Randomised comparison of a biodegradable polymer ultra-thin sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients with de novo native coronary artery lesions: the meriT-V trial
EuroIntervention 2018;14:e1207-e1214 published online September 2018 published online e-edition December 2018. DOI: 10.4244/EIJ-D-18-00762
1. Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil; 2. University Clinic of Cardiology, Skopje, FYR of Macedonia; 3. Isala Hospital, Zwolle, the Netherlands; 4. Royal Bournemouth Hospital, Bournemouth, United Kingdom; 5. Latvian Research Institute of Cardiology, Riga, Latvia; 6. ICRC, St. Anne’s University Hospital, Brno, Czech Republic; 7. University Hospital Clinic de Barcelona, Barcelona, Spain; 8. Manchester Heart Centre, Manchester, United Kingdom; 9. Heart Institute-InCor, University of Sao Paulo, Sao Paulo, Brazil; 10. American Heart of Poland S.A., Katowice, Poland; 11. Eurolatino Pesquisas Médicas, Uberlândia, Brazil; 12. New York University School of Medicine, New York, NY, USA
Aims: The aim of this study was to evaluate the safety and efficacy of the BioMime sirolimus-eluting coronary stent (SES) compared to the XIENCE family of everolimus-eluting coronary stents (EES) in the treatment of patients with de novo native coronary artery lesions.
Methods and results: The meriT-V is a prospective, multicentre, randomised, open-label, active-controlled, 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 nine-month follow-up. The major adverse cardiac events rate was numerically lower in the 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 a durable polymer EES (XIENCE) at nine-month follow-up. Further studies powered for clinical endpoints are needed.