Fernando Alfonso1, Maria Jose Pérez-Vizcayno2, Alberto Cárdenas2, Bruno García Del Blanco3, Bernhard Seidelberger4, Andrés Iñiguez5, Manuel Gómez-Recio6, Mónica Masotti7, M Teresa Velázquez8, Juan Sanchís9, Arturo García-Touchard10, Javier Zueco11, Armando Bethencourt12, Rafael Melgares13, Angel Cequier14, Antonio Dominguez15, Vicente Mainar16, José R López-Mínguez17, José Moreu18, Vicens Martí19, Raúl Moreno20, Pilar Jiménez-Quevedo2, Nieves Gonzalo2, Cristina Fernández2, Carlos Macaya2. 1. Hospital Universitario de La Princesa, Madrid, Spain; Hospital Universitario Clínico San Carlos, Madrid, Spain. Electronic address: falf@hotmail.com. 2. Hospital Universitario Clínico San Carlos, Madrid, Spain. 3. Hospital Universitario Vall d'Hebron, Barcelona, Spain. 4. Hospital Universitario de La Princesa, Madrid, Spain. 5. Complejo Hospitalario Universitario de Vigo, Pontevedra, Spain. 6. Hospital Universitario de Torrecárdenas, Almería, Spain. 7. Hospital Universitario Clinic de Barcelona, Barcelona, Spain. 8. Hospital Universitario 12 de Octubre, Madrid, Spain. 9. Hospital Universitario Clínico de Valencia, Valencia, Spain. 10. Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain. 11. Hospital Universitario Marqués de Valdecilla, Santander, Spain. 12. Hospital Universitario Son Espases, Palma de Mallorca, Spain. 13. Hospital Universitario Virgen de las Nieves, Granada, Spain. 14. Hospital Universitario de Bellvitge, Barcelona, Spain. 15. Hospital Universitario Virgen de la Victoria, Málaga, Spain. 16. Hospital Universitario de Alicante, Alicante, Spain. 17. Hospital Universitario Infanta Cristina Badajoz, Badajoz, Spain. 18. Hospital Universitario Virgen de la Salud Toledo, Toledo, Spain. 19. Hospital Universitario Sant Pau, Barcelona, Spain. 20. Hospital Universitario La Paz, Madrid, Spain.
Abstract
OBJECTIVES: This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR). BACKGROUND: Treatment of patients with ISR remains a challenge. METHODS: This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up. RESULTS: A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups. CONCLUSIONS: In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953).
RCT Entities:
OBJECTIVES: This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR). BACKGROUND: Treatment of patients with ISR remains a challenge. METHODS: This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up. RESULTS: A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups. CONCLUSIONS: In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953).
Authors: Guy F A Prado; Expedito E Ribeiro; Pedro H M C Melo; Fabio A Pinton; Antonio Esteves-Filho; Celso K Takimura; Jose Mariani; Luiz J Kajita; Gilberto Marchiori; Breno de Alencar Araripe Falcao; Micheli Z Galon; Paulo R Soares; Silvio Zalc; Pedro A Lemos Journal: Cardiovasc Diagn Ther Date: 2015-12