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Dobutamine Stress Echocardiography Ischemia as a Predictor of the Placebo-Controlled Efficacy of Percutaneous Coronary Intervention in Stable Coronary Artery Disease: The Stress Echocardiography-Stratified Analysis of ORBITA.
Circulation ( IF 35.5 ) Pub Date : 2019-11-11 , DOI: 10.1161/circulationaha.119.042918
Rasha K Al-Lamee 1, 2 , Matthew J Shun-Shin 1, 2 , James P Howard 1, 2 , Alexandra N Nowbar 1, 2 , Christopher Rajkumar 1, 2 , David Thompson 1 , Sayan Sen 1, 2 , Sukhjinder Nijjer 1, 2 , Ricardo Petraco 1, 2 , John Davies 3, 4 , Thomas Keeble 3, 4 , Kare Tang 3 , Iqbal Malik 1, 2 , Nina Bual , Christopher Cook 1, 2 , Yousif Ahmad 1, 2 , Henry Seligman 1, 2 , Andrew S P Sharp 5 , Robert Gerber 6 , Suneel Talwar 7 , Ravi Assomull 2 , Graham Cole 1, 2 , Niall G Keenan 8 , Gajen Kanaganayagam 2 , Joban Sehmi 8 , Roland Wensel 1 , Frank E Harrell 9 , Jamil Mayet 1, 2 , Simon Thom 1 , Justin E Davies 2 , Darrel P Francis 1, 2
Affiliation  

BACKGROUND Dobutamine stress echocardiography is widely used to test for ischemia in patients with stable coronary artery disease. In this analysis, we studied the ability of the prerandomization stress echocardiography score to predict the placebo-controlled efficacy of percutaneous coronary intervention (PCI) within the ORBITA trial (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina). METHODS One hundred eighty-three patients underwent dobutamine stress echocardiography before randomization. The stress echocardiography score is broadly the number of segments abnormal at peak stress, with akinetic segments counting double and dyskinetic segments counting triple. The ability of prerandomization stress echocardiography to predict the placebo-controlled effect of PCI on response variables was tested by using regression modeling. RESULTS At prerandomization, the stress echocardiography score was 1.56±1.77 in the PCI arm (n=98) and 1.61±1.73 in the placebo arm (n=85). There was a detectable interaction between prerandomization stress echocardiography score and the effect of PCI on angina frequency score with a larger placebo-controlled effect in patients with the highest stress echocardiography score (Pinteraction=0.031). With our sample size, we were unable to detect an interaction between stress echocardiography score and any other patient-reported response variables: freedom from angina (Pinteraction=0.116), physical limitation (Pinteraction=0.461), quality of life (Pinteraction=0.689), EuroQOL 5 quality-of-life score (Pinteraction=0.789), or between stress echocardiography score and physician-assessed Canadian Cardiovascular Society angina class (Pinteraction=0.693), and treadmill exercise time (Pinteraction=0.426). CONCLUSIONS The degree of ischemia assessed by dobutamine stress echocardiography predicts the placebo-controlled efficacy of PCI on patient-reported angina frequency. The greater the downstream stress echocardiography abnormality caused by a stenosis, the greater the reduction in symptoms from PCI. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02062593.

中文翻译:

多巴酚丁胺负荷超声心动图缺血作为稳定型冠状动脉疾病经皮冠状动脉介入治疗的安慰剂控制疗效的预测因子:负荷超声心动图 - ORBITA 分层分析。

背景技术多巴酚丁胺负荷超声心动图广泛用于检测稳定性冠状动脉疾病患者的缺血情况。在此分析中,我们研究了随机化前负荷超声心动图评分在 ORBITA 试验(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)中预测经皮冠状动脉介入治疗 (PCI) 安慰剂对照疗效的能力。方法 183 名患者在随机分组前接受了多巴酚丁胺负荷超声心动图检查。负荷超声心动图评分大致是峰值负荷时异常节段的数量,运动障碍节段计数两倍,运动障碍节段计数三倍。通过使用回归模型测试随机化前负荷超声心动图预测 PCI 对反应变量的安慰剂对照作用的能力。结果 在随机分组前,负荷超声心动图评分在 PCI 组 (n=98) 中为 1.56±1.77,在安慰剂组 (n=85) 中为 1.61±1.73。随机化前负荷超声心动图评分与 PCI 对心绞痛频率评分的影响之间存在可检测的相互作用,在负荷超声心动图评分最高的患者中具有更大的安慰剂对照效果 (Pinteraction = 0.031)。根据我们的样本量,我们无法检测到负荷超声心动图评分与任何其他患者报告的反应变量之间的相互作用:无心绞痛 (Pinteraction=0.116)、身体限制 (Pinteraction=0.461)、生活质量 (Pinteraction=0.689) , EuroQOL 5 生活质量评分 (Pinteraction=0.789),或负荷超声心动图评分与医生评估的加拿大心血管学会心绞痛等级 (Pinteraction=0.693) 和跑步机运动时间 (Pinteraction=0.426) 之间。结论 通过多巴酚丁胺负荷超声心动图评估的缺血程度可预测 PCI 对患者报告的心绞痛频率的安慰剂对照效果。由狭窄引起的下游负荷超声心动图异常越大,PCI 症状减轻得越多。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT02062593。结论 通过多巴酚丁胺负荷超声心动图评估的缺血程度可预测 PCI 对患者报告的心绞痛频率的安慰剂对照效果。由狭窄引起的下游负荷超声心动图异常越大,PCI 症状减轻得越多。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT02062593。结论 通过多巴酚丁胺负荷超声心动图评估的缺血程度可预测 PCI 对患者报告的心绞痛频率的安慰剂对照效果。由狭窄引起的下游负荷超声心动图异常越大,PCI 症状减轻得越多。临床试验注册网址:https://www.clinicaltrials.gov。唯一标识符:NCT02062593。
更新日期:2019-12-11
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