NEJM：PCI后高危患者接受常规功能检测和标准治疗的比较

Abstract

Background: There are limited data from randomized trials to guide a specific follow-up surveillance approach after myocardial revascularization. Whether a follow-up strategy that includes routine functional testing improves clinical outcomes among high-risk patients who have undergone percutaneous coronary intervention (PCI) is uncertain.

目前可为心肌血运重建后的具体随访监测方法提供指导的随机试验数据有限。尚不确定对于已接受经皮冠状动脉介入治疗（PCI）的高危患者，包括常规功能检测在内的随访策略可否改善临床结局。

Methods: We randomly assigned 1706 patients with high-risk anatomical or clinical characteristics who had undergone PCI to a follow-up strategy of routine functional testing (nuclear stress testing, exercise electrocardiography, or stress echocardiography) at 1 year after PCI or to standard care alone. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. Key secondary outcomes included invasive coronary angiography and repeat revascularization.

我们将1,706例已接受PCI，并且具有高危解剖或临床特征的患者随机分组，一组接受在PCI后1年时实施常规功能检测（核素负荷试验、运动心电图试验或负荷超声心动图）的随访策略，另一组接受单纯标准治疗。主要结局是由2年时全因死亡、心肌梗死或因不稳定型心绞痛住院构成的复合结局。关键次要结局包括有创冠状动脉造影和再次血运重建。

Results: The mean age of the patients was 64.7 years, 21.0% had left main disease, 43.5% had bifurcation disease, 69.8% had multivessel disease, 70.1% had diffuse long lesions, 38.7% had diabetes, and 96.4% had been treated with drug-eluting stents. At 2 years, a primary-outcome event had occurred in 46 of 849 patients (Kaplan-Meier estimate, 5.5%) in the functional-testing group and in 51 of 857 (Kaplan-Meier estimate, 6.0%) in the standard-care group (hazard ratio, 0.90; 95% confidence interval [CI], 0.61 to 1.35; P = 0.62). There were no between-group differences with respect to the components of the primary outcome. At 2 years, 12.3% of the patients in the functional-testing group and 9.3% in the standard-care group had undergone invasive coronary angiography (difference, 2.99 percentage points; 95% CI, -0.01 to 5.99), and 8.1% and 5.8% of patients, respectively, had undergone repeat revascularization (difference, 2.23 percentage points; 95% CI, -0.22 to 4.68).

患者平均年龄为64.7岁，21.0%有左主干病变，43.5%有分叉病变，69.8%有多支血管病变，70.1%有弥漫性长病变，38.7%有糖尿病，96.4%接受过药物洗脱支架治疗。2年时，功能检测组849例患者中的46例（Kaplan-Meier估计值，5.5%）和标准治疗组857例患者中的51例（Kaplan-Meier估计值，6.0%）发生了主要结局事件（风险比，0.90；95%置信区间[CI]，0.61～1.35；P=0.62）。在主要结局的构成部分方面，两组之间无差异。2年时，功能检测组12.3%的患者和标准治疗组9.3%的患者已接受有创冠状动脉造影（差异，2.99个百分点；95% CI，－0.01～5.99），两组分别有8.1%和5.8%的患者已接受再次血运重建（差异，2.23个百分点；95% CI，－0.22～4.68）。

Conclusions: Among high-risk patients who had undergone PCI, a follow-up strategy of routine functional testing, as compared with standard care alone, did not improve clinical outcomes at 2 years. (Funded by the CardioVascular Research Foundation and Daewoong Pharmaceutical; POST-PCI ClinicalTrials.gov number, NCT03217877.). 

在已接受PCI的高危患者中，与单纯标准治疗相比，实施常规功能检测的随访策略未能改善2年时的临床结局（由心血管研究基金会[CardioVascular Research Foundation]和大熊制药[Daewoong Pharmaceutical]资助，POST-PCI在ClinicalTrials.gov注册号为NCT03217877）。