Ahmed-Jushuf Fiyyaz, Foley Michael J, Rajkumar Christopher A, Chotai Shayna, Simader Florentina A, Wang Danqi, Macierzanka Krzysztof, Sehmi Joban, Kanaganayagam Gajen, Lloyd Guy, Keenan Niall, Bual Nina, Davies John R, Keeble Thomas R, O'Kane Peter D, Haworth Peter, Routledge Helen, Kotecha Tushar, Williams Rupert, Din Jehangir, Nijjer Sukhjinder S, Curzen Nick, Sinha Manas, Ruparelia Neil, Gamma Reto, Spratt James C, Cole Graham D, Harrell Frank E, Howard James P, Francis Darrel P, Shun-Shin Matthew J, Al-Lamee Rasha K
National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
National Heart and Lung Institute, Imperial College London, London, United Kingdom.
J Am Coll Cardiol. 2025 May 13;85(18):1740-1753. doi: 10.1016/j.jacc.2025.02.034.
ORBITA-2 (The Placebo-Controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina) found that percutaneous coronary intervention (PCI) relieved angina in patients with single-vessel and multivessel stable coronary artery disease (CAD) on little or no antianginal medication. Whereas symptom characteristics and invasive physiological assessments can predict PCI efficacy, the role of noninvasive imaging with dobutamine stress echocardiography (DSE) remains unclear.
This DSE-stratified secondary analysis of ORBITA-2 investigates the relationship between ischemia, assessed by DSE, and the placebo-controlled efficacy of PCI.
Participants with angina, single-vessel or multivessel CAD, and ischemia were enrolled. Following discontinuation of antianginal medications, patients were evaluated prerandomization using the ORBITA-app, questionnaires, DSE, and exercise treadmill testing. Stress echocardiography scores were calculated for each left ventricular segment at peak stress, with normal, hypokinetic, akinetic, dyskinetic, and aneurysmal segments scoring 0 to 4, respectively. Bayesian proportional odds modeling was used.
Prerandomization DSE data were available for 262 patients. The median age was 65.5 years (Q1-Q3: 59-71 years), and 208 (79.4%) were male. At baseline, the median stress echocardiography score was 1.42 in the PCI group (n = 133) and 1.00 in the placebo group (n = 129), with an overall median score of 1.25 (Q1-Q3: 0.33-2.92). Higher stress echocardiography scores were strongly associated with greater placebo-controlled improvements in angina symptom score following PCI (OR: 1.23; 95% credible interval [CrI]: 1.13-1.35; Pr(interaction) > 99.9%). Higher scores also predicted significant reduction in daily angina episodes (OR: 1.36; 95% CrI: 1.24-1.49; Pr(interaction) > 99.9%), as well as improvement in the Seattle Angina Questionnaire angina frequency score (8.22; 95% CrI: 0.96-15.50; Pr(interaction) = 98.7%), and Seattle Angina Questionnaire quality of life score (8.95; 95% CrI: 2.05-16.00; Pr(interaction) = 99.3%). The relationship between stress echocardiography score and reduction in daily angina episodes remained consistent, irrespective of symptom characteristics.
In patients with single- and multivessel stable CAD on little or no antianginal medication, the placebo-controlled efficacy of PCI was predicted by the degree of ischemia detected on DSE. The greater the burden of baseline ischemia, the greater the improvement in symptoms and quality of life with PCI.
ORBITA-2（经皮冠状动脉介入治疗缓解稳定型心绞痛的安慰剂对照试验）发现，经皮冠状动脉介入治疗（PCI）可缓解单支血管和多支血管稳定型冠状动脉疾病（CAD）且很少或未使用抗心绞痛药物的患者的心绞痛症状。虽然症状特征和有创生理评估可预测PCI疗效，但多巴酚丁胺负荷超声心动图（DSE）这种无创成像的作用仍不明确。
这项对ORBITA-2进行的DSE分层二次分析研究了通过DSE评估的心肌缺血与PCI的安慰剂对照疗效之间的关系。
纳入有胸痛症状、单支血管或多支血管CAD以及心肌缺血的参与者。停用抗心绞痛药物后，在随机分组前使用ORBITA应用程序、问卷、DSE和运动平板试验对患者进行评估。在负荷峰值时计算每个左心室节段的负荷超声心动图评分，正常、运动减弱、运动消失、运动障碍和室壁瘤节段的评分分别为0至4分。采用贝叶斯比例优势模型。
262例患者有随机分组前的DSE数据。中位年龄为65.5岁（四分位间距：59 - 71岁），208例（79.4%）为男性。基线时，PCI组（n = 133）的负荷超声心动图中位评分为1.42，安慰剂组（n = 129）为1.00，总体中位评分为1.25（四分位间距：0.33 - 2.92）。较高的负荷超声心动图评分与PCI后心绞痛症状评分在安慰剂对照下的更大改善密切相关（比值比：1.23；95%可信区间[CrI]：1.13 - 1.35；交互作用概率>99.9%）。较高评分还预测每日心绞痛发作次数显著减少（比值比：1.36；95% CrI：1.24 - 1.49；交互作用概率>99.9%），以及西雅图心绞痛问卷心绞痛发作频率评分改善（8.22；95% CrI：0.96 - 15.50；交互作用概率 = 98.7%）和西雅图心绞痛问卷生活质量评分改善（8.95；95% CrI：2.05 - 16.00；交互作用概率 = 99.3%）。无论症状特征如何，负荷超声心动图评分与每日心绞痛发作次数减少之间的关系均保持一致。
在很少或未使用抗心绞痛药物的单支血管和多支血管稳定型CAD患者中，DSE检测到的心肌缺血程度可预测PCI的安慰剂对照疗效。基线心肌缺血负担越重，PCI治疗后症状和生活质量的改善就越大。
