Journal article
Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study
Circulation. Cardiovascular interventions, Vol.16(10), pp.669-676
01 Oct 2023
PMID: 37847768
Featured in Collection : UN Sustainable Development Goals @ Drexel
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.
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Details
- Title
- Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study
- Creators
- Mitchell J. Silver - OhioHealthC. Michael Gibson - Harvard UniversityJay Giri - University of PennsylvaniaSameer Khandhar - University of PennsylvaniaWissam Jaber - Emory University HospitalCatalin Toma - University of Pittsburgh Medical CenterBushra Mina - Lenox Hill HospitalTerry Bowers - Beaumont Hospital, Royal OakLee Greenspon - Lankenau Medical CenterHerman Kado - Beaumont Hospital, Royal OakDavid M. Zlotnick - Buffalo General Medical CenterMithun Chakravarthy - Allegheny General HospitalAaron R. DuCoffe - Inova Health SystemPaul Butros - Inova Health SystemJames M. Horowitz - New York University
- Publication Details
- Circulation. Cardiovascular interventions, Vol.16(10), pp.669-676
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 8
- Grant note
- Inari Medical
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- General Internal Medicine
- Web of Science ID
- WOS:001084347200006
- Scopus ID
- 2-s2.0-85174749740
- Other Identifier
- 991022053781104721
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- Web of Science research areas
- Cardiac & Cardiovascular Systems