Lorenzo Azzalini1, Gennaro Giustino2, Soledad Ojeda2, Antonio Serra2, Alessio La Manna2, Hung Q Ly2, Barbara Bellini2, Susanna Benincasa2, Jorge Chavarría2, Livia L Gheorghe2, Giovanni Longo2, Eligio Miccichè2, Guido D'Agosta2, Fabien Picard2, Manuel Pan2, Corrado Tamburino2, Azeem Latib2, Mauro Carlino2, Alaide Chieffo2, Antonio Colombo2. 1. From the Interventional Cardiology Unit, Cardio-Thoraco-Vascular Department, San Raffaele Scientific Institute, Milan, Italy (L.A., B.B., S.B., A.L., M.C., A. Chieffo, A. Colombo); Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (G.G.); Department of Cardiology, Reina Sofía Hospital, University of Córdoba (IMIBIC), Spain (S.O., J.C., M.P.); Interventional Cardiology Unit, Division of Cardiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (A.S., L.L.G.); Division of Cardiology, Ferrarotto Hospital and Policlinico Vittorio Emanuele University Hospitals, Catania, Italy (A.L.M., G.L., E.M., G.D., C.T.); and Interventional Cardiology Division, Department of Medicine, Montreal Heart Institute, University of Montreal, QC, Canada (H.Q.L., F.P.). azzalini.lorenzo@hsr.it. 2. From the Interventional Cardiology Unit, Cardio-Thoraco-Vascular Department, San Raffaele Scientific Institute, Milan, Italy (L.A., B.B., S.B., A.L., M.C., A. Chieffo, A. Colombo); Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (G.G.); Department of Cardiology, Reina Sofía Hospital, University of Córdoba (IMIBIC), Spain (S.O., J.C., M.P.); Interventional Cardiology Unit, Division of Cardiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (A.S., L.L.G.); Division of Cardiology, Ferrarotto Hospital and Policlinico Vittorio Emanuele University Hospitals, Catania, Italy (A.L.M., G.L., E.M., G.D., C.T.); and Interventional Cardiology Division, Department of Medicine, Montreal Heart Institute, University of Montreal, QC, Canada (H.Q.L., F.P.).
Abstract
BACKGROUND: There is little evidence regarding the efficacy and safety of bioresorbable scaffolds (BRS) for the percutaneous treatment of chronic total occlusions. METHODS AND RESULTS: We performed a multicenter registry of consecutive chronic total occlusion patients treated with BRS (Absorb; Abbott Vascular) and second-generation drug-eluting stents (DES) at 5 institutions. Long-term target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-lesion revascularization) was the primary end point. Inverse probability of treatment weight-adjusted Cox regression was used to account for pretreatment differences between the 2 groups. A total of 537 patients (n=153 BRS; n=384 DES) were included. BRS patients were younger and had lower prevalence of comorbidities. Overall mean Japan-Chronic Total Occlusion (J-CTO) score was 1.43±1.16, with no differences between groups. Procedural success was achieved in 99.3% and 96.6% of BRS- and DES-treated patients, respectively (P=0.07). At a median follow-up of 703 days, there were no differences in target-vessel failure between BRS and DES (4.6% versus 7.7%; P=0.21). By adjusted Cox regression analysis, there were still no significant differences between BRS and DES (hazard ratio, 1.54; 95% confidence interval, 0.69-3.72; P=0.34). However, secondary analyses suggested a signal toward higher ischemia-driven target-lesion revascularization with BRS. CONCLUSIONS: Implantation of BRS versus second-generation DES in chronic total occlusion was associated with similar risk of target-vessel failure at long-term follow-up. However, a signal toward increased ischemia-driven target-lesion revascularization with BRS was observed. Large randomized studies should confirm these findings.
BACKGROUND: There is little evidence regarding the efficacy and safety of bioresorbable scaffolds (BRS) for the percutaneous treatment of chronic total occlusions. METHODS AND RESULTS: We performed a multicenter registry of consecutive chronic total occlusionpatients treated with BRS (Absorb; Abbott Vascular) and second-generation drug-eluting stents (DES) at 5 institutions. Long-term target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-lesion revascularization) was the primary end point. Inverse probability of treatment weight-adjusted Cox regression was used to account for pretreatment differences between the 2 groups. A total of 537 patients (n=153 BRS; n=384 DES) were included. BRS patients were younger and had lower prevalence of comorbidities. Overall mean Japan-Chronic Total Occlusion (J-CTO) score was 1.43±1.16, with no differences between groups. Procedural success was achieved in 99.3% and 96.6% of BRS- and DES-treated patients, respectively (P=0.07). At a median follow-up of 703 days, there were no differences in target-vessel failure between BRS and DES (4.6% versus 7.7%; P=0.21). By adjusted Cox regression analysis, there were still no significant differences between BRS and DES (hazard ratio, 1.54; 95% confidence interval, 0.69-3.72; P=0.34). However, secondary analyses suggested a signal toward higher ischemia-driven target-lesion revascularization with BRS. CONCLUSIONS: Implantation of BRS versus second-generation DES in chronic total occlusion was associated with similar risk of target-vessel failure at long-term follow-up. However, a signal toward increased ischemia-driven target-lesion revascularization with BRS was observed. Large randomized studies should confirm these findings.
Authors: Luigi Di Serafino; Plinio Cirillo; Tullio Niglio; Francesco Borgia; Bruno Trimarco; Giovanni Esposito; Eugenio Stabile Journal: World J Cardiol Date: 2017-08-26
Authors: Luiz Fernando Ybarra; Marcelo J C Cantarelli; Viviana M G Lemke; Alexandre Schaan de Quadros Journal: Arq Bras Cardiol Date: 2018-05 Impact factor: 2.000