Table 5. Recent trials of ultrasound-assisted catheter-directed thrombolysis in patients with pulmonary embolism109,115,116.
ULTIMA | SEATTLE II | OPTALYSE PE | |
Publication year | 2014 | 2015 | 2018 |
Patient no. | 59 | 150 | 101 |
Design | Two arms comparing thrombolysis and no thrombolysis | Single arm | Four arms comparing four thrombolytic regimens |
No control group | |||
PE severity | Intermediate-risk PE defined by RV/LV diameter ratio ≥ 1.0 on imaging | Massive or submassive PE | Intermediate-risk PE defined by RV/LV diameter ratio ≥ 0.9 on imaging |
Thrombolysis regimen | Alteplase 1 mg/h per catheter for 5 hours then 0.5 mg/h per catheter for 10 hours (the maximum dose was 20 ± 1 mg for patients with bilateral device placement and 10 ± 0.5 mg for patients with unilateral device placement) | Alteplase 1 mg/h for 24 hours if unilateral device placement and for 12 hours if bilateral device placement | Either one of the following: Arm 1: alteplase 2 mg/h per catheter for 2 hours. Arm 2: alteplase 1 mg/h per catheter for 4 hours. Arm 3: alteplase 1 mg/h per catheter for 6 hours. Arm 4: alteplase 2 mg/h per catheter for 6 hours. |
Primary endpoint | The difference in RV/LV diameter ratio from baseline to 24 hours | The change in RV/LV diameter ratio from baseline to 48 hours | The change in RV/LV diameter ratio from baseline to 48 hours |
LV, left ventricle; PE, pulmonary embolism; RV, right ventricle.