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Original Research |
1 Department of Radiology, Southern Illinois University School of Medicine, 800
E Carpenter St., Springfield, IL 62769.
2 Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School
of Medicine, Shanghai, China.
3 Department of Radiology, Massachusetts General Hospital, Boston, MA.
4 Radiologists PC, Mobile, AL.
5 Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City,
IA.
6 Mallinckrodt Institute of Radiology, Washington University, St. Louis,
MO.
7 Department of Radiology, Torrance Memorial Medical Center, Torrance, CA.
Received October 31, 2007;
accepted after revision January 23, 2008.
This study was funded by a clinical grant from Bracco Diagnostics, Inc.,
Princeton, NJ.
Abstract
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SUBJECTS AND METHODS. Two hundred sixty-three patients with moderate
to severe chronic kidney disease (estimated glomerular filtration rate [GFR] =
20–59 mL/min/1.73 m2) and diabetes mellitus were randomized
to receive at least 65 mL of iopamidol 370 or iodixanol 320 for a CT
procedure. Serum creatinine levels were measured at baseline and 48–72
hours after contrast administration. CIN was defined as an increase in the
serum creatinine level after contrast administration of 
25% from the
baseline level. The incidence of CIN in the total study population and the
incidence of CIN in patients at increased risk for CIN were compared using
Fisher's exact test.
RESULTS. Two hundred forty-eight patients were included in the CIN
analysis: 125 receiving iopamidol 370 and 123 receiving iodixanol 320. Study
population demographics were comparable, as was baseline renal function
(estimated GFR = 47.6 mL/min/1.73 m2 for the iopamidol 370 group vs
49.9 mL/min/1.73 m2 for the iodixanol 320 group; p =
0.16). Increases in the serum creatinine value of 25% occurred in seven
patients (5.6%) receiving iopamidol 370 and in six patients (4.9%) receiving
iodixanol 320 (95% CI, –4.8% to 6.3%; p = 1.0). The mean serum
creatinine change from the baseline level was 0.04 mg/dL in both groups
(analysis of covariance, p = 0.80). In patients with a baseline serum
creatinine value of 2.0 mg/dL, baseline estimated GFR of 
40
mL/min/1.73 m2, or those receiving > 140 mL of contrast medium,
the incidence of CIN was low and comparable between the two study groups
(p = 1.0 in all instances).
CONCLUSION. The incidence of CIN in patients with diabetes and chronic kidney disease receiving IV contrast medium was not significantly different after CT using iopamidol 370 or iodixanol 320.
Keywords: contrast-induced nephropathy • contrast media • CT • diabetes mellitus • iodixanol • iopamidol • kidney disease • renal insufficiency
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0.5
mg/dL, 25%, or both) or a diminution of renal function identified by a
decrease in creatinine clearance or the estimated glomerular filtration rate
(GFR) 2–3 days after contrast medium exposure
[8,
9]. Recently, investigators
have suggested that a relative increase of 25% is more clinically meaningful
and more sensitive as a quantifier of renal damage than an absolute increase
in serum creatinine of 0.5 mg/dL because a relative 25% increase in serum
creatinine value intrinsically adjusts for baseline renal function
[10]. Preexisting renal dysfunction and diabetes mellitus are both independent predictors of CIN [3, 11]. The use of low-osmolar contrast media is associated with a significantly lower incidence of CIN compared with high-osmolar contrast media in patients with baseline renal insufficiency [5, 12–14]. Whether the use of an isotonic contrast agent confers any additional benefit compared with a low-osmolar agent is less clear [15]. Few clinical studies have compared the renal effects of a low-osmolar and an isoosmolar contrast agent after IV contrast medium administration in patients with kidney disease, and few patients in those studies have been reported to have diabetes mellitus [16, 17]. Here, we report results of the PREDICT (patients with renal impairment and diabetes undergoing computed tomography) study, which compared the incidence of CIN in patients with diabetes and moderate to severe chronic renal failure undergoing MDCT after IV administration of a low-osmolar (iopamidol 370, 796 mOsm/kg) or an isoosmolar (iodixanol 320, 290 mOsm/kg) contrast agent.
