Aims: This study reports the 12-month clinical outcomes of the LEADERS clinical trial which compared a biolimus eluting stent with a biodegradable polymer (BES) to a sirolimus eluting stent with a durable polymer (SES).
Methods and results: The multicentre LEADERS trial employed an all-comers approach to recruit 1,707 patients who were randomised to treatment with either BES (n=857) or SES (n=850) in a non-inferiority design. The primary clinical endpoint of this study was a composite of cardiac death, myocardial infarction and clinical-indicated target vessel revascularisation. Follow-up was obtained in 97.6% of patients. At 12 months, BES remained non-inferior compared to SES for the primary endpoint (BES 10.6% vs. SES 12.0%, HR:0.88, 95% CI:0.66-1.17, p=0.37). Rates of cardiac death (2.1% vs. 2.7%, HR:0.77, 95% CI:0.42-1.44, p=0.42), MI (5.8% vs. 4.6%, HR:1.27, 95% CI:0.84-1.94, p=0.26) and clinically-indicated target vessel revascularisation (5.8% vs. 7.1%, HR:0.82, 95%CI:0.56-1.19, p=0.29) were similar for BES and SES. Similarly, there was no difference in the incidence of definite stent thrombosis at 12 months.
Conclusions: These findings support the safety and efficacy of the BES stent with a biodegradable polymer at 12-month clinical follow-up, and suggest it is a suitable alternative to the SES stent with a durable polymer.