Table 2.
Patient characteristics and main results of the included RCTs.
| Trial | DIRECT-MT | DEVT | SKIP | MR CLEAN-NO IV | SWIFT-DIRECT | DIRECT-SAFE |
|---|---|---|---|---|---|---|
| Number of patients (main analysis) | 654 | 234 | 204 | 539 | 408*** | 293 |
| Median (IQR) age (years) | 69 (61–76) | 70 (60–78) | 74 (67 – 80) | 71 (61 – 79) | 73 (64–81, dMT group) vs. 72 (65 – 81) | 70 (61–78, dMT group) vs. 69 (60–79) |
| Median (IQR) NIHSS score | 17 (13–22) | 16 (12–20) | 18 (12–23) | 16 (10–20) | 17 (13–20, dMT group) vs. 17 (12–20) | 15 (11–20, dMT group) vs. 15 (10–20) |
| Median (IQR) ASPECTS | 9 (7–10) | 8 (7–9) | 8 (6–9) | 9 (8–10) | 8 (7–9) | 10 (9–10) |
| Occlusion site (%) | ICA: 35% M1: 52% M2: 12% Tandem: 10% |
ICA: 15% M1: 82% M2: 2% Tandem: NA |
ICA: 35% M1: 50% M2: 15% Tandem: 11% |
ICA: 22% M1: 61% M2: 16% Tandem: 17% |
ICA: 29% M1: 71% M2: 0.2% Tandem: 15% |
ICA: 22% M1: 56% M2: 15% Basilar artery: 6% Tandem: 16% |
| mRS 0–2 at 90 days | 36.5% vs. 36.9% Adj OR 0.97 (0.68–1.37) | 54.3% vs. 46.6% Adj OR 1.48 (0.81 –2.74) | 59.4% vs. 57.3% Unadj OR 1.09 (0.63–1.90*) | 49.1% vs. 51.1% Adj OR 0.95 (0.65–1.39) | 56.7% vs. 65.2% Unadj OR 0.70 (0.47–1.04) | 54.8% vs. 60.5% Adj OR 0.75 (0.45–1.24) |
| mRS 0–1 at 90 days | 24.5% vs. 22.6% Adj OR 1.09 (0.74–1.59) | 37.9% vs. 31.4% Adj OR 1.38 (0.75 –2.56) | 40.6% vs. 44.6% Unadj OR 0.85 (0.49-1.48)* | 16.1% vs. 15.4% Adj OR 1.01 (0.63 - 1.63) | 40% vs. 43% | 42.5% vs. 48.3% Adj OR 0.76 (0.64–1.24 |
| Whole range of the mRS | Adj cOR 1.07 (0.81–1.40) | Adj cOR 1.13 (0.71–1.79) | Unadj cOR 0.97 (0.60–1.57*) | Adj cOR 0.84 (0.62–1.15) | Adj cOR 0.75 (0.53–1.06) | Adj cOR 0.85 (0.56–1.28) |
| Death at 90 days | 17.8% vs. 18.9% Unadj OR 0.93 (0.62–1.38)* | 17.2% vs. 17.8% Unadj OR 0.96 (0.49–1.89)* | 7.9% vs. 8.7% Unadj OR 0.90 (0.33–2.43) | 20.5% vs. 15.8% Adj OR 1.39 (0.84–2.30) | 10.9% vs. 8.2% Unadj OR 1.37 (0.71–2.67) | 15.1% vs. 16.3% Adj OR 0.92 (0.46–1.84) |
| sICH (definition) | 4.3% vs. 6.1% (Heidelberg) Unadj OR 0.69 (0.34–1.39)* | 6.1% vs. 6.8% (Heidelberg) Unadj OR 0.88 (0.31 - 2.52)* | 5.9% vs. 7.8% (SITS-MOST) Unadj OR 0.75 (0.25–2.24) | 5.9% vs. 5.3% (Heidelberg) Adj OR 1.30 (0.60 - 2.81) | 1.5% vs. 4.9% (Modified SITS-MOST definition**) Unadj OR 0.30 (0.08–1.10) | 2.7% vs. 4.8% (Definition not provided) Adj OR 0.57 (0.16-1.99) |
| Any ICH | 37.6% vs. 42.3% | 21.7% vs. 32.5% | 33.7% vs. 50.5% Unadj OR 0.50 (0.28–0.88) | 35.9% vs. 35.6% Adj OR 0.97 (0.68– 1.38) | 29.3% vs. 33.7% | NA |
| mTICI ≥2b at the end of the procedure | 79.4% vs. 84.5% OR 0.70 (0.47–1.06) | 88.5% vs. 87.2% OR 1.14 (0.50 - 2.61) | 90.1% vs. 93.2% Unadj OR 0.66 (0.24–1.82) | 78.7% vs. 83.1% Adj OR 0.73 (0.47–1.13) | 90.5% vs. 96.6% | 88.8% vs. 89.0% Adj OR 0.84 (0.39–1.82) |