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Patient Population
Patients 18 years old and older with type 1 or type 2 diabetes mellitus and
chronic renal impairment (estimated glomerular filtration rate [GFR] =
20–59 mL/min/1.73 m2) scheduled to undergo a clinically
indicated contrast-enhanced MDCT examination were considered for eligibility
at each participating study center, provided that the procedure called for at
least 65 mL of contrast agent to be administered. Patients were excluded from
the trial if they were pregnant or lactating or if they had New York Heart
Association class IV congestive heart failure, hypersensitivity to
iodine-containing compounds, hyperthyroidism, uncontrolled diabetes mellitus,
or unstable renal function. Patients were also excluded if they received any
iodinated contrast agent within 7 days before the administration of the
investigational product or were scheduled to receive an iodinated contrast
agent within 72 hours after administration of the investigational product, if
they received any nephrotoxic medication (chemotherapeutic agents,
nonsteroidal antiinflammatory drugs other than acetylsalicylic acid up to 325
mg/d) within 24 hours before to 24 hours after the administration of the study
agent, or if they had medical conditions or circumstances that would have
substantially decreased the chances of obtaining reliable data.
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Study Conduct
Baseline estimated GFR was calculated via the abbreviated Modification of
Diet in Renal Disease method
[18] from a serum creatinine
value obtained within 72 hours of enrollment in the study and before
initiation of any prophylactic hydration regimen and administration of the
investigational product. Blood samples were also obtained 48–72 hours
after administration of the investigational product. Cen tral laboratories
were used for evalu ations of serum creatinine levels to ensure consist ency
of measurement and reporting of laboratory data.
Prophylaxis of CIN via hydration was undertaken for each patient in whom it was deemed clinically necessary or desirable. Prophy lactic hydration was administered before, during, or after (or a combination of those times) contrast administration according to the clinical practice or protocols of each site. For analysis purposes, a patient was considered to have received hydration before the procedure if at least 500 mL of IV fluid was administered within 12 hours of contrast medium administration. The only prophylactic medication permitted in this protocol was N-acetylcysteine, which was administered at the sole discretion of the investigator.
Patients referred for CT angiography or CT of the brain, head and neck, thorax, abdomen, or pelvis were eligible for entry in the study. Once enrolled, patients were randomly assigned to receive an IV bolus of either iopamidol 370 or iodixanol 320 as part of their scheduled MDCT procedure. All groups and individuals associated with the trial remained blinded until the database was unlocked and the data analyzed. To ensure blinding at the investigational sites, a third party managed the preparation, dispensing, and accountability of the investigational agents. The drug-dispensing person at each site was responsible for preserving the blind and therefore did not participate in any study assessments. The investigational products were warmed to body temperature (37°C) and then administered IV by power injection. The actual dose administered to each patient was determined by the investigator based on the clinical requirements of the examination being performed and was recorded at the time of the procedure.
CIN Evaluation
CIN was prospectively defined as an increase in serum creatinine level of
at least 25% at 48–72 hours after receiving the contrast dose. Decreases
in estimated GFR of at least 25% and mean changes in serum creatinine levels
from baseline were also assessed. The incidence of CIN, along with any changes
in concomitant medications and general observations of the patient's clinical
renal status, was evaluated. In addition, the proportion of patients who
required dialysis, died, or required dialysis and died from acute renal
failure due to CIN was recorded. The rate of CIN was also evaluated in three
prospectively defined higher-risk subgroups: those with a baseline serum
creatinine value of 2.0 mg/dL, those with a baseline estimated GFR of
40 mL/min/1.73 m2, and those receiving > 140 mL of contrast
medium.
Statistical Analysis
Evaluable patients for CIN analysis included patients who provided informed
consent, met all the inclusion and none of the exclusion criteria, had an
estimated GFR of between 20 and 59 mL/min/1.73 m2 at screening,
received randomized investigational product, and had serum creatinine
collected as required by the protocol. Continuous variables (age, body weight,
body mass index, contrast dose, dose of contrast medium by body weight, volume
of IV hydration, serum creatinine level, creatinine clearance) were summarized
as mean ± 1 SD. For categoric variables such as sex, race, type of
diabetes mellitus, use of any volume supplementation, and use of con comitant
nephrotoxic medications, the number and percentage of patients in each
category were calculated.
