Author + information
- Received September 18, 2017
- Revision received January 15, 2018
- Accepted January 30, 2018
- Published online May 21, 2018.
- Sabine Steiner, MD, MSca,
- Andrea Willfort-Ehringer, MDb,
- Horst Sievert, MDc,d,
- Volker Geist, MDe,
- Michael Lichtenberg, MDf,
- Costantino Del Giudice, MDg,
- Antoine Sauguet, MDh,
- Juan Diaz-Cartelle, MDi,
- Claudia Marx, MDj,
- Armin Ströbel, PhDj,
- Ingolf Schult, PhDk,
- Dierk Scheinert, MDa,∗ (, )
- on behalf of the RANGER SFA Investigators
- aUniversitätsklinikum Leipzig, Leipzig, Germany
- bMedizinische Universität Wien, Vienna, Austria
- cCardiovascular Center Frankfurt, Frankfurt, Germany
- dAnglia Ruskin University, Chelmsford, United Kingdom
- eHerzzentrum Bad Segeberg, Bad Segeberg, Germany
- fKlinikum Arnsberg, Arnsberg, Germany
- gHôpital Européen Georges Pompidou, Paris, France
- hClinique Pasteur Toulouse, Toulouse, France
- iBoston Scientific, Marlborough, Massachusetts
- jCERES Evaluation & Research, Lörrach, Germany
- kHemoteq, Würselen, Germany
- ↵∗Address for correspondence:
Dr. Dierk Scheinert, Division of Interventional Angiology, Department for Internal Medicine, Neurology and Dermatology, University Leipzig Medical Centre, Liebigstrasse 20, 04103 Leipzig, Germany.
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.
- drug-coated balloon
- drug-eluting balloon
- femoropopliteal segment
- late lumen loss
- peripheral artery disease
- peripheral vascular diseases
- popliteal artery
- superficial femoral artery
Twelve-month study results were presented at the Charing Cross Symposium (April 25 to 28, 2017, London, United Kingdom) and the 2017 meeting of the Cardiovascular and Interventional Radiological Society of Europe (September 16 to 20, 2017, Copenhagen, Denmark). RANGER SFA was sponsored by Hemoteq (a member of the Freudenberg Medical Group). Additional funding for data analysis and medical writing assistance with manuscript preparation was provided by Boston Scientific. Dr. Steiner is a consultant for Abbott and C.R. Bard. Dr. Sievert has received study honoraria, travel expenses, or consulting fees from Abbott, Ablative Solutions, Acoredis, Atrium, Biosense Webster, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, CardioKinetix, Celonova, Cibiem, CGuard, Coherex, Comed, Contego, CSI, CVRx, ev3, FlowCardia, Gardia, Gore, GTIMD Medical, Ancona Heart, Hemoteq, InspireMD, Kona Medical, Lumen Biomedical, Lifetech, Medtronic, Occlutech, pfm Medical, Recor, SentreHeart, St. Jude Medical, Svelte Medical Systems, Terumo, Trivascular, Valtech, Vascular Dynamics, Venus Medical, and Veryan; and has stock options with Cardiokinetix, Access Closure, Coherex, and SMT. Dr. Lichtenberg is a consultant or advisory board member for Biotronik, Boston Scientific, Cook Medical, Cordis, C.R. Bard, Straub Medical, Veryan, Optimed, and Veniti. Dr. Diaz-Cartelle is an employee of and owns stock in Boston Scientific. Drs. Marx and Ströbel are employees of CERES. Dr. Schult is an employee of Hemoteq. Dr. Scheinert is a consultant or advisory board member for Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, C.R. Bard, Gardia Medical, Medtronic/Covidien, TriReme Medical, Trivascular, and Upstream Peripheral Technologies. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 18, 2017.
- Revision received January 15, 2018.
- Accepted January 30, 2018.
- 2018 The Authors