Document Type
Article
Publication Title
Circ Cardiovasc Interv
Abstract
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.
First Page
013406
Last Page
013406
DOI
10.1161/CIRCINTERVENTIONS.123.013406
Publication Date
10-1-2023
Recommended Citation
Silver, Mitchell J; Gibson, C Michael; Giri, Jay; Khandhar, Sameer; Jaber, Wissam; Toma, Catalin; Mina, Bushra; Bowers, Terry; Greenspon, Lee; Kado, Herman; Zlotnick, David M; Chakravarthy, Mithun; DuCoffe, Aaron R; Butros, Paul; and Horowitz, James M, "Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study." (2023). Heart and Vascular Articles. 15.
https://scholarlyworks.ohiohealth.com/heart-vascular-articles/15