Comparison of Iodixanol and Iopromide in Patients With Renal Insufficiency and Congestive Heart Failure Undergoing Coronary Angiography by Hemodynamic Monitoring.
Qian Geng,Yang Yong-Qiang,Dong Wei,Cao Feng,Chen Yun-Dai
We investigated the impact of contrast media (CM) with different osmolality on cardiac preload in patients with chronic kidney disease (CKD) and congestive heart failure (CHF). Patients with CKD and CHF were equally randomized to receive either iso-osmolar contrast media (IOCM) iodixanol or low-osmolar contrast media iopromide. We measured cardiac preload indexes by invasive hemodynamic monitoring before and after CM injection. Major adverse cardiac events postprocedures were recorded. Increase in extravascular lung water index was only seen in the iopromide group ( P < .001), while global end diastolic index and central venous pressure were all significantly increased from baseline in the both groups ( P < .001, respectively), and the increase in cardiac preload indexes was significantly greater in the iopromide group than in the iodixanol group ( P < 0.001). The overall incidence of acute heart failure was more frequently observed in the iopromide group ( P = 0.027). Low-osmolar contrast media iopromide significantly increased cardiac preload in patients with CKD and CHF undergoing cardiac catheterization procedures compared with IOCM iodixanol.
Pain in femoral arteriography. A double-blind, randomized, clinical study comparing safety and efficacy of the iso-osmolar iodixanol 270 mgI/ml and the low-osmolar iomeprol 300 mgI/ml in 9 European centers.
Manke C,Marcus C,Page A,Puey J,Batakis O,Fog A
Acta radiologica (Stockholm, Sweden : 1987)
PURPOSE:To compare the injection-associated pain and heat sensation after administration of the iso-osmolar contrast medium (IOCM) iodixanol (Visipaque trade mark 270 mg I/ml) and the low osmolar contrast medium (LOCM) iomeprol (Iomeron trade mark 300 mg I/ml) in femoral arteriography. MATERIAL AND METHODS:352 patients received iodixanol or iomeprol in a prospective, double-blind, randomized, parallel-group clinical trial. The first injection during femoral arteriography (DSA with automated stepping) was standardized. Injection-associated pain and heat sensation, efficacy and safety up to 72 h were evaluated. RESULTS:The iodixanol group reported significant less injection-associated pain than the iomeprol group after the first injection (7.4% vs. 17.6%; p = 0.007), and after all injections (11% vs. 19.4%; p = 0.045). Iodixanol caused less heat sensation after the first injection (p = 0.007) and after all injections (p = 0.029). Heat sensations in the iodixanol group were less intense after all injections (p < 0.0001). No difference was found between the groups regarding the frequency of patients having adverse reactions (5.1% vs. 4%). CONCLUSION:The IOCM iodixanol caused significantly less frequent injection-associated pain and heat sensation than the LOCM iomeprol during femoral arteriography.
Patient discomfort associated with the use of intra-arterial iodinated contrast media: a meta-analysis of comparative randomized controlled trials.
McCullough Peter A,Capasso Patrizio
BMC medical imaging
BACKGROUND:Discomfort characterized by pain and warmth are common adverse effects associated with the use of intra-arterial iodinated contrast media (CM). The objective of this review was to pool patient-reported outcomes available from head-to-head randomized controlled trials (RCTs) and to compare the discomfort rates associated with iso-osmolar contrast media (IOCM; i.e., iodixanol) to those reported with various low-osmolar contrast media (LOCM). METHODS:A review of the literature published between 1990 and 2009 available through Medline, Medline Preprints, Embase, Biological Abstracts, BioBase, Cab Abstracts, International Pharmaceutical Abstracts, Life Sciences Collection, Inside Conferences, Energy Database, Engineering Index and Technology Collection was performed to compare rates of discomfort associated with the use of the IOCM (iodixanol) vs. various LOCM agents in head-to-head RCTs. All trials with a Jadad score ≥2 that reported patient discomfort data following intra-arterial administration of CM were reviewed, coded, and extracted. RESULTS:A total of 22 RCTs (n = 8087) were included. Overall discomfort (regardless of severity) was significantly different between patients receiving IOCM and various LOCMs (risk difference [RD] -0.049; 95% confidence interval [CI]: -0.076, -0.021; p = 0.001). IOCM was favored over all LOCMs combined with a summary RD value of -0.188 (95% CI: -0.265, -0.112; p < 0.001) for incidence of pain, regardless of severity. A greater reduction in the magnitude of pain was observed with IOCM (iodixanol), particularly with selective limb and carotid/intracerebral procedures. Similarly, the meta-analysis of warmth sensation, regardless of severity, favored IOCM over LOCMs with an RD of -0.043 (95% CI: -0.074, -0.011; p = 0.008). A positive linear relationship was observed between the discomfort effect size and age and a negative relationship with increasing proportion of women. The opposite trends were observed with warmth sensation. CONCLUSIONS:IOCM was associated with less frequent and severe patient discomfort during intra-arterial administration. These data support differences in osmolality as a possible determinant of CM discomfort.
Post-marketing surveillance study with iodixanol in 20 185 Chinese patients from routine clinical practices.