| First-pass complete reperfusion | NA | 44.0% vs. 43.2% | NA | NA | NA | NA |
| Number of passes (median) | NA | Stent retriever passes: 1 (1-2) vs. 1 (0-2) Aspiration device passes: 0 (0-1) vs. 0 (0-1) | NA | NA | NA | NA |
| Distal embolisation / Embolisation in new territory | 10.7% vs. 9.4% | Clot migration: 17.7% vs 23.9% | NA | 5.2% vs. 3.3% Adj OR 1.31 (0.68–2.53) | NA | NA |
| Infarct volume at 24-36hrs | At a median follow-up time of 6 days: 36.3 vs. 36.7 ml (NCCT) | NA | NA | 24 vs. 17 ml | NA | NA |
| Onset-to-IVT time (median) | 177 (randomisation) + 7 | 176 | 100 (door)+ 36 (randomisation) +14 (IVT) | 98 | 144 | NA |
| Onset-to-arterial puncture time (median) | 167 (randomisation) + 31 vs. 177 (randomisation) + 36 | 200 vs. 210 | 92 (door) +37 (randomisation) +20 (puncture) vs. 100 (door) + 36 (randomisation) + 22 (puncture) | 130 vs. 135 | NA | NA |
| Onset-to-reperfusion time (median) | 167 (randomisation) + 102 vs. 177 (randomisation) + 96 | 289 vs. 285 | NA | 188 vs. 178 | NA | 231 vs. 248 |
| Door-to-IVT time (median) | 59 | 61 | 36 (door to randomisation) + 14 (randomisation-to-IVT time) | 31 | NA | NA |
| Door-to-arterial puncture time (median) | 84 vs. 85.5 | 101 vs. 105 | NA | 63 vs. 64 | 75 vs. 80 | NA |
| Door-to-reperfusion time (median) | NA | NA | NA | NA | 111 vs. 117 | NA |
*Post-hoc calculation based on published data
**Symptomatic intracranial haemorrhage at 24±6 h post-randomization was defined as any parenchymal haematoma type 1 or 2, remote intracranial haemorrhage, subarachnoid haemorrhage, or intraventricular haemorrhage (IVH) associated with a ≥4-point worsening on the NIHSS within 24 h.
***30-day mRS was available for 407 patients; Abbreviations: ASPECTS: Alberta Stroke Program Early Computed Tomography Score; CI: confidence interval; cOR: common odds ratio; CT: computed tomography; dMT: direct mechanical thrombectomy (MT alone); ICA: internal carotid artery; ICH: intracranial haemorrhage; IQR: interquartile range; IVT: intravenous thrombolysis with alteplase; MCA: middle cerebral artery; MRI: magnetic resonance imaging; mRS: modified Rankin Scale; M1: first segment of the middle cerebral artery; M2: second segment of the middle cerebral artery; MT: mechanical thrombectomy; mTICI: modified Treatment In Cerebral Ischaemia scale; NA: not available; NCCT: Non-contrast computed tomography; NIHSS: National Institutes of Health Stroke Scale; OR: odds ratio; PROBE: prospective randomized open blinded endpoint trial; RCT: randomized controlled clinical trial; sICH: symptomatic intracranial haemorrhage.