Percutaneous Coronary Intervention in Stable Angina (ORBITA): A Double-Blind, Randomized Controlled Trial
Percutaneous Coronary Intervention in Stable Angina (ORBITA): A Double-Blind, Randomized Controlled Trial
复制标题
稳定型心绞痛经皮冠状动脉介入治疗 (ORBITA)：双盲、随机对照试验
DOI：
10.1016/j.jvs.2017.11.046
复制
发表时间：
2018
影响因子：
4.3
通讯作者：
J. Davies
中科院分区：
文献类型：
--
作者：
R. Al;D. Thompson;H. Dehbi;S. Sen;K. Tang;J. Davies
症状缓解是稳定性心绞痛经皮冠状动脉介入治疗(PCI)的首要目标，临床上普遍观察到。然而，没有来自盲目、安慰剂对照的随机试验的证据表明其有效性。方法ORBITA是在英国的五个研究地点进行的一项关于冠状动脉介入治疗和安慰剂缓解心绞痛的多中心随机试验。我们招募了严重(≥70%)单血管狭窄的患者。登记后，患者接受了为期6周的药物优化。然后，患者通过心肺运动试验、症状问卷和多巴酚丁胺负荷超声心动图进行预随机评估。患者通过使用自动在线随机工具以1：1随机方式接受经皮冠状动脉介入治疗或安慰剂治疗。随访6周后，在最终评估时重复随机前所做的评估。主要终点是不同组之间运动时间增量的差异。所有分析都基于意向治疗原则，研究人群包含了所有接受随机分组的参与者。这项研究在ClinicalTrials.gov注册，编号NCT02062593。发现ORBITA纳入了230名有缺血症状的患者。在药物优化阶段之后，在2014年1月6日至2017年8月11日期间，200名患者接受了随机分组，其中105名患者接受了经皮冠状动脉介入治疗，95名患者接受了安慰剂治疗。病变平均面积狭窄84·4%(SD 10·2)，血流储备分数0·69(0·16)，瞬时消失率0·76(0·22)。运动时间增量的主要终点在两组间无显著差异(冠状动脉介入治疗+安慰剂16.6 S，95%CI−8.9~42.0，p=0.200)。没有人死亡。严重的不良事件包括安慰剂组4例与压力线相关的并发症，需要行经皮冠状动脉介入治疗，以及5例主要出血事件，其中2例在经皮冠状动脉介入治疗组，3例在安慰剂组。侵入性手术的疗效可以通过安慰剂对照进行评估，这是药物治疗的标准。资金来源：NIHR帝国生物医学研究中心、循环健康基金会、帝国学院医疗慈善机构、飞利浦火山、NIHR Barts生物医学研究中心。
BackgroundSymptomatic relief is the primary goal of percutaneous coronary intervention (PCI) in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy.MethodsORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief that was done at five study sites in the UK. We enrolled patients with severe (≥70%) single-vessel stenoses. After enrolment, patients received 6 weeks of medication optimisation. Patients then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. Patients were randomised 1:1 to undergo PCI or a placebo procedure by use of an automated online randomisation tool. After 6 weeks of follow-up, the assessments done before randomisation were repeated at the final assessment. The primary endpoint was difference in exercise time increment between groups. All analyses were based on the intention-to-treat principle and the study population contained all participants who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02062593.FindingsORBITA enrolled 230 patients with ischaemic symptoms. After the medication optimisation phase and between Jan 6, 2014, and Aug 11, 2017, 200 patients underwent randomisation, with 105 patients assigned PCI and 95 assigned the placebo procedure. Lesions had mean area stenosis of 84·4% (SD 10·2), fractional flow reserve of 0·69 (0·16), and instantaneous wave-free ratio of 0·76 (0·22). There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16·6 s, 95% CI −8·9 to 42·0, p=0·200). There were no deaths. Serious adverse events included four pressure-wire related complications in the placebo group, which required PCI, and five major bleeding events, including two in the PCI group and three in the placebo group.InterpretationIn patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure. The efficacy of invasive procedures can be assessed with a placebo control, as is standard for pharmacotherapy.FundingNIHR Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, Philips Volcano, NIHR Barts Biomedical Research Centre.