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ReACT 试验:经皮冠状动脉介入治疗后常规冠状动脉造影随访的随机评估试验。

The ReACT Trial: Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial.

机构信息

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan.

Department of Clinical Epidemiology, Hyogo College of Medicine, Hyogo, Japan.

出版信息

JACC Cardiovasc Interv. 2017 Jan 23;10(2):109-117. doi: 10.1016/j.jcin.2016.10.018. Epub 2016 Dec 28.

Abstract

OBJECTIVES

The purpose of this study was to evaluate long-term clinical impact of routine follow-up coronary angiography (FUCAG) after percutaneous coronary intervention (PCI) in daily clinical practice in Japan.

BACKGROUND

The long-term clinical impact of routine FUCAG after PCI in real-world clinical practice has not been evaluated adequately.

METHODS

In this prospective, multicenter, open-label, randomized trial, patients who underwent successful PCI were randomly assigned to routine angiographic follow-up (AF) group, in which patients were to receive FUCAG at 8 to 12 months after PCI, or clinical follow-up alone (CF) group. The primary endpoint was defined as a composite of death, myocardial infarction, stroke, emergency hospitalization for acute coronary syndrome, or hospitalization for heart failure over a minimum of 1.5 years follow-up.

RESULTS

Between May 2010 and July 2014, 700 patients were enrolled in the trial among 22 participating centers and were randomly assigned to the AF group (n = 349) or the CF group (n = 351). During a median of 4.6 years of follow-up (interquartile range [IQR]: 3.1 to 5.2 years), the cumulative 5-year incidence of the primary endpoint was 22.4% in the AF group and 24.7% in the CF group (hazard ratio: 0.94; 95% confidence interval: 0.67 to 1.31; p = 0.70). Any coronary revascularization within the first year was more frequently performed in AF group than in CF group (12.8% vs. 3.8%; log-rank p < 0.001), although the difference between the 2 groups attenuated over time with a similar cumulative 5-year incidence (19.6% vs. 18.1%; log-rank p = 0.92).

CONCLUSIONS

No clinical benefits were observed for routine FUCAG after PCI and early coronary revascularization rates were increased within routine FUCAG strategy in the current trial. (Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial [ReACT]; NCT01123291).

摘要

目的

本研究旨在评估日本日常临床实践中经皮冠状动脉介入治疗(PCI)后常规随访冠状动脉造影(FUCAG)的长期临床影响。

背景

在真实世界的临床实践中,常规 FUCAG 后 PCI 的长期临床影响尚未得到充分评估。

方法

在这项前瞻性、多中心、开放标签、随机试验中,成功接受 PCI 的患者被随机分配至常规血管造影随访(AF)组,患者将在 PCI 后 8 至 12 个月接受 FUCAG,或仅接受临床随访(CF)组。主要终点定义为至少 1.5 年随访期间死亡、心肌梗死、卒、因急性冠状动脉综合征急诊住院或因心力衰竭住院的复合终点。

结果

2010 年 5 月至 2014 年 7 月期间,在 22 个参与中心中,共有 700 名患者入组该试验,并被随机分配至 AF 组(n=349)或 CF 组(n=351)。在中位随访 4.6 年(四分位间距[IQR]:3.1 至 5.2 年)期间,AF 组的 5 年累积主要终点发生率为 22.4%,CF 组为 24.7%(风险比:0.94;95%置信区间:0.67 至 1.31;p=0.70)。AF 组在第一年行任何冠状动脉血运重建的频率均高于 CF 组(12.8%比 3.8%;对数秩检验 p<0.001),尽管随着时间的推移,两组之间的差异逐渐减弱,且累积 5 年发生率相似(19.6%比 18.1%;对数秩检验 p=0.92)。

结论

本研究中,PCI 后常规 FUCAG 并未观察到临床获益,且常规 FUCAG 策略中早期冠状动脉血运重建的比例增加。(经皮冠状动脉介入治疗后常规随访冠状动脉造影随机评估试验[ReACT];NCT01123291)。

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