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Comparative Study
. 2021 Feb 8;14(3):319-329.
doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13.

Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial

Akhilesh K Sista  1 , James M Horowitz  2 , Victor F Tapson  3 , Michael Rosenberg  4 , Mahir D Elder  5 , Brian J Schiro  6 , Suhail Dohad  3 , Nancy E Amoroso  2 , David J Dexter  7 , Christopher T Loh  8 , Daniel A Leung  9 , Bruce Kirke Bieneman  10 , Paul E Perkowski  11 , Michael L Chuang  12 , James F Benenati  6 ; EXTRACT-PE Investigators
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Free article
Comparative Study

Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial

Akhilesh K Sista et al. JACC Cardiovasc Interv. .
Free article

Abstract

Objectives: This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE).

Background: PE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking.

Methods: This study was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE ≤14 days, systolic blood pressure ≥90 mm Hg, and right ventricular-to-left ventricular (RV/LV) ratio >0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post-procedure on core lab-adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device-related death, major bleeding, and device-related serious adverse events (clinical deterioration, pulmonary vascular, or cardiac injury). All sites received Institutional Review Board approval.

Results: A total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p < 0.0001). Two (1.7%) patients experienced 3 major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively.

Conclusions: In this prospective, multicenter study the Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients. Intraprocedural thrombolytic drugs were avoided in 98.3% of patients. (Evaluating the Safety and Efficacy of the Indigo aspiration system in Acute Pulmonary Embolism [EXTRACT-PE]; NCT03218566).

Keywords: mechanical aspiration; pulmonary embolism; thrombectomy.

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Conflict of interest statement

Funding Support and Author Disclosures This trial was funded by Penumbra. Dr. Sista has received institutional research grant support from Penumbra. Dr. Horowitz has served as a speaker for Inari Medical; and has served as a consultant for Abiomed and Penumbra. Dr. Tapson has received institutional research grant support from Bristol Myers Squibb, Inari, Penumbra, EKOS/BTG (Boston Scientific), Daiichi, and Bayer; served as a consultant for Bristol Myers Squibb, Inari Medical, Janssen, EKOS/BTG (Boston Scientific), and Daiichi; and has served as a speaker for Janssen. Dr. Rosenberg has served on the medical advisory board for Angiodynamics; and has served as a consultant for Medtronic and Boston Scientific. Drs. Schiro, Dohad, Dexter, Perkowski, and Benenati have served as speakers for Penumbra. Dr. Dohad has received research funding from Penumbra and EKOS/BTG (Boston Scientific); served as a consultant for EKOS/BTG (Boston Scientific); and served as a speaker for Daiichi, Janssen, and EKOS/BTG (Boston Scientific). Dr. Dexter has served as a consultant for Penumbra, Boston Scientific, and Inari Medical. Dr. Leung has served as a consultant to Boston Scientific. Dr. Perkowski has served as a consultant for Penumbra. Dr. Benenati is a stockholder of and has served as a consultant for Penumbra. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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