Drug-Coated Balloon versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and/or Popliteal Peripheral Artery Disease: 12-Month Results From the IN.PACT SFA Randomized Trial

Abstract

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...

Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment

“…In published randomized trials of femoropopliteal disease, [7][8][9][10] DCBs were generally studied in focal or short lesions, while long, complex disease or severe calcification were excluded to prevent primary angioplasty failure and to minimize bailout stenting.…”

Eluvia™ peripheral stent system for the treatment of peripheral lesions above the knee

“…This 'leave nothing behind' philosophy garners support from studies reporting 12-month patency rates for drug-coated balloons similar to those achieved with bare metal stents (i.e. up to approximately 83% [34,36,38]). But is this strategy carrying over into clinical studies and real-world use?…”

“…Reported patency rates for the polymer-free paclitaxel-eluting stent ZilverPTX (Cook Medical, Bloomington IN) were 83% at 12 months, 75% at 24 months, and 66% at 5 years in a randomized trial [4,32,33]. Patency rates for the In.Pact paclitaxel-coated balloon (Medtronic, Dublin, Ireland) were 82% at 12 months and 79% at 24 months in a randomized trial [34,35] and 84% and 72%, respectively, in a multicenter registry [36,37]. The 12-month patency rate for the Lutonix paclitaxel-coated balloon (Bard, Murray Hill, NJ) was 65% in a randomized trial [38].…”

“…In one clinical study of a drug-coated balloon which allowed stratification to stent treatment, primary stenting was selected over balloon-only treatment for approximately 25% of patients [40], and in a registry of patients treated with a drug-coated balloon, 23% of patients also had a stent implanted [41]. Provisional stenting rates after acute percutaneous angioplasty (PTA) failure in the aforementioned and other recent clinical trials averaged approximately 13% [34,36,38,40,42]. In a study designed to compare efficacy of balloon-based PTA with that of a drugcoated stent, 50% of those patients who had been randomly assigned to the PTA arm received provisional stents [4].…”

An Update on Methods for Revascularization and Expansion of the TASC Lesion Classification to Include Below-the-Knee Arteries: A Supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II)

“…50) Finally, the results of a large international prospective multicenter RCT of drug-coated balloon vs bare balloon angioplasty have been published, demonstrating a significant advantage of the drug-coated balloon when analyzing patency and TLR. 51) It is anticipated that the results of the corresponding LEVANT 2 study will be published shortly.…”