Author + information
- Received March 24, 2011
- Revision received May 24, 2011
- Accepted May 31, 2011
- Published online October 4, 2011.
- Patrick W. Serruys, MD, PhD⁎,⁎ (, )
- Yoshinobu Onuma, MD⁎,
- Dariusz Dudek, MD†,
- Pieter C. Smits, MD, PhD‡,
- Jacques Koolen, MD, PhD§,
- Bernard Chevalier, MD∥,
- Bernard de Bruyne, MD, PhD¶,
- Leif Thuesen, MD#,
- Dougal McClean, MD⁎⁎,
- Robert-Jan van Geuns, MD, PhD†,
- Stephan Windecker, MD††,
- Robert Whitbourn, MD‡‡,
- Ian Meredith, MD, PhD§§,
- Cecile Dorange, MSc∥∥,
- Susan Veldhof, RN∥∥,
- Karine Miquel Hebert, PhD∥∥,
- Krishnankutty Sudhir, MD, PhD¶¶,
- Hector M. Garcia-Garcia, MD, PhD## and
- John A. Ormiston, MBChB⁎⁎⁎
- ↵⁎Reprint requests and correspondence:
Dr. Patrick W. Serruys, Thoraxcenter, Ba-583, ‘s Gravendijkwal 230, 3015 CE Rotterdam, the Netherlands
Objectives The aim of this study was to demonstrate that the prevention of early scaffold area shrinkage of the ABSORB BVS (Rev.1.1, Abbott Vascular, Santa Clara, California) was sustained and not simply delayed by a few months.
Background With improved scaffold design and modified manufacturing process of its polymer, the second iteration of ABSORB (BVS 1.1) has improved performance to prevent a scaffold area reduction at 6 months.
Methods Fifty-six patients were enrolled and received 57 ABSORB scaffolds. Quantitative coronary angiography, intravascular ultrasound (IVUS), analysis of radiofrequency backscattering, echogenicity and optical coherence tomography (OCT) were performed at baseline and at 12-month follow-up.
Results Overall the scaffold area remained unchanged with IVUS as well as with OCT, whereas the radiofrequency backscattering and the echogenicity of the struts decreased by 16.8% (p < 0.001) and 20% (p < 0.001), respectively; more specifically, the strut core area on OCT decreased by 11.4% (p = 0.003). Despite the absence of scaffold area loss, pharmacological vasomotion was restored. On an intention-to-treat basis, the angiographic late lumen loss amounted to 0.27 ± 0.32 mm with an IVUS relative decrease in minimal lumen area of 1.94% (p = 0.12), without significant changes in mean lumen area. The OCT at follow-up showed that 96.69% of the struts were covered and that malapposition, initially observed in 18 scaffolds was only detected at follow-up in 4 scaffolds. Two patients experienced peri-procedural and iatrogenic myocardial infarction, respectively, whereas 2 underwent repeat intervention, resulting in the major adverse cardiac event rate of 7.1% (4 of 56).
Conclusions The 12-month performance of the second-generation ABSORB bioresorbable everolimus-eluting scaffold justifies the conduct of a randomized trial against current best standards. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856)
- bioresorbable scaffold
- coronary artery disease
- intravascular ultrasound
- optical coherence tomography
Abbott Vascular was the sponsor and funded the trial. Drs. Ormiston and Serruys are co-principal and principal investigators. Prof. Dudek has received research grants or served as a consultant/advisory board member for Abbott, Adamed, AstraZeneca, Biotronik, Balton, Bayer, BBraun, BioMatrix, Boston Scientific, Boehringer Ingelheim, Bristol-Myers Squibb, Cordis, Cook, Eli Lilly, EuroCor, Glaxo, Invatec, Medtronic, The Medicines Co., MSD, Nycomed, Orbus-Neich, Pfizer, Possis, Promed, Sanofi-Aventis, Siemens, Solvay, Terumo, and Tyco. Dr. Smits has received travel and speaking fees from Abbott Vascular. Dr. Chevalier has received a research grant from Medtronic; and is a consultant for Abbott Vascular, Cordis, and Terumo. Dr. Windecker has received research grants to his institution from Abbott, Cordis, Medtronic, Bionsensors, and Boston Scientific. Dr. Meredith has relationships with Abbott Vascular, Medtronic Vascular, and Boston Scientific; and is on the advisory boards of coronary and scientific for these organizations. Dr. Ormiston is on the advisory board of and has received minor honoraria from Abbott Vascular and Boston Scientific. Ms. Dorange, Ms. Veldhorf, Dr. Hebert, and Dr. Sudhir are employees of Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 24, 2011.
- Revision received May 24, 2011.
- Accepted May 31, 2011.
- American College of Cardiology Foundation