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Symptoms as a Predictor of the Placebo-Controlled Efficacy of PCI in Stable Coronary Artery Disease
Journal of the American College of Cardiology ( IF 21.7 ) Pub Date : 2024-05-15 , DOI: 10.1016/j.jacc.2024.04.016 Florentina A Simader 1 , Christopher A Rajkumar 1 , Michael J Foley 1 , Fiyyaz Ahmed-Jushuf 1 , Shayna Chotai 1 , Nina Bual 2 , Arif Khokhar 2 , Aisha Gohar 2 , Ioannis Lampadakis 3 , Sashiananthan Ganesananthan 1 , Rachel H Pathimagaraj 1 , Alexandra Nowbar 4 , John R Davies 5 , Tom R Keeble 5 , Peter D O'Kane 6 , Peter Haworth 7 , Helen Routledge 8 , Tushar Kotecha 9 , James C Spratt 10 , Rupert Williams 11 , Sukhjinder S Nijjer 1 , Sayan Sen 2 , Nick Curzen 12 , Manas Sinha 13 , James P Howard 1 , Graham Cole 1 , Frank E Harrell 14 , Darrel P Francis 1 , Matthew J Shun-Shin 1 , Rasha K Al-Lamee 1 ,
Journal of the American College of Cardiology ( IF 21.7 ) Pub Date : 2024-05-15 , DOI: 10.1016/j.jacc.2024.04.016 Florentina A Simader 1 , Christopher A Rajkumar 1 , Michael J Foley 1 , Fiyyaz Ahmed-Jushuf 1 , Shayna Chotai 1 , Nina Bual 2 , Arif Khokhar 2 , Aisha Gohar 2 , Ioannis Lampadakis 3 , Sashiananthan Ganesananthan 1 , Rachel H Pathimagaraj 1 , Alexandra Nowbar 4 , John R Davies 5 , Tom R Keeble 5 , Peter D O'Kane 6 , Peter Haworth 7 , Helen Routledge 8 , Tushar Kotecha 9 , James C Spratt 10 , Rupert Williams 11 , Sukhjinder S Nijjer 1 , Sayan Sen 2 , Nick Curzen 12 , Manas Sinha 13 , James P Howard 1 , Graham Cole 1 , Frank E Harrell 14 , Darrel P Francis 1 , Matthew J Shun-Shin 1 , Rasha K Al-Lamee 1 ,
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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.
中文翻译：
症状作为 PCI 在稳定性冠状动脉疾病中安慰剂对照疗效的预测因子
ORBITA-2（稳定型心绞痛血管成形术最佳药物治疗的客观随机盲法调查-2）的安慰剂对照证据发现，稳定型冠状动脉疾病的经皮冠状动脉介入治疗（PCI）在很少或没有抗心绞痛药物的情况下可以缓解心绞痛，但残留症状许多患者持续存在。其原因尚不清楚。该 ORBITA-2 二次分析调查了症状与疾病严重程度（解剖性、非侵入性和侵入性缺血）之间的关系，以及症状预测 PCI 安慰剂对照疗效的能力。使用 ORBITA 智能手机应用程序以及症状和生活质量调查问卷（包括世界卫生组织玫瑰心绞痛调查问卷（Rose））评估随机分组前症状的严重程度和性质。使用定量冠状动脉造影、负荷超声心动图、血流储备分数和瞬时无波比来评估疾病严重程度。使用贝叶斯序数回归。随机分组前，每日心绞痛发作中位数为 0.8 次（Q1-Q3：0.4-1.6），64% 患有玫瑰色心绞痛，定量冠状动脉造影直径狭窄为 61%（Q1-Q3：49%-74%），负荷超声心动图评分为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关系不大：心绞痛症状评分与定量冠状动脉造影序数相关系数：0.06（95%可信区间[CrI]：0.00-0.08）；负荷超声心动图：0.09（95% CrI：0.02-0.10）；流量储备分数：0.04（95% CrI：-0.03 至 0.07）；瞬时无波比：0.04（95%CrI：-0.01～0.07）。 然而，玫瑰色心绞痛和基于指南的典型心绞痛是安慰剂对照 PCI 疗效的强预测因子（心绞痛症状评分：OR：1.9；95% CrI：1.6-2.1；相互作用概率 [Pr] = 99.9%；OR：1.8 ；95%CrI：1.6-2.1；Pr=99.9%）。尽管症状的严重程度和性质与疾病的严重程度关联不大，但症状的性质有力地预测了 PCI 的安慰剂对照疗效。
更新日期：2024-05-15
中文翻译：
症状作为 PCI 在稳定性冠状动脉疾病中安慰剂对照疗效的预测因子
ORBITA-2（稳定型心绞痛血管成形术最佳药物治疗的客观随机盲法调查-2）的安慰剂对照证据发现，稳定型冠状动脉疾病的经皮冠状动脉介入治疗（PCI）在很少或没有抗心绞痛药物的情况下可以缓解心绞痛，但残留症状许多患者持续存在。其原因尚不清楚。该 ORBITA-2 二次分析调查了症状与疾病严重程度（解剖性、非侵入性和侵入性缺血）之间的关系，以及症状预测 PCI 安慰剂对照疗效的能力。使用 ORBITA 智能手机应用程序以及症状和生活质量调查问卷（包括世界卫生组织玫瑰心绞痛调查问卷（Rose））评估随机分组前症状的严重程度和性质。使用定量冠状动脉造影、负荷超声心动图、血流储备分数和瞬时无波比来评估疾病严重程度。使用贝叶斯序数回归。随机分组前，每日心绞痛发作中位数为 0.8 次（Q1-Q3：0.4-1.6），64% 患有玫瑰色心绞痛，定量冠状动脉造影直径狭窄为 61%（Q1-Q3：49%-74%），负荷超声心动图评分为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关系不大：心绞痛症状评分与定量冠状动脉造影序数相关系数：0.06（95%可信区间[CrI]：0.00-0.08）；负荷超声心动图：0.09（95% CrI：0.02-0.10）；流量储备分数：0.04（95% CrI：-0.03 至 0.07）；瞬时无波比：0.04（95%CrI：-0.01～0.07）。 然而，玫瑰色心绞痛和基于指南的典型心绞痛是安慰剂对照 PCI 疗效的强预测因子（心绞痛症状评分：OR：1.9；95% CrI：1.6-2.1；相互作用概率 [Pr] = 99.9%；OR：1.8 ；95%CrI：1.6-2.1；Pr=99.9%）。尽管症状的严重程度和性质与疾病的严重程度关联不大，但症状的性质有力地预测了 PCI 的安慰剂对照疗效。
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