title: Second-generation drug-eluting stent implantation followed by 6- versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial.
abstract: BACKGROUND
  The optimal duration of dual antiplatelet therapy (DAPT) following second-generation drug-eluting stent (DES) implantation is still debated.
  
  
  OBJECTIVE
  The aim of this study was to test the noninferiority of 6 versus 12 months of DAPT in patients undergoing percutaneous coronary intervention with second-generation DES.
  
  
  METHODS
  The SECURITY (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial was a 1:1 randomized, multicenter, international, investigator-driven, noninferiority study conducted from July 2009 to June 2014. Patients with a stable or unstable angina diagnosis or documented silent ischemia undergoing revascularization with at least 1 second-generation DES were eligible. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12 months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable stent thrombosis, or BARC type 2, 3, or 5 bleeding at 12 and 24 months.
  
  
  RESULTS
  Overall, 1,399 patients were enrolled in the study and randomized to receive 6 months (n = 682) versus 12 months (n = 717) DAPT. The primary composite endpoint occurred, respectively, in 4.5% versus 3.7% (risk difference 0.8%; 95% confidence interval [CI]: -2.4% to 1.7%; p = 0.469) at 12 months. The upper 95% CI limit was lower than the pre-set margin of 2%, confirming the noninferiority hypothesis (p < 0.05). Moreover, no differences were observed in the occurrence of the secondary endpoint at 12 months (5.3% vs. 4.0%, difference: 1.2%; 95% CI: -1.0 to 3.4; p = 0.273) and between 12 and 24 months (1.5% vs. 2.2%, difference: -0.7%; 95% CI: -2.1 to 0.6; p = 0.289). Finally, no differences were observed in definite or probable stent thrombosis at 12 months (0.3% vs. 0.4%; difference: -0.1%; 95% CI: -0.7 to 0.4; p = 0.694) and between 12 and 24 months of follow-up (0.1% vs. 0%; difference: 0.1%; 95% CI: -0.1 to 0.4; p = 0.305).
  
  
  CONCLUSIONS
  In a low-risk population, the noninferiority hypothesis of 6 vs. 12 months DAPT following second-generation DES implantation appears accepted for the incidence of cardiac death, MI, stroke, definite/probable stent thrombosis, and BARC type 3 or 5 bleeding at 12 months. (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy; NCT00944333).
authors.affiliation: San Raffaele Scientific Institute, Invasive Cardiology and Hemodynamic Department, Milan, Italy. Electronic address: colombo.antonio@hsr.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: San Raffaele Scientific Institute, Invasive Cardiology and Hemodynamic Department, Milan, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
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
authors.initials: JF
authors.lastname: Oteo Dominguez
authors.affiliation: Hesperia Hospital, Hemodynamic Department, Modena, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Steffanon
authors.affiliation: Azienda Ospedaliera di Padova, Hemodynamic Department, Padova, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tarantini
authors.affiliation: IRCCS Humanitas, Invasive Cardiology and Hemodynamic Department, Rozzano, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Presbitero
authors.affiliation: Azienda Ospedaliero-Universitaria di Parma, Cardiology Department, Parma, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Menozzi
authors.affiliation: Ospedale Santa Maria Goretti, Hemodynamic Department, Latina, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Pucci
authors.affiliation: Hospital Universitari Germans Trias i Pujol, Hemodynamic Department, Badalona, Spain.
authors.forename: Josepa
authors.initials: J
authors.lastname: Mauri
authors.affiliation: Biostatistics Unit, Brescia University, Brescia, Italy.
authors.forename: Bruno Mario
authors.initials: BM
authors.lastname: Cesana
authors.affiliation: San Raffaele Scientific Institute, Invasive Cardiology and Hemodynamic Department, Milan, Italy.
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
mesh_terms: D000368:Aged; D003327:Coronary Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery*; D054855:Drug-Eluting Stents / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000639:trends*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors
keywords: coronary artery disease; percutaneous coronary intervention; platelet aggregation inhibitors; prospective studies; stents; thrombosis