SECURITY: Six Month vs. 12 Month DAT Following DES Implantation
Dual antiplatelet therapy (DAPT) following second-generation drug-eluting stent (DES) implantation appears to be acceptable at 12 months in regards to incidences of cardiac death, myocardial infarction, stroke, definite/probable sent thrombosis, and Bleeding Academic Research Consortium (BARC) type three or five bleeding, according to results from the SECURITY trial presented Sept. 15 at TCT 2014, and simultaneously published in the Journal of the American College of Cardiology.
Investigating the optimal duration of DAPT following second-generation DES implantation, specifically the impact of six-month or 12-month strategy, the trial was led by Antonio Colombo, MD, FACC, San Raffaele Scientific Institute, Milan, Italy. A one-to-one randomized, multicenter, international, investigator-driven, non-inferiority study conducted from July 2009 to June 2014, the trial enrolled overall 1,399 patients and randomized them to receive six-month (n=682) vs. 12-month (n=717) DAPT. The researchers’ primary composite endpoint (cardiac death, myocardial infarction, stroke, definite or probable stent thrombosis or BARC type three or five bleeding at 12 months) occurred respectively in 4.5 percent vs. 3.7 percent (risk difference, 0.8 percent; 95 percent CI: -2.4 percent to 1.7 percent; p = 0.469) of patients at 12 months.
In addition to these findings, no differences were observed in the occurrence of the study’s secondary endpoint (cardiac death, myocardial infarction, stroke, definite or probable stent thrombosis or BARC type two, three or five bleeding at 12 and 24 months) at 12 months (5.3 percent vs. 4.0 percent, difference: 1.2 percent; 95 percent CI: -1.0 to 3.4, p = 0.273) and between 12 and 24 months (1.5 percent vs. 2.2 percent, difference: -0.7 percent; 95 percent 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 percent vs. 0.4 percent; difference: -0.1 percent; 95 percent CI: -0.7 to 0.4; p = 0.694) and between 12 and 24 months of follow-up (0.1 percent vs. 0 percent; difference: 0.1 percent; 95 percent CI: -0.1 to 0.4; p = 0.305).
“The scientific underpinnings of the crucial debate on the duration of DAPT required to optimize safety and efficacy of current more advanced generation DES remain somewhat wobbly; different societal guideline documents reviewing the same date have come to somewhat different conclusions,” writes David R. Holmes, Jr., MD, MACC, a past president of the ACC, in a commenting editorial. “In this case, art and some attempt at wisdom needs to be used to help decide on what to recommend for Mr. or Mrs. Smith who you have just treated with one of several second generation DES. That process needs to include information about exactly who Mr. or Mrs. Smith are, what their lesions were like, details of the specific stent approach such as number of stents, stent size, and adequacy of the result, how did the procedure go, their risk for bleeding, the potential need for subsequent surgical procedures, their tolerance of unknowns, and mitigating often other but unmeasurable data. It is in the consideration of these issues, that art comes to play a prominent role. In the setting of patients similar to those entered into the SECURITY Trial, in the absence of rigorous data to the contrary, shorter duration of DAPT seems to be a very reasonable approach for consideration and is increasingly used in the art of taking care of these patients."
Keywords: Myocardial Infarction, Stroke, Follow-Up Studies, Thrombosis, Drug-Eluting Stents, Angioplasty, Balloon, Coronary
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