Five-Year Data Published for Terumo's Nobori DES With Biodegradable Polymer

December 23, 2014—Bernard Chevalier, MD, et al published the 5-year clinical outcome data of the Nobori coronary drug-eluting stent (DES) system (Terumo Interventional Systems) in the treatment of patients with coronary artery disease. These final results of the NOBORI 1 trial are available online ahead of print in EuroIntervention.

The aim of the NOBORI 1 study was to assess the safety and performance of the Nobori DES with biodegradable polymer versus the Taxus DES (Boston Scientific Corporation) with permanent polymer in the treatment of patients with de novo coronary artery lesions.

As summarized in EuroIntervention, NOBORI 1 was a multicenter, randomized (2:1), prospective, controlled, clinical trial that enrolled 363 patients (238 Nobori and 125 Taxus) with up to two de novo lesions in two epicardial vessels. The primary endpoint was in-stent late loss at 9 months. Secondary endpoints included safety and efficacy up to 5 years.

The NOBORI 1 investigators reported that at 5 years, clinical data were available for 350 patients (96%). There were no differences in the composite of death and myocardial infarction (10.9% vs 11.2%) and target lesion failure (9.2% and 10.4%), while ischemia- and nonischemia-driven target lesion revascularizations were less frequent in the Nobori (6.3%) than in the Taxus arm (16%). The rates of stent thrombosis (definite and probable according to the ARC definitions) were 0.0% and 3.2% in the Nobori stents and Taxus stents, respectively (P = .014).

The investigators concluded that at 5 years after implantation, the Nobori DES resulted in durable treatment effects with very low target lesion revascularization rates and no stent thrombosis. The study was not powered to assess the differences in clinical endpoints and these are hypothesis-generating data, advised the NOBOR-1 investigators in EuroIntervention.