Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes.

Abstract

Background: The first-generation bioresorbable scaffolds (BRS) have been associated with higher rates of device-related adverse outcomes in comparison to everolimus-eluting stents. We aimed to evaluate the efficacy and safety of the thinner-strut (100/125 μm) poly-L-lactic acid-based sirolimus-eluting Firesorb BRS in patients with de novo coronary lesions.

Methods: Patient-level data derived from 1205 patients in the FUTURE-II RCT (n = 215) and FUTURE-III registry (n = 990) were prospectively collected, pooled, and analyzed. The primary endpoint of 1-year target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization was also analyzed.

Results: At 1-year follow-up, the cumulative rate of TLF was 1.67%, with an upper 95% confidence interval of 2.57%, significantly lower than the objective performance criterion goal of 6.6% (P < 0.001). The rate of single TLF components was 0.42% for cardiac death, 0.92% for target vessel myocardial infarction, and 0.42% for ischemia-driven target lesion revascularization. The cumulative rate of POCE at 1 year was 3.34%. No patient experienced definite or probable device thrombosis during 1-year follow-up.

Conclusions: This pooled, patient-level analysis indicates that the thinner strut Firesorb BRS exhibits promising 1-year efficacy and safety profiles with regard to TLF. However, our findings are only applicable to non-complex lesions; large-scale randomized clinical trials powered to assess clinical endpoints are necessary to evaluate the strategy of Firesorb BRS compared to drug-eluting stents.

Trial registration: ClinicalTrials.gov Identifier: NCT02890160 and NCT03660202.