Statistical testing was based on two-sided tests at a 95% level, and CIs were calculated for the observed differences between groups. The comparisons of baseline data between the two treatment groups were performed using the chi-square test or Fisher's exact test (categoric variables) or the Student's t test (continuous variables). A two-sided Student's t test was used for comparison of mean changes in serum creatinine levels and in estimated GFRs at baseline and 48–72 hours after contrast administration in patients who received iopamidol 370 and those who received iodixanol 320.
Mean changes from baseline in serum creatinine level and estimated GFR were
tested for normality and analyzed with an analysis of covariance model,
treating baseline measurements as covariate. The rates of increases in serum
creatinine level of 25% and decreases in estimated GFR of 25% from
baseline were analyzed using Fisher's exact test. The proportions of patients
in each group with CIN were compared, and 95% CIs were calculated for the
observed differences between groups. An analysis of CIN rates was also
performed in the subgroup of patients with creatinine clearance of 40
mL/min, serum creatinine level of 2.0 mg/dL, or both. All statistical
analyses were conducted using SAS software (version 8.2, SAS Institute) under
the Windows operating system (Microsoft).
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The rate of hydration was low, but a comparable number of patients in the two groups were hydrated: 11 in the iopamidol 370 group and nine in the iodixanol 320 group (p = 0.82). The mean administered volume (± SD) of hydration was similar in the two groups (iopamidol 370 vs iodixanol 320, 832.5 ± 740.2 vs 928.4 ± 803.2 mL, respectively; p = 0.78).
Patients in both groups received a similar volume of contrast agent (iopamidol: mean = 106.5 mL, range = 66–185 mL; iodixanol: mean = 101.6 mL, range = 70–150 mL; p = 0.12); however, because of the higher iodine concentration of iopamidol 370, patients receiving that agent had a higher total iodine dose than those receiving iodixanol 320 (39.4 vs 32.5 g I, respectively; p < 0.0001). Most pa tients enrolled underwent CT of the chest, abdomen, or pelvis (77%) or CT angio graphy (18%), and the remaining patients underwent CT or the brain or head and neck. No differences were evident between the two study groups with regard to the type of studies performed.
The Incidence of CIN and Postdose Serum Creatinine Changes
A postdose increase in serum creatinine value of at least 25% occurred in
5.6% (7/125) of the patients receiving iopamidol 370 and in 4.9% (6/123) of
the patients receiving iodixanol 320 (95% CI of the difference, –4.8% to
6.3%; p = 1.0) (Table
2). The mean serum creatinine change from baseline was also
comparable between the two treatment groups (0.04 mg/dL for both groups;
p = 0.80), as was the mean change in estimated GFR from baseline
(–0.77 mL/min/1.73 m2 for iopamidol 370 and –0.46
mL/min/1.73 m2 for iodixanol 320; p = 0.61). A decrease in
estimated GFR of at least 25% was noted in three patients in each group.
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Further analysis of higher-risk subpopulations (i.e., those with a baseline
serum creatinine value of 2.0 mg/dL, those with a baseline estimated GFR
of 40 mL/min/1.73 m2, and those receiving > 140 mL of con
trast medium) was performed. Twenty-one patients had a baseline serum
creatinine value of 2.0 mg/dL: 12 in the iopamidol 370 group and nine in
the iodixanol 320 group. Baseline demographics were similar between the two
agents for all higher-risk subpopulations, although as in the overall
population, patients in the iopamidol group received significantly more iodine
because of the higher iodine concentration of iopamidol versus iodixanol for
any given contrast medium volume. The incidence of CIN was very low (no cases,
one case, or two cases [< 10%]) and was comparable between the two contrast
agent groups for all three higher-risk sub populations (p = 1.000 in
all cases).
Two patients in the iopamidol 370 group experienced a worsening in clinical status 48–72 hours after investigational product administration. One patient showed increased urination 10 hours after contrast administration, and another reported worsening edema that resolved by day 7 after the CT examination. Neither change in clinical status was reported as an adverse event, and neither was considered related to contrast agent administration. No patient in this trial required dialysis and no patient died from acute renal failure.
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2 mg/dL and estimated GFR 40
mL/min/1.73 m2) and those receiving the highest doses of contrast
medium (> 140 mL).
