5-Year Outcomes With a Novel Coronary Sirolimus-Eluting Bioresorbable Scaffold: The NeoVas Randomized Trial.

BACKGROUND: Previous trials have demonstrated increased 5-year risks for adverse clinical events after coronary artery implantation of poly-l-lactic acid-based bioresorbable scaffolds (BRS) compared with cobalt chromium (CoCr) everolimus-eluting stents (EES).

OBJECTIVES: The aim of this study was to evaluate the 5-year clinical outcomes of the novel sirolimus-eluting NeoVas BRS compared with CoCr EES.

METHODS: A total of 560 patients with single de novo native coronary artery lesions with reference vessel diameter 2.5 to 3.75 mm and lesion length ≤20 mm were randomized 1:1 to NeoVas BRS vs CoCr EES and followed for 5 years. Optical coherence tomography and fractional flow reserve were performed in a prespecified subgroup of 166 patients at 3-year follow-up.

RESULTS: The 5-year target lesion failure rates were 9.5% in the NeoVas group and 7.2% in the CoCr EES group (HR: 1.33; 95% CI: 0.74 to 2.38; P = 0.33). The 5-year rates of device thrombosis were not different between the groups (1.5% vs 0.7%, respectively; HR: 2.05; 95% CI: 0.37 to 11.16; P = 0.45). In a subset of patients in whom optical coherence tomography was performed at 3 years, it demonstrated that NeoVas was substantially absorbed (72.3% ± 13.2%). Fractional flow reserve was not significantly different between the 2 groups either postprocedure or at 3 years (0.89 ± 0.07 vs 0.90 ± 0.05, respectively; P = 0.11).

CONCLUSIONS: At 5-year follow-up, target lesion failure and stent thrombosis rates were comparable after NeoVas BRS and CoCr EES implantation in noncomplex lesions. However, comparability or the potential signs of harm of NeoVas BRS should be investigated in appropriately sized randomized trials in the future. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485).