Midterm and one-year outcome of amphilimus polymer free drug eluting stent in patients needing short dual antiplatelet therapy. Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTer rEgistry)

C Godino, M Chiarito, M Donahue, L Testa, Riccardo Colantonio, Alberto Cappelletti, A Monello, V Magni, Diego Milazzo, Rosario Parisi, A Nicolino, S Moshiri, R Fattori, G Aprigliano, A Palloshi, G Caramanno, M Montorfano, F Bedogni, C Briguori, A MargonatoA Colombo

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Abstract

Background To assess clinical outcomes of patients needing short dual antiplatelet therapy (S-DAPT) after PCI with Cre8 polymer-free amphilimus eluting-stent (AES). The Cre8-AES with pure i-Carbofilm coating was supposed to induce faster stent endothelialization and reduce device thrombogenicity. Methods We performed a sub-analysis of unrestricted consecutive patients treated with Cre8-AES between August 2011 and January 2015. Two groups were formed: 1) patients discharged with S-DAPT (≤ 3-month), because of high bleeding risk or attending urgent non-cardiac surgery; and 2) patients discharged with Recommended DAPT duration (R-DAPT; ≥ 6-month). The primary ischemic- and bleeding-safety endpoints were Target Vessel Failure (TVF, composite endpoint of cardiac-death, target vessel-myocardial infarction and target vessel-revascularization), and major-bleeding (BARC ≥ type-3a) at 6-month and 1-year. Results 106 patients (8.7%) were discharged with ≤ 3-month DAPT (83 ± 19 days; S-DAPT group) and 1102 patients (90.6%) with ≥ 6-month DAPT (342 ± 62 days; R-DAPT group). Between S-DAPT and R-DAPT groups no significant differences were observed in TVF at 1-year (5.7% vs 5.1%); 1-year BARC major bleeding rate was higher in S-DAPT group (3.4% vs 0.2%, p = 0.007) with all bleeding events occurred within 3 months. The landmark analysis (started at 90 days, ended at 1 year) showed no differences in BARC major bleedings between groups (0% vs. 0.3%). Conclusions The results of this multicenter registry show that the use of Cre8 AES in patients needing short DAPT (≤ 3-month) was safe regarding ischemic events and could favor a reduction of bleeding events related to the recommended DAPT. A large randomized trial is necessary to support these preliminary findings. © 2017 Elsevier B.V.
Original languageEnglish
Pages (from-to)54-60
Number of pages7
JournalInternational Journal of Cardiology
Volume231
Issue number11
DOIs
Publication statusPublished - 2017

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