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低剂量替格瑞洛在高缺血风险和既往心肌梗死患者中的应用:一项多中心前瞻性真实世界观察研究。

Low-Dose Ticagrelor in Patients With High Ischemic Risk and Previous Myocardial Infarction: A Multicenter Prospective Real-World Observational Study.

机构信息

Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli," Naples, Italy.

Division of Clinical Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano," Caserta, Italy.

出版信息

J Cardiovasc Pharmacol. 2020 Aug;76(2):173-180. doi: 10.1097/FJC.0000000000000856.

Abstract

Prolonged dual antiplatelet therapy after 12 months in patients with previous myocardial infarction (MI) is attractive to reduce long-term ischemic complications. In the PEGASUS-TIMI 54, the use of low-dose ticagrelor (60 mg b.i.d.) plus aspirin after 12 months from MI reduced the risk of ischemic events, at the price of limited increase on bleeding complications. However, data on the use of low-dose ticagrelor in real-world practice lack. We aim at providing data on prescription/eligibility criteria and outcomes in patients receiving low-dose ticagrelor in the real-world setting. We enrolled consecutive patients eligible for ticagrelor 60 mg according to Italian national regulation in 3 high-volume centers and collected 1-year outcomes. The primary objective of the study is to generate real-world data about clinical characteristics, eligibility criteria, major adverse cardiovascular events, bleeding, and adverse event in patients receiving low-dose ticagrelor from our cohort. One hundred eighty-one patients were consecutively enrolled with a median follow-up of 18 months. The most used and the least used prescription criteria were multivessel coronary disease (72.4%) and chronic kidney disease (15.5%), respectively. At 1-year follow-up, the rate of major adverse cardiovascular events was 4.97%; of these, 3.86% of patients had a MI, and 1.1% had a stroke/transient ischemic attack, whereas no major bleeding occurred. In conclusion, in a real-world study, including patients with previous MI, low-dose ticagrelor for prolonged dual antiplatelet therapy showed to be effective and safe, with no major bleeding occurring at follow-up.

摘要

对于有既往心肌梗死(MI)病史的患者,延长 12 个月的双联抗血小板治疗(DAPT)以减少长期缺血性并发症是很有吸引力的。在 PEGASUS-TIMI 54 研究中,MI 后 12 个月使用低剂量替格瑞洛(60mg,bid)加阿司匹林降低了缺血性事件的风险,但增加了出血并发症的有限风险。然而,真实世界实践中使用低剂量替格瑞洛的数据缺乏。我们旨在提供在真实世界环境中使用低剂量替格瑞洛的处方/入选标准和结局数据。我们连续纳入了 3 个大中心符合意大利国家规定的可使用替格瑞洛 60mg 的患者,并收集了 1 年的结局。该研究的主要目的是从我们的队列中生成关于接受低剂量替格瑞洛治疗的患者的临床特征、入选标准、主要心血管不良事件、出血和不良事件的真实世界数据。181 例患者连续入组,中位随访时间为 18 个月。最常用和最少用的处方标准分别是多血管性冠状动脉疾病(72.4%)和慢性肾脏疾病(15.5%)。在 1 年随访时,主要心血管不良事件的发生率为 4.97%;其中,3.86%的患者发生心肌梗死,1.1%的患者发生卒中/短暂性脑缺血发作,而没有发生重大出血。总之,在一项真实世界研究中,包括既往有 MI 的患者,延长 DAPT 使用低剂量替格瑞洛显示有效且安全,随访期间未发生重大出血。

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