NOBORI™ stent is non-inferior to Taxus® stents in the NOBORI 1 trial

May 20, 2008 By Vijayalakshmi Kunadian MBBS MD MRCP [mailto:vkunadian@perfuse.org]

EUROPCR 08, Barcelona, Spain: Dr Bernard Chevalier presented the results of the NOBORI trial at the EUROPCR 08 meeting in Barcelona last week which demonstrated the non-inferiority of the NOBORI™ drug eluting stent over the Taxus® drug eluting stents.

NOBORI™ drug eluting stent is made up of a modified S-stent, PLA biodegradable polymer and Biolimus A9™ (rapamycin derivative). Biolimus A9™ is proposed to have anti-proliferative and anti-inflammatory properties. It is also highly lipophilic with optimal local tissue uptake and minimal systemic exposure.

A total of 363 patients from 29 sites in this trial were randomized to receive either the NOBORI™ stent or the Taxus® stent. In phase 1, Taxus Express® and in phase 2, Taxus Liberte® stents were used. The primary endpoint consisted of in-stent late lumen loss by QCA at 9 months. The secondary endpoints consisted of in-segment late loss, major adverse cardiac events-MACE (death, myocardial infarction, and target vessel revascularization), target lesion revascularization (TLR) and target vessel failure (TVF) at 9 months.

Among all patients (phase 1 and 2), the primary endpoint of late loss was significantly reduced in the NOBORI™ stent group (0.11±0.30 vs. 0.32±0.50 mm) compared with the TAXUS® group (NOBORI™: non-inferior, p<0.001, superior p=0.001). There was a significant reduction in the occurrence of in-stent and in-segment binary restenosis with NOBORI™ compared with Taxus® (p=0.01). On IVUS, there was a significant reduction in volume obstruction (1.93±5.54 vs. 6.76±8.04, p<0.001), neointimal hyperplasia (3.11±8.84 vs. 13.5±20.4, p=0.003) and mean plaque area (0.15±0.48 vs. 0.52±0.64, p<0.001) with NOBORI™ vs. Taxus®. Angiographic restenosis was significantly lower in the NOBORI™ group vs. the Taxus® group (0.4% vs. 4.6%, p<0.01). MACE rate and TVF occurred in fewer patients in the NOBORI™ group (5.4% vs. 8% and 5% vs. 8% respectively). Stent thrombosis up to 2 years occurred in none of the patients in the NOBORI™ group compared with 2.4% in the Taxus® group (ARC definition).

Dr. Chevalier concluded that NOBORI™ stent is non-inferior to Taxus® Express and Taxus® Liberte stents with respect to in-stent loss. NOBORI™ stent appeared clinically effective and safe up to 2 years in this trial which is reflected by the absence of clinically driven TLR, low TVF rate and the absence of stent thrombosis.

Source

 * 1) EUROPCR Scientific Sessions, Barcelona 2008. Presented by Dr Bernard Chevalier.