Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation
Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation
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DOI：
10.1016/j.jcin.2017.04.019
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发表时间：
2017-06-26
影响因子：
11.3
通讯作者：
Yokoi, Hiroyoshi
中科院分区：
文献类型：
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作者：
Nakamura, Masato;Iijima, Raisuke;Yokoi, Hiroyoshi
目的日本研究是一项多中心的随机双抗血小板治疗(DAPT)研究，研究对象是日本东京Terumo的Nobori药物洗脱支架(DES)患者的短期和长期双重抗血小板治疗(DAPT)的非劣性。方法3773例稳定型和急性冠脉综合征患者接受Nobori支架置入术。他们被随机分为6个月或18个月接受DAPT治疗。主要终点是支架植入后6至18个月的净不良临床和脑血管事件(NACCE)(全因死亡、心肌梗死、中风和大出血)。结果接受短期DAPT治疗的34例患者(2.1%)和长期接受DAPT治疗的24例患者(1.5%)发生NACCE(差异0.6%，95%可信区间[CI]：1.5~0.3)。由于95%可信区间的下限在-2%的规定范围内，因此证实了短期DAPT的非劣性。短期DAPT的死亡率为1.0%，长期DAPT的死亡率为0.4%，而心肌梗死的死亡率为0.2%，大出血的死亡率为0.7%。长期DAPT组发生NAPCE的概率较低(风险比：1.44，95%CI：0.86~2.43)。结论DAPT术后6个月的DAPT不低于DAPT术后18个月的DAPT。然而，考虑到本研究的开放标签设计和广泛的非劣势范围，这一结果需要谨慎地解释。(Nobori Dual抗血小板治疗适当持续时间[Nippon]；NCT01514227)(C)2017年，爱思唯尔代表美国心脏病学会基金会发表。
OBJECTIVES The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term versus long-term dual antiplatelet therapy (DAPT) in patients with implantation of the Nobori drug-eluting stent (DES) (Terumo, Tokyo, Japan), which has a biodegradable abluminal coating.BACKGROUND The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. METHODS The subjects were 3,773 patients with stable or acute coronary syndromes undergoing Nobori stent implantation. They were randomized 1: 1 to receive DAPT for 6 or 18 months. The primary endpoint was net adverse clinical and cerebrovascular events (NACCE) (all-cause mortality, myocardial infarction, stroke, and major bleeding) from 6 to 18 months after stenting. Intention-to-treat analysis was performed in 3,307 patients who were followed for at least 6 months.RESULTS NACCE occurred in 34 patients (2.1%) receiving short-term DAPT and 24 patients (1.5%) receiving long-term DAPT (difference 0.6%, 95% confidence interval [CI]: 1.5 to 0.3). Because the lower limit of the 95% CI was inside the specified margin of -2%, noninferiority of short-term DAPT was confirmed. Mortality was 1.0% with short-term DAPT versus 0.4% with long-term DAPT, whereas myocardial infarction was 0.2% versus 0.1%, and major bleeding was 0.7% versus 0.7%, respectively. The estimated probability of NACCE was lower in the long-term DAPT group (hazard ratio: 1.44, 95% CI: 0.86 to 2.43).CONCLUSIONS Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227) (C) 2017 Published by Elsevier on behalf of the American College of Cardiology Foundation.