Efficacy outcomes at 3 months grouped by onset to treatment times
| Outcome | Onset to treatment times, min | Tenecteplase | Alteplase | OR (95% CI) | P for trend | |||
| No/total no (%) | Unadjusted | P value | Adjusted | P value | ||||
| Primary outcome (modified intention-to-treat) | ||||||||
| mRS score 0–1 at 3 months* | ||||||||
| 0–90 | 29/42 (69.1) | 28/41 (68.3) | 1.04 (0.41 to 2.62) | 0.94 | 0.99 (0.37 to 2.67) | 0.98 | 0.84 | |
| 91–180 | 192/307 (62.5) | 181/308 (58.8) | 1.17 (0.85 to 1.62) | 0.34 | 1.23 (0.88 to 1.71) | 0.22 | ||
| 181–270 | 216/353 (61.2) | 194/345 (56.2) | 1.27 (0.91 to 1.67) | 0.18 | 1.21 (0.88 to 1.65) | 0.23 | ||
| Secondary outcomes (modified Intention-to-treat)† | ||||||||
| mRS score 0–2 at 3 months | ||||||||
| 0–90 | 33/42 (78.6) | 33/41 (80.5) | 0.89 (0.31 to 2.59) | 0.83 | 0.85 (0.28 to 2.6) | 0.77 | 0.94 | |
| 91–180 | 228/307 (74.3) | 224/308 (72.7) | 1.08 (0.76 to 1.55) | 0.67 | 1.15 (0.8 to 1.66) | 0.46 | ||
| 181–270 | 253/353 (71.7) | 243/345 (70.4) | 1.06 (0.77 to 1.47) | 0.72 | 1.05 (0.74 to 1.47) | 0.8 | ||
| Ordinal mRS at 3 months | ||||||||
| 0–90 | 1 (0–2) | 1 (0–2) | 0.98 (0.45 to 2.13) | 0.96 | 0.92 (0.42 to 2.04) | 0.84 | 0.85 | |
| 91–180 | 1 (0–3) | 1 (0–3) | 1.08 (0.82 to 1.44) | 0.58 | 1.12 (0.84 to 1.49) | 0.43 | ||
| 181–270 | 1 (0–3) | 1 (0–3) | 1.11 (0.85 to 1.45) | 0.44 | 1.09 (0.84 to 1.43) | 0.51 | ||
| Improvement on NIHSS of ≥4 points or a score ≤1 at 24 hours‡ | ||||||||
| 0–90 | 21/42 (50.0) | 28/41 (68.3) | 0.46 (0.19 to 1.14) | 0.09 | 0.45 (0.18 to 1.12) | 0.09 | 0.20 | |
| 91–180 | 162/301 (53.8) | 167/311 (53.7) | 1.01 (0.73 to 1.38) | 0.98 | 1.01 (0.73 to 1.39) | 0.96 | ||
| 181–270 | 158/345 (45.8) | 150/344 (43.6) | 1.09 (0.81 to 1.48) | 0.56 | 1.08 (0.8 to 1.46) | 0.63 | ||
| Improvement on NIHSS of ≥4 points or a score ≤1 at 7 days or discharge | ||||||||
| 0–90 | 25/41 (61.0) | 34/40 (85.0) | 0.28 (0.09 to 0.81) | 0.02 | 0.22 (0.07 to 0.7) | 0.01 | 0.06 | |
| 91–180 | 211/298 (70.8) | 213/309 (68.9) | 1.09 (0.77 to 1.55) | 0.62 | 1.08 (0.76 to 1.54) | 0.65 | ||
| 181–270 | 218/335 (65.1) | 202/335 (60.3) | 1.23 (0.90 to 1.68) | 0.20 | 1.2 (0.87 to 1.65) | 0.26 | ||
| Barthel index ≥95 | ||||||||
| 0–90 | 29/39 (74.4) | 31/40 (77.5) | 0.84 (0.30 to 2.37) | 0.74 | 0.78 (0.25 to 2.42) | 0.67 | 0.66 | |
| 91–180 | 204/190 (70.3) | 206/297 (69.4) | 1.05 (0.74 to 1.49) | 0.80 | 1.12 (0.78 to 1.61) | 0.54 | ||
| 181–270 | 227/327 (69.4) | 215/323 (66.6) | 1.14 (0.82 to 1.59) | 0.44 | 1.14 (0.81 to 1.6) | 0.47 | ||
*Scores on the mRS range from 0 to 6, with 0 indicating no disability, 3 indicating moderate disability and 6 indicating death.
†Common OR with its 95% CI was calculated using ordinal logistic regression for the outcome of ordinal mRS at 90 days, and ORs with their 95% CIs were calculated using binary logistic regression for other secondary outcomes and safety outcomes.
‡NIHSS scores range from 0 to 42, with higher scores indicating more severe stroke.
MRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.