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急性冠状动脉综合征患者支架血栓形成风险评分的制定与验证。

Development and validation of a stent thrombosis risk score in patients with acute coronary syndromes.

机构信息

Department of Cardiology, Mount Sinai Medical Center, New York, NY 10029, USA.

出版信息

JACC Cardiovasc Interv. 2012 Nov;5(11):1097-105. doi: 10.1016/j.jcin.2012.07.012.

Abstract

OBJECTIVES

This study sought to develop a practical risk score to predict the risk of stent thrombosis (ST) after percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS).

BACKGROUND

ST is a rare, yet feared complication after PCI with stent implantation. A risk score for ST after PCI in ACS can be a helpful tool to personalize risk assessment.

METHODS

This study represents a patient-level pooled analysis of 6,139 patients undergoing PCI with stent implantation for ACS in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trials who were randomized to treatment with bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor. The cohort was randomly divided into a risk score development cohort (n = 4,093) and a validation cohort (n = 2,046). Cox regression methods were used to identify clinical, angiographic, and procedural characteristics associated with Academic Research Consortium-defined definite/probable ST at 1 year. Each covariate in this model was assigned an integer score based on the regression coefficients.

RESULTS

Variables included in the risk score were type of ACS (ST-segment elevation myocardial infarction, non-ST-segment elevation ACS with ST deviation, or non-ST-segment elevation ACS without ST changes), current smoking, insulin-dependent diabetes mellitus, prior PCI, baseline platelet count, absence of early (pre-PCI) anticoagulant therapy, aneurysmal/ulcerated lesion, baseline TIMI (Thrombolysis In Myocardial Infarction) flow grade 0/1, final TIMI flow grade <3, and number of treated vessels. Risk scores 1 to 6 were considered low risk, 7 to 9 intermediate risk, and 10 or greater high risk for ST. Rates of ST at 1 year in low-, intermediate-, and high-risk categories were 1.36%, 3.06%, and 9.18%, respectively, in the development cohort (p for trend <0.001), and 1.65%, 2.77%, and 6.45% in the validation cohort (p for trend = 0.006). The C-statistic for this risk score was over 0.65 in both cohorts.

CONCLUSIONS

The individual risk of ST can be predicted using a simple risk score based on clinical, angiographic, and procedural variables. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966) (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACUITY]; NCT00093158).

摘要

目的

本研究旨在开发一种实用的风险评分模型,以预测急性冠脉综合征(ACS)经皮冠状动脉介入治疗(PCI)后支架血栓形成(ST)的风险。

背景

ST 是 PCI 术后支架植入后一种罕见但令人担忧的并发症。ACS 患者 PCI 术后 ST 风险评分可作为个体化风险评估的有用工具。

方法

本研究为 HORIZONS-AMI(急性心肌梗死中经皮冠状动脉介入治疗和支架的血管重建与稳定)和 ACUITY(急性冠状动脉介入治疗和紧急干预策略的急性经皮冠状动脉介入治疗)试验中接受 PCI 联合支架植入治疗 ACS 的 6139 例患者的患者水平汇总分析,这些患者被随机分为比伐卢定治疗组和肝素加糖蛋白 IIb/IIIa 抑制剂治疗组。该队列被随机分为风险评分开发队列(n=4093)和验证队列(n=2046)。采用 Cox 回归方法确定与学术研究联合会定义的 1 年时明确/可能 ST 相关的临床、血管造影和手术特征。该模型中的每个协变量根据回归系数被赋予一个整数评分。

结果

风险评分纳入的变量包括 ACS 类型(ST 段抬高型心肌梗死、伴有 ST 段偏移的非 ST 段抬高型 ACS 或无 ST 段改变的非 ST 段抬高型 ACS)、当前吸烟、胰岛素依赖型糖尿病、既往 PCI、基线血小板计数、无早期(PCI 前)抗凝治疗、动脉瘤/溃疡性病变、基线 TIMI(血栓溶解治疗心肌梗死)血流分级 0/1、最终 TIMI 血流分级<3、以及治疗血管数量。风险评分 1 至 6 分被认为是低危,7 至 9 分是中危,10 分或更高是高危。在开发队列中,低、中、高危 ST 发生率分别为 1.36%、3.06%和 9.18%(趋势检验 p<0.001),在验证队列中,低、中、高危 ST 发生率分别为 1.65%、2.77%和 6.45%(趋势检验 p=0.006)。该风险评分在两个队列中的 C 统计值均超过 0.65。

结论

可基于临床、血管造影和手术变量使用简单的风险评分预测 ST 的个体风险。(急性心肌梗死中经皮冠状动脉介入治疗和支架的血管重建与稳定[HORIZONS-AMI];NCT00433966)(急性冠脉综合征中 Angiomax 与肝素的比较[ACUITY];NCT00093158)。

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