Abstract
Background: The choice of radiographic contrast media for use in patients at increased risk of contrast-induced nephropathy (CIN) is of ongoing interest. Methods: The current study is a prospective, multicenter, randomized, double-blind design comparing the renal effects of the non-ionic, iso-osmolal agent, iodixanol, versus the non-ionic, low-osmolal agent, iopamidol, in 526 subjects with impaired baseline renal function (chronic kidney disease) and diabetes mellitus undergoing diagnostic and/or therapeutic coronary angiographic procedures. The co-primary end points were the peak increase in serum creatinine (SCr) and the incidence of CIN (increase ≥0.5 mg/dL) in SCr from baseline within 3 days of receiving contrast media. Results: In 418 evaluable subjects with complete postcontrast media SCr data, the median peak increase in SCr in the iodixanol arm was 0.10 mg/dL, whereas in the iopamidol arm, the median peak increase was 0.09 mg/dL (P = .13). The overall CIN incidence was 10.5% (11.2% % in the iodixanol arm and 9.8% in the iopamidol arm, P = .7). The volume of contrast media, volume of saline administered, frequency of coronary interventional procedures, and severity of baseline kidney disease and of diabetes mellitus were similar between treatments. Conclusions: In the present study, the overall rate of CIN in patients with chronic kidney disease and DM undergoing coronary angiographic procedures was 10.5%. There was no significant difference between iodixanol and iopamidol in either peak increase in SCr or risk of CIN.
Original language | English (US) |
---|---|
Pages (from-to) | 822-828.e3 |
Journal | American heart journal |
Volume | 158 |
Issue number | 5 |
DOIs | |
State | Published - Nov 2009 |
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
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Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures. / Laskey, Warren; Aspelin, Peter; Davidson, Charles; Rudnick, Michael; Aubry, Pierre; Kumar, Sreenivas; Gietzen, Frank; Wiemer, Marcus.
In: American heart journal, Vol. 158, No. 5, 11.2009, p. 822-828.e3.Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures
AU - Laskey, Warren
AU - Aspelin, Peter
AU - Davidson, Charles
AU - Rudnick, Michael
AU - Aubry, Pierre
AU - Kumar, Sreenivas
AU - Gietzen, Frank
AU - Wiemer, Marcus
N1 - Funding Information: Center no. Investigator/affiliation No. of subjects enrolled ⁎ /given CM 001 Prof Peter Aspelin † /Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden 6/6 002 Dr Knut Endresen/Dept of Cardiology, Rikshospitalet University Hospital, Sognsvannsveien 20, 0027 Oslo, Norway 1/0 003 Dr Victor Legrand/Service de Cardiologie, Centre Hospitalier Universitaire, Domaine du Sart Tilman, 4000 Liège, Belgium 1/1 004 Dr Claude Hanet/Cliniques Universitaires St Luc, Service de Cardiologie, 10 avenue Hippocrate, 1200 Brussels, Belgium 0/0 005 PD Dr Willenbrock/Krankenhaus St Elisabeth und St Barbara, Klinik für Innere Medizin II, Mauerstrasse 5, Postfach 20 02 54, 06110 Halle (Saale), Germany 12/12 006 Dr Rainer Wessely Deutsches Herzzentrum München des Freistaates Bayern, Munich, Germany 4/4 007 Dr Marcus Wiemer/Herz- und Diabeteszentrum Nordrhein-Westfalen, Kardiologische Klinik, Georgstrasse 11, 32545 Bad Oeynhausen, Germany 29/27 008 Dr Rémi Sabatier/CHU Cote de Nacre, Service de Cardiologie, 14033 Caen Cedex, France 5/5 009 Prof Dr Ruth Strasser/Medizinische Klinik/Kardiologie, Technische Universität Dresden, Fetscherstrasse 76, 01307 Dresden, Germany 