Why the study?
Systemic thrombolysis is guideline-recommended for high-risk PE despite limited evidence, prompting the need to evaluate interventional treatments.
Does FlowTriever mechanical thrombectomy reduce in-hospital adverse clinical outcomes in patients with hemodynamically unstable high-risk pulmonary embolism compared to other contemporary therapies?
Does FlowTriever mechanical thrombectomy reduce in-hospital adverse clinical outcomes in patients with hemodynamically unstable high-risk pulmonary embolism compared to other contemporary therapies?
In patients with high-risk pulmonary embolism, FlowTriever mechanical thrombectomy was associated with a significantly lower rate of in-hospital mortality (1.9%) compared to other contemporary therapies (29.5%).
FlowTriever may lower mortality in high-risk PE; hypothesis-generating and requires randomized confirmation before practice change.
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. 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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Silver et al. (2023) studied this question.
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