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Title: A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Randomized Clinical Trial.
Author: Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García del Blanco B, García-Touchard A, López-Minguéz JR, Benedicto A, Masotti M, Zueco J, Iñiguez A, Velázquez M, Moreno R, Mainar V, Domínguez A, Pomar F, Melgares R, Rivero F, Jiménez-Quevedo P, Gonzalo N, Fernández C, Macaya C, RIBS IV Study Investigators (under auspices of Interventional Cardiology Working Group of Spanish Society of Cardiology).
Journal: J Am Coll Cardiol; 2015 Jul 07; 66(1):23-33. PubMed ID: 26139054.
Abstract:
BACKGROUND: Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge. OBJECTIVES: This study evaluated the comparative efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients presenting with DES-ISR. METHODS: The study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint, in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up. RESULTS: A total of 309 patients with DES-ISR from 23 Spanish university hospitals were randomly allocated to DEB (n = 154) or EES (n = 155). At late angiography (median 247 days; 90% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01) (absolute mean difference: 0.23 mm; 95% CI: 0.07 to 0.38) [corrected], net lumen gain (1.28 ± 0.7 mm vs. 1.01 ± 0.7 mm; p < 0.01), and lower percent diameter stenosis (23 ± 22% vs. 30 ± 22%; p < 0.01) and binary restenosis rate (11% vs. 19%; p = 0.06), compared with patients in the DEB arm. Consistent results were observed in the in-lesion analysis. At the 1-year clinical follow-up (100% of patients), the main clinical outcome measure (composite of cardiac death, myocardial infarction, and target vessel revascularization) was significantly reduced in the EES arm (10% vs. 18%; p = 0.04; hazard ratio: 0.58; 95% CI: 0.35 to 0.98), mainly driven by a lower need for target vessel revascularization (8% vs. 16%; p = 0.035). CONCLUSIONS: In patients with DES-ISR, EES provided superior long-term clinical and angiographic results compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent [RIBS IV]; NCT01239940).

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