Author + information
- Received May 9, 2017
- Revision received June 22, 2017
- Accepted June 22, 2017
- Published online September 18, 2017.
- Fernando Alfonso, MDa,∗ (, )
- Javier Cuesta, MDa,
- María José Pérez-Vizcayno, MDb,c,
- Bruno García del Blanco, MDd,
- José Ramón Rumoroso, MDe,
- Francisco Bosa, MDf,
- Armando Pérez de Prado, MDg,
- Mónica Masotti, MDh,
- Raul Moreno, MDi,
- Angel Cequier, MDj,
- Hipólito Gutiérrez, MDk,
- Arturo García Touchard, MDl,
- José Ramón López-Mínguez, MDm,
- Javier Zueco, MDn,
- Vicens Martí, MDo,
- Maite Velázquez, MDp,
- César Morís, MDq,
- Teresa Bastante, MDa,
- Marcos García-Guimaraes, MDa,
- Fernando Rivero, MDa,
- Cristina Fernández, MDb,
- Interventional Cardiology Working Group of the Spanish Society of Cardiology
- aHospital Universitario de La Princesa, Madrid, Spain
- bHospital Universitario Clínico San Carlos, Madrid, Spain
- cFundación Interhospitalaria Investigación Cardiovascular, Madrid, Spain
- dHospital Universitario Vall d’Hebron, Barcelona, Spain
- eHospital de Galdakao, Vizcaya, Spain
- fHospital Universitario de Canarias, Santa Cruz de Tenerife, Spain
- gHospital Universitario de León, León, Spain
- hHospital Universitario Clinic de Barcelona, Barcelona, Spain
- iHospital Universitario La Paz, Madrid, Spain
- jHospital Universitario de Bellvitge, Barcelona, Spain
- kHospital Universitario de Valladolid, Valladolid, Spain
- lHospital Universitario de Puerta de Hierro-Majadahonda, Madrid, Spain
- mHospital Universitario Infanta Cristina, Badajoz, Badajoz, Spain
- nHospital Universitario Marqués de Valdecilla, Santander, Spain
- oHospital Universitario San Pau, Barcelona, Spain
- pHospital Universitario 12 de Octubre, Madrid, Spain
- qHospital Universitario Central de Asturias, Oviedo, Spain
- ↵∗Address for correspondence:
Dr. Fernando Alfonso, Departamento de Cardiología, Hospital Universitario de La Princesa, Instituto Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, Calle de Diego de León, 62, 28006 Madrid, Spain.
Objectives This study sought to assess the value of bioresorbable vascular scaffolds (BVS) in patients with in-stent restenosis (ISR).
Background Currently both drug-eluting stents (DES) and drug-eluting balloons (DEB) are recommended in patients with ISR. However, the value of BVS in this setting remains unclear.
Methods RIBS VI (Restenosis Intra-stent: drug-eluting Balloon vs everolimus-eluting Stent) was a prospective multicenter study (19 Spanish sites) that included 141 patients treated with BVS for either bare-metal stent (BMS) ISR or DES-ISR. Late angiography was scheduled at 6 to 9 months. Inclusion/exclusion criteria were similar to those used in the RIBS IV (patients with DES-ISR) and RIBS V (patients with BMS-ISR) trials, where DEB (n = 249) was compared with everolimus (EES)-DES (n = 249). Results of BVS in RIBS VI were compared with those obtained with DEB and EES in the RIBS IV and V trials.
Results On late angiography (n = 134; 95% of eligible) the in-segment minimal lumen diameter (primary endpoint) was 1.87 ± 0.5 mm, late lumen loss was 0.23 ± 0.4 mm, and restenosis rate was 11%. At 1-year follow-up (100% of patients) no patient died, 4 (2.8%) experienced a myocardial infarction, and 16 (11.3%) required target lesion revascularization. One patient (0.7%) who discontinued antiplatelet therapy experienced definitive BVS thrombosis. Freedom from cardiac death, myocardial infarction, and target lesion revascularization was 86%. The minimal lumen diameter at follow-up after BVS was similar to that obtained with DEB (1.88 ± 0.6 mm; p = NS) but smaller than that achieved after EES (2.16 ± 0.7 mm; p < 0.001). Likewise, target lesion revascularization rates after BVS were similar to those seen with DEB (10.4%) but higher than with EES (3.2%; p < 0.001). Results remained unchanged after adjusting for potential confounders in baseline characteristics.
Conclusions This study suggests the safety and efficacy of BVS in patients with ISR. In this challenging anatomic scenario BVS obtained late angiographic and clinical results similar to DEB but inferior to EES. (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment [RIBS VI]; NCT02672878)
All authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 9, 2017.
- Revision received June 22, 2017.
- Accepted June 22, 2017.
- 2017 American College of Cardiology Foundation