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  • Percutaneous coronary intervention versus medical therapy in patients with angina and grey-zone fractional flow reserve values: a randomised clinical trial

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Coronary artery disease
Original research
Percutaneous coronary intervention versus medical therapy in patients with angina and grey-zone fractional flow reserve values: a randomised clinical trial
  1. Barry Hennigan1,2,3,
  2. Colin Berry1,2,
  3. Damien Collison1,2,
  4. David Corcoran2,
  5. Hany Eteiba1,2,
  6. Richard Good1,
  7. Margaret McEntegart1,2,
  8. Stuart Watkins1,
  9. John D McClure2,
  10. Kenneth Mangion2,
  11. Thomas Joseph Ford2,
  12. Mark C Petrie2,
  13. Stuart Hood1,2,
  14. Paul Rocchiccioli1,2,
  15. Aadil Shaukat1,
  16. Mitchell Lindsay1,
  17. Keith G Oldroyd1,2
  1. 1 Cardiology Department, Golden Jubilee National Hospital, Glasgow, United Kingdom
  2. 2 BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK
  3. 3 Cardiology Department, The Mater Private Hospital Cork, Cork, Ireland
  1. Correspondence to Dr Barry Hennigan, Cardiology, Mater Private Hospital, Cork, Ireland; barrywhennigan{at}gmail.com

Abstract

Introduction There is conflicting evidence regarding the benefits of percutaneous coronary intervention (PCI) in patients with grey zone fractional flow reserve (GZFFR artery) values (0.75–0.80). The prevalence of ischaemia is unknown. We wished to define the prevalence of ischaemia in GZFFR artery and assess whether PCI is superior to optimal medical therapy (OMT) for angina control.

Methods We enrolled 104 patients with angina with 1:1 randomisation to PCI or OMT. The artery was interrogated with a Doppler flow/pressure wire. Patients underwent Magnetic Resonance Imaging (MRI) with follow-up at 3 and 12 months. The primary outcome was angina status at 3 months using the Seattle Angina Questionnaire (SAQ).

Results 104 patients (age 60±9 years), 79 (76%) males and 79 (76%) Left Anterior Descending (LAD) stenoses were randomised. Coronary physiology and SAQ were similar. Of 98 patients with stress perfusion MRI data, 17 (17%) had abnormal perfusion (≥2 segments with ≥25% ischaemia or ≥1 segment with ≥50% ischaemia) in the target GZFFR artery. Of 89 patients with invasive physiology data, 26 (28%) had coronary flow velocity reserve <2.0 in the target GZFFR artery. After 3 months of follow-up, compared with patients treated with OMT only, patients treated by PCI and OMT had greater improvements in SAQ angina frequency (21 (28) vs 10 (23); p=0.026) and quality of life (24 (26) vs 11 (24); p=0.008) though these differences were no longer significant at 12 months.

Conclusions Non-invasive evidence of major ischaemia is uncommon in patients with GZFFR artery. Compared with OMT alone, patients randomised to undergo PCI reported improved symptoms after 3 months but these differences were no longer significant after 12 months.

Trial registration number NCT02425969.

  • fractional flow reserve
  • combined pressure and doppler flow coronary wire
  • percutaneous coronary intervention
  • stress perfusion MRI
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/heartjnl-2019-316075

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    Footnotes

    • Twitter @barryhennigan, @kenneth_mangion, @tomjford

    • Contributors BH, KGO and CB designed the trial and obtained funding. BH coordinated the execution of the trial and collated and analysed the physiological, demographic, MRI and questionnaire data. DC analysed the QCA data. SW acquired and contributed data, analysed the MRI data and approved the final manuscript. CB, KM, DC and BH analysed the MRI data. TJF coordinated 12-month questionnaire data. HE, RG, MM, MCP, SH, PR, AS and ML acquired and contributed data and reviewed the manuscript prior to final approval. BH and JDM performed the statistical analysis. KGO and BH had access to all the data in the study and BH takes responsibility for the integrity of the data and the accuracy of the data analysis.

    • Funding This study was performed in the Golden Jubilee National Hospital, Clydebank, UK and was supported by British Heart Foundation Project Grant (PG/14/97/31263) and an institutional grant from the British Heart Foundation to the University of Glasgow (RE/186134217).

    • Competing interests There was no industry sponsorship of this trial. CB has undertaken research, consulting and lectures for Abbott Vascular, Opsens and Coroventis based on contracts with The University of Glasgow. KGO has received speaker fees from Abbott Vascular, Boston Scientific and Biosensors. BH has received honoraria from Philips Volcano for consultancy.

    • Patient consent for publication Obtained.

    • Ethics approval This study was supported financially by British Heart Foundation; however, the British Heart Foundation was not involved in the design or conduct of the study, collection of data, management of data, analysis/interpretation of data, preparation of manuscripts, review or approval of manuscripts or decision to submit the manuscript for publication. This study was approved by local research committee and complies with the declaration of Helsinki. Informed consent was obtained from all research participants.

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

    • Data availability statement Data are available on reasonable request. Trial protocol is available on request. Anonymised data may be shared on request.

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