Terumo's Nobori Biolimus Stent Shows Equivalence to Everolimus Stent at 1 Year

March 10, 2013—The American College of Cardiology announced data from the NEXT study, which is evaluating the Nobori biolimus-eluting stent (BES) from Terumo Interventional Systems, Inc. (Somerset, NJ) versus a market-leading everolimus-eluting stent (EES). The study was presented at the American College of Cardiology's (ACC) 62nd annual scientific session in San Francisco.

According to the ACC, the Nobori stent, which features a biodegradable coating, demonstrated 1-year results that were statistically comparable to the Xience V EES (Abbott Vascular, Santa Clara, CA) or the Promus EES (Boston Scientific Corporation, Natick, MA). Promus is an identical, private-label version of Xience V, which Abbott Vascular 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. The NEXT study was sponsored by Terumo, whose global headquarters are located in Tokyo, Japan, noted the ACC.

“Our results suggest that BES could be the alternative to EES, a current gold standard second-generation drug-eluting stent,” commented Masahiro Natsuaki, MD, in the ACC press release. “Because the polymer will completely disappear 1 year after stent insertion, at least a 3-year timeframe will be needed to demonstrate the potential advantage of BES over other available stents.” Dr. Natsuaki is with Kyoto University Graduate School of Medicine's Department of Cardiovascular Medicine.

As summarized in the ACC announcement, the NEXT is a large, multicenter, randomized, open-label trial that enrolled 3,235 patients to either Nobori or the Xience/Promus. The study enrolled all patients scheduled for implantation of a drug-eluting stent at 98 participating centers in Japan, with no exclusion criteria.

The BES met the goal of noninferiority to the EES in target lesion revascularization at 1 year, with target lesion revascularization in 67 BES patients versus 66 EES patients (4.2% or both groups). The cumulative rates of definite stent thrombosis were low and similar at 0.25% in the BES group versus 0.06% in the EES group. In a substudy of 528 patients, angiographic imaging confirmed similar rates of restenosis in both study arms, expressed as late lumen loss at 266 days ± 43 days after the procedure: loss of 0.03 ± 0.39 mm in BES patients versus 0.06 ± 0.45 mm in EES patients.

The study's other primary outcome is death or heart attack at 3 years after stent insertion, with multiple secondary outcome measures for that 3-year time frame. Interim 2-year data will also be analyzed.

Many patients in this study were older (mean age, 69.2 ± 9.8 years), had diabetes (46%), or already had a coronary stent (51%). Analysis found no differences in outcomes for these subgroups between the two types of stents. An earlier study's findings had raised concerns about acute success rate with BES—the ability to deliver all intended stents to the target site and achieve the target artery diameter. Acute success rates in this trial were very high for BES and EES at 99.6% in both groups, noted the ACC.

Dr. Natsuaki observed that despite the study's all-comer design, the actual study population mostly included patients with stable coronary artery disease; the 1-year rate of target lesion revascularization was lower than expected, leading to a relatively large margin of noninferiority; and the high incidence of follow-up angiography inflated rates of target lesion revascularization. Nevertheless, “given the equivalent 1-year outcome, long-term clinical data for biodegradable-polymer BES compared with durable-polymer EES will have crucial implications for future development of improved metallic drug-eluting stents,” he said in the ACC press release.