Author + information
- Received March 22, 2016
- Accepted March 24, 2016
- Published online June 27, 2016.
- Fernando Alfonso, MDa,∗ (, )
- María José Pérez-Vizcayno, MDb,c,
- Bruno García del Blanco, MDd,
- Imanol Otaegui, MDd,
- Mónica Masotti, MDe,
- Javier Zueco, MDf,
- Maite Veláquez, MDg,
- Juan Sanchís, MDh,
- Arturo García-Touchard, MDi,
- Rosa Lázaro-García, MDj,
- José Moreu, MDk,
- Armando Bethencourt, MDl,
- Javier Cuesta, MDa,
- Fernando Rivero, MDa,
- Alberto Cárdenas, MDc,
- Nieves Gonzalo, MDc,
- Pilar Jiménez-Quevedo, MDc,
- Cristina Fernández, MDc,
- RIBS V Study Investigators
- aHospital Universitario de La Princesa, Madrid, Spain
- bFundación Interhospitalaria Investigación Cardiovascular, Madrid, Spain
- cHospital Universitario Clínico San Carlos, Madrid, Spain
- dHospital Universitario Vall d’Hebrón, Barcelona, Spain
- eHospital Universitario Clínic de Barcelona, Barcelona, Spain
- fHospital Universitario Marqués de Valdecilla, Santander, Spain
- gHospital Universitario 12 de Octubre, Madrid, Spain
- hHospital Universitario Clínico de Valencia, Valencia, Spain
- iHospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain
- jHospital Universitario de Torrecárdenas, Almería, Spain
- kHospital Universitario Virgen de la Salud, Toledo, Spain
- lHospital Universitario Son Espases, Palma de Mallorca, Spain
- ↵∗Reprint requests and correspondence:
Dr. Fernando Alfonso, Departamento de Cardiología, Hospital Universitario de La Princesa, IIS-IP, Universidad Autónoma de Madrid, c/ Diego de León 62, Madrid 28006, Spain.
Objectives 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).
Background The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown.
Methods 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.
Results 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.
Conclusions 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)
Dr. Cárdenas is currently affilated with the Universidad San Francisco de Quito USFQ, School of Medicine, Quito, Ecuador. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 22, 2016.
- Accepted March 24, 2016.
- American College of Cardiology Foundation