韩国蔚山大学医学院Seung-Jung Park团队比较了高危患者PCI术后的常规功能检测或标准护理对预后的影响。这一研究成果于2022年8月28日发表在《新英格兰医学杂志》上。

用于指导心肌血运重建术后具体随访监测方法的随机试验数据有限。包括常规功能测试在内的随访策略是否能改善接受经皮冠状动脉介入治疗（PCI）的高危患者临床预后尚不确定。

研究组随机分配1706名具有高危解剖或临床特征的患者，他们在PCI术后1年接受常规功能测试（核心负荷测试、运动心电图或负荷超声心动图）的随访策略，或单独标准护理。主要结局是2年内全因死亡、心肌梗死或因不稳定心绞痛住院的综合结局。关键次要结局包括有创冠状动脉造影和二次血运重建术。

患者的平均年龄为64.7岁，21.0%为左主干病变，43.5%为分叉病变，69.8%为多血管病变，70.1%为弥漫性长病变，38.7%为糖尿病，96.4%为药物洗脱支架治疗。在2年时，功能测试组849名患者中有46名（卡普兰一梅尔估计量为5.5%）出现了主要结局事件，标准护理组857名中有51名（卡普兰一梅尔估计量为6.0%），风险比为0.90。

在主要结局的组成部分方面，组间无差异。在2年时，功能测试组和标准护理组分别有12.3%和9.3%的患者接受了有创冠状动脉造影（差异为2.99个百分点），分别有8.1%和5.8%的患者进行了二次血运重建（差异为2.23个百分点）。

研究结果表明，在接受PCI的高危患者中，与单独标准护理相比，常规功能测试的随访策略并不能改善2年后的临床预后。

附：英文原文

Title: Routine Functional Testing or Standard Care in High-Risk Patients after PCI

Author: Duk-Woo Park, M.D.,, Do-Yoon Kang, M.D.,, Jung-Min Ahn, M.D.,, Sung-Cheol Yun, Ph.D.,, Yong-Hoon Yoon, M.D.,, Seung-Ho Hur, M.D.,, Cheol Hyun Lee, M.D.,, Won-Jang Kim, M.D.,, Se Hun Kang, M.D.,, Chul Soo Park, M.D.,, Bong-Ki Lee, M.D.,, Jung-Won Suh, M.D.,, Jung Han Yoon, M.D.,, Jae Woong Choi, M.D.,, Kee-Sik Kim, M.D.,, Si Wan Choi, M.D.,, Su Nam Lee, M.D.,, and Seung-Jung Park, M.D.

Issue&Volume: 2022-08-28

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.

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.

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).

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.

DOI: 10.1056/NEJMoa2208335

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2208335