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OBJECTIVE

To assess the long term comparative effectiveness of P2Y inhibitor monotherapy compared with aspirin monotherapy in patients after percutaneous coronary intervention (PCI) and discontinuation of dual antiplatelet therapy (DAPT).

DESIGN

Individual participant data (IPD) meta-analysis of randomised clinical trials.

DATA SOURCES

PubMed/Medline, Scopus, Web of Science, and Ovid/Embase.

ELIGIBILITY CRITERIA FOR SELECTING STUDIES

Randomised trials investigating monotherapy with a P2Y inhibitor or aspirin for secondary prevention of ischaemic events in patients with coronary artery disease who underwent PCI.

DATA EXTRACTION AND SYNTHESIS

Anonymised IPD were extracted and transferred to the coordinating centre by dedicated electronic spreadsheets. Data were primarily combined by mixed effects models (one stage analysis) and complemented with multivariable mixed effects models and two stage analyses based on random effects models. The primary and co-primary outcomes were a composite of major adverse cardiac and cerebrovascular events (MACCE) and major bleeding, respectively. The secondary outcomes included a net composite of adverse cardiac and cerebrovascular events (NACCE), derived from the combination of the primary and co-primary outcomes, and individual ischaemic and bleeding events.

RESULTS

A total of 16 117 patients assigned to P2Y inhibitor or aspirin monotherapy after PCI and completion of the recommended DAPT regimen (median duration of 12 months) in five randomised trials were included. At a median follow-up of 1351 days (interquartile range 373-1791 days), P2Y inhibitor monotherapy was associated with a lower risk of MACCE compared with aspirin monotherapy (one stage analysis: hazard ratio 0.77 (95% confidence interval (CI) 0.67 to 0.89), P<0.001; multivariable one stage analysis: adjusted hazard ratio 0.77 (0.67 to 0.89), P<0.001; two stage analysis: hazard ratio 0.77 (0.67 to 0.89), P<0.001), yielding a number needed to treat to benefit of 45.5 (95% CI 31.4 to 93.6). No significant difference in major bleeding (one stage analysis: hazard ratio 1.26 (0.78 to 2.04), P=0.35; multivariable one stage analysis: 1.12 (0.74 to 1.70), P=0.60; two stage analysis: 1.15 (0.69 to 1.92), P=0.59) was observed. NACCE, myocardial infarction, and stroke were lower in patients assigned to a P2Y inhibitor compared with those assigned to aspirin. These findings were confirmed across multiple sensitivity and subgroup analyses.

CONCLUSIONS

In patients who had undergone PCI and discontinued DAPT, at a follow-up of about 5.5 years, P2Y inhibitor monotherapy with ticagrelor or clopidogrel was associated with lower MACCE, owing to reduced rates of myocardial infarction and stroke compared with aspirin monotherapy, without a concurrent increased risk of major bleeding.

REVIEW REGISTRATION

PROSPERO CRD42024517983.

目的

评估经皮冠状动脉介入治疗（PCI）后停用双联抗血小板治疗（DAPT）的患者中，P2Y抑制剂单药治疗与阿司匹林单药治疗的长期比较疗效。

设计

随机临床试验的个体参与者数据（IPD）荟萃分析。

数据来源

PubMed/Medline、Scopus、Web of Science和Ovid/Embase。

研究选择的纳入标准

调查P2Y抑制剂或阿司匹林单药治疗对接受PCI的冠心病患者缺血事件二级预防效果的随机试验。

数据提取与合成

通过专用电子表格提取匿名的IPD并传输至协调中心。数据主要采用混合效应模型（单阶段分析）合并，并辅以多变量混合效应模型以及基于随机效应模型的两阶段分析。主要结局和共同主要结局分别为主要不良心脑血管事件（MACCE）和大出血的复合结局。次要结局包括不良心脑血管事件净复合结局（NACCE），由主要结局和共同主要结局合并得出，以及个体缺血和出血事件。

结果

五项随机试验中，共有16117例患者在PCI后并完成推荐的DAPT疗程（中位疗程12个月）后被分配接受P2Y抑制剂或阿司匹林单药治疗。在中位随访1351天（四分位间距373 - 1791天）时，与阿司匹林单药治疗相比，P2Y抑制剂单药治疗的MACCE风险更低（单阶段分析：风险比0.77（95%置信区间（CI）0.67至0.89），P<0.001；多变量单阶段分析：调整后风险比0.77（0.67至0.89），P<0.001；两阶段分析：风险比0.77（0.67至0.89），P<0.001），需治疗获益人数为45.5（95%CI 31.4至93.6）。大出血方面未观察到显著差异（单阶段分析：风险比1.26（0.78至2.04），P = 0.35；多变量单阶段分析：1.12（0.74至1.70），P = 0.60；两阶段分析：1.15（0.69至1.92），P = 0.59）。与接受阿司匹林治疗的患者相比，接受P2Y抑制剂治疗的患者NACCE、心肌梗死和中风发生率更低。这些发现通过多项敏感性和亚组分析得到证实。