Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials

Background-Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. Methods and Results-A pooled analysis of...

Descripción completa

Detalles Bibliográficos
Autores: Alfonso, F, Perez-Vizcayno, MJ, del Blanco, BG, Garcia-Touchard, A, Lopez-Minguez, JR, Masotti, M, Zueco, J, Melgares, R, Mainar, V, Moreno, R, Dominguez, A, Sanchis, J, Bethencourt, A, Moreu, J, Cequier, A, Marti, V, Otaegui, I, Bastante, T, Gonzalo, N, Jimenez-Quevedo, P, Cardenas, A, Fernandez, C
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2016
País:España
Institución:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p14369
Acceso en línea:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=14369
Access Level:acceso abierto
Palabra clave:angiography
drug-eluting stents
everolimus
metal
regression analysis
restenosis
Descripción
Sumario:Background-Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. Methods and Results-A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22 +/- 0.5 versus 2.38 +/- 0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03 +/- 0.7 versus 2.36 +/- 0.6 mm, P<0.001) and diameter stenosis (23 +/- 22 versus 13 +/- 17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at followup remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. Conclusions-This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DESISR than in those with bare-metal stent ISR.