Complex coronary bifurcation lesions treated with the novelpolymer-free dedicated bifurcation paclitaxel-eluting stent (Nilepax): clinical and angiographic clinical results of theprospective, multicentre bipax clinical trial

ABSTRACT

Aims: We report the angiographic and clinical outcomes of patients with de novocoronary bifurcation lesions treated with the Nile PAX dedicated device.Methods and results: From Dec/08 to Mar/09, a total of 102 pts with singlebifurcation lesion were prospectively enrolled in this non-randomised, multicenter(10 sites in Europe/South America) study. Lesion criteria were vessel size 2.5-3.5mm in the parent vessel (PV) and 2.0-3.0 mm in the SB, and lesion length <14 mmin the PV. Clinical follow-up (FU) was scheduled at 1, 3, 6, 9 and 12 months, andyearly up to 5 years. Angiographic FU was scheduled at 9 months (primaryendpoint). Angiographic analysis was performed by an independent angiographiccore laboratory. Data analysis and management was performed by an independentdata coordinating center; also, all clinical events were independently adjudicatedby a clinical events committee. Mean age was 63 years, 29% had diabetes, 16previous MI, and 40% previous intervention. The LAD/Dg was the most prevalentlocation (75%), and 60% had significant involvement of both branches. In theprocedure, PV was predilated in 97%; the study stent was successfully attemptedand implanted in 99%. Overall, 25% of SB received an additional stent; and 94%of lesions had final kissing-balloon inflation. By quantitative coronary angiography,baseline mean lesion length, vessel diameter and% diameter stenosis were 10.9mm, 2.99 mm and 72% in the PV, and 4.1 mm, 2.28 mm, and 38% in the SB, respectively. Angiographic success (residual stenosis <50%, final TIMI 3 flow, andabsence of dissection) was achieved in 98%. There was only 1 major adversecardiac event (MACE) during hospitalisation, which was adjudicated as a non-Qmyocardial infarction during hospitalisation, and no additional adverse events werereported up to 30 days...