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Coronary artery disease
Original article
Symptoms and quality of life in patients with suspected angina undergoing CT coronary angiography: a randomised controlled trial
  1. Michelle C Williams1,
  2. Amanda Hunter1,
  3. Anoop Shah1,
  4. Valentina Assi2,
  5. Stephanie Lewis2,
  6. Kenneth Mangion3,
  7. Colin Berry3,
  8. Nicholas A Boon1,
  9. Elizabeth Clark1,
  10. Marcus Flather4,
  11. John Forbes5,
  12. Scott McLean6,
  13. Giles Roditi3,
  14. Edwin JR van Beek1,
  15. Adam D Timmis7,
  16. David E Newby1
  17. on behalf of the Scottish COmputed Tomography of the HEART (SCOT-HEART) Trial Investigators
    1. 1 British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK
    2. 2 Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK
    3. 3 Institute for Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK
    4. 4 Norwich Medical School, University of East Anglia, UK
    5. 5 University of Limerick, Limerick, Ireland
    6. 6 National Health Service, Fife, UK
    7. 7 William Harvey Research Institute, Queen Mary University of London, London, UK
    1. Correspondence to Professor David Newby, University/BHF Centre for Cardiovascular Science, Chancellor's Building, SU314, 49 Little France Crescent, Edinburgh EH16 4SA, UK; d.e.newby{at}ed.ac.uk

    Abstract

    Background In patients with suspected angina pectoris, CT coronary angiography (CTCA) clarifies the diagnosis, directs appropriate investigations and therapies, and reduces clinical events. The effect on patient symptoms is currently unknown.

    Methods In a prospective open-label parallel group multicentre randomised controlled trial, 4146 patients with suspected angina due to coronary heart disease were randomised 1:1 to receive standard care or standard care plus CTCA. Symptoms and quality of life were assessed over 6 months using the Seattle Angina Questionnaire and Short Form 12.

    Results Baseline scores indicated mild physical limitation (74±0.4), moderate angina stability (44±0.4), modest angina frequency (68±0.4), excellent treatment satisfaction (92±0.2) and moderate impairment of quality of life (55±0.3). Compared with standard care alone, CTCA was associated with less marked improvements in physical limitation (difference −1.74 (95% CIs, −3.34 to −0.14), p=0.0329), angina frequency (difference −1.55 (−2.85 to −0.25), p=0.0198) and quality of life (difference −3.48 (−4.95 to −2.01), p<0.0001) at 6 months. For patients undergoing CTCA, improvements in symptoms were greatest in those diagnosed with normal coronary arteries or who had their preventative therapy discontinued, and least in those with moderate non-obstructive disease or had a new prescription of preventative therapy (p<0.001 for all).

    Conclusions While improving diagnosis, treatment and outcome, CTCA is associated with a small attenuation of the improvements in symptoms and quality of life due to the detection of moderate non-obstructive coronary artery disease.

    Trial registration number: NCT01149590.

    This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

    https://doi.org/10.1136/heartjnl-2016-310129

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      Footnotes

      • Collaborators SCOT-HEART investigators: chief investigator: Prof David Newby. Trial research fellows: Dr Michelle Williams, Dr Amanda Hunter, Dr Tania Pawade and Dr Anoop Shah. Grant applicants: Prof David Newby (principal applicant), Dr Andrew Flapan, Prof John Forbes, Dr Allister Hargreaves, Prof Stephen Leslie, Dr Steff Lewis, Dr Graham McKillop, Dr Scott McLean, Dr John Reid, Dr James Spratt and Dr Neal Uren. Trial steering committee: Prof Adam Timmis (chair), Prof Colin Berry, Dr Nicholas Boon, Mrs Liz Clark, Dr Peter Craig, Dr Tom Barlow, Dr Marcus Flather, Prof John Forbes, Dr Steff Lewis, Dr Chiara McCormack, Dr Scott McLean, Prof David Newby, Dr Giles Roditi, Prof Edwin van Beek, Dr Michelle Williams, Dr Amanda Hunter, Mrs Susan Shepherd and Ms Marise Bucukoglu. Edinburgh clinical trials unit: Dr Steff Lewis, Dr Valentina Assi, Dr Richard Parker, Ms Ashma Krishan, Dr Chiara McCormack, Mrs Fiona Wee, Mr Anthony Wackett, Mr Allan Walker, Ms Lynsey Milne and Ms Kat Oatey.

