The BYPASS-CTCA Study: the value of Computed Tomography Cardiac Angiography (CTCA) in improving patient-related outcomes in patients with previous bypass operation undergoing invasive coronary angiography: Study Protocol of a Randomised Controlled Trial

Anne-Marie Beirne, Krishnaraj S Rathod, Emily Castle, Mervyn Andiapen, Amy Richards, Anna Bellin, Victoria Hammond, Thomas Godec, James C Moon, Ceri Davies, Christos V Bourantas, Andrew Wragg, Amrita Ahluwalia, Francesca Pugliese, Anthony Mathur, Daniel A Jones, Anne-Marie Beirne, Krishnaraj S Rathod, Emily Castle, Mervyn Andiapen, Amy Richards, Anna Bellin, Victoria Hammond, Thomas Godec, James C Moon, Ceri Davies, Christos V Bourantas, Andrew Wragg, Amrita Ahluwalia, Francesca Pugliese, Anthony Mathur, Daniel A Jones

Abstract

Background: Patients with ischaemic heart disease and previous coronary artery bypass grafting (CABG) often need coronary evaluation by means of invasive coronary angiography (ICA). ICA in such patients is technically more challenging and carries a higher risk of complications including kidney damage, myocardial infarction, stroke and death. Improvements in Computed Tomography Cardiac Angiography (CTCA) technology have ensured its emergence as a useful clinical tool in CABG assessment, allowing for its potential use in planning interventional procedures in this patient group.

Methods: The BYPASS-CTCA study is a prospective, single centre, randomised controlled trial assessing the value of upfront CTCA in patients with previous surgical revascularisation undergoing ICA procedures. A total of 688 patients with previous CABG, requiring ICA for standard indications, will be recruited and randomised to receive ICA alone, or CTCA prior to angiography. Subjects will be followed up over a 12-month period post procedure. The primary endpoints are ICA procedural duration, incidence of contrast-induced nephropathy (CIN) and patient satisfaction scores post ICA. Secondary endpoints include contrast dose (mL) and radiation dose (mSv) during ICA, number of catheters used, angiography-related complications and cost-effectiveness of CTCA (QALY) over 12 months.

Discussion: The study will investigate the hypothesis that CTCA prior to ICA in patients with previous CABG can reduce procedural duration, post-procedural kidney damage and improve patient satisfaction, therefore strengthening its role in this group of patients.

Trial registration: The study is registered on ClinicalTrials.gov which is a resource maintained by the U.S. National Library of Medicine. Registration number NCT03736018.

Keywords: Computed Tomography Cardiac Angiography (CTCA); Ischaemic heart disease; contrast-induced nephropathy (CIN); coronary artery bypass grafting (CABG); invasive coronary angiography (ICA).

Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://dx.doi.org/10.21037/atm-21-1455). FP reports receiving institutional research support from Siemens Healthineers. The other authors have no conflicts of interest to declare.

2021 Annals of Translational Medicine. All rights reserved.

Figures

Figure 1
Figure 1
Reconstructed computed tomography (CT) images showing (A) severe stenosis in a saphenous vein graft to the right coronary artery in 2D, and (B) severe stenosis in the same vessel (saphenous vein graft to right coronary artery) reconstructed in 3D.
Figure 2
Figure 2
Study flowchart. CTCA, Computed Tomography Cardiac Angiography; EQ5D, Quality of Life Questionnaire; CIN, contrast-induced nephropathy; eGFR, estimated glomerular filtration rate; MACE, major adverse cardiac events; SAQ, Seattle Angina Questionnaire. CCS, Canadian Chest Pain Score, CTCA, Computed Tomography Coronary Angiography; CABG, coronary artery bypass grafts.

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Source: PubMed

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