Recent advances in risk stratification and treatment of acute pulmonary embolism

Table 2 Major trials of interventional treatment for acute pulmonary embolism[48]

Ref.	Trial name	Device	Design	Population	Pe risk category	Intervention	Control	Outcomes	Follow up
[9]	FLARE, 2019	FlowTriever	Single-arm	106	Intermediate-risk, PE	Anticoagulation plus FlowTriever	-	∆RV/LV ratio at 48 hours: 0.41 ± 0.05 (P < 0.0001)/0 all-cause deaths/major bleeding: 0.9% at 48 hours	30 days
[11]	EXTRACT-PE, 2021	Indigo	Single-arm	119	Intermediate-risk	Anticoagulation plus Indigo	-	∆RV/LV ratio at 48 hours: 0.43 ± 0.26 (P < 0.0001)/all-cause death: 1.1%; major bleeding: 1.6% at 48 hours	30 days
[13]	SEATTLE II, 2015	EkoSonic	Single-arm	150	Intermediate high-risk PE	Anticoagulation plus tPA-USAT (12-24 mg)	-	∆RV/LV ratio at 48 hours: 0.42 ± 0.36 (P < 0.0001)/7 deaths, 15 major bleeds at 30 days	30 days
[10]	OPTALYSE PE, 2018	EkoSonic	Randomised, open-label	101	Intermediate high-risk PE	Anticoagulation plus tPA-USAT (4 mg, 6 mg, or 12 mg)	Compared 4 tPA regimens	RV/LV ratio reduced in all arms at 48 hours/5 major bleeds at 72 hours	365 days
[14]	FLAME, 2023	FlowTriever	Prospective, non-randomised	104	High-risk PE	Anticoagulation plus FlowTriever	Other therapies	Composite of all-cause mortality, clinical deterioration, bailout, and major bleeding: 17% vs 63.9%/all-cause death: 1.9% vs 29.5%; major bleeding: 11.3% vs 24.6%	In hospital
[46]	PEERLESS, 2024	FlowTriever	Open-label	550	Intermediate high-risk PE	FlowTriever	Catheter directed thrombolysis	Primary composite win ratio: 5.01 (P < 0.001) driven by fewer clinical deteriorations and reduced ICU utilization/all-cause death: 0% at discharge/no increase in ICH or major bleeding	7 days

PE: Pulmonary embolism; LV: Left ventricular; RV: Right ventricular; tPA: Tissue plasminogen activator; USAT: Ultrasound-assisted thrombolysis; ICU: Intensive care unit; ICH: Intracranial bleeding.