title: Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy.
abstract: OBJECTIVE
  The randomized SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial showed the non-inferiority of 6 vs. 12-month DAPT after percutaneous coronary intervention (PCI) with second-generation DES in a low-risk population. Nevertheless, diabetes mellitus (DM) remained a major predictor of adverse cardiovascular events. We aimed to assess the interaction between DAPT duration and outcome in DM patients.
  
  
  METHODS
  All diabetic patients included in the SECURITY trial treated by second-generation DES PCI were analyzed. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable ST, or BARC type 2, 3, or 5 bleeding at 24months.
  
  
  RESULTS
  Four hundred-twenty nine DM patients received either 6 (n=206) or 12 (n=223) months of DAPT. The primary endpoint occurred in 3.9% and 5.4% of patients in the 6 and 12-month DAPT group, respectively (log-rank test p=0.83). Similarly, no statistically significant difference in the secondary endpoint was observed between the two study groups (5.4% vs. 7.6%, p=0.620). Stent thrombosis rate was low irrespective of DAPT duration at both 12 (0.5% vs. 0.4%; p=0.804) and between 12 and 24months of follow-up (0.5% vs. 0%, p=0.291). At multivariable analysis, female gender (HR: 3.42; 95% CI 1.32-8.85; p=0.011 and HR 2.28; 95% CI 1.09-4.75; p=0.027) and insulin-treated diabetes mellitus (HR: 2.62; 95% CI 1.15-6.75; p=0.004 and HR: 2.23; 95% CI 1.09-6.33; p=0.003) were independent predictors of both primary and secondary endpoint.
  
  
  CONCLUSIONS
  In diabetic patients treated by second-generation DES PCI, we failed to find any additional benefit of prolonging DAPT beyond 6months, regardless of insulin-requiring status.
authors.affiliation: Azienda Ospedaliera di Padova, Hemodynamic Department, Padova, Italy. Electronic address: giuseppe.tarantini.1@unipd.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tarantini
authors.affiliation: Azienda Ospedaliera di Padova, Hemodynamic Department, Padova, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Nai Fovino
authors.affiliation: Azienda Ospedaliera di Padova, Hemodynamic Department, Padova, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Tellaroli
authors.affiliation: San Raffaele Scientific Institute, Invasive Cardiology and Hemodynamic Department, Milan, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.affiliation: Azienda Ospedaliera di Padova, Hemodynamic Department, Padova, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Barioli
authors.affiliation: Azienda Ospedaliero-Universitaria di Parma, Cardiology Department, Parma, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Menozzi
authors.affiliation: ASL Trapani-P.O., Sant'Antonio Abate Cardiology and Hemodynamic Department, Sant Erice, Italy.
authors.forename: Arian
authors.initials: A
authors.lastname: Frasheri
authors.affiliation: San Giovanni Bosco Hospital, Cardiology Department, Turin, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Garbo
authors.affiliation: Hospital Clínic, Hemodynamic Department, Barcelona, Spain.
authors.forename: Monica
authors.initials: M
authors.lastname: Masotti-Centol
authors.affiliation: Hospital del Mar, Hemodynamic Department, Barcelona, Spain.
authors.forename: Neus
authors.initials: N
authors.lastname: Salvatella
authors.affiliation: Hospital Puerta de Hierro, Hemodynamic Department, Madrid, Spain.
authors.forename: Juan Francisco Oteo
authors.initials: JF
authors.lastname: Dominguez
authors.affiliation: Hesperia Hospital, Hemodynamic Department, Modena, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Steffanon
authors.affiliation: IRCCS Humanitas, Invasive Cardiology and Hemodynamic Department, Rozzano, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Presbitero
authors.affiliation: Ospedale Santa Maria Goretti, Hemodynamic Department, Latina, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Pucci
authors.affiliation: Azienda Ospedaliera di Padova, Hemodynamic Department, Padova, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Fraccaro
authors.affiliation: Hospital Universitari Germans Trias i Pujol, Hemodynamic Department, Badalona, Spain.
authors.forename: Josepa
authors.initials: J
authors.lastname: Mauri
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Giustino
authors.affiliation: Policlinico Umberto I, Invasive Cardiology Department, Rome, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Sardella
authors.affiliation: San Raffaele Scientific Institute, Invasive Cardiology and Hemodynamic Department, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D003920:Diabetes Mellitus / Q000175:diagnosis* / Q000188:drug therapy*; D054855:Drug-Eluting Stents / Q000639:trends; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011446:Prospective Studies; D013997:Time Factors
chemical_list: D010975:Platelet Aggregation Inhibitors
keywords: Diabetes; Dual antiplatelet therapy; Second-generation drug-eluting stent