Diabetes mellitus is known to be an independent predictor of CIN
[3,
11]. In patients with normal
renal function, diabe tic patients have a higher risk of developing CIN than
nondiabetic patients, and this risk increases progressively as renal function
declines, with those with both severe chronic kidney disease and diabetes
having the highest risk of developing CIN
[3–5].
Prediabetic patients may also be at increased risk: In a recent study, the
incidence of CIN (defined as a 25% increase in the serum creatinine value
over the baseline value within 48 hours of angiography) in patients stratified
by fasting blood glucose level was inter mediate in prediabetic patients
(11.4%) com pared with healthy patients (5.5%) and diabetic patients (20%)
[19]. In addition, clinical
outcomes for patients with both renal in sufficiency and diabetes have been
shown to be more severe than for patients with either condition in isolation.
In a study of 7,445 con secutive patients undergoing cardiac interventions,
Nikolsky and Mehran [20] found
that 1-year mortality was substantially higher for patients with both renal
insufficiency and diabetes (25.9%) than for those with renal insufficiency
(17.5%) or diabetes (6.7%) alone.
In previous studies, investigators have established that the use of low-osmolar contrast agents is associated with a significantly lower incidence of CIN com pared with the use of high-osmolar contrast agents [5, 12–14], at least in patients with baseline renal in sufficiency. Several head-to-head comparisons of isoosmolar contrast medium and low-osmolar contrast medium have examined the incidence of CIN in patients with preexisting renal dysfunction undergoing cardiac or other interventional angiography (or both) [21–23]. The number of patients with diabetes in these studies was limited, except in one small study in which all patients had reduced renal function (mean serum creatinine value = 1.5–1.6 mg/dL) and diabetes [22]. In that study, conducted in 129 patients under going coronary or aortofemoral angiography, a significant decrease in the rate of CIN was observed when the isoosmolar agent iodixanol was used rather than the low-osmolar agent iohexol (3% vs 26%, respectively; p < 0.001). How ever, the results of subsequent studies and analyses of the literature have suggested that the low incidence of CIN observed with the isoosmolar contrast med ium in that study [22] may not be reproducible [15, 24–26]. Published rates of CIN after iodixanol range from 3% to 21% after intraarterial use [15] and from 3% to 9% after IV use [27–29]. In several reports, researchers have also suggested that the low-osmolar contrast medium comparator used in that study [22], iohexol, may be associated with a higher incidence of CIN than some of the other available low-osmolar contrast agents [15, 26, 30]. These studies suggest that given the low rates of CIN observed in patients with renal insufficiency receiving intraarterial iopamidol (osmolality, 796 mOsmol/kg) com pared with intraarterial io hexol (osmolality, 844 mOsmol/kg), factors other than contrast medium osmolality may play a significant role in the pathogenesis of CIN.
A meta-analysis of clinical studies funded by GE Healthcare, the manufacturer of iodixanol, suggested that iodixanol results in lower rises of serum creatinine values and fewer cases of CIN than other low-osmolar contrast agents [31]. However, most patients in that analysis did not have baseline renal dysfunction; the low-osmolar contrast agents were not evaluated individually; and the overall analysis was heavily weighted to just two contrast agents, the low-osmolar iohexol (28% of patients) and the ionic dimer ioxaglate (59% of patients). The meta-analysis contained only one study in which iopamidol was compared with iodixanol in 144 patients; in that study, CIN was observed only after iodixanol [32].
Recently, the largest head-to-head trial reporting results from a
comparison of iodixanol and a low-osmolar contrast agent (iopamidol) in
high-risk patients was published
[33]. The CARE (cardiac
angiography in renally impaired patients) trial
[33] enrolled 414 patients
with an estimated GFR between 20 and 59 mL/min/1.73 m2 undergoing
cardiac catheterization. Overall, no difference was found between the two
study groups with respect to the incidence of CIN: An increase in serum
creatinine level of 25% was observed in 20 patients (9.8%) receiving
iopamidol and in 26 patients (12.4%) receiving iodixanol (p = 0.44).
