REnal Insufficiency Following Contrast MEDIA Administration TriaL III - REMEDIAL III

Sep 29, 2019
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Presenter/Author:
Carlo Briguori, MBBS, FACC
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Guerbet
Date Presented:
09/29/2019
Date Published:
09/14/2020
Date Updated:
09/29/2019
Original Posted Date:
09/29/2019
References

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.

Description:

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).

Study Design

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%

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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%

Principal Findings:

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).

Interpretation:

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.

References:

Briguori C, D’Amore C, De Micco F, et al. Left Ventricular End-Diastolic Pressure Versus Urine Flow Rate–Guided Hydration in Preventing Contrast-Associated Acute Kidney Injury. JACC Cardiovasc Interv 2020;13:2065-74.

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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