Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study.
Circulation. Cardiovascular interventions
BACKGROUND: Hemodynamically unstable high-risk, or massive, pulmonary embolism (PE) has a reported in-hospital mortality of over 25%. Systemic thrombolysis is the guideline-recommended treatment despite limited evidence. The FLAME study (FlowTriever for Acute Massive PE) was designed to generate evidence for interventional treatments in high-risk PE.
METHODS: The FLAME study was a prospective, multicenter, nonrandomized, parallel group, observational study of high-risk PE. Eligible patients were treated with FlowTriever mechanical thrombectomy (FlowTriever Arm) or with other contemporary therapies (Context Arm). The primary end point was an in-hospital composite of all-cause mortality, bailout to an alternate thrombus removal strategy, clinical deterioration, and major bleeding. This was compared in the FlowTriever Arm to a prespecified performance goal derived from a contemporary systematic review and meta-analysis.
RESULTS: A total of 53 patients were enrolled in the FlowTriever Arm and 61 in the Context Arm. Context Arm patients were primarily treated with systemic thrombolysis (68.9%) or anticoagulation alone (23.0%). The primary end point was reached in 9/53 (17.0%) FlowTriever Arm patients, significantly lower than the 32.0% performance goal (
CONCLUSIONS: Among patients selected for mechanical thrombectomy with the FlowTriever System, a significantly lower associated rate of in-hospital adverse clinical outcomes was observed compared with a prespecified performance goal, primarily driven by low all-cause mortality of 1.9%.
REGISTRATION: URL: https://www.
CLINICALTRIALS: gov; Unique identifier: NCT04795167.
Silver MJ, Gibson CM, Giri J, Khandhar S, Jaber W, Toma C, et al [Bowers T, Kado H] Outcomes in high-risk pulmonary embolism patients undergoing flowtriever mechanical thrombectomy or other contemporary therapies: results from the FLAME study. Circ Cardiovasc Interv. 2023 Oct;16(10):e013406. doi: 10.1161/CIRCINTERVENTIONS.123.013406. PMID: 37847768.