Author + information
- Received January 4, 2016
- Revision received March 16, 2016
- Accepted March 24, 2016
- Published online June 27, 2016.
- Pannipa Suwannasom, MDa,b,c,
- Yohei Sotomi, MDb,
- Yuki Ishibashi, MD, PhDa,
- Rafael Cavalcante, MD, PhDa,
- Felipe N. Albuquerque, MDd,
- Carlos Macaya, MDe,
- John A. Ormiston, MDf,
- Jonathan Hill, MDg,
- Irene M. Lang, MDh,
- Mohaned Egred, MDi,
- Jean Fajadet, MDj,
- Maciej Lesiak, MDk,
- Jan G. Tijssen, MD, PhDb,
- Joanna J. Wykrzykowska, MD, PhDb,
- Robbert J. de Winter, MD, PhDb,
- Bernard Chevalier, MDl,
- Patrick W. Serruys, MD, PhDm,∗ ( and )
- Yoshinobu Onuma, MD, PhDa
- aThoraxCenter, Erasmus University Medical Center, Rotterdam, the Netherlands
- bAcademic Medical Center, Amsterdam, the Netherlands
- cNorthern Region Heart Center, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
- dMontefiore Medical Center, Albert Einstein College of Medicine, New York, New York
- eHospital Universitario Clínico San Carlos, Madrid, Spain
- fGreen Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
- gKing’s College Hospital, London, England
- hDivision of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
- iFreeman Hospital, Newcastle upon Tyne, England
- jDepartment of Cardiology, Pasteur Hospital, Toulouse, France
- k1st Department of Cardiology, Medical University of Poznan, Poland
- lInstitut Jacques Cartier, Massy, France
- mInternational Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, England
- ↵∗Reprint requests and correspondence:
Dr. Patrick W. Serruys, P.O. Box 2125, 3000 CC Rotterdam, the Netherlands.
Objectives The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up.
Background Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent.
Methods The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 − minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected.
Results Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p < 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p = 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037).
Conclusions BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)
The ABSORB II trial was sponsored by Abbott Vascular. Dr. Lang has served as a consultant for Abbott Vascular, Medtronic, Biotronik, and Edwards Lifesciences. Dr. Egred has served as a proctor for Abbott Vascular; and has received honoraria for bioresorbable vascular scaffold workshops. Dr. Lesiak has received payments as an individual for advisory board and speaker honoraria from Abbott Vascular. Dr. Chevalier has served as a consultant for Abbott Vascular. Dr. Serruys has served on the international advisory board for Abbott Vascular; and on the advisory board for Boston Scientific. Dr. Onuma has served on the international advisory board for Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 4, 2016.
- Revision received March 16, 2016.
- Accepted March 24, 2016.
- American College of Cardiology Foundation