Study design
A prospective, international, single-blind trial conducted across North America, Europe and Japan. Participants were assigned to Supreme DES (1,086 patients) or a durable-polymer everolimus-eluting stent comparator (543 patients).
Primary outcome
Target-lesion failure at 12 months occurred in 5.4% of the Supreme DES group and 5.1% of the comparator group. The absolute risk difference was 0.32% (95% CI, -1.87 to 2.50), meeting the prespecified non-inferiority endpoint (Pnon-inferiority=0.002).
Interpretation
The publication concluded that Supreme DES was non-inferior to the durable-polymer everolimus-eluting stent comparator for the primary endpoint. No significant between-group differences were reported for device success, clinically driven target-lesion revascularisation or stent thrombosis at 12 months.
Important context
The paper also reported a higher rate of combined clinically and non-clinically driven target-lesion revascularisation with Supreme DES at 12 months. The complete publication should be reviewed for endpoint definitions, limitations and disclosures.