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低剂量替格瑞洛在中国接受经皮冠状动脉介入治疗的急性冠状动脉综合征患者中的安全性和有效性。

Safety and efficacy of low-dose ticagrelor in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.

作者信息

Wang Yue, Liu Beibei, Chen Leilei, Wang Yue, Wang Zhiqiang, Zhang Xiaojiang, Suo Min, Mintz Gary S, Wu Xiaofan

机构信息

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.

Emergency and Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.

出版信息

Platelets. 2022 Feb 17;33(2):304-311. doi: 10.1080/09537104.2021.1909717. Epub 2021 Apr 4.

Abstract

It remains unclear whether low-dose ticagrelor offers better safety and similar efficacy for Asian patients with acute coronary syndromes (ACS). We aimed to compare the safety and effectiveness of low-dose ticagrelor vs standard-dose ticagrelor in Chinese patients with ACS undergoing percutaneous coronary intervention (PCI). In this observational cohort study, a total of 2110 ACS patients who were event-free at 3 months after the index PCI were divided into standard-dose ticagrelor (90 mg twice daily) (n = 1830) or low-dose ticagrelor (45 mg twice daily) (n = 280) on a background of aspirin 100 mg once daily for at least another 9 months. The primary end point was type 2, 3, or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) criteria over a 1-year follow-up period post-PCI. Predictors of the primary end point were identified. Both Cox regression and propensity score matching analyses were used. The cumulative incidence of BARC type 2, 3, or 5 bleeding was lower in the low-dose ticagrelor group vs the standard-dose group either before (adjusted HR 0.24; 95% CI 0.07-0.77; = .016) or after matching (HR 0.25; 95% CI 0.08-0.85; = .026). A composite of cardiac death, myocardial infarction, or stroke was not significantly different between the two groups (0.4% vs 0.9%, respectively). By multivariate analysis, only low-dose ticagrelor was a protected predictor of BARC type 2, 3, or 5 bleeding either before (HR 0.28, 95% CI 0.09-0.89) or after matching (HR 0.24, 95% CI 0.07-0.82). A low-dose regimen of ticagrelor might provide better safety than standard-dose ticagrelor in Chinese patients with ACS undergoing PCI.

摘要

低剂量替格瑞洛对亚洲急性冠状动脉综合征(ACS)患者是否能提供更好的安全性及相似的疗效仍不明确。我们旨在比较低剂量替格瑞洛与标准剂量替格瑞洛对接受经皮冠状动脉介入治疗(PCI)的中国ACS患者的安全性和有效性。在这项观察性队列研究中,共有2110例在首次PCI术后3个月无事件发生的ACS患者,在每日服用100mg阿司匹林的基础上,被分为标准剂量替格瑞洛组(每日两次,每次90mg)(n = 1830)或低剂量替格瑞洛组(每日两次,每次45mg)(n = 280),并至少持续另外9个月。主要终点是PCI术后1年随访期内根据出血学术研究联盟(BARC)标准定义的2、3或5型出血。确定了主要终点的预测因素。使用了Cox回归和倾向评分匹配分析。在匹配前(调整后HR 0.24;95%CI 0.07 - 0.77;P = 0.016)或匹配后(HR 0.25;95%CI 0.08 - 0.85;P = 0.026),低剂量替格瑞洛组的BARC 2、3或5型出血的累积发生率均低于标准剂量组。两组间心脏性死亡、心肌梗死或卒中的复合终点无显著差异(分别为0.4%和0.9%)。通过多变量分析,仅低剂量替格瑞洛在匹配前(HR 0.28,95%CI 0.09 - 0.89)或匹配后(HR 0.24,95%CI 0.07 - 0.82)是BARC 2、3或5型出血的保护性预测因素。对于接受PCI的中国ACS患者,低剂量替格瑞洛方案可能比标准剂量替格瑞洛提供更好的安全性。

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