Author + information
- Received June 7, 2013
- Revision received July 16, 2013
- Accepted July 17, 2013
- Published online January 1, 2014.
- Stefan Verheye, MD, PhD∗∗ (, )
- John A. Ormiston, MB ChB†,‡,
- James Stewart, MD†,‡,
- Mark Webster, MD‡,
- Elias Sanidas, MD∗,
- Ricardo Costa, MD, PhD§,
- J. Ribamar Costa Jr., MD§,
- Daniel Chamie, MD, PhD§,
- Andrea S. Abizaid, MD, PhD§,
- Ibraim Pinto, MD, PhD§,
- Lynn Morrison, MPH‖,
- Sara Toyloy, BS‖,
- Vinayak Bhat, PhD‖,
- John Yan, MS‖ and
- Alexandre Abizaid, MD, PhD§
- ∗Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium
- †Mercy Angiography Unit, Auckland, New Zealand
- ‡Auckland City Hospital, Auckland, New Zealand
- §Cardiovascular Research Center, Sao Paulo, Brazil
- ‖Elixir Medical Corporation, Sunnyvale, California
- ↵∗Reprint requests and correspondence:
Dr. Stefan Verheye, Antwerp Cardiovascular Center, ZNA Middelheim Hospital, Lindendreef 1, 2020 Antwerp, Belgium.
Objectives This study sought to perform clinical and imaging assessments of the DESolve Bioresorbable Coronary Scaffold (BCS).
Background BCS, which is drug eluting, may have potential advantages compared with conventional metallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid–based scaffold with the antiproliferative myolimus.
Methods The DESolve First-in-Man (A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolve MYOLIMUS ELUTING BIORESORBABLE CORONARY STENT IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS) trial was a prospective multicenter study enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) was performed at 12 months.
Results Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At 12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 ± 0.19 mm; neointimal volume (by IVUS) was 7.19 ± 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmed with OCT and showed uniform, thin neointimal coverage (0.12 ± 0.04 mm). At 12 months, MSCT demonstrated excellent vessel patency.
Conclusions This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study.
(DESolve First-in-Man; EudraCT number 2011-000027-32)
This study was funded by Elixir Medical Corporation. Ms. Morrison, Ms. Toyloy, Dr. Bhat, and Mr. Yan are employees of Elixir Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 7, 2013.
- Revision received July 16, 2013.
- Accepted July 17, 2013.
- American College of Cardiology Foundation