阿司匹林与氯吡格雷在慢性冠脉综合征中的种族差异荟萃分析
结果显示氯吡格雷总体显著降低主要不良心血管事件(IRR 0.83,95%CI 0.69-0.99),但获益主要见于东亚人群,非东亚人群未观察到显著获益,且种族交互作用显著。
要点
- 氯吡格雷总体降低MACE(IRR 0.83,95%CI 0.69-0.99),不增加大出血。
- 东亚人群MACE获益显著(IRR 0.76,95%CI 0.59-0.98),非东亚人群无显著获益(IRR 1.00,95%CI 0.74-1.36)。
- 种族交互作用对MACE(Pint=0.010)和死亡(Pint=0.014)均显著。
核心结论
- 在慢性冠脉综合征患者中,氯吡格雷较阿司匹林总体改善结局,但对死亡无明显影响。
- 对上述发现的高置信度目前仅限于东亚人群,非东亚患者的适用性需进一步证据。
研究设计与样本
- 中位随访36.0个月,预设种族亚组交互分析(东亚 vs 非东亚),并使用试验序贯分析评估统计效能。
主要发现
- 氯吡格雷较阿司匹林显著降低MACE(IRR 0.83,95%CI 0.69-0.99)和净不良临床事件(IRR 0.83,95%CI 0.69-0.99)。
- 两组间大出血、心肌梗死或死亡率无差异。
- 东亚人群MACE的IRR为0.76(95%CI 0.59-0.98),非东亚人群为1.00(95%CI 0.74-1.36),交互作用Pint=0.010。
- 死亡率的种族交互作用Pint=0.014,非东亚患者未观察到显著获益。
- 东亚人群多数结局分析具有统计效能,非东亚人群所有结局均无统计效能。
临床怎么用
- 在东亚慢性冠脉综合征患者中,氯吡格雷可作为阿司匹林用于二级预防的合理替代,且不增加大出血风险。
- 对非东亚患者,现有证据不支持常规以氯吡格雷替代阿司匹林,需个体化评估。
局限性
- 非东亚人群样本量及事件数有限,所有结局分析均缺乏统计效能。
- 研究注册号PROSPERO CRD420251145176。
以上解读依据论文摘要(全文未开放获取或许可不允许翻译转载)。
原文
BACKGROUND AND AIMS: Emerging data suggest that, in patients with chronic coronary syndromes (CCS), clopidogrel provides superior antithrombotic protection compared with aspirin for secondary prevention, without an associated increase in bleeding risk. The consistency of the observed benefits across ethnicities remains uncertain. METHODS: Randomized controlled trials (RCTs) comparing aspirin vs clopidogrel for secondary prevention in patients with CCS were screened. The primary endpoint was trial-defined major adverse cardiovascular events (MACE). Prespecified subgroup interaction by ethnicity (East Asian vs non-East Asian) was performed. Trial sequential analysis was used to assess the statistical power of the results. RESULTS: Seven RCTs were included, encompassing 30 165 patients, of whom 75.1% were East Asians. Median follow-up was 36.0 months. Overall, clopidogrel was associated with significant reductions in MACE (incidence rate ratio [IRR] 0.83, 95% confidence interval [CI] 0.69-0.99) and net adverse clinical events (IRR 0.83, 95% CI 0.69-0.99), compared with aspirin. There were no differences between groups in major bleeding, myocardial infarction, or mortality. The results were consistent in the East Asian population, whereas a significant interaction by ethnicity was observed for MACE (East Asians: IRR 0.76, 95% CI 0.59-0.98; non-East Asians: IRR 1.00, 95% CI 0.74-1.36; Pint = 0.010) and mortality (Pint = 0.014), with no significant benefits observed in non-East Asian patients. The analyses were statistically powered for most outcomes in East Asian populations but for none in non-East Asian populations. CONCLUSIONS: In patients with CCS, the overall body of evidence suggests improved outcomes with clopidogrel compared with aspirin, without an apparent effect on mortality. However, a high level of confidence in these findings is currently limited to East Asian populations, and additional evidence is needed to clarify their applicability to non-East Asian patients. STUDY REGISTRATION: PROSPERO (CRD420251145176).
引用
- Laudani C, Occhipinti G, Costa F, et al. Aspirin vs clopidogrel in chronic coronary syndromes: a meta-analysis of ethnic differences. Eur Heart J. 2026. PMID: 42154959. doi:10.1093/eurheartj/ehag351
供执业医师工作参考,不替代临床判断;数值与分级以指南原文为准。