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

Jan Baan, Bimmer E. Claessen, Kirsten Boerlage-van Dijk, Jeroen Vendrik, René J. van der Schaaf, Martijn Meuwissen, Niels van Royen, A. T. Marcel Gosselink, Marleen H. van Wely, Atilla Dirkali, E. Karin Arkenbout, Robbert J. de Winter, Karel T. Koch, Krischan D. Sjauw, Marcel A. Beijk, M. Marije Vis, Joanna J. Wykrzykowska, Jan J. Piek, Jan G. P. Tijssen, José P. S. Henriques

Research output: Contribution to journalArticleAcademicpeer-review

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.
Original languageEnglish
Pages (from-to)287-297
JournalJACC: Cardiovascular Interventions
Volume11
Issue number3
DOIs
Publication statusPublished - 2018

Cite this

Baan, Jan ; Claessen, Bimmer E. ; Dijk, Kirsten Boerlage-van ; Vendrik, Jeroen ; van der Schaaf, René J. ; Meuwissen, Martijn ; van Royen, Niels ; Gosselink, A. T. Marcel ; van Wely, Marleen H. ; Dirkali, Atilla ; Arkenbout, E. Karin ; de Winter, Robbert J. ; Koch, Karel T. ; Sjauw, Krischan D. ; Beijk, Marcel A. ; Vis, M. Marije ; Wykrzykowska, Joanna J. ; Piek, Jan J. ; Tijssen, Jan G. P. ; Henriques, José P. S. / A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial. In: JACC: Cardiovascular Interventions. 2018 ; Vol. 11, No. 3. pp. 287-297.
@article{f116e534a03a4a0b8a55f78195a73bce,
title = "A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial",
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.",
author = "Jan Baan and Claessen, {Bimmer E.} and Dijk, {Kirsten Boerlage-van} and Jeroen Vendrik and {van der Schaaf}, {Ren{\'e} J.} and Martijn Meuwissen and {van Royen}, Niels and Gosselink, {A. T. Marcel} and {van Wely}, {Marleen H.} and Atilla Dirkali and Arkenbout, {E. Karin} and {de Winter}, {Robbert J.} and Koch, {Karel T.} and Sjauw, {Krischan D.} and Beijk, {Marcel A.} and Vis, {M. Marije} and Wykrzykowska, {Joanna J.} and Piek, {Jan J.} and Tijssen, {Jan G. P.} and Henriques, {Jos{\'e} P. S.}",
year = "2018",
doi = "10.1016/j.jcin.2017.10.024",
language = "English",
volume = "11",
pages = "287--297",
journal = "JACC Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "3",

}

Baan, J, Claessen, BE, Dijk, KB, Vendrik, J, van der Schaaf, RJ, Meuwissen, M, van Royen, N, Gosselink, ATM, van Wely, MH, Dirkali, A, Arkenbout, EK, de Winter, RJ, Koch, KT, Sjauw, KD, Beijk, MA, Vis, MM, Wykrzykowska, JJ, Piek, JJ, Tijssen, JGP & Henriques, JPS 2018, 'A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial' JACC: Cardiovascular Interventions, vol. 11, no. 3, pp. 287-297. https://doi.org/10.1016/j.jcin.2017.10.024

A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial. / Baan, Jan; Claessen, Bimmer E.; Dijk, Kirsten Boerlage-van; Vendrik, Jeroen; van der Schaaf, René J.; Meuwissen, Martijn; van Royen, Niels; Gosselink, A. T. Marcel; van Wely, Marleen H.; Dirkali, Atilla; Arkenbout, E. Karin; de Winter, Robbert J.; Koch, Karel T.; Sjauw, Krischan D.; Beijk, Marcel A.; Vis, M. Marije; Wykrzykowska, Joanna J.; Piek, Jan J.; Tijssen, Jan G. P.; Henriques, José P. S.

In: JACC: Cardiovascular Interventions, Vol. 11, No. 3, 2018, p. 287-297.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial

AU - Baan, Jan

AU - Claessen, Bimmer E.

AU - Dijk, Kirsten Boerlage-van

AU - Vendrik, Jeroen

AU - van der Schaaf, René J.

AU - Meuwissen, Martijn

AU - van Royen, Niels

AU - Gosselink, A. T. Marcel

AU - van Wely, Marleen H.

AU - Dirkali, Atilla

AU - Arkenbout, E. Karin

AU - de Winter, Robbert J.

AU - Koch, Karel T.

AU - Sjauw, Krischan D.

AU - Beijk, Marcel A.

AU - Vis, M. Marije

AU - Wykrzykowska, Joanna J.

AU - Piek, Jan J.

AU - Tijssen, Jan G. P.

AU - Henriques, José P. S.

PY - 2018

Y1 - 2018

N2 - 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.

AB - 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.

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UR - https://www.ncbi.nlm.nih.gov/pubmed/29413242

U2 - 10.1016/j.jcin.2017.10.024

DO - 10.1016/j.jcin.2017.10.024

M3 - Article

VL - 11

SP - 287

EP - 297

JO - JACC Cardiovascular Interventions

JF - JACC Cardiovascular Interventions

SN - 1936-8798

IS - 3

ER -