Table 2.
Main pulmonary embolism trials.
| Trial | N | Randomisation | Comparison | Follow-up time (days) | Intermediate-risk PE, n (%) | High-risk PE, n (%) | Efficacy |
|---|---|---|---|---|---|---|---|
| PEITHO, 2014 [10] Systemic fibrinolysis |
1006 | Tenecteplase, systemic (30–50 mg) | Heparin/LMWH Fondaparinux |
30 | 1005 (100) | 0 (0) | Mortality/Cardiac decompensation at d7: tenecteplase 2.6% vs placebo 5.6% (odds ratio: 0.44; 95% CI: 0.23–0.87; P = 0.02) |
| PERFECT, 2015 [22] Endovascular thrombolysis |
101 | tPA or urokinase + catheter-directed | Single arm | 30 | 73 (72) | 28 (28) | PASP 51.17 ± 14.06 to 37.23 ± 15.81 mmHg (P < 0.0001) |
| ULTIMA, 2013 [9] Ultrasound |
59 | tPA (20 mg) + ultrasound | Heparin | 90 | 59 (100) | 0 (0) | Reduction of RV/LV ratio from 1.28 ± 0.19 to 0.99 ± 0.17 at 24 h (P < 0.001) |
| SEATTLE II, 2015 [21] Ultrasound |
150 | tPA (24 mg) + ultrasound | Single arm | 30 | 119 (79) | 31 (21) | Reduction of RV/LV ratio from 1.55 to 1.13 at 48 h (P < 0.0001), reduction of PASP from 51.4 to 36.9 mmHg (P < 0.0001) at 48 h |
| OPTALYSE PE, 2018 [25] Ultrasound |
101 | tPA (8–24 mg) + ultrasound | 4 different protocols/tPA | 3 | 101 (100) | 0 (0) | Reduction of RV/LV ratio in both arms |
| FLARE, 2019 Mechanical [39] |
106 | FlowTriever Pulmonary Embolectomy |
Single arm | 30 | 104 (100) | 0 (0) | Reduction of RV/LV ratio from 1.53 to 1.15 at 48 h |
tPA: tissue plasminogen activator; LMWH: low molecular weight heparin; CI: confidence interval; PASP: pulmonary artery systolic pressure; RV: right ventricle; LV: left ventricle.