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评估可能从真实世界中使用利伐沙班获益的冠心病患者:TERCET 注册研究人群中 COMPASS 试验标准的实施。

Assessment of patients with coronary artery disease who may benefit from the use of rivaroxaban in the real world: implementation of the COMPASS trial criteria in the TERCET registry population.

机构信息

3rd Department of Cardiology, Silesian Centre for Heart Diseases in Zabrze, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Zabrze, Poland

Department of Cardiovascular Disease Prevention, Department of Metabolic Disease Prevention, School of Public Health in Bytom, Medical University of Silesia, Bytom, Poland

出版信息

Pol Arch Intern Med. 2019 Aug 29;129(7-8):460-468. doi: 10.20452/pamw.14907. Epub 2019 Jul 25.

Abstract

INTRODUCTION

The positive outcomes of the COMPASS trial raise questions about the proportion of patients who could benefit from additional therapy with rivaroxaban in real‑world practice.

OBJECTIVES

We aimed to identify the proportion of patients from the TERCET registry with significant coronary artery disease (TERCET‑CAD) who could benefit from the use of rivaroxaban and to assess their clinical characteristics and long‑term prognosis in comparison with the corresponding measures in the COMPASS trial.

PATIENTS AND METHODS

The COMPASS criteria were applied in the TERCET‑CAD population. Patients who met the criteria of the COMPASS trial were included in the COMPASS‑like group. The baseline characteristics and long‑term outcomes of the COMPASS‑like group were compared with the corresponding measures in the acetylsalicylic acid (ASA)-alone arm from the COMPASS trial.

RESULTS

The COMPASS‑like group included 3884 patients (31.6%) out of the 12 286 patients constituting the TERCET‑CAD population. Patients in the COMPASS‑like group were characterized by older age (P <0.001) and a more frequent occurrence of risk factors for CAD than those in the ASA‑alone arm of the COMPASS trial. The rate of a composite endpoint in the COMPASS‑like group was 9%, and in the ASA‑alone arm of the COMPASS trial, it was 6% (P <0.001).

CONCLUSIONS

Less than one-third of the TERCET‑CAD population met the COMPASS criteria and could potentially benefit from low‑dose rivaroxaban therapy. Unfavorable clinical profiles and higher rates of adverse events in the TERCET registry compared with those in the COMPASS trial may predict greater benefits from the implementation of low‑dose rivaroxaban in the real‑world population.

摘要

简介

COMPASS 试验的阳性结果引发了疑问,即在真实世界实践中,有多少患者可以从利伐沙班的额外治疗中获益。

目的

我们旨在确定 TERCET 登记处有显著冠状动脉疾病(TERCET-CAD)的患者中有多少比例可以受益于利伐沙班的使用,并评估与 COMPASS 试验中相应措施相比他们的临床特征和长期预后。

患者和方法

将 COMPASS 标准应用于 TERCET-CAD 人群。符合 COMPASS 试验标准的患者被纳入 COMPASS 样组。将 COMPASS 样组的基线特征和长期结局与 COMPASS 试验中乙酰水杨酸(ASA)单药组的相应措施进行比较。

结果

在 TERCET-CAD 人群的 12286 例患者中,有 3884 例(31.6%)符合 COMPASS 样组标准。与 COMPASS 试验中 ASA 单药组相比,COMPASS 样组的患者年龄更大(P<0.001),且发生 CAD 危险因素的频率更高。COMPASS 样组的复合终点发生率为 9%,而 COMPASS 试验中 ASA 单药组的发生率为 6%(P<0.001)。

结论

不到三分之一的 TERCET-CAD 人群符合 COMPASS 标准,可能受益于低剂量利伐沙班治疗。与 COMPASS 试验相比,TERCET 登记处的临床特征较差和不良事件发生率较高可能预示着在真实世界人群中实施低剂量利伐沙班将带来更大的益处。

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