Marianne Brodmann1, Martin Werner2, Dirk-Roelfs Meyer3, Peter Reimer4, Karsten Krüger5, Juan F Granada6, Michael R Jaff7, Henrik Schroeder8. 1. Division of Angiology, Department of Internal Medicine, Medical University Graz, Graz, Austria. Electronic address: marianne.brodmann@medunigraz.at. 2. Department of Angiology, Hanusch Hospital, Vienna, Austria. 3. Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany. 4. Institute for Diagnostic and Interventional Radiology, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany. 5. Department of Radiology and Interventional Therapy, Vivantes Humboldt Hospital, Berlin, Germany; Department of Radiology and Interventional Therapy, Vivantes Hospital Spandau, Berlin, Germany. 6. Cardiovascular Research Foundation, Columbia University Medical Center, New York, New York. 7. Department of Medicine, Newton-Wellesley Hospital, Newton, Massachusetts. 8. Center for Diagnostic Radiology & Minimally Invasive Therapy, The Jewish Hospital, Berlin, Germany.
Abstract
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).
RCT Entities:
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).
Authors: Abraham R Tzafriri; Benny Muraj; Fernando Garcia-Polite; Antonio G Salazar-Martín; Peter Markham; Brett Zani; Anna Spognardi; Mazen Albaghdadi; Steve Alston; Elazer R Edelman Journal: Biomaterials Date: 2020-08-20 Impact factor: 12.479
Authors: William A Gray; Michael R Jaff; Sahil A Parikh; Gary M Ansel; Marianne Brodmann; Prakash Krishnan; Mahmood K Razavi; Frank Vermassen; Thomas Zeller; Roseann White; Kenneth Ouriel; Mark A Adelman; Sean P Lyden Journal: Circulation Date: 2019-09-30 Impact factor: 29.690
Authors: Juan F Granada; Marco Ferrone; Gilberto Melnick; Lesley Crookall; Daniel Schulz-Jander; Stefan Tunev; Robert J Melder; Grzegorz L Kaluza Journal: JACC Basic Transl Sci Date: 2021-03-31
Authors: Michael D Dake; Gary M Ansel; Marc Bosiers; Andrew Holden; Osamu Iida; Michael R Jaff; Aaron E Lottes; Erin E O'Leary; Alan T Saunders; Marc Schermerhorn; Hiroyoshi Yokoi; Thomas Zeller Journal: Cardiovasc Intervent Radiol Date: 2019-09-09 Impact factor: 2.740