‘No additional benefit’ with RenalGuard for contrast-induced nephropathy after PCI

Source/Disclosures

Disclosures:
RenalGuard Solutions funded the STRENGTH study. Garot reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures. Gurm reports receiving research support from Blue Cross and Blue Shield of Michigan and the Michigan Translational Research and Commercialization for Life Sciences Innovation Hub. Gurm is also the co-founder of Amplitude Vascular Systems; owns equity in Amplitude Vascular Systems and Jiaxing Bossh Medical Technology Partnership; is a consultant for Amplitude Vascular Systems and Osprey Medical; and is the chair of the clinical events committee for the PERFORMANCE trial sponsored by Contego Medica.


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Compared with conventional IV hydration, furosemide-induced high urine output with matched hydration did not reduce risk for contrast-induced nephropathy in adults with chronic kidney disease undergoing complex CV interventions, data show.

Contrast-induced nephropathy can occur after CV procedures using contrast media, which is associated with increased morbidity and mortality, Philippe Garot, MDFESC, an interventional cardiologist and department head at Institut Cardiovasculaire Paris Sud, Massy, ​​France, and colleagues wrote in JACC: Cardiovascular Interventions. RenalGuard (PLC Medical Systems), a closed-loop system designed to deliver real-time IV hydration with diuretic-induced diuresis, has shown mixed results in the prevention of contrast-induced nephropathy in previous randomized controlled trials.

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“The use of RenalGuard had no additional benefit over hyper-hydration in patients with moderate to severe renal failure treated for complex CV interventions in experienced centers,” Garot told Healio. “Good clinical practices, including contrast media reduction and optimal hydration of the patient before and after percutaneous interventions, are crucial to decrease the rate of contrast-induced nephropathy.”

New postmarket data

Philippe Garot

For the STRENGTH study, a prospective, open-label postmarket study conducted across 10 interventional cardiology centers in France and Germany, Garot and colleagues analyzed data from 259 adults with moderate to severe chronic kidney disease requiring a complex coronary, structural or peripheral procedure with an expected contrast injection of at least three times the estimated glomerular filtration rate (eGFR). The mean age of participants was 79 years; 50% were men and the mean baseline eGFR was 32 mL/min/1.73 m2. Researchers randomly assigned participants to RenalGuard or IV saline hydration according to current guidelines. The primary endpoint was incidence of contrast-induced nephropathy at day 3 after the procedure.

Researchers found that the primary endpoint incidence was similar between groups, with rates of 15.9% in the RenalGuard group and 13.9% in the control group (P = .62). There were no between-group differences for any of the secondary endpoints, which included change in serum creatinine value and eGFR at 12 months; the percentage of patients on chronic or temporary hemodialysis at 12 months; and a composite of MACCE, defined as CV or all-cause death, fatal or nonfatal MI, stroke, and target vessel or nontarget vessel/target lesion or nontarget lesion revascularization after the index/staged procedure.

“Although the benefit of RenalGuard has not been shown, it was applied safely in the present study,” the researchers wrote. “The risk profile of RenalGuard, especially related to the volume load and diuretic administration, was low and similar between the groups. Also, the urological complications related to the insertion of the Foley catheter (ie, different infection and bleeding) were rare and not between the groups.”

Changing hydration practices ‘premature’

Hitinder S. Gurm

In a related editorial, Hitinder S. Gurm, MBBS, associate chief clinical officer of University of Michigan, wrote that the best approach for preventing contrast-induced acute kidney injury in people with advanced chronic kidney disease is likely to remain a combination of contrast minimization and hemodynamically guided hydration. Additionally, left ventricular end-diastolic pressure-guided hydration remains an attractive approach in such patients because it ensures adequate hydration while avoiding the risk of volume overload, Gurm wrote.

“In the absence of evidence to the contrary, it would be premature for catheterization laboratories to change their hydration practice for those with more advanced renal disease,” Gurm wrote. “It must be acknowledged, however, that the ideal hydration strategy in patients with advanced kidney disease coming to the catheterization laboratory remains unknown and is a clinical question worthy of a multicenter randomized controlled trial.”

Reference:

Gurm HS. JACC Cardiovasc Interv. 2022;doi:10.1016/j.jcin.2022.06.030.

For more information:

Philippe Garot, MDFESC, can be reached at pgarot@angio-icps.com; Twitter: @drgarot.