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)
Bibliographical noteFunding Information:
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.
The authors thank the members of the Clinical Events Committee (Dr. A. Comerota, Dr. W. Gray, and Dr. C. Bime), the Data Safety Monitoring Board (Dr. A. Matsumoto, Dr. M. Mehta, Dr. S. Hamilton, and Dr. A. Comerota), and the Imaging Core Laboratory (Dr. J. Popma) for their contributions. They thank all the additional Principal Investigators for their role and work in this study: Dr. S. Madassery, Dr. M. Khaja, Dr. E. Avgerinos, Dr. M. Razavi, Dr. S. Lemons, Dr. R. Lookstein, Dr. J. Moriarty, Dr. J. Paul, Dr. R. Rajani, Dr. V. Marques, Dr. A. Santos, Dr. C. Henneyer, Dr. A. Nanjundappa, Dr. R. Mendes, and Dr. M. C. Alraies. They thank Erin Archard, Sam Watcha, and Susan M. Bezenek from Penumbra.
© 2021 American College of Cardiology Foundation
- mechanical aspiration
- pulmonary embolism
PubMed: MeSH publication types
- Journal Article
- Research Support, Non-U.S. Gov't