The Role of Drug-Coated Balloon for the Treatment of Native Below-the-Knee Arteries

Abstract

The use of drug-coated balloons (DCBs) has provided a relevant change in peripheral interventions. The opportunity of locally delivering paclitaxel into the arterial wall without the need of a chronically implanted delivery system has got undeniable advantages for femoropopliteal procedures: the risk of stent fracture and consequent restenosis are avoided, with a patency rate that was shown to be to be much better than the one observed with plain balloons. Notably, the clinical value of DCBs is supported by robust preclinical evidence regarding safety and efficacy including multiple randomized clinical trials in the superficial femoral artery (SFA) and proximal popliteal artery territory. On the contrary, there is still not a sufficient evidence about the role of DCBs in below-the-knee (BTK) interventions for treatment of critical limb ischemia (CLI). While in the femoropopliteal region, results of endovascular therapy depend on lesion length, grade of calcification, and quality of outflow, in BTK vessels additional issues like tissue damage (CLI patients), angiosomal perfusion, ongoing infection as well as comorbidities such as diabetes, and dependency on hemodialysis are also relevant. Of note, all studies evaluating the benefits of endovascular treatment on CLI have a great limitation related to the non-standardized wound therapy.