Trial DesignsRationale and design of the Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) in PCI randomized controlled trial
Section snippets
Background and rationale
Invasive coronary angiography remains a cornerstone in the diagnosis and treatment of obstructive coronary artery disease. Percutaneous coronary intervention (PCI), the most frequent modality of coronary revascularization, requires the use of iodinated contrast to define the coronary anatomy and to guide the navigation of dedicated equipment such as guidewires, balloons and stents. It has been demonstrated that contrast volume is directly associated with the risk of contrast induced nephropathy
Study design
The DCR4Contrast study is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial designed to assess whether using DCR reduces the total iodinated contrast volume used for PCI procedures compared to the control group of PCI without DCR. During the randomization process, all subjects undergoing PCI (ad hoc or elective) will be stratified according to the number of intended vessels requiring treatment (single vessel, 2 vessel or 3 or more vessel PCI), see Figure 1 for
Sample Size Justification for Primary End point
Calculation of sample size was based primarily on 2 previous studies.19,20 The study by Yabe et al19 demonstrated that DCR was associated with a 21.9% reduction in contrast administration compared to the control group (152.1 ± 73.0 mL in the control group vs 118.8 ± 49.7 mL, in the DCR group P = .006). Using the outcomes from this study as input with a margin of 7% for the contrast reduction, ie, the sample size calculation is performed to reliably show a 15% contrast reduction in the DCR group
Discussion
The DCR4Contrast trial will provide objective evidence regarding the impact of using DCR on the volume of iodinated contrast used during routine PCI procedures, in addition to a reduction in the cine angiographic runs used to complete the procedure. If the trial demonstrates a benefit, this would provide evidence in favor of the use of DCR in routine clinical practice to reduce contrast administration to improve procedural safety particularly in patients at high risk of developing CIN.
Awareness
Limitations
As the statistical power of the study has been gauged to its primary end point, it is not anticipated that the DCR4Contrast trial will find a significant difference in the incidence of AKI between study groups due to the low incidence. The incidence of AKI in the study groups constitutes an exploratory end point. In keeping with institutional standard practices, the majority of the patients in the trial will be discharged 24 hours following the intervention, such that diagnosis of an AKI
Conclusions
The DCR4Contrast trial will be the first multi-center, prospective, randomized-control trial to evaluate whether using DCR reduces the total iodinated contrast volume required per PCI procedure in patients undergoing non-emergent PCI.
Conflict of interest
Breda Hennessey: Speaker at educational events for Philips. John Messenger: Institutional Grant Support, Philips Medical Systems. Ajay Kirtane: Institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck. In addition to research grants, institutional funding includes fees
Funding
This study is sponsored by Philip Medical Systems, Best, The Netherlands.
Author contributions
Breda Hennessey: Writing. John Messenger: Methodology. Ajay Kirtane: Methodology. Manish Parikh: Methodology. Haim Danenberg: Critical Review. Frédéric De Vroey: Critical Review. Alejandro Curcio: Critical Review. Peter Eshuis: Writing, Conceptualization, Methodology. Javier Escaned: Writing, Conceptualization, Methodology.
Acknowledgments
The authors would like to acknowledge Iris ter Horst and Petra Koopmans (both Philips Medical Systems, Best, The Netherlands) for their input to the study design and statistics, respectively. Figure 2 is adapted from Piayda K., Kleinebrecht L., Afzal S., et al. Dynamic coronary roadmapping during percutaneous coronary intervention: a feasibility study. European Journal of Medical Research 2018;23(1):36 (17). Copyright of the figure belongs to the original publisher, European Journal of Medical
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