Author + information
- Received October 16, 2017
- Accepted October 19, 2017
- Published online October 30, 2017.
- Jan Baan Jr., MD, PhD1,∗ (, )
- Bimmer E. Claessen, MD, PhD1,
- Kirsten Boerlage-van Dijk, MD, PhD2,
- Jeroen Vendrik, MD1,
- René J. van der Schaaf, MD, PhD2,
- Martijn Meuwissen, MD, PhD3,
- Niels van Royen, MD, PhD4,
- A. T. Marcel Gosselink, MD, PhD5,
- Marleen H. van Wely, MD6,
- Atilla Dirkali, MD7,
- E. Karin Arkenbout, MD, PhD8,
- Robbert J. de Winter, MD, PhD1,
- Karel T. Koch, MD, PhD1,
- Krischan D. Sjauw, MD, PhD1,
- Marcel A. Beijk, MD, PhD1,
- M. Marije Vis, MD, PhD1,
- Joanna J. Wykrzykowska, MD, PhD1,
- Jan. J. Piek, MD, PhD1,
- Jan G.P. Tijssen, PhD1 and
- José P.S. Henriques, MD, PhD1
- 1Academic Medical Center - University of Amsterdam, Amsterdam, The Netherlands
- 2Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
- 3Amphia Ziekenhuis, Breda, The Netherlands
- 4Vrije Universiteit Medical Center, Amsterdam, The Netherlands
- 5Isala Klinieken, Zwolle, The Netherlands
- 6Radboud University, Nijmegen, The Netherlands
- 7Albert Schweitzer ziekenhuis, Dordrecht, The Netherlands
- 8Tergooi Ziekenhuis, Blaricum, The Netherlands
- ↵∗Correspondence to: Jan Baan Jr, MD, PhD Department of Cardiology B2-115 Academic Medical Center – University of Amsterdam Meibergdreef 9 1105 AZ Amsterdam, The Netherlands Phone: +31-20-5669111 Fax: +31-20-6962609
Background The treatment of in-stent restenosis (ISR) remains challenging in contemporary clinical practice.
Objectives To evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare metal or drug-eluting stent) ISR.
Methods In a multicenter randomized non-inferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, BBraun Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, CA). The primary endpoint was non-inferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months.
Results A total of 278 patients of whom 56% had DES-ISR were randomized at 8 sites to treatment with DEB (n=141) or DES (n=137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84±0.46 vs 1.72±0.35, p=0.018 and 26±10% vs. 30±10%, p=0.03). Angiographic follow up was completed at 196±53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was non-inferior to DES (DEB 1.71±0.51mm vs. DES 1.74±0.61mm, p noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs DEB 8.8%, p=0.65).
Conclusions In patients with ISR, treatment with DEB was non-inferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for in-stent restenosis withholding the need for additional stent implantation.
Dr. Baan has received an unrestricted research grant from BBraun and Abbott Vascular
Dr. Piek is a member of the medical advisory board for Abbott Vascular
Dr. Henriques received an unrestricted research grant from BBraun
Remaining authors have no conflicts of interest to disclose
- Received October 16, 2017.
- Accepted October 19, 2017.