TY - JOUR
T1 - A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis
T2 - 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.
N1 - Publisher Copyright:
© 2018 American College of Cardiology Foundation
PY - 2018/2/12
Y1 - 2018/2/12
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.
KW - drug-eluting balloon
KW - drug-eluting stent
KW - in-stent restenosis
KW - percutaneous coronary intervention
UR - http://www.scopus.com/inward/record.url?scp=85041892277&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2017.10.024
DO - 10.1016/j.jcin.2017.10.024
M3 - Article
C2 - 29413242
AN - SCOPUS:85041892277
SN - 1936-8798
VL - 11
SP - 275
EP - 283
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 3
ER -