8.1 Effectiveness Assessment in PAD: What are the Leading Treatments?

These proceedings summarize the educational activity of the 16th Biennial Meeting of the International Andreas Gruentzig Society held January 31-February 3, 2022 in Punta Cana, Dominican Republic

Faculty Disclosures     Vendor Acknowledgments

2022 IAGS Summary Document

Statement of the problem or issue

Peripheral artery disease (PAD) affects more than 200 million people worldwide. The primary drivers of the rising prevalence are the ongoing epidemics of diabetes, chronic kidney disease, and an aging population. PAD has a wide spectrum of presentation ranging from asymptomatic disease to typical claudication to limb-threatening ischemia (also called critical limb ischemia, or CLI). Interventions are aimed at improving symptoms of claudication and preventing limb amputation.

Varied clinical presentation is coupled with a similarly wide spectrum of intravascular anatomic disease, which can make treatment challenging from an endovascular perspective. The presence of multilevel disease (iliac, femoral popliteal, infrapopliteal), chronic total occlusions, calcified disease, and long lesions all pose technical challenges and can affect the durability of treatment.

Effective treatment of PAD requires an interventionalist to think outside the box and be familiar with a wide range of techniques and tools to tackle the specific endovascular challenges a patient may pose. The landscape of endovascular devices available for treatment of PAD has grown markedly over the last decade. This offers a great deal of flexibility to the interventionalist. However, it is important to remember the adage that “a carpenter is only as good as his tools.” While new devices are available, it is important that the modern interventionist spend time and effort to become facile in the use of these devices and understand which devices are best suited for which patient.

In particular, CLI is extremely challenging to treat from an endovascular perspective. On the other hand, these patients may also derive the most benefit from successful intervention. Staving off limb amputation can increase the quality of a patient’s life tremendously. However, this requires patience on the part of the interventionalist, and unfortunately, current patterns of reimbursement do not offer economic incentives commensurate with the effort required for successful interventions. As the landscape of peripheral vascular interventions continues to evolve and move away from procedures performed in hospitals to ones performed in outpatient-based labs (OBLs) or ambulatory surgical centers (ASCs), it may change the paradigm and incentive structure. Importantly, multiple studies have demonstrated that procedures performed in the OBL setting have similar safety to those performed in the hospital setting. This may be due in part to the advanced technology available for peripheral vascular interventions.

Gaps in knowledge

Many new devices have been introduced for the treatment of PAD (Table 1). Conventional pathways of approval of these devices need to be re-evaluated. To address unmet needs in PAD, we must explore why certain devices work well in some settings but not others. The case of the drug-coated balloon (DCB) illustrates this point. DCBs were shown to be safe and effective in the treatment of PAD above the knee. However, these devices did not perform as expected below the knee (BTK). This suggests there is substantial heterogeneity in vascular disease at different levels of the arterial tree, and devices must cater to the specific challenges. BTK lesions may be more prone to elastic recoil and have more calcified plaque, which may limit the effectiveness of balloon angioplasty and impair drug delivery. Additional studies investigating these areas are needed for the field to advance.

Possible solutions and future directions

Overall, the field of peripheral vascular interventions has progressed significantly over the last several years, and has evolved rapidly and continuously to meet the challenges of a rapidly growing number of patients who need care. The goal of treatment must be to personalize care and match treatments and setting to the patient’s unique needs. Future research to understand heterogeneity in patients and address the most recalcitrant problems in PAD interventions: restenosis, multilevel disease, and BTK lesions, still awaits us.