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. 1 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.2,3 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 (p¼0.002 and 0.02).2 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, p¼0.009), which was mainly driven by the reduction in target lesion revascularization (TLR) from 38.9% to 9.3% (p¼0.004).

Drug‐Eluting Balloon Angioplasty for In‐Stent Restenosis Following Carotid Artery Stent Placement

“…DEB can circumnavigate the limitations of stent placement, while concurrently releasing an antiproliferative agent to minimize neointimal hyperplasia. Unlike the drug‐eluting stent in which the drug is slowly released from a polymer coating, the DEB is freely coated with drug, avoiding the need for a polymer, which leads to more rapid vascular healing 13,28 . DEBs consist of a balloon catheter, a lipophilic antiproliferative drug, and a drug carrier (excipient) that increases the solubility of the drug 28 .…”

“…It is highly lipophilic, allowing a unique duality of longer retention in vascular smooth muscle and therefore longer antiproliferative action and a lower systemic toxicity, making it an ideal drug for use in the DEB 13 . The IN.PACT™ Admiral™ (Medtronic) DEBs that were used in our 2 patients contain 3.5 μg/mm 2 of paclitaxel with urea as the excipient, which has been considered a better alternative to older excipients such as contrast, as they are associated with cases of delayed intimal healing and inflammation 28 . Although an inflation time of 180 seconds is strongly recommended, as per the manufacturer, adequate drug transfer occurs in the first 60 seconds of inflation, with studies showing that even a short exposure to the drug causes sustainable modifications in the cytoskeletal structure 29 .…”

A Review on the Comparison of Different Treatments for Carotid In-Stent Restenosis

“…9 Previous reports have indicated that repeated stent placement, angioplasty with balloon techniques, and surgical treatments are the main treatments for ISR. Recently, drug-coated balloons (DCBs) or drug-eluting balloons (DEBs), with the features of homogenous distribution of antiproliferative drugs to the vessel wall, 10 have been advocated for treatment of ISR in the coronary and femoropopliteal areas in recent years, but an overview of this application in the carotid artery restenosis is still lacking. 11,12 It has been reported that DCB angioplasty showed satisfactory efficacy in carotid artery stenosis and in-stent restenosis in several studies.…”

Safety and Efficacy of A Single Embolic Protection Device-Stent Combo for Carotid Revascularization

“…Accordingly, when the lesion was not suitable for Precise implantation (e.g. in case of in-stent restenosis or when the reference vessel diameter was too large), we used balloon-only angioplasty or employed other types of stents [8][9] . All devices were used according to their instructions for use, unless in bailout conditions.…”