Paclitaxel- and Sirolimus-coated Balloons in Peripheral Artery Disease Treatment: Current Perspectives and Concerns

Abstract

Drug-coated balloons (DCBs) have become an established therapy for the treatment of above-the-knee peripheral artery disease. The paclitaxel DCB has shown clinical benefit in terms of patency and freedom from re-intervention in multiple randomised trials. However, a recent meta-analysis has suggested an association between mortality and the use of paclitaxel-coated devices. Sirolimus is another potential choice of anti-proliferative agent for use in DCBs because of its wider therapeutic index and lower risk for dose-dependent toxicity. More recently, encapsulating sirolimus in micro-reservoirs or polymers has facilitated the development of effective sirolimus DCBs, some of which are available in Europe and Asia. In this review, the authors focus on paclitaxel and sirolimus DCB technologies from the standpoint of drug characteristics and clinical trials.

Combined Treatment of Native Femoropopliteal Occlusions in Chronic Limb-Threatening Ischemia Using Atherectomy Debulking and a New Sirolimus Drug-Coated Balloon (SELUTION SLR)

“…14 While the efficacy of sirolimus over paclitaxel is still subject to investigation, with only limited pilot studies published on DCBs in the peripheral vasculature, 31 it has been suggested that it has a preferential therapeutic safety margin compared to paclitaxel and it has become the preferred drug coating for devices used in coronary artery intervention. 31 37 This could be setting a precedent for what is to occur in the peripheral vascular field. If sirolimus is to become the preferred drug-coating for DCBs used in peripheral vascular disease, investigation into its combined use with other techniques and devices is just as critical.…”

A review of the current state in neointimal hyperplasia development following endovascular intervention and minor emphasis on new horizons in immunotherapy

“…Furthermore, these agents are both nonspecific and cytotoxic, and significantly increase the risk of long-term morbidity and mortality due to their off-target effects, which are activity that differs from the targeted biological effect [ 32 34 ]. Due to the broader therapeutic index and lower risk of dose-related toxicity, less mortality outcomes are expected for sirolimus [ 35 ]. On the other hand, a meta-analysis study comparing paclitaxel-coated devices with control arms showed that the mortality rate gradually increased in patients treated with paclitaxel-coated devices at follow-up up to the 5th year, despite a similar mortality rate at first year [ 36 ].…”