Results of the trial, which was conducted in 29 centers across Europe, Asia and Australia, demonstrated non-inferiority of the Nobori™ stent system compared to Taxus® Liberte™ stent system, with respect to the study's primary endpoint of angiographic in-stent late loss at 9-months (0.11±0.30 mm for Nobori™, vs. 0.32±0.51 mm for Taxus® Liberte™, p<0.001).
The superiority of Nobori™ versus Taxus® Liberte™ for the same endpoint, which was a secondary objective, has also been confirmed (p=0.001). Late loss is the measure of change in the vessel diameter between the time immediately after the procedure and at nine-months.
Major secondary endpoints showed superior results for the Nobori™ stent system including a significant reduction in angiographic binary restenosis rate and percent diameter stenosis at 9-months. Furthermore, the intravascular ultrasound findings favor Nobori™ with significantly lower in-stent volume obstruction.
The 9-months Major Adverse Cardiac Events (MACE) rate for Nobori™ was 3.9-percent versus 5.6-percent for Taxus®. As defined in NOBORI 1 clinical trial the MACE rate includes cardiac death, heart attacks, and target vessel revascularization at 9-months.
One of the most striking findings of this clinical trial is 0-percent Stent thrombosis rate for the Nobori™ stent versus 4.4-percent rate for the Taxus® Liberte™ stent. Stent thrombosis had been one of the gravest safety concerns for interventional cardiologists.
"Besides already proven non-inferiority to the first generation Taxus® stent, the Nobori™ stent confirmed in this trial its non-inferiority and even superiority to the second generation Taxus® Liberte™ stent with respect to in-stent late loss. The continued positive results make the Nobori™ stent a promising treatment option for the patients with coronary artery disease", said Bernard Chevalier M.D. of the Centre Cardiologique du Nord, Paris, France, Principal Investigator of this study, who presented the trial results. "The absence of stent thrombosis in the Nobori™ stent and its exceptionally low restenosis rate are particularly appealing", added Dr. Chevalier.
"These great clinical results, combined with the results of other recently reported NOBORI trials reinforce our confidence in the Nobori™ stent system and give us powerful scientific evidence for successful launch of Nobori™ stent in Europe, upon regulatory approval" said President & CEO Terumo Europe N.V. "The outstanding results of NOBORI 1 trial with regards to efficacy, but also to safety, with very low MACE and stent thrombosis rates, raises our expectations that Nobori DES will make a substantial contribution to the improvement of the outcomes for patients with coronary artery disease" said Yutaro Shintaku, Group President, Cardiac & Vascular Business, Terumo Corporation.
The Nobori™ stent system utilizes Biolimus A9™, an analogue of sirolimus which is expected to reduce tissue proliferation and which is eluted from a biodegradable polymer, poly-lactic acid. The stent delivery system applies Terumo's proprietary hydrophilic coating which enhances deliverability and reduces arterial wall damage.
NOBORI 1 is a 360-patient prospective, randomized (2:1), two phase clinical trial, evaluating Nobori™ versus Taxus® coronary stent system in 29 centers across Europe, Asia and Australia. The NOBORI 1 trial allowed treatment of up to two coronary arteries, considered as a higher risk procedure. The results of the first phase which randomized Nobori™ versus Taxus® Express™ were reported in 2006, while the current presentation included the final results of the second phase, which enrolled 243 patients (153 in Nobori™ and 90 in Taxus® Liberte™ arm).
Terumo is a global health care company dedicated to research, development manufacturing and marketing of medical products and equipment, including pharmaceuticals, nutritional food supplement, blood bags, disposable medical devices, cardiovascular systems, vascular grafts, peritoneal dialysis, blood glucose monitoring system, medical electronic, and digital thermometers. The main company vision is to contribute to the society through health care using its unique technology which makes medical treatment kinder and gentler. Terumo employs more than 12.000 people and its products are available in over 160 countries world-wide.
Biolimus A9™ and technology of its elution from biodegradable polymer (poly-lactic acid) is a proprietary of Biosensors International with whom Terumo, in the year 2003, signed a licensing agreement for the development and marketing of drug eluting stent.
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