I’m not the first one to this party, but this is worth a short note to touch upon, regardless, in case you missed it before the holiday break. I’ve written about retrospective propensity-matched analyses and other data suggesting the impact of contrast administration on acute kidney injury is overstated. This is yet another piece of the puzzle supporting these conclusions.
This is a beautifully massive trial, the PRESERVE Trial, with 5,177 patients enrolled in a 2×2 factorial design to test the impact of sodium bicarbonate and acetylcysteine on kidney injury following coronary angiography. This study was conducted in the United States, Australia, Malaysia and New Zealand, and was planned to enroll 7,680 to detect an increase in the primary end point of 8.7% to 6.5% for each trial intervention. As you might now have gathered, they stopped the trial early after an interim analysis when their statistical analysis met criteria for futility. The incidence of the primary end point, a composite between increase in creatinine, dialysis, and death, was effectively identical between each of the various arms, as were non-renal adverse events.
The short takeaway from these data: if contrast-induced nephropathy cannot be prevented by any available treatment, is it a true clinical entity at the doses currently used in clinical practice? Or, rather, do the clinically ill simply suffer kidney injury, regardless?
“Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine”