3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents
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, RIBS IV Study Investigators (Under the Auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology), P Jiménez-Quevedo, N Gonzalo, J Escaned, A Fernández-Ortiz, C Macaya, B García Del Blanco, J Goicolea, A García-Touchard, J R López-Mínguez, F Alfonso, A Benedicto, F Rivero, M Masotti, J Zueco, A Iñiguez, V Jiménez, T Velázquez, R Moreno, V Mainar, J M Hernández, A Domínguez, F Pomar, R Melgares, A Cequier, V Martí, A Bethencourt, J Moreu, C Morís, R Del Valle, J Sanchís, C A Urbano-Carrillo, I Calvo, M C Ferrer, N Vázquez, 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, RIBS IV Study Investigators (Under the Auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology), P Jiménez-Quevedo, N Gonzalo, J Escaned, A Fernández-Ortiz, C Macaya, B García Del Blanco, J Goicolea, A García-Touchard, J R López-Mínguez, F Alfonso, A Benedicto, F Rivero, M Masotti, J Zueco, A Iñiguez, V Jiménez, T Velázquez, R Moreno, V Mainar, J M Hernández, A Domínguez, F Pomar, R Melgares, A Cequier, V Martí, A Bethencourt, J Moreu, C Morís, R Del Valle, J Sanchís, C A Urbano-Carrillo, I Calvo, M C Ferrer, N Vázquez
Abstract
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).
Keywords: drug-eluting ballon(s); drug-eluting stent(s); everolimus-eluting stent(s); in-stent restenosis.
Published by Elsevier Inc.
Source: PubMed