Polymer-free amphilimus-eluting stent versus biodegradable polymer biolimus-eluting stent in patients with and without diabetes mellitus

Objectives This study sought to compare clinical outcome of polymer-free amphilimus-eluting stent (PF-AES) versus biodegradable-polymer biolimus-eluting stent (BD-BES) in “all-comer” diabetes mellitus (DM) and non-DM patients who underwent percutaneous coronary intervention. Background The PF-AES has shown promising preliminary results in patients with DM. Methods Data from 2 multicentre-national registries (the ASTUTE and the INSPIRE-1) were used to analyse 1776 patients stratified in non-DM and DM. A double 1:1 propensity-score matched analysis (PF-AES vs. BD-BES) was performed in each group to adjust for clinical and procedural characteristics. Primary stent-efficacy and stent-safety endpoints were 1-year target-lesion revascularization (TLR) and target-lesion failure (TLF, composed of cardiac-death, target-vessel myocardial infarction and any TLR). Results After propensity-score matching, 850 patients were stratified as non-DM (425 PF-AES/425 BD-BES) and 480 as DM patients (240 PF-AES/240 BD-BES). Both TLF (20 of 425 [5%] vs. 24 of 425 [6%]; Plog-rank = 0.527) and TLR (9 of 425 [2%] vs. 18 of 425 [4%]; Plog-rank = 0.079) were similar between PF-AES and BD-BES in non-DM patients. In DM, TLF (12 of 240 [5%] vs. 31 of 240 [13%]; Plog-rank = 0.002) and TLR (9 of 240 [4%] vs. 21 of 240 [9%]; Plog-rank = 0.019) were significantly lower in PF-AES compared to BD-BES. Upon multivariate analysis, the most powerful predictors of TLF were chronic kidney disease in non-DM (OR 4.24, 95% CI: 2.07–8.70, p < 0.001) and stent type in DM patients (OR 2.76, 1.36–5.56, p = 0.005). Conclusions This matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM.