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阿司匹林停药联合经皮冠状动脉介入治疗后患者 P2Y 抑制剂的安全性和有效性:系统评价和荟萃分析。

The Safety and Efficacy of Aspirin Discontinuation on a Background of a P2Y Inhibitor in Patients After Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis.

机构信息

TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA.

出版信息

Circulation. 2020 Aug 11;142(6):538-545. doi: 10.1161/CIRCULATIONAHA.120.046251. Epub 2020 Jun 19.

Abstract

BACKGROUND

Dual antiplatelet therapy with aspirin and a P2Y inhibitor has been shown to reduce the risk of major adverse cardiovascular events (MACE) compared with aspirin alone after percutaneous coronary intervention (PCI) or acute coronary syndrome but with increased risk of bleeding. The safety of discontinuing aspirin in favor of P2Y inhibitor monotherapy remains disputed.

METHODS

A meta-analysis was conducted from randomized trials (2001-2020) that studied discontinuation of aspirin 1 to 3 months after PCI with continued P2Y inhibitor monotherapy compared with traditional dual antiplatelet therapy. Five trials were included; follow-up duration ranged from 12 to 15 months after PCI. Primary bleeding and MACE outcomes were the prespecified definitions in each trial.

RESULTS

The study population included 32 145 patients: 14 095 (43.8%) with stable coronary artery disease and 18 046 (56.1%) with acute coronary syndrome. In the experimental arm, background use of a P2Y inhibitor included clopidogrel in 2649 (16.5%) and prasugrel or ticagrelor in 13 408 (83.5%) patients. In total, 820 patients experienced a primary bleeding outcome and 937 experienced MACE. Discontinuation of aspirin therapy 1 to 3 months after PCI significantly reduced the risk of major bleeding by 40% compared with dual antiplatelet therapy (1.97% versus 3.13%; hazard ratio [HR], 0.60 [95% CI, 0.45-0.79]), with no increase observed in the risk of MACE (2.73% versus 3.11%; HR, 0.88 [95% CI, 0.77-1.02]), myocardial infarction (1.08% versus 1.27%; HR, 0.85 [95% CI, 0.69-1.06]), or death (1.25% versus 1.47%; HR, 0.85 [95% CI, 0.70-1.03]). Findings were consistent among patients who underwent PCI for an acute coronary syndrome, in whom discontinuation of aspirin after 1 to 3 months reduced bleeding by 50% (1.78% versus 3.58%; HR, 0.50 [95% CI, 0.41-0.61]) and did not appear to increase the risk of MACE (2.51% versus 2.98%; HR, 0.85 [95% CI, 0.70-1.03]).

CONCLUSIONS

Discontinuation of aspirin with continued P2Y inhibitor monotherapy reduces risk of bleeding when stopped 1 to 3 months after PCI. An increased risk of MACE was not observed after discontinuation of aspirin, including in patients with acute coronary syndrome.

摘要

背景

与单独使用阿司匹林相比,经皮冠状动脉介入治疗(PCI)或急性冠状动脉综合征后,使用阿司匹林和 P2Y 抑制剂的双联抗血小板治疗可降低主要不良心血管事件(MACE)的风险,但出血风险增加。停止使用阿司匹林转而使用 P2Y 抑制剂单药治疗的安全性仍存在争议。

方法

对 2001 年至 2020 年期间进行的随机试验进行了荟萃分析,研究了 PCI 后 1 至 3 个月停用阿司匹林并继续使用 P2Y 抑制剂单药治疗与传统双联抗血小板治疗相比的安全性。纳入了 5 项试验;PCI 后的随访时间范围为 12 至 15 个月。每个试验都有预先确定的主要出血和 MACE 结局定义。

结果

研究人群包括 32145 名患者:14095 名(43.8%)患有稳定型冠状动脉疾病,18046 名(56.1%)患有急性冠状动脉综合征。在实验组中,背景使用的 P2Y 抑制剂包括氯吡格雷 2649 名(16.5%)和普拉格雷或替格瑞洛 13408 名(83.5%)患者。共有 820 名患者发生主要出血结局,937 名患者发生 MACE。与双联抗血小板治疗相比,PCI 后 1 至 3 个月停用阿司匹林可显著降低大出血风险 40%(1.97%与 3.13%;风险比[HR],0.60[95%CI,0.45-0.79]),而 MACE 风险无增加(2.73%与 3.11%;HR,0.88[95%CI,0.77-1.02])、心肌梗死(1.08%与 1.27%;HR,0.85[95%CI,0.69-1.06])或死亡(1.25%与 1.47%;HR,0.85[95%CI,0.70-1.03])。在因急性冠状动脉综合征而行 PCI 的患者中,发现的结果一致,其中 1 至 3 个月后停用阿司匹林可降低 50%的出血风险(1.78%与 3.58%;HR,0.50[95%CI,0.41-0.61]),且似乎不会增加 MACE 风险(2.51%与 2.98%;HR,0.85[95%CI,0.70-1.03])。

结论

PCI 后 1 至 3 个月停用阿司匹林并继续使用 P2Y 抑制剂单药治疗可降低出血风险。停用阿司匹林后未观察到 MACE 风险增加,包括在急性冠状动脉综合征患者中。

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