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Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial.

Authors
  • Al-Lamee, Rasha1
  • Thompson, David1
  • Dehbi, Hakim-Moulay2
  • Sen, Sayan1
  • Tang, Kare3
  • Davies, John3
  • Keeble, Thomas3
  • Mielewczik, Michael4
  • Kaprielian, Raffi5
  • Malik, Iqbal S5
  • Nijjer, Sukhjinder S5
  • Petraco, Ricardo1
  • Cook, Christopher1
  • Ahmad, Yousif1
  • Howard, James1
  • Baker, Christopher5
  • Sharp, Andrew6
  • Gerber, Robert7
  • Talwar, Suneel8
  • Assomull, Ravi5
  • And 7 more
  • 1 Imperial College London, London, UK; Imperial College Healthcare NHS Trust, London, UK.
  • 2 Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.
  • 3 Essex Cardiothoracic Centre, Basildon, UK.
  • 4 Imperial College London, London, UK.
  • 5 Imperial College Healthcare NHS Trust, London, UK.
  • 6 Royal Devon and Exeter NHS Trust, Exeter, UK.
  • 7 East Sussex Healthcare NHS Trust, Hastings, UK.
  • 8 Royal Bournemouth and Christchurch NHS Trust, Bournemouth, UK.
  • 9 William Harvey Research Institute, Queen Mary University of London, London, UK.
  • 10 Imperial College London, London, UK; Imperial College Healthcare NHS Trust, London, UK. Electronic address: [email protected]
Type
Published Article
Journal
The Lancet
Publisher
Elsevier
Publication Date
Jan 06, 2018
Volume
391
Issue
10115
Pages
31–40
Identifiers
DOI: 10.1016/S0140-6736(17)32714-9
PMID: 29103656
Source
Medline
Language
English
License
Unknown

Abstract

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. 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. This study is registered with ClinicalTrials.gov, number NCT02062593. 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. 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. NIHR Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, Philips Volcano, NIHR Barts Biomedical Research Centre. Copyright © 2018 Elsevier Ltd. All rights reserved.

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