National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom. Electronic address: https://twitter.com/rajkumar_chris.
National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
J Am Coll Cardiol. 2024 Jul 2;84(1):1-12. doi: 10.1016/j.jacc.2024.04.001. Epub 2024 May 14.
In stable coronary artery disease, 30% to 60% of patients remain symptomatic despite successful revascularization. Perhaps not all symptoms reported by a patient with myocardial ischemia are, in fact, angina.
This study sought to determine whether independent symptom verification using a placebo-controlled ischemic stimulus could distinguish which patients achieve greatest symptom relief from percutaneous coronary intervention (PCI).
ORBITA-STAR was a multicenter, n-of-1, placebo-controlled study in patients undergoing single-vessel PCI for stable symptoms. Participants underwent 4 episodes (60 seconds each) of low-pressure balloon occlusion across their coronary stenosis, randomly paired with 4 episodes of placebo inflation. Following each episode, patients reported the similarity of the induced symptom in comparison with their usual symptom. The similarity score ranged from -10 (placebo replicated the symptom more than balloon occlusion) to +10 (balloon occlusion exactly replicated the symptom). The primary endpoint was the ability of the similarity score to predict symptom relief with PCI.
Fifty-one patients were recruited, aged 62.9 ± 8.6 years. The median fractional flow reserve was 0.68 (Q1-Q3: 0.57-0.79), and the instantaneous wave-free ratio was 0.80 (Q1-Q3: 0.48-0.89). The median similarity score was 3 (Q1-Q3: 0.875-5.25). The similarity score was a strong predictor of symptom improvement following PCI: a patient with an upper quartile similarity score of 5.25 was significantly more likely to have lower angina frequency at follow-up (OR: 8.01; 95% credible interval: 2.39-15.86) than a patient with a lower quartile similarity score of 0.875 (OR: 1.31; 95% credible interval: 0.71-1.99), Pr >99.9%.
Similarity score powerfully predicted symptom improvement from PCI. These data lay the foundation for independent symptom mapping to target PCI to those patients most likely to benefit. (Systematic Trial of Angina Assessment Before Revascularization [ORBITA-STAR]; NCT04280575).
在稳定型冠状动脉疾病中，尽管血运重建成功，仍有 30%至 60%的患者存在症状。也许并非所有报告有心肌缺血症状的患者的症状实际上都是心绞痛。
本研究旨在确定使用安慰剂对照缺血刺激进行独立症状验证是否可以区分经皮冠状动脉介入治疗（PCI）后症状缓解最大的患者。
ORBITA-STAR 是一项多中心、n-of-1、安慰剂对照的研究，纳入了因稳定症状而行单支血管 PCI 的患者。参与者接受了 4 次（每次 60 秒）低压力球囊闭塞术，随机配对 4 次安慰剂充气。每次发作后，患者报告诱导症状与他们通常的症状的相似程度。相似评分范围从-10（安慰剂比球囊闭塞更能复制症状）到+10（球囊闭塞完全复制症状）。主要终点是相似评分预测 PCI 后症状缓解的能力。
共招募了 51 名年龄为 62.9±8.6 岁的患者。中位血流储备分数为 0.68（Q1-Q3：0.57-0.79），瞬时无波比为 0.80（Q1-Q3：0.48-0.89）。中位相似评分 3（Q1-Q3：0.875-5.25）。相似评分是 PCI 后症状改善的有力预测指标：相似评分处于第 4 四分位数（5.25）的患者在随访时心绞痛发作频率明显低于相似评分处于第 1 四分位数（0.875）的患者（比值比：8.01；95%可信区间：2.39-15.86），Pr>99.9%。
相似评分有力地预测了 PCI 后症状的改善。这些数据为将独立症状映射到最有可能受益的患者进行 PCI 治疗奠定了基础。（血管重建前心绞痛评估的系统试验[ORBITA-STAR]；NCT04280575）。
