Randomized comparison of the nobori biolimus A9-eluting stent with the sirolimus-eluting stent in patients with stenosis in native coronary arteries
Kadota K., Muramatsu T., Iwabuchi M., Saito S., Hayashi Y., Ikari Y., Nanto S., Fujii K., Inoue N., Namiki A., Kimura T., Mitsudo K.
Objectives: The aim of this randomized-controlled trial is to compare Biolimus A9-eluting stent (Nobori) to sirolimus eluting stent (Cypher). Background: The Nobori coronary stent is coated only abluminally with a biodegradable polymer, poly-lactic acid, and the antiproliferative agent Biolimus A9. This stent has been studied in randomized trials versus Taxus Express and Taxus Liberte and showed noninferiority and superiority for in-stent late loss. This is the first randomized trial of Nobori stent versus Cypher stent. Methods: We conducted a randomized (3:2), controlled trial comparing Nobori and Cypher, in 335 patients (198 Nobori and 137 Cypher) at 15 centers in Japan. Patients with de-novo lesions in up to two native coronary arteries were considered for enrollment. The primary endpoint was freedom from target vessel failure (TVF), a composite of cardiac death, myocardial infarction, and target vessel revascularization at 9 months. Results: At 9 months, the primary endpoint of freedom from TVF was 92.6% in Nobori and 93.8% in Cypher arm (noninferiority test P \textless 0.001). As main secondary endpoints, the in-stent late loss was 0.12 +/- 0.30 mm and 0.14 +/- 0.34 mm in Nobori and Cypher stents, respectively. Target lesion revascularization was 0.5% in Nobori and 3.9% in Cypher treated patients (P = 0.04). Definite and probable stent thromboses were not recorded in any patient. Conclusions: Despite the relatively small number of patients, this well controlled clinical trial confirmed the primary hypothesis of non-inferiority of the Nobori Biolimus A9-eluting stent to the Cypher sirolimus-eluting stent for freedom from TVF. Both stents showed excellent midterm results. (c) 2011 Wiley Periodicals, Inc.