Stefan Verheye1, Mathias Vrolix2, Indulis Kumsars3, Andrejs Erglis3, Dace Sondore3, Pierfrancesco Agostoni4, Kristoff Cornelis5, Luc Janssens6, Michael Maeng7, Ton Slagboom8, Giovanni Amoroso8, Lisette Okkels Jensen9, Juan F Granada10, Pieter Stella11. 1. Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium. Electronic address: stefan.verheye@gmail.com. 2. Department of Cardiology, Ziekenhuis Oost Limburg, Genk, Belgium. 3. Latvian Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia. 4. Department of Cardiology, St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands. 5. Department of Cardiology, AZ Maria Middelares Ghent, Ghent, Belgium. 6. Department of Cardiology, Imeldaziekenhuis Bonheiden, Bonheiden, Belgium. 7. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. 8. Department of Cardiology, OLVG Amsterdam, Amsterdam, the Netherlands. 9. Department of Cardiology, Odense University Hospital, Odense, Denmark. 10. Skirball Center for Innovation, Cardiovascular Research Foundation, Orangeburg, New York. 11. Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands.
Abstract
OBJECTIVES: The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). BACKGROUND: Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR. METHODS: In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. RESULTS: Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. CONCLUSIONS: This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies.
OBJECTIVES: The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). BACKGROUND: Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR. METHODS: In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. RESULTS: Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. CONCLUSIONS: This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies.