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RhC1-Inhibitor in Prevention of Contrast-Induced Kidney Injury
Study Questions:
What is the efficacy profile and safety of recombinant human C1 esterase inhibitor (rhC1INH) in the prevention of contrast-associated acute kidney injury after elective coronary angiography?
Methods:
The PROTECT (Prophylactic RhC1-inhibitor to Prevent Contrast-induced Nephropathy) trial investigators randomized 77 patients with chronic kidney disease to receive 50 IU/kg rhC1INH before and 4 hours after elective coronary angiography or placebo in this placebo-controlled, double-blind, single-center trial. The primary outcome was the peak change of urinary neutrophil gelatinase-associated lipocalin (NGAL) within 48 hours, a surrogate marker of kidney injury. A modified intention-to-treat analysis was primarily used for this trial including all participants who had received at least one dose of study medication and underwent coronary angiography. The per-protocol population consisted of patients fully complying with the trial protocol. A post hoc analysis of patients receiving a larger amount of contrast media and undergoing percutaneous coronary intervention was performed.
Results:
Median peak change of urinary NGAL was lower in the rhC1INH group (4.7 vs. 22.5 ng/ml, p = 0.038) in the per-protocol population, but not in the modified intention-to-treat analysis, and in patients with percutaneous coronary interventions (median 1.8 vs. 26.2 ng/ml, p = 0.039 corresponding to a median percentage peak change of 11% vs. 205%, p = 0.002). The incidence of a cystatin C increase ≥10% within 24 hours was lower in the rhC1INH group (16% vs. 33%, p = 0.045), whereas the frequency of contrast-associated acute kidney injury was comparable. Adverse events during a 3-month follow-up were similarly distributed.
Conclusions:
The authors concluded that administration of rhC1INH before coronary angiography may attenuate renal injury as reflected by urinary NGAL and cystatin C.
Perspective:
This randomized clinical trial reports that the prophylactic administration of rhC1INH attenuated the rise in urinary NGAL, a marker of renal injury, and decreased the incidence of a relevant cystatin C increase compared to placebo in patients with chronic renal disease undergoing elective coronary angiography. Of note, no safety signal or unexpected adverse reactions related to rhC1INH administration emerged during the study, despite the inclusion of an elderly patient population with several comorbidities. Additional larger trials with hard clinical endpoints are required to determine its true efficacy and safety.
Clinical Topics: Anticoagulation Management, Diabetes and Cardiometabolic Disease, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Interventions and Imaging, Angiography, Nuclear Imaging
Keywords: Acute Kidney Injury, Complement C1 Inhibitor Protein, Contrast Media, Coronary Angiography, Cystatin C, Diagnostic Imaging, Kidney Failure, Chronic, Metabolic Syndrome, Percutaneous Coronary Intervention, Primary Prevention, Recombinant Proteins, Renal Insufficiency, Chronic
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