Penumbra has announced the completion of enrollment in STRIKE-PE, the largest prospective study of mechanical thrombectomy for pulmonary embolism (PE) to date. The international study enrolled 1,500 intermediate- or high-risk PE patients across 77 sites. It is designed to evaluate both acute and longer-term outcomes following treatment with computer assisted vacuum thrombectomy (CAVT®), including right heart recovery, safety, as well as functional and quality-of-life outcomes with longitudinal follow-up out to one year.
The completion of STRIKE-PE enrollment marks an important step toward expanding the clinical evidence base for advanced PE therapies and deepening our understanding of how patients recover following a potentially life-threatening blood clot in the lungs.
STRIKE-PE follows patients for one year after treatment, capturing measures that reflect the patient journey beyond acute procedural outcomes, including functional status, quality of life, exercise capacity, and symptom burden. As follow-up continues, the study is expected to provide one of the most comprehensive assessments to date of outcomes after mechanical thrombectomy for PE.
“The completion of STRIKE-PE represents an important milestone in our collective effort to better understand pulmonary embolism and the factors that influence recovery,” said Dr. James F. Benenati, MD, FSIR, chief medical officer at Penumbra. “The study’s unprecedented scale and focus on long-term patient outcomes reflect a growing recognition that success should be measured not only by acute procedural outcomes, but also by how patients feel and function months after treatment. We look forward to the insights STRIKE-PE will provide as we continue to advance PE care.”
Results from the Largest STRIKE-PE Analysis to Date Show Sustained Recovery One Year After PE
A new one-year analysis from the STRIKE-PE study includes outcomes reported for 1,000 patients treated with CAVT, offering a large prospective assessment of recovery after mechanical thrombectomy for PE. In addition to demonstrating strong acute recovery, the data show that many patients experienced sustained improvements in dyspnea, functional capacity, and quality of life through one year after treatment. The analysis was presented by steering committee member Andrew Holden, MBChB, FRANZCR, director of interventional radiology, Auckland Hospital during the 16th Venous Endovascular INterventional Strategies (VEINS) meeting in Las Vegas, NV.
“These findings are particularly relevant given the growing recognition of post-PE syndrome, which can lead to persistent shortness of breath, exercise intolerance, and reduced quality of life for PE survivors,” said Dr. Holden. “Together, these results suggest that the benefits of CAVT may extend well beyond initial clot removal, supporting meaningful long-term recovery and helping patients return to their daily lives.”
Key findings from the 1,000-patient analysis include:
Primary Performance Endpoint
- Mean RV/LV ratio decreased 27.2% from 1.38 to 0.97 at 48 hours (P < .001).
Primary Safety Endpoint
- Composite major adverse events rate within 48 hours was 1.9%.
Device Time
- Median thrombectomy time of 28 minutes.
NYHA Functional Class
- By 90 days after CAVT, NYHA functional class distribution had returned to levels comparable to patients’ pre-PE functional status and was sustained through one year.
6-Minute Walk Test
- Significant improvement in 6MWT from 90 days to one year with a mean gain of 26.9 m (P < .001).
Borg Dyspnea Scale
- Median dyspnea at rest score improved from 6.0 at baseline to 0.5 at discharge, reaching 0.0 at 90 days and sustained at 0.0 at one year (all P < .001 from baseline).
Quality of Life Measures
- Substantial improvements in quality of life, including significant gains in EQ-5D-5L and EQ VAS scores, reaching population norms by one year and continued improvement in PE-specific quality-of-life burden through one year.
These data add to the growing body of evidence from STRIKE-PE demonstrating the benefits of CAVT for acute PE patients while providing new insights into longer-term recovery.
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 the Instructions for Use (IFU) for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. For the complete Penumbra IFU Risk Summary Statements, visit: peninc.info/risk. Please contact your local Penumbra representative for more information.
Copyright ©2026 Penumbra, Inc. All rights reserved. CAVT is a registered trademark or trademark of Penumbra, Inc. in the USA and other countries.