14/14 010 Dr Pierre Aubry/Hôpital Bichat, Service de Cardiologie B, 46, rue Henri Huchard, 75018 Paris, France 6/6 011 Dr Azfar Zaman/Freeman Hospital, Freeman Road, Newcastle NE7 7DN, UK 7/7 012 Centre withdrawn – 013 Dr Thorsten Dill/Kerckhoff-Klinik GmbH, Benekestrasse 2-8, 61231 Bad Nauheim, Germany 9/9 014 Dr Eulogio García/Hospital Gregorio Marañón, Cardiology Dept, Doctor Esquerdo, 46, 28007 Madrid, Spain 4/4 015 Dr Franscisco Fernández-Avilés/Hospital Universitario de Valladolid, Cardiology Dept, Avda Ramón y Cajal, 3, 47011 Valladolid, Spain 10/10 016 Dr Paolo Rubartelli, Ospedale Villascassi, Corso Scassi, 16126 Genova, Italy 5/5 017 Centre withdrawn – 018 Dr Charles Knight/The London Chest Hospital, Bonner Road, Bethnal Green, London E2 9JX, UK 0/0 019 Dr Joachim Schümmelfeder (until July 1, 2006), Dr Frank Gietzen (from July 1, 2006)/Herz- und Gefäss-Klinik GmbH, Salzburger Leite 1, 97616 Bad Neustadt/Saale, Germany 19/19 020 Prof Dr Franz-Josef Neumann/Herzzentrum Bad Krozingen, Am Südring 15, 79189 Bad Krozingen, Germany 14/14 021 Dr Jacques Boschat/CHU de Brest-Hôpital de la Cavale Blanche, Boulevard Tanguy Prigent, 29 200 Brest cedex, France 1/1 022 Dr Michael Rosseel/Algemeen Stedelijk Ziekenhuis, Cardiologie, Merestraat 80, 9300 Aalst, Belgium 0/0 023 Dr Marc Vincent/Brussels Heart Centre, Clinique Générale St Jean, 32 bd du Jardin Botanique, 1000 Brussels, Belgium 7/7 024 Dr Mathias Vrolix/ZOl-Campus St Jan, Cardiology department, Schiepsebos 6, 3600 Genk, Belgium 4/4 025 Prof Ludwig Thierfelder/Franz-Volhard-Klinik, Charitè Campus Berlin-Buch, Wiltbergstrasse 50, 13125 Berlin, Germany 9/9 026 PD Dr Stefan Sack/Universitätsklinikum Essen, Zentrum für Innere Medizin, Klinik für Kardiologie, Westdeutsches Herzzentrum Essen, Hufelandstrasse 55, 45122 Essen, Germany 0/0 027 Dr Antonio Manari/Azienda Ospedaliera Arcispedale Santa Maria Nuova di Reggio Emilia, Struttura Complessa di Diagnostica e Interventistica Cardiologia, Viale Risorgimento, 80, 42100 Reggio Emilia, Italy 5/5 028 Dr Nick Ossei-Gerning/University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK 2/2 029 Dr Matthias R. Schulze/Klinikum Schwalmstadt, Schwalm-Eder-Kliniken GmbH, Krankenhausstrasse 27, 34613 Schwalmstadt, Germany 18/18 030 Prof Forster Tamás/Szegedi Orvostudományi Egyetem, Kardiológiai Centrum, Korányi fasor 6, 6720 Szeged, Hungary 6/5 031 Dr Lupkovics Géza/Zala Megyei Kórház, Kardiológiai Osztály, Zrínyi Miklós u. 1, 8900 Zalaegerszeg, Hungary 7/7 032 Dr Apró Dezsõ/Állami Szívkórház Balatonfüred, 1. sz. Kardiológiai Osztály, Gyógy tér 2, 8230 Balatonfüred, Hungary 10/10 033 Prof. Tomasz Pasierski/Miedzyleski Szpital Specjalistyczny, Oddzial Kardiologii, Ul. Bursztynowa 2, 04-749 Warszawa, Poland 14/14 034 Prof Slawomir Dobrzycki/Samodzielny Publiczny Szpital Kliniczny AM w Bialymstoku, Zaklad Kardiologii Inwazyjnej, Ul. M. Sklodowskiej-Curie 24A, 15-276 Bialystok, Poland 16/15 035 Prof. Waldemar Banasiak/4 Wojskowy Szpital Kliniczny, Osrodek Chorób Serca, Ul. Weigla 5, 53-114 Wroclaw, Poland 12/12 101 Warren Laskey, MD ‡ /The University of New Mexico Health Science Center School of Medicine, Department of Internal Medicine MSC10-5550, 1 University of New Mexico, Albuquerque, NM 87131, USA 19/17 D Michelle Ratliff, MD/Albuquerque Veterans Affairs Med ical Center, 1501 San Pedro SE, Albuquerque, NM 87108, USA 102 Charles J. Davidson, MD/251 East Huron Street, Feinberg 8-256, Chicago, IL 60611, USA 26/26 103 Michael Rudnick, MD/Renal Electrolyte and Hypertension