Computer-Aided Mechanical Aspiration Thrombectomy with the Indigo Lightning 12 Aspiration System for the Treatment of Acute Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study

Sunday, March 5, 2023

4:21 PM – 4:30 PM

Location: Phoenix Convention Center, 226ABC

Presenting Author(s)

John M. Moriarty, MD FSIR

Professor
David Geffen School of Medicine at UCLA

Disclosure(s): Angiodynamics: Consultant (); Boston Scientific: Consultant (); Innova Medical: Consultant (); Medtronic: Consultant (); Penumbra: Consultant (); Pfizer: Consultant (); Retriever Medical: Consultant ()

Author/Co-author(s)

Michael S. Rosenberg, MD

Vascular & Interventional Radiologist
University of Minnesota Medical School
Brian J. Schiro, MD

Vascular and Interventional Radiologist
Miami Cardiac & Vascular Institute / Radiology Associates of South Florida
LW

Lawrence R. Whitney, III, MD

Interventional Radiologist
Radiology and Imaging Specialists of Lakeland
Ido Weinberg, MD

Associate Professor of Medicine
Massachusetts General Hospital / Harvard Medical School

Disclosure(s):

John M. Moriarty, MD FSIR: Angiodynamics: Consultant (); Boston Scientific: Consultant (); Innova Medical: Consultant (); Medtronic: Consultant (); Penumbra: Consultant (); Pfizer: Consultant (); Retriever Medical: Consultant ()

Brian J. Schiro, MD: Cook Inc.: Speaking and Teaching (Ongoing); Medtronic: Speaking and Teaching (Ongoing); Penumbra: Speaking and Teaching (Ongoing); Philips: Consultant (Ongoing)

Purpose: Aspiration thrombectomy is a feasible alternative to thrombolytics for the treatment of acute pulmonary embolism (PE). The objective of the STRIKE-PE study is to evaluate real-world functional outcomes, safety, and performance of computer-aided mechanical aspiration thrombectomy with the Indigo Aspiration System (Penumbra, Inc., Alameda, CA) for the treatment of PE. The objective of the current abstract is to report results from an interim analysis of this study.

Materials and Methods: The STRIKE-PE study is a prospective multicenter study that will enroll 600 adult patients with clinical symptoms consistent with acute PE of 14 days or less and a right ventricle/left ventricle (RV/LV) ratio of 0.9 or greater. In this interim analysis, 87 patients (mean age 59.4 years, 41.4% female, 94.1% with submassive PE) received frontline endovascular treatment with Lightning 12.

Results: Median baseline RV/LV ratio was 1.52. Mean baseline systolic pulmonary artery pressure (sPAP) was 50.2 mm Hg. Median thrombectomy time was 32 minutes. Of the patients with an ICU stay, the median ICU length of stay was 2 days; 28 of 79 patients (35.4%) did not require an ICU stay. Median length of hospital stay was 4 days. Composite major adverse events within 48 hours occurred in 2 patients (2.3%).

The RV/LV ratio decreased significantly from baseline to 48 hours after the procedure (median decrease 0.30 [IQR 0.18-0.59], P < .001), and sPAP decreased significantly from baseline to after aspiration (mean decrease 9.2 ± 10.2 mm Hg, P < .001). At 90-day follow-up, the functional outcome measures of perceived dyspnea (Borg scale) at rest and 6-minute walk test (6MWT) and the quality of life measures of EQ-5D-5L Visual Analog Scale (VAS) and overall Pulmonary Embolism Quality of Life (PEmb-QoL) significantly improved (P < .001) and each measure's average improvement exceeded that measure’s minimal clinically important difference (MCID; Table).

Conclusion: STRIKE-PE interim study results demonstrated a rapid reduction in RV/LV ratio and sPAP, an acceptable safety profile, and improvements in functional outcomes and quality of life at 90 days after treatment with Lightning 12 aspiration thrombectomy.