Cardiovascular Outcome Trials in Patients With Advanced Kidney Disease
Time for Action
This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
Kidney disease is prevalent among patients with cardiovascular disease, and its presence is associated with an increased risk of cardiovascular events or death. Despite widespread acceptance of this tenet, patients with kidney disease, especially advanced kidney disease, are frequently excluded from cardiovascular outcome trials. Systematic reviews published in 20061,2 reported that 56% to 80% of major randomized trials in chronic heart failure, acute myocardial infarction, or coronary artery disease excluded patients with kidney disease. Despite a call by these authors >10 years ago encouraging greater enrollment of patients with kidney disease in cardiovascular trials,1,2 a later systematic review (updated to reflect clinical trials published between 2006 and 2013 in the top 10 medical journals ranked by impact factor) found persistent exclusion of these patients from the majority (57%) of heart failure or acute coronary syndrome cardiovascular outcome trials (Figure).3 A few recent examples (ie, SPRINT [Systolic Blood Pressure Intervention Trial] allowed an estimated glomerular filtration rate of ≥20 mL·min–1·1.73 m–2; and SHARP [Study of Heart and Renal Protection] required serum creatinine ≥1.5 mg/dL [women] or ≥1.7 mg/dL [men] with or without dialysis for inclusion) are worth noting for their enrollment of patients with kidney disease, but, in general, these patients remain underrepresented in cardiovascular outcome trials. As a result, the best treatment approaches for patients with kidney disease remain shrouded by uncertainty. Insufficient data impair physician and patient decision making in terms of both safety and …