Article Figures & Data
- Figure 1
Distribution of the modified Rankin Scale (mRS) scores at 90–120 days in the intention-to-treat population. mRS scores range from 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death.
- Figure 2
Forest plot of the adjusted risk ratios for mRS 0–1 at 90–120 days stratified by clinically relevant subgroups. Models were adjusted for age, sex and occlusion location as fixed-effects variables, and site as a random-effects variable. P values for interactions were not significant for all subgroups (p<0.05). *There were no patients with intracranial internal carotid artery occlusions in the alteplase group. ASPECTS, Alberta Stroke Program Early CT score; LVO, large vessel occlusion; M1-MCA, first segment of the middle cerebral artery; M2-MCA, second segment of the middle cerebral artery; mRS, modified Rankin Scale.
- Table 1
Baseline characteristics of study participants with minor stroke (NIHSS <6) treated with tenecteplase and alteplase
Baseline characteristic Tenecteplase (N=194) Alteplase (N=184) Age, median (IQR), years 72 (62–83) 71 (59–81) Female sex, N (%) 75 (38.7) 75 (40.8) Baseline NIHSS, median (IQR) 4 (3–5) 4 (3–5) Baseline ASPECTS score (n=143)†, median (IQR) 9 (9–10) 9 (9–10) Intracranial occlusion site on baseline CT angiography (n=376)* Internal carotid artery (ICA), N (%) 3 (1.5) 0 (0) M1 segment middle cerebral artery (MCA), N (%) 9 (4.7) 6 (3.3) M2 segment MCA, N (%) 42 (21.8) 17 (9.3) Other distal occlusions (MCA, ACA, PCA)‡, N (%) 43 (22.3) 41 (22.4) Vertebrobasilar arterial system, N (%) 11 (5.7) 14 (7.6) Cervical ICA, N (%) 3 (1.5) 3 (1.6) No visible occlusions, N (%) 82 (42.5) 102 (55.7) Presence of large vessel occlusion on baseline CT angiography, N (%) 13 (6.7) 6 (3.3) Type of enrolling centre Primary stroke centre, N (%) 14 (7.2) 8 (4.3) Comprehensive stroke centre, N (%) 180 (92.8) 176 (95.6) Workflow times, median (IQR), min Stroke symptom onset to randomisation, min 146 (100–212) 149 (106–205) Stroke symptom onset to start of thrombolysis, min 150 (106–218) 159 (111–214) Baseline CT to arterial puncture (in patients undergoing EVT), min 78 (58–188) 95 (51–216) Arterial puncture to successful reperfusion (in patients undergoing EVT), min 33 (18–41) 21 (13–25) Data are n (%), n/N (%) or median (IQR). Large vessel occlusion is defined as large vessel occlusion of the ICA, M1 segment MCA or functional M1 segment MCA occlusion, that is, all M2 segments MCA occluded on baseline CT angiography scan. If patients had more than one occlusion site, the most proximal occlusion is listed.
*Two patients had baseline non-contrast CT but did not have a baseline CT angiography.
†ASPECTS was available for patients who had ICA or MCA occlusion at baseline.
‡MCA (M3 and beyond), ACA (A2 and beyond) or PCA (P2 and beyond).
ACA, anterior cerebral artery; ASPECTS, Alberta Stroke Program Early CT Score; EVT, endovascular thrombectomy; NIHSS, National Institutes of Health Stroke Scale; PCA, posterior cerebral artery.
