Focal and Diffuse Coronary Artery Disease Patterns and Placebo-Controlled Angina Relief With Percutaneous Coronary Intervention: ORBITA-2.

However, data from the first placebo-controlledstudy did not demonstrate a differential impact of disease pattern on symptom endpoints.

然而，首个安慰剂对照研究的数据并未显示疾病模式对症状终点的差异影响。

The study sought to test the ability of pattern of coronary artery disease to predict the placebo-controlledefficacy of PCI.

该研究旨在测试冠状动脉疾病模式预测安慰剂对照下经皮冠状动脉介入治疗（PCI）疗效的能力。

method

In the ORBITA-2 (Objective Randomised Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina-2) randomized placebo-controlledtrial of angioplasty for stable angina, patients underwent prerandomization nonhyperemic pressure wire pullback assessments.

在ORBITA-2（稳定型心绞痛患者最佳药物治疗下血管成形术的客观随机盲法研究-2）的随机安慰剂对照试验中，患者在随机化前接受了非高血流压力导丝拉回评估。

Seven blinded interventional cardiologists independently reviewed each pullback trace to categorize disease patterns as focal, diffuse, or mixed.

七位蒙蔽的介入心脏病专家独立审查了每一次拉回轨迹，将疾病模式分类为局灶性、弥漫性或混合性。

These were assigned numerical values of 1, 0, and 0.5, respectively.

这些分别被赋予数值1、0和0.5。

Overall disease pattern score was determined by the mean.

整体疾病模式评分由平均值确定。

A score >0.5 was considered focal and ≤0.5 was considered diffuse.

得分>0.5被认为是局灶性的，而≤0.5被认为是弥漫性的。

Bayesian proportional odds modeling was used.

使用了贝叶斯比例优势模型。

Results

A total of 245 patients with 300 target vessel pullbacks were analyzed.

分析了245名患者的300个目标血管拉回。

With adjustment for prerandomization nonhyperemic pressure ratio, PCI in focal compared with diffuse disease resulted in greater improvement in angina symptom score (OR: 1.80; 95% credible interval [CrI]: 1.48-2.18; Pr[Benefit] > 99.9%) and daily episodes of angina (OR: 1.55; 95% CrI: 1.26-1.89; Pr[Benefit] > 99.9%).

在调整了随机化前的非高灌注压力比后，与弥漫性疾病相比，PCI在局灶性疾病中导致心绞痛症状评分（OR: 1.80; 95%可信区间[CrI]: 1.48-2.18; Pr[Benefit] > 99.9%）和每日心绞痛发作次数（OR: 1.55; 95% CrI: 1.26-1.89; Pr[Benefit] > 99.9%）的更大改善。

Focal disease also predicted greater placebo-controlledbenefit in exercise treadmill time (Pr[Interaction] > 99.9%), Canadian Cardiovascular Society class (Pr[Interaction] = 99.0%), EuroQol Group 5-Dimensions 5-Level questionnaire (Pr[Interaction] = 95.1%), and Seattle Angina Questionnaire angina frequency (Pr[Interaction] = 99.5%).

局灶性疾病还预测了在运动平板试验时间（Pr[Interaction] > 99.9%）、加拿大心血管病学会分级（Pr[Interaction] = 99.0%）、欧洲五维五级问卷（Pr[Interaction] = 95.1%）和西雅图心绞痛问卷心绞痛频率（Pr[Interaction] = 99.5%）方面，与安慰剂相比更大的益处。

There was weaker evidence of interaction between disease pattern and the placebo-controlledimpact of PCI on improvement in dobutamine stress echocardiography score (Pr[Interaction] = 83%).

疾病模式与PCI在多巴酚丁胺应激超声心动图评分改善方面的安慰剂对照效果之间的相互作用证据较弱（Pr[相互作用] = 83%）。

Conclusions

In focal disease, PCI resulted in greater placebo-controlledimprovement of symptoms compared with diffuse disease.

在局灶性疾病中，与弥漫性疾病相比，PCI在症状的安慰剂对照改善方面效果更佳。

Physiological patterns of disease may be useful to guide treatment decision making with PCI for symptom relief.

疾病的生理模式可能有助于指导使用经皮冠状动脉介入治疗（PCI）以缓解症状的治疗决策。