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JACC Cardiovasc Interv. 2018 Feb 12;11(3):275-283. doi: 10.1016/j.jcin.2017.10.024. Epub 2017 Nov 7.

A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial.

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Division of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. Electronic address:
Division of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Division of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.
Division of Cardiology, Amphia Ziekenhuis, Breda, the Netherlands.
Division of Cardiology, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.
Division of Cardiology, Isala Klinieken, Zwolle, the Netherlands.
Division of Cardiology, Radboud University, Nijmegen, the Netherlands.
Division of Cardiology, Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands.
Division of Cardiology, Tergooi Ziekenhuis, Blaricum, the Netherlands.



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).


The treatment of ISR remains challenging in contemporary clinical practice.


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.


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).


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.


drug-eluting balloon; drug-eluting stent; in-stent restenosis; percutaneous coronary intervention

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