Table 4.
Comparison of baseline characteristics and outcome measures of the recent endovascular trials [27, 194, 286]
| Trials | MR CLEAN [110] | ESCAPE [111] | EXTEND-IA [76] | SWIFT PRIME [112] | REVASCAT [113] | THERAPY [128] | THRACE [127] |
|---|---|---|---|---|---|---|---|
| Region | Netherlands | United States, Canada, South Korea, Ireland, United Kingdom | Australia and New Zealand | United States and Europe | Spain | United States | France |
| Number of centres | 16 | 22 | 10 | 39 | 4 | 4 | 26 |
| Number of patients; n (CG/IA) | 500 (267/233) | 315 (150/165) | 70 (35/35) | 196 (98/98) | 206 (103/103) | 108 (54/54) | 412 (208/204) |
| BASELINE CHARACTERISTICS | |||||||
| Age Range | ≥ 18 | ≥ 18 | ≥ 18 | 18–80 years | 18–80 years | 18–85 | 18–80 |
| NIHSS Range | ≥ 2 | > 5 | N.R. | 8–29 | ≥ 6 | ≥8 | 10–25 |
| Control group | Standard medical therapy (+/− IV tPA) | Standard medical therapy (+/− IV tPA) | IV-tPA only | IV-tPA only | Standard medical therapy (+/− IV tPA) | IV-tPA only | IV-tPA only |
| Intervention group | IAT | IAT | ET with Solitaire FR stentriever | ET with Solitaire FR stentriever | ET with Solitaire FR stentriever | ET with Penumbra aspiration system | Endovascular MT |
| Intervention using Stent retriever in IA arm | 81.5% | 86.1% | 100% | 100% | 100% | 0% | N.R. |
| Time window | 0–6 h | 0–12 h | 0–6 h | 0–6 h | 0–8 h | 0–4.5 h | 0–5 h |
| Neurologic inclusion criteria | N.A. | Barthel Index of ≥90 | mRS scores of 0–2 | mRS scores of 0–1 | mRS scores of 0–1 | ||
| Neuroimaging techniques | CT/CTA | CT/CTA/CTA Multiphase (for collaterals) | CT/CTA/CTP (for mismatch) | CT/CTA/MRA/MRP/CTP (for infarct core) | CT/CTA(MRA/DSA) | CT/CTA | CT/CTA |
| Large artery occlusion | CTA | CTA | CTA or MRA | CTA or MRA | CTA or MRA | CTA | CTA or MRA |
| Affected arteries | TICA, M1, M2, A1, A2 | TICA, M1 | TICA, M1, M2 | TICA, M1, M2 | TICA, M1 | MCA | ICA, M1, TB, M2 |
| Infarct core/perfusion | N.R. | NCCT, CBV or CBF ASPECTS ≥6 | CoreΨ < 70 ml (>1.2)¥ | CoreΦ< 50 ml (>1.8)¥ NCCT ASPECTS ≥6 | NCCT ASPECTS ≥7 DWI ASPECTS ≥6 | Clot length ≥ 8 mm | N.R. |
| Collateral status | N.R. | Good/Moderate | N.R. | N.R. | N.R. | N.R. | N.R. |
| Median stroke onset to groin puncture | 260 min | 241 min | 210 min | 224 min | 269 min | 226 min | 255 min |
| Baseline NIHSS [Median (IQR)]; CG vs IA | 18 (14–22) vs17 (14–21) | 17 (12–20) vs 16 (13–20) | 13 (9–19) vs 17 (13–20) | 17 (13–19) vs 17 (13–20) | 17 (12–19) vs 17 (14–20) | N.R. | 17 (13–20) vs 18 (15–21) |
| Median ASPECTS (%); CG/IA | 9/9 | 9/9 | NR/NR | 9/9 | 8/7 | N.R. | N.R. |
| Patients Receiving IV-rtPA (%); CG/IA | 91/87 | 79/73 | 100/100 | 100/100 | 78/68 | 100/100 | 100/100 |
| STUDY OUTCOMES | |||||||
| Primary Outcomes | Shift in mRS at 90 days | Shift in mRS at 90 days | Reduction in perfusion lesion volume; NIHSS reduction ≥8 pointsor mRS score of 0–1 at day 3 | Distribution of mRS at 90 days; % mRS 0–2 at 90 days | Shift in mRS at 90 days | Shift in mRS at 90 days | Shift in mRS at 90 days |
| mRS (0–2) at 90 days %; CG vs IA | 19.1 vs 32.6, P < 0.05 | 29.3 vs 53, P < 0.001 | 40 vs 70, P = 0.001 | 35.5 vs 60.2, P < 0.001 | 28.2 vs 43.7 | 30.4 vs 38 | 42.1 vs 54.2 |
