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比较药物洗脱支架植入术后高再狭窄风险患者的三联抗血小板治疗与双联抗血小板治疗(来自 DECLARE-DIABETES 和 -LONG 试验)。

Comparison of Triple antiplatelet therapy and dual antiplatelet therapy in patients at high risk of restenosis after drug-eluting stent implantation (from the DECLARE-DIABETES and -LONG Trials).

机构信息

Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

出版信息

Am J Cardiol. 2010 Jan 15;105(2):168-73. doi: 10.1016/j.amjcard.2009.08.667. Epub 2009 Dec 3.

DOI:10.1016/j.amjcard.2009.08.667
PMID:20102913
Abstract

Although cilostazol has decreased restenosis and target lesion revascularization (TLR) after drug-eluting stent implantation, it is not known if this effect is durable at 2 years. We analyzed 2 randomized studies (Drug-Eluting stenting followed by Cilostazol treatment reduces LAte REstenosis in patients with DIABETES mellitus and Drug-Eluting Stenting Followed by Cilostazol treatment reduces LAte REstenosis in patients with LONG native coronary lesions trials) in which 900 patients were randomly assigned to triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol; triple group, n = 450) and dual antiplatelet therapy (aspirin and clopidogrel; standard group, n = 450) for 6 months in patients with diabetes or long lesions receiving drug-eluting stents. We evaluated 2-year major adverse cardiac events (MACEs) including death, myocardial infarction (MI), and TLR. Nine-month TLRs and MACEs were significantly decreased in the triple versus standard group. At 2 years, the triple group sowed significantly decreased TLRs (4.2% vs 9.1%, hazard ratio 0.45, 95% confidence interval 0.26 to 0.78, p = 0.004) and MACEs (5.6% vs 10.4%, hazard ratio 0.52, 95% confidence interval 0.32 to 0.84, p = 0.008) compared to the standard group with no differences in death and MI. In subgroup analysis, triple antiplatelet therapy decrease of 2-year TLR was favorable in all subgroups, especially in patients with paclitaxel-eluting stents, diabetes mellitus, small vessels, long lesions, and left anterior descending coronary artery lesions. In conclusion, compared to the standard group, initial benefit in decreases of 9-month TLRs and MACEs in the triple group was sustained at 2 years with no differences in death or MI. Triple antiplatelet therapy decrease of 2-year TLR was favorable in all subgroups, especially in patients with high-risk profiles.

摘要

虽然西洛他唑可降低药物洗脱支架植入后的再狭窄和靶病变血运重建(TLR),但尚不清楚这种效果在 2 年后是否持久。我们分析了 2 项随机研究(药物洗脱支架置入后西洛他唑治疗可降低糖尿病患者的晚期再狭窄和药物洗脱支架置入后西洛他唑治疗可降低长原发性冠状动脉病变患者的晚期再狭窄),其中 900 例患者随机分为三联抗血小板治疗(阿司匹林、氯吡格雷和西洛他唑;三联组,n=450)和双联抗血小板治疗(阿司匹林和氯吡格雷;标准组,n=450),用于接受药物洗脱支架置入的糖尿病或长病变患者,治疗 6 个月。我们评估了 2 年的主要不良心脏事件(MACE),包括死亡、心肌梗死(MI)和 TLR。三联组 9 个月时 TLR 和 MACE 显著低于标准组。2 年时,三联组 TLR 显著降低(4.2% vs. 9.1%,风险比 0.45,95%置信区间 0.26 至 0.78,p=0.004),MACE 显著降低(5.6% vs. 10.4%,风险比 0.52,95%置信区间 0.32 至 0.84,p=0.008),与标准组相比,死亡和 MI 无差异。亚组分析显示,三联抗血小板治疗降低 2 年 TLR 在所有亚组中均有益,尤其是在紫杉醇洗脱支架、糖尿病、小血管、长病变和左前降支病变患者中。总之,与标准组相比,三联组 9 个月时 TLR 和 MACE 降低的初始获益在 2 年内持续存在,死亡或 MI 无差异。三联抗血小板治疗降低 2 年 TLR 在所有亚组中均有益,尤其是在高危患者中。

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