Characteristics and outcome comparison of six trials treating patients with AIS with low ASPECT from an LVO
Trial | TENSION | RESCUE-Japan LIMIT | LASTE | TESLA | SELECT-2 | ANGEL-ASPECT |
Year started | July 2018 | November 2018 | April 2019 | July 2019 | October 2019 | September 2020 |
Country | European eight countries and Canada | Japan | USA-Europe | USA | USA, Canada, Europe, Australia and New Zealand | China |
Age (years) | >18 | >18 | ≥18 | 18–85 | 18–85 | 18–80 |
National Institute of Health Stroke Scale (NIHSS) | <26 | ≥6 | >5 | >6 | ≥6 | 6–30 |
Imaging criteria | NCCT or DWI ASPECT 3–5 | CT or DWI ASPECT 3–5 | NCCT or DWI ASPECT 0–5 | NCCT ASPECT 2–5 | 1. ASPECT >6 and core ≥50 cc 2. ASPECT 3–5 and core ≥50 cc 3. ASPECT 3–5 and core <50 cc | 1. ASPECT 3–5 2. ASPECT 0–2: 70–100 cc |
Imaging characteristic | NCCT ASPECT 82% | DWI-ASPECT >90% | ASPECT 0–2 56% | Only NCCT ASPECT 2–5 | ASPECT+Core | ASPECT+Core 24 hours, all had NCCT |
Time window | <12 hours LKW | <6 hours LKW, 6–24 hours FLAIR (-) | <6.5 hours LKW | <24 hours | <24 hours (0–12 vs 6–24) | <24 hours |
No. of patients enrolled (ITT) | 253 (125 vs 128) of 665 planned | 202 (100 vs 102), 200 planned | 324 (165 vs 159) of 450 planned | 300 planned | 352 (178 vs 174) of 560 planned | 455 (230 vs 225) of 502 planned |
90-day mRS 0–2 | 17% vs 2% 7.16 (95% CI 2.12 to 24.21) P=0.0016 | 14.0% vs 7.8% | 13.2% vs 4.8% | 14.6% vs 8.9% | 20.3% vs 7.0% 2.97 (95% CI 1.60 to 5.51) P<0.0001 | 30.0% vs 11.6% 2.62 (95% CI 1.69 to 4.06) P<0.0001 |
90-day mRS 0–3 | 31% vs 13% 2.84 (95% CI 1.48 to 5.47) P=0.0018 | 31% vs 12.7% | 46% vs 12.7% | 30% vs 20% | 37.9% vs 18.7% 2.06 (95% CI 1.43 to 2.96) P<0.0001 | 47.0% vs 33.3% 1.50 (95% CI 1.17 to 1.91) P<0.0001 |
sICH | 5% vs 5% | 9.0% vs 4.9% | 9.6% vs 5.7% | 3.97% vs 1.34% | 0.6% vs 1.1% | 6.1% vs 2.7% |
Death | 40% vs 51% HR 0.67 (95% CI 0.46 to 0.98) P=0.038 | 18.0% vs 23.5% | 55.5% vs 36.1% | 35.3% vs 33.3% | 38.4% vs 41.5% Relative Risk (0.91 (95% CI 0.71 to 1.18) | 21.7% vs 20.0% HR 1.00 (95% CI 0.65 to 1.54) P=0.99 |
NNT for functional independence at 90 days (mRS of 0–2) | 7 | 16 | 12 | 18 | 8 | 5 |
NNT for independent ambulation at 90 days (mRS of 0–3) | 5 | 5 | 3 | 10 | 5 | 7 |
NNH for symptomatic intracranial haemorrhage | 143 | 24 | 26 | 38 | −200 Negative NNH favours intervention | 29 |
ANGEL-ASPECT, Endovascular Therapy for Acute Ischaemic Stroke with Large Infarct; ASPECT, Alberta Stroke Programme Early CT Score; ITT, intention to treat; LASTE, LArge Stroke Therapy Evaluation; LKW, last known well; mRS, modified Rankin Scale; NCCT, non-contrast CT; NNH, number needed to harm; NNT, number needed to treat; RESCUE-Japan LIMIT, Endovascular Therapy for Acute Stroke with a Large Ischaemic Region; SELECT-2, Trial of Endovascular Thrombectomy for Large Ischaemic Strokes; sICH, symptomatic intracranial haemorrhage; TENSION, Endovascular Thrombectomy for Acute Ischaemic Stroke with Established Large Infarct; TESLA, Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischaemic Stroke.