Six months of DAPT was noninferior to 12 months for the composite of cardiac death, MI, stroke, stent thrombosis, or major bleeding at 12 months (risk difference 0.8%; P<0.05 for noninferiority).
RCT (n=1,399)
1:1
Yes
Does 6 months of DAPT compared to 12 months of DAPT prevent adverse cardiovascular and bleeding events in patients undergoing PCI with second-generation DES?
Six months of DAPT is noninferior to 12 months of DAPT for the composite of ischemic and bleeding events at 12 months in low-risk patients receiving second-generation DES.
Effect estimate: risk difference 0.8% (95% CI -2.4 to 1.7)
Absolute Event Rate: 4.5% vs 3.7%
p-value: p=0.469 (<0.05 for noninferiority)
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).
Colombo et al. (2014) conducted an RCT in Stable or unstable angina or documented silent ischemia (n=1,399). 6 months of dual antiplatelet therapy (DAPT) vs. 12 months of DAPT was evaluated on 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 (risk difference 0.8%, 95% CI -2.4 to 1.7, p=0.469 (<0.05 for noninferiority)). Six months of DAPT was noninferior to 12 months for the composite of cardiac death, MI, stroke, stent thrombosis, or major bleeding at 12 months (risk difference 0.8%; P<0.05 for noninferiority).