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. 2023 Oct;16(10):e013406.
doi: 10.1161/CIRCINTERVENTIONS.123.013406. Epub 2023 Oct 17.

Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study

Mitchell J Silver  1 , C Michael Gibson  2 , Jay Giri  3 , Sameer Khandhar  3 , Wissam Jaber  4 , Catalin Toma  5 , Bushra Mina  6 , Terry Bowers  7 , Lee Greenspon  8 , Herman Kado  7   9 , David M Zlotnick  10 , Mithun Chakravarthy  11 , Aaron R DuCoffe  12 , Paul Butros  12 , James M Horowitz  13
Affiliations

Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study

Mitchell J Silver et al. Circ Cardiovasc Interv. 2023 Oct.

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 (P<0.01). The primary end point was reached in 39/61 (63.9%) Context Arm patients. In-hospital mortality occurred in 1/53 (1.9%) patients in the FlowTriever Arm and in 18/61 (29.5%) patients in the Context Arm.

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.

Keywords: anticoagulant; pulmonary embolism; thrombosis.

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Conflict of interest statement

Disclosures Dr Silver reports consulting fees from Medtronic, Boston Scientific, WL Gore and Associates, Cook Medical, Contego Medical, and Inari Medical; and speakers’ bureau for Bristol Myers Squibb, Astra Zeneca, and Pfizer. Dr Gibson reports consulting fees and research grant support from Inari Medical to Boston Clinical Research Institute and consulting fees from Johnson and Johnson and Bristol Myers Squibb. Dr Giri reports research funds to the institution and advisory boards for Inari Medical, Boston Scientific, Abbott Vascular, Abiomed, Recor Medical, Biosense Webster and equity in Endovascular Engineering. Dr Jaber reports consulting fees from Medtronic and Inari Medical. Dr Toma reports consulting fees from Medtronic, Philips and Neptune Medical. Dr Mina reports consulting fees from Inari Medical. Dr Bowers reports consulting fees from Imperative Vascular and Inari Medical, speakers’ bureau and consulting for Janssen Pharmaceuticals, and equity interest in Imperative Vascular and Biostar Ventures. Dr Greenspon reports research support from Inari Medical and Exponent Inc. Dr Zlotnick reports speakers’ bureau for Abiomed, Angiodynamics, and Inari Medical. Dr Chakravarthy reports equity in Edwards Lifesciences. Dr DuCoffe reports consulting fees from Inari Medical. Dr Butros reports consulting fees from and speakers’ bureau for Inari Medical. Dr Horowitz reports consulting fees from Inari Medical and Penumbra. The other authors report no conflicts.

Comment in

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