title: A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent).
abstract: OBJECTIVE
  This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR).
  
  
  BACKGROUND
  Treatment of patients with ISR remains a challenge.
  
  
  METHODS
  This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up.
  
  
  RESULTS
  A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups.
  
  
  CONCLUSIONS
  In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (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; Hospital Universitario Clínico San Carlos, 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: Maria 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 de La Princesa, Madrid, Spain.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Seidelberger
authors.affiliation: Complejo Hospitalario Universitario de Vigo, Pontevedra, Spain.
authors.forename: Andrés
authors.initials: A
authors.lastname: Iñiguez
authors.affiliation: Hospital Universitario de Torrecárdenas, Almería, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Gómez-Recio
authors.affiliation: Hospital Universitario Clinic de Barcelona, Barcelona, Spain.
authors.forename: Mónica
authors.initials: M
authors.lastname: Masotti
authors.affiliation: Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: M Teresa
authors.initials: MT
authors.lastname: Velázquez
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 Marqués de Valdecilla, Santander, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Zueco
authors.affiliation: Hospital Universitario Son Espases, Palma de Mallorca, Spain.
authors.forename: Armando
authors.initials: A
authors.lastname: Bethencourt
authors.affiliation: Hospital Universitario Virgen de las Nieves, Granada, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Melgares
authors.affiliation: Hospital Universitario de Bellvitge, Barcelona, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Cequier
authors.affiliation: Hospital Universitario Virgen de la Victoria, Málaga, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Dominguez
authors.affiliation: Hospital Universitario de Alicante, Alicante, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Mainar
authors.affiliation: Hospital Universitario Infanta Cristina Badajoz, Badajoz, Spain.
authors.forename: José R
authors.initials: JR
authors.lastname: López-Mínguez
authors.affiliation: Hospital Universitario Virgen de la Salud Toledo, Toledo, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Moreu
authors.affiliation: Hospital Universitario Sant Pau, Barcelona, Spain.
authors.forename: Vicens
authors.initials: V
authors.lastname: Martí
authors.affiliation: Hospital Universitario La Paz, Madrid, Spain.
authors.forename: Raúl
authors.initials: R
authors.lastname: Moreno
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 / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000401:mortality / Q000628:therapy; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D018570:Risk Assessment; D012720:Severity of Illness Index; D020123:Sirolimus / Q000627:therapeutic use; D013030:Spain; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D008670:Metals; D017239:Paclitaxel; D020123:Sirolimus
keywords: device thrombosis; drug-eluting balloon; everolimus-eluting stent; in-stent restenosis