Author + information
- Received October 18, 2013
- Revision received November 12, 2013
- Accepted December 3, 2013
- Published online April 15, 2014.
- Fernando Alfonso, MD∗,†∗ (, )
- Maria Jose Pérez-Vizcayno, MD†,
- Alberto Cárdenas, MD†,
- Bruno García del Blanco, MD‡,
- Bernhard Seidelberger, MD∗,
- Andrés Iñiguez, MD§,
- Manuel Gómez-Recio, MD‖,
- Mónica Masotti, MD¶,
- M. Teresa Velázquez, MD#,
- Juan Sanchís, MD∗∗,
- Arturo García-Touchard, MD††,
- Javier Zueco, MD‡‡,
- Armando Bethencourt, MD§§,
- Rafael Melgares, MD‖‖,
- Angel Cequier, MD¶¶,
- Antonio Dominguez, MD##,
- Vicente Mainar, MD∗∗∗,
- José R. López-Mínguez, MD†††,
- José Moreu, MD‡‡‡,
- Vicens Martí, MD§§§,
- Raúl Moreno, MD‖‖‖,
- Pilar Jiménez-Quevedo, MD†,
- Nieves Gonzalo, MD†,
- Cristina Fernández, MD†,
- Carlos Macaya, MD†,
- RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology
- ∗Hospital Universitario de La Princesa, Madrid, Spain
- †Hospital Universitario Clínico San Carlos, Madrid, Spain
- ‡Hospital Universitario Vall d'Hebron, Barcelona, Spain
- §Complejo Hospitalario Universitario de Vigo, Pontevedra, Spain
- ‖Hospital Universitario de Torrecárdenas, Almería, Spain
- ¶Hospital Universitario Clinic de Barcelona, Barcelona, Spain
- #Hospital Universitario 12 de Octubre, Madrid, Spain
- ∗∗Hospital Universitario Clínico de Valencia, Valencia, Spain
- ††Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain
- ‡‡Hospital Universitario Marqués de Valdecilla, Santander, Spain
- §§Hospital Universitario Son Espases, Palma de Mallorca, Spain
- ‖‖Hospital Universitario Virgen de las Nieves, Granada, Spain
- ¶¶Hospital Universitario de Bellvitge, Barcelona, Spain
- ##Hospital Universitario Virgen de la Victoria, Málaga, Spain
- ∗∗∗Hospital Universitario de Alicante, Alicante, Spain
- †††Hospital Universitario Infanta Cristina Badajoz, Badajoz, Spain
- ‡‡‡Hospital Universitario Virgen de la Salud Toledo, Toledo, Spain
- §§§Hospital Universitario Sant Pau, Barcelona, Spain
- ‖‖‖Hospital Universitario La Paz, Madrid, Spain
- ↵∗Reprint requests and correspondence:
Dr. Fernando Alfonso, Departamento de Cardiología, Hospital Universitario de La Princesa, IIS-IP, Universidad Autónoma de Madrid, c/Diego de León 62. Madrid 28006, Madrid, Spain.
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)
This study was supported by unrestricted research grants from B. Braun Surgical and Abbott Vascular. Dr. Gonzalo has received speaker honoraria from St. Jude Medical and Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 18, 2013.
- Revision received November 12, 2013.
- Accepted December 3, 2013.
- American College of Cardiology Foundation