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  • Quantitative coronary angiography versus intravascular ultrasound guidance for drug-eluting stent implantation (GUIDE-DES): study protocol for a randomised controlled non-inferiority trial

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Cardiovascular medicine
Protocol
Quantitative coronary angiography versus intravascular ultrasound guidance for drug-eluting stent implantation (GUIDE-DES): study protocol for a randomised controlled non-inferiority trial
  1. Pil Hyung Lee1,
  2. Soon Jun Hong2,
  3. Hyun-Sook Kim3,
  4. Young won Yoon4,
  5. Jong-Young Lee5,
  6. Seung-Jin Oh6,
  7. Soo-Jin Kang1,
  8. Young-Hak Kim1,
  9. Seong-Wook Park1,
  10. Seung-Whan Lee1,
  11. Cheol Whan Lee1
  12. The GUIDE-DES Trial Research Group
  1. 1Division of Cardiology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Songpa-gu, Seoul, Korea (the Republic of)
  2. 2Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Korea (the Republic of)
  3. 3Department of Cardiology, Hallym University Sacred Heart Hospital, Anyang, Korea (the Republic of)
  4. 4Division of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (the Republic of)
  5. 5Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of)
  6. 6Department of Cardiology, National Health Insurance Service Ilsan Hospital, Gyeonggi-do, Korea
  1. Correspondence to Dr Cheol Whan Lee; cheolwlee{at}amc.seoul.kr

Abstract

Introduction Angiography remains the gold standard for guiding percutaneous coronary intervention (PCI). However, it is prone to suboptimal stent results due to the visual estimation of coronary measurements. Although the benefit of intravascular ultrasound (IVUS)-guided PCI is becoming increasingly recognised, IVUS is not affordable for many catheterisation laboratories. Thus, a more practical and standardised angiography-based approach is necessary to support stent implantation.

Methods and analysis The Quantitative Coronary Angiography versus Intravascular Ultrasound Guidance for Drug-Eluting Stent Implantation trial is a randomised, investigator-initiated, multicentre, open-label, non-inferiority trial comparing the quantitative coronary angiography (QCA)-guided PCI strategy with IVUS-guided PCI in all-comer patients with significant coronary artery disease. A novel, standardised, QCA-based PCI protocol for the QCA-guided group will be provided to all participating operators, while the PCI optimisation criteria will be predefined for both strategies. A total of 1528 patients will be randomised to either group at a 1:1 ratio. The primary endpoint is the 12-month cumulative incidence of target-lesion failure defined as a composite of cardiac death, target-vessel myocardial infarction or ischaemia-driven target-lesion revascularisation. Clinical follow-up assessments are scheduled at 1, 6 and 12 months for all patients enrolled in the study.

Ethics and dissemination Ethics approval for this study was granted by the Institutional Review Board of Asan Medical Center (no. 2017-0060). Informed consent will be obtained from every participant. The study findings will be published in peer-reviewed journal articles and disseminated through public forums and academic conference presentations. Cost-effectiveness and secondary imaging analyses will be shared in secondary papers.

Trial registration number NCT02978456.

  • coronary heart disease
  • coronary intervention
  • ischaemic heart disease
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/bmjopen-2021-052215

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    Footnotes

    • Contributors PHL, S-WL and CWL developed the trial concept and wrote the protocol and the manuscript of the protocol publication. SJH, H-SK, YWY, J-YL, S-JO, S-JK, Y-HK and S-WP helped to develop the trial concept and revised the manuscript critically for important intellectual content.

    • Funding This study is funded by an unrestricted grant from Biotronik, Bülach, Switzerland (G1709).

    • Competing interests None declared.

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

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.