Article Figures & Data
- Figure 1
Flowchart.
- Figure 2
mRS at 90 days in the per-protocol population. mRS, modified Rankin Scale.
- Table 1
Characteristics of patients at baseline
Characteristic rhTNK-tPA rt-PA 0.1 mg/kg (N=60) 0.25 mg/kg (N=57) 0.32 mg/kg (N=60) 0.9 mg/kg (N=59) Age (years) Mean (SD) 62.4 (11.1) 64.3 (12.8) 64.8 (12.1) 66.5 (12.6) Age group (n) <60 28 (46.7) 21 (36.8) 15 (25.0) 17 (28.8) 60–80 31 (51.7) 28 (49.1) 40 (66.7) 36 (61.0) >80 1 (1.7) 8 (14.0) 5 (8.3) 6 (10.2) Sex (n) Women 12 (20.0) 15 (26.3) 18 (30.0) 21 (35.6) BMI (kg/m2) Mean (SD) 24.52 (3.3) 25.00 (3.8) 24.64 (4.4) 23.77 (3.4) Hypertension (n, %) 43 (71.7) 37 (64.9) 35 (58.3) 42 (71.2) Diabetes mellitus (n, %) 14 (23.3) 9 (15.8) 15 (25.0) 11 (18.6) Hyperlipidaemia (n, %) 17 (28.3) 13 (22.8) 10 (16.7) 11 (18.6) Atrial fibrillation (n, %) 8 (13.3) 4 (7.0) 14 (23.3) 6 (10.2) Current smoking (n, %) 25 (41.7) 25 (43.9) 21 (35.0) 24 (40.7) Medical history (n, %) Antiplatelet 11 (18.3) 6 (10.5) 13 (21.7) 13 (22.0) Anticoagulant 2 (3.3) 0 (0.0) 0 (0.0) 2 (3.4) NIHSS score Median (IQR) 7.0 (5.0–10.0) 8.0 (5.0–12.0) 7.5 (6.0–12.0) 8.0 (5.0–12.0) Premorbid mRS score (n, %) 0 55 (91.7) 54 (94.7) 47 (78.3) 50 (84.8) 1 5 (8.3) 3 (5.3) 11 (18.3) 5 (8.5) 2 0 (0.0) 0 (0.0) 2 (3.3) 4 (6.8) Onset-to-needle time (min) Median (IQR) 154 (56–195) 149 (80–179) 147 (69–220) 153 (18–187) Door-to-needle time (min) Median (IQR) 71 (28–149) 60 (5–180) 69 (10–134) 71 (10–146) BMI, body mass index; mRS, modified Rankin Scale; rhTNK-tPA, recombinant human tenecteplase tissue-type plasminogen activator.
- Table 2
Prespecified safety outcomes and other serious adverse events
rhTNK-tPA rt-PA P value 0.1 mg/kg (N=60) 0.25 mg/kg (N=57) 0.32 mg/kg (N=60) 0.9 mg/kg (N=59) Symptomatic ICH at 36 hours (ECASS III) 3 (5.0) 0 (0.0) 2 (3.3) 1 (1.7) 0.52 Death 6 (10.0) 1 (1.8) 5 (8.3) 6 (10.2) 0.22 Asymptomatic intracranial haemorrhage 4 (6.7) 3 (5.3) 5 (8.3) 2 (3.4) 0.75 Other extracranial bleeding 18 (30.0) 18 (31.6) 22 (36.7) 14 (23.7) 0.49 Serious adverse events 12 (20.0) 7 (12.3) 11 (18.3) 14 (23.7) 0.46 ECASS, European Cooperative Acute Stroke Study; ICH, intracranial haemorrhage; rhTNK-tPA, recombinant human tenecteplase tissue-type plasminogen activator.
- Table 3
Primary efficacy outcome and secondary efficacy outcome in the intention-to-treat and per-protocol populations at 90 days
rhTNK-tPA rt-PA 0.1 mg/kg 0.25 mg/kg 0.32 mg/kg 0.9 mg/kg Intention-to-treat analysis N=60 N=57 N=60 N=59 Primary efficacy outcome Improvement on NIHSS at 14 days n (%) 38 (63.3) 44 (77.2) 40 (66.7) 37 (62.7) OR (95% CI) 1.03 (0.49 to 2.16) 2.01 (0.89 to 4.54) 1.19 (0.56 to 2.52) ref. Secondary efficacy outcomes mRS score ≤1 point at 3 months n.(%) 33 (55.0) 35 (63.6) 36 (62.1) 35 (59.3) OR (95% CI) 0.84 (0.41 to 1.73) 1.20 (0.56 to 2.56) 1.12 (0.53 to 2.36) ref. mRS score ≤2 point at 3 months n.(%) 41 (68.3) 42 (76.7) 41 (70.7) 43 (72.9) OR (95% CI) 0.80 (0.36 to 1.77) 1.20 (0.52 to 2.80) 0.90 (0.40–2.01) ref. Ordinal distribution of mRS at 3 months OR (95% CI) 0.91 (0.47 to 1.73) 1.12 (0.57 to 2.17) 1.00 (0.52 to 1.92) ref. Per-protocol analysis N=55 N=47 N=56 N=57 Primary efficacy outcome Improvement on NIHSS at 14 days n (%) 37 (67.3) 37 (78.7) 39 (69.6) 37 (64.9) OR (95% CI) 1.11 (0.51 to 2.43) 2.00 (0.83 to 4.85) 1.24 (0.56 to 2.73) ref. Secondary efficacy outcomes mRS score ≤1 point at 3 months n (%) 32 (58.2) 29 (63.0) 35 (63.6) 34 (59.7) OR (95% CI) 0.94 (0.44 to 2.00) 1.15 (0.52 to 2.57) 1.18 (0.55 to 2.54) ref. mRS score ≤2 point at 3 months n (%) 38 (69.1) 35 (76.1) 40 (72.7) 42 (73.7) OR (95% CI) 0.80 (0.35 to 1.82) 1.14 (0.46 to 2.79) 0.95 (0.41 to 2.20) ref. Ordinal distribution of mRS at 3 months OR (95% CI) 0.95 (0.49 to 1.86) 1.17 (0.58 to 2.37) 1.03 (0.53 to 2.02) ref. mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; rhTNK-tPA, recombinant human tenecteplase tissue-type plasminogen activator.
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