Author + information
- Received January 12, 2018
- Revision received February 20, 2018
- Accepted February 28, 2018
- Published online May 21, 2018.
- Fernando Alfonso, MDa,∗ (, )
- María José Pérez-Vizcayno, MDb,
- Javier Cuesta, MDa,
- Bruno García del Blanco, MDc,
- Arturo García-Touchard, MDd,
- José Ramón López-Mínguez, MDe,
- Mónica Masotti, MDf,
- Javier Zueco, MDg,
- Angel Cequier, MDh,
- Maite Velázquez, MDi,
- Raúl Moreno, MDj,
- Vicente Mainar, MDk,
- Antonio Domínguez, MDl,
- Cesar Moris, MDm,
- Eduardo Molina, MDn,
- Fernando Rivero, MDa,
- Pilar Jiménez-Quevedo, MDb,
- Nieves Gonzalo, MDb,
- Cristina Fernández-Pérez, MDb,
- for the RIBS IV Study Investigators (Under the Auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology)
- aHospital Universitario de La Princesa, Madrid, Spain
- bHospital Universitario Clínico San Carlos, Madrid, and Fundación Interhospitalaria Investigacion Cardiovascular, Madrid, Spain
- cHospital Universitario Vall d’Hebron, Barcelona, Spain
- dHospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain
- eHospital Universitario Infanta Cristina, Badajoz, Badajoz, Spain
- fHospital Universitario Clinic de Barcelona, Barcelona, Spain
- gHospital Universitario Marqués de Valdecilla, Santander, Spain
- hHospital Universitario de Belvitge, Barcelona, Spain
- iHospital Universitario 12 de Octubre, Madrid, Spain
- jHospital Universitario La Paz, Madrid, Spain
- kHospital Universitario de Alicante, Alicante, Spain
- lHospital Universitario Virgen de la Victoria, Málaga, Spain
- mHospital Universitario Central de Asturias, Oviedo, Spain
- nHospital Universitario Virgen de las Nieves, Granada, Spain
- ↵∗Address for correspondence:
Dr. Fernando Alfonso, Departamento de Cardiología, Hospital Universitario de La Princesa, Instituto Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, c/Diego de León 62, Madrid 28006, Madrid, Spain.
Objectives This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES).
Background Treatment of patients with DES-ISR remains a challenge.
Methods The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study.
Results A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for “late” (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms.
Conclusions The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940)
This study was funded by unrestricted research grants from B. Braun Surgical and Abbott Vascular. The Fundación Interhospitalaria de Investigación Cardiovascular was the promoter. The investigators kept the study dataset, performed the statistical analysis, decided to submit the study for publication, and take full responsibility for the study. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 12, 2018.
- Revision received February 20, 2018.
- Accepted February 28, 2018.
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.