美国哈默史密斯医院Rasha K. Al-Lamee团队比较了经皮冠状动脉介入与安慰剂治疗稳定型心绞痛的疗效与安全性。这一研究成果于2023年11月11日发表在《新英格兰医学杂志》上。

经皮冠状动脉介入治疗（PCI）经常用于减轻稳定型心绞痛的症状。在未接受抗心绞痛药物治疗的患者中，PCI是否比安慰剂更能缓解心绞痛，目前尚不清楚。

研究组进行了一项双盲、随机、安慰剂对照的PCI治疗稳定型心绞痛患者的试验。患者停止服用所有抗心脏病药物，并在随机分组前进行为期2周的症状评估。然后以1:1的比例将患者随机分配接受PCI或安慰剂治疗，并随访12周。

主要终点是心绞痛症状评分，该评分是根据某一天发生的心绞痛发作次数、当天开的抗心绞痛药物的数量和临床事件（包括因不可接受的心绞痛或急性冠状动脉综合征或死亡而出现的揭盲情况）每天计算的。得分范围从0到79分，得分越高表明心绞痛的健康状况越差。

共有301名患者接受了随机分组：151名患者进入PCI组，150名患者进入安慰剂组。平均（±SD）年龄为64±9岁，79%为男性。242名患者的一个心脏区域（80%）、52名患者的两个心脏区域（17%）和7名患者的三个心脏区域（2%）存在缺血。在靶血管中，血流储备分数中位数为0.63（四分位间距，0.49至0.75），瞬时无波比值中位数为0.78（四分位数间距，0.55至0.87）。

在12周的随访中，PCI组的平均心绞痛症状评分为2.9，安慰剂组为5.6（比值比为2.21；P<0.001）。安慰剂组中有一名患者出现不可接受的心绞痛，导致揭盲。PCI组有4名患者发生急性冠状动脉综合征，安慰剂组有6名患者发生。

研究结果表明，在很少或没有服用抗心绞痛药物且有缺血客观证据的稳定型心绞痛患者中，PCI导致的心绞痛症状评分低于安慰剂治疗，表明心绞痛的健康状况更好。

附：英文原文

Title: A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina | NEJM

Author: anonymous

Issue&Volume: 2023-11-11

Abstract:

Background

Percutaneous coronary intervention (PCI) is frequently performed to reduce the symptoms of stable angina. Whether PCI relieves angina more than a placebo procedure in patients who are not receiving antianginal medication remains unknown.

Methods

We conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina. Patients stopped all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina.

Results

A total of 301 patients underwent randomization: 151 to the PCI group and 150 to the placebo group. The mean (±SD) age was 64±9 years, and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%). In the target vessels, the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75), and the median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55 to 0.87). At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; P<0.001). One patient in the placebo group had unacceptable angina leading to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group.

Conclusions

Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina.

DOI: 10.1056/NEJMoa2310610

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2310610