This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (64)  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Topic Collections  • Cardiovascular System  • Renal Diseases  • Renal Diseases, Other  • Review  • Randomized Controlled Trial  • Cardiovascular Disease/ Myocardial Infarction  • Alert me on articles by topic  Social Bookmarking   What's this?

Steven G. Coca, DO; Harlan M. Krumholz, MD; Amit X. Garg, MD, PhD; Chirag R. Parikh, MD, PhD

JAMA. 2006;296:1377-1384.

Context  Patients with renal disease are at high risk for cardiovascular mortality. Determining which interventions best offset this risk remains a health priority.

Objective  To quantify the representation of patients with renal disease in randomized controlled trials for interventions proven efficacious for cardiovascular disease.

Data Sources  We searched MEDLINE for trials published from 1985 through 2005 in 11 major medical and subspecialty journals.

Study Selection  Randomized controlled trials for chronic congestive heart failure and acute myocardial infarction of treatments that are currently listed as class I or II recommendations in the current American College of Cardiology/American Heart Association guidelines were included.

Data Extraction  Two reviewers independently abstracted data on study and patient characteristics, renal measurements, outcomes, and prognostic features.

Data Synthesis  A total of 153 trials were reviewed. Patients with renal disease were reported as excluded in 86 (56%) trials. Patients with renal disease were more likely to be excluded from trials that were multicenter; of moderate enrollment size; North American; that tested renin-angiotensin-aldosterone system antagonists and anticoagulants; and that tested chronic congestive heart failure. Only 8 (5%) original articles reported the proportion of enrolled patients with renal disease, and only 15 (10%) reported mean baseline renal function. While 81 (53%) trials performed subgroup analyses of some baseline characteristic in the original article, only 4 (3%) subgroup analyses of treatment stratified by renal disease were performed.

Conclusion  Major cardiovascular disease trials frequently exclude patients with renal disease and do not provide adequate information on the renal function of enrollees or the effect of interventions on patients with renal disease.

Author Affiliations: Clinical Epidemiology Research Center, Veterans Affairs Medical Center, West Haven, Conn (Drs Coca and Parikh); Department of Medicine, Yale University School of Medicine, New Haven, Conn (Drs Coca, Krumholz, and Parikh); and Departments of Medicine and Epidemiology and Biostatistics, University of Western Ontario, London (Dr Garg).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Implantable cardioverter defibrillator therapy in chronic kidney disease: a meta-analysis
Korantzopoulos et al.
Europace 2009;11:1469-1475.
ABSTRACT | FULL TEXT  

Influence of Renal Function on the Effects of Early Revascularization in Non-ST-Elevation Myocardial Infarction: Data From the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART)
Szummer et al.
Circulation 2009;120:851-858.
ABSTRACT | FULL TEXT  

Should statins be prescribed for primary prevention of cardiovascular disease in patients with chronic kidney disease?
Connor and Tomson
BMJ 2009;339:b2949-b2949.
FULL TEXT  

Effect of spironolactone on left ventricular mass and aortic stiffness in early-stage chronic kidney disease: a randomized controlled trial.
Edwards et al.
J Am Coll Cardiol 2009;54:505-512.
ABSTRACT | FULL TEXT  

The scope of coronary heart disease in patients with chronic kidney disease.
Hage et al.
J Am Coll Cardiol 2009;53:2129-2140.
ABSTRACT | FULL TEXT  

The future of European Nephrology 'Guidelines'--a declaration of intent by European Renal Best Practice (ERBP)
Vanholder et al.
NDT Plus 2009;2:213-221.
FULL TEXT  

Cystatin C for Enhancement of Risk Stratification in Non-ST Elevation Acute Coronary Syndrome Patients with an Increased Troponin T
Windhausen et al.
Clin. Chem. 2009;55:1118-1125.
ABSTRACT | FULL TEXT  

Angiotensin II receptor blocker-based vs. non-angiotensin II receptor blocker-based therapy in patients with angiographically documented coronary artery disease and hypertension: the Heart Institute of Japan Candesartan Randomized Trial for Evaluation in Coronary Artery Disease (HIJ-CREATE)
Kasanuki et al.
Eur Heart J 2009;30:1203-1212.
ABSTRACT | FULL TEXT  

Temporal management patterns and outcomes of non-ST elevation acute coronary syndromes in patients with kidney dysfunction
Wong et al.
Eur Heart J 2009;30:549-557.
ABSTRACT | FULL TEXT  

Policy Research: Using Evidence to Improve Healthcare Delivery Systems
Ross and Gross
Circulation 2009;119:891-898.
FULL TEXT  