In patients with diabetes (n = 170), there was also no statistically
significant difference in the incidence of CIN between iopamidol and iodixanol
(10.3% vs 15.2%, respectively; p = 0.37). However, mean postdose
serum creatinine increases in that study were significantly lower with
iopamidol 370 than with iodixanol 320, both in the total population (0.07 vs
0.12 mg/dL, respectively; p = 0.03) and in the population of patients
with diabetes (0.07 vs 0.16 mg/dL, p = 0.01).
In most published studies examining the incidence of CIN, investigators
have focused on intraarterial administration of contrast medium in patients
with renal dysfunction. The risk of CIN with any contrast medium is estimated
to be more than twofold lower when administered IV rather than intraarterially
[24–35].
Several studies have examined the incidence of CIN after the IV use of
iodixanol in patients with mild to moderate kidney disease. In patients with
mild renal impairment (serum creatinine value > 1.1 mg/dL, GFR < 90
mL/min/1.73 m2, or both), a CIN rate of 3% was observed
[27]. A separate study in 100
consecutive patients with a base line serum creatinine level of 1.5 mg/dL
undergoing CT with iodixanol reported a 9% rate of CIN
[28]. A recent retrospective
evaluation compared CIN rates after IV iodixanol in patients with normal
baseline renal function or with under lying renal insufficiency. CIN developed
in 9% of the 189 patients with renal insufficiency receiving iodixanol, with
4.8% of patients developing irreversible renal damage. In patients with normal
renal function at base line, CIN was observed in 4.9% of patients receiving io
dixanol, with irreversible renal damage developing in 3.2% of patients
[29].
Few studies are available in which the incidence of CIN is compared after
IV administration of iodixanol or one of the low-osmolar contrast agents in
patients with renal impairment. Carraro and colleagues
[16] compared the effect of
iodixanol and the nonionic monomer iopromide on renal function in 64 patients
with mild to moderate renal insufficiency (serum creatinine level =
1.5–3.0 mg/dL) undergoing excretory urography. CIN in that study was
defined as an increase of 50% in serum creatinine level within 24 hours
of the examination. A postprocedure increase in serum creatinine level was
observed in both study groups, but no significant difference between the two
groups was found. Transient CIN developed in one patient who received
iodixanol. A second study, available only as an abstract, compared iodixanol
and iobitridol in 50 patients with more severe renal impairment (mean baseline
serum creatinine level = 2.6–2.7 mg/dL) undergoing cranial or whole-body
CT (Kolehmainen H and Soiva M, presented at the 2003 annual meeting of the
European Society of Urogenital Radiology Congress). No difference in the
incidence of CIN was found between the two study groups: Four patients in each
group (17%) had a 0.5 mg/dL increase in serum creatinine level.
More recently, the IMPACT (Isovue-370 and Visipaque-320 in Renally Impaired
Patients Undergoing Computed Tomography) study compared the effects on renal
function of iopamidol 370 with iodixanol 320 in 153 patients with renal
impairment undergoing contrast-enhanced MDCT
[17]. All patients had stable,
moderate to severe chronic renal disease (serum creatinine level 1.5
mg/dL, creatinine clearance = 10–59 mL/min, or both), and a relative
increase in serum creatinine value of 25% was observed in three of 76
patients (4%) who had received iodixanol and in three of 77 patients (4%) who
had received iopamidol 370. Approximately 24% of the patients in the IMPACT
study were diabetic, and only one case of CIN was recorded in a patient with
diabetes. Eighteen patients had a baseline serum creatinine value of 2.0
mg/dL (11 receiving iopamidol and seven receiving iodixanol). Of these
higher-risk patients, CIN was observed in none of the patients who received
iopamidol and in two patients who received iodixanol. These findings support
the conclusion that the rate of CIN after IV administration of contrast medium
is low and is not significantly different in patients with moderate to severe
chronic renal dysfunction receiving iodixanol or iopamidol.
Our study, the PREDICT study, differs from the IMPACT study in that we report results for a larger patient population (248 vs 153 patients in the IMPACT trial) and on a patient population at significantly higher risk for developing CIN—that is, patients with both diabetes mellitus and chronic kidney disease.
