title: 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).
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±19days; S-DAPT group) and 1102 patients (90.6%) with ≥6-month DAPT (342±62days; 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 3months. The landmark analysis (started at 90days, ended at 1year) 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.
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy. Electronic address: cosmogodino@gmail.com.
authors.forename: Cosmo
authors.initials: C
authors.lastname: Godino
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Chiarito
authors.affiliation: Clinica Mediterranea, Naples, Italy.
authors.forename: Michael
authors.initials: M
authors.lastname: Donahue
authors.affiliation: IRCCS Policlinico San Donato, San Donato M.ne, Milan, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Testa
authors.affiliation: Ospedale San Pietro FBF, Rome, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Colantonio
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Cappelletti
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Monello
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Magni
authors.affiliation: Ospedale San Giovanni di Dio, Agrigento, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Milazzo
authors.affiliation: Ospedali Riuniti Marche Nord, Pesaro, Italy.
authors.forename: Rosario
authors.initials: R
authors.lastname: Parisi
authors.affiliation: Ospedale Santa Corona, Pietra Ligure, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Nicolino
authors.affiliation: Ospedale Santa Corona, Pietra Ligure, Italy.
authors.forename: Shahram
authors.initials: S
authors.lastname: Moshiri
authors.affiliation: Ospedali Riuniti Marche Nord, Pesaro, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Fattori
authors.affiliation: Istituto Clinico Città Studi, Milan, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Aprigliano
authors.affiliation: Istituto Clinico Città Studi, Milan, Italy.
authors.forename: Altin
authors.initials: A
authors.lastname: Palloshi
authors.affiliation: Ospedale San Giovanni di Dio, Agrigento, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Caramanno
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Montorfano
authors.affiliation: IRCCS Policlinico San Donato, San Donato M.ne, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bedogni
authors.affiliation: Clinica Mediterranea, Naples, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Margonato
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy; EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy / Q000601:surgery*; D000368:Aged; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D009204:Myocardial Revascularization / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011108:Polymers; D012042:Registries; D012189:Retrospective Studies; D013030:Spain / Q000453:epidemiology; D013997:Time Factors
chemical_list: D010975:Platelet Aggregation Inhibitors; D011108:Polymers
keywords: Amphilimus eluting stent; Bleeding risk; Dual antiplatelet therapy; Stent thrombosis