1. Procedural and Long-Term Outcomes of Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions: The BONITO Registry (Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions)
- Author
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Barbara Bellini, Eligio Miccichè, Susanna Benincasa, Antonio Colombo, Azeem Latib, Manuel Pan, Fabien Picard, Hung Q. Ly, Alessio La Manna, Jorge Chavarría, Livia L. Gheorghe, Soledad Ojeda, Gennaro Giustino, Alaide Chieffo, Guido D'Agosta, Antonio Serra, Corrado Tamburino, Mauro Carlino, Giovanni Longo, Lorenzo Azzalini, [Azzalini, Lorenzo] Ist Sci San Raffaele, Cardiothoracovasc Dept, Intervent Cardiol Unit, Milan, Italy, [Bellini, Barbara] Ist Sci San Raffaele, Cardiothoracovasc Dept, Intervent Cardiol Unit, Milan, Italy, [Benincasa, Susanna] Ist Sci San Raffaele, Cardiothoracovasc Dept, Intervent Cardiol Unit, Milan, Italy, [Latib, Azeem] Ist Sci San Raffaele, Cardiothoracovasc Dept, Intervent Cardiol Unit, Milan, Italy, [Carlino, Mauro] Ist Sci San Raffaele, Cardiothoracovasc Dept, Intervent Cardiol Unit, Milan, Italy, [Chieffo, Alaide] Ist Sci San Raffaele, Cardiothoracovasc Dept, Intervent Cardiol Unit, Milan, Italy, [Colombo, Antonio] Ist Sci San Raffaele, Cardiothoracovasc Dept, Intervent Cardiol Unit, Milan, Italy, [Giustino, Gennaro] Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, Intervent Cardiovasc Res & Clin Trials, New York, NY 10029 USA, [Ojeda, Soledad] Univ Cordoba, IMIBIC, Reina Sofia Hosp, Dept Cardiol, E-14071 Cordoba, Spain, [Chavarria, Jorge] Univ Cordoba, IMIBIC, Reina Sofia Hosp, Dept Cardiol, E-14071 Cordoba, Spain, [Pan, Manuel] Univ Cordoba, IMIBIC, Reina Sofia Hosp, Dept Cardiol, E-14071 Cordoba, Spain, [Serra, Antonio] Hosp Santa Creu & Sant Pau, Div Cardiol, Intervent Cardiol Unit, Barcelona, Spain, [Gheorghe, Livia L.] Hosp Santa Creu & Sant Pau, Div Cardiol, Intervent Cardiol Unit, Barcelona, Spain, [La Manna, Alessio] Ferrarotto Hosp, Div Cardiol, Catania, Italy, [Longo, Giovanni] Ferrarotto Hosp, Div Cardiol, Catania, Italy, [Micciche, Eligio] Ferrarotto Hosp, Div Cardiol, Catania, Italy, [D'Agosta, Guido] Ferrarotto Hosp, Div Cardiol, Catania, Italy, [Tamburino, Corrado] Ferrarotto Hosp, Div Cardiol, Catania, Italy, [La Manna, Alessio] Policlin Vittorio Emanuele Univ Hosp, Catania, Italy, [Longo, Giovanni] Policlin Vittorio Emanuele Univ Hosp, Catania, Italy, [Micciche, Eligio] Policlin Vittorio Emanuele Univ Hosp, Catania, Italy, [D'Agosta, Guido] Policlin Vittorio Emanuele Univ Hosp, Catania, Italy, [Tamburino, Corrado] Policlin Vittorio Emanuele Univ Hosp, Catania, Italy, [Ly, Hung Q.] Univ Montreal, Montreal Heart Inst, Dept Med, Intervent Cardiol Div, Montreal, PQ H3C 3J7, Canada, and [Picard, Fabien] Univ Montreal, Montreal Heart Inst, Dept Med, Intervent Cardiol Div, Montreal, PQ H3C 3J7, Canada
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Male ,Time Factors ,medicine.medical_treatment ,Myocardial Infarction ,Comorbidity ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,Coronary Angiography ,regression analysis ,Trial ,Coronary-artery-disease ,0302 clinical medicine ,Coated Materials, Biocompatible ,Risk Factors ,Absorbable Implants ,030212 general & internal medicine ,Myocardial infarction ,Registries ,Hazard ratio ,drug-eluting stents ,Drug-Eluting Stents ,Middle Aged ,follow-up studies ,comorbidity ,myocardial infarction ,Treatment Outcome ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,Intervention ,Revascularization ,Prosthesis Design ,03 medical and health sciences ,Percutaneous Coronary Intervention ,Internal medicine ,medicine ,Humans ,Propensity Score ,Aged ,Proportional Hazards Models ,Chi-Square Distribution ,business.industry ,Proportional hazards model ,fungi ,Percutaneous coronary intervention ,Thrombosis ,Cardiovascular Agents ,Vascular scaffolds ,medicine.disease ,Confidence interval ,Logistic Models ,Metallic stents ,Coronary Occlusion ,Coronary occlusion ,Cardiovascular agent ,Chronic Disease ,Multivariate Analysis ,business - 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.