Polymer-free amphilimus-eluting stent versus biodegradable polymer biolimus-eluting stent in patients with and without diabetes mellitus.
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Godino Cosmo, Pivato Carlo Andrea, Chiarito Mauro, Donahue Michael, Testa Luca, Colantonio Riccardo, Cappelletti Alberto, Milazzo Diego, Parisi Rosario, Nicolino Annamaria, Moshiri Shahram, Aprigliano Gianfranco, Palloshi Altin, Zavalloni Parenti Dennis, Rutigliano David, Locuratolo Nicola, Melillo Francesco, Scotti Andrea, Arrigoni Luca, Montorfano Matteo, Fattori Rossella, Presbitero Patrizia, Sardella Gennaro, Bedogni Francesco, Margonato Alberto, Briguori Carlo, Colombo Antonio, Italian Nobori Stent ProspectIve REgistry-1 (INSPIRE-1) and AmphilimuS iTalian mUlticenTre rEgistry (ASTUTE) investigators
Аннотация
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.