The Sage Group

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

This report reviews the characteristics of infrapopliteal peripheral artery disease (PAD) as well as the treatment challenges associated with it. The primary purpose is to investigate the incidence of restenosis following infrapopliteal endovascular interventions.

Infrapopliteal artery disease is also characterized as tibioperoneal disease, or below-the-knee disease (BTK).

Restenosis is defined as the clinical need to revascularize the initial lesion, or the rate of clinically-driven target lesion revascularization (CD-TLR). Restenosis requires a repeat endovascular revascularization, surgical bypass, or if adequate blood flow cannot be restored, amputation.

Incidence of CD-TLR in clinical trials and registries is assessed and compared for four primary device types: percutaneous transluminal angioplasty (PTA), bare metal stents (BMS), drug-eluting stents (DES) and drug-coated balloons (DCB). PTA is also known as plain old balloon angioplasty (POBA).

While paclitaxel-coated balloons (PCB) have shown improved treatment efficacy over conventional devices in femoropopliteal disease, this has not been the case in BTK disease. Results with PCBs in the infrapopliteal territory have been inconsistent. An extensive review of the reasons for the inconsistent PCB results is included.

Since atherectomy (ATH) is commonly used for vessel preparation prior to treatment with other devices, the atherectomy discussion focuses on restenosis after ATH used in combination with other therapies.

Restenosis rates following treatment with currently approved endovascular therapies remain high. Because there is a need for devices that can reduce restenosis, several new technologies for treatment of BTK disease are reviewed. These include two U.S. Food and Drug Administration (FDA) approved drug delivery devices, intravascular lithotripsy (IVL), sirolimus-coated DCB and bioresorbable vascular scaffolds (BVS).

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