CLINICAL RESEARCH: CLINICAL TRIAL
Renal Toxicity Evaluation and Comparison Between Visipaque (Iodixanol) and Hexabrix (Ioxaglate) in Patients With Renal Insufficiency Undergoing Coronary Angiography
The RECOVER Study: A Randomized Controlled Trial
Sang-Ho Jo, MD*,1,
Tae-Jin Youn, MD*,1,
Bon-Kwon Koo, MD*,*,
Jin-Shik Park, MD*,
Hyun-Jae Kang, MD*,
Young-Seok Cho, MD*,
Woo-Young Chung, MD*,
Gwon-Wook Joo, MD ,
In-Ho Chae, MD*,
Dong-Ju Choi, MD*,
Byung-Hee Oh, MD*,
Myoung-Mook Lee, MD ,
Young-Bae Park, MD* and
Hyo-Soo Kim, MD*,*
* Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine/Cardiovascular Center, Seoul National University Hospital, Seoul, Korea
Division of Nephrology, Department of Internal Medicine, Seoul National University College of Medicine/Cardiovascular Center, Seoul National University Hospital, Seoul, Korea
Cardiovascular Center, Dongguk University International Hospital, Goyang-si, Gyeonggi-do, Korea.
Manuscript received April 17, 2006;
revised manuscript received June 1, 2006,
accepted June 26, 2006.
* Reprint requests and correspondence: Dr. Hyo-Soo Kim or Dr. Bon-Kwon Koo, Department of Internal Medicine, Seoul National University College of Medicine, 28 Yongon-dong Jongno-gu, Seoul 110-744, Korea. (Email: hyosoo{at}snu.ac.kr).
OBJECTIVES: This study sought to compare the nephrotoxicity of iodixanol and ioxaglate in patients with renal impairment undergoing coronary angiography.
BACKGROUND: Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than low-osmolar contrast media (LOCM) in high-risk patients.
METHODS: In a prospective, randomized trial in 300 adults with creatinine clearance (CrCl)  60 ml/min, patients received either iodixanol or ioxaglate and underwent coronary angiography with or without percutaneous coronary intervention. The primary end point was the incidence of contrast-induced nephropathy (CIN) (an increase in serum creatinine [SCr]  25% or 0.5 mg/dl [44.2 µmol/l]). The incidence of CIN in patients with severe renal impairment at baseline (CrCl <30 ml/min) or diabetes and in those receiving large doses (140 ml) of contrast medium was also determined.
RESULTS: The incidence of CIN was significantly lower with iodixanol (7.9%) than with ioxaglate (17.0%; p = 0.021), corresponding to an odds ratio (OR) of CIN of 0.415 (95% confidence interval [CI] 0.194 to 0.889) for iodixanol. The incidence of CIN was also significantly lower with iodixanol in patients with severe renal impairment (p = 0.023) or concomitant diabetes (p = 0.041), or in patients given 140 ml of contrast media (p = 0.038). Multivariate analysis identified use of ioxaglate (OR 2.65, 95% CI 1.11 to 6.33, p = 0.028), baseline SCr, mg/dl (OR 2.0, 95% CI 1.04 to 3.85, p = 0.038), and left ventricular ejection fraction, % (OR 0.97, 95% CI 0.94 to 0.99, p = 0.019) as independent risk factors for CIN.
CONCLUSIONS: The IOCM iodixanol was significantly less nephrotoxic than ioxaglate, an ionic, dimeric LOCM. (The RECOVER Trial; http://clinicaltrials.gov; NCT00247325
[ClinicalTrials.gov]
)
|
Abbreviations and Acronyms
| | CI = confidence interval | | CIN = contrast-induced nephropathy | | CM = contrast medium | | CrCl = creatinine clearance | | HOCM = high-osmolar contrast medium | | IOCM = iso-osmolar contrast medium | | LOCM = low-osmolar contrast medium | | LVEF = left ventricular ejection fraction | | OR = odds ratio | | PCI = percutaneous coronary intervention | | SCr = serum creatinine |
|
This article has been cited by other articles:
|
|
|
|
 
E. Seeliger, M. Sendeski, C. S. Rihal, and P. B. Persson
Contrast-induced kidney injury: mechanisms, risk factors, and prevention
Eur. Heart J.,
January 19, 2012;
(2012)
ehr494v1.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. S. Wright, J. L. Anderson, C. D. Adams, C. R. Bridges, D. E. Casey Jr, S. M. Ettinger, F. M. Fesmire, T. G. Ganiats, H. Jneid, A. M. Lincoff, et al.
