The Sage Group

According to THE SAGE GROUP, High Restenosis Rates Following Endovascular Treatment of Infrapopliteal Disease Create a Significant Need for Improved Technologies

BEAUFORT, SC, February 16, 2023 (BUSINESS WIRE)—Recent research published by THE SAGE GROUP examines the challenges of infrapopliteal Peripheral Artery Disease (PAD) and incidence of restenosis.

“It is difficult to reach strong conclusions regarding device superiority for endovascular treatment of infrapopliteal disease,” stated Mary L. Yost, President of THE SAGE GROUP.

“This reflects limitations in the research due to heterogeneity of numerous factors that affect restenosis. In addition to lesion length, these include primary efficacy end points, patient characteristics, lesion characteristics and morphology, as well as disease severity. Furthermore, many of the studies enrolled a small number of patients,” explained Yost.

Commenting on drug-eluting stents (DES) Ms. Yost stated, “Several trials and numerous meta-analyses found that coronary DES reduce infrapopliteal restenosis, versus other devices including drug-coated balloons (DCB). However, DES studies were conducted in short lesions, representing the minority of infrapopliteal lesions. Furthermore, the stents had different designs and coatings, and eluted various antiproliferative drugs.”

Yost, concluded, “Coronary DES might reduce TLR in short lesions. However, the disappointing results with the first dedicated infrapopliteal DES in the SAVAL trial raise questions about potential DES superiority in longer lesions.”

“Paclitaxel-coated balloons (PCB) have shown improved treatment efficacy over other devices in femoropopliteal disease. This has not been the case in infrapopliteal disease. PCB results in the infrapopliteal territory have been inconsistent. This reflects numerous factors. DCBs are not interchangeable. There have also been differences in study designs, variations in lesion preparation, differences in the amount of paclitaxel transferred to the lesion and slow flow due to paclitaxel embolization,” stated Yost.

“Sirolimus-coated balloons (SCB) may be a better treatment for infrapopliteal disease than PCB. Safety and efficacy has been demonstrated with reduced restenosis at 6- and 12-months. Large, randomized controlled trials with long-term follow up are needed,” commented Yost.

In the U.S., four SCB have been granted FDA breakthrough device designation for infrapopliteal disease: Selution SLR BTK (Med Alliance/Cordis), Magic Touch (Concept Medical), Virtue BTK (Orchestra BioMed) and Sundance BTK (Surmodics).

“In infrapopliteal disease, we believe that new, more effective endovascular devices are needed to reduce restenosis and improve patient outcomes. In addition to SCB, several promising technologies are under investigation, including intravascular lithotripsy, next-generation bioresorbable vascular scaffolds and unique drug delivery devices, such as the Pressana Occlusion Perfusion Catheter,” Ms. Yost stated.

About the Report: The Challenge of Infrapopliteal Disease: Characteristics, Restenosis After Endovascular Revascularization and Review of Several New Technologies

The report reviews the characteristics of infrapopliteal PAD as well as the treatment challenges associated with it. The primary purpose is to investigate the incidence of restenosis following infrapopliteal endovascular interventions. Additional information:

THE SAGE GROUP, a research and consulting company, specializes in arterial and venous disease in the lower limbs.

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Mary Yost, (404) 520-6652