Author + information
- Received August 12, 2014
- Revision received September 4, 2014
- Accepted September 6, 2014
- Published online November 18, 2014.
- Antonio Colombo, MD∗∗ (, )
- Alaide Chieffo, MD∗,
- Arian Frasheri, MD†,
- Roberto Garbo, MD‡,
- Monica Masotti-Centol, MD§,
- Neus Salvatella, MD‖,
- Juan Francisco Oteo Dominguez, MD¶,
- Luigi Steffanon, MD#,
- Giuseppe Tarantini, MD∗∗,
- Patrizia Presbitero, MD††,
- Alberto Menozzi, MD‡‡,
- Edoardo Pucci, MD§§,
- Josepa Mauri, MD‖‖,
- Bruno Mario Cesana, MD¶¶,
- Gennaro Giustino, MD∗ and
- Gennaro Sardella, MD##
- ∗San Raffaele Scientific Institute, Invasive Cardiology and Hemodynamic Department, Milan, Italy
- †ASL Trapani–P.O., Sant’Antonio Abate Cardiology and Hemodynamic Department, Sant Erice, Italy
- ‡San Giovanni Bosco Hospital, Cardiology Department, Turin, Italy
- §Hospital Clínic, Hemodynamic Department, Barcelona, Spain
- ‖Hospital del Mar, Hemodynamic Department, Barcelona, Spain
- ¶Hospital Puerta de Hierro, Hemodynamic Department, Madrid, Spain
- #Hesperia Hospital, Hemodynamic Department, Modena, Italy
- ∗∗Azienda Ospedaliera di Padova, Hemodynamic Department, Padova, Italy
- ††IRCCS Humanitas, Invasive Cardiology and Hemodynamic Department, Rozzano, Italy
- ‡‡Azienda Ospedaliero-Universitaria di Parma, Cardiology Department, Parma, Italy
- §§Ospedale Santa Maria Goretti, Hemodynamic Department, Latina, Italy
- ‖‖Hospital Universitari Germans Trias i Pujol, Hemodynamic Department, Badalona, Spain
- ¶¶Biostatistics Unit, Brescia University, Brescia, Italy
- ##Policlinico Umberto I, Invasive Cardiology Department, Rome, Italy
- ↵∗Reprint requests and correspondence:
Dr. Antonio Colombo, Interventional Cardiology Unit, San Raffaele Scientific Institute, Via Olgettina 60, 20132 Milan, Italy.
Background The optimal duration of dual antiplatelet therapy (DAPT) following second-generation drug-eluting stent (DES) implantation is still debated.
Objectives 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)
- coronary artery disease
- percutaneous coronary intervention
- platelet aggregation inhibitors
- prospective studies
Fondazione Evidence, a nonprofit organization based in Milan, Italy, supported this study, and received generous grants from Biosensors, Medtronic, and Terumo. Dr. Garbo is a consultant for Terumo and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Colombo and Chieffo are joint first authors.
- Received August 12, 2014.
- Revision received September 4, 2014.
- Accepted September 6, 2014.
- American College of Cardiology Foundation