Author + information
- Received April 4, 2018
- Revision received July 18, 2018
- Accepted August 14, 2018
- Published online December 3, 2018.
- Marianne Brodmann, MDa,∗ (, )
- Martin Werner, MDb,
- Dirk-Roelfs Meyer, MDc,
- Peter Reimer, MDd,
- Karsten Krüger, MDe,f,
- Juan F. Granada, MDg,
- Michael R. Jaff, DOh,
- Henrik Schroeder, MDi,
- for the ILLUMENATE EU RCT Investigators
- aDivision of Angiology, Department of Internal Medicine, Medical University Graz, Graz, Austria
- bDepartment of Angiology, Hanusch Hospital, Vienna, Austria
- cDepartment of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany
- dInstitute for Diagnostic and Interventional Radiology, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany
- eDepartment of Radiology and Interventional Therapy, Vivantes Humboldt Hospital, Berlin, Germany
- fDepartment of Radiology and Interventional Therapy, Vivantes Hospital Spandau, Berlin, Germany
- gCardiovascular Research Foundation, Columbia University Medical Center, New York, New York
- hDepartment of Medicine, Newton-Wellesley Hospital, Newton, Massachusetts
- iCenter for Diagnostic Radiology & Minimally Invasive Therapy, The Jewish Hospital, Berlin, Germany
- ↵∗Address for correspondence:
Prof. Dr. Marianne Brodmann, Division of Angiology, Department of Internal Medicine, Medical University Graz, Auenbruggerplatz 27, A-8036 Graz, Austria.
Objectives The aim of this study was to assess the safety and effectiveness of a next-generation low-dose drug-coated balloon (DCB) designed to optimize the amount of drug transferred into the vessel wall and to maximize the amount of time the drug resides in the vessel wall.
Background Several randomized controlled studies evaluating various DCBs have demonstrated a significantly higher patency rate compared with noncoated percutaneous transluminal angioplasty balloons at 1 year. However, the data are limited and vary by DCB at longer follow-up time points. An earlier generation low-dose DCB failed to demonstrate significant treatment effect at 2 years, raising questions regarding the durability of low-dose DCBs.
Methods In this prospective, multicenter trial, 294 patients were randomized (3:1) to treatment with a DCB or an uncoated percutaneous transluminal angioplasty balloon. Assessments at 2 years included primary patency with duplex ultrasonography, clinically driven target lesion revascularization, and functional outcomes.
Results Primary patency at 2 years was significantly higher in the DCB cohort (75.9% vs. 61.0%; p = 0.025), and the rate of clinically driven target lesion revascularization was significantly lower (12.1% vs. 30.5%; p < 0.001). There were no major limb amputations in either group. The rates of all-cause (6.5% vs. 5.1%; p = 1.00) and cardiovascular-related (1.6% vs. 1.7%; p = 1.00) mortality were similar between groups. Functional improvements over baseline were sustained in both groups, with 60% fewer reinterventions in the DCB group.
Conclusions A sustained treatment effect is achievable with a low-dose DCB with an optimized coating formulation. This trial demonstrated for the first time a statistically significantly higher primary patency rate for a low-dose DCB versus PTA at 2 years. (CVI Drug Coated Balloon European Randomized Clinical Trial; NCT01858363)
- drug-coated balloon
- drug-eluting balloon
- peripheral artery disease
- superficial femoral artery
This study was sponsored by Philips Spectranetics. Additional funding for data analysis and medical writing assistance with manuscript preparation was provided by Philips Spectranetics. Dr. Brodmann is a consultant for Spectranetics, BARD, Medtronic, Intact Vascular, Surmodics, Bayer Healthcare, and Shockwave. Dr. Granada has received research grants from Spectranetics Philips, Medtronic, and Boston Scientific. Dr. Jaff is an uncompensated advisor to Abbott Vascular/Boston Scientific/Cordis, a Cardinal Health Company/Medtronic; is a consultant to Philips/Volcano, Micell, Vactronix, and Venarum; and is an equity investor with Primacea, PQ Bypass, Embolitech, Vascular Therapies, Gemini, Sano V, and EFemoral. Dr. Schroeder has received speaking honoraria and consulting fees from Spectranetics and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 4, 2018.
- Revision received July 18, 2018.
- Accepted August 14, 2018.
- 2018 American College of Cardiology Foundation
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