Imperial College London, London, United Kingdom; Imperial College Healthcare National Health Service (NHS) Trust, London, United Kingdom.
Imperial College Healthcare National Health Service (NHS) Trust, London, United Kingdom.
J Am Coll Cardiol. 2024 Jul 2;84(1):13-24. doi: 10.1016/j.jacc.2024.04.016. Epub 2024 May 15.
Placebo-controlled evidence from ORBITA-2 (Objective Randomised Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina-2) found that percutaneous coronary intervention (PCI) in stable coronary artery disease with little or no antianginal medication relieved angina, but residual symptoms persisted in many patients. The reason for this was unclear.
This ORBITA-2 secondary analysis investigates the relationship between presenting symptoms and disease severity (anatomic, noninvasive, and invasive ischemia) and the ability of symptoms to predict the placebo-controlled efficacy of PCI.
Prerandomization symptom severity and nature were assessed using the ORBITA smartphone application and symptom and quality of life questionnaires including the World Health Organization Rose angina questionnaire (Rose). Disease severity was assessed using quantitative coronary angiography, stress echocardiography, fractional flow reserve, and instantaneous wave-free ratio. Bayesian ordinal regression was used.
At prerandomization, the median number of daily angina episodes was 0.8 (Q1-Q3: 0.4-1.6), 64% had Rose angina, quantitative coronary angiography diameter stenosis was 61% (Q1-Q3: 49%-74%), stress echocardiography score was 1.0 (Q1-Q3: 0.0-2.7), fractional flow reserve was 0.63 (Q1-Q3: 0.49-0.75), and instantaneous wave-free ratio was 0.78 (Q1-Q3: 0.55-0.87). There was little relationship between symptom severity and nature and disease severity: angina symptom score with quantitative coronary angiography ordinal correlation coefficient: 0.06 (95% credible interval [CrI]: 0.00-0.08); stress echocardiography: 0.09 (95% CrI: 0.02-0.10); fractional flow reserve: 0.04 (95% CrI: -0.03 to 0.07); and instantaneous wave-free ratio: 0.04 (95% CrI: -0.01 to 0.07). However, Rose angina and guideline-based typical angina were strong predictors of placebo-controlled PCI efficacy (angina symptom score: OR: 1.9; 95% CrI: 1.6-2.1; probability of interaction [Pr] = 99.9%; and OR: 1.8; 95% CrI: 1.6-2.1; Pr = 99.9%, respectively).
Although symptom severity and nature were poorly associated with disease severity, the nature of symptoms powerfully predicted the placebo-controlled efficacy of PCI.
来自 ORBITA-2（优化药物治疗的血管成形术稳定型心绞痛的客观随机盲法研究）的安慰剂对照证据发现，在稳定型冠状动脉疾病中进行经皮冠状动脉介入治疗（PCI），即使使用很少或不使用抗心绞痛药物，也能缓解心绞痛，但许多患者仍存在残留症状。其原因尚不清楚。
本 ORBITA-2 二次分析旨在探讨主要症状与疾病严重程度（解剖学、非侵入性和侵入性缺血）之间的关系，并探讨症状预测 PCI 安慰剂对照疗效的能力。
使用 ORBITA 智能手机应用程序和症状及生活质量问卷（包括世界卫生组织玫瑰心绞痛问卷（Rose））在随机分组前评估症状严重程度和性质。使用定量冠状动脉造影术、超声心动图负荷试验、血流储备分数和瞬时无波比评估疾病严重程度。采用贝叶斯有序回归分析。
在随机分组前，每日心绞痛发作次数中位数为 0.8（Q1-Q3：0.4-1.6），64%的患者存在 Rose 心绞痛，定量冠状动脉造影术直径狭窄率为 61%（Q1-Q3：49%-74%），超声心动图负荷试验评分 1.0（Q1-Q3：0.0-2.7），血流储备分数为 0.63（Q1-Q3：0.49-0.75），瞬时无波比为 0.78（Q1-Q3：0.55-0.87）。症状严重程度和性质与疾病严重程度之间的关系不大：心绞痛症状评分与定量冠状动脉造影术的有序相关系数为 0.06（95%可信区间[CrI]：0.00-0.08）；超声心动图负荷试验为 0.09（95%CrI：0.02-0.10）；血流储备分数为 0.04（95%CrI：-0.03 至 0.07）；瞬时无波比为 0.04（95%CrI：-0.01 至 0.07）。然而，Rose 心绞痛和基于指南的典型心绞痛是 PCI 安慰剂对照疗效的有力预测因子（心绞痛症状评分：OR：1.9；95%CrI：1.6-2.1；交互概率[Pr] = 99.9%；OR：1.8；95%CrI：1.6-2.1；Pr = 99.9%，分别）。
尽管症状严重程度和性质与疾病严重程度相关性较差，但症状性质有力地预测了 PCI 的安慰剂对照疗效。
