on May 8, 2009
Published online before print May 8, 2009, doi: 10.1161/CIRCINTERVENTIONS.108.823443
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Original Article |
A Randomized Comparison of the Nobori Biolimus A9-Eluting Coronary Stent with the Taxus Liberté Paclitaxel-Eluting Coronary Stent in Patients with Stenosis in Native Coronary Arteries: The NOBORI 1 Trial–Phase 2
1 Institut Cardiovasculaire Paris-Sud, Massy, France;
2 Kardiologische Gemeinschaftspraxis und Praxisklinik, München, Germany;
3 Asan Medical Centre, Seoul, Republic of Korea;
4 Gregorio Marañón, Madrid, Spain;
5 University of Leipzig, Heart Centre, Leipzig, Germany;
6 Isala Clinic, Zwolle, The Netherlands;
7 Catharina Ziekenhuis, Eindhoven, The Netherlands;
8 Krankenhaus der Barmherzigen Brüder, Trier, Germany;
9 Cardiovascular Center, Aalst, Belgium;
10 CHU Rangueil, Toulouse, France;
11 Cardialysis, Rotterdam, The Netherlands;
12 Terumo Europe NV, Leuven, Belgium;
13 Erasmus MC, Thoraxcentre, Rotterdam, The Netherlands
14 E-mail: bchevali{at}aol.com
Background—The newly developed Nobori coronary stent coated with a bioresorbable polymer, poly-lactic acid, and the anti-proliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation.
Methods and Results—We conducted a randomized (2:1), controlled trial comparing the Biolimus A9-eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberté, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia and Australia. Patients with previously untreated lesions in up to two native coronary arteries were considered for enrolment. The primary endpoint was in-stent late loss at 9 months, while secondary endpoints included other QCA parameters, such as in-segment late loss and the rate of restenosis as well as key IVUS parameters. Clinical secondary endpoints were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction and target vessel revascularization. At nine months the in-stent late loss was significantly lower in the Nobori group as compared to the Taxus group (0.11±0.30 mm versus 0.32±0.50 mm) reaching both the primary hypothesis of non-inferiority of Nobori stent versus Taxus Liberté stent (p<0.001), and the secondary hypothesis of superiority (p=0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (p=0.02) and neointimal volume obstruction, detected by IVUS, from 5.5±7.2% in Taxus to 1.8±5.2% in Nobori (p=0.01). Major adverse cardiac events rate was 4.6% in Nobori and 5.6% in Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm.
Conclusions—The NOBORI 1 clinical trial confirmed its primary hypothesis - non-inferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberté stent in reducing neointimal proliferation. Both stents showed low major adverse cardiac events rate in the studied population.
Key Words: angioplasty • stents • Biolimus A9 • Drug eluting stent • Paclitaxel • Randomized trial
Author contributions: On behalf of the NOBORI 1 Clinical Investigators