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Noticias
Dr. Frank J Criado
The CORAL study results were presented on November 18, 2013 at the AHA 2013 Scientific Sessions in Dallas. The findings were published concurrently in the New England Journal of Medicine.
The study investigators noted that renal artery stenting had increased an impressive 364% in the Medicare population between 1996 and 2000, and that an estimated 78 million Americans have hypertension and nearly 4 million may have renal artery stenosis. Dr. Christopher J Cooper (from the University of Toledo, Ohio), lead investigator for the clinical trial, stated “our larger study demonstrates that this procedure (renal artery stenting) offers no incremental benefit when added to treatment with medication.”
The CORAL study (funded by the NIH, Pfizer and Cordis) randomized 947 patients with ≥60% renal artery stenosis, and either systolic blood pressure of 150 mmHg or higher while taking two or more drugs or stage 3 (moderate) chronic kidney disease. Clinical researchers from more than 100 institutions randomly assigned enrollees to receive medical therapy only or medical therapy plus stenting. The primary endpoint was a composite of major cardiovascular or renal events (death from renal or cardiovascular causes, stroke, myocardial infarction, hospitalization for heart failure, progressive renal insufficiency, and permanent renal replacement therapy). During an average follow-up period of 43 months, researchers found that 35.1% of patients who received medical therapy and stents experienced one of the primary endpoints vs 35.8% of patients who received medication alone. The difference was not statistically significant (P=.58). In a separate analysis for the secondary endpoint of cardiovascular or renal death, stroke, myocardial infarction, heart failure, progressive renal insufficiency and renal replacement, the investigators also did not find significant differences. The same results were seen when the patients were analyzed by subgroups. Cooper concluded that “Renal artery stenting did not confer a benefit to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal artery stenosis and hypertension or chronic kidney disease.”