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).

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.