New data show Penumbra’s Indigo aspiration system used in a single session without overnight thrombolytics is safe and effective for patients with lower extremity ALI

Indigo aspiration system

During the Society of Interventional Radiology (SIR) 2024 annual meeting (23–28 March, Salt Lake City, USA), newly presented data from a subgroup analysis of the STRIDE study showed that Penumbra’s Indigo aspiration system used in a single session without the need for overnight tissue plasminogen activator (tPA) is safe and effective for patients with lower extremity acute limb ischaemia (ALI)

“Although the use of tPA following aspiration thrombectomy with [the] Indigo system was not limited during the STRIDE study, the majority of patients did not receive it and still experienced excellent outcomes,” said STRIDE investigator Jayer Chung (Baylor College of Medicine, Houston, USA).

“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 [lower extremity] ALI.”

A press release details that, although widely used, 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.

“The high risk of associated major bleeding is a notable limitation of thrombolytics as an intervention across many disease states, and [lower extremity] ALI is no exception,” said Thomas Maldonado (New York University of Langone Health, New York, USA), national principal investigator of the STRIDE study. “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.”

STRIDE is an international, prospective, single-arm, multicentre, observational study of patients with lower extremity ALI and using the Indigo aspiration system as a frontline intervention. 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 utilisation was significantly lower in single-session Indigo patients.

Penumbra notes that ALI is associated with a high risk of amputation and death. Studies have shown that ALI patients treated with catheter-directed thrombolysis often risk further vascular complications, such as major bleeding.


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