Taken together, the results of the PREDICT, IMPACT, and CARE studies add to the growing body of evidence that although CIN does occur after IV contrast medium ad ministration, it occurs less frequently than after intraarterial contrast medium administration and with a similar frequency after iopamidol or iodixanol administration. Whether these findings are related to the route of administration or characteristics of the different patient populations involved is not known. However, patients perceived to be at high risk for developing CIN after intraarterial ad ministration of contrast medium may, in fact, be reasonably good candidates for undergoing contrast-enhanced MDCT. For example, elderly patients, who more commonly have decreased levels of renal function and have diabetes, or patients who may require repeat exposures or examinations with higher doses of contrast agent may be considered at relatively low risk for development of CIN when contrast medium is administered IV.
In the PREDICT study, the absolute difference between CIN rates in the two groups was small (0.7%), and the 95% CI around the observed difference (–4.8% to 6.3%) strongly suggests that if a difference existed between the two agents, the trial would have shown that difference. Given the low rates of CIN observed in this study, approximately 7,000 patients per group (14,000 patients in all) would be needed to show a significant difference between the two contrast agents in terms of the rate of CIN. Although such a difference may have been statistically significant, the clinical relevance of such a small difference would remain questionable.
To maximize enrollment in a difficult study, we permitted patients with a fairly wide range of kidney disease (estimated GFR, 20–59 mL/min/1.73 m2) to be enrolled provided that the patient also had diabetes mellitus. However, this range in kidney disease is identical to that used in other recent studies, such as the IMPACT study by Barrett et al. [17], and evaluation of CIN in those patients at the highest risk (i.e., lowest GFR) shows a comparable safety profile for the two agents in the sickest patients.
In the PREDICT study, iopamidol 370 was chosen as the comparator agent because it is a low-osmolar contrast medium with a reported incidence of CIN comparable to that of iodixanol 320 in other studies. The highest available concentration for each agent was used in this trial based on the assumption that the safety at lower concentrations will be equal to or better than the safety at a higher concentration. Although the two study populations were comparable in nearly every respect, patients receiving iopamidol 370 received a higher total iodine dose than those receiving iodixanol 320 by virtue of the greater iodine concentration of iopamidol 370 (370 mg I/mL vs 320 mg I/mL for iodixanol). Despite the greater iodine dose, there was no statistically significant difference in the rate of CIN observed with the two agents.
The type of power injector used for each examination (single- or double-headed) was not recorded, so we cannot determine from our data which patients received a saline flush as part of their injection. Without a saline chaser, some contrast medium may be left in the IV line, reducing the total dose administered to the patient and resulting in a possible overestimation of the recorded dose for that patient. However, randomization would be expected to balance this variable between the two study groups, and the administered volume was similar for both agents in our study. No pretreatment regimen was recommended or required in this study, and most patient examinations did not meet the definition of hydration defined for this study (i.e., at least 500 mL of IV fluid within 12 hours of the procedure). Sites were allowed to use bicarbonate hydration if they wished, and a small but equal proportion of patients in the two groups received bicarbonate hydration. However, the use of any type of prophylaxis in our study was very low, so it cannot be determined from our data whether any prophylactic measure is helpful in lowering the incidence of CIN in high-risk patients undergoing CT procedures. The low incidence of CIN in our study suggests that when using iopamidol or iodixanol extensive prophylaxis is not required in most patients. Whether these findings can be extrapolated to patients undergoing CT with other low-osmolar agents is unclear.
Fifteen patients (5.7%) were excluded from the CIN analysis before the trial data were unblinded, seven in the iopamidol 370 group and eight in the iodixanol 320 group. These patients were excluded because their baseline estimated GFR was outside the screening range (n = 3), because their post-dose blood samples were obtained less than 45 hours after contrast medium exposure (n = 5), because they did not have a postdose serum creatinine value at 45–72 hours after contrast administration (n = 5), or because of unrelated critical clinical events (n = 2). However, none of these cases met the criteria for CIN, and inclusion of these patients in the analysis would not have changed the findings of the study.
In conclusion, the incidence of CIN in high-risk diabetic patients with moderate to severe chronic renal impairment receiving IV contrast medium is low and is not statistically significantly different after administration of iopamidol 370 or iodixanol 320. These results confirm those of earlier published studies showing a similar rate of CIN after administration of the low-osmolar agent iopamidol or of the isoosmolar agent iodixanol in high-risk patients.
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