Elsevier

American Heart Journal

Volume 263, September 2023, Pages 151-158
American Heart Journal

Trial Designs
Rationale and design of the Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) in PCI randomized controlled trial

https://doi.org/10.1016/j.ahj.2023.04.004Get rights and content

Background

The clinical and anatomic complexity of patients undergoing percutaneous coronary interventions (PCI) has increased significantly over the past 2 decades. Contrast induced nephropathy (CIN) significantly impacts prognosis after PCI, therefore minimizing the risk of CIN is important in improving clinical outcomes. Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool which may decrease CIN by projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially reducing iodinated contrast volume during PCI.

Study design and objectives

The Dynamic Coronary Roadmap for Contrast Reduction trial (DCR4Contrast) is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial investigating if DCR use reduces the total contrast volume administered during PCI compared to PCI performed without DCR guidance. DCR4Contrast aims to recruit 394 patients undergoing PCI. The primary end point is the total undiluted iodinated contrast volume administered during the PCI, performed with or without DCR. As of November 14, 2022, 346 subjects have been enrolled.

Conclusions

The DCR4Contrast study will investigate the potential contrast-sparing effect of the DCR navigation support tool in patients undergoing PCI. By reducing iodinated contrast administration, DCR has the potential to contribute to reduced risk of CIN and thus increase PCI safety.

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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