Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. Academic Article uri icon

Overview

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).

authors

  • Sista, Akhilesh
  • Horowitz, James M
  • Tapson, Victor F
  • Rosenberg, Michael
  • Elder, Mahir D
  • Schiro, Brian J
  • Dohad, Suhail
  • Amoroso, Nancy E
  • Dexter, David J
  • Loh, Christopher T
  • Leung, Daniel A
  • Bieneman, Bruce Kirke
  • Perkowski, Paul E
  • Chuang, Michael L
  • Benenati, James F

publication date

  • January 13, 2021

Research

keywords

  • Pulmonary Embolism

Identity

Scopus Document Identifier

  • 85099645720

Digital Object Identifier (DOI)

  • 10.1016/j.jcin.2020.09.053

PubMed ID

  • 33454291

Additional Document Info

volume

  • 14

issue

  • 3