Author + information
- Received February 24, 2017
- Revision received June 6, 2017
- Accepted June 15, 2017
- Published online October 16, 2017.
- Stefan Verheye, MD, PhDa,∗ (, )
- Mathias Vrolix, MDb,
- Indulis Kumsars, MD, PhDc,
- Andrejs Erglis, MD, PhDc,
- Dace Sondore, MDc,
- Pierfrancesco Agostoni, MD, PhDd,
- Kristoff Cornelis, MDe,
- Luc Janssens, MDf,
- Michael Maeng, MD, PhDg,
- Ton Slagboom, MDh,
- Giovanni Amoroso, MD, PhDh,
- Lisette Okkels Jensen, MD, PhD, DMScii,
- Juan F. Granada, MDj and
- Pieter Stella, MD, PhDk
- aAntwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium
- bDepartment of Cardiology, Ziekenhuis Oost Limburg, Genk, Belgium
- cLatvian Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia
- dDepartment of Cardiology, St. Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands
- eDepartment of Cardiology, AZ Maria Middelares Ghent, Ghent, Belgium
- fDepartment of Cardiology, Imeldaziekenhuis Bonheiden, Bonheiden, Belgium
- gDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark
- hDepartment of Cardiology, OLVG Amsterdam, Amsterdam, the Netherlands
- iDepartment of Cardiology, Odense University Hospital, Odense, Denmark
- jSkirball Center for Innovation, Cardiovascular Research Foundation, Orangeburg, New York
- kDepartment of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands
- ↵∗Address for correspondence:
Dr. Stefan Verheye, Antwerp Cardiovascular Center ZNA Middelheim, Interventional Cardiology, Lindendreef 1, Antwerp, Antwerp 2020, Belgium.
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.
- drug-eluting balloon
- extended release
- in-stent restenosis
- porous angioplasty balloon
- sirolimus nanoparticle
The SABRE trial was sponsored by Caliber Therapeutics, Inc. (New Hope, Pennsylvania). Dr. Maeng has received research grant support from Boston Scientific, Biosensors, and Volcano. Dr. Slagboom is a consultant for Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 24, 2017.
- Revision received June 6, 2017.
- Accepted June 15, 2017.
- 2017 American College of Cardiology Foundation