Procedural and early clinical outcomes of patients withde novo coronary bifurcation lesions treated with the novelNile PAX dedicated bifurcation polymer-free paclitaxelcoated stents: results from the prospective, multicentre,non-randomised BIPAX clinical trial

ABSTRACT

Aims: To demonstrate the acute and early outcomes of the novel Nile PAX dedicated polymer-free paclitaxelcoatedstents (Minvasys SAS, Gennevilliers, France) in the treatment of de novo coronary bifurcation lesions.Methods and results: The Nile PAX device incorporates a cobalt-chromium alloy with a side aperture inthe mid-stent designed to optimise scaffold at the bifurcation carina and side branch (SB) ostium, while maintainingSB access during procedure. From December 2008 to February 2010, 101 patients were prospectivelyenrolled in a non-randomised, multicentre study. Lesion criteria were vessel size 2.5-3.5 mm in the parentvessel (PV) and 2.0-3.0 mm in the SB, and lesion length <14 mm in the PV, and <5 mm in the SB. Mean agewas 63 years, 29% had diabetes, LAD/Dg was involved in 80.4%, and 61.7% had significant involvement ofboth branches. The study stent was successfully attempted and implanted in 98%. SB received additionalstent in 26%; final kissing-balloon inflation was performed in 93%; and lesion (angiographic) success wasachieved in 98%. There was only one non-Q myocardial infarction during hospitalisation, and no additionalevents up to 30 days.Conclusions: Preliminary results of the prospective, non-randomised, multicentre BIPAX clinical trial demonstratedencouraging results with the novel Nile PAX bifurcation DES in the treatment of coronary bifurcationlesions, including high device and procedural success. Overall, there was only one major adverse cardiac eventduring hospitalisation, with no additional events up to 30 days follow-up. Long-term follow-up is warranted.