San Raffaele Scientific Institute, Invasive Cardiology and Hemodynamic Department, Milan, Italy.
San Raffaele Scientific Institute, Invasive Cardiology and Hemodynamic Department, Milan, Italy.
J Am Coll Cardiol. 2014;64(20):2086-97. doi: 10.1016/j.jacc.2014.09.008. Epub 2014 Sep 15.
The optimal duration of dual antiplatelet therapy (DAPT) following second-generation drug-eluting stent (DES) implantation is still debated.
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.
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.
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).
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).
第二代药物洗脱支架（DES）植入后双联抗血小板治疗（DAPT）的最佳持续时间仍存在争议。
本研究旨在检验第二代 DES 置入后 6 个月与 12 个月 DAPT 的非劣效性。
SECURITY（第二代药物洗脱支架植入后 6 个月与 12 个月双联抗血小板治疗）试验是一项 1:1 随机、多中心、国际、研究者驱动、非劣效性研究，于 2009 年 7 月至 2014 年 6 月进行。入选标准为稳定或不稳定型心绞痛诊断或有记录的无症状性缺血，需要至少 1 枚第二代 DES 进行血运重建的患者。主要终点为 12 个月时的心脏死亡、心肌梗死（MI）、卒、确定或可能的支架血栓形成、或 Bleeding Academic Research Consortium（BARC）类型 3 或 5 出血。主要次要终点为 12 和 24 个月时的心脏死亡、MI、卒、确定或可能的支架血栓形成、或 BARC 类型 2、3 或 5 出血的复合终点。
共有 1399 例患者入组并随机接受 6 个月（n=682）或 12 个月（n=717）DAPT。主要复合终点分别发生在 4.5%和 3.7%（风险差异 0.8%；95%置信区间：-2.4%至 1.7%；p=0.469）。12 个月时，上界 95%置信区间低于预设的 2%界限，证实了非劣效性假设（p<0.05）。此外，12 个月时次要终点的发生率也没有差异（5.3%比 4.0%，差异：1.2%；95%置信区间：-1.0 至 3.4；p=0.273），12 至 24 个月时也没有差异（1.5%比 2.2%，差异：-0.7%；95%置信区间：-2.1 至 0.6；p=0.289）。12 个月时确定或可能的支架血栓形成发生率也没有差异（0.3%比 0.4%；差异：-0.1%；95%置信区间：-0.7 至 0.4；p=0.694），12 至 24 个月时也没有差异（0.1%比 0%；差异：0.1%；95%置信区间：-0.1 至 0.4；p=0.305）。
在低危人群中，第二代 DES 植入后 6 个月与 12 个月 DAPT 的非劣效性假设似乎可以接受 12 个月时心脏死亡、MI、卒、确定/可能的支架血栓形成和 BARC 类型 3 或 5 出血的发生率。（第二代药物洗脱支架植入后 6 个月与 12 个月双联抗血小板治疗；NCT00944333）。
