MR CLEAN) NO IV study group.
*Intracranial atherosclerosis.
†Large artery atherosclerosis.
‡The Heidelberg Bleeding Classification: new intracranial hemorrhage detected by brain imaging associated with any of the item below: ≥4 points total NIHSS at the time of diagnosis compared with immediately before worsening. ≥2 points in one NIHSS category. The rationale for this is to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory. For example, a new remote hemorrhage in the contralateral occipital lobe may cause new hemianopia that is clearly symptomatic but the patient will not have worsening of ≥4 points on the NIHSS score.
§SITS-MOST: a large local or remote parenchymal intracranial hemorrhage (>30% of the infarcted area affected by hemorrhage with a mass effect or extension outside the infarct) in combination with neurologic deterioration from baseline (increase of 4 in the NIHSS score) or death within 36 hours.
AF, atrial fibrillation; ASPECT, Alberta Stroke Program Early CT score; CT, computed tomography; CTA, CT angiography; DM, diabetes mellitus; DWI, diffusion weighted imaging; EVT, endovascular thrombectomy; ICA, internal carotid artery; IV, intravenous; IVT, intravenous thrombolysis; MCA, middle cerebral artery; MRA, magnetic resonance angiography; MRI, magnetic resonance imaging; mRS, modified Rankin Scale; NA, not available; NIHSS, National Institutes of Health Stroke Scale; rt-PA, recombinant tissue plasminogen activator; sICH, symptomatic intracranial hemorrhage.