Chotai Shayna, Salih Ahmed, Ahmed-Jushuf Fiyyaz, Foley Michael, Al-Lamee Rasha K
National Heart and Lung Institute, Imperial College London, London, UK; Imperial College Healthcare NHS Trust, London, UK.
Imperial College Healthcare NHS Trust, London, UK.
Cardiovasc Revasc Med. 2025 Jul;76:11-16. doi: 10.1016/j.carrev.2025.03.018. Epub 2025 Mar 22.
It is now widely accepted that in the setting of stable angina, the primary remit of percutaneous coronary intervention (PCI) is for symptom relief. However, prior to the Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina (ORBITA) trial, there had been no placebo-controlled trial to assess the efficacy of this common procedure to improve angina. ORBITA randomised 200 patients with significant single-vessel coronary artery disease on maximal anti-anginal medications to either PCI or a placebo procedure. The results were striking and unexpected: after 6 weeks, there was no significant difference in the primary endpoint of treadmill exercise time between groups. Questions arose; how could PCI fail to outperform a placebo procedure, despite resolving significant epicardial stenosis and ischaemia? Clearly the relationship between symptoms, ischaemia and stenosis was more complex than previously understood. ORBITA-2 was designed to assess the effect of PCI compared to placebo in patients with single or multivessel disease, without the possible attenuation of anti-anginal medication, at 12 weeks. In this setting, PCI convincingly improved symptoms, with a significant increment over placebo as assessed by the angina symptom score, a patient-orientated primary endpoint. Taken together, these trials highlight a key insight: when offered first without anti-anginal medications, PCI offers meaningful symptom benefit. When offered after anti-anginal medications, as is recommended by international guidelines, it's added benefit is much smaller. This suggests the sequence of treatment matters, with the first therapy, whether PCI or medications, yielding the most demonstrable benefit, with subsequent interventions then offering little added value. As clinicians, the decision to advocate for PCI or anti-anginal medications first, will depend on many factors including individual patient characteristics and preferences. Importantly, in the absence of a head-to-head placebo-controlled trial of PCI alone versus medication alone, the question of which approach offers the greatest symptomatic benefit remains unresolved.
目前人们普遍认为，在稳定型心绞痛的情况下，经皮冠状动脉介入治疗（PCI）的主要作用是缓解症状。然而，在稳定型心绞痛血管成形术优化药物治疗客观随机双盲研究（ORBITA）试验之前，尚无安慰剂对照试验来评估这种常见手术改善心绞痛的疗效。ORBITA将200例服用最大剂量抗心绞痛药物的单支冠状动脉疾病严重患者随机分为PCI组或安慰剂手术组。结果惊人且出乎意料：6周后，两组之间跑步机运动时间这一主要终点并无显著差异。问题出现了；尽管PCI解决了明显的心外膜狭窄和缺血问题，但为何它未能优于安慰剂手术呢？显然，症状、缺血和狭窄之间的关系比之前所理解的更为复杂。ORBITA - 2旨在评估在无抗心绞痛药物可能减弱作用的情况下，PCI与安慰剂相比对单支或多支血管疾病患者在12周时的影响。在这种情况下，PCI显著改善了症状，与安慰剂相比，心绞痛症状评分（一个以患者为导向的主要终点）有显著提高。综合来看，这些试验突出了一个关键见解：在未首先使用抗心绞痛药物的情况下进行PCI，能带来有意义的症状改善。按照国际指南的建议，在使用抗心绞痛药物之后进行PCI，其额外益处要小得多。这表明治疗顺序很重要，首次治疗（无论是PCI还是药物治疗）能产生最明显的益处，后续干预则几乎没有额外价值。作为临床医生，主张首先进行PCI还是抗心绞痛药物治疗的决定，将取决于许多因素，包括患者的个体特征和偏好。重要的是，在缺乏单纯PCI与单纯药物治疗的直接安慰剂对照试验的情况下，哪种方法能提供最大的症状改善这一问题仍未得到解决。
