Article Figures & Data
- Figure 1
Forest plot of randomised comparisons of intravenous tenecteplase or alteplase for patients with AIS within 4.5 hours of stroke onset. AIS, acute ischaemic stroke; NIHSS, National Institutes of Health Stroke Scale; OTT, onset to treatment time.
- Figure 2
Model estimating OR for excellent outcome at 3 months in tenecteplase-treated patients compared with alteplase-treated patients by OTT. OTT, onset to treatment time.
- Figure 3
Pooled risk difference for modified Rankin Scale Scores 0–1 at 90 days by OTT and stroke severity. OTT, onset to treatment time; TRACE-2, Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-2.
- Table 1
Baseline characteristics of patients grouped by onset to treatment times
Onset to treatment times
0–90 min (N=84)Onset to treatment times
91–180 min (N=622)Onset to treatment times
181–270 min (N=706)P value Mean age—year 62.4±10.4 65.1±11.5 65.6±11.2 0.02 Age group—year 0.05 18–59 34 (40.5) 196 (31.5) 197 (27.9) 60–79 47 (56.0) 361 (58.0) 440 (62.3) ≥80 3 (3.6) 65 (10.5) 69 (9.8) Male sex—no (%) 59 (70.2) 420 (67.5) 488 (69.1) 0.77 Weight (IQR)—kg 68 (60–77) 67 (60–75) 65 (58–75) 0.12 Medical history—no (%) Hypertension 63 (75.0) 438 (70.4) 517 (73.2) 0.43 Diabetes mellitus 23 (27.4) 166 (26.7) 188 (26.6) 0.99 Hyperlipidaemia 17 (20.2) 138 (22.2) 132 (18.7) 0.29 Coronary heart disease 17 (20.2) 156 (25.1) 158 (22.4) 0.40 Arrhythmia 10 (11.9) 139 (22.3) 132 (18.7) 0.04 Current smoking—no (%) 35 (41.7) 228 (36.7) 276 (39.1) 0.50 History of medication use—no (%) Antiplatelet agents 10 (11.9) 82 (13.2) 90 (12.7) 0.94 Anticoagulant agents 1 (1.2) 2 (0.3) 9 (1.3) 0.16 Antihypertensive drugs 41 (48.8) 256 (41.2) 317 (44.9) 0.23 Hypoglycaemic drugs 11 (13.1) 109 (17.5) 104 (14.7) 0.29 Lipid-lowering drugs 10 (11.9) 53 (8.5) 64 (9.1) 0.59 Pre-stroke mRS—no (%) 0.19 0 76 (90.5) 566 (91.0) 621 (88.0) 1 8 (9.5) 56 (9.0) 85 (12.0) NIHSS score* Median (IQR) 8 (6–11) 7 (6–10) 7 (6–10) 0.02 Mild (≤7) 37 (44.0) 340 (54.7) 427 (60.5) 0.003 Moderate (8–14) 43 (51.2) 225 (36.2) 218 (30.9) Severe (≥15) 4 (4.8) 57 (9.2) 61 (8.6) Onset-to-needle time (IQR)—min 75 (65–84) 140 (117–84) 226 (204–248) <0.001 Door-to-needle time—min 46 (39–56) 58 (47–74) 65 (48–90) <0.001 Bridging thrombectomy 7 (8.3) 24 (3.9) 19 (2.7) 0.03 *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.
- Table 2
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.
- Table 3
Safety outcomes at 3 months grouped by onset to treatment times
Outcome Onset to treatment times, min Tenecteplase Alteplase OR (95%CI) P value No/total no (%) Symptomatic intracranial haemorrhage within 36 hours 0–90 0/43 (0) 0/41 (0) -- -- 91–180 7/309 (2.3) 5/313 (1.6) 1.43 (0.45 to 4.55) 0.55 181–270 8/356 (2.3) 8/350 (2.3) 0.98 (0.37 to 2.65) 0.97 Symptomatic intracranial haemorrhage within 90 days 0–90 0/43 (0) 0/41 (0) -- -- 91–180 7/309 (2.3) 7/313 (2.2) 1.01 (0.35 to 2.92) 0.98 181–270 10/356 (2.8) 8/350 (2.3) 1.24 (0.48 to 3.17) 0.66 PH2 intracranial haemorrhage within 36 hours 0–90 0/43 (0) 0/41 (0) -- -- 91–180 5/309 (1.6) 0/313 (0) -- -- 181–270 5/356 (1.4) 3/350 (0.9) 1.65 (0.39 to 6.95) 0.50 Any intracranial haemorrhage within 90 days 0–90 1/43 (2.3) 1/41 (2.4) 0.95 (0.06 to 15.75) 0.97 91–180 23/309 (7.4) 22/313 (7.0) 1.06 (0.58 to 1.95) 0.84 181–270 20/356 (5.6) 27/350 (7.7) 0.71 (0.39 to 1.30) 0.27 Other significant haemorrhage events within 90 days 0–90 0/43 (0) 0/41 (0) -- -- 91–180 2/309 (0.7) 3/313 (1.0) 0.67 (0.11 to 4.06) 0.67 181–270 3/356 (0.8) 2/350 (0.6) 1.48 (0.25 to 8.90) 0.67 Deaths 0–90 3/43 (7.0) 1/41 (2.4) 3.00 (0.30 to 30.07) 0.35 91–180 16/309 (5.2) 12/313 (3.8) 1.37 (0.64 to 2.95) 0.42 181–270 26/356 (7.3) 22/350 (6.3) 1.18 (0.65 to 2.12) 0.59 Adverse events 0–90 40/43 (93.0) 38/41 (92.7) 1.05 (0.20 to 5.54) 0.95 91–180 275/309 (89.0) 271/313 (86.6) 1.25 (0.77 to 2.03) 0.36 181–270 292/356 (82.0) 302/350 (86.3) 0.73 (0.48 to 1.09) 0.12 Serious adverse events 0–90 10//43 (23.3) 5/41 (12.2) 2.18 (0.68 to 7.05) 0.19 91–180 48/309 (15.5) 44/313 (14.1) 1.12 (0.72 to 1.75) 0.60 181–270 57/356 (16.0) 57/350 (16.3) 0.98 (0.66 to 1.46) 0.92 PH2, parenchymal haematoma 2.
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