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Original Articles

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

Bernard Chevalier, MD; Sigmund Silber, MD; Seung-Jung Park, MD, PhD; Eulogio Garcia, MD; Gerhard Schuler, MD, PhD; Harry Suryapranata, MD, PhD; Jacques Koolen, MD, PhD; Karl E. Hauptmann, MD; William Wijns, MD, PhD; Marie-Claude Morice, MD; Didier Carrie, MD, PhD; Gerrit-Anne van Es, PhD; Hirofumi Nagai, PhD; Danny Detiege, MS; Dragica Paunovic, MD; Patrick W. Serruys, MD, PhD for the NOBORI 1 Clinical Investigators

From the Institut Cardiovasculaire Paris Sud (B.C.), Massy/Quincy, France; Kardiologische Gemeinschaftspraxis und Praxisklinik (S.S.), München, Germany; Department of Medicine (S.J.P.), Asan Medical Centre, Seoul, Republic of Korea; Gregorio Marañón (E.G.), Madrid, Spain; Heart Centre (G.S.), University of Leipzig, Leipzig, Germany; Isala Clinic (H.S.), Zwolle, The Netherlands; Department of Cardiology (J.K.), Catharina Ziekenhuis, Eindhoven, The Netherlands; Krankenhaus der Barmherzigen Brüder (K.E.H.), Trier, Germany; Cardiovascular Center (W.W.), Aalst, Belgium; L’Institut Cardiovasculaire Paris-Sud (M.C.M.), Massy, France; CHU Rangueil (D.C.), Department of Cardiology, Toulouse, France; Cardialysis (G.A.v.E.), Rotterdam, The Netherlands; Terumo Europe (H.N., D.D., D.P.), Leuven, Belgium; and Erasmus MC (P.W.S.), Thoraxcentre, Rotterdam, The Netherlands.

Correspondence to Bernard Chevalier, MD, Institut Cardiovasculaire Paris Sud, Massy/Quincy, 6 Ave Noyer Lambert, 91300 Massy, France. E-mail Bchevali{at}aol.com

Received September 22, 2008; accepted April 20, 2009.

Background— The newly developed Nobori coronary stent coated with a bioresorbable polymer, polylactic acid, and the antiproliferative 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 2 native coronary arteries were considered for enrollment. The primary end point was in-stent late loss at 9 months, whereas secondary end points included other quantitative coronary angiography parameters, such as in-segment late loss and the rate of restenosis as well as key intravascular ultrasound parameters. Clinical secondary end points were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction, and target vessel revascularization. At 9 months, the in-stent late loss was significantly lower in the Nobori group compared with the Taxus group (0.11±0.30 mm versus 0.32±0.50 mm) reaching both the primary hypothesis of noninferiority 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 intravascular ultrasound, from 5.5±7.2% in Taxus to 1.8±5.2% in Nobori (P=0.01). The major adverse cardiac events rate was 4.6% in the Nobori and 5.6% in the 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—noninferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberté stent in reducing neointimal proliferation. Both stents showed a low major adverse cardiac events rate in the studied population.

Key Words: drug eluting stent • angioplasty • Biolimus A9 • paclitaxel • randomized trial

The online-only Data Supplement is available at http://circinterventions.ahajournals.org/cgi/content/full/10.1161/CIRCINTERVENTIONS.108.823443/DC1.