| Improvement in mRS 0–2 at 90 days | 13.5% | 23.7% | 31.4% | 24.7% | 15.5% | 7.6% | 12.1% |
| sICH risk (%); CG vs IA, P | 6.4 vs 7.7, P > 0.05 | 2.7 vs 3.6, P > 0.05 | 5.7 vs 0, P > 0.05 | 3.1 vs 0, P = 0.12 | 1.9 vs 1.9, P > 0.05 | 11.3 vs 10.9 | 2 vs 2, P = 0.71. |
| Parenchymal Hematoma Risk (%); CG/IA | 6 vs 6 | 2.0 vs 4.8 | 8.6 vs 11.4 | N.R. vs N.R. | 5.8 vs 5.8 | N.A. | 9.45 vs 13.8, P = 0.53 |
| Mortality (%); CG vs IA, P | 22.1 vs 21, P > 0.05 | 19 vs10.4, P = 0.04 | 20 vs 8.6, P > 0.05 | 12.4 vs 9.2, P > 0.05 | 15.5 vs 18.4, P = 0.06 | 23.9 vs 12 | 13 vs 12; P = 0.70 |
| Decrease in mortality at 90 days | 1.1% | 8.6% | 11.4% | 3.2% | −2.9% | 11.9% | 1% |
| Complete recanalization rates | |||||||
| mTICI Score 2b/3 | 58.7% | 72.4% | 86.2% | 88.0% | 65.7% | N.R. | N.R. |
| Complete recanalization based on neuroimaging 24–27 h later; CG vs IA | 68/207 (33%)a vs 141/187 (75%)a | N.A. vs N.A. | 15/35 (43%)a vs 33/35 (94%)a | 21/52 (40%)b vs 53/64 (83%)b | N.A. vs N.A. | N.A. | N.A. |
| Brain infarction volume at 24 hc (mean, 95% CI); CG vs IA, P | 79 mL (34–125) vs 49 mL (22–96), P < 0.01 | N.A. vs N.A. | N.A. vs N.A. | 35 mL (0–407) vs 32 mL (0–503), P = 0.09 | 39 mL (12–87) vs 16 mL (8–59), P = 0.02 | N.A. | N.A. |
| NNT | 7.1 | 4.2 | 3.2 | 4.0 | 6.3 | 13.2 | 8.3 |
IQR Interquartile range; TICA Terminal internal carotid artery (Carotid T/L); M1 and M2 Branches of the MCA; A1 and A2 Branches of the ACA; mTICI Modified Thrombolysis in Cerebral Infarction; mRS Modified Rankin Scale; N.R. Not required; N.S. Not significant; N.A. Not available; CTA Computed tomography angiography; NCCT Non-contract computed tomography; CBV Cerebral blood volume; CBF Cerebral blood flow; MRA Magnetic resonance angiography; ASPECTS Alberta Stroke Program Early CT score; CG Control group; IA Intervention arm; IAT Intra-arterial therapy; TB Upper third of the basilar artery; MCA Middle cerebral artery; M2 Insular portion of the MCA; M1 Proximal portion of the MCA; ET Endovascular Thrombectomy; MT Mechanical thrombectomy; ESCAPE Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times; EXTEND-IA Extending the Time for Thrombolysis in Emergency Neurological Deficits—Intra-Arterial; MR CLEAN Multicentre Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; NIHSS National Institutes of Health Stroke Scale; REVASCAT Randomized Trial of Revascularization with Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation LVO Presenting within 8 h of Symptom Onset; SWIFT PRIME Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment; NNT Number needed to treat for benefit (mRS score 0–2); THRACE Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke
¥Target mismatch ratio; λ Sum of median of parameters; ΦThe ischemic core was assessed by MRI or CT; ΨThe ischemic core was defined by regional cerebral blood flow on CT perfusion or diffusion-weighted imaging; aRecanalization shown in brain CTA/MRA at 24 h; bReperfusion shown in brain CT perfusion/MR perfusion at 27 h; cBrain infarction volume at 24 h after treatment measured with CT in MR CLEAN trial and with CT or MRI in SWIFT PRIME and REVASCAT trials