Author + information
- Received December 31, 2015
- Revision received February 29, 2016
- Accepted March 21, 2016
- Published online June 27, 2016.
- Yohei Sotomi, MDa,
- Yuki Ishibashi, MD, PhDb,
- Pannipa Suwannasom, MDa,b,c,
- Shimpei Nakatani, MDb,
- Yun-Kyeong Cho, MD, PhDb,
- Maik J. Grundeken, MDa,
- Yaping Zeng, MD, PhDb,
- Hiroki Tateishi, MD, PhDb,
- Pieter C. Smits, MD, PhDd,
- Paul Barragan, MD, PhDe,
- Ran Kornowski, MDf,
- Anthony H. Gershlick, MD, PhDg,
- Stephan Windecker, MD, PhDh,
- Robert-Jan van Geuns, MD, PhDb,
- Antonio L. Bartorelli, MD, PhDi,
- Robbert J. de Winter, MD, PhDa,
- Jan Tijssen, MD, PhDa,
- Patrick W. Serruys, MD, PhDj,∗ ( and )
- Yoshinobu Onuma, MD, PhDb
- aHeart Center, Academic Medical Center, Amsterdam, the Netherlands
- bThorax Center, Erasmus Medical Center, Rotterdam, the Netherlands
- cNorthern Region Heart Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
- dMaasstad Ziekenhuis, Rotterdam, the Netherlands
- ePolyclinique les Fleurs, Ollioules, France
- fRabin Medical Center, Petah Tikva, Israel
- gGlenfield Hospital, Leicester, United Kingdom
- hBern University Hospital, Bern, Switzerland
- iCentro Cardiologico Monzino, University of Milan, Milan, Italy
- jInternational Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom
- ↵∗Reprint requests and correspondence:
Dr. Patrick W. Serruys, MD, PhD, International Centre for Circulatory Health, NHLI, Imperial College London, London SW7 2AZ, United Kingdom.
Objectives The study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices.
Background It is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb.
Methods Of a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks.
Results Lower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46 mm2 vs. 4.27 mm2, respectively; p < 0.001; risk ratio: 3.04; 95% confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (p = 0.003) during post-dilation.
Conclusions At the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)
The ABSORB II study was sponsored by Abbott Vascular. Dr. Sotomi is a consultant for Goodman; and has received grants from Fukuda Memorial Foundation. Drs. Onuma and Serruys are on the advisory board of Abbott Vascular. Dr. Smits has received research grants, speaker fees, and honoraria from Abbott Vascular, St. Jude Medical, and Terumo. Dr. Windecker has received institutional research grants from Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Edwards Lifesciences, and St. Jude Medical. Dr. van Geuns has received speaker fees and institutional research grants from Abbott Vascular. Dr. Bartorelli has received speaker fees and travel support from Abbott Vascular. Dr. Gershlick has received lecture fees from Abbott Vascular and AstraZeneca. Drs. Grundeken and de Winter have received institutional grants from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Drs. Sotomi and Ishibashi contributed equally to this work.
- Received December 31, 2015.
- Revision received February 29, 2016.
- Accepted March 21, 2016.
- American College of Cardiology Foundation