Summary of key studies of DCT in intermediate-risk PE
| Study . | N . | Study design . | Study population . | Treatment . | Comparison . | Efficacy . | Safety . |
|---|---|---|---|---|---|---|---|
| ULTIMA22 | 59 | RCT | Intermediate-risk PE | USAT: tPA at 10 mg via EKOS catheter + therapeutic anticoagulation (n = 30) | UFH alone (n = 29) | Mean difference in RV/LV ratio from baseline to 24 h | No major bleeding |
| USAT tPA: 0.30 ± 0.20 | Minor bleeding | ||||||
| UFH alone: 0.03 ± 0.16 (P < .001) | USAT rtPA: 10% | ||||||
| No difference in hemodynamic decompensation, recurrent VTE, mortality at 90 d | UFH alone: 3% (P = .61) | ||||||
| SEATTLE II23 | 150 | Prospective single arm | Massive PE (n = 31; 21%) | USAT: tPA at 24 mg via EKOS catheter + therapeutic anticoagulation | None | Mean RV/LV ratio decreased from baseline (1.55) to 48 h (1.13; P < .001) | 30-d major bleeding, 10% |
| Submassive PE (n = 119; 79%) | PASP decreased at 48 h | 30-d mortality, 2.7%; no ICH | |||||
| PERFECT24 | 101 | Prospective single arm | Massive PE (n = 28; 28%) | Standard CDT (64%) or USAT via EKOS catheter (36%) with tPA at 0.5-1.0 mg/h or urokinase 100 000 IU/hr + therapeutic anticoagulation | None | Clinical success* achieved in 85.7% massive PE and 97.3% submassive PE | In-hospital mortality, 5.9% |
| Submassive PE (n = 73; 72%) | PASP decreased post-CDT | No major bleeding or ICH at 30 d | |||||
| No difference in PASP change, tPA dose, or infusion between USAT and standard CDT | |||||||
| OPTALYSE-PE25 | 101 | Randomized comparison of 4 USAT regimens | Intermediate-risk PE | USAT: tPA at 8-24 mg via EKOS catheter + therapeutic anticoagulation | 4 USAT regimens | Mean RV/LV ratio decreased at 48 h in all 4 regimens | Major bleeding at 72 h, 4% |
| 2 ICHs (1 attributable to USAT tPA) | |||||||
| Recurrent PE, 1% | |||||||
| 30-d mortality, 1% | |||||||
| FLARE26 | 104 | Prospective single arm | Intermediate-risk PE | Catheter-directed mechanical thrombectomy without thrombolysis + therapeutic anticoagulation | None | Mean RV/LV ratio decreased from baseline (1.56) to 48 h (1.15; P < .0001) | 1 major bleeding |
| No ICH | |||||||
| 4 clinical deterioration | |||||||
| 1 death at 23 d |
| Study . | N . | Study design . | Study population . | Treatment . | Comparison . | Efficacy . | Safety . |
|---|---|---|---|---|---|---|---|
| ULTIMA22 | 59 | RCT | Intermediate-risk PE | USAT: tPA at 10 mg via EKOS catheter + therapeutic anticoagulation (n = 30) | UFH alone (n = 29) | Mean difference in RV/LV ratio from baseline to 24 h | No major bleeding |
| USAT tPA: 0.30 ± 0.20 | Minor bleeding | ||||||
| UFH alone: 0.03 ± 0.16 (P < .001) | USAT rtPA: 10% | ||||||
| No difference in hemodynamic decompensation, recurrent VTE, mortality at 90 d | UFH alone: 3% (P = .61) | ||||||
| SEATTLE II23 | 150 | Prospective single arm | Massive PE (n = 31; 21%) | USAT: tPA at 24 mg via EKOS catheter + therapeutic anticoagulation | None | Mean RV/LV ratio decreased from baseline (1.55) to 48 h (1.13; P < .001) | 30-d major bleeding, 10% |
| Submassive PE (n = 119; 79%) | PASP decreased at 48 h | 30-d mortality, 2.7%; no ICH | |||||
| PERFECT24 | 101 | Prospective single arm | Massive PE (n = 28; 28%) | Standard CDT (64%) or USAT via EKOS catheter (36%) with tPA at 0.5-1.0 mg/h or urokinase 100 000 IU/hr + therapeutic anticoagulation | None | Clinical success* achieved in 85.7% massive PE and 97.3% submassive PE | In-hospital mortality, 5.9% |
| Submassive PE (n = 73; 72%) | PASP decreased post-CDT | No major bleeding or ICH at 30 d | |||||
| No difference in PASP change, tPA dose, or infusion between USAT and standard CDT | |||||||
| OPTALYSE-PE25 | 101 | Randomized comparison of 4 USAT regimens | Intermediate-risk PE | USAT: tPA at 8-24 mg via EKOS catheter + therapeutic anticoagulation | 4 USAT regimens | Mean RV/LV ratio decreased at 48 h in all 4 regimens | Major bleeding at 72 h, 4% |
| 2 ICHs (1 attributable to USAT tPA) | |||||||
| Recurrent PE, 1% | |||||||
| 30-d mortality, 1% | |||||||
| FLARE26 | 104 | Prospective single arm | Intermediate-risk PE | Catheter-directed mechanical thrombectomy without thrombolysis + therapeutic anticoagulation | None | Mean RV/LV ratio decreased from baseline (1.56) to 48 h (1.15; P < .0001) | 1 major bleeding |
| No ICH | |||||||
| 4 clinical deterioration | |||||||
| 1 death at 23 d |
EKOS, EndoWave Infusion Catheter System; ICH, intracranial hemorrhage; LV, left ventricular; PASP, pulmonary artery systolic pressure; rtPA, recombinant tPA; UFH, unfractionated heparin; USAT, ultrasound-assisted CDT.
Clinical success was defined as stabilization of hemodynamics, improvement in pulmonary hypertension and/or right-sided heart strain, and survival to hospital discharge.