Long-term safety, efficacy of bioresorbable SES confirmed in CENTURY II trial

A bioresorbable polymer sirolimus-eluting stent appears to be as safe and effective as a permanent polymer everolimus-eluting stent out to 5 years, according to data from the CENTURY II trial.

The results were presented at EuroPCR and simultaneously published in EuroIntervention.

The single-blind, controlled, noninferiority trial enrolled patients with CAD scheduled for PCI at 58 centers in Europe, Japan and Korea. The researchers then randomly assigned patients to treatment with a bioresorbable polymer SES (Ultimaster, Terumo) or a permanent polymer EES (Xience, Abbott Vascular).

Endpoints included a device-oriented composite endpoint of target lesion failure (cardiac death, non-target-vessel MI and clinically driven target lesion revascularization); rate of target vessel failure (a composite of cardiac death, non-target-vessel MI and clinically driven target vessel revascularization); a patient-oriented composite endpoint (all deaths, all MI and all coronary revascularizations); and rates of bleeding and vascular complications according to Bleeding Academic Research Consortium criteria.

At 1 year, results demonstrated no significant difference between patients assigned to the bioresorbable SES (n = 551) and those assigned to the permanent polymer EES (n = 550) in all-cause death, any MI, revascularizations or any of the composite endpoints. There were also similar rates of stent thrombosis, bleeding and vascular complications.

Findings were consistent in the cohort with Japanese requirements, which included 362 patients treated with the bioresorbable polymer SES and 353 treated with the permanent polymer EES.

At 5 years, freedom from TLF was not significantly different in the bioresorbable polymer SES arm compared with the permanent polymer EES arm in the total population (90% vs. 91.1%, respectively; P = .54). Similarly, there were no differences in the composite safety endpoint (5.8% vs. 7.1%, respectively; P = .39) and the patient-oriented composite endpoint (24.1% vs. 25.6%, respectively; P = .57).

Rates of bleeding and vascular complications were also comparable for patients treated with the bioresorbable polymer SES vs. the permanent polymer EES (19.2% vs. 19.1%, respectively; P = .95). Importantly, the rate of very late stent thrombosis was low — 0.2% in both study arms.

Additionally, the researchers found no differences between study arms in the relative risk for TLF at 5 years in high-risk subgroups, including patients with diabetes, long lesions, bifurcation, high-risk ACS and multivessel disease.

“This report presents the longest available clinical data regarding efficacy and safety following bioresorbable polymer sirolimus-eluting stent implantation, showing that comparable clinical outcomes to the current benchmark device, a durable polymer everolimus-eluting stent, are maintained up to 5 years. Notably, observed rates of very late stent thrombosis are remarkably low, supporting the safe use of this thin-strut stent in routine clinical PCI practice,” the researchers wrote. – by Melissa Foster

References:

Romo AI, et al. Trial updates – DES trials. Presented at: EuroPCR; May 22-25, 2018; Paris.

Wijns W, et al. EuroIntervention. 2018;doi:10.4244/EIJ-D-18-00358.

Disclosures: CENTURY II was funded by Terumo Corporation. One author reports he receives personal fees from Abbott Biotronik, Boston Scientific and Medtronic. All other authors report no relevant financial disclosures.