Discomfort assessment in peripheral angiography: randomized clinical trial of Iodixanol 270 versus Ioversol 320 in diabetics with critical limb ischemia.
OBJECTIVE
To assess and compare the intra-arterial injection-associated discomfort of iodinated contrast media (CM) and the impact on diagnostic efficacy in diabetics with critical limb ischemia (CLI).


BACKGROUND
Arterial revascularization is a mainstay in patients with CLI. Previous diagnostic angiography is a crucial step that can be affected by CM injection discomfort compromising the revascularization results, and it could vary related to the CM agents.


METHODS
One hundred forty-eight patients received Iodixanol 270 mg iodine pro ml or Ioversol 320 mg iodine pro ml in a prospective, double-blind, randomized, parallel-group clinical trial. Injection-associated discomfort was assessed by Visual Analogic Scale (VAS). Diagnostic efficacy and safety up to 1 week were evaluated.


RESULTS
The incidence of pain has been around 50% of the all population in study, with lesser incidence of pain (25.7% vs 74.3%; P < 0.0001) and of heat sensation (55.4% vs 85.1%; P < 0.0001), after Iodixanol than after Ioversol injection. Discomfort mean score, according to VAS assessment, was less in the Iodixanol group (8.1 ± 15.3) than in the Ioversol group (36.0 ± 29.7), after first injection (P < 0.001) and for all injections (P < 0.001). A significant difference was also observed in favor of Iodixanol (P < 0.001), respect to mean score of discomfort and heat sensation, assessed by the operators after all the CM injections.


CONCLUSIONS
Iodixanol caused less frequent and severe discomfort, characterized as pain and heat during intra-arterial administration compared with Ioversol. The pain severity is tightly related to image and diagnosis quality with an impact on the patients for additional injections and larger CM volumes.
Interventional Radiology Unit, Policlinico Abano Terme, Abano Terme (PD), Italy.
Luis Mariano
LM
Palena
Zeno Dal
ZD
Sacco
Cesare
C
Brigato
Enrico
E
Sultato
Domenico
D
Barra
Alessandro
A
Candeo
Marco
M
Manzi
D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D016638:Critical Illness; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging* / Q000628:therapy; D004311:Double-Blind Method; D057510:Endovascular Procedures; D005260:Female; D006801:Humans; D015994:Incidence; D007269:Injections, Intra-Arterial; D007511:Ischemia / Q000000981:diagnostic imaging* / Q000628:therapy; D007558:Italy / Q000453:epidemiology; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology; D010147:Pain Measurement; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging* / Q000628:therapy; D011446:Prospective Studies; D011859:Radiography; D013997:Time Factors; D014283:Triiodobenzoic Acids / Q000008:administration & dosage / Q000009:adverse effects*
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C044834:iodixanol; C054871:ioversol
contrast agents; critical limb ischemia; diabetes; discomfort; peripheral angiography