title: One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients: Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTre rEgistry).
abstract: BACKGROUND
  Despite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a "real-world" multicenter-independent cohort of patients.
  
  
  METHODS
  1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively.
  
  
  RESULTS
  1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p<0.001) and dyslipidemia (p<0.001) and more frequently dialyzed (p=0.010). At 1-year, TLF occurred in 50 (5.1%) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3%, respectively, p=0.788). The secondary endpoint (TLR) occurred in 3% of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5%, respectively, p=0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients.
  
  
  CONCLUSIONS
  The results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings.
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy; EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy. Electronic address: cosmogodino@gmail.com.
authors.forename: Cosmo
authors.initials: C
authors.lastname: Godino
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: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Chiarito
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Anna Giulia
authors.initials: AG
authors.lastname: Pavon
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: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Margonato
authors.affiliation: Clinica Mediterranea, Naples, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000188:drug therapy / Q000628:therapy*; D003920:Diabetes Mellitus / Q000188:drug therapy / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002317:Cardiovascular Agents
keywords: Amphilimus; Diabetes mellitus; Polymer-free drug eluting; Stent restenosis