SIR 2026: Closing the Gap — What the STRIKE-PE Study Reveals About CAVT Outcomes in Male and Female Patients

Pulmonary embolism (PE) is a life-threatening condition that affects men and women at similar rates — but research has shown that women often face a more complicated path to diagnosis, treatment, and recovery.¹ Historically, female patients report more shortness of breath,² experience lower quality of life before and after PE,³ and are less likely to be selected for reperfusion therapies than male patients.¹

A new STRIKE-PE analysis including 315 male and 280 female patients treated with Computer Assisted Vacuum Thrombectomy (CAVT™) found similar improvements in right heart strain, as well as in quality of life (QOL), and dyspnea from baseline to 1-year in both sexes. Both groups had low major adverse event rates, though more female patients were impacted due to an increased rate of major bleeding, which may have been impacted by higher rates of baseline anemia and more access site hematomas. The data was presented on April 15 by Vivian Bishay, MD, interventional radiologist and site principal investigator for STRIKE-PE at the Mount Sinai Medical Center in New York City at the Society of Interventional Radiology’s Annual Scientific Meeting in Toronto.⁴

“This interim analysis from STRIKE-PE reinforces that CAVT can offer meaningful, durable recovery for patients with intermediate- and high-risk PE regardless of sex,” said Dr. Bishay. “Historically, female patients have faced higher symptom burden and lower quality of life after PE, yet our data show that both male and female patients experience comparable improvements in right heart function, dyspnea, and PE-specific quality of life through one year.”

Baseline characteristics were largely similar between sexes.

Key differences include:⁴

• Higher rates of tobacco use in male patients
• Higher rates of concurrent DVT in male patients
• Higher rates of baseline anemia in female patients

Despite these differences, both groups presented with similar PE severity, symptom burden, and risk profiles.

CAVT Improves RV/LV Ratio Equally in Male and Female Patients

Right heart strain is a defining feature of intermediate- and high-risk PE and relieving right heart strain (as measured by RV/LV ratio) is a critical therapeutic goal.

The STRIKE-PE data demonstrates:⁴

• Significant improvement in RV/LV ratio at 48 hours in both sexes (P < 0.001).
• Almost identical magnitude of improvement in RV/LV ratio between male patients (Δ0.39) and female patients (Δ0.40).

Sustained Relief from Dyspnea

Dyspnea, or shortness of breath, is one of the most debilitating symptoms after PE, and female patients often experience it more frequently.²

STRIKE-PE shows:⁴

• Significant improvement in dyspnea at rest (P < 0.001) and after 6-minute walk test for both sexes at discharge (Male: P < 0.001; Female: P ≤ 0.007).
• Improvements were sustained through 1 year.
• No significant differences in dyspnea outcomes between male and female patients were detected.

Despite female patients reporting worse dyspnea in previously published literature, CAVT helped both groups recover similarly over time.

Quality of Life Improved for Everyone

• Both male and female patients showed significant improvement in QOL from baseline to 1 year (P < 0.001).⁴
• Generic QOL (EQ 5D 5L) improved at a similar trajectory for both sexes, but female patients started and finished slightly lower overall.⁴
• PE-specific QOL differences seen early on converged by 1 year.⁴

Quality of life (QOL) was assessed using two measures:

1. Generic QOL, as measured by EQ-5D-5L, which evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
2. PE-specific QOL, as measured by PEmb-QoL, which provides a score indicating the percent of time a patient is impacted by their PE symptoms.

These results suggest that CAVT, which rapidly reduces right heart strain, may play a role in supporting the post‑PE recovery trajectory.

Low MAE Rates, with One Notable Difference

Overall, CAVT was safe in both groups, with low device-related serious adverse events:⁴

• Device-related complications did not occur in male patients and only occurred in two female patients (0.7%).
• All-cause mortality and recurrent PE rates within 30 days were low in both groups.

Composite major adverse events (MAEs), however, were higher in female patients (3.6%) vs. male patients (0.3%) (P = 0.003), driven largely by more major bleeding in females. This aligns with previous research showing female patients experience more bleeding complications during catheter-directed therapies.⁵ The female patients in STRIKE-PE presented with higher rates of baseline anemia and experienced more access site hematomas, both of which may contribute to a difference in major bleeding.⁴

“The STRIKE-PE data continues to demonstrate the benefits of CAVT for a variety of PE patients, including female patients,” says James F. Benenati, MD, FSIR, chief medical officer at Penumbra. “Despite long-recognized differences in how PE presents and impacts quality of life between sexes, this study shows that both male and female patients experience similarly strong improvements in right heart function, dyspnea, and QOL after CAVT. These insights not only reinforce the consistency of this therapy across diverse patient populations but also move us closer to more equitable PE care.”

STRIKE-PE is the largest prospective effort evaluating CAVT for intermediate- and high-risk PE. STRIKE-PE adds valuable insights and hope showing that with CAVT, male and female patients can achieve similarly meaningful recovery. Future STRIKE-PE analyses will further clarify these trends and help clinicians personalize PE care with even greater precision.

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: 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.

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4. Bishay VL; STRIKE-PE Investigators. One-year dyspnea and quality of life after mechanical thrombectomy for treatment of pulmonary embolism in male versus female patients: STRIKE-PE interim analysis. Presented at: Society of Interventional Radiology (SIR) Annual Scientific Meeting; April 15, 2026.
5. Agarwal MA, Dhaliwal JS, Yang EH, et al. Sex differences in outcomes of percutaneous pulmonary artery thrombectomy in patients with pulmonary embolism. Chest. 2023;163(1):216-225. doi:10.1016/j.chest.2022.07.020.</sup>