Comparison of the Efficacy of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With In-Stent Restenosis (from the RIBS IV and V Randomized Clinical Trials)

• Published in: The American journal of cardiology Vol. 117; no. 4; pp. 546 - 554
• Main Authors: Alfonso, Fernando, MD, Pérez-Vizcayno, María José, MD, García del Blanco, Bruno, MD, García-Touchard, Arturo, MD, Masotti, Mónica, MD, López-Minguez, José R., MD, Iñiguez, Andrés, MD, Zueco, Javier, MD, Velazquez, Maite, MD, Cequier, Angel, MD, Lázaro-García, Rosa, MD, Martí, Vicens, MD, Moris, César, MD, Urbano-Carrillo, Cristobal, MD, Bastante, Teresa, MD, Rivero, Fernando, MD, Cárdenas, Alberto, MD, Gonzalo, Nieves, MD, Jiménez-Quevedo, Pilar, MD, Fernández, Cristina, MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 15-02-2016; Elsevier Limited
• Subjects: Aged; Angioplasty; Angioplasty, Balloon, Coronary - instrumentation; Cardiology; Cardiovascular; Clinical trials; Confidence intervals; Coronary Angiography; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - surgery; Drug-Eluting Stents; Everolimus - pharmacology; Female; Follow-Up Studies; Graft Occlusion, Vascular - diagnostic imaging; Graft Occlusion, Vascular - surgery; Heart attacks; Humans; Immunosuppressive Agents - pharmacology; Laboratories; Male; Percutaneous Coronary Intervention - methods; Prospective Studies; Prosthesis Design; Stents; Studies; Time Factors; Treatment Outcome
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2015.11.042

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p <0.0001). At follow-up, patients treated with EESs had larger in-segment minimal lumen diameter (primary end point 2.16 ± 0.7 vs 1.88 ± 0.6 mm, p <0.0001; absolute mean difference 0.28 mm; 95% confidence interval [CI] 0.16 to 0.40) and net lumen gain (1.33 ± 0.6 vs 1.00 ± 0.7 mm, p <0.0001) and had lower %diameter stenosis (19 ± 21% vs 28 ± 22%, p <0.0001) and binary restenosis rate (8.7% vs 15.7%, p = 0.02). Consistent results were observed in the in-lesion analysis. No interactions were found between the underlying stent type and treatment effects. At 1-year clinical follow-up, the composite of cardiac death, myocardial infarction, and target vessel revascularization was significantly reduced in the EES arm (8.8% vs 14.5%, p = 0.03; hazard ratio 0.59, 95% CI 0.31 to 0.94) mainly driven by a lower need for target vessel revascularization (6% vs 12.4%, p = 0.01, hazard ratio 0.46, 95% CI 0.25 to 0.86). This pooled analysis of the RIBS IV and RIBS V randomized trials demonstrates the superiority of EES over DEB in the treatment of patients with ISR.