- Table 2
Primary and secondary outcomes at 90–120 days for study participants treated with tenecteplase versus alteplase
Tenecteplase (n=194) Alteplase (n=184) Unadjusted risk ratio (95% CI) Adjusted risk ratio (95% CI)* Primary outcome Modified Rankin Scale score 0–1 at 90–120 days, n (%) 100 (51.8) 86 (47.5) 1.09 (0.88 to 1.23) 1.14 (0.92 to 1.40) Secondary outcomes Modified Rankin Scale score 0–2 at 90–120 days, n (%) 143 (74.1) 126 (69.6) 1.06 (0.93 to 1.20) 1.09 (0.94 to 1.26) Modified Rankin Scale score at 90–120 days, median (IQR) 1 (0–3) 2 (1–3) 0.74 (0.52 to 1.07) 0.69 (0.47 to 1.00)† EQ-5D VAS at 90–120 days, median (IQR) 75 (61–86) 75 (60–90) 0.62 (-3.50 to 4.77) 0.99 (0.97-1.02)‡ Return to baseline function, n (%) 80 (42.5) 61 (35.3) 1.20 (0.92 to 1.56) 1.20 (0.90 to 1.59) Endovascular thrombectomy utilisation, n (%) 22 (11.3) 15 (8.1) 1.39 (0.74 to 2.59) 0.88 (0.53 to 1.47) eTICI 2b/3 at first angiographic run, n (%) 8 (36.4) 1 (6.7) 5.45 (0.75 to 39.21) 6.68 (0.49 to 90.57) eTICI 2b/3 at final angiographic run, n (%) 9 (60) 21 (95.4) 1.59 (1.04 to 2.42) 1.57 (0.58 to 4.25) Length of hospital stay, median days (IQR) 4 (2–8) 4 (2–7) −0.47 (−2.6 to 1.70) 0.86 (0.79 to 0.93)‡ Data are n (%), median (IQR), mean (SD) or effect estimate with 95% CI in parentheses.
*Adjusted for age, sex, occlusion location as fixed-effects variables and participating site as a random-effects variable.
†Common OR is the OR for a unit increase in the modified Rankin Scale score for tenecteplase versus alteplase.
‡Risk ratio using mixed-effects linear regression model adjusted for age, sex, occlusion location as fixed-effects variables and participating site as a random-effects variable.
eTICI, expanded treatment in cerebral infarction; VAS, Visual Analogue Scale.
- Table 3
Safety outcomes in study participants treated with tenecteplase versus alteplase
Endpoints Tenecteplase (n=194), n (%) Alteplase (n=184), n (%) Unadjusted risk ratio (95% CI) Death within 90 days 11 (5.7) 20 (11.0) 0.99 (0.96 to 1.02)* Symptomatic intracranial haemorrhage 5 (2.6) 6 (3.3) 0.79 (0.24 to 2.54) Peripheral bleeding requiring blood transfusions 0 (0) 0 (0) NA Orolingual angioedema 1 (0.5) 1 (0.5) 0.94 (0.06 to 15.05) Other 17 (8.8) 17 (9.2) 0.94 (0.49 to 1.80) Imaging-identified haemorrhage 23 (11.9) 27 (14.7) 0.80 (0.48 to 1.35) Subarachnoid haemorrhage 5 (2.6) 4 (2.2) 1.18 (0.32 to 4.34) Subdural haemorrhage 0 (0) 1 (0.5) NA Intraventricular haemorrhage 5 (2.6) 3 (1.6) 1.58 (0.38 to 6.52) HI1 (scattered small petechiae) 1 (0.5) 5 (2.7) 0.18 (0.02 to 1.59) HI2 (confluent petechiae) 12 (6.2) 13 (7.1) 0.86 (0.40 to 1.84) PH1 (haematoma occupying <30% of infarct with no substantive mass effect)† 6 (3.1) 3 (1.6) 1.87 (0.47 to 7.39) PH2 (haematoma occupying ≥30% of infarct with obvious mass effect)‡ 2 (1) 3 (1.6) 0.62 (0.10 to 3.70) Imaging-identified intracranial haemorrhages were assessed in a central core laboratory in a blinded manner and classified using the Heidelberg classification.
*HR using Cox proportional hazard adjusted for age, sex and occlusion site.
†Remote PH type 1 was defined as haematoma outside the infarcted tissue with no substantive mass effect.
‡Remote PH type 2 was defined as haematoma outside the infarcted tissue, with obvious mass effect.
HI, haemorrhagic infarction; NA, not applicable; PH, parenchymal haematoma.
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