2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
J. Am. Coll. Cardiol.,
May 10, 2011;
57(19):
e215 - e367.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. L. Anderson, C. D. Adams, E. M. Antman, C. R. Bridges, R. M. Califf, D. E. Casey Jr, W. E. Chavey II, F. M. Fesmire, J. S. Hochman, T. N. Levin, et al.
2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
Circulation,
May 10, 2011;
123(18):
e426 - e579.
[Full Text]
[PDF]
|
|
|
|
|
|
|
Z. Serafin, M. Karolkiewicz, M. Gruszka, P. Strozecki, W. Lasek, G. Odrowaz-Sypniewska, J. Manitius, and W. Beuth
High incidence of nephropathy in neurosurgical patients after intra-arterial administration of low-osmolar and iso-osmolar contrast media
Acta Radiol,
May 1, 2011;
52(4):
422 - 429.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
Developed with the special contribution of the Eur, Authors/Task Force Members, W. Wijns, P. Kolh, N. Danchin, C. Di Mario, V. Falk, T. Folliguet, S. Garg, K. Huber, et al.
Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)
Eur. Heart J.,
October 2, 2010;
31(20):
2501 - 2555.
[Full Text]
[PDF]
|
|
|
|
|
|
|
The Task Force on Myocardial Revascularization of
Guidelines on myocardial revascularization
Eur J Cardiothorac Surg,
September 1, 2010;
38(Supplement_1):
S1 - S52.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. M. From, F. J. Al Badarin, F. S. McDonald, B. J. Bartholmai, S. S. Cha, and C. S. Rihal
Iodixanol Versus Low-Osmolar Contrast Media for Prevention of Contrast Induced Nephropathy: Meta-analysis of Randomized, Controlled Trials
Circ Cardiovasc Interv,
August 1, 2010;
3(4):
351 - 358.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. B. Mark, D. S. Berman, M. J. Budoff, J. J. Carr, T. C. Gerber, H. S. Hecht, M. A. Hlatky, J. M. Hodgson, M. S. Lauer, J. M. Miller, et al.
ACCF/ACR/AHA/NASCI/SAIP/SCAI/SCCT 2010 Expert Consensus Document on Coronary Computed Tomographic Angiography: A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents
J. Am. Coll. Cardiol.,
June 8, 2010;
55(23):
2663 - 2699.
[Full Text]
[PDF]
|
|
|
|
|
|
|
WRITING COMMITTEE MEMBERS, D. B. Mark, D. S. Berman, M. J. Budoff, J. J. Carr, T. C. Gerber, H. S. Hecht, M. A. Hlatky, J. M. Hodgson, M. S. Lauer, et al.
ACCF/ACR/AHA/NASCI/SAIP/SCAI/SCCT 2010 Expert Consensus Document on Coronary Computed Tomographic Angiography: A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents
Circulation,
June 8, 2010;
121(22):
2509 - 2543.
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. G. Kushner, M. Hand, S. C. Smith Jr, S. B. King III, J. L. Anderson, E. M. Antman, S. R. Bailey, E. R. Bates, J. C. Blankenship, D. E. Casey Jr, et al.
2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (Updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (Updating the 2005 Guideline and 2007 Focused Update): A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
J. Am. Coll. Cardiol.,
December 1, 2009;
54(23):
2205 - 2241.
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. G. Kushner, M. Hand, S. C. Smith Jr, S. B. King III, J. L. Anderson, E. M. Antman, S. R. Bailey, E. R. Bates, J. C. Blankenship, D. E. Casey Jr, et al.
2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (Updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (Updating the 2005 Guideline and 2007 Focused Update): A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
Circulation,
December 1, 2009;
120(22):
2271 - 2306.
