Article Figures & Data
Figures
- Figure 1
Flow diagram of the patients’ selection. ANGEL-ASPECT, Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core (ClinicalTrials.gov number NCT04551664).
- Figure 2
Distribution of scores on the modified Rankin Scale (mRS) at 90 days among patients presenting with a large infarct core.
Tables
- Table 1
Baseline characteristics
Variables Endovascular therapy (n=77） Bridging therapy (n=45） P value Demographics Age (years), mean (SD) 67.5±7.7 67.1±7.8 0.80 Sex (female), n (%) 38 (49.4) 18 (40.0) 0.32 BMI (kg/m2), mean (SD) 24.3±2.7 25.1±4.6 0.23 Risk factors Hypertension, n (%) 53 (68.8) 24 (53.3) 0.09 Diabetes, n (%) 16 (20.8) 8 (17.8) 0.69 Dyslipidaemia, n (%) 3 (3.9) 4 (8.9) 0.42 Current smoker, n (%) 23 (29.9) 8 (17.8) 0.14 Current drinker, n (%) 7 (9.1) 8 (17.78) 0.16 Medical history Cerebral infarction, n (%) 14 (18.2) 8 (17.8) 0.96 Atrial fibrillation, n (%) 26 (33.8) 10 (22.2) 0.17 Coronary heart disease, n (%) 12 (15.6) 11 (24.4) 0.23 Stroke subtype Atherothrombotic, n (%) 20 (26.0) 10 (22.2) 0.85 Cardioembolic, n (%) 44 (57.1) 26 (57.8) Undetermined or other, n (%) 13 (16.9) 9 (20.0) Occlusion site* ICA, n (%) 29 (37.7) 17 (37.8) 0.74 M1 segment, n (%) 47 (61.0) 28 (62.2) M2 segment, n (%) 1 (1.3) 0 (0) Interval between stroke onset and arrival <4.5 hours, n (%) 54 (70.1) 32 (71.1) 0.91 4.5–6 hours, n (%) 23 (29.9) 13 (28.9) ASPECTS value based on CT, n (%) 0 1 (1.3) 2 (4.4) 0.19 1 7 (9.1) 2 (4.4) 2 2 (2.6) 4 (8.9) 3 37 (48.1) 16 (35.6) 4 21 (27.3) 11 (24.4) 5 9 (11.7) 10 (22.2) NIHSS score at admission, median (IQR) 17 (14–20) 18 (13–20) 0.83 Median infarct core volume, mean (SD)† 67.0±40.0 61.6±37.6 0.52 *M1 segment indicates the middle cerebral artery horizontal or sphenoidal segment; M2 segment indicates the middle cerebral artery insular segment.
†The definition of infarct core was an area with an apparent diffusion coefficient ≤620×10−6 mm2/s on MRI or a relative cerebral blood flow below 30% on CT perfusion.
ASPECTS, Alberta Stroke Program Early CT Score; BMI, body mass index; ICA, internal carotid artery; NIHSS, National Institutes of Health Stroke Scale.
- Table 2
Comparison of outcome parameters between endovascular therapy alone and bridging therapy
Outcomes Endovascular therapy (n=77） Bridging therapy (n=45） Treatment effect* (95% CI) P value Primary outcome mRS score at 90 days 4 (2–6) 3 (2–5) 1.36 (0.71 to 2.61) 0.35 Secondary outcomes mRS score at 90 days, n (%) 0–2 21 (27.3) 16 (35.6) 1.30 (0.76 to 2.23) 0.34 0–3 33 (42.9) 23 (51.1) 1.19 (0.81 to 1.75) 0.38 NIHSS 0–1 or improved ≥10 points at 36 hours, n (%) 6 (7.8) 2 (4.4) 0.57 (0.12 to 2.71) 0.47 Change from baseline in infarct core volume, mean (SD) 87.4±91.3 111.4±119.5 24.02 (−14.09 to 62.13) 0.21 Target artery recanalisation at 36 hours, n (%) 60 (90.9) 32 (86.5) 0.95 (0.82 to 1.1) 0.49 Safety outcomes Symptomatic intracranial haemorrhage within 2 days, n (%) 3 (3.9) 3 (6.7) 1.71 (0.36 to 8.12) 0.50 Any intracranial haemorrhage within 2 days, n (%) 34 (44.2) 23 (51.1) 1.16 (0.79 to 1.69) 0.46 Death within 90 days, n (%) 24 (31.2) 11 (24.4) 0.75 (0.37 to 1.54) 0.43 Decompressive hemicraniectomy during hospitalisation, n (%) 3 (3.9) 6 (13.3) 3.42 (0.9 to 13.02) 0.06 *Treatment effects are reported including the primary outcome as a cOR for the ordinal shift on the mRS; the safety outcome of death as an HR; the secondary outcomes of alteration in the volume of infarct core as the mean difference; and the remaining outcomes as the RR.
mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.
- Table 3
Subgroup analyses of the outcome parameters
Subgroup* Endovascular therapy Bridging therapy RR (95% CI) P value P for interaction Overall 77 45 Interval between stroke onset and arrival 0.10 <4.5 hours 14/54 (25.9) 14/32 (43.8) 1.69 (0.93 to 3.07) 0.09 4.5–6 hours 7/23 (30.4) 2/13 (15.4) 0.51 (0.12 to 2.08) 0.32 Stroke subtype 0.16 Atherothrombotic 6/20 (30.0) 4/10 (40.0) 1.33 (0.48 to 3.67) 0.59 Cardioembolic 10/44 (22.7) 11/26 (42.3) 1.86 (0.92 to 3.77) 0.09 Undetermined or other 5/13 (38.5) 1/9 (11.1) 0.29 (0.04 to 2.08) 0.17 NIHSS score at admission 0.75 <16 13/30 (43.3) 9/18 (50.0) 1.15 (0.62 to 2.14) 0.66 ≥16 8/47 (17.0) 7/27 (25.9) 1.52 (0.62 to 3.74) 0.36 Infarct core volume 0.78 <70 mL 15/43 (34.9) 12/26 (46.2) 1.32 (0.74 to 2.37) 0.36 ≥70 mL 6/34 (17.7) 4/19 (21.1) 1.19 (0.38 to 3.71) 0.76 *The outcome parameter of the subgroup analysis was the score of mRS ≤2.
mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; RR, relative risk.
Supplementary data
