<p>IN.PACT^TM Admiral^TM drug-coated balloons in peripheral artery disease: current perspectives</p>

Abstract

Endovascular therapy has evolved as a main treatment option especially in patients with short (<25 cm) femoropopliteal lesion. The latest guideline recommends the use of drugeluting devices (both drug-coated balloons [DCBs] and drug-eluting stents) in short femoropopliteal lesions as class IIb recommendation. DCB usage is also recommended for in-stent restenosis lesions (class IIb). DCBs are a more attractive treatment option because the lack of metal prosthesis allows for more flexibility in future treatment options including the option of treating nonstenting zones, previously DCB-treated zones with DCBs again. The IN.PACT™ Admiral™ DCB has shown promising clinical performance in several randomized control trials and global registries, and is currently the market DCB leader for the treatment of femoropopliteal lesions with more than 200,000 patients treated thus far. Currently, more than 10 DCBs have received Conformité Européene mark for the treatment of femoropopliteal atherosclerotic disease. Three of these (including IN.PACT Admiral DCBs) have also received Food and Drug Administration approval in the USA. However, some Conformité Européene-marked DCBs have failed to show consistent results in their clinical studies suggesting all DCBs are not created equal. Each DCB is unique (ie, drug type, drug dose, crystallinity, and excipient) with different clinical outcomes. In the current review, we will focus on the preclinical and clinical results of not only IN.PACT Admiral DCB, but also the other currently available DCBs.

Multiple drug-coated balloons can be used effectively for peripheral arterial disease including long femoropopliteal lesions

“…Endovascular treatment of long occlusive arterial lesions remains complicated and requires further research and development [ 1 10 12 17 ]. The popularization of DCB has led to significant improvement in treatment outcomes for femoropopliteal artery lesions [ 2 4 8 9 ]. However, more favorable long-term patency after bypass surgery is reported for long and complex vascular lesions classified as TASC II C or D [ 5 7 10 18 ].…”

“…For the treatment of femoropopliteal artery stenosis, balloon angioplasty has been recognized as the first-line treatment for short femoropopliteal artery segments of <50 mm or simple lesions classified as the Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC II) A or B. However, the treatment outcome is poorer for long and complex lesions classified as TASC C or D and inferior to traditional bypass surgery, even to prosthetic graft [ 4 5 6 ]. This is because patients with long femoropopliteal artery stenosis or occlusion often have multiple inflow or outflow lesions; recoiling stenosis due to severe calcification or total chronic occlusion can easily occur in such patients [ 6 7 ].…”

“…This is because patients with long femoropopliteal artery stenosis or occlusion often have multiple inflow or outflow lesions; recoiling stenosis due to severe calcification or total chronic occlusion can easily occur in such patients [ 6 7 ]. However, with the emergence of DCBs, endovascular treatment outcomes for femoropopliteal lesions have greatly improved [ 1 4 8 9 ]. Accordingly, good patency could be expected in such long and complex lesions, with some studies already reporting improved therapeutic outcomes [ 1 10 11 12 13 14 ].…”

Drug-coated balloons: Technical and clinical progress

“…The pharmacokinetic profile of Lutonix was found to have a lower PTX tissue bioavailability compared to IN.PACT (Medtronic, Minneapolis MN, USA) and Stellarex DCB (Philips, Amsterdam, The Netherlands) after 28 days. 37 This might have attributed to lower primary patency and freedom from TLR at 1-year follow-up in the LEVANT 2 study published in 2015. 38,39 More recently, the COMPARE multicenter RCT (NCT02701543) examined two DCB and showed that the Ranger DCB (Boston Scientific, Marlborough, MA, USA) was comparable with the IN.PACT DCB for the treatment of symptomatic femoropopliteal lesions.…”

Long-term outcome upon treatment of calcified lesions of the lower limb using scoring angioplasty balloon (AngioSculpt™)

“…Recoils upon standard percutaneous angioplasty (PTA) lead to the necessity of deploying additional devices, including atherectomy, as well as implantation of stents [4], with the consequence of longer procedure durations, material costs and radiation exposure, as well as a prolonged antithrombotic treatment regime and thus, bleeding risk [5]. Drug-eluting balloons (DEB) have also failed to markedly improve patency in such calcified lesions, probably due to insufficient diffusion of the antiproliferative medication through the barrier of the calcified vessel wall [6][7][8][9]. Hence, there is a valid notion that a careful indentation of the target lesion using scoring balloons with built-in helical nitinol elements a more atraumatic preparation and higher lumen gain of the target vessel could be achieved, thus minimizing the rate of periprocedural complications and additional procedures [10].…”