Gadolinium-based contrast media compared with iodinated media for digital subtraction angiography in azotaemic patients.
BACKGROUND
To determine whether gadolinium-based contrast media (CM) could be used safely for angiographies in patients with renal dysfunction we investigated renal function after gadobutrol exposure and compared the results with standard iodinated CM (iohexol) in a randomized clinical study.


METHODS
Twenty-one patients (aged 67+/-11 years, nine female and 12 male) with severely impaired renal function [mean serum creatinine 3.2+/-1.3 mg/dl, mean glomerular filtration rate (GFR) 31+/-16 ml/min/1.73 m(2)] who needed to have angiography because of severe peripheral vascular disease, renal artery stenosis or aortic aneurysms were randomized to receive in a blinded manner either gadobutrol (Gadovist 1.0 mmol/ml) or iohexol (Omnipaque 350) as contrast agents. GFR was measured by CM clearance (Renalyzer) at baseline and 48 h after CM administration. The primary end point was the mean change of GFR from baseline at 48 h, the secondary one the incidence of CM-induced acute renal failure, defined as a decrease in GFR of >50% from baseline within 48 h of CM administration.


RESULTS
In the gadobutrol group (n = 10) we observed a statistically significant decrease in GFR of 10.6+/-13.8 ml/min/1.73 m(2) within 48 h after CM administration (P<0.05, paired t test). The incidence of CM-induced ARF amounted to 50%. In comparison, the iohexol group (n = 11) also showed a statistically significant GFR reduction of 8.7+/-8.8 ml/min/1.73 m(2) (P<0.05, paired t test), and of ARF by 45%. The percentile of differences of GFR decreases between the two groups was not significant (P = 0.70). No patient demonstrated other adverse effects of gadobutrol or iohexol administration, apart from GFR reduction. Despite the decline in GFR, no patient required haemodialysis in the 10 following days.


CONCLUSIONS
In our study, gadolinium-based angiography showed no benefit over iohexol angiography with respect to preventing GFR reduction in patients with severely impaired renal function.
University of Tübingen, Department of Internal Medicine, Section for Nephrology and Hypertension, Germany. christiane.erley@sjk.de
Christiane M
CM
Erley
Birgit D
BD
Bader
Elke D
ED
Berger
Nurdan
N
Tuncel
Sabine
S
Winkler
Gunnar
G
Tepe
Teut
T
Risler
Stephan
S
Duda
D000368:Aged; D015901:Angiography, Digital Subtraction; D001014:Aortic Aneurysm / Q000000981:diagnostic imaging; D003287:Contrast Media / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005682:Gadolinium / Q000009:adverse effects; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007472:Iohexol / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects; D010865:Pilot Projects; D012078:Renal Artery Obstruction / Q000000981:diagnostic imaging; D051437:Renal Insufficiency / Q000150:complications* / Q000503:physiopathology; D012720:Severity of Illness Index; D014511:Uremia / Q000000981:diagnostic imaging* / Q000209:etiology*; D014652:Vascular Diseases / Q000000981:diagnostic imaging
D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D007472:Iohexol; D005682:Gadolinium