Optimal Method of Coronary Revascularization in Patients Receiving Dialysis: Systematic Review
Nevis et al.
CJASN 2009;4:369-378.
ABSTRACT | FULL TEXT  

Reperfusion in Patients With Renal Dysfunction After Presentation With ST-Segment Elevation or Left Bundle Branch Block: GRACE (Global Registry of Acute Coronary Events)
Medi et al.
J Am Coll Cardiol Intv 2009;2:26-33.
ABSTRACT | FULL TEXT  

In-Hospital and 1-Year Outcomes Among Percutaneous Coronary Intervention Patients With Chronic Kidney Disease in the Era of Drug-Eluting Stents: A Report From the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) Registry
Latif et al.
J Am Coll Cardiol Intv 2009;2:37-45.
ABSTRACT | FULL TEXT  

Improving the reporting of pragmatic trials: an extension of the CONSORT statement
Zwarenstein et al.
BMJ 2008;337:a2390-a2390.
ABSTRACT | FULL TEXT  

Cardiovascular disease in chronic kidney disease
Saran and DuBose
Ther Adv Cardiovasc Dis 2008;2:425-434.
ABSTRACT  

The Cardiovascular Research Network: A New Paradigm for Cardiovascular Quality and Outcomes Research
Go et al.
Circ Cardiovasc Qual Outcomes 2008;1:138-147.
ABSTRACT | FULL TEXT  

Beyond the Randomized Clinical Trial: The Role of Effectiveness Studies in Evaluating Cardiovascular Therapies
Nallamothu et al.
Circulation 2008;118:1294-1303.
FULL TEXT  

European best practice quo vadis? From European best practice guidelines (EBPG) to European renal best practice (ERBP)
Zoccali et al.
Nephrol Dial Transplant 2008;23:2162-2166.
FULL TEXT  

Intensive Lipid Lowering With Atorvastatin in Patients With Coronary Heart Disease and Chronic Kidney Disease: The TNT (Treating to New Targets) Study
Shepherd et al.
J Am Coll Cardiol 2008;51:1448-1454.
ABSTRACT | FULL TEXT  

Mortality, kidney disease and cardiac procedures following acute coronary syndrome
Inrig et al.
Nephrol Dial Transplant 2008;23:934-940.
ABSTRACT | FULL TEXT  

Management of Cardiovascular Disease in Renal Transplant Recipients
Shirali and Bia
CJASN 2008;3:491-504.
ABSTRACT | FULL TEXT  

Q: Should all patients with chronic kidney disease take a statin?
RIFKIN and SARNAK
Cleveland Clinic Journal of Medicine 2008;75:118-120.
FULL TEXT  

2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention
American College of Cardiology/American Heart Asso et al.
J Am Coll Cardiol 2008;51:172-209.
FULL TEXT  

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
King et al.
Circulation 2008;117:261-295.
FULL TEXT  

Homocysteine and Diabetic Retinopathy
Brazionis et al.
Diabetes Care 2008;31:50-56.
ABSTRACT | FULL TEXT  

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
Anderson et al.
J Am Coll Cardiol 2007;50:e1-e157.
FULL TEXT  

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
Anderson et al.
J Am Coll Cardiol 2007;50:652-726.
FULL TEXT  

Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes: The Task Force for the Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of the European Society of Cardiology
Authors/Task Force Members et al.
Eur Heart J 2007;28:1598-1660.
FULL TEXT  

Chronic Kidney Disease and the Public Health: Gaps in Evidence From Interventional Trials
Himmelfarb
JAMA 2007;297:2630-2633.
FULL TEXT  

Chronic Kidney Disease: Cause and Consequence of Cardiovascular Disease
Freedman and DuBose
Arch Intern Med 2007;167:1113-1115.
FULL TEXT  

American Society of Nephrology Presidential Address 2006: Chronic Kidney Disease as a Public Health Threat--New Strategy for a Growing Problem
DuBose
J. Am. Soc. Nephrol. 2007;18:1038-1045.
FULL TEXT  

Anemia of Kidney Disease and Clinical Practice Guidelines: Quo Vadis?
Himmelfarb et al.
CJASN 2007;2:213-214.
FULL TEXT  

Chronic Kidney Disease: Common, Harmful, and Treatable--World Kidney Day 2007
Levey et al.
CJASN 2007;2:401-405.
FULL TEXT  

Chronic Kidney Disease: Common, Harmful, and Treatable--World Kidney Day 2007
Levey et al.
J. Am. Soc. Nephrol. 2007;18:374-378.
FULL TEXT  

CVD Trials Often Exclude Patients with Renal Disease
Journal Watch Cardiology 2006;2006:3-3.
FULL TEXT