Novel Strategies to Reduce Femoropopliteal Restenosis
Low-Dose Paclitaxel-Coated Balloons and Paclitaxel-Coated Balloons Plus Stenting
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Articles, see p 2218 and p 2227
Peripheral artery disease affects >200 million individuals worldwide, and those with exertional leg discomfort, rest pain, and tissue or limb loss have significantly impaired functional status and quality of life. Despite their lower associated risk of repeat revascularization, open surgical procedures have been largely supplanted by endovascular intervention for symptomatic peripheral artery disease given the lower associated morbidity and mortality.1 Although standalone plain-old percutaneous transluminal angioplasty (PTA) was previously the standard endovascular strategy for these patients, high procedural failure and restenosis rates led to the development of new therapeutic technologies.2 Stent implantation improved procedural success,3 and a recent meta-analysis of randomized trials suggests that bare metal stenting (BMS) results in half as much restenosis as PTA. Nevertheless, restenosis after femoropopliteal BMS occurs in up to 37% of patients within 12 months,4 and observational data suggest that by 5 years, primary patency rates are roughly equivalent (41±4% for BMS versus 36±3% for PTA; P=0.31).5
Drug-coated balloons (DCBs) were developed as means to further reduce restenosis rates.6 Currently available DCBs carry the antiproliferative agent paclitaxel, which stabilizes microtubules, preventing mitotic spindle formation and ultimately resulting in reduced neointimal hyperplasia. Paclitaxel doses range from 2 to 3.5 μg/mm2 of balloon surface area, and carrier molecules (“excipients”) facilitate drug delivery to the vessel wall. LEVANT 2 (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis 2) demonstrated that in patients with intermittent claudication or rest pain due to femoropopliteal disease, a low-dose paclitaxel (2 μg/mm2) DCB with polysorbate/sorbitol excipient (Lutonix, Bard, Tempe, AZ) was superior to PTA for primary patency (65.2% versus 52.6%; P=0.02), equivalent to PTA for clinically driven target lesion revascularization (TLR; 12.3% versus16.8%; P=0.21), and noninferior to PTA on its primary safety end …