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Results from the REMEDIAL III Trial Reported at TCT 2019

SAN FRANCISCO – September 29, 2019 – A randomized trial of urine flow rate-guided (UFR) versus left ventricular end-diastolic pressure-guided (LVEDP) hydration in patients at high risk for contrast-induced kidney injury found that the UFR-guided technique was more effective in preventing complications such as acute kidney injury and/or acute pulmonary edema.

Findings were reported today at the 31^st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

Patients with chronic kidney disease are at risk for acute kidney injury following the administration of contrast dye used for diagnostic and interventional procedures. REMEDIAL III was a randomized, multicenter, investigator-initiated trial designed to compare two hydration strategies for reducing the risk of acute kidney injury. A total of 708 patients with an estimated glomerular filtration rate≤45 mL/min/1.73 m² and/or with a Mehran’s score greater than or equal to 11 and/or a Gurm’s score greater than 7 were enrolled. Patients were randomized 1:1 to LVEDP-guided hydration with normal saline (LVEDP-guided group; n=355), or UFR-guided hydration controlled by the RenalGuard system (UFR-guided group; n=353). In all cases iobitridol (a low-osmolar, non-ionic contrast agent) was administered.

The primary endpoint was the composite of contrast-induced acute kidney injury (defined as a serum creatinine increase greater than or equal to 25% and/or greater than or equal to 0.5 mg/dL from the baseline to 48 hours) and/or acute pulmonary edema. The primary endpoint occurred in 5.7% (n=20/351) of patients in the UFR-guided group and in 10.3% (n=36/351) of patients in the LVEDP-guided group (relative risk = 0.56; 95% confidence interval 0.39-0.79; p = 0.036).

“Acute kidney injury can be a serious complication due to the contrast received during invasive diagnostic or interventional procedures,” said Carlo Briguori, MD, PhD, Chief of the Laboratory of Interventional Cardiology at the Mediterranea Cardiocentro in Naples, Italy. “Hydration is the cornerstone to prevent this complication. However, uncontrolled hydration may lead to acute pulmonary edema. The REMEDIAL III trial compared two tailored hydration regimens to reduce these risks as a whole in high risk patients. The study found that UFR-guided hydration is superior to LVEDP-guided hydration to prevent acute kidney injury and acute pulmonary edema. The number needed to treat to prevent one event with the RenalGuard system was 22.”

The REMEDIAL III study was supported by an unrestricted grant from Guerbet (Villepinte, France) provided to the Mediterranea Cardiocentro. Dr. Briguori had nothing to disclose.