%0 Journal Article
%T Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Arterial¨CThe ILLUMENATE Global Study: 12-Month Results From a Prospective, Multicenter, Single-Arm Study - Journal of Vascular Surgery
%A A.H. Holden
%A H. Schroe
%A K. Keirse
%A P. Peeters
%A S.J. Jansen
%A Y. Goueffic
%J Journal of Vascular Surgery Home Page
%D 2018
%R https://doi.org/10.1016/j.jvs.2018.05.026
%X prospective, multicenter, international, single-arm study between July 2013 and June 2015 evaluating the Stellarex drug-coated balloon (DCB; Spectranetics Corp, Colorado Springs, Colo). The authors treated 417 femoropopliteal (FP) lesions in 371 patients for claudication or rest pain with the Stellarex DCB after successful lesion predilation with an uncoated balloon. Lesions averaged about 7-cm long, almost half were severely calcified, and about one-third of lesions were total occlusions. Bail-out stents were placed for residual stenosis or dissection in 17% of lesions. One-year primary patency was 81% as defined by freedom from restenosis based on duplex ultrasonography with peak systolic velocity ratio < 2.5. This study confirms the strong safety profile and 1-year effectiveness of Stellarex DCB to treat FP occlusive disease. Treatment of peripheral atherosclerotic occlusive disease may include the use of paclitaxel-coated angioplasty balloons where the active antiproliferative drug is delivered to the arterial wall while performing the angioplasty. The absorption of an effective amount of drug into the arterial wall depends on the drug dose, coating morphology, and excipient. A limiting factor using DCBs has been the amount of calcium in the arterial wall, which may act a potential barrier to drug absorption. Although unproven, proponents of debulking atherectomy catheters suggest these devices may expose the underlying arterial wall to increased amounts of the drug after debulking the calcium. The Stellarex DCB has a low-dose (2 microgram/mm2) paclitaxel concentration coupled with the excipient polyethylene glycol designed to limit drug loss and facilitate effective drug tissue transfer. One-year patency of the Stellarex DCB to treat FP lesions was comparable to the IN.PACT and LEVANT 2 trials, which is impressive considering in this series almost half the lesions were densely calcified and about one-third were occlusions. However, some patients who would be expected to have poor results with endovascular intervention were excluded, such as those with creatinine >2.5 mg/dL or lesions > 20-cm long or with ˇ°severe calcification that precluded adequate balloon angioplasty treatment.ˇ± There are a wide variety of DCBs available today to treat FP occlusive disease. Most hospitals cannot afford to store all of these DCBs on their shelves, so we need to pick and choose. But, it is increasingly difficult to keep track of which DCBs have the best long-term patency, especially compared to other adjunctive interventions such as stents and atherectomy, and
%U https://www.jvascsurg.org/article/S0741-5214(18)31100-5/fulltext