Author + information
- Received September 29, 2011
- Revision received January 9, 2012
- Accepted February 14, 2012
- Published online June 1, 2012.
- Bill D. Gogas, MD⁎,
- Patrick W. Serruys, MD, PhD⁎,⁎ (, )
- Roberto Diletti, MD⁎,
- Vasim Farooq, MBChB⁎,
- Salvatore Brugaletta, MD⁎,
- Maria D. Radu, MD⁎,
- Jung Ho Heo, MD⁎,
- Yoshinobu Onuma, MD⁎,
- Robert-Jan M. van Geuns, MD, PhD⁎,
- Evelyn Regar, MD, PhD⁎,
- Bernard De Bruyne, MD, PhD†,
- Bernard Chevalier, MD‡,
- Leif Thuesen, MD§,
- Pieter C. Smits, MD, PhD∥,
- Dariusz Dudek, MD¶,
- Jacques Koolen, MD, PhD#,
- Stefan Windecker, MD⁎⁎,
- Robert Whitbourn, MD††,
- Karine Miquel-Hebert, PhD‡‡,
- Cecile Dorange, MSc‡‡,
- Richard Rapoza, PhD§§,
- Hector M. Garcia-Garcia, MD, MSc, PhD∥∥,
- Dougal McClean, MD¶¶ and
- John A. Ormiston, MBChB, PhD##
- ↵⁎Reprint requests and correspondence:
Prof. P. W. Serruys, Thoraxcenter, Bd583a, Dr. Molewaterplein 40, 3015-GD Rotterdam, the Netherlands
Objectives This study sought to investigate in vivo the vascular response at the proximal and distal edges of the second-generation ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS).
Background The edge vascular response after implantation of the BVS has not been previously investigated.
Methods The ABSORB Cohort B trial enrolled 101 patients and was divided into B1 (n = 45) and B2 (n = 56) subgroups. The adjacent (5-mm) proximal and distal vessel segments to the implanted ABSORB BVS were investigated at either 6 months (B1) or 1 year (B2) with virtual histology intravascular ultrasound (VH-IVUS) imaging.
Results At the 5-mm proximal edge, the only significant change was modest constrictive remodeling at 6 months (Δ vessel cross-sectional area: −1.80% [−3.18; 1.30], p < 0.05), with a tendency to regress at 1 year (Δ vessel cross-sectional area: −1.53% [−7.74; 2.48], p = 0.06). The relative change of the fibrotic and fibrofatty (FF) tissue areas at this segment were not statistically significant at either time point. At the 5-mm distal edge, a significant increase in the FF tissue of 43.32% [−19.90; 244.28], (p < 0.05) 1-year post-implantation was evident. The changes in dense calcium need to be interpreted with caution since the polymeric struts are detected as “pseudo” dense calcium structures with the VH-IVUS imaging modality.
Conclusions The vascular response up to 1 year after implantation of the ABSORB BVS demonstrated some degree of proximal edge constrictive remodeling and distal edge increase in FF tissue resulting in nonsignificant plaque progression with adaptive expansive remodeling. This morphological and tissue composition behavior appears to not significantly differ from the behavior of metallic drug-eluting stents at the same observational time points.
- ABSORB bioresorbable vascular scaffold
- edge vascular response
- virtual histology intravascular ultrasound assessment
Dr. Gogas wishes to acknowledge the American College of Cardiology Foundation for the International Society of Cardiovascular Translational Research Award, and Hellenic Cardiological Society and Hellenic Heart Foundation for providing funding support. Dr. Chevalier is a consultant for Abbott Vascular. Prof. Dudek has received research grants or served as consultant/advisory board member for Abbott, Adamed, AstraZeneca, Biotronik, Balton, Bayer, BBraun, BioMatrix, Boston Scientific, Boehringer-Ingelheim, Bristol-Myers Squibb, Cordis, Cook, Eli Lilly & Co., EuroCor, GlaxoSmithKline, Invatec, Medtronic, The Medicines Company, MSD, Nycomed, Orbus-Neich, Pfizer, Possis, Promed, Sanofi-Aventis, Siemens, Solvay, Terumo, and Tyco. Dr. Windecker received research grants to the institution from Abbott, Biotronik, Biosensors, Boston Scientific, and Cordis. Dr. Ormiston was on the advisory board of and received minor honoraria from Abbott Vascular and Boston Scientific. Drs. Miquel-Hebert and Rapoza and Ms. Dorange are employees of Abbott Vascular. Michael Kutcher, MD, served as Guest Editor for this paper.
All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 29, 2011.
- Revision received January 9, 2012.
- Accepted February 14, 2012.
- American College of Cardiology Foundation