Clinical Outcomes of Acute Pulmonary Embolism Patients With vs Without Syncope and Treated With Computer Assisted Vacuum Thrombectomy: STRIKE-PE Interim Analysis

Sunday, March 30, 2025

3:09 PM – 3:18 PM CT

Location: Music City Center, 201 AB

Presenting Author(s)

John Moriarty, MD, FSIR (he/him/his)

Professor
UCLA, United States

Author/Co-author(s)

Brian J. Schiro, MD

Vascular and Interventional Radiologist
Miami Cardiac & Vascular Institute / Radiology Associates of South Florida, United States
SD

Suhail Y. Dohad, MD, MBBS

Cardiology Specialist
Cedars-Sinai Medical Center, United States
HT

Houman Tamaddon, MD

Vascular Surgeon and Endovascular Specialist
University Hospital, United States
HD

Hugh Davis, MD

Interventional Radiologist
University of Florida College of Medicine - Shands, United States
DS

David M. Shavelle, MD

Director, Interventional Cardiology
MemorialCare Heart & Vascular Institute, United States
GC

George S. Chrysant, MD

Chairman, Department of Cardiology
INTEGRIS Baptist Medical Center / INTEGRIS Cardiovascular Physicians, United States
EI

Elias A. Iliadis, MD, RPVI

Interventional Cardiologist
Cooper University Hospital, United States
DD

David J. Dexter, II, MD, RPVI

Vascular Surgeon
Sentara Vascular Specialists, United States
JC

Juan J. Ciampi Dopazo, MD

Vascular and Interventional Radiologist
Hospital Universitario Virgen de las Nieves in Granada, Spain
Andrew Holden, FRANZCR

Associate Professor
Aukland District Health Board / Auckland Hospital, New Zealand
FW

Frances Mae West, MD, MS, FACP

Assistant Professor, Associate Program Director, Pulmonary & Critical Care Fellowship
Thomas Jefferson University, United States
WK

W. Brent Keeling, MD

Associate Professor
Emory University Hospital, United States
AS

Andrew S. P. Sharp, MD, MBBS

Professor of Cardiology
University College Dublin, Ireland
IW

Ido Weinberg, MD, MS

Associate Professor
Massachusetts General Hospital, United States

Purpose:

Syncope, an indicator of compromised cardiac output, is a severe symptom of acute pulmonary embolism (PE) and is associated with a higher prevalence of hemodynamic instability and increased short-term mortality. The STRIKE-PE study is evaluating safety, efficacy, and performance of computer assisted vacuum thrombectomy (CAVT; Penumbra Inc, Alameda, CA) for the treatment of PE. This interim analysis of 300 patients from STRIKE-PE compares outcomes of acute PE patients with vs without syncope.

Materials and Methods:

STRIKE-PE is a prospective, international, multicenter study to enroll up to 1500 patients with acute PE symptoms of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9. Patients from this interim analysis with (n = 72) vs without (n = 228) syncope were compared.

Results:

At baseline, patients with syncope had a higher percentage of a modified Miller score of ≥12 (91.7% vs 80.7%, P = .03), a shorter time from symptom onset to venous puncture (47.5 h vs 81.0 h, P = .04), and a higher RV/LV ratio (1.48 vs 1.37, P = .03). No significant difference was detected between the groups for their other baseline characteristics and presentation, including ESC risk stratification (P = .11).

The RV/LV ratio improved from baseline to 48 hours postprocedure (primary effectiveness endpoint) for both groups; improvement was significantly greater for patients with syncope (∆ 0.51 vs ∆ 0.37, P = .004; ∆ 31.7% vs ∆ 25.2%, P = .002). The RV/LV ratio at 48 hours postprocedure was similar for both groups (0.97 vs 1.00, P = .22). No significant difference was detected between the groups for rate of composite major adverse events (MAEs) within 48 hours (primary safety endpoint; 1.4% vs 2.2%, P = .67) or 30-day mortality (0% vs 1.3%, P = .33).

Both groups had reduced dyspnea (Borg scale) at rest from baseline to discharge (∆ 4.0 vs ∆ 3.0, P = .96). No significant difference between the groups was detected for dyspnea after the 6-minute walk test (6MWT) at discharge (2.0 vs 2.0, P = .20).

Conclusion:

In this STRIKE-PE interim analysis, patients with syncope had a higher RV/LV ratio at baseline, yet after CAVT were restored to a condition similar to that of patients without syncope. Both groups had similar clinical outcomes after CAVT: RV/LV ratio at 48 hours, rates of composite MAEs within 48 hours and 30-day mortality, improvement in dyspnea at discharge, and dyspnea after the 6MWT at discharge. These findings indicate that the clinical benefits of CAVT may be especially valuable for patients presenting with syncope and highlight the need to elucidate clinical markers to further the understanding of patients with acute PE.