      • Trial sites: Borders General Hospital, Melrose: Dr Paul Neary Mrs Gillian Donaldson, Mr Terry Fairbairn, Mrs Marlene Fotheringham and Mrs Fiona Hall. Forth Valley Royal Hospital, Larbert: Dr Allister Hargreaves, Dr James Spratt, Dr Stephen Glen, Ms Sarah Perkins, Ms Fiona Taylor, Mrs Louisa Cram, Ms Catherine Beveridge, Ms Avril Cairns and Ms Frances Dougherty. Glasgow Royal Infirmary : Dr Hany Eteiba, Dr Alan Rae, Ms Kate Robb, Ms Wenda Crawford, Ms Patricia Clarkin and Ms Elisabeth Lennon. Ninewells Hospital, Dundee: Prof Graeme Houston, Prof Stuart Pringle, Dr Prasad Guntur Ramkumar, Dr Thiru Sudarshan, Dr Yvonne Fogarty, Ms Dawn Barrie, Ms Kim Bissett, Dr Adelle Dawson, Mr Scott Dundas, Mrs Deborah Letham, Ms Linda O'Neill, Mrs Valerie Ritchie and Dr Jonathan Weir-McCall. Perth Royal Infirmary, Perth: Dr Hamish Dougall. Royal Alexandra Hospital, Paisley: Dr Faheem Ahmed, Dr Alistair Cormack, Dr Iain Findlay, Dr Stuart Hood, Dr Clare Murphy, Dr Eileen Peat, Ms Lynne McCabe and Ms Margaret McCubbin. Royal Infirmary of Edinburgh, Edinburgh: Ms Barbara Allen, Prof Edwin van Beek, Dr Miles Behan, Ms Danielle Bertram, Mr David Brian, Ms Amy Cowan, Dr Nicholas Cruden, Dr Martin Denvir, Dr Marc Dweck, Ms Laura Flint, Dr Andrew Flapan, Ms Samantha Fyfe, Dr Neil Grubb, Mrs Collette Keanie, Dr Chris Lang, Dr Tom MacGillivray, Dr David MacLachlan, Ms Margaret MacLeod, Dr Saeed Mirsadraee, Mrs Avril Morrison, Dr Nicholas Mills, Dr David Northridge, Mrs Alyson Phillips, Ms Laura Queripel, Dr John Reid, Dr Neal Uren and Dr Nicholas Weir. St John ’ s Hospital, Livingston: Dr Ashok Jacob, Mrs Fiona Bett, Mrs Frances Divers, Ms Katie Fairley, Ms Edith Keegan, Ms Tricia White and Ms Julia Fowler. University Hospital, Ayr: Dr John Gemmill, Dr James McGowan, Mrs Margo Henry. Victoria Hospital, Kirkcaldy: Dr Mark Francis, Mr Dennis Sandeman and Ms Lorraine Dinnel. Western General Hospital, Edinburgh: Prof David Newby, Dr Peter Bloomfield, Dr Martin Denvir, Dr Peter Henriksen, Dr Donald MacLeod and Mrs Avril Morrison. Western Infirmary, Glasgow/Institute of Cardiovascular & Medical Sciences, University of Glasgow: Prof Colin Berry, Dr Kenneth Mangion, Dr Ify Mordi, Dr Giles Roditi, Dr Nikolaos Tzemos, Dr Eugene Connolly, Mrs Heather Boylan, Mrs Ammani Brown, Ms Lesley Farrell, Mrs Alison Frood, Ms Caroline Glover, Mrs Janet Johnstone, Mrs Kirsten Lanaghan, Mrs Deborah McGlynn, Ms Lorraine McGregor, Ms Evonne McLennan, Ms Laura Murdoch, Ms Victoria Paterson, Ms Fiona Teyhan, Ms Marion Teenan, Ms Rosie Woodward and Ms Tracey Steedman.

      • Contributors All authors and the SCOT-HEART investigators contributed to the conception or design of the work, or the acquisition or interpretation of data for the work. VA and SL analysed the data. MCW and DEN drafted the first version of the manuscript. AH, ASVS, VA, SL, KM, CB, NAB, EC, MF, JF, SM, GR, EJRvB and ACT contributed to the content and revision of the manuscript and have given final approval of the version to be published. On behalf of the authors and SCOT-HEART investigators, DEN is accountable for the overall content of the work. DEN had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

      • Funding This trial was funded by The Chief Scientist Office of the Scottish Government Health and Social Care Directorates (CZH/4/588), with supplementary awards from Edinburgh and Lothian's Health Foundation Trust and the Heart Diseases Research Fund. All researchers were independent of the trial funders. The Royal Bank of Scotland supported the provision of 320-multidetector CT for NHS Lothian and the University of Edinburgh. The Clinical Research Imaging Centre (Edinburgh) is supported by the National Health Service Research Scotland (NRS) through National Health Service Lothian Health Board. The Clinical Research Facility Glasgow and Clinical Research Facility Tayside are supported by National Health Service Research Scotland (NRS). The SCOT-HEART trial was co-sponsored by the University of Edinburgh and NHS Lothian Health Board.

      • Competing interests DEN, EvB, GR and GMcK have received honoraria and consultancy from Toshiba Medical Systems. GR has received honoraria from companies (Bracco, Bayer-Schering, GE Healthcare and Guerbet) producing contrast media. DEN (CH/09/002) and MCW (FS/11/014) are supported by the British Heart Foundation. DEN is the recipient of a Wellcome Trust Senior Investigator Award (WT103782AIA). AT is supported by Barts Cardiovascular Biomedical Research Unit, funded by the National Institute for Health Research. EvB is supported by the Scottish Imaging Network: A Platform of Scientific Excellence (SINAPSE).

      • Ethics approval The study was conducted in accordance with the Declaration of Helsinki and with research ethics committee approval.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Data sharing statement The SCOT-HEART Investigators will be happy to provide relevant anonymised patient-level data available on reasonable request.

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