Study finds no significant difference in safety and efficacy outcomes of biodegradable versus durable polymer DES

The study found that there was no significant difference in the efficacy and safety outcomes for biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at one year and up to 10 years after stent implantation.

Considering that no randomized trials reported clinical outcomes of BP-BES and DP-EES at ten years, Masahiro Natsuaki, Department of Cardiovascular Medicine, Saga University, Saga, Japan, and colleagues aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES.

The randomized NEXT trial (NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent) was designed originally to assess the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at one year. They also assessed the primary safety endpoint of myocardial infarction (MI) or death at three years. Clinical outcomes were compared from 1 year after stent implantation to 19 years between patients with DP-EES and BP-BES in this extended follow-up study.

The NEXT trial enrolled 3,241 patients from 98 centres in Japan from May to October 2011. The study population comprised 2,417 patients (1,204 patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. 87.5% of patients achieved complete 10-year follow-up.

Following were the key findings:

• The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04).
• TLR occurred in 15.9% of patients in the BP-BES group and 14.1% of the DP-EES group (HR 1.12).
• In a landmark analysis at one year, the cumulative incidences of death or MI and TLR were not significantly different between the two groups.

"BP-BES's safety and efficacy outcomes were not significantly different from those for DP-EES at one year and up to 10 years after stent implantation," the researchers concluded.

Reference:

The study "Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomized NEXT Trial" was published in EuroIntervention. DOI: 10.4244/EIJ-D-23-00076