NEXT: Biolimus-eluting stent comparable to everolimus-eluting stent at 1 year

SAN FRANCISCO — One-year results from the NEXT trial indicate that the Nobori biolimus-eluting stent appears to be as efficacious as everolimus-eluting stents.

“One-year clinical outcome after both biolimus-eluting stent and everolimus-eluting stent use was excellent with low rate of target lesion revascularization and very low rate of stent thrombosis,” Masahiro Natsuaki, MD, of the Kyoto University Graduate School of Medicine in Japan, said during a late-breaking clinical trial session at the American College of Cardiology Scientific Sessions.

Masahiro Natsuaki

In the large, prospective, multicenter, randomized, open-label trial, Natsuaki and colleagues randomly assigned 3,235 patients (mean age, 69 years; 46% diabetes; 51% prior PCI) to receive the Nobori biolimus-eluting stent (Terumo; BES; n=1,617) or an everolimus-eluting stent (EES; n=1,618). They also included 263 patients from the BES group and 265 patients from the EES group in an angiographic substudy to assess in-segment late loss at 8 to 12 months.

According to the data presented, BES met its primary endpoint of noninferiority in terms of target lesion revascularization at 1 year (4.2% for both groups; P<.0001). Cumulative incidence of definite stent thrombosis was very low and similar between the BES and EES groups (0.25% vs. 0.06%; P=.18). The researchers also found no significant differences in cumulative incidence of target vessel revascularization, all-cause death or MI, and no significant treatment effect across subgroups.

Natsuaki reported that the acute device success rate was very high among patients who received a BES (99.8%) and comparable with the rate observed among patients who received an EES (99.7%; P=.34). Similarly, the patient success rate was 96.6% for in the BES group and 96.7% in the EES group (P=.92).

Results from the angiographic substudy showed similar rates of restenosis in the BES and EES groups, with an in-segment late loss of 0.3 mm in BES patients vs. 0.06 mm in EES patients at 8- to 12-month follow-up (P<.0001).

“In this large-scale, randomized, controlled trial, BES was demonstrated to be noninferior to EES with respect to 1-year target lesion revascularization rate and 8 to 12 months angiographic in-segment late loss,” Natsuaki said. “Long-term follow-up of the biodegradable polymer BES compared with the durable polymer EES will provide crucial implications for the future development of metallic drug-eluting stents.” – by Melissa Foster

For more information:

Natsuaki M. Late-breaking clinical trials II: Interventional. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.

Disclosure: Terumo Japan sponsored the NEXT trial. Natsuaki reports no relevant financial disclosures.