TCT 2025: STRIKE-PE Analyses Show CAVT Can Improve Functional Outcomes and Quality of Life for Intermediate- and High-Risk PE Patients

An ongoing prospective multi-center study provides promising results for the treatment of pulmonary embolism (PE) with computer-assisted vacuum thrombectomy (CAVT™). Multiple analyses of the STRIKE-PE study were presented this week at the TCT conference in San Francisco. These analyses suggest that CAVT performs with safety and efficiency for patients with intermediate- and high-risk PE, offering improvement in functional outcomes as well as quality of life.

“The STRIKE-PE data continue to demonstrate the benefits of CAVT for a broad spectrum of PE patients, including for the first time patients with massive PE,” says James F. Benenati, MD, FSIR, chief medical officer at Penumbra. “Along with the landmark randomized STORM-PE findings, these results will help clinicians better identify appropriate candidates for catheter directed therapies. The data from these trials will ultimately help influence guidelines to recommend CAVT as a treatment option for PE patients.”

The STRIKE-PE study was designed to evaluate the long-term safety and results of CAVT — an advanced, minimally invasive technique that uses intelligent algorithms designed to quickly detect and remove clots. The study is enrolling patients with acute PE symptoms lasting 14 days or less and evidence of right heart strain, and it tracks outcomes including right ventricular (RV) function, major adverse events, and relief of shortness of breath, quality of life, and ability to function.

STRIKE-PE High-Risk Interim Analysis

An interim analysis presented by Andrew S.P. Sharp, FRCP, MBBCh, MD, University College Dublin, Dublin, Ireland on Oct. 27, looked at 48 patients with a high-risk/massive PE and found that those who underwent CAVT showed significant improvement in functional outcomes with low major adverse events and mortality rates.

Key CAVT outcomes among high-risk patients:

• RV Function Improvement: This high-risk cohort showed a 30% reduction in RV/LV ratio (1.5 to 1.02), indicating significant relief of right heart strain.
• Hemodynamic Improvement: Systolic pulmonary artery pressure decreased by an average of 14% (51.6 mm Hg to 43.4 mm Hg).
• Improved Functional Outcomes: Treatment with CAVT was associated with improved breathing. Borg dyspnea score at rest decreased from 7 at baseline to 0.25 at discharge and remained at 0.0 at 90 days.
• Safety Profile: The rate of major adverse events within 48 hours and 30-day mortality were both 2.1%.
• Efficiency: Median thrombectomy time was 42 minutes with a median total procedure time of 72 minutes.ⁱ

Other analyses presented at TCT found that CAVT was associated with right heart recovery and with significant improvement in functional outcomes that encompass perceived dyspnea, distance walked, and functional status, as well as improvement in quality-of-life metrics.

Earlier this year, an analysis of 300 patients from the STRIKE-PE study treated with the Indigo® System was published in the Journal of the American Heart Association. That analysis also found that the procedure significantly improved right heart function and reduced shortness of breath with a low rate of complications.¹ The latest analysis presented at TCT includes data from 595 patients from the STRIKE-PE study — the largest cohort to date of PE patients treated with CAVT.

These findings come on the heels of the landmark release of the STORM-PE RCT findings presented at TCT on October 26, which found that the use of CAVT with anticoagulation resulted in superior reduction in RV/LV ratio compared to anticoagulation therapy alone.

Learn more about CAVT.

Important Safety Information

Additional information about Penumbra’s products can be located on Penumbra’s website at: https://www.penumbrainc.com/products/peripheral-thrombectomy-cavt/. The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Prior to use, please refer to Instructions for Use (IFU) for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. For the complete Penumbra IFU Summary Statements, visit: http://peninc.info/risk. Please contact your local Penumbra representative for more information.

Copyright ©2025 Penumbra, Inc. All rights reserved. CAVT and Indigo System are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. All other trademarks are the property of their respective owners.

^{1. Moriarty JM, Schiro BJ, Dohad SY, et al. Periprocedural results and right ventricular outcomes of computer assisted vacuum thrombectomy treatment of acute pulmonary embolism: interim analysis of 300 patients from the STRIKE‐PE study. J Am Heart Assoc. 2025;14(17):e039975. doi:10.1161/JAHA.124.039975
i. Thrombectomy time IQR was 27-56 minutes, and total procedure time IQR was 63-97 minutes.}