One-Year Results Published From NEXT Trial of Terumo's Nobori Biolimus-Eluting Stent

July 9, 2013—In the Journal of the American College of Cardiology (JACC), Masahiro Natsuaki, MD, et al published results from the NEXT trial, which was designed to evaluate the noninferiority of a biolimus-eluting stent (BES) relative to an everolimus-eluting stent (EES) in terms of target lesion revascularization (TLR) at 1 year (2013;62:181–190).

The study results were first presented at the American College of Cardiology's 62nd annual scientific session in San Francisco, California, on March 10, 2013. The NEXT Trial was conducted in Japan at the Kyoto University Graduate School of Medicine's Department of Cardiovascular Medicine under the direction of Principal Investigator Takeshi Morimoto, MD.

The NEXT study is evaluating the Nobori BES, which features a biodegradable coating, from Terumo Interventional Systems (Somerset, NJ) versus a market-leading EES, the Xience V (Abbott, Santa Clara, CA) or the Promus (Boston Scientific Corporation, Natick, MA). Promus is an identical, private-label version of Xience V, which Abbott supplies to Boston Scientific in Japan and some other commercial markets. The Xience V/Promus received Japanese regulatory approval for the treatment of coronary artery disease in November 2009. The Nobori stent was approved in Japan in 2011. Terumo's global headquarters are located in Tokyo, Japan.

As summarized in JACC, the NEXT trial is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BES with EES. Between May and October 2011, 3,235 patients were randomly assigned to receive either BES (n = 1,617) or EES (n = 1,618).

The investigators reported that at 1 year, the primary efficacy endpoint of TLR occurred in 67 patients (4.2%) in the BES group and in 66 patients (4.2%) in the EES group, demonstrating noninferiority of BES relative to EES (P for noninferiority < .0001; P for superiority = .93). The cumulative incidence of definite stent thrombosis was low and similar between the two groups (0.25% vs 0.06%; P = .18).

Additionally, an angiographic substudy enrolling 528 patients (BES: n = 263; EES: n = 265) demonstrated noninferiority of BES relative to EES regarding the primary angiographic endpoint of in-segment late loss (0.03 ± 0.39 mm vs 0.06 ± 0.45 mm; P for noninferiority < .0001; P for superiority = .52) at 266 ± 43 days after stent implantation.

The NEXT investigators concluded that 1-year clinical and angiographic outcomes after BES implantation were noninferior to and not different from that after EES implantation in a mostly stable coronary artery disease population. One-year clinical outcomes after both BES and EES use were excellent, with a low rate of TLR and an extremely low rate of stent thrombosis, stated the investigators in JACC.