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

• DOI: 10.1161/circinterventions.108.823443
• Publication Date: 2009-05-09T01:44:38Z
• Authors: Bernard Chevalier; Sigmund Silber; Seung-Jung Park; Eulogio Garcia; Gerhard Schuler; Harry Suryapranata; Jacques Koolen; Karl E. Hauptmann; William Wijns; Marie-Claude Morice; Didier Carrie; Gerrit-Anne van Es; Hirofumi Nagai; Danny Detiege; Dragica Paunovic; Patrick W. Serruys
• Keywords: Coronary arteries; Coronary stent

Background— The newly developed Nobori coronary stent coated with a bioresorbable polymer, polylactic acid, and the antiproliferative agent Biolimus A9 has potential to reduce restenosis by suppressing neointima formation. Methods Results— We conducted randomized (2:1), controlled trial comparing A9-eluting paclitaxel-eluting Taxus Liberté, in 243 patients (153 90 Taxus) at 29 centers Europe, Asia, Australia. Patients previously untreated lesions up 2 native arteries were considered for enrollment. primary end point was in-stent late loss 9 months, whereas secondary points included other quantitative angiography parameters, such as in-segment rate of well key intravascular ultrasound parameters. Clinical thrombosis composite major adverse cardiac events comprising death, myocardial infarction, target vessel revascularization. At significantly lower group compared (0.11�0.30 mm versus 0.32�0.50 mm) reaching both hypothesis noninferiority Liberté ( P <0.001) superiority =0.001). This finding confirmed significant reduction binary from 6.2% 0.7% =0.02) neointimal volume obstruction, detected ultrasound, 5.5�7.2% 1.8�5.2% =0.01). 4.6% 5.6% cohort patients. 0% arm 4.4% arm. Conclusions— NOBORI 1 clinical its hypothesis—noninferiority reducing proliferation. Both stents showed low studied population.