• Fernando Alfonso, María José Pérez-Vizcayno, Javier Cuesta, Bruno García Del Blanco, Arturo García-Touchard, José Ramón López-Mínguez, Mónica Masotti, Javier Zueco, Angel Cequier, Maite Velázquez, Raúl Moreno, Vicente Mainar, Antonio Domínguez, Cesar Moris, Eduardo Molina, Fernando Rivero, Pilar Jiménez-Quevedo, Nieves Gonzalo, Cristina Fernández-Pérez, and RIBS IV Study Investigators (Under the Auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology).
• Hospital Universitario de La Princesa, Madrid, Spain. Electronic address: falf@hotmail.com.
• JACC Cardiovasc Interv. 2018 May 28; 11 (10): 981-991.

ObjectivesThis 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).BackgroundTreatment of patients with DES-ISR remains a challenge.MethodsThe 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.ResultsA 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.ConclusionsThe 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).Published by Elsevier Inc.

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