Results Published From EXTRACT-PE Trial of Penumbra’s Indigo Aspiration System

January 13, 2021—The multicenter prospective EXTRACT-PE study demonstrated that the Indigo aspiration system (Penumbra, Inc.) was associated with a significant reduction in the right ventricular-to-left ventricular (RV/LV) ratio and a low major adverse event rate in submassive pulmonary embolism (PE) patients. Additionally, intraprocedural thrombolytic drugs were avoided in 98.3% of patients.

The findings from EXTRACT-PE evaluating the safety and efficacy of the Indigo device in submassive acute PE were published by Akhilesh K. Sista, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

As summarized in JACC: Cardiovascular Interventions, EXTRACT-PE was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE ≤ 14 days; systolic blood pressure ≥ 90 mm Hg; and RV/LV ratio > 0.9.

The primary efficacy endpoint was a change in RV/LV ratio from baseline to 48 hours postprocedure on core lab-adjudicated CTA. The primary safety endpoint was a composite of 48-hour 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.

In JACC: Cardiovascular Interventions, the investigators reported the following:

• A total of 119 patients (mean age 59.8 ± 15 years) were enrolled at 22 sites in the United States between November 2017 and March 2019
• Median device insertion-to-removal time was 37 (interquartile range: 23.5-60) minutes
• Two (1.7%) patients received intraprocedural thrombolytics
• Mean RV/LV ratio reduction from baseline to 48 hours postprocedure was 0.43 (95% CI, 0.38-0.47; P < .0001)
• Two (1.7%) patients experienced three major adverse events
• Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 hours were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively