A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent)
Fernando Alfonso, Maria Jose Pérez-Vizcayno, Alberto Cárdenas, Bruno García Del Blanco, Bernhard Seidelberger, Andrés Iñiguez, Manuel Gómez-Recio, Mónica Masotti, M Teresa Velázquez, Juan Sanchís, Arturo García-Touchard, Javier Zueco, Armando Bethencourt, Rafael Melgares, Angel Cequier, Antonio Dominguez, Vicente Mainar, José R López-Mínguez, José Moreu, Vicens Martí, Raúl Moreno, Pilar Jiménez-Quevedo, Nieves Gonzalo, Cristina Fernández, Carlos Macaya, RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology, Fernando Alfonso, Maria Jose Pérez-Vizcayno, Alberto Cárdenas, Bruno García Del Blanco, Bernhard Seidelberger, Andrés Iñiguez, Manuel Gómez-Recio, Mónica Masotti, M Teresa Velázquez, Juan Sanchís, Arturo García-Touchard, Javier Zueco, Armando Bethencourt, Rafael Melgares, Angel Cequier, Antonio Dominguez, Vicente Mainar, José R López-Mínguez, José Moreu, Vicens Martí, Raúl Moreno, Pilar Jiménez-Quevedo, Nieves Gonzalo, Cristina Fernández, Carlos Macaya, RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology
Abstract
Objectives: This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR).
Background: Treatment of patients with ISR remains a challenge.
Methods: This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up.
Results: A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups.
Conclusions: In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953).
Keywords: device thrombosis; drug-eluting balloon; everolimus-eluting stent; in-stent restenosis.
Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed