Final 3-Year NEXT Outcomes Published for Terumo's Nobori Biolimus-Eluting Stent

October 26, 2015—The final 3-year outcomes from the NEXT trial were published by Masahiro Natsuaki, MD, et al online ahead of print in Circulation: Cardiovascular Interventions. NEXT compared the Nobori biolimus-eluting stent (Terumo Interventional Systems) versus the Xience (Abbott Vascular) or Promus (Boston Scientific Corporation) everolimus-eluting stents (EES).

The NEXT investigators concluded that the safety and efficacy outcomes of the Nobori device were noninferior to those of EES at 3 years after stent implantation.

As summarized in Circulation: Cardiovascular Interventions, NEXT is a prospective, multicenter, randomized, open-label, noninferiority trial comparing Nobori with the EES in patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria among 98 participating centers in Japan. 

The NEXT trial was designed to evaluate noninferiority of Nobori relative to the EES in terms of any target lesion revascularization at 1 year and death or myocardial infarction at 3 years. Between May and October 2011, 3,235 patients were randomly assigned to receive either the Nobori (1,617 patients) or the EES (1,618 patients). Complete 3-year follow-up was achieved in 97.6% of patients. 

The investigators found that at 3 years, the primary safety endpoint of death or myocardial infarction occurred in 159 patients (9.9%) in the Nobori group and in 166 patients (10.3%) in the EES group, demonstrating noninferiority of Nobori relative to the EES (P-noninferiority < .0001 and P-superiority = .7). Cumulative incidence of target lesion revascularization was not significantly different between the two groups (7.4% vs 7.1%; P = .8). By a landmark analysis at 1 year, the cumulative incidences of death or myocardial infarction and target lesion revascularization were also not significantly different between the two groups (4.6% vs 5.2%; P = .46, and 3.3% vs 2.7%; P = .39, respectively), reported the investigators in Circulation: Cardiovascular Interventions.