Everolimus versus paclitaxel eluting biodegradable polymer coated stents for coronary revascularisation: clinical and angiographic results from the pivotal randomised trial

Abstract

Aims: The impact of each individual DES component (i.e. drug vs. polymer) in the overall outcome is difficult to evaluate and the independent role of an eluted agent in the overall clinical and angiographic outcome has not been established. Therefore, in this study, we randomly compared the results of percutaneous coronary revascularisation (PCI) utilising identical biodegradable polymer coated stents eluting everolimus (BP-EES) and paclitaxel (BP-PES). Methods and results: In this multicentre, prospective, pivotal trial 205 patients with stable angina or non ST elevation acute coronary syndrome and at least one significant coronary artery lesion (>50{%} diameter stenosis, vessel reference diameter of 2.5-4.0) were randomised in 1:1 ratio to PCI exclusively with BP-EES (n=101, Carlo, Balton, Warsaw) or BP-PES (n=104,Luc-Chopin2, Balton, Warsaw). Clinical follow-up was obtained at 12 months in all patients, whereas angiographic follow-up occurred at 9 months in a subset of 81 patients. At 9 months, angiographic measures of neointimal proliferation were comparable between BP-EES and BP-PES groups as expressed by in stent late lumen loss (0.30±0.5 vs. 0.31±0.4 mm; p=0.93) and percent diameter stenosis (23.2±17{%} vs. 23.9±19{%}; p=0.91). After one year, target vessel failure (cardiac death, myocardial infarction, and ischemia-driven target vessel revascularisation) rates were 7.0{%} vs. 6.8{%} in BP-EES and BP-PES respectively (HR:0.96, 95{%} CI: 0.4-2.7, p=0.94). Similarly the rates of major adverse cardiac events (8.0{%} vs. 7.7{%}, HR:0.96 95{%} CI: 0.4-2.6; p=0.94), ischaemia driven target lesion revascularisations (6.0{%} vs. 5.9{%}, HR:0.97 95{%} CI: 0.3-3.0; p=0.96) and stent thrombosis (ST) (1.0{%} vs. 0.97{%}; p=0.98) were equivalent. Conclusions: In this pivotal trial, BP-EES did not show superiority over BP-PES reporting similar safety and efficacy profile, exclusive to different anti-proliferative agents eluted from identical biodegradable polymer - stent matrices. This highlights the necessity of a holistic stent design evaluation in large randomised clinical trials.