Objectives

The study sought to assess the proportion of patients in modern U.S. interventional practice that fulfilled criteria for enrollment in the ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial.

Background

The ISCHEMIA trial, which enrolled patients with stable ischemic heart disease (SIHD), showed that revascularization improved angina symptoms with little effect on death or myocardial infarction.

Methods

A cross-sectional analysis of the National Cardiovascular Data Registry CathPCI Registry (v5.0), including 1,662 hospitals, was performed. Patients undergoing percutaneous coronary intervention (PCI) for SIHD in routine clinical practice meeting ISCHEMIA trial inclusion criteria and those that did not were evaluated.

Results

During the study period, 388,212 patients underwent PCI for SIHD, comprising 41.88% of all patients undergoing PCI during the study period. Of these, 125,302 (32.28%; 13.52% of all patients undergoing PCI) met criteria for enrollment in the ISCHEMIA trial. Among SIHD patients that did not meet criteria, 71,852 (18.51%) had SIHD with high-risk features (35.2% left main disease, 43.7% left ventricular systolic dysfunction, 16.8% end-stage renal disease), 67,159 (17.3%) had SIHD with negative or low-risk functional testing, and 123,899 (31.92%) either had no stress testing or did not have ischemic burden reported. At the median hospital, 32.1% (interquartile range: 23.5%-40.6%) of SIHD patients met criteria for enrollment in the ISCHEMIA trial, with these patients experiencing lower unadjusted in-hospital mortality rate than comparator groups who met exclusion criteria for the trial (0.11%) (P < 0.01 for all comparisons).

Conclusions

Among contemporary U.S. patients undergoing PCI for SIHD, 32.28% clearly met enrollment criteria for the ISCHEMIA trial. There was significant variation among individual centers in the proportion of SIHD patients meeting criteria for the ISCHEMIA trial.

中文翻译：

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当代美国实践中接受经皮冠状动脉介入治疗的患者与缺血试验人群的比较

目标

该研究旨在评估现代美国介入实践中符合 ISCHEMIA（医学和侵入性方法比较健康有效性国际研究）试验标准的患者比例。

背景

纳入稳定缺血性心脏病 (SIHD) 患者的 ISCHEMIA 试验表明，血运重建可改善心绞痛症状，但对死亡或心肌梗塞几乎没有影响。

方法

对包括 1,662 家医院在内的国家心血管数据登记处 CathPCI 登记处 (v5.0) 进行了横断面分析。在常规临床实践中因 SIHD 接受经皮冠状动脉介入治疗 (PCI) 的患者符合 ISCHEMIA 试验纳入标准，而那些未接受评估的患者。

结果

在研究期间，388,212 名患者因 SIHD 接受了 PCI，占研究期间接受 PCI 的所有患者的 41.88%。其中，125,302 人（32.28%；占接受 PCI 的所有患者的 13.52%）符合 ISCHEMIA 试验的入组标准。在不符合标准的 SIHD 患者中，71852 例（18.51%）有高危特征（35.2% 左主干病变，43.7% 左心室收缩功能不全，16.8% 终末期肾病），67159 例（17.3%）有功能测试为阴性或低风险的 SIHD 和 123,899 (31.92%) 人没有进行压力测试或没有报告缺血性负担。在中位医院，32.1%（四分位距：23.5%-40.6%）的 SIHD 患者符合 ISCHEMIA 试验的入组标准，所有比较的P  < 0.01）。

结论

在接受 PCI 治疗 SIHD 的当代美国患者中，32.28% 明显符合 ISCHEMIA 试验的入组标准。在满足 ISCHEMIA 试验标准的 SIHD 患者比例方面，各个中心之间存在显着差异。