Ticagrelor 60 vs. 90 mg in elderly ACS patients undergoing PCI: a randomized, crossover trial.

IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS European Heart Journal - Cardiovascular Pharmacotherapy Pub Date : 2024-11-06 DOI:10.1093/ehjcvp/pvae054
Raffaele Piccolo, Fiorenzo Simonetti, Marisa Avvedimento, Maria Cutillo, Mario Enrico Canonico, Valeria Conti, Giuseppe Gargiulo, Roberta Paolillo, Fabrizio Dal Piaz, Amelia Filippelli, Bruno Charlier, Alessandra Spinelli, Stefano Cristiano, Plinio Cirillo, Luigi Di Serafino, Anna Franzone, Giovanni Esposito
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引用次数: 0

Abstract

Aims: Although dual antiplatelet therapy with aspirin and a potent P2Y12 receptor inhibitor is currently recommended in patients with acute coronary syndrome (ACS), its use in elderly patients remains challenging. The aim of this trial is to evaluate the pharmacodynamic and pharmacokinetic profile of ticagrelor 60 vs. 90 mg twice daily among elderly patients (≥75 years) with ACS undergoing percutaneous coronary intervention (PCI).

Methods and results: PLINY The ELDER (NCT04739384) was a randomized, crossover trial testing the non-inferiority of a lower vs. standard dose of ticagrelor with respect to the primary endpoint of P2Y12 inhibition as determined by pre-dose P2Y12 reaction units (PRU) using the VerifyNow-P2Y12 (Accumetrics, San Diego, CA, USA). Other pharmacodynamic tests included light transmittance aggregometry, multiple electrode aggregometry, and response to aspirin. Plasma levels of ticagrelor and its active metabolite AR-C124910XX were also evaluated. A total of 50 patients (mean age 79.6 ± 4.0 years, females 44%) were included in the trial. Ticagrelor 60 mg was non-inferior to ticagrelor 90 mg according to VerifyNow-P2Y12 results (PRU 26.4 ± 32.1 vs. 30.4 ± 39.0; least squares mean difference: -4; 95% confidence interval: -16.27 to 8.06; P for non-inferiority = 0.002). Other pharmacodynamic parameters were similar between the two ticagrelor doses and there were no differences in response to aspirin. Plasma levels of ticagrelor (398.29 ± 312.36 ng/mL vs. 579.57 ± 351.73 ng/mL, P = 0.006) and its active metabolite were significantly lower during treatment with ticagrelor 60 mg.

Conclusion: Although plasma concentrations were lower, ticagrelor 60 mg twice daily provided a similar magnitude of platelet inhibition compared with ticagrelor 90 mg twice daily among elderly patients undergoing PCI.

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接受 PCI 治疗的老年 ACS 患者服用 60 毫克与 90 毫克替卡格雷:一项随机交叉试验。
目的:尽管目前推荐急性冠状动脉综合征(ACS)患者使用阿司匹林和强效 P2Y12 受体抑制剂的双重抗血小板疗法(DAPT),但在老年患者中使用该疗法仍具有挑战性。本试验旨在评估接受经皮冠状动脉介入治疗(PCI)的急性冠状动脉综合征老年患者(≥75 岁)中,替卡格雷 60 mg 与 90 mg 每日两次的药效学和药代动力学特征:PLINY The ELDER (NCT04739384)是一项随机交叉试验,测试在使用VerifyNow-P2Y12 (Accumetrics, San Diego, CA)通过剂量前P2Y12反应单位(PRU)确定的P2Y12抑制主要终点方面,低剂量与标准剂量替卡格雷的非劣效性。其他药效学测试包括透光率聚集测定法、多电极聚集测定法和对阿司匹林的反应。此外,还对替卡格雷及其活性代谢物 AR-C124910XX 的血浆水平进行了评估。共有 50 名患者(平均年龄为 79.6±4.0 岁,女性占 44%)参与了试验。根据 VerifyNow-P2Y12 的结果,替卡格雷 60 毫克的疗效不劣于替卡格雷 90 毫克(PRU 26.4±32.1 vs. 30.4±39.0;最小二乘法均值差:-4;95% 置信区间:16.0±4.0):-4;95% 置信区间:-16.27 至 8.06;非劣效性 p=0.002)。两种剂量的替卡格雷的其他药效学参数相似,对阿司匹林的反应也无差异。在使用ticagrelor 60 mg治疗期间,血浆中的ticagrelor(398.29±312.36 ng/mL vs. 579.57±351.73 ng/mL,p=0.006)及其活性代谢物水平显著降低:结论:虽然血浆浓度较低,但在接受PCI治疗的老年患者中,与替卡格雷90毫克每天两次相比,替卡格雷60毫克每天两次可提供相似程度的血小板抑制作用。临床试验注册:EudraCT 2019-002391-13。Clinicaltrials.gov NCT04739384。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
European Heart Journal - Cardiovascular Pharmacotherapy
European Heart Journal - Cardiovascular Pharmacotherapy Medicine-Cardiology and Cardiovascular Medicine
CiteScore
10.10
自引率
14.10%
发文量
65
期刊介绍: The European Heart Journal - Cardiovascular Pharmacotherapy (EHJ-CVP) is an international, peer-reviewed journal published in English, specifically dedicated to clinical cardiovascular pharmacology. EHJ-CVP publishes original articles focusing on clinical research involving both new and established drugs and methods, along with meta-analyses and topical reviews. The journal's primary aim is to enhance the pharmacological treatment of patients with cardiovascular disease by interpreting and integrating new scientific developments in this field. While the emphasis is on clinical topics, EHJ-CVP also considers basic research articles from fields such as physiology and molecular biology that contribute to the understanding of cardiovascular drug therapy. These may include articles related to new drug development and evaluation, the physiological and pharmacological basis of drug action, metabolism, drug interactions, and side effects.
期刊最新文献
Safety and efficacy of early initiation of sodium-glucose cotransporter-2 inhibitors after an acute coronary syndrome event: a meta-analysis of randomized controlled trials. Ticagrelor 60 vs. 90 mg in elderly ACS patients undergoing PCI: a randomized, crossover trial. P2Y12 inhibitor monotherapy after short DAPT in acute coronary syndrome: a systematic review and meta-analysis. Management of dyslipidaemia in patients with comorbidities: facing the challenge. Cardiac adverse drug reactions to COVID-19 vaccines. A cross-sectional study based on the Europe-wide data.
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