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.