Division, Penn Presbyterian Medical Center, 240 Medical Office Building, 39th and Market St, Philadelphia, PA 19104, USA 9/9 104 Reda Ibrahim, MD/Montreal Heart Institute, 5000 East Belanger Street, Roulotte 1000A, Montréal, Québec, H1T 1C8, Canada 13/13 105 Center did not participate – 106 Steven Rohrbeck, MD/Carolina Cardiology Associates, 306 Westwood Ave, Ste 401, High Point, NC 27262, USA 13/13 107 J. Lawrence Stafford, MD/University of Maryland Medical Center, 22 S Greene St, Room S3B08, Baltimore, MD 21201, USA 11/10 108 Edward O. McFalls, MD/Minneapolis Veterans Affairs Medical Center, One Veterans Dr, Cardiology 111C, Minneapolis, MN 55417, USA 13/13 109 Kendrick Shunk, MD/San Francisco Veterans Affairs Medical Center, 4150 Clement St, Mail Stop 151 CRC, San Francisco, CA 94121, USA 3/3 110 Frederick Weiland, MD/Sutter Roseville Medical Center, One Medical Plaza, Roseville, CA 95661, USA 0/0 111 Gary Schaer, MD/Rush University Medical Center, 1653 W Congress Pkwy, Ste 1035 Jelke, Chicago, IL 60612, USA 12/11 112 J. Huger Richardson, MD/South Carolina Heart Center, 2001 Laurel St, Columbia, SC 29204, USA 1/1 113 Peter C. Nishan, MD/LeBauer Cardiovascular Research Foundation, 1126 N Church St, Ste 300, Greensboro, NC 27401, USA 7/7 114 Christian Bounds, MD/Delmarva Heart Research Foundation, Inc, 106 Milford St, Ste 605, Salisbury, MD 21804, USA 10/10 115 Maurice Buchbinder, MD/Foundation for Cardiovascular Medicine, 9834 Genesee Ave, Ste 310, La Jolla, CA 92037, USA 0/0 116 Jesse Goldman, MD/Temple University Hospital, Parkinson Pavilion 658, 3401 N Broad St, Philadelphia, PA 19140, USA 10/10 117 Anthony Fung, MD/The University of British Columbia, Vancouver Hospital (VCH), Interventional Cardiology Research, 9176-2775 Laurel St, Vancouver, BC V5Z 1M9, Canada 15/15 118 Center withdrawn – 119 John Hirshfeld, MD/University of Pennsylvania Medical Center, 9.119 Founders Pavilion, 3400 Spruce Street, Philadelphia, PA 19104, USA 12/12 120 Joseph Moore, MD/Jacksonville Center for Clinical Research, 4085 University Blvd South, Ste 1, Jacksonville, FL 32216, USA 4/3 121 Steven Weisbord, MD, MSc/University of Pittsburgh, 200 Lathrop St, Pittsburgh, PA 15213, USA 15/14 122 Steven Weisbord, MD, MSc/VA Pittsburgh Healthcare System, University Drive Division (111F-U), Room 7E 120, Pittsburgh, PA 15240, USA 1/1 123 Lee A. MacDonald, MD, South Denver Cardiology Associates, PC, 1000 Southpark Dr, Littleton, CO 80120, USA 4/4 124 Anjali Acharya, MD, Jacobi Medical Center, North Bronx Healthcare Network, 1400 Pelham Parkway South, 6E-23B, Bldg I, Box 10461, Bronx, NY 10461, USA 4/4 125 John Colleran, MD, The Heart & Vascular Institute of Florida, 6006 49th St North, Ste 200, St Petersburg, Fl 33709, USA 1/1 201a Dr V Seshiah/Dr V Seshiah Diabetes Care and Research Institute, 31/A, Ormes Road Kilpauk, Chennai-600 010, Tamil Nadu, India 0/0 202a Dr Vijay Viswanathan/Diabetes Research Centre & Hospital For Diabetes, 4, West Mada Church Street, Royapuram, Chennai-600 013, Tamil Nadu, India 0/0 203 Dr Shreenivas Kumar/CARE Hospital, Road #1, Banjara Hills, Hyderabad-500 034, Andhra Pradesh, India 46/46 204 Dr Parthap Kumar (MD, DM FIC)/Manipal Hospital, Airport Road, 98 Rustumbagh, Bangalore-560 017, India 18/18 205 Dr Pramod Jaiswal/Institute of Cardiac Vascular Disease, R-30-C, Ambattur Industrial Estate Road, Chennai-600 101, Tamil Nadu, India 16/14 ⁎ Assigned a subject study number. † Coordinating investigator, Europe and India. ‡ Coordinating investigator, North America.
