Bioresorbable Vascular Scaffolds for Patients With In-Stent Restenosis The RIBS VI Study
Por:
Alfonso, F, Cuesta, J, Perez-Vizcayno, MJ, del Blanco, BG, Rumoroso, JR, Bosa, F, de Prado, AP, Masotti, M, Moreno, R, Cequier, A, Gutierrez, H, Touchard, AG, Lopez-Minguez, JR, Zueco, J, Marti, V, Velazquez, M, Moris, C, Bastante, T, Garcia-Guimaraes, M, Rivero, F, Fernandez, C
Publicada:
25 sep 2017
Resumen:
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. (C) 2017 by the American College of Cardiology Foundation.
Filiaciones:
Alfonso, F:
Hosp Univ La Princesa, Madrid, Spain
Cuesta, J:
Hosp Univ La Princesa, Madrid, Spain
Perez-Vizcayno, MJ:
Hosp Univ Clin San Carlos, Madrid, Spain
Fdn Interhosp Invest Cardio, Madrid, Spain
del Blanco, BG:
Hosp Univ Vall dHebron, Barcelona, Spain
Rumoroso, JR:
Hosp Galdakao, Vizcaya, Spain
Bosa, F:
Hosp Univ Canarias, Santa Cruz De Tenerife, Spain
de Prado, AP:
Hosp Univ Leon, Leon, Spain
Masotti, M:
Hosp Univ Clin Barcelona, Barcelona, Spain
Moreno, R:
Hosp Univ La Paz, Madrid, Spain
Cequier, A:
Hosp Univ Bellvitge, Barcelona, Spain
Gutierrez, H:
Hosp Univ Valladolid, Valladolid, Spain
Touchard, AG:
Hosp Univ Puerta Hierro Majadahonda, Madrid, Spain
Lopez-Minguez, JR:
Hosp Univ Infanta Cristina, Badajoz, Spain
Zueco, J:
Hosp Univ Marques de Valdecilla, Santander, Spain
Marti, V:
Hosp Univ San Pau, Barcelona, Spain
Velazquez, M:
Hosp Univ 12 Octubre, Madrid, Spain
Moris, C:
Hosp Univ Cent Asturias, Oviedo, Spain
Bastante, T:
Hosp Univ La Princesa, Madrid, Spain
Garcia-Guimaraes, M:
Hosp Univ La Princesa, Madrid, Spain
Rivero, F:
Hosp Univ La Princesa, Madrid, Spain
Fernandez, C:
Hosp Univ Clin San Carlos, Madrid, Spain
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