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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.

Author information

1
Division of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: j.baan@amc.uva.nl.
2
Division of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
3
Division of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.
4
Division of Cardiology, Amphia Ziekenhuis, Breda, the Netherlands.
5
Division of Cardiology, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.
6
Division of Cardiology, Isala Klinieken, Zwolle, the Netherlands.
7
Division of Cardiology, Radboud University, Nijmegen, the Netherlands.
8
Division of Cardiology, Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands.
9
Division of Cardiology, Tergooi Ziekenhuis, Blaricum, the Netherlands.

Abstract

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.

KEYWORDS:

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

PMID:
29413242
DOI:
10.1016/j.jcin.2017.10.024
[Indexed for MEDLINE]
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