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DAPT 联合西洛他唑优于传统 DAPT 或阿司匹林联合替格瑞洛作为中高危复杂病例的择期 PCI:基于 PRU 的台湾前瞻性随机研究。

DAPT Plus Cilostazol is Better Than Traditional DAPT or Aspirin Plus Ticagrelor as Elective PCI for Intermediate-to-Highly Complex Cases: Prospective, Randomized, PRU-Based Study in Taiwan.

机构信息

Graduate Institute of Medical Sciences, National Defense Medical Center, Taipei, Taiwan, ROC.

Division of Cardiology, Department of Internal Medicine, Taipei City Hospital, Renai Branch, Taipei, Taiwan, ROC.

出版信息

Am J Cardiovasc Drugs. 2019 Feb;19(1):75-86. doi: 10.1007/s40256-018-0302-3.

DOI:10.1007/s40256-018-0302-3
PMID:30467686
Abstract

PURPOSE

Current treatment guidelines do not recommend different antiplatelet treatments for patients in different coronary risk categories; nor do they consider ethnic differences in responses to individual drugs.

OBJECTIVES

We performed a prospective, single-blind, randomized, comparative study of Taiwanese patients with stable angina and scheduled stent implantation for intermediate-to-highly complex coronary lesions and compared the platelet reactivity unit (PRU) levels and 24-month outcomes of groups receiving three different antiplatelet treatments.

METHODS

Patients (N = 334) were randomized into three treatment groups (aspirin + clopidogrel, aspirin + ticagrelor, or aspirin + clopidogrel + cilostazol) for 6 months of treatment and were then switched to aspirin only. PRU levels were determined 24 h, 7 days, and 1 month after stent implantation. Clinical outcomes and adverse events were recorded over 24 months.

RESULTS

Clopidogrel treatment reached full effect after 1 month. Ticagrelor decreased PRU levels more than did clopidogrel but often to levels that increased the risk of hemorrhage. The addition of cilostazol to clopidogrel decreased PRU levels earlier and more strongly than clopidogrel alone but not as strongly as did ticagrelor. Ticagrelor treatment caused fewer major adverse cardiovascular events (MACEs) and more episodes of minor bleeding than the other two treatments.

CONCLUSIONS

Clopidogrel appears safer than ticagrelor in Taiwanese patients with stable angina after stent implantation for intermediate-to-highly complex coronary lesions. The addition of cilostazol to clopidogrel may provide a more rapid decrease in PRU to therapeutic levels without increasing the risk of hemorrhage.

CLINICAL TRIAL REGISTRATION NUMBER

NCT02101411.

摘要

目的

目前的治疗指南并未针对不同冠脉风险类别的患者推荐不同的抗血小板治疗方案;也未考虑到不同种族对单一药物的反应存在差异。

目的

我们对计划接受支架植入术治疗中-高度复杂冠脉病变的稳定型心绞痛台湾患者进行了一项前瞻性、单盲、随机、对照研究,比较了接受三种不同抗血小板治疗方案的患者的血小板反应单位(PRU)水平和 24 个月的结局。

方法

患者(N=334)随机分为三组(阿司匹林+氯吡格雷、阿司匹林+替格瑞洛或阿司匹林+氯吡格雷+西洛他唑),接受 6 个月的治疗,然后改为仅服用阿司匹林。在支架植入后 24 小时、7 天和 1 个月测定 PRU 水平。记录 24 个月的临床结局和不良事件。

结果

氯吡格雷治疗在 1 个月后达到完全效果。替格瑞洛降低 PRU 水平的效果优于氯吡格雷,但常使出血风险增加。与氯吡格雷相比,西洛他唑与氯吡格雷联合使用可更早且更强地降低 PRU 水平,但不如替格瑞洛。替格瑞洛治疗引起的主要不良心血管事件(MACE)较少,轻度出血事件更多。

结论

在中-高度复杂冠脉病变支架植入术后的台湾稳定型心绞痛患者中,氯吡格雷似乎比替格瑞洛更安全。与氯吡格雷相比,西洛他唑联合氯吡格雷可能更迅速地将 PRU 降低至治疗水平,而不会增加出血风险。

临床试验注册号

NCT02101411。

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