DO; for the RESILIENT InvestigatorsBackground-Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation.

Conclusions: Drug-Coated balloon therapy is superior to percutaneous transluminal angioplasty in the treatment of patients using catheter based techniques for symptomatic femoral popliteal peripheral artery disease.Summary: Endovascular treatment of symptomatic peripheral arterial disease (PAD) is now accepted and in many cases recommended as a primary revascularization strategy in a wide range of clinical and anatomic scenarios. However, optimal methods of catheter based treatment for superficial femoral and popliteal artery disease remain controversial. Dynamic stresses applied by the superficial femoral and popliteal artery can result in stent fracture and in-stent restenosis. One approach, given these limitations of stenting, has been the use of drug-coated balloons to try and combine balloon dilatation with local delivery of an antiproliferative drug. In this study the authors compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for treatment of symptomatic superficial femoral artery and/or popliteal artery disease. The IN.PACT SFA trial is a prospective, multicenter, single-blinded randomized trial of 331 patients with intermittent claudication or ischemic rest pain secondary to superficial femoral and/or popliteal PAD. Patients were randomly assigned in a 2 to 1 treatment ratio to drug-coated balloons (DCB) or PTA. Primary efficacy end point was primary patency defined as freedom from restenosis or clinically-driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and percent of total occlusions for the DCB and PTA trials were 8.94 6 4.89 and 8.81 6 5.12 cm (P ¼ .82) and 25.8% and 19.5% (P ¼ .22), respectively. DCB therapy resulted in higher primary patency vs PTA (82.2% vs 52.4%; P < .001). Clinically driven target lesion revascularization was 2.4% in the DCB arm compared with 20.6% in the PTA arm (P < .001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA (P ¼ .10). There were no device-or procedural-related deaths and no amputations. At 12 months there were no significant differences between treatment groups in changes from baseline quality-of-life assessment. There was improvement in walking impairment in both groups at 12 months with similar functional outcomes at 12 months; however, PTA subjects required more clinically driven target lesion revascularization to achieve the same levels of functional outcomes as the DCB subjects. It is noted that the 2.4% target lesion revascularization rate of the DCB patients is the lowest reported for an SFA device trial at 12 months.Comment: The trial was composed primarily of patients with claudication and perhaps best serves as a proof of concept study. The results cannot be generalized to patients not included in the trial and cost effectiveness studies will be needed, However, it does appear drug-coated balloons will become an important treatment option for patients with superficial femoral and popliteal artery P...

The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461).

No abstract

Supplemental Digital Content is available in the text.