经皮冠状动脉介入治疗术后患者口服低剂量与高剂量阿司匹林对不良心脑血管事件的影响

Effects of low versus high doses of Aspirin on cardiac and cerebrovascular events after PCI

目的通过比较我国经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)术后患者采用低剂量阿司匹林与高剂量阿司匹林对预防不良心脑血管事件的有效性和安全性,以及检测服用不同剂量阿司匹林后血浆中血栓烷素B2(thromboxane B2,TXB2)和P选择素的水平,探讨PCI后口服低剂量阿司匹林的策略是否适合我国人群,为我国PCI术后患者口服阿司匹林的合理剂量提供依据。方法于2011年5月至2012年12月,在长海医院心血管病科连续入选PCI术后患者400例,随机分为低剂量阿司匹林组(PCI术后阿司匹林100 mg/d)和高剂量阿司匹林组(PCI术后阿司匹林300 mg/d,服用3个月后改为100 mg/d),对入选患者分别在PCI术后住院期间,以及术后1个月、3个月、6个月及12个月时进行随访,主要终点是主要不良心脑血管事件。结果在入选的400例患者中失访11例,其余389例中包括低剂量阿司匹林组198例,高剂量阿司匹林组191例。随访3个月时共有7例患者发生心脑血管事件,其中低剂量阿司匹林组3例(1.5%),高剂量阿司匹林组4例(2.1%);低剂量阿司匹林组、高剂量阿司匹林组的次要出血事件发生率分别是7例(3.5%)和8例(4.2%),主要出血事件发生率均为2例(1.0%),两组间心脑血管事件以及出血事件发生率比较,差异均无统计学意义(P>0.05)。12个月时共有11例发生心脑血管事件,其中低剂量阿司匹林组6例(3.0%),高剂量阿司匹林组5例(2.6%);低剂量阿司匹林组、高剂量阿司匹林组的次要出血事件发生率分别是10例(5.1%)、11例(5.8%),主要出血事件发生率分别是3例(1.5%)和2例(1.0%),两组间心脑血管事件以及出血事件发生率比较,差异均无统计学意义(P>0.05)。阿司匹林上消化道症状(反酸、嗳气、上腹不适)在低剂量组、高剂量组的发生率分别是4例(2.0%)、12例(6.3%)(P<0.05),差异有统计学意义;比较两组间血浆中TXB2、P选择素水平,均无统计学差异,P>0.05。结论 PCI术后服用低剂量阿司匹林是有效和安全的;低剂量阿司匹林组上消化道症状的发生率低于高剂量组。

Objective It remains unclear whether low-dose aspirin （100 mg/day） following PCI is appropriate for Chinese patients or not. We sought to compare the effectiveness and safety of low versus high doses of aspirin on prevention of major adverse cardiac and cerebrovascular events （MACCEs） in Chinese patients after PCI. Methods We recruited 400 patients consecutively who have undergone percutaneous coronary intervention in the cardiology department of Changhai Hospital from May 2011 to December 2012. The patients were randomly assigned to low-dose （100mg daily） group versus high-dose （300 mg for 3 month after PCI then 100mg daily） group after PCI. The patients were assessed as in-patients after PCI and followed up as out-patients in 1, 3, 6 and 12 months after PCI. The primary end-points were MACCEs. Results MACCEs were observed in 7 patients at 3 months, 3 （1.5%） occurred in the low-dose group and 4 （2.1%） in the high- dose group. The incidence of minor bleeding was 7 （3.1%） in the low-dose group and 8 （3.5%） in the high-dose aspirin group, respectively. The incidence of major bleeding was 2 （1.0%） in the low- dose group and 2 （1.0%） in the high- dose group, respectively. There were no significant differences in the MACCEs and bleeding events between the two groups （P 〉 0.05）. MACCEs were observed in 11 patients in 12 months, 6 （3.0%） occurred in the low-dose group and 5 （2.6%） in the high- dose group. The incidence of minor bleeding was 10 （5.1%） in the low-dose group and 11 （5.6%） in the high- dose group respectively. The incidence of major bleeding was 3 （1.5%） in the low-dose aspirin group and 2 （1.0%） in the high-dose aspirin group, respectively. There were no significant differences in the MACCEs and bleeding events between the two groups （P 〉 0.05）. The incidence of upper gastrointestinal symptoms （acid reflux, belching, abdominal discomfort） of aspirin was 4 （2.02%） in the low-dose group and 12 （6.28%） in the high-dose group respectively at 3 months. There were significant differences between the two groups （P 〈 0.05）. Comparing serum TXBz and P-selectin levels, there were no statistical difference between the two groups （P 〉 0.05）. Conclusions Low-dose aspirin is effective and safe for the patients undergone PCI, and was associated with lower incidence of upper gastrointestinal symptoms.