Author + information
- Received October 16, 2017
- Accepted October 19, 2017
- Published online February 5, 2018.
- Jan Baan Jr., MD, PhDa,∗ (, )
- Bimmer E. Claessen, MD, PhDa,
- Kirsten Boerlage-van Dijk, MD, PhDb,
- Jeroen Vendrik, MDa,
- René J. van der Schaaf, MD, PhDb,
- Martijn Meuwissen, MD, PhDc,
- Niels van Royen, MD, PhDd,
- A.T. Marcel Gosselink, MD, PhDe,
- Marleen H. van Wely, MDf,
- Atilla Dirkali, MDg,
- E. Karin Arkenbout, MD, PhDh,
- Robbert J. de Winter, MD, PhDa,
- Karel T. Koch, MD, PhDa,
- Krischan D. Sjauw, MD, PhDa,
- Marcel A. Beijk, MD, PhDa,
- M. Marije Vis, MD, PhDa,
- Joanna J. Wykrzykowska, MD, PhDa,
- Jan J. Piek, MD, PhDa,
- Jan G.P. Tijssen, PhDa and
- José P.S. Henriques, MD, PhDa
- aDivision of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
- bDivision of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
- cDivision of Cardiology, Amphia Ziekenhuis, Breda, the Netherlands
- dDivision of Cardiology, Vrije Universiteit Medical Center, Amsterdam, the Netherlands
- eDivision of Cardiology, Isala Klinieken, Zwolle, the Netherlands
- fDivision of Cardiology, Radboud University, Nijmegen, the Netherlands
- gDivision of Cardiology, Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands
- hDivision of Cardiology, Tergooi Ziekenhuis, Blaricum, the Netherlands
- ↵∗Address for correspondence:
Dr. Jan Baan Jr., Department of Cardiology, B2-115, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
Objectives The authors sought 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) in-stent restenosis (ISR).
Background The treatment of ISR remains challenging in contemporary clinical practice.
Methods In a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority 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 noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for 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 noninferior 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.
The DARE study was financially supported through a research grant provided by B. Braun Melsungen. The grant givers had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Dr. Baan has received an unrestricted research grant from B. Braun Melsungen and Abbott Vascular. Dr. Piek is a member of the medical advisory board for Abbott Vascular; and a consultant for Philips/Volcano. Dr. Henriques has received an unrestricted research grant from B. Braun Melsungen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 16, 2017.
- Accepted October 19, 2017.
- 2018 American College of Cardiology Foundation