Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial
Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial
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DOI：
10.1016/s0140-6736(17)32714-9
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发表时间：
2018-01-06
期刊：
影响因子：
168.9
通讯作者：
Francis, Darrel P.
中科院分区：
文献类型：
--
作者：
Al-Lamee, Rasha;Thompson, David;Francis, Darrel P.
背景缓解症状是经皮冠状动脉介入治疗（PCI）治疗稳定型心绞痛的主要目的，在临床上也很常见。然而，没有来自盲法、安慰剂对照的随机试验的证据表明其有效性。方法：ORBITA是一项在英国五个研究地点进行的PCI与安慰剂治疗心绞痛缓解的多中心盲法随机试验。我们招募了严重（>= 70%）单血管狭窄的患者。入组后，患者接受6周的药物优化治疗。然后对患者进行心肺运动测试、症状问卷调查和多巴酚丁胺应激超声心动图的预随机评估。通过使用自动在线随机化工具，将患者1:1随机化，接受PCI或安慰剂治疗。随访6周后，在最终评估时重复随机化前的评估。主要终点为两组间运动时间增量的差异。所有分析均基于意向治疗原则，研究人群包含所有随机化的参与者。结果：ORBITA纳入了230例有缺血性症状的患者。在药物优化阶段之后，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PCI治疗，95名患者接受了安慰剂治疗。病变平均狭窄面积为84.4% (SD 10.2)，血流储备分数为0.69(0.16)，瞬时无波比0.76（0.22）。各组间运动时间增加的主要终点无显著差异（PCI -安慰剂组16.6 s, 95% CI -8.9 ~ 42.0, p= 0.200）。没有人员死亡。严重不良事件包括安慰剂组4例压力丝相关并发症（需要PCI）和5例主要出血事件，其中PCI组2例，安慰剂组3例。在经药物治疗的心绞痛和严重冠状动脉狭窄患者中，PCI治疗并没有比安慰剂治疗增加更多的运动时间。侵入性手术的疗效可以用安慰剂对照来评估，这是药物治疗的标准。
Background Symptomatic 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.Methods ORBITA 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.Findings ORBITA 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.Interpretation In 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.