Commentary: Drug-Eluting Balloons for Carotid In-Stent Restenosis: Can This Technology Deliver the Goods?

Abstract

Percutaneous transluminal treatment of coronary and peripheral artery diseases has revolutionized the field of interventional medicine. Over the years, progressive technological and pharmacological advances have improved clinical outcome and offered an effective alternative to surgical treatment of atherosclerotic disease in both coronary and peripheral districts. Relatively new to this field are drug-eluting balloons (DEBs), which represent an attractive and novel treatment modality that offers numerous theoretical advantages over standard angioplasty and stent technologies. Among these benefits are homogenous distribution of an antiproliferative drug to the vessel wall (not just to segments of the wall in direct contact with stent struts); immediate drug release without the use of a polymer that could trigger late thrombosis; no prolonged, direct drug contact with the arterial wall, allowing better reendothelization of the vessel if a bare metal stent (BMS) is used in conjunction; no foreign object left in the body, which is especially important in peripheral applications where stents may be used for suboptimal results; maintenance of original vessel anatomy and flexibility, important during superficial femoral artery revascularization especially; and finally, lower restenosis rates in some indications. Recently, data from randomized clinical trials (RCT) showed that this technology is a viable alternative for the treatment of coronary in-stent restenosis (ISR) and of de novo and restenotic lesions in the peripheral arteries. Furthermore, treatment of bifurcation lesions, de novo lesions in small vessels, long lesions, and cerebrovascular interventions have been proposed. In the setting of ISR, the first major impact of DEBs in the management of ISR was shown by the results of the Paccocath ISR I trial (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons) comparing the efficacy of the Paccocath drug-eluting balloon vs. an uncoated balloon. The 6-month angiographic results showed binary restenosis and major adverse cardiovascular event (MACE) rates of 5% and 4%, respectively, in the DEB group compared with 43% and 31%, respectively, in the uncoated balloon group (p1⁄40.002 and 0.02). During a follow-up of 5.461.2 years, the clinical event rate was significantly reduced in patients treated with the DEB (59.3% vs. 27.8% MACE, p1⁄40.009), which was mainly driven by the reduction in target lesion revascularization (TLR) from 38.9% to 9.3% (p1⁄40.004).