Original title: Second Generation Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month – Dual Antiplatelet Therapy- The SECURITY Randomized Clinical Trial. Reference: Antonio Colombo et al. J Am CollCardiol. 2014 Nov 18;64(20):2086-97.
The optimal duration of dual antiplatelet therapy after second-generation DES implantation is still debated and apparently will remain controversial for some time.
The aim of this study was to test the non-inferiority of 6 versus 12 months of dual antiplatelet therapy in patients undergoing PCI with second-generation DES.
The SECURITY trial was a 1:1 randomized, multicenter, international, investigator-driven, non-inferiority study conducted between July 2009 and June 2014. Patients with stable or unstable angina or silent ischemia undergoing PCI with at least 1 second-generation DES were eligible. The primary endpoint was a composite of cardiac death, acute myocardial infarction, stroke, definite or probable stent thrombosis, and bleeding at 12 and 24 months.
1399 patients were included and randomized to receive 6 months (n = 682) versus 12 months (n = 717) double antiaggregation therapy. At one year follow up, primary end point composite was observed in 4.5% of patients in the 6 months arm versus 3.7% of patients in the 12 month arm (risk difference 0.8%; 95% CI −2.4% to 1.7%; p = 0.469).
Given that the upper 95% CI limit was lower than the pre-set margin of 2%, the non-inferiority hypothesis was confirmed (p < 0.05). Finally, no differences were observed in definite or probable stent thrombosis at 12 months (0.3% with 6 months vs. 0.4% with 12 months; p = 0.694) and at 24 months of follow-up (0.1% vs. 0% respectively; p = 0.305).
Conclusion
In this low risk population, the non-inferiority hypothesis between 6 and 12 months of double antiaggregation therapy after second generation DES implantation was confirmed, taking into account cardiac death, infarction, stroke, definite/probable thrombosis and bleeding.
Editorial Comment
In the multivariable analysis, independent predictors of primary end point were +75 age, and type, number, diameter and length of implanted stents.
This study, as well as others recently published that test the opposite hypothesis (double antiaggregation for more than 12 months) all arrive to the conclusion that not all patients are equal and, more importantly, not all stents are equally effective.
SOLACI