REnal Insufficiency Following Contrast MEDIA Administration TriaL III - REMEDIAL III
Contribution To Literature:
The REMEDIAL III trial showed that a UFR-guided strategy using the RenalGuard system is superior to a LVEDP-guided strategy based on IV hydration in reducing contrast-induced acute kidney injury among patients with CKD and at high risk for this endpoint.
The goal of the trial was to compare the safety and efficacy of left ventricular end-diastolic pressure (LVEDP)-guided vs. urine flow rate (UFR)-guided hydration to prevent contrast-induced nephropathy among patients with chronic kidney disease (CKD) undergoing angiography or percutaneous coronary intervention (PCI).
Eligible patients were randomized in a 1:1 fashion to LVEDP-guided (n = 355) or UFR-guided angiography/PCI using the RenalGuard system (n = 353). Infusion rates of intravenous (IV) fluids in the LVEDP arm were adjusted based on LVEDP pre- and intra-procedurally. In the UFR-guided arm, the goal was to reach ≥300 ml/hour pre-procedure and ≥450 ml/hour post-procedure, augmented by use of bolus IV furosemide. In all cases, iobitridol, a low-osmolar, nonionic contrast agent, was administered.
- Total number of enrollees: 708
- Duration of follow-up: 48 hours
- Mean patient age: 74 years
- Percentage female: 38%
- CKD, with estimated glomerular filtration rate (eGFR) ≤45 ml/min/1.73 m2
- At high-risk for contrast-induced nephropathy based on Mehran score of ≥11 and/or Gurm score ≥7
- Age <18 years
- Women who are pregnant
- Acute pulmonary edema
- Acute myocardial infarction (STEMI)
- Recent contrast media exposure
- End-stage CKD on chronic dialysis
- Multiple myeloma
- Current enrollment in any other study when enrollment in REMEDIAL III would involve deviation from either protocol
- Cardiogenic shock
- Administration of theophylline, dopamine, mannitol, and fenoldopam
Other salient features/characteristics:
- Median serum creatinine: 1.68 mg/dl
- Coronary angiography: 36%, PCI: 12%, coronary angiography followed by ad hoc PCI: 49%, peripheral procedure: 3%
- Mean LVEF: 50%
- LVEDP >18: 22%
- Gurm score ≥7: 25%; Mehran score ≥11: 44%
The primary endpoint, contrast-induced acute kidney injury, for UFR-guided vs. LVEDP-guided angiography/PCI, was 5.7% vs. 10.3% (p = 0.036).
The results of this trial indicate that a UFR-guided strategy using the RenalGuard system is superior to a LVEDP-guided strategy based on IV hydration in reducing contrast-induced acute kidney injury among patients with CKD and at high risk for this endpoint. This effect was consistent across LVEDP and UFR subgroups. This is an interesting study; the device needs further validation, including with other contrast agents. Assessment of hard endpoints (need for dialysis, hospitalization, etc.) and cost-effectiveness analyses will also be important.
Presented by Dr. Carlo Briguori at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2019), San Francisco, CA, September 29, 2019.
Keywords: Acute Kidney Injury, Blood Pressure, Coronary Angiography, Creatinine, Furosemide, Glomerular Filtration Rate, Percutaneous Coronary Intervention, Primary Prevention, Renal Insufficiency, Chronic, TCT19, Transcatheter Cardiovascular Therapeutics
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