TY  - JOUR
A1  - Steiner, Sabine
A1  - Willfort-Ehringer, Andrea
A1  - Sievert, Horst
A1  - Geist, Volker
A1  - Lichtenberg, Michael
A1  - Del Giudice, Costantino
A1  - Sauguet, Antoine
A1  - Diaz-Cartelle, Juan
A1  - Marx, Claudia
A1  - Ströbel, Armin
A1  - Schult, Ingolf
A1  - Scheinert, Dierk
T1  - 12-month results from the first-in-human randomized study of the ranger paclitaxel-coated balloon for femoropopliteal treatment
T2  - JACC Cardiovascular interventions
N2  - 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.
KW  - drug-coated balloon
KW  - drug-eluting balloon
KW  - femoropopliteal segment
KW  - late lumen loss
KW  - paclitaxel
KW  - patency
KW  - peripheral artery disease
KW  - peripheral vascular diseases
KW  - popliteal artery
KW  - restenosis
KW  - stenosis
KW  - superficial femoral artery
Y1  - 2018
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/53416
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-534165
SN  - 1876-7605
SN  - 1936-8798
N1  - This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
VL  - 11
IS  - 10
SP  - 934
EP  - 941
PB  - Elsevier ; American College of Cardiology
CY  - New York, NY
ER  -