局灶性与弥漫性冠状动脉病变模式与PCI安慰剂对照的心绞痛缓解：ORBITA-2研究
ORBITA-2随机安慰剂对照试验纳入245例稳定型心绞痛患者共300条靶血管压力回撤曲线，由7名盲法介入心脏病学家将病变模式分为局灶性、弥漫性或混合性并计算评分。贝叶斯比例优势模型显示，局灶性病变相比弥漫性病变，PCI在改善心绞痛症状评分和每日心绞痛发作次数方面具有更大的安慰剂对照获益。
要点
- 局灶性病变PCI安慰剂对照的心绞痛症状评分改善优于弥漫性病变（OR 1.80）。
- 局灶性病变每日心绞痛发作次数的安慰剂对照改善亦优于弥漫性病变（OR 1.55）。
- 生理性病变模式可能有助于指导PCI缓解症状的治疗决策。
核心结论
- 在局灶性病变中，PCI相比弥漫性病变带来更大的安慰剂对照症状改善。
- 生理性病变模式可能有助于指导PCI缓解症状的治疗决策。
研究设计与样本
- ORBITA-2随机安慰剂对照试验，评估稳定型心绞痛患者PCI的安慰剂对照疗效。
- 共分析245例患者、300条靶血管压力回撤曲线。
- 7名盲法介入心脏病学家独立审阅每条回撤曲线，将病变模式分为局灶性（赋值1）、弥漫性（赋值0）或混合性（赋值0.5）。
- 病变模式总评分取均值，评分>0.5判定为局灶性，≤0.5判定为弥漫性。
- 采用贝叶斯比例优势模型分析，并校正随机化前非充血压力比。
主要发现
- 校正随机化前非充血压力比后，局灶性相比弥漫性病变PCI的心绞痛症状评分改善更优（OR 1.80；95% CrI 1.48-2.18；Pr[Benefit] > 99.9%）。
- 局灶性相比弥漫性病变PCI的每日心绞痛发作次数改善更优（OR 1.55；95% CrI 1.26-1.89；Pr[Benefit] > 99.9%）。
- 局灶性病变预测更大的安慰剂对照运动平板时间获益（Pr[Interaction] > 99.9%）。
- 局灶性病变预测更大的安慰剂对照加拿大心血管学会分级获益（Pr[Interaction] = 99.0%）。
- 局灶性病变预测更大的安慰剂对照EuroQol五维五水平问卷获益（Pr[Interaction] = 95.1%）和西雅图心绞痛问卷心绞痛频率获益（Pr[Interaction] = 99.5%）。
关键数值与推荐
- 病变模式评分：局灶性=1，弥漫性=0，混合性=0.5，总评分取均值，>0.5为局灶性，≤0.5为弥漫性。
- 局灶性vs弥漫性病变PCI心绞痛症状评分OR 1.80（95% CrI 1.48-2.18；Pr[Benefit] > 99.9%）。
- 局灶性vs弥漫性病变PCI每日心绞痛发作次数OR 1.55（95% CrI 1.26-1.89；Pr[Benefit] > 99.9%）。
- 病变模式与多巴酚丁胺负荷超声心动图评分改善的安慰剂对照交互作用证据较弱（Pr[Interaction] = 83%）。
临床怎么用
- 对于稳定型心绞痛患者，生理性压力回撤评估显示的局灶性病变模式可能提示PCI缓解症状的安慰剂对照获益更大。
- 病变模式分析或可作为PCI缓解症状治疗决策的辅助参考。
局限性
- 原文摘要未报告局限性信息。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
BACKGROUND: Unblinded studies have demonstrated superior procedural and clinical outcomes of percutaneous coronary intervention (PCI) in focal compared with diffuse coronary artery disease. However, data from the first placebo-controlled study did not demonstrate a differential impact of disease pattern on symptom endpoints. OBJECTIVES: The study sought to test the ability of pattern of coronary artery disease to predict the placebo-controlled efficacy of PCI. METHOD: In the ORBITA-2 (Objective Randomised Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina-2) randomized placebo-controlled trial of angioplasty for stable angina, patients underwent prerandomization nonhyperemic pressure wire pullback assessments. Seven blinded interventional cardiologists independently reviewed each pullback trace to categorize disease patterns as focal, diffuse, or mixed. These were assigned numerical values of 1, 0, and 0.5, respectively. Overall disease pattern score was determined by the mean. A score >0.5 was considered focal and ≤0.5 was considered diffuse. Bayesian proportional odds modeling was used. RESULTS: A total of 245 patients with 300 target vessel pullbacks were analyzed. 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%). Focal disease also predicted greater placebo-controlled benefit 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%). There was weaker evidence of interaction between disease pattern and the placebo-controlled impact of PCI on improvement in dobutamine stress echocardiography score (Pr[Interaction] = 83%). CONCLUSIONS: In focal disease, PCI resulted in greater placebo-controlled improvement of symptoms compared with diffuse disease. Physiological patterns of disease may be useful to guide treatment decision making with PCI for symptom relief.
引用
- Chiew K, Foley MJ, Chotai S, et al. Focal and Diffuse Coronary Artery Disease Patterns and Placebo-Controlled Angina Relief With Percutaneous Coronary Intervention: ORBITA-2. J Am Coll Cardiol. 2026. PMID: 42017887. doi:10.1016/j.jacc.2026.02.5126
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。