Fernando Alfonso1, Javier Cuesta2, María José Pérez-Vizcayno3, Bruno García Del Blanco4, José Ramón Rumoroso5, Francisco Bosa6, Armando Pérez de Prado7, Mónica Masotti8, Raul Moreno9, Angel Cequier10, Hipólito Gutiérrez11, Arturo García Touchard12, José Ramón López-Mínguez13, Javier Zueco14, Vicens Martí15, Maite Velázquez16, César Morís17, Teresa Bastante2, Marcos García-Guimaraes2, Fernando Rivero2, Cristina Fernández18. 1. Hospital Universitario de La Princesa, Madrid, Spain. Electronic address: falf@hotmail.com. 2. Hospital Universitario de La Princesa, Madrid, Spain. 3. Hospital Universitario Clínico San Carlos, Madrid, Spain; Fundación Interhospitalaria Investigación Cardiovascular, Madrid, Spain. 4. Hospital Universitario Vall d'Hebron, Barcelona, Spain. 5. Hospital de Galdakao, Vizcaya, Spain. 6. Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain. 7. Hospital Universitario de León, León, Spain. 8. Hospital Universitario Clinic de Barcelona, Barcelona, Spain. 9. Hospital Universitario La Paz, Madrid, Spain. 10. Hospital Universitario de Bellvitge, Barcelona, Spain. 11. Hospital Universitario de Valladolid, Valladolid, Spain. 12. Hospital Universitario de Puerta de Hierro-Majadahonda, Madrid, Spain. 13. Hospital Universitario Infanta Cristina, Badajoz, Badajoz, Spain. 14. Hospital Universitario Marqués de Valdecilla, Santander, Spain. 15. Hospital Universitario San Pau, Barcelona, Spain. 16. Hospital Universitario 12 de Octubre, Madrid, Spain. 17. Hospital Universitario Central de Asturias, Oviedo, Spain. 18. Hospital Universitario Clínico San Carlos, Madrid, Spain.
Abstract
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).
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).
Authors: Jung Min Ahn; Duk Woo Park; Sung Jin Hong; Young Keun Ahn; Joo Yong Hahn; Won Jang Kim; Soon Jun Hong; Chang Wook Nam; Do Yoon Kang; Seung Yul Lee; Woo Jung Chun; Jung Ho Heo; Deok Kyu Cho; Jin Won Kim; Sung Ho Her; Sang Wook Kim; Sang Yong Yoo; Myeong Ki Hong; Seung Jea Tahk; Kee Sik Kim; Moo Hyun Kim; Yangsoo Jang; Seung Jung Park Journal: Korean Circ J Date: 2017-11-06 Impact factor: 3.243
Authors: Annunziata Nusca; Michele Mattia Viscusi; Francesco Piccirillo; Aurelio De Filippis; Antonio Nenna; Cristiano Spadaccio; Francesco Nappi; Camilla Chello; Fabio Mangiacapra; Francesco Grigioni; Massimo Chello; Gian Paolo Ussia Journal: Life (Basel) Date: 2022-03-08