Author + information
- Received March 12, 2017
- Revision received April 23, 2017
- Accepted May 1, 2017
- Published online June 26, 2017.
- Patrick W. Serruys, MD, PhDa,∗ (, )
- Yuki Katagiri, MDb,
- Yohei Sotomi, MDb,
- Yaping Zeng, MD, PhDc,
- Bernard Chevalier, MDd,
- René J. van der Schaaf, MD, PhDe,
- Andreas Baumbach, MD, PhDf,
- Pieter Smits, MDg,
- Nicolas M. van Mieghem, MD, PhDc,
- Antonio Bartorelli, MDh,
- Paul Barragan, MD, PhDi,
- Anthony Gershlick, MD, PhDj,k,
- Ran Kornowski, MDl,
- Carlos Macaya, MDm,
- John Ormiston, MDn,
- Jonathan Hill, MDo,
- Irene M. Lang, MDp,
- Mohaned Egred, MBChB, MDq,
- Jean Fajadet, MDr,
- Maciej Lesiak, MDs,
- Stephan Windecker, MD, PhDt,
- Robert A. Byrne, MBBCh, PhDu,
- Lorenz Räber, MDt,
- Robert-Jan van Geuns, MD, PhDc,
- Gary S. Mintz, MDv and
- Yoshinobu Onuma, MD, PhDc
- aThe National Heart and Lung Institute, Imperial College London, London, United Kingdom
- bAcademic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
- cThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands
- dDepartment of Interventional Cardiology, Institut Jacques Cartier, Massy, France
- eOnze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
- fBristol Heart Institute, Bristol, United Kingdom
- gMaasstad Hospital, Rotterdam, the Netherlands
- hCentro Cardiologico Monzino, University of Milan, Milan, Italy
- iPolyclinique les Fleurs, Ollioules, France
- jDepartment of Cardiology, University of Leicester, Leicester, United Kingdom
- kNIHR Leicester Cardiovascular Biomedical Research Centre, Leicester, United Kingdom
- lRabin Medical Center, Petah Tikva, Israel
- mHospital Clinico San Carlos, Universidad Complutense, Madrid, Spain
- nGreen Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
- oKing's College Hospital, London, England
- pDivision of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
- qFreeman Hospital & Newcastle University, Institute of Cellular Medicine, Newcastle upon Tyne, United Kingdom
- rClinique Pasteur, Toulouse, France
- sDepartment of Cardiology, Poznan University of Medical Sciences, Poznan, Poland
- tDepartment of Cardiology, Bern University Hospital, Bern, Switzerland
- uDeutsches Herzzentrum München, Technische Universität München, Munich, Germany
- vCardiovascular Research Foundation, New York, New York
- ↵∗Address for correspondence:
Prof. Patrick W. Serruys, ThoraxCenter, Erasmus Medical Center, Westblaak 98, Entrance B, 6th Floor, P.O. Box 2125, 3000 CC Rotterdam, the Netherlands.
Background Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion.
Objectives This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling.
Methods In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements.
Results The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. −1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling.
Conclusions Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281)
This study was funded by Abbott Vascular. Dr. Serruys has served as a member of the advisory board for Abbott Vascular. Dr. Chevalier has served as a consultant for Abbott Vascular. Dr. van der Schaaf has received institutional research grants from Abbott Vascular. Dr. Baumbach has received research support from Abbott Vascular. Dr. Smits has received research grants from Abbott Vascular and St. Jude Medical; and has received speaker fees from Abbott Vascular and Medinol. Dr. Gershlick has served on the advisory board of and received lecture fees and travel sponsorship from Abbott Vascular. Dr. Ormiston has served on the advisory boards of Boston Scientific and Abbott Vascular. Dr. Egred has received honoraria for proctorship from Abbott, Boston Scientific, Volcano, Biosensors, Vascular Perspectives, Vascular Solutions, and Merrill. Dr. Fajadet has received educational grants from Abbott, Boston Scientific, Medtronic, and Terumo. Dr. Lesiak has received honoraria as a speaker and/or advisory board member from Abbott Vascular, Boston Scientific, AstraZeneca, Biotronik, St. Jude Medical, Terumo, and Volcano. Dr. Windecker has received research grants to his institution from Bracco, Boston Scientific, and Terumo. Dr. Byrne has received lecture fees from B. Braun Melsungen AG, Biotronik, and Boston Scientific; and has received research grants to his institution from Boston Scientific and Heartflow. Dr. Räber has received speaker fees and institutional grants from Abbott, Biotronik, St. Jude Medical, and Sanofi/Regeneron. Dr. van Geuns has received a research grant from Abbott Vascular. Dr. Mintz has received honoraria or grant support from Boston Scientific, Volcano, and ACIST. Dr. Onuma has served as a member of the advisory board for Abbott Vascular; and has received speaker honoraria from Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 12, 2017.
- Revision received April 23, 2017.
- Accepted May 1, 2017.
- 2017 American College of Cardiology Foundation