Benefits and Challenges of Drug-Coated Balloons in Peripheral Artery Disease: From Molecular Mechanisms to Clinical Practice

Abstract

Multiple clinical trials have reported favorable outcomes after drug-coated balloon therapy for peripheral artery disease in above-the-knee and below-the-knee lesions and in both de novo and in-stent restenosis. However, there are still insufficient data to identify and tackle the risk factors associated with a higher risk of restenosis, which is the primary concern for patients who are treated with an endovascular approach. A modern armamentarium, which includes improved lesion preparation techniques such as plaque modification balloons, mechanical atherectomy, intravascular lithotripsy, and imaging, is crucial for obtaining better long-term clinical outcomes. Moreover, a better understanding of the molecular properties of drug-coated balloons has led to improved devices that could tackle the shortcomings of previous generations. This comprehensive review focuses on drug-coated balloon technology as a tool to treat peripheral artery disease and the effects of the molecular mechanisms involved in preventing vascular restenosis.

Keywords: below-the-knee (BTK); drug-coated balloon (DCB); femoropopliteal (FP); in-stent restenosis (ISR); paclitaxel; peripheral artery disease (PAD); sirolimus.

Figure 1

DCB pharmacokinetics properties of drug delivery.

Figure 2

Proposed clinical algorithm for lesion preparation before DCB deployment. (ISR—in-stent restenosis; IVUS—intravascular ultrasound; OCT—optical coherence tomography; SC—semi-compliant; NC—non-compliant; RA—rotational atherectomy; OA—orbital atherectomy; LA—laser atherectomy; IVL—intravascular lithotripsy; DCB—drug-coated balloon).