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3-Year Clinical Follow-Up of the RIBS IV Clinical Trial

2018; Elsevier BV; Volume: 11; Issue: 10 Linguagem: Inglês

10.1016/j.jcin.2018.02.037

1936-8798

Fernándo Alfonso, Marı́a José Pérez-Vizcayno, Javier Cuesta, Bruno García del Blanco, Arturo García‐Touchard, José Ramón López-Mínguez, Mónica Masotti, Javier Zueco, Ángel Cequier, Maite Velázquez Martín, Raúl Moreno, Vicente Mainar, Antonio Domínguez, César Morı́s, Eduardo Molina, Fernando Rivero, Pilar Jiménez‐Quevedo, Nieves Gonzalo, Cristina Fernández, Pilar Jiménez‐Quevedo, Nieves Gonzalo, Javier Escaned, Antonio Fernández-Ortı́z, Carlos Macaya, Bruno García del Blanco, J. Goicolea, Arturo García‐Touchard, José Ramón López-Mínguez, Fernándo Alfonso, Amparo Benedicto, Fernando Rivero, Mónica Masotti, Javier Zueco, Andrés Íñiguez, Víctor Jiménez, Teresa Caballero‐Velázquez, Raúl Moreno, Vicente Mainar, José M. de la Torre Hernández, Antonio Domínguez, Francisco Pomar, Rafael Melgares, Ángel Cequier, Vicens Martı́, Armando Bethencourt, José Moreu, César Morı́s, Raquel Del Valle, Juan Sanchís, Cristóbal A. Urbano-Carrillo, Isabel Calvo, María Cruz Ferrer, Natalia Vázquez,

Cardiac Imaging and Diagnostics

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).Treatment of patients with DES-ISR remains a challenge.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.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.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).