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.
abstract: BACKGROUND
  Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge.
  
  
  OBJECTIVE
  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).
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: Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: María Jose
authors.initials: MJ
authors.lastname: Pérez-Vizcayno
authors.affiliation: Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Cárdenas
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 Infanta Cristina, Badajoz, Spain.
authors.forename: José Ramón
authors.initials: JR
authors.lastname: López-Minguéz
authors.affiliation: Hospital Universitario de La Princesa, Madrid, Spain.
authors.forename: Amparo
authors.initials: A
authors.lastname: Benedicto
authors.affiliation: Hospital Universitario Clinic 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 de Meixoeiro, Vigo, Spain.
authors.forename: Andrés
authors.initials: A
authors.lastname: Iñiguez
authors.affiliation: Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: Maite
authors.initials: M
authors.lastname: Velázquez
authors.affiliation: Hospital Universitario La Paz, Madrid, Spain.
authors.forename: Raúl
authors.initials: R
authors.lastname: Moreno
authors.affiliation: Hospital Universitario de Alicante, Alicante, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Mainar
authors.affiliation: Hospital Universitario Virgen de la Victoria, Málaga, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Domínguez
authors.affiliation: Hospital Universitario General de Valencia, Valencia, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Pomar
authors.affiliation: Hospital Universitario Virgen de las Nieves, Granada, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Melgares
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: Pilar
authors.initials: P
authors.lastname: Jiménez-Quevedo
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: Cristina
authors.initials: C
authors.lastname: Fernández
authors.affiliation: Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D023903:Coronary Restenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus
keywords: angiography; percutaneous coronary intervention; proliferation; revascularization