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

Abstract

, on behalf of the RANGER SFA InvestigatorsAbstract 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.

Low-Dose Paclitaxel-Coated Balloon Angioplasty versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: 6-Month Results in a Tertiary Care Hospital of Central India

“…This study revealed superiority of DEB over PTA (patency rate 83.9% [188 of 224] in DEB vs. 60.6% [40 of 66] in PTA group; p < 0.001). 9 The result is also consistent with studies by Ott et al, 10 Giacoppo et al (2016), 11 Bausback et al, 12 Tepe et al (2018), 13 and MDT-2113 SFA trial 14 that showed superiority of DEB angioplasty over plain balloon angioplasty.…”

Systematic evaluation of particle loss during handling in the percutaneous transluminal angioplasty for eight different drug-coated balloons

“…However, this process is not automatically comparable to higher transfer of drugs to the vessel wall. Differences can be caused by the excipient intended to optimize paclitaxel microcrystallinity 27 . For Stellarex and Lutonix 035 it can be seen that the excipient binds the drug very strongly for a slower dissolution rate 23 , 28 and that, even with the greatest force, hardly any drug is released.…”

Comparison of treatment strategies for femoro‐popliteal disease: A network meta‐analysis

“…We evaluated 126 abstracts from which 68 full text publications were reviewed in detail. Following rigorous examination, 29 studies were included in the network meta‐analysis (Figure ) . These studies included 4,820 patients with a mean study follow‐up of 22 ± 14 months.…”