Clinical Trials
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Acronym: Nobori Biolimus-Eluting Versus Xience/Promus Everolimus-Eluting Stent Trial
Purpose: Analysis of 5-year outcomes of a biodegradable biolimus-eluting stent with a durable everolimus-eluting stent
Format: Randomized, parallel-assignment, open-label
Treatment Group: Biodegradable biolimus-eluting stent (Nobori, Terumo)
Control group: Durable polymer everolimus-eluting stent (Xience/Promus, Abbott Vascular)
Number of Participants: 3,235
Centers: 98
Primary Outcome(s):
- Primary safety endpoint was death or myocardial infarction
- Primary efficacy endpoint was target lesion revascularization
Follow-up: 5 years
Summary: Death or myocardial infarction occurred in 15.1% of patients assigned the biodegradable-polymer stent vs. 16.5% of those assigned the durable-polymer stent at 5 years (HR = 0.91; 95% CI, 0.75-1.11; P for noninferiority < .0001). Target lesion revascularization occurred in 9.8% of those in the biodegradable-polymer group vs. 9.3% of those in the durable-polymer group at 5 years (HR = 1.04; 95% CI, 0.8-1.34; P for noninferiority = .01). Cumulative incidences of death/myocardial infarction, target lesion revascularization and definite stent thrombosis between 1 year and 5 years were not different between the groups. The results were consistent across subgroups.
Original Publication:
Natsuaki M, et al. Eurointervention. 2018;doi:10.4244/EIJ-D-17-01050.
Link to Cardiology Today Article:
https://www.healio.com/cardiac-vascular-intervention/percutaneous-coronary-intervention/news/online/%7b813c56f4-f01f-4a03-bd24-058e938319bd%7d/next-biodegradable-des-remains-noninferior-to-durable-stent-at-5-years