NOBORI™ stent is non-inferior to Taxus® stents in the NOBORI 1 trial
You don't need to be Editor-In-Chief to add or edit content to WikiDoc. You can begin to add to or edit text on this WikiDoc page by clicking on the edit button at the top of this page. Next enter or edit the information that you would like to appear here. Once you are done editing, scroll down and click the Save page button at the bottom of the page.
May 20, 2008 By Vijayalakshmi Kunadian MBBS MD MRCP [1]
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
- EUROPCR Scientific Sessions, Barcelona 2008. Presented by Dr Bernard Chevalier.
Acknowledgement and Attribution Regarding Sources of Content
Some of the initial content on this page may be incorporated in part from copyleft sources in the public domain including wikis such as Wikipedia and AskDrWiki. Drug information for patients came from the The National Library of Medicine. Infectious disease information may have come from the Centers for Disease Control (CDC). Differential Diagnoses are drawn from clinicians as well as an amalgamation of 3 sources: 1.The Disease Database; 2. Kahan, Scott, Smith, Ellen G. In A Page: Signs and Symptoms. Malden, Massachusetts: Blackwell Publishing, 2004:3; 3. Sailer, Christian, Wasner, Susanne. Differential Diagnosis Pocket. Hermosa Beach, CA: Borm Bruckmeir Publishing LLC, 2002:7 .
