From anticoagulation to intervention: The expanding role of percutaneous therapies in pulmonary embolism

Table 3 Major clinical trials and registries evaluating catheter-based therapies for acute pulmonary embolism

Trial	Therapy/device	Study design	Population	Main findings
ULTIMA	UATh (EkoSonic)	RCT	Intermediate-risk PE	Significant improvement in RV/LV ratio at 24 hours compared with anticoagulation alone, without increased major bleeding
SEATTLE II	UATh	Prospective single-arm study	Massive and submassive PE	Improved RV function and pulmonary pressures, but higher thrombolytic dose associated with increased bleeding
OPTALYSE PE	UATh	Randomized dose-optimization trial	Intermediate-risk PE	Lower-dose and shorter-duration thrombolysis improved RV function with favorable bleeding profile
SUNSET-sPE	UATh vs standard CDT	RCT	Intermediate-risk PE	Similar thrombus reduction between techniques with low major bleeding rates
CANARY	CDT vs anticoagulation	RCT	Intermediate–high-risk PE	Trial terminated early; interim data supported safety and feasibility of CDT
HI-PEITHO	UATh (EkoSonic) + anticoagulation vs anticoagulation alone	RCT	Intermediate-risk PE with RV dysfunction and cardiorespiratory distress	UATh significantly reduced the composite endpoint of PE-related death, hemodynamic decompensation/collapse or recurrent PE at 7 days (4.0% vs 10.3%) without increased major bleeding or intracranial hemorrhage
KNOCOUT PE	UATh	Prospective registry	Intermediate-high and high-risk PE	Low rates of major bleeding and intracranial hemorrhage with improved RV function
FLARE	FlowTriever thrombectomy	Prospective multicenter trial	Intermediate-risk PE	Significant reduction in RV/LV ratio with low major bleeding and minimal ICU utilization
FLASH	FlowTriever thrombectomy	Prospective registry	Real-world PE population	Confirmed safety and effectiveness with low adverse event rates
FLAME	FlowTriever vs contemporary therapies	Prospective comparative study	High-risk PE	Lower in-hospital adverse outcomes and mortality with thrombectomy
EXTRACT-PE	Indigo aspiration system	Prospective multicenter trial	Intermediate-risk PE	Significant reduction in RV strain with low major bleeding rates
PEERLESS	FlowTriever vs CDT	RCT	Intermediate-risk PE	Mechanical thrombectomy reduced clinical deterioration and ICU utilization without increasing bleeding
STORM-PE	Mechanical thrombectomy + anticoagulation vs anticoagulation	RCT	Intermediate–high-risk PE	Greater improvement in RV/LV ratio and thrombus burden without excess major adverse events

UATh: Ultrasound-assisted thrombolysis; CDT: Catheter-directed thrombolysis; RCT: Randomized controlled trial; PE: Pulmonary embolism; RV: Right ventricle; LV: Left ventricular; ICU: Intensive care unit.