Procedural and early clinical outcomes of patients with de novo coronary bifurcation lesions treated with the novel Nile PAX dedicated bifurcation polymer-free paclitaxel coated stents: results from the prospective, multicentre, non-randomised BIPAX clinical trial

Abstract

To demonstrate the acute and early outcomes of the novel Nile PAX dedicated polymer-free paclitaxel-coated stents (Minvasys SAS, Gennevilliers, France) in the treatment of de novo coronary bifurcation lesions. The Nile PAX device incorporates a cobalt-chromium alloy with a side aperture in the mid-stent designed to optimise scaffold at the bifurcation carina and side branch (SB) ostium, while maintaining SB access during procedure. From December 2008 to February 2010, 101 patients were prospectively enrolled in a non-randomised, multicentre study. Lesion criteria were: vessel size 2.5-3.5 mm in the parent vessel (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 age was 63 years, 29% had diabetes, LAD/Dg was involved in 80.4%, and 61.7% had significant involvement of both branches. The study stent was successfully attempted and implanted in 98%. SB received additional stent in 26% final kissing-balloon inflation was performed in 93% and lesion (angiographic) success was achieved in 98%. There was only one non-Q myocardial infarction during hospitalisation, and no additional events up to 30 days. Preliminary results of the prospective, non-randomised, multicentre BIPAX clinical trial demonstrated encouraging results with the novel Nile PAX bifurcation DES in the treatment of coronary bifurcation lesions, including high device and procedural success. Overall, there was only one major adverse cardiac event during hospitalisation, with no additional events up to 30 days follow-up. Long-term follow-up is warranted.