Predictors of clinical outcomes after coronary implantation of bioresorbable polymer sirolimus-eluting Ultimaster stents in all-comers: A report of 1,727 cases.

BACKGROUND

Although bioresorbable polymer sirolimus-eluting Ultimaster stents (BP-SESs) are likely useful for percutaneous coronary interventions (PCIs), the clinical data from real-world cases are insufficient. Furthermore, the predictors of adverse clinical outcomes after BP-SES implantation have not been fully investigated.

OBJECTIVES

This study evaluated the 1-year clinical outcomes after BP-SES implantation in real-world PCI cases and identified the predictors of adverse outcomes.

METHODS

In this single-center, all-comers study, we consecutively implanted BP-SESs in all patients who required coronary stents between October 2015 and August 2016. We conducted a clinical follow-up assessment of these patients.

RESULTS

The sample comprised 1,727 patients; 67% were men, the mean age was 72 years, and 37% had diabetes. Of the 2,085 lesions detected, 88% were type B2/C lesions, 4% were chronic total occlusions (CTOs), and 23% were bifurcations. The cumulative incidences of target lesion revascularization (TLR) and target lesion failure (TLF) at 1-year were 2.4% and 5.2%, respectively. A multivariate analysis revealed that hemodialysis (HD) (hazard ratio [HR] 8.40) and CTO (HR 4.21) were independent predictors of TLR. Stent sizes ≤2.5 mm were not associated with either TLR or TLF.

CONCLUSIONS

The current study indicates that patients on HD and those with CTO were more likely to experience adverse clinical outcomes after BP-SES implantation. In contrast, small vessel diameter was not significantly related to adverse outcomes. The 1-year clinical outcomes after BP-SES implantation were found to be favorable among all-comer PCI cases, including patients receiving HD and those with in-stent restenosis.