title: Rationale and design of the RIBS IV randomised clinical trial (drug-eluting balloons versus everolimus-eluting stents for patients with drug-eluting stent restenosis).
abstract: OBJECTIVE
  This study will compare the efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with drug-eluting stent (DES) in-stent restenosis (ISR).
  
  
  RESULTS
  This is a prospective, multicentre, randomised clinical trial comparing DEB and EES in patients with DES-ISR. The study is an investigator-driven initiative generated within the RIBS study programme. A total of 310 patients with DES-ISR will be included and randomised (1:1) to DEB or EES. Angiographic follow-up has been scheduled at six to nine months. Quantitative coronary analyses will be performed in a centralised core lab by blinded personnel. The primary endpoint of the study is minimal lumen diameter at angiographic follow-up. Other secondary angiographic endpoints include % diameter stenosis, late loss, net gain and binary restenosis rate. An independent clinical events committee will adjudicate clinical events after reviewing source documents. The main clinical outcome measure is a combined endpoint of cardiac death, myocardial infarction and target vessel revascularisation at one year. Individual components of the combined clinical endpoint and rates of target lesion revascularisation and stent thrombosis will also be compared.
  
  
  CONCLUSIONS
  This randomised clinical trial will determine the relative efficacy of EES versus DEB in patients presenting with DES-ISR. (ClinicalTrials.gov Identifier: NCT01239940).
authors.affiliation: Hospital Universitario de La Princesa, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfonso
authors.forename: María José
authors.initials: MJ
authors.lastname: Pérez-Vizcayno
authors.forename: Alberto
authors.initials: A
authors.lastname: Cárdenas
authors.forename: Bruno
authors.initials: B
authors.lastname: García Del Blanco
authors.forename: Arturo
authors.initials: A
authors.lastname: García-Touchard
authors.forename: José Ramón
authors.initials: JR
authors.lastname: López-Minguéz
authors.forename: Fernando
authors.initials: F
authors.lastname: Rivero
authors.forename: Mónica
authors.initials: M
authors.lastname: Masotti
authors.forename: Javier
authors.initials: J
authors.lastname: Zueco
authors.forename: Angel
authors.initials: A
authors.lastname: Cequier
authors.forename: Cesar
authors.initials: C
authors.lastname: Morís
authors.forename: Antonio
authors.initials: A
authors.lastname: Fernández-Ortíz
authors.forename: Javier
authors.initials: J
authors.lastname: Escaned
authors.forename: Pilar
authors.initials: P
authors.lastname: Jiménez-Quevedo
authors.forename: Nieves
authors.initials: N
authors.lastname: Gonzalo
authors.forename: Cristina
authors.initials: C
authors.lastname: Fernández
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D023903:Coronary Restenosis / Q000188:drug therapy / Q000601:surgery*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000068338:Everolimus