STRIDE Subanalysis Evaluates Penumbra’s Indigo System Without Overnight tPA Use

April 2, 2024—Penumbra, Inc. recently announced new data from a subgroup analysis of the STRIDE study. The analysis demonstrated the safety and efficacy of computer-assisted vacuum thrombectomy with the company’s Indigo aspiration system used in a single-session without the need for overnight tissue plasminogen activator (tPA) in patients with lower extremity acute limb ischemia (LE-ALI).

“Although the use of tPA following aspiration thrombectomy with Indigo system was not limited during the STRIDE study, the majority of patients did not receive it and still experienced excellent outcomes,” commented STRIDE Investigator Jayer Chung, MD, in the company’s press release. “These findings demonstrate that the use of aspiration mechanical thrombectomy, without overnight tPA, yields high procedural success, low complication rates, and high target limb salvage rates in LE-ALI.” Dr. Chung is with Baylor College of Medicine in Houston, Texas.

The findings were presented at SIR 2024, the Society of Interventional Radiology’s annual scientific meeting held March 23-28 in Salt Lake City, Utah.

As noted in the press release, there are many complications associated with tPA and other clot-busting drugs. In the case of the overnight lytic group, tPA was also associated with an increased need for intensive care unit (ICU) monitoring as shown by the higher median length of ICU stay among those patients.

Penumbra reported that the latest findings include:

• No significant differences were detected between patients who received overnight tPA and those who did not for target limb salvage rate at 30 days, patency at 30 days and 30-day mortality.
• ICU resource utilization was significantly lower in single-session Indigo patients.

Additionally, the company noted that ALI is associated with a high risk of amputation and death and that ALI patients treated with catheter-directed thrombolysis often risk further vascular complications, such as major bleeding, as shown in “Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia,” which was published by Thomas S. Maldonado, MD, et al in Journal of Vascular Surgery (2024;79:584-592).

Dr. Maldonado is Professor of Surgery at NYU Langone Health of New York University in New York, New York, and national Principal Investigator of the STRIDE study.

“The high risk of associated major bleeding is a notable limitation of thrombolytics as an intervention across many disease states, and LE-ALI is no exception,” stated Dr. Maldonado in the Penumbra press release. “The data show that aspiration mechanical thrombectomy is a safe and effective minimally invasive procedure, which may offer an option to eliminate thrombolytic use for some patients.”

According to the company, STRIDE is an international, prospective, single-arm, multicenter, observational study of patients with LE-ALI and using Indigo aspiration system as a front line intervention. The study enrolled 119 patients from 16 centers across the United States and Europe.

In May 2023, the company announced the presentation of the 30-day data from the fully enrolled study demonstrating that the treatment was safe and effective with excellent 30-day limb salvage rates and low mortality.