A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis.

AIMS: Treatment of in-stent restenosis of coronary stents is challenging. The use of drug-coated balloons (DCB) is a promising technique to treat in-stent restenosis without adding another metal layer. The aim of the AGENT ISR randomised trial is to evaluate angiographic and clinical outcomes in patients with ISR of a previously treated lesion who were treated with either a DCB with a new coating formulation (Agent) or a standard DCB (SeQuent Please). METHODS AND RESULTS: AGENT ISR is a multicentre, randomised, open-label, non-inferiority study comparing the Agent and SeQuent Please DCB. A total of 125 patients (mean age ~68 years, 18% female) with in-stent restenosis of a previously treated lesion <28 mm in length were randomised at 11 sites in Europe to Agent (n=65) or SeQuent Please (n=60). The primary endpoint, six-month in-stent late lumen loss, in the Agent group (0.397±0.43 mm [n=51]) was non-inferior to that of the SeQuent Please group (0.393±0.536 mm [n=49]), as the two-sided upper 95% confidence boundary for the difference between groups was less than the pre-specified non-inferiority margin of 0.20 (difference 0.004, 95% CI [-0.189, 0.196]; pnon-inferiority=0.046). At one year, mortality was 3.1% in Agent and 1.7% in SeQuent Please patients (p>0.99), target lesion revascularisation 7.7% versus 10.0% (p=0.89), and stent thrombosis 0% versus 3.3% (p=0.44). Similar improvements in quality of life were seen in the two groups. CONCLUSIONS: In this head-to-head comparison of two DCB, Agent proved to be non-inferior to SeQuent Please for in-stent late lumen loss at six months. CLINICAL TRIALS REGISTRATION: NCT02151812 (http://clinicaltrials.gov/).

12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment.

OBJECTIVES: The authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months. BACKGROUND: Drug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study. METHODS: The prospective, randomized RANGER SFA (Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries) study (NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2 to 4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68 ± 8 years, n = 53 men) were enrolled in the Ranger DCB arm, and 34 patients (mean age 67 ± 9 years, n = 23 men) were assigned to the control group. Twelve-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments. RESULTS: The DCB group had a greater primary patency rate at 12 months (Kaplan-Meier estimate 86.4% vs. 56.5%), with a significantly longer time to patency failure (log-rank p < 0.001). The estimated freedom from target lesion revascularization rate was 91.2% in the DCB group and 69.9% in the control group at 12 months, with a significantly longer time to reintervention (p = 0.010). No target limb amputations or device-related deaths occurred in either group. CONCLUSIONS: Twelve-month results show that patency was maintained longer after Ranger DCB treatment than after conventional balloon angioplasty, and this result was associated with a low revascularization rate and good clinical outcomes.

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

PURPOSE: To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions. METHODS: Between January 2014 and October 2015, the prospective, randomized RANGER SFA study ( ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2-4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68±8 years; 53 men) were enrolled in the Ranger drug-coated balloon (DCB) arm and 34 patients (mean age 67±9 years; 23 men) were assigned to the control group. Six-month analysis included angiographic late lumen loss and safety and clinical outcomes assessments. RESULTS: Baseline characteristics of the DCB and control groups were similar, as were lesion lengths (68±46 vs 60±48 mm; p=0.731), severity of calcification (p=0.236), and the prevalence of occlusions (34% vs 34%; p>0.999). At 6 months, late lumen loss was significantly less for the DCB group vs controls (-0.16±0.99 vs 0.76±1.4; p=0.002). The DCB group had significantly greater freedom from binary restenosis (92% vs 64%; p=0.005) and primary patency rates (87% vs 60%; p=0.014). Target lesion revascularization rates were 5.6% in the DCB group and 12% in the control group (p=0.475). No target limb amputations or device-related deaths occurred in either group. CONCLUSION: Six-month results suggest that Ranger DCB treatment effectively inhibited restenosis in symptomatic femoropopliteal disease, resulting in improved vessel patency and a low revascularization rate in the short term compared with uncoated balloon angioplasty.