Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan.
Department of Clinical Epidemiology, Hyogo College of Medicine, Hyogo, Japan.
JACC Cardiovasc Interv. 2017 Jan 23;10(2):109-117. doi: 10.1016/j.jcin.2016.10.018. Epub 2016 Dec 28.
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.
The long-term clinical impact of routine FUCAG after PCI in real-world clinical practice has not been evaluated adequately.
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.
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).
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).
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。
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。
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。
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)。
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)。