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

• Published in: BMJ open 2022-01, Vol.12 (1), p.e052215
• Main Authors: Lee, Pil Hyung, Hong, Soon Jun, Kim, Hyun-Sook, Yoon, Young won, Lee, Jong-Young, Oh, Seung-Jin, Kang, Soo-Jin, Kim, Young-Hak, Park, Seong-Wook, Lee, Seung-Whan, Lee, Cheol Whan
• Format: Article
• Language: English
• Subjects: Algorithms; Angioplasty; Calcification; Cancer; Cardiovascular disease; Cardiovascular Medicine; Coronary Angiography - methods; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - surgery; coronary heart disease; coronary intervention; Coronary vessels; Drug-Eluting Stents; Ejection fraction; Humans; Informed consent; ischaemic heart disease; Ischemia; Laboratories; Medical imaging; Multicenter Studies as Topic; Onsite; Patients; Percutaneous Coronary Intervention - methods; Randomized Controlled Trials as Topic; Stents; Transplants & implants; Treatment Outcome; Ultrasonic imaging; Ultrasonography, Interventional - methods; Vein & artery diseases
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2021-052215

IntroductionAngiography 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 analysisThe 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 disseminationEthics 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 numberNCT02978456.