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经药物洗脱支架 PCI 术后的冠状动脉血栓形成和大出血:PARIS 风险评分。

Coronary Thrombosis and Major Bleeding After PCI With Drug-Eluting Stents: Risk Scores From PARIS.

机构信息

Mount Sinai Heart, Mount Sinai Medical Center, New York, New York.

Mount Sinai Heart, Mount Sinai Medical Center, New York, New York.

出版信息

J Am Coll Cardiol. 2016 May 17;67(19):2224-2234. doi: 10.1016/j.jacc.2016.02.064. Epub 2016 Apr 11.

DOI:10.1016/j.jacc.2016.02.064
PMID:27079334
Abstract

BACKGROUND

Dual-antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention reduces the risk for coronary thrombotic events (CTEs) at the expense of increasing risk for major bleeding (MB). Metrics to accurately predict the occurrence of each respective event and inform clinical decision making are lacking.

OBJECTIVES

The aim of this study was to develop and validate separate models to predict risks for out-of-hospital thrombotic and bleeding events after percutaneous coronary intervention with drug-eluting stents.

METHODS

Using data from 4,190 patients treated with drug-eluting stents and enrolled in the PARIS (Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients) registry, separate risk scores were developed to predict CTE (defined as the composite of stent thrombosis or myocardial infarction) and MB (defined as the occurrence of a Bleeding Academic Research Consortium type 3 or 5 bleed). External validation was performed in the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) registry.

RESULTS

Over 2 years, CTEs occurred in 151 patients (3.8%) and MB in 133 (3.3%). Independent predictors of CTEs included acute coronary syndrome, prior revascularization, diabetes mellitus, renal dysfunction, and current smoking. Independent predictors of MB included older age, body mass index, triple therapy at discharge, anemia, current smoking, and renal dysfunction. Each model displayed moderate levels of discrimination and adequate calibration.

CONCLUSIONS

Simple risk scores of baseline clinical variables may be useful to predict risks for ischemic and bleeding events after PCI with DES, thereby facilitating clinical decisions surrounding the optimal duration of DAPT. (Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients [PARIS]; NCT00998127).

摘要

背景

经皮冠状动脉介入治疗(PCI)后,阿司匹林和氯吡格雷双联抗血小板治疗可降低冠状动脉血栓事件(CTE)的风险,但会增加大出血(MB)的风险。目前缺乏准确预测每种事件发生风险并为临床决策提供信息的指标。

目的

本研究旨在建立并验证分别预测药物洗脱支架 PCI 术后发生院内血栓和出血事件风险的模型。

方法

利用 PARIS(支架患者抗血小板方案不依从模式)注册研究中 4190 例接受药物洗脱支架治疗的患者数据,分别建立预测 CTE(定义为支架血栓形成或心肌梗死的复合事件)和 MB(定义为发生 Bleeding Academic Research Consortium 3 型或 5 型出血)的风险评分。在 ADAPT-DES(药物洗脱支架双重抗血小板治疗评估)注册研究中进行外部验证。

结果

在 2 年的随访期间,151 例(3.8%)患者发生 CTE,133 例(3.3%)患者发生 MB。CTE 的独立预测因素包括急性冠脉综合征、既往血运重建、糖尿病、肾功能不全和当前吸烟。MB 的独立预测因素包括年龄较大、体重指数、出院时三联抗栓治疗、贫血、当前吸烟和肾功能不全。每个模型的区分度和校准度均处于中等水平。

结论

基于基线临床变量的简单风险评分,可能有助于预测 DES 后 PCI 患者发生缺血和出血事件的风险,从而有助于围绕 DAPT 最佳持续时间做出临床决策。(支架患者抗血小板方案不依从模式 [PARIS];NCT00998127)

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