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. Wessely, T. Koppara, C. Bradaric, M. Vorpahl, S. Braun, S. Schulz, J. Mehilli, A. Schomig, A. Kastrati, and for the Contrast Media and Nephrotoxicity Followin
Choice of Contrast Medium in Patients With Impaired Renal Function Undergoing Percutaneous Coronary Intervention
Circ Cardiovasc Interv,
October 1, 2009;
2(5):
430 - 437.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Reed, P. Meier, U. U. Tamhane, K. B. Welch, M. Moscucci, and H. S. Gurm
The Relative Renal Safety of Iodixanol Compared With Low-Osmolar Contrast Media: A Meta-Analysis of Randomized Controlled Trials
J. Am. Coll. Cardiol. Intv.,
July 1, 2009;
2(7):
645 - 654.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Treitl, H. Rupprecht, S. Wirth, M. Korner, M. Reiser, and J. Rieger
Assessment of renal vasoconstriction in vivo after intra-arterial administration of the isosmotic contrast medium iodixanol compared to the low-osmotic contrast medium iopamidol
Nephrol. Dial. Transplant.,
May 1, 2009;
24(5):
1478 - 1485.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. Mehran, E. Nikolsky, A. J. Kirtane, A. Caixeta, S. C. Wong, P. S. Teirstein, W. E. Downey, W. B. Batchelor, P. J. Casterella, Y.-H. Kim, et al.
Ionic Low-Osmolar Versus Nonionic Iso-Osmolar Contrast Media to Obviate Worsening Nephropathy After Angioplasty in Chronic Renal Failure Patients: The ICON (Ionic versus non-ionic Contrast to Obviate worsening Nephropathy after angioplasty in chronic renal failure patients) Study
J. Am. Coll. Cardiol. Intv.,
May 1, 2009;
2(5):
415 - 421.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. J. Bruce, A. Djamali, K. Shinki, S. J. Michel, J. P. Fine, and M. A. Pozniak
Background Fluctuation of Kidney Function Versus Contrast-Induced Nephrotoxicity
Am. J. Roentgenol.,
March 1, 2009;
192(3):
711 - 718.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Goldfarb, P. A. McCullough, J. McDermott, and S. B. Gay
Contrast-Induced Acute Kidney Injury: Specialty-Specific Protocols for Interventional Radiology, Diagnostic Computed Tomography Radiology, and Interventional Cardiology
Mayo Clin. Proc.,
February 1, 2009;
84(2):
170 - 179.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
N. Lameire, W. Van Biesen, E. Hoste, and R. Vanholder
The prevention of acute kidney injury: an in-depth narrative review Part 1: volume resuscitation and avoidance of drug- and nephrotoxin-induced AKI
Clinical Kidney Journal,
December 1, 2008;
1(6):
392 - 402.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Maioli, A. Toso, M. Leoncini, M. Gallopin, D. Tedeschi, C. Micheletti, and F. Bellandi
Sodium Bicarbonate Versus Saline for the Prevention of Contrast-Induced Nephropathy in Patients With Renal Dysfunction Undergoing Coronary Angiography or Intervention
J. Am. Coll. Cardiol.,
August 19, 2008;
52(8):
599 - 604.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. A. Baumgarten and J. H. Ellis
Contrast-Induced Nephropathy: Contrast Material Not Required?
Am. J. Roentgenol.,
August 1, 2008;
191(2):
383 - 386.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S.-H. Jo, B.-K. Koo, T.-J. Youn, and H.-S. Kim
Conclusion of recent 'osmolality trials' in preventing contrast-induced nephropathy by NAC--what is the standard?
Nephrol. Dial. Transplant.,
July 1, 2008;
23(7):
2424 - 2424.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Kimmel and D. M. Alscher
Reply
Nephrol. Dial. Transplant.,
July 1, 2008;
23(7):
2424 - 2425.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. J. Kuhn, N. Chen, D. V. Sahani, D. Reimer, E. J. R. van Beek, J. P. Heiken, and G. J. So
The PREDICT Study: A Randomized Double-Blind Comparison of Contrast-Induced Nephropathy After Low- or Isoosmolar Contrast Agent Exposure
Am. J. Roentgenol.,
July 1, 2008;
191(1):
151 - 157.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. D. Weisbord, M. K. Mor, A. L. Resnick, K. C. Hartwig, A. F. Sonel, M. J. Fine, and P. M. Palevsky
Prevention, Incidence, and Outcomes of Contrast-Induced Acute Kidney Injury
Arch Intern Med,
June 23, 2008;
168(12):
1325 - 1332.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. A. McCullough
Contrast-Induced Acute Kidney Injury
J. Am. Coll. Cardiol.,
April 15, 2008;
51(15):
1419 - 1428.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Kimmel, M. Butscheid, S. Brenner, U. Kuhlmann, U. Klotz, and D. M. Alscher
Improved estimation of glomerular filtration rate by serum cystatin C in preventing contrast induced nephropathy by N-acetylcysteine or zinc--preliminary results
Nephrol. Dial. Transplant.,
April 1, 2008;
23(4):
1241 - 1245.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. Ritz
Cardiovascular Literature--Beyond Nephrology
Clin. J. Am. Soc. Nephrol.,
March 1, 2008;
3(2):
317 - 323.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. M. Kelly, B. Dwamena, P. Cronin, S. J. Bernstein, and R. C. Carlos
Meta-analysis: Effectiveness of Drugs for Preventing Contrast-Induced Nephropathy
Ann Intern Med,
February 19, 2008;
148(4):
284 - 294.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
American College of Cardiology/American Heart Asso, 2007 Writing Group to Review New Evidence and Upda, S. B. King III, S. C. Smith Jr, J. W. Hirshfeld Jr, A. K. Jacobs, D. A. Morrison, and D. O. Williams
2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention
J. Am. Coll. Cardiol.,
January 15, 2008;
51(2):
172 - 209.
