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

• Published in: International journal of cardiology 2017-10, Vol.245, p.69-76
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Absorbable Implants - standards; Aged; Anti-Inflammatory Agents - administration & dosage; Biodegradable polymer biolimus eluting stent; Cohort Studies; Coronary Artery Disease - epidemiology; Coronary Artery Disease - physiopathology; Coronary Artery Disease - surgery; Diabetes mellitus; Diabetes Mellitus - epidemiology; Diabetes Mellitus - physiopathology; Diabetes Mellitus - surgery; Drug-Eluting Stents - standards; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous coronary intervention; Percutaneous Coronary Intervention - methods; Percutaneous Coronary Intervention - standards; Polymer-free amphilimus eluting stent; Polymers; Registries; Sirolimus - administration & dosage; Sirolimus - analogs & derivatives
• ISSN: 0167-5273; 1874-1754
• DOI: 10.1016/j.ijcard.2017.06.028

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. The PF-AES has shown promising preliminary results in patients with DM. 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). 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