Table 3. Efficacy and Safety End Points (n = 86).
Variables | Group I (TNK; n = 45) | Group II (placebo; n = 41) | P-value |
---|---|---|---|
Primary composite outcome within 7 days | 2 (4.5%) | 8 (20%) | 0.04 |
Secondary end points | |||
All cause death | 2 (4.5%) | 2 (5%) | 0.3 |
Hemodynamic decompensation | 2 (4.5%) | 8 (20%) | 0.04 |
Recurrent PE within 7 days | 2 (4.5%) | 1 (2%) | 0.3 |
Rehospitalization within 30 days | 2 (4.5%) | 4 (10%) | 0.29 |
Death within 30 days | 2 (4.5%) | 2 (5%) | 0.18 |
Others | |||
Mean PASP at D7 (mm Hg) | 32.80 ± 4.02 | 38.13 ± 4.49 | 0.04 |
Mean ↓ in PASP from baseline (mm Hg) | 14.10 ± 3.95 | 11.08 ± 4.23 | 0.003 |
Improvement in RV function | 31 (70%) | 16 (40%) | 0.001 |
Need for mechanical ventilation | 2 (4.5%) | 2 (5%) | 0.6 |
Mean hospital stay (days) | 8.1 ± 2.51 | 11.1 ± 2.14 | 0.001 |
Safety end points (bleeding within D7) | |||
Major bleeding | 1 (2%) | 1 (2%) | 0.45 |
Minor Bleeding | 7 (16%) | 5 (12%) | 0.04 |
Hemorrhagic stroke | 1 (2%) | 0 (0%) | 0 |
PE: pulmonary embolism; PASP: pulmonary artery systolic pressure; RV: right ventricle.