title: Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.
abstract: The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR).
  
  
  
  The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown.
  
  
  
  The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire.
  
  
  
  A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p < 0.001). At 3 years, the rates of cardiac death (2% vs. 1%), myocardial infarction (4% vs. 5%) and target vessel revascularization (9% vs. 5%) were similar in the DEB and EES arms. Importantly, however, at 3 years, the rate of target lesion revascularization was significantly lower in the EES arm (2% vs. 8%; p = 0.04; hazard ratio: 0.23; 95% confidence interval: 0.06 to 0.93). The need for "late" (>1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms.
  
  
  
  The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953).
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; Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: María José
authors.initials: MJ
authors.lastname: Pérez-Vizcayno
authors.affiliation: Hospital Universitario Vall d'Hebrón, Barcelona, Spain.
authors.forename: Bruno
authors.initials: B
authors.lastname: García Del Blanco
authors.affiliation: Hospital Universitario Vall d'Hebrón, Barcelona, Spain.
authors.forename: Imanol
authors.initials: I
authors.lastname: Otaegui
authors.affiliation: Hospital Universitario Clínic de Barcelona, Barcelona, Spain.
authors.forename: Mónica
authors.initials: M
authors.lastname: Masotti
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: Veláquez
authors.affiliation: Hospital Universitario Clínico de Valencia, Valencia, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Sanchís
authors.affiliation: Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.
authors.forename: Arturo
authors.initials: A
authors.lastname: García-Touchard
authors.affiliation: Hospital Universitario de Torrecárdenas, Almería, Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Lázaro-García
authors.affiliation: Hospital Universitario Virgen de la Salud, Toledo, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Moreu
authors.affiliation: Hospital Universitario Son Espases, Palma de Mallorca, Spain.
authors.forename: Armando
authors.initials: A
authors.lastname: Bethencourt
authors.affiliation: Hospital Universitario de La Princesa, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Cuesta
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 / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D013030:Spain; D015607:Stents; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals; D000068338:Everolimus; D017239:Paclitaxel
keywords: drug-eluting balloon(s); drug-eluting stent(s); everolimus-eluting stent(s); in-stent restenosis