Comparative Risk of Hospitalized Bleeding of P2Y12 Inhibitors for Secondary Prophylaxis in Acute Coronary Syndrome After Percutaneous Coronary Intervention.

Comparative Risk of Hospitalized Bleeding of P2Y12 Inhibitors for Secondary Prophylaxis in Acute Coronary Syndrome After Percutaneous Coronary Intervention.
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DOI:
10.1002/cpt.2806
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发表时间:
2023-02
影响因子:
6.7
通讯作者:
Farley, Joel F.
Farley, Joel F.
中科院分区:
医学2区
文献类型:
--
作者:
Kumar, Arun;Lutsey, Pamela L.;St. Peter, Wendy L.;Schommer, Jon C.;Van't Hof, Jeremy R.;Rajpurohit, Abhijeet;Farley, Joel F.

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在密切监测的随机对照试验(RCT)中,较新的P2 Y12药物(替格瑞洛和普拉格雷)与氯吡格雷相比,可降低急性冠脉综合征经皮冠状动脉介入治疗(PCI)后的心血管结局。然而,这些随机对照试验表明这些新药物的出血风险更高。本研究在真实的世界人群中评价了每种P2 Y12抑制剂对因大出血住院治疗的相对安全性。这项回顾性、倾向评分匹配(PSM)队列研究使用了6年(2013-2018)的IBM MarketScan数据库,以识别年龄≥18岁的P2 Y12抑制剂事件使用者。主要安全性结局为因任何大出血事件(包括胃肠道、颅内和其他严重形式的出血)而住院。在使用考克斯-比例风险模型的成对比较中,比较了替格瑞洛、普拉格雷和氯吡格雷使用者在PCI后首次处方P2 Y12抑制剂后30、90和180天的主要安全性结局。有21,719(替格瑞洛与氯吡格雷)、11,513(普拉格雷与氯吡格雷)和11,065(普拉格雷与替格瑞洛)PSM对。总体而言,所有P2 Y12抑制剂的大出血风险相似。与氯吡格雷相比,替格瑞洛使用者因大出血住院的比例通常较低,而普拉格雷使用者因大出血住院的比例高于氯吡格雷。重要的是,与氯吡格雷相比,普拉格雷在90天时的大出血风险高66%(风险比1.66; 95%置信区间,1.11-2.48)。这项研究表明普拉格雷的短期出血风险高于氯吡格雷,这与RCT的结果一致。
In closely monitored randomized controlled trials (RCTs), newer P2Y12 agents (ticagrelor and prasugrel) reduced cardiovascular outcomes compared with clopidogrel following percutaneous coronary intervention (PCI) in acute coronary syndrome. However, these RCTs indicated a higher bleeding risk with these newer agents. This study evaluated the comparative safety of each P2Y12 inhibitor on hospitalizations due to major bleeding in a real‐world population. This retrospective, propensity score‐matched (PSM) cohort study utilized the IBM MarketScan database over 6 years (2013–2018) to identify incident users of P2Y12 inhibitors with age ≥18 years. The primary safety outcome was hospitalization due to any major bleeding event including gastrointestinal, intracranial, and other serious forms of bleeding. In pairwise comparisons using Cox‐proportional hazards models, ticagrelor, prasugrel, and clopidogrel users were compared for the primary safety outcome at 30, 90, and 180 days following the first prescription of P2Y12 inhibitor after PCI. There were 21,719 (ticagrelor vs. clopidogrel), 11,513 (prasugrel vs. clopidogrel), and 11,065 (prasugrel vs. ticagrelor) PSM pairs. Overall, the risk of major bleeding was similar for all P2Y12 inhibitors. Hospitalization for major bleeding was generally lower among ticagrelor users vs. clopidogrel and higher among prasugrel users compared with clopidogrel. Importantly, a 66% higher risk of major bleeding at 90 days is suggested with prasugrel compared with clopidogrel (hazard ratio 1.66; 95% confidence interval, 1.11–2.48). This study indicated a higher short‐term bleeding risk with prasugrel compared with clopidogrel, which concurs with the results of RCTs.
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