Wiederkehr Daniel, Ogbonnaya Augustina, Casciano Roman, Makenbaeva Dinara, Mozaffari Essy, Corbelli John
Analytica International, New York, NY, USA.
Curr Med Res Opin. 2009 Sep;25(9):2327-34. doi: 10.1185/03007990903156087.
To evaluate the association between discontinuation of clopidogrel therapy and risk of acute myocardial infarction (AMI) hospitalization or cardiac revascularization in a nationally-representative patient population following hospitalization for an AMI or coronary stent insertion.
This observational cohort study was performed using data on patients from the PharMetrics Anonymous Patient-Centric Database who were hospitalized for an AMI or coronary stent insertion and subsequently treated with clopidogrel. Cox proportional hazard modeling was used to evaluate the association between clopidogrel discontinuation prior to 1 year post-initial AMI hospitalization and the primary endpoint of repeat AMI hospitalization or coronary intervention defined as percutaneous coronary intervention (PCI) with or without stent, or coronary artery bypass graft (CABG).
The main outcome for this study was AMI hospitalization or coronary intervention defined as PCI with or without stent placement or CABG.
A total of 31 835 patients were included in the analyses. Patients were predominantly male and the average patient age was approximately 60 years. After controlling for baseline patient characteristics and follow-up time, discontinuation of clopidogrel was associated with a significantly higher rate of hospitalization for AMI or coronary intervention (HR 1.34, 95% CI 1.22-1.44).
Within a population of ACS patients drawn from a database of 85 US health plans, clopidogrel discontinuation within 1 year following hospitalization for AMI or stent placement is associated with an increased risk of AMI hospitalization or coronary intervention. The results of this study should be interpreted within the context of observational research, which does not address cause and effect relationships.
在全国代表性患者群体中，评估急性心肌梗死（AMI）住院或冠状动脉支架置入术后停用氯吡格雷治疗与再次发生 AMI 住院或心脏血运重建风险之间的关联。
本观察性队列研究使用了 PharMetrics 匿名患者中心数据库中因 AMI 或冠状动脉支架置入而住院并随后接受氯吡格雷治疗的患者数据。采用 Cox 比例风险模型评估初次 AMI 住院后 1 年内停用氯吡格雷与再次 AMI 住院或冠状动脉介入（定义为有或无支架的经皮冠状动脉介入治疗（PCI）或冠状动脉旁路移植术（CABG））这一主要终点之间的关联。
本研究的主要结局是 AMI 住院或冠状动脉介入，定义为有或无支架置入的 PCI 或 CABG。
共有 31835 名患者纳入分析。患者以男性为主，平均年龄约为 60 岁。在控制了患者基线特征和随访时间后，停用氯吡格雷与 AMI 住院或冠状动脉介入的发生率显著升高相关（风险比 1.34，95%置信区间 1.22 - 1.44）。
在从 85 个美国健康计划数据库中选取的急性冠状动脉综合征（ACS）患者群体中，AMI 住院或支架置入术后 1 年内停用氯吡格雷与 AMI 住院或冠状动脉介入风险增加相关。本研究结果应在观察性研究的背景下进行解读，观察性研究未涉及因果关系。
