Results from 17 randomised studies for thrombolysis in pulmonary embolism and reported events of major, fatal and intracranial bleedings
| n | Thrombolysis | Major bleeding criteria | Follow-up (days) | Age mean (SD) (years) | Invasive angiography (%) | Major bleeding number events/total in group (%) | Fatal/intracranial bleeding number events/total in group (%) | |||
| Thrombolysis | Anticoagulation | Thrombolysis | Anticoagulation | |||||||
| UPET21 | 160 | UK 12 hours | Hct drop>10 patients, ≥2 units PRBCs | 14 | – | 100 | 22/82 (26.8) | 11/78 (14.1) | 1/82 (1.2) | 0/78 |
| Tibbutt22 | 23 | SK 600000UIU 30 min through PA cath 100 000 U/h intravenous 72 hours) | Not specified | 3 | 49 (25) | – | 0/11 | 0/12 | 0/11 | 0/12 |
| Ly23 | 25 | SK 600000IU loading and then 100 000 U/h intravenous 72 hours | Not specified | 10 | 53 (25) | 100 | 4/14 (28.6) | 2/11 (18.1) | 0/14 | 0/11 |
| Dotter24 | 31 | SK 2–11 MIU 18–72 hours | Not specified | In-hospital | – | 100 | – | – | 0/15 | 0/16 |
| Marini25 | 30 | UK 2.4–3.3 MIU/12–72 hours | Not specified | 7 | 53 (30) | 100 | 0/20 | 0/10 | 0/20 | 0/10 |
| Stein (PIOPED)26 | 13 | Alteplase 40–80 mg/ 40–90 min +heparin | Not specified | 7 | 62 (3) | 100 | 1/9 (11.1) | 0/4 | 1/9 (11.1) | 0/4 |
| Levine81 | 58 | Alteplase 0.6 mg/kg/2 min | ICH, Hb drop>2 g/dL, ≥2 units PRBCs | 10 | 58 (16) | 67 | 0/33 | 0/25 | 0/33 | 0/25 |
| Dalla Volta27 (PAIMS) | 36 | Alteplase 100 mg/2 hours+heparin | ICH, any transfusion | 30 | 65 (13) | 100 | 3/20 (15)15 | 2/16 (12.5) | 2/20 (10)10 | 0/16 |
| Goldhaber82 | 101 | Alteplase 100 mg/2 hours+heparin | ICH/need for surgery | 14 | 59 (17) | 21 | 3/46 (6.5) | 2/55 (3.6) | 0/46 | 1/55 (1.8) |
| Jerjes-Sanchez16 | 8 | SK 1.5 MIU/ 2 hours | Not specified | 240 | 51 (23) | No | 0/4 | 0/4 | 0/4 | 0/4 |
| Konstantinides29 | 256 | Alteplase 100 mg/2 hours plus heparin | ICH, fatal, Hb drop>4 g/dL | 30 | 62 (10) | 16 | 1/118 (0.9) | 5/138 (3.6) | 0/118 | 1/138 (0.7) |
| Becattini30 (TIPES) | 58 | Tenecteplase 30–50 mg+heparin | ICH, fatal, transfusion, surgery | 7 | 68 (2) | No | 2/28 (7.1) | 1/30 (3.3) | 1/28 (3.6) | 0/30 |
| Fasullo31 | 72 | Alteplase 100 mg/2 hours+heparin | ICH, fatal, any transfusion | 180 | 56 (16) | No | 2/37 (5.4) | 0/35 | 0/37 | 0/35 |
| Kucher32 (ULTIMA) | 59 | Alteplase max 20 mg into PA over 16 hours) | ICH, spinal, joint, RP, pericardial, Hb drop>2 g/dL and transfusion | 90 | 63 (14) | 100 | 0/30 | 0/29 | 0/30 | 0/29 |
| Sharifi33 (MOPETT) | 121 | Alteplase 50 mg/ 2 hours+heparin | Not specified | 840 | 58.5 (10) | No | 0/61 | 0/60 | 0/61 | 0/60 |
| Meyer34 (PEITHO) | 1005 | Tenecteplase 30–50 mg+heparin | ICH, life threatening, fatal, need for transfusion | 30 | 66 (15) | 1.40 | 58/506 (11.5) | 12/499 (2.4) | 10/506 (2)2 | 1/499 (0.2) |
| Kline35 (TOPCOAT) | 83 | Tenecteplase 30–50 mg +enoxaparin | ICH, fatal, need for surgery, Hb drop>2 g/dL and transfusion | 90 | 55 (14) | No | 0/40 | 0/43 | 1/40 (2.5) | 0/43 |
‘–’ indicates missing data.
Adapted from Levine et al10 and Chatterjee et al11
Hb, haemoglobin; Hct, haematocrit; ICH, intracranial haemorrhage; MIU, mega international units; PA, pulmonary artery; PRBC, packed red blood cells; RP, retroperitoneal; SK, streptokinase; UK, urokinase.