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双联抗血小板治疗在老年人群预防卒中的疗效和安全性:CHANCE-2 试验的亚组分析。

Efficacy and safety of dual antiplatelet therapy in the elderly for stroke prevention: a subgroup analysis of the CHANCE-2 trial.

机构信息

Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

China National Clinical Research Center for Neurological Diseases, Beijing, China.

出版信息

Stroke Vasc Neurol. 2024 Nov 5;9(5):541-550. doi: 10.1136/svn-2023-002450.

DOI:10.1136/svn-2023-002450
PMID:38286485
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11732837/
Abstract

OBJECTIVES

Evidence of the optimal antiplatelet therapy for elderly patients who had a stroke is limited, especially those elder than 80 years. This study aimed to explore the efficacy and safety of dual antiplatelet therapy (DAPT) in old-old patients compared with younger patients in the ticagrelor or Clopidogrel with aspirin in High-risk patients with Acute Non-disabling Cerebrovascular Events-II (CHANCE-2) trial.

METHODS

CHANCE-2 was a randomised, double-blind, placebo-controlled trial in China involving patients with high-risk transient ischaemic attack or minor stroke with CYP2C19 loss-of-function alleles. In our substudy, all enrolled patients were stratified by age: old-old (≥80 years), young-old (65-80 years) and younger (<65 years). The primary outcomes were stroke recurrence and moderate to severe bleeding within 90 days, respectively.

RESULTS

Of all the 6412 patients, 406 (6.3%) were old-old, 2755 (43.0%) were young-old and 3251 (50.7%) were younger. Old-old patients were associated with higher composite vascular events (HR 1.41, 95% CI 1.00 to 1.98, p=0.048), disabling stroke (OR 2.43, 95% CI 1.52 to 3.88, p=0.0002), severe or moderate bleeding (HR 8.40, 95% CI 1.95 to 36.21, p=0.004) and mortality (HR 7.56, 95% CI 2.23 to 25.70, p=0.001) within 90 days. Ticagrelor-aspirin group was associated with lower risks of stroke recurrence within 90 days in younger patients (HR 0.68, 95% CI 0.51 to 0.91, p=0.008), which was no differences in old-old patients.

CONCLUSION

Elderly patients aged over 80 in CHANCE-2 trial had higher risks of composite vascular events, disabling stroke, severe or moderate bleeding and mortality within 90 days. Genotype-guided DAPT might not be as effective in old-old patients as in younger ones.

TRIAL REGISTRATION NUMBER

NCT04078737.

摘要

目的

对于发生卒中的老年患者,最佳抗血小板治疗的证据有限,尤其是年龄 80 岁以上的患者。本研究旨在探讨替格瑞洛或氯吡格雷联合阿司匹林双联抗血小板治疗(DAPT)在 CHANCE-2 试验中高龄(≥80 岁)与年轻患者(<65 岁)中的疗效和安全性。

方法

CHANCE-2 是一项在中国进行的、随机、双盲、安慰剂对照的临床试验,纳入了伴有 CYP2C19 失活等位基因的高风险短暂性脑缺血发作或小卒中患者。在我们的亚研究中,所有入组患者均按年龄分层:高龄(≥80 岁)、中龄(65-80 岁)和年轻(<65 岁)。主要结局分别为 90 天内卒中复发和中重度出血。

结果

在 6412 例患者中,406 例(6.3%)为高龄,2755 例(43.0%)为中龄,3251 例(50.7%)为年轻。高龄患者复合血管事件(HR 1.41,95%CI 1.00 至 1.98,p=0.048)、致残性卒中(OR 2.43,95%CI 1.52 至 3.88,p=0.0002)、严重或中度出血(HR 8.40,95%CI 1.95 至 36.21,p=0.004)和 90 天内死亡率(HR 7.56,95%CI 2.23 至 25.70,p=0.001)更高。替格瑞洛-阿司匹林组在年轻患者中 90 天内卒中复发风险较低(HR 0.68,95%CI 0.51 至 0.91,p=0.008),但在高龄患者中无差异。

结论

CHANCE-2 试验中 80 岁以上的老年患者在 90 天内发生复合血管事件、致残性卒中、严重或中度出血和死亡的风险更高。基因指导的 DAPT 可能不如年轻患者有效。

试验注册

NCT04078737。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2813/11732837/887344bbcbce/svn-9-5-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2813/11732837/887344bbcbce/svn-9-5-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2813/11732837/887344bbcbce/svn-9-5-g001.jpg

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