Rajkumar Christopher A, Foley Michael J, Ahmed-Jushuf Fiyyaz, Nowbar Alexandra N, Simader Florentina A, Davies John R, O'Kane Peter D, Haworth Peter, Routledge Helen, Kotecha Tushar, Gamma Reto, Clesham Gerald, Williams Rupert, Din Jehangir, Nijjer Sukhjinder S, Curzen Nick, Ruparelia Neil, Sinha Manas, Dungu Jason N, Ganesananthan Sashiananthan, Khamis Ramzi, Mughal Lal, Kinnaird Tim, Petraco Ricardo, Spratt James C, Sen Sayan, Sehmi Joban, Collier David J, Sohaib Afzal, Keeble Thomas R, Cole Graham D, Howard James P, Francis Darrel P, Shun-Shin Matthew J, Al-Lamee Rasha K
From Imperial College London (C.A.R., M.J.F., F.A.-J., F.A.S., S.G., R.K., R.P., G.D.C., J.P.H., D.P.F., M.J.S.-S., R.K.A.-L.), Imperial College Healthcare NHS Trust (C.A.R., M.J.F., F.A.-J., F.A.S., S.S.N., S.G., R.K., R.P., S.S., G.D.C., J.P.H., D.P.F., M.J.S.-S., R.K.A.-L.), Barking Havering and Redbridge University Hospitals NHS Trust (A.N.N., A.S.), Royal Free London NHS Foundation Trust (T. Kotecha), St. George's University Hospitals NHS Foundation Trust (R.W., J.C.S.), St. George's University of London (J.C.S.), Queen Mary University of London (D.J.C., A.S.), and Barts Health NHS Trust (A.S.), London, Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon (J.R.D., R.G., G.C., J.N.D., T.R.K.), Anglia Ruskin University, Chelmsford (J.R.D., G.C., T.R.K.), University Hospitals Dorset NHS Foundation Trust, Poole (P.D.O., J.D.), Portsmouth Hospitals University NHS Trust, Portsmouth (P.H.), Worcestershire Acute Hospitals NHS Trust, Worcester (H.R., L.M.), University Hospital Southampton NHS Foundation Trust and the University of Southampton, Southampton (N.C.), Royal Berkshire NHS Foundation Trust, Reading (N.R.), Salisbury NHS Foundation Trust, Salisbury (M.S.), Cardiff and Vale University Health Board, Cardiff (T. Kinnaird), Keele University, Keele (T. Kinnaird), Buckinghamshire Healthcare NHS Trust, Amersham (R.P.), and West Hertfordshire Hospitals NHS Trust, Watford (J.S.) - all in the United Kingdom.
N Engl J Med. 2023 Dec 21;389(25):2319-2330. doi: 10.1056/NEJMoa2310610. Epub 2023 Nov 11.
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.
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.
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.
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. (Funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050.).
经皮冠状动脉介入治疗（PCI）常用于缓解稳定型心绞痛的症状。对于未接受抗心绞痛药物治疗的患者，PCI缓解心绞痛的效果是否优于安慰剂治疗仍不清楚。
我们对稳定型心绞痛患者进行了一项PCI的双盲、随机、安慰剂对照试验。患者停用所有抗心绞痛药物，并在随机分组前进行为期2周的症状评估阶段。然后患者按1:1的比例随机分配接受PCI或安慰剂治疗，并随访12周。主要终点是心绞痛症状评分，该评分根据给定日期发生的心绞痛发作次数、当天开具的抗心绞痛药物数量以及临床事件（包括因无法接受的心绞痛、急性冠状动脉综合征或死亡导致的揭盲情况）每日计算。评分范围为0至79分，分数越高表明心绞痛方面的健康状况越差。
共有301例患者进行了随机分组：151例进入PCI组，150例进入安慰剂组。平均（±标准差）年龄为64±9岁，79%为男性。242例患者（80%）的一个心脏区域存在缺血，52例患者（17%）的两个区域存在缺血，7例患者（2%）的三个区域存在缺血。在靶血管中，中位血流储备分数为0.63（四分位间距，0.49至0.75），中位瞬时无波比值为0.78（四分位间距，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分，安慰剂组为5.6分（优势比，2.21；95%置信区间，1.41至3.47；P<0.001）。安慰剂组有1例患者因无法接受的心绞痛导致揭盲。PCI组有4例患者发生急性冠状动脉综合征，安慰剂组有6例患者发生急性冠状动脉综合征。
在接受很少或未接受抗心绞痛药物治疗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，表明在心绞痛方面的健康状况更好。（由国家卫生与保健研究机构帝国生物医学研究中心等资助；ORBITA-2临床试验注册号，NCT03742050。）
