西洛他唑与阿司匹林用于冠脉支架术后预防心血管事件对比研究

Application of Cilostazol and Aspirin in Preventing Cardiovascular Events after Coronary Stenting Implantation

目的观察急性冠脉综合征冠脉支架植入术后,西洛他唑联合氯吡格雷用于预防心血管事件的效果及安全性。方法将324例患者随机均分为西洛他唑联用氯吡格雷组(A组)和阿司匹林联用氯吡格雷组(B组),各162例。两组均在冠脉支架术后长期应用阿司匹林或西洛他唑联用氯吡格雷,并随访12个月。观察两组患者主要终点事件(心源性死亡、非致命性心肌梗死、缺血性卒中、心肌缺血需靶病变再通治疗等),同时观察两组之间全因死亡、再狭窄率、抗血小板不良反应(消化道出血、血小板减少、白细胞减少等)的发生率。结果 12个月随访,A组与B组相比,冠脉造影发现支架内再狭窄(9.76%比12.00%,P=0.47),靶病变需血运重建(6.92%比8.92%,P=0.42)。主要不良心血管事件发生情况,组间无统计学差异(11.95%比15.92%,P=0.21),A组消化道出血事件及其他不良药品反应发生率更低(12.96%比33.33%,P=0.01)。结论急性冠脉综合征冠脉支架植入术后,西洛他唑联用氯吡格雷与阿司匹林联用氯吡格雷对预防心血管事件的发生有类似作用,但前者出血事件及药品不良反应更少。

Objective To observe the effect and safety of cilostazol combined with clopidogrel for preventing the cardiovascular events after coronary stenting implantation in the patients with acute coronary syndrome（ ACS）. Methods 324 patients with ACS undergoing coronary stenting implantation were randomly divided into the cilostazol combined clopidogrel group A and the combined clopidogrel group B 162 Cases in each group. The two groups took the long- term use of aspirin combined clopidogrel or cilostazol combined clopidogrel and followed up for 12 months after coronary stenting implantation. The primary end point events [ cardiac death, nonfatal myocardial infarction, myocardial ischemia needing target lesion revascularization（ TLR）, etc. ] were observed in the two groups, meanwhile the occurrence rate of all- cause death, restenosis, anti- platelet side effects（ alimentary tract hemorrhage, thrombocytopenia,leukopenia,etc） were also observed in the two groups. Results The 12- month follow- up in group A and group B showed the in-stent restenosis（ 9. 76% vs. 12. 00%, P = 0. 47）, and the target lesion revascularization（ 6. 92% vs. 8. 92%, P = 0. 42）. The occurrence of primary end point events had no statistical difference between the two groups（ 11. 95% vs. 15. 92%, P = 0. 42）. The occurrence rate of alimentary tract bleeding and other side effects group A was significantly lower than that in group B（ 12. 96% vs. 33. 33%, P = 0. 01）.Conclusion Cilostazol combined clopidogrel and aspirin combined clopidogrel have similar effect for preventing the occurrence of cardiovascular events after coronary stenting implantation in the patients with ACS, but the combination use of cilostazol combined clopidogrel has much less hemorrhage events and occurrence of adverse drug reactions and is more safe.