Drug Delivering Technology for Endovascular Management of Infrainguinal Peripheral Artery Disease
The following are 10 points to remember about endovascular management of infrainguinal peripheral artery disease (PAD):
1. Endovascular intervention is a well-recognized treatment modality for PAD, especially for patients with multiple comorbidities, such as coronary artery disease and chronic kidney disease.
2. However, the durability of endovascular interventions for PAD has been limited by high rates of restenosis, most notably in the infrainguinal and infrapopliteal vasculature, after percutaneous transluminal angioplasty (PTA) and bare-metal stent (BMS) implantation.
3. Recently, drug-coated stents (DCS) and drug-coated balloons (DCB) have been the focus of technological innovation in preventing and treating restenosis.
4. Overall, DCS improves mid-term (<2 year) outcomes in femoropopliteal and below-the-knee (BTK) lesions, reducing restenosis and increasing limb salvage rates. It should be noted that to date, the Zilver PTX is the only DCS to have U.S. Food and Drug Administration approval for use during peripheral artery interventions.
5. There is a growing body of evidence indicating significantly lower restenosis with DCB therapy using paclitaxel over PTA for de novo stenosis and in-stent restenosis of the femoropopliteal and BTK PAD.
6. Additionally, after reviewing all current DCS and DCB trials for femoropopliteal PAD interventions, the literature does not show an advantage of DCS over DCB.
7. Irrespective of comparable efficacy, questions remain about the use of DCBs. A lot more work is needed to demonstrate reliable targeted, dose-dependent biological and vascular bed–associated clinical responses. These concerns have been at the heart of the potential US Food and Drug Administration (FDA) concerns regarding DCB.
8. The body of evidence demonstrating the superior efficacy of DCS and DCB compared with that of BMS and PTA for PAD is growing. Evidence for the mid- and long-term (>2-year) efficacy of DCS in PAD is promising, but more data from well-powered, multicenter trials are needed.
9. For femoropopliteal disease, the current evidence suggests similar restenosis and target lesion revascularization outcomes for DCS and DCB. Treatment choice may thus be dictated by rate of stent fracture compared with rate of acute complications associated with balloon angioplasty.
10. For infrapopliteal disease, DCB may ultimately become the treatment of choice due to typically long lesion lengths and diffuse disease. However, the number of well-powered, multicentered randomized clinical trials remains small, and further research is needed to compare clinical outcomes before any firm conclusions can be made.
Keywords: Paclitaxel, Endovascular Procedures, United States Food and Drug Administration, Drug-Eluting Stents, Limb Salvage, Comorbidity, Peripheral Arterial Disease, Constriction, Pathologic, Popliteal Artery, Renal Insufficiency, Chronic
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