Fernando Alfonso1, María José Pérez-Vizcayno2, Bruno García Del Blanco2, Arturo García-Touchard2, José-Ramón López-Mínguez2, Mónica Masotti2, Javier Zueco2, Rafael Melgares2, Vicente Mainar2, Raul Moreno2, Antonio Domínguez2, Juan Sanchís2, Armando Bethencourt2, José Moreu2, Angel Cequier2, Vicens Martí2, Imanol Otaegui2, Teresa Bastante2, Nieves Gonzalo2, Pilar Jiménez-Quevedo2, Alberto Cárdenas2, Cristina Fernández2. 1. From the Hospital Universitario de La Princesa, Madrid, Spain (F.A., T.B.); Hospital Universitario Clínico San Carlos, Madrid, Spain (M.J.P.-V., N.G., P.J.-Q., A. Cárdenas, C.F.); Fundación Interhospitalaria Investigación Cardiovascular, Madrid, Spain (M.J.P.-V.); Hospital Universitario Vall d'Hebron, Barcelona, Spain (B.G.d.B., I.O.); Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain (A.G.-T.); Hospital Universitario Infanta Cristina, Badajoz, Spain (J.-R.L.-M.); Hospital Universitario Clinic de Barcelona, Spain (M.M.); Hospital Universitario Marqués de Valdecilla, Santander, Spain (J.Z.); Hospital Universitario Virgen de las Nieves, Granada, Spain (R. Melgares); Hospital Universitario de Alicante, Spain (V. Mainar); Hospital Universitario La Paz, Madrid, Spain (R. Moreno); Hospital Universitario Virgen de la Victoria, Málaga, Spain (A.D.); Hospital Universitario Clínico de Valencia, Spain (J.S.); Hospital Universitario Son Espases, Palma de Mallorca, Spain (A.B.); Hospital Universitario Virgen de la Salud Toledo, Spain (J.M.); Hospital Universitario de Bellvitge, Barcelona, Spain (A. Cequier); and Hospital Universitario de San Pau, Barcelona, Spain (V. Martí). falf@hotmail.com. 2. From the Hospital Universitario de La Princesa, Madrid, Spain (F.A., T.B.); Hospital Universitario Clínico San Carlos, Madrid, Spain (M.J.P.-V., N.G., P.J.-Q., A. Cárdenas, C.F.); Fundación Interhospitalaria Investigación Cardiovascular, Madrid, Spain (M.J.P.-V.); Hospital Universitario Vall d'Hebron, Barcelona, Spain (B.G.d.B., I.O.); Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain (A.G.-T.); Hospital Universitario Infanta Cristina, Badajoz, Spain (J.-R.L.-M.); Hospital Universitario Clinic de Barcelona, Spain (M.M.); Hospital Universitario Marqués de Valdecilla, Santander, Spain (J.Z.); Hospital Universitario Virgen de las Nieves, Granada, Spain (R. Melgares); Hospital Universitario de Alicante, Spain (V. Mainar); Hospital Universitario La Paz, Madrid, Spain (R. Moreno); Hospital Universitario Virgen de la Victoria, Málaga, Spain (A.D.); Hospital Universitario Clínico de Valencia, Spain (J.S.); Hospital Universitario Son Espases, Palma de Mallorca, Spain (A.B.); Hospital Universitario Virgen de la Salud Toledo, Spain (J.M.); Hospital Universitario de Bellvitge, Barcelona, Spain (A. Cequier); and Hospital Universitario de San Pau, Barcelona, Spain (V. Martí).
Abstract
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 follow-up 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 DES-ISR than in those with bare-metal stent ISR. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940.
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 follow-up 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 DES-ISR than in those with bare-metal stent ISR. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940.