Article Figures & Data
- Figure 1
Study design: umbrella Simon’s two-stage design. TLSW, time from last seen well.
- Figure 2
Trial profile. CTP, perfusion CT; mRS, modified Rankin Scale
- Table 1
Baseline characteristics of the patients randomised
Tenecteplase 0.25 mg/kg
(n=43)Tenecteplase 0.32 mg/kg
(n=43)Age, years 68.3 (13.1) 67.1 (11.5) Male sex 25 (58.1%) 31 (72.1%) NIHSS score at randomisation 11 (8–15) 9 (6–13) Stroke aetiology Cardioembolism 15 (34.9%) 7 (16.3%) Large artery atherosclerosis 20 (46.5%) 28 (65.2%) Undetermined aetiology 8 (18.6%) 8 (18.6%) Medical history Atrial fibrillation 14 (32.6%) 4 (9.3%) Hypertension 27 (62.8%) 29 (67.4%) Diabetes 12 (27.9%) 16 (37.2%) Smoking 15 (34.9%) 25 (58.1%) Ischaemic stroke or transient ischaemic attack 6 (14.0%) 5 (11.6%) TLSW to randomisation 4.5–12 hours 25 (58.1%) 26 (60.5%) 12- 24 hours 18 (41.9%) 17 (39.5%) Witnessed stroke 21 (48.8%) 28 (65.1%) Transferred to catheter lab 17 (39.5%) 18 (41.9%) Underwent endovascular treatment 17 (39.5%) 17 (39.5%) TLSW to hospital arrival, min 497 (310–815) 513 (394–632) TLSW to initiation of intravenous therapy, min 645 (481–973) 674 (516–808) Time from hospital arrival to initiation of intravenous therapy, min 130 (99–159) 140 (111–217) Time from initiation of intravenous thrombolysis to initial angiographic assessment, min* 69.0 (45.0–94.5) 62.5 (41.8–93.3) Site of artery occlusion or severe stenosis Extracranial segment of intracranial carotid artery 3 (7.0%) 6 (14.0%) Intracranial segment of intracranial carotid artery 3 (7.0%) 4 (9.3%) First segment of middle cerebral artery 25 (58.1%) 15 (34.9%) Second segment of middle cerebral artery 9 (20.9%) 11 (25.6%) Anterior cerebral artery 3 (7.0%) 6 (14.0%) Tandem occlusion 0 (0.0%) 1 (2.3%) Vessel severe stenosis at baseline 8 (18.6%) 5 (11.6%) Hypoperfusion lesion volume at baseline, mL 77 (50–114) 76 (46–120) Ischaemic core volume at baseline, mL 8 (4–15) 8 (4–19) Data are mean (SD), n (%), median (IQR).
*Tenecteplase 0.25 mg/kg: n=17; tenecteplase 0.32 mg/kg: n=18.
IQR, interquartile range; NIHSS, National Institutes of Health Stroke Scale; SD, standard deviation; TLSW, time from last seen well.
- Table 2
Primary and secondary efficacy and safety outcomes
Tenecteplase 0.25 mg/kg
(n=43)Tenecteplase 0.32 mg/kg
(n=43)Primary outcome*
(major reperfusion without the occurrence of symptomatic ICH)14 (32.6%) 10 (23.3%) Secondary outcome Efficacy Recanalisation† 18 (43.9%) 18 (43.9%) Infarct growth at 3–5 days, mL‡ 23.9 (3.5–55.3) 16.9 (6.7–81.0) Major neurological improvement at 24–48 hours§ 7 (17.1%) 8 (18.6%) Change in NIHSS score at 24–48 hours compared with baseline§ −1.0 (−6.5, 2.0) 0.0 (−3.0, 2.0) mRS score 0–1 at 90 days 12 (27.9%) 21 (48.8%) mRS score 0–2 at 90 days 20 (46.5%) 26 (60.5%) mRS score at 90 days 0 7 (16.3%) 8 (18.6%) 1 5 (11.6%) 13 (30.2%) 2 8 (18.6%) 5 (11.6%) 3 5 (11.6%) 3 (7.0%) 4 7 (16.3%) 7 (16.3%) 5 5 (11.6%) 5 (11.6%) 6 6 (14.0%) 2 (4.7%) Safety Symptomatic ICH 4 (9.3%) 4 (9.3%) Any ICH 21 (48.8%) 13 (30.2%) Parenchymal haematoma type 2 5 (11.6%) 1 (2.3%) mRS score 5–6 at 90 days 11 (25.6%) 7 (16.3%) Systematic haemorrhage 3 (7.0%) 1 (2.3%) Barthel Index at 90 days¶ 95.0 (50.0–100.0) 95.0 (47.5–100.0) Data are n (%), median (IQR).
*Major reperfusion was assessed at the initial catheter angiography or repeated CTP 4–6 hours and symptomatic ICH was assessed at 24–48 hours after intravenous tenecteplase treatment.
†Tenecteplase 0.25 mg/kg: n=41; tenecteplase 0.32 mg/kg: n=41.
‡Tenecteplase 0.25 mg/kg: n=36; tenecteplase 0.32 mg/kg: n=41.
§Tenecteplase 0.25 mg/kg: n=41.
¶Tenecteplase 0.25 mg/kg: n=33; tenecteplase 0.32 mg/kg: n=41.
CTP, perfusion CT; ICH, intracranial haemorrhage; IQR, interquartile range; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.
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