Randomized Comparison of Biodegradable Polymer Ultra-thin Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Coronary Stent in Patients with De Novo Native Coronary Artery Lesions: The meriT-V Trial.

AIMS: To evaluate the safety and efficacy of BioMime™ sirolimus-eluting coronary stent (SES) compared to the XIENCE family everolimus-eluting coronary stent (EES) in the treatment of patients with de novo native coronary artery lesions.

METHODS AND RESULTS: The meriT-V is a prospective, multicenter, randomized, open-label, active-controlled, and non-inferiority trial. A total of 256 patients with up to two de novo native coronary artery lesions were enrolled and randomly assigned (2:1) to BioMime SES or XIENCE EES. BioMime SES was non-inferior to XIENCE EES for the primary endpoint of in-stent late lumen loss (0.15±0.27 mm vs. 0.15±0.29 mm; difference: -0.006 mm; 95% confidence interval: -0.085 to 0.072; p=0.87; p for non-inferiority <0.0001) at 9-month follow-up. The major adverse cardiac event rate was numerically lower in BioMime SES group (2.98% vs. 7.14%; p=0.13), driven by a statistically significant lower risk of any myocardial infarction (0.60% vs. 4.76%; p=0.03), when compared with the XIENCE EES group. There was no difference in target vessel myocardial infarction (p=0.62) between the groups. There was no definite or probable stent thrombosis in either group.

CONCLUSIONS: In the treatment of de novo native coronary artery lesions, the biodegradable polymer ultra-thin SES (BioMime) was non-inferior to durable polymer EES (XIENCE) at 9-month follow-up. Further studies powered for clinical endpoints are needed.