Zhang B-C,Hou L,Lv B,Xu Y-W
The British journal of radiology
OBJECTIVE:To determine the incidence of immediate and delayed adverse drug reactions (ADRs), and to assess patient discomfort following administration of iodixanol during imaging examinations in routine clinical practice. METHODS:A total of 20 185 patients across 95 clinical centres were enrolled in a prospective post-marketing surveillance registry with iodixanol. Patients were monitored for occurrence of ADRs immediately following iodixanol administration and for up to 7 days after administration. RESULTS:The overall rate of ADRs was 1.52%, of which 0.58% was immediate and 0.97% was delayed onset. Two patients had non-fatal serious ADRs (0.01%). The ADRs were significantly more common in patients who underwent contrast-enhanced CT/coronary CT angiography vs others (p < 0.001), in those receiving pre-heated iodixanol vs non-heating (p < 0.001), in those aged 70 years or younger (p < 0.001), in those in whom a power injector was used for contrast delivery (p < 0.001) and in those with a history of an allergic reaction to contrast (p = 0.024). Multivariate analysis showed that female gender, intravenous route of contrast injection, body weight ≥ 80 kg, age less than 65 years, contrast flow rate ≥ 4 ml s⁻¹ and prior reaction to iodinated contrast medium were all significant and independent contributors to ADRs. Pre-treatment contrast volume and history of cardiac disease, gout, hypertension, diabetes mellitus or asthma did not affect the rate of ADRs. Discomfort was generally mild, with 94.8% of patients reporting a composite score of 0-3. CONCLUSION:The safety of iodixanol in routine clinical practice was shown to be similar to the published safety profiles of other non-ionic iodinated contrast agents. Patient discomfort during administration was mild or absent in most patients. ADVANCES IN KNOWLEDGE:The major strength of this study is that it included 20 185 patients enrolled in various types of imaging examinations. The safety profile of iodixanol was comparable to previously published work.
Iso-osmolar contrast media and adverse renal and cardiac events after percutaneous cardiovascular intervention.
McCullough Peter A,David Guy,Todoran Thomas M,Brilakis Emmanouil S,Ryan Michael P,Gunnarsson Candace
Journal of comparative effectiveness research
AIM:To assess the relationship between type of contrast media (CM), iso-osmolar contrast media (IOCM) or low-osmolar contrast media (LOCM), and major adverse renal and cardiovascular events (MARCE). MATERIALS & METHODS:Coronary or peripheral angioplasty visits were stratified into CM cohorts: IOCM or LOCM. Multivariable regression analysis used hospital fixed effects to assess the relationship between MARCE events and type of CM. RESULTS:Among 333,533 visits (357 hospitals), the incidence of MARCE was 7.41%. After controlling for observable and unobservable time invariant within-hospital characteristics, administration of IOCM versus LOCM was associated with a 0.69% absolute and 9.32% relative risk reduction in MARCE rate. CONCLUSION:Our study indicates that as compared with LOCM, IOCM may be associated with reduction of MARCE events in coronary or peripheral angioplasty patients.
A prospective, double-blind, randomized, controlled trial on the efficacy and cardiorenal safety of iodixanol vs. iopromide in patients with chronic kidney disease undergoing coronary angiography with or without percutaneous coronary intervention.
Nie Bin,Cheng Wan-Jun,Li Yan-Fang,Cao Zheng,Yang Qing,Zhao Ying-Xin,Guo Yong-He,Zhou Yu-Jie
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
OBJECTIVES:This study was undertaken to compare the renal safety as well as cardiovascular (CV) effects and diagnostic image quality of iso-osmolar iodixanol vs. low-osmolar iopromide in patients with chronic kidney disease (CKD) undergoing coronary interventions. BACKGROUND:With the growing number of contrast-enhanced procedures being performed for coronary artery disease management, the safety and efficacy of iodinated contrast media (CM) have come under increased scrutiny. METHODS:: Patients with CKD (CrCl < or =60 mL/min) were randomized to iodixanol (n = 106) or iopromide (n = 102). The primary endpoint was incidence of contrast-induced nephropathy (CIN), defined as an increase in serum creatinine (SCr) > or =25% or 0.5 mg/dL within 72 hr of CM administration. Secondary endpoints were mean SCr increase, a composite of CV events in-hospital and 30 days postdischarge, and diagnostic image quality. RESULTS:: CIN incidence was significantly lower with iodixanol than iopromide (5.7% vs. 16.7%; P = 0.011). Baseline SCr (OR 2.21, 95% CI: 1.25-3.47; P = 0.031), iopromide use (OR 2.56, 95% CI: 1.18-5.76; P = 0.024), and CM volume (OR 2.01, 95% CI: 1.01-3.21; P = 0.038) were identified as independent risk factors for CIN. Cardiovascular events were reduced with iodixanol (1.9% vs. 8.8%; P = 0.025); diagnostic image quality was similar for both CM (P = 0.353). CONCLUSIONS:: Consistent with several previous trials comparing iso-osmolar iodixanol and low-osmolar comparator CM, iodixanol was associated with a lower incidence of CIN and fewer CV events than iopromide.