Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Single-Vessel Coronary Artery Disease: Physiology-Stratified Analysis of ORBITA
Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Single-Vessel Coronary Artery Disease: Physiology-Stratified Analysis of ORBITA
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DOI：
10.1161/circulationaha.118.033801
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发表时间：
2018-10-23
期刊：
影响因子：
37.8
通讯作者：
Francis, Darrel P.
中科院分区：
文献类型：
--
作者：
Al-Lamee, Rasha;Howard, James P.;Francis, Darrel P.
背景资料：目前还没有关于血流储备分数（FFR）和瞬时无波比率（iFR）与经皮冠状动脉介入治疗（PCI）在稳定性单支冠状动脉疾病中的安慰剂对照疗效相关的数据。我们报告了在奥比塔内随机分组前的侵入性生理学之间的相关性，（稳定型心绞痛血管成形术最佳药物治疗的客观随机盲法研究），一项安慰剂对照试验，研究对象为稳定型心绞痛伴血管造影显示的严重单支冠状动脉疾病且临床上符合PCI条件的患者。患者接受了随机化前研究FFR和iFR评估。操作员对这些值不知情。在随机化前和盲法随访时评估反应变量、平板运动时间、负荷超声心动图评分、症状频率和心绞痛严重程度。通过协方差分析计算效应。FFR和iFR预测安慰剂对照的反应变量变化的能力进行了测试，通过使用回归modeling.Results：有创生理数据可在196例患者（103 PCI和93安慰剂）。在随机化前，大多数患者有加拿大心血管学会II级或III级症状（150/196，76.5%）。平均FFR和iFR分别为0.69 ± 0.16和0.76 ± 0.22; 97%的患者有1次阳性缺血试验。PCI对组间随机化前调整的总运动时间的估计影响为20.7 s（95%置信区间[CI]，-4.0至45.5; P=0.100），FFR（P-相互作用=0.318）或iFR（P-相互作用=0.523）无相互作用。PCI改善负荷超声心动图评分的作用大于安慰剂组（1.07节段单位; 95%CI，0.70-1.44; P
Background: There are no data on how fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are associated with the placebo-controlled efficacy of percutaneous coronary intervention (PCI) in stable single-vessel coronary artery disease.Methods: We report the association between prerandomization invasive physiology within ORBITA (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina), a placebo-controlled trial of patients who have stable angina with angiographically severe single-vessel coronary disease clinically eligible for PCI. Patients underwent prerandomization research FFR and iFR assessment. The operator was blinded to these values. Assessment of response variables, treadmill exercise time, stress echocardiography score, symptom frequency, and angina severity were performed at prerandomization and blinded follow-up. Effects were calculated by analysis of covariance. The ability of FFR and iFR to predict placebo-controlled changes in response variables was tested by using regression modeling.Results: Invasive physiology data were available in 196 patients (103 PCI and 93 placebo). At prerandomization, the majority had Canadian Cardiovascular Society class II or III symptoms (150/196, 76.5%). Mean FFR and iFR were 0.690.16 and 0.760.22, respectively; 97% had 1 positive ischemia tests. The estimated effect of PCI on between-arm prerandomization-adjusted total exercise time was 20.7 s (95% confidence interval [CI], -4.0 to 45.5; P=0.100) with no interaction of FFR (P-interaction=0.318) or iFR (P-interaction=0.523). PCI improved stress echocardiography score more than placebo (1.07 segment units; 95% CI, 0.70-1.44; P