PY - 2009/11
Y1 - 2009/11
N2 - Background: The choice of radiographic contrast media for use in patients at increased risk of contrast-induced nephropathy (CIN) is of ongoing interest. Methods: The current study is a prospective, multicenter, randomized, double-blind design comparing the renal effects of the non-ionic, iso-osmolal agent, iodixanol, versus the non-ionic, low-osmolal agent, iopamidol, in 526 subjects with impaired baseline renal function (chronic kidney disease) and diabetes mellitus undergoing diagnostic and/or therapeutic coronary angiographic procedures. The co-primary end points were the peak increase in serum creatinine (SCr) and the incidence of CIN (increase ≥0.5 mg/dL) in SCr from baseline within 3 days of receiving contrast media. Results: In 418 evaluable subjects with complete postcontrast media SCr data, the median peak increase in SCr in the iodixanol arm was 0.10 mg/dL, whereas in the iopamidol arm, the median peak increase was 0.09 mg/dL (P = .13). The overall CIN incidence was 10.5% (11.2% % in the iodixanol arm and 9.8% in the iopamidol arm, P = .7). The volume of contrast media, volume of saline administered, frequency of coronary interventional procedures, and severity of baseline kidney disease and of diabetes mellitus were similar between treatments. Conclusions: In the present study, the overall rate of CIN in patients with chronic kidney disease and DM undergoing coronary angiographic procedures was 10.5%. There was no significant difference between iodixanol and iopamidol in either peak increase in SCr or risk of CIN.
AB - Background: The choice of radiographic contrast media for use in patients at increased risk of contrast-induced nephropathy (CIN) is of ongoing interest. Methods: The current study is a prospective, multicenter, randomized, double-blind design comparing the renal effects of the non-ionic, iso-osmolal agent, iodixanol, versus the non-ionic, low-osmolal agent, iopamidol, in 526 subjects with impaired baseline renal function (chronic kidney disease) and diabetes mellitus undergoing diagnostic and/or therapeutic coronary angiographic procedures. The co-primary end points were the peak increase in serum creatinine (SCr) and the incidence of CIN (increase ≥0.5 mg/dL) in SCr from baseline within 3 days of receiving contrast media. Results: In 418 evaluable subjects with complete postcontrast media SCr data, the median peak increase in SCr in the iodixanol arm was 0.10 mg/dL, whereas in the iopamidol arm, the median peak increase was 0.09 mg/dL (P = .13). The overall CIN incidence was 10.5% (11.2% % in the iodixanol arm and 9.8% in the iopamidol arm, P = .7). The volume of contrast media, volume of saline administered, frequency of coronary interventional procedures, and severity of baseline kidney disease and of diabetes mellitus were similar between treatments. Conclusions: In the present study, the overall rate of CIN in patients with chronic kidney disease and DM undergoing coronary angiographic procedures was 10.5%. There was no significant difference between iodixanol and iopamidol in either peak increase in SCr or risk of CIN.
UR - http://www.scopus.com/inward/record.url?scp=70350173723&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=70350173723&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2009.08.016
DO - 10.1016/j.ahj.2009.08.016
M3 - Article
C2 - 19853704
AN - SCOPUS:70350173723
VL - 158
SP - 822-828.e3
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
IS - 5
ER -