title: Usefulness of Drug-Eluting Balloons for Bare-Metal and Drug-Eluting In-Stent Restenosis (from the RIBS IV and V Randomized Trials).
abstract: Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is particularly challenging. We sought to compare results of drug-eluting balloons in patients with DES-ISR with those in patients with bare-metal stent (BMS) ISR. A pooled analysis of the Restenosis Intra-Stent: Drug-Eluting Balloon versus Everolimus-Eluting Stent IV and V randomized trials was performed. Both trials had identical inclusion and exclusion criteria. Results of drug-eluting balloons in 95 patients with BMS-ISR and 154 patients with DES-ISR were compared. Patients with DES-ISR were more frequently diabetics, presented more often as an acute coronary syndrome and had more severe lesions and more frequently a focal pattern, including edge-ISR. Late angiographic findings (92% of eligible patients), including minimal lumen diameter (1.80 ± 0.6 vs 2.01 ± 0.6 mm, p = 0.001; absolute mean difference 0.21 mm; 95% confidence interval 0.04 to 0.38; p = 0.014) and restenosis rate (19% vs 9.5%, p <0.05) were poorer in DES-ISR. Results were consistent across 10 prespecified subgroups. Moreover, on multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR after adjusting for potential confounders (adjusted absolute mean difference 0.17 mm; 95% confidence interval 0.04 to 0.41; p = 0.019). Finally, at 1-year clinical follow-up (100% of patients), rates of target vessel revascularization (16% vs 6%, p = 0.02) and of the main combined clinical end point (18% vs 8%, p = 0.03) were significantly higher in patients treated for DES-ISR. In conclusion, this study confirms the efficacy of DEB for patients with ISR. However, the long-term clinical and angiographic results of DEB are poorer in patients with DES-ISR than in those with BMS-ISR. (ClinicalTrials.govIdentifier:NCT01239953&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; Funación 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 Infanta Cristina, Badajoz, Badajoz, Spain.
authors.forename: José-Ramón
authors.initials: JR
authors.lastname: López-Mínguez
authors.affiliation: Hospital Universitario Clinic de Barcelona, Barcelona, Spain.
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
authors.affiliation: Hospital Universitario Marqués de Valdecilla, Santander, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Zueco
authors.affiliation: Hospital Universitario Virgen de las Nieves, Granada, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Melgares
authors.affiliation: Hospital Universitario Ramón y Cajal, Madrid, Spain.
authors.forename: Rosana
authors.initials: R
authors.lastname: Hernández
authors.affiliation: Hospital Universitario La Paz, Madrid, Spain.
authors.forename: Raul
authors.initials: R
authors.lastname: Moreno
authors.affiliation: Hospital Universitario Virgen de la Victoria, Málaga, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Domínguez
authors.affiliation: Hospital Universitario Clínico de Valencia, Valencia, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Sanchís
authors.affiliation: Hospital Universitario Central de Asturias, Oviedo, Spain.
authors.forename: Cesar
authors.initials: C
authors.lastname: Moris
authors.affiliation: Hospital Universitario Virgen de la Salud Toledo, Toledo, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Moreu
authors.affiliation: Hospital Universitario de Bellvitge, Barcelona, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Cequier
authors.affiliation: Hospital Universitario de Bellvitge, Barcelona, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Romaguera
authors.affiliation: Hospital Universitario de La Princesa, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Rivero
authors.affiliation: Hospital Universitario de La Princesa, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Cuesta
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: Alberto
authors.initials: A
authors.lastname: Cárdenas
authors.affiliation: Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Fernández
mesh_terms: D000368:Aged; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D017239:Paclitaxel / Q000627:therapeutic use; D015607:Stents; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus; D017239:Paclitaxel