TY - JOUR
T1 - Comparison of cardiovascular and renal toxicity after cardiac catheterization using a nonionic versus ionic radiographic contrast agent
AU - Harding, Michael B.
AU - Davidson, Charles J.
AU - Pieper, Karen S.
AU - Hlatky, Mark
AU - Schwab, Steven J.
AU - Morris, Kenneth G.
AU - Hermiller, James B.
AU - Bashore, Thomas M.
N1 - Funding Information:
From Duke University Medical Center, Box 3012, Durham, North Carolina 27710. This report was supported in part by a grant from Squibb Diagnostics, Princeton, New Jersey; and Research Training Grant NRSA ST32HL071011-15 from the National Institutes of Health, Bethesda, Maryland. Manuscript received April 2, 1991; revised manuscript received May 3 1, 199 1, and accepted June 3.
PY - 1991/10/15
Y1 - 1991/10/15
N2 - Both ionic and nonionic contrast agents used in angiography are relatively well tolerated but have a number of undesirable effects, particularly on the cardiovascular system and the kidney.1-7 Whereas low osmolar agents may reduce acute events, contrast nephropathy remains a common cause of in-hospital renal injury, and the potential advantage of one contrast agent over another is less well defined.2,3 The best method of evaluating the relative toxicity of iopamidol and diatrizoate is by a randomized controlled clinical trial. In principle, there are 2 major designs for a randomized trial: (1) a cohort trial that compares results between different patients, and (2) a crossover trial that compares results within the same patient. The crossover design provides the greatest assurance that between-patient differences will not affect the results, and this design is generally well suited for investigations of pharmaceuticals. As part of a randomized trial using a cohort design,1,2 we prospectively designed a crossover protocol so that any patient randomized in the trial would receive the alternative contrast agent if a second coronary angiogram proved to be clinically indicated within the study period. In all, 67 of the 443 randomized patients had a second procedure, 41 of whom received the alternative agent. This report summarizes the results of 41 randomized patients in this prospective controlled crossover investigation.
AB - Both ionic and nonionic contrast agents used in angiography are relatively well tolerated but have a number of undesirable effects, particularly on the cardiovascular system and the kidney.1-7 Whereas low osmolar agents may reduce acute events, contrast nephropathy remains a common cause of in-hospital renal injury, and the potential advantage of one contrast agent over another is less well defined.2,3 The best method of evaluating the relative toxicity of iopamidol and diatrizoate is by a randomized controlled clinical trial. In principle, there are 2 major designs for a randomized trial: (1) a cohort trial that compares results between different patients, and (2) a crossover trial that compares results within the same patient. The crossover design provides the greatest assurance that between-patient differences will not affect the results, and this design is generally well suited for investigations of pharmaceuticals. As part of a randomized trial using a cohort design,1,2 we prospectively designed a crossover protocol so that any patient randomized in the trial would receive the alternative contrast agent if a second coronary angiogram proved to be clinically indicated within the study period. In all, 67 of the 443 randomized patients had a second procedure, 41 of whom received the alternative agent. This report summarizes the results of 41 randomized patients in this prospective controlled crossover investigation.
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U2 - 10.1016/0002-9149(91)90513-K
DO - 10.1016/0002-9149(91)90513-K
M3 - Article
C2 - 1927936
AN - SCOPUS:0026038964
SN - 0002-9149
VL - 68
SP - 1117
EP - 1119
JO - The American journal of cardiology
JF - The American journal of cardiology
IS - 10
ER -