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替格瑞洛与氯吡格雷治疗急性冠状动脉综合征合并糖尿病患者的临床结局比较。

Clinical Outcome between Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndrome and Diabetes.

机构信息

Department of Cardiology, The Second Affiliated Hospital, Army Medical University, Chongqing, China.

Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.

出版信息

Cardiovasc Ther. 2021 Oct 15;2021:5546260. doi: 10.1155/2021/5546260. eCollection 2021.

DOI:10.1155/2021/5546260
PMID:34737792
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8536459/
Abstract

BACKGROUND

The increased thrombotic risk in patients with acute coronary syndrome (ACS) and diabetes highlights the need for adequate antithrombotic protection. We aimed to compare the 6-month clinical outcomes between ticagrelor and clopidogrel in patients with ACS and diabetes.

METHODS AND RESULTS

The study was a single-center, prospective, randomized, open-label, blinded endpoint, and controlled registry trial. A total of 270 ACS patients with diabetes were randomly assigned in a 1 : 1 ratio to either the ticagrelor group or the clopidogrel group. Follow-up was performed for 6 months, and the data on efficacy outcomes and bleeding events were collected. At 6 months, complete follow-up data were available for 266 (98.5%) of 270 patients, and 4 were lost to follow-up. There was no significant difference in the survival rate of the effective endpoints between the ticagrelor group ( = 133) and the clopidogrel group ( = 133) (HR 0.83, 95% CI 0.44-1.56, = 0.561), but the incidence of bleeding events in the ticagrelor group was higher than that in the clopidogrel group (HR 1.76, 95% CI 1.00-3.10, = 0.049).

CONCLUSION

Ticagrelor did not improve the composite of nonfatal MI, target vessel revascularization, rehospitalization, stroke, and death from any cause; however, it significantly increased the incidence of bleeding events defined by the Bleeding Academic Research Consortium (BARC) criteria in Chinese patients with ACS and diabetes during the 6-month follow-up compared with clopidogrel.

摘要

背景

急性冠脉综合征(ACS)和糖尿病患者的血栓形成风险增加,突出了充分的抗血栓保护的必要性。我们旨在比较替格瑞洛和氯吡格雷在 ACS 和糖尿病患者中的 6 个月临床结局。

方法和结果

这是一项单中心、前瞻性、随机、开放标签、盲终点、对照登记研究。共纳入 270 例 ACS 合并糖尿病患者,按 1:1 比例随机分配至替格瑞洛组或氯吡格雷组。随访 6 个月,收集疗效结局和出血事件的数据。在 6 个月时,270 例患者中的 266 例(98.5%)获得了完整的随访数据,4 例失访。替格瑞洛组(n=133)和氯吡格雷组(n=133)的有效终点生存率无显著差异(HR 0.83,95%CI 0.44-1.56,=0.561),但替格瑞洛组出血事件的发生率高于氯吡格雷组(HR 1.76,95%CI 1.00-3.10,=0.049)。

结论

替格瑞洛并未改善非致命性 MI、靶血管血运重建、再住院、卒中和任何原因导致的死亡的复合终点;然而,与氯吡格雷相比,它在 6 个月随访期间显著增加了中国 ACS 和糖尿病患者中根据 Bleeding Academic Research Consortium(BARC)标准定义的出血事件的发生率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77df/8536459/63e667ed04ae/CDTP2021-5546260.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77df/8536459/6ff0a6f1f302/CDTP2021-5546260.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77df/8536459/63e667ed04ae/CDTP2021-5546260.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77df/8536459/6ff0a6f1f302/CDTP2021-5546260.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/77df/8536459/63e667ed04ae/CDTP2021-5546260.002.jpg

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