De novo coronary lesions treated with the novel polymer-freeBiolimus-A9 coated stents: four- and twelve-month angiographicresults from the prospective, randomised, multicentreBIOFREEDOM clinical trial

ABSTRACT

Aims: We report the results of the first-in-man evaluation of the BioFreedom (BF)Biolimus A9 (BA9) coated stent (Biosensors Int., Singapore), available in 2different formulations standard dose (SD 15.6 μg/mm) and low dose (LD 7.8μg/mm).Methods and results: A total of 182 pts w/ single lesion were included in theprospective, multicenter (4 sites in Germany), randomised (111 ratio)BIOFREEDOM trial. Pts were treated with the BF-SD (n=60), BF-LD (n=62) vs.Taxus paclitaxel-eluting stents (PES) (n=60). Lesion criteria were native vessels2.25-3.0 mm in diameter, and <14 mm in length. Overall, pts were divided into 2cohorts w/ similar randomisation ratio 1st cohort (n=75), enrolled Sep/08-Jan/09(angiographic FU at 4-month); and 2 cohort (n=107), enrolled Jan-Jun/09(angiographic FU at 12-month). Primary endpoint was in-stent late lumen loss(LLL) (non-inferiority, margin=0.24 mm) at 12-month FU (2nd cohort). Baselineclinical/angiographic characteristics were comparable among the 3 groups; 38% oflesions were located in LAD, and all pts achieved angiographic success. At4-month FU (1 cohort), QCA results showed significant decrease in in-stent LLL w/BF-SD and BF-LD vs. PES 0.08 and 0.12 vs. 0.37mm (p<0.0001 for BF-SD vs.PES; p=0.002 for BF-LD vs. PES); at 12-month, similar results were foundincluding in-stent LLL of 0.17 and 0.22 vs. 0.35 mm for BF-SD and BF-LD vs. PES(p=0.001 for BF-SD vs. PES; p=0.21 for BF-LD vs. PES – p values fornon-inferiority). In addition, the rates of major adverse cardiac events at 12-monthfollow-up were 6.1% in BF-SD, 11.6% in BF-LD, and 5.5% in PES, including targetlesion revascularisation rates of 1.8%, 10% and 5.5% for BF-SD, BF-LD andPES, respectively. Importantly, there were neither death nor stent thrombosis(ARC) up to 12 months.Conclusions: The novel BF polymer-free BA9-coated stents showed excellentacute results, and sustained safety and efficacy through 12-month FU.