Mid-term outcome of biolimus-eluting stents with biodegradable polymer: results from a multinational prospective 'all-comers' registry.

BACKGROUND: The Nobori biolimus-eluting stent (BES) is a biodegradable polymer drug-eluting stent (DES). Several studies have shown its noninferiority in comparison with durable polymer DES.

AIM: We sought to investigate the efficacy and the safety of Nobori BES in an all-comer population undergoing a percutaneous coronary intervention.

PATIENTS AND METHODS: A total of 12 912 patients with 19 947 coronary lesions, undergoing percutaneous coronary intervention with Nobori BES implantation at 200 centres around the world between August 2010 and December 2015, were included in this prospective registry. Patients were stratified into four groups according to the total stent length, with cutoffs at 18, 24 and 28 mm. The primary endpoint was the occurrence of major adverse cardiac events defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization at 1 year.

RESULTS: At 1 year, the major adverse cardiac events rate was the highest (4.6%) in the fourth quartile of stent length (>28 mm), whereas the overall rate of the primary endpoint in the all cohort was 3.5%. Both target lesion revascularization and target vessel revascularization rates were significantly higher in patients with longer stent length was implanted (all P<0.05). The incidence of definite and probable stent thrombosis at 1 year was 0.5% in all cohort and similar across the four groups (varying from 0.4 to 0.7%, all P=NS).

CONCLUSION: Our data confirmed the efficacy and the safety of the Nobori BES in routine clinical practice. Longer stent length is associated with a higher risk of adverse cardiac events, and yet, this risk is comparable with that of other DES.