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. B. King III, S. C. Smith Jr, J. W. Hirshfeld Jr, A. K. Jacobs, D. A. Morrison, D. O. Williams, 2005 WRITING COMMITTEE MEMBERS, S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, et al.
2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines: 2007 Writing Group to Review New Evidence and Update the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention, Writing on Behalf of the 2005 Writing Committee
Circulation,
January 15, 2008;
117(2):
261 - 295.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. L. Anderson, C. D. Adams, E. M. Antman, C. R. Bridges, R. M. Califf, D. E. Casey Jr, W. E. Chavey II, F. M. Fesmire, J. S. Hochman, T. N. Levin, et al.
ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine
J. Am. Coll. Cardiol.,
August 14, 2007;
50(7):
e1 - e157.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. L. Anderson, C. D. Adams, E. M. Antman, C. R. Bridges, R. M. Califf, D. E. Casey Jr, W. E. Chavey II, F. M. Fesmire, J. S. Hochman, T. N. Levin, et al.
ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine
J. Am. Coll. Cardiol.,
August 14, 2007;
50(7):
652 - 726.
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. R. Dixon, C. L. Grines, and W. W. O'Neill
The Year in Interventional Cardiology
J. Am. Coll. Cardiol.,
July 17, 2007;
50(3):
270 - 285.
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. Solomon
Contrast media nephropathy--how to diagnose and how to prevent?
Nephrol. Dial. Transplant.,
July 1, 2007;
22(7):
1812 - 1815.
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. J. Solomon, M. K. Natarajan, S. Doucet, S. K. Sharma, C. S. Staniloae, R. E. Katholi, J. L. Gelormini, M. Labinaz, A. E. Moreyra, and the Investigators of the CARE Study
Cardiac Angiography in Renally Impaired Patients (CARE) Study: A Randomized Double-Blind Trial of Contrast-Induced Nephropathy in Patients With Chronic Kidney Disease
Circulation,
June 26, 2007;
115(25):
3189 - 3196.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. Deray
Visipaque (Iodixanol) and Hexabrix (Ioxaglate) in Renal Insufficiency
J. Am. Coll. Cardiol.,
April 17, 2007;
49(15):
1668 - 1668.
[Full Text]
[PDF]
|
|
|
|
|
|
|
S.-H. Jo, B.-K. Koo, T.-J. Youn, and H.-S. Kim
Reply.
J. Am. Coll. Cardiol.,
April 17, 2007;
49(15):
1669 - 1670.
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. Persson, P. Liss, and P. Hansell
Evaluation and Comparison Between Visipaque (Iodixanol) and Hexabrix (Ioxaglate) in Coronary Angiography
J. Am. Coll. Cardiol.,
April 17, 2007;
49(15):
1668 - 1669.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. N. DeMaria, O. Ben-Yehuda, G. K. Feld, G. S. Ginsburg, B. H. Greenberg, W. Y.W. Lew, J. A.C. Lima, A. S. Maisel, J. Narula, D. J. Sahn, et al.
Highlights of the Year in JACC 2006
J. Am. Coll. Cardiol.,
January 30, 2007;
49(4):
509 - 527.
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. A. Herzog
Kidney disease in cardiology
Nephrol. Dial. Transplant.,
January 1, 2007;
22(1):
43 - 46.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
