title: 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).
abstract: 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.
authors.affiliation: Hospital Universitario de La Princesa, Madrid, Spain. Electronic address: falf@hotmail.com.
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfonso
authors.affiliation: Fundación Interhospitalaria Investigación Cardiovascular, Madrid, Spain.
authors.forename: María José
authors.initials: MJ
authors.lastname: Pérez-Vizcayno
authors.affiliation: Hospital Universitario Vall d'Hebron, Barcelona, Spain.
authors.forename: Bruno
authors.initials: B
authors.lastname: García Del Blanco
authors.affiliation: Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.
authors.forename: Arturo
authors.initials: A
authors.lastname: García-Touchard
authors.affiliation: Hospital Universitario Clinic de Barcelona, Barcelona, Spain.
authors.forename: Mónica
authors.initials: M
authors.lastname: Masotti
authors.affiliation: Hospital Universitario Infanta Cristina, Badajoz, Spain.
authors.forename: José R
authors.initials: JR
authors.lastname: López-Minguez
authors.affiliation: Hospital Universitario de Meixoeiro, Vigo, Spain.
authors.forename: Andrés
authors.initials: A
authors.lastname: Iñiguez
authors.affiliation: Hospital Universitario Marqués de Valdecilla, Santander, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Zueco
authors.affiliation: Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: Maite
authors.initials: M
authors.lastname: Velazquez
authors.affiliation: Hospital Universitario de Bellvitge, Barcelona, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Cequier
authors.affiliation: Hospital Universitario de Torrecárdenas, Almería, Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Lázaro-García
authors.affiliation: Hospital Universitario Sant Pau, Barcelona, Spain.
authors.forename: Vicens
authors.initials: V
authors.lastname: Martí
authors.affiliation: Hospital Universitario Central Asturias, Oviedo, Spain.
authors.forename: César
authors.initials: C
authors.lastname: Moris
authors.affiliation: Hospital Universitario Carlos Haya, Málaga, Spain.
authors.forename: Cristobal
authors.initials: C
authors.lastname: Urbano-Carrillo
authors.affiliation: Hospital Universitario de La Princesa, Madrid, Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Bastante
authors.affiliation: Hospital Universitario de La Princesa, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Rivero
authors.affiliation: Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Cárdenas
authors.affiliation: Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: Nieves
authors.initials: N
authors.lastname: Gonzalo
authors.affiliation: Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Jiménez-Quevedo
authors.affiliation: Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Fernández
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus