CORAL: Renal stenting fails to reduce clinical events vs. medical therapy
DALLAS — Among patients with atherosclerotic renal artery stenosis, renal stenting did not confer a benefit with regard to a reduction in clinical events as compared with multifactorial medical therapy, according to results of the CORAL trial.
There were also no significant reductions in the individual endpoints with renal stenting.
Christopher J. Cooper, MD, with the University of Toledo in Ohio, presented the data from CORAL and explained at a press conference that stenting was safe, resulting in limited peri-procedural clinical complications. He also added that renal stenting did result in a significant reduction of BP, although this did not translate into difference in clinical events.
In the study, Cooper and fellow investigators randomly assigned 947 patients (50% women; mean age, 69 years) with atherosclerotic renal artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal stenting or to medical therapy alone.
Patients presented with a mean systolic BP of 150 ± 23 mm Hg and mean glomerular filtration rate of 58 ± 22 mL/min. Inclusion criteria were an atherosclerotic renal stenosis of at least 60% and hypertension despite being on at least two antihypertensive medications and/or at least stage III chronic kidney disease.
Investigators examined the occurrence of adverse CV and renal events, the study’s primary endpoint, which was defined as a composite of death from CV or renal causes, MI, stroke, hospitalization for congestive HF, progressive renal insufficiency or the need for renal replacement therapy. The statistical plan of the study included a sample size that was selected to provide 90% power to test the hypothesis that stenting reduced the incidence of the primary endpoint by 25%, Cooper said.
During follow-up (median, 43 months), the rate of the primary composite endpoint was comparable between patients in both groups (renal stenting, 35.1% vs. medical therapy alone, 35.8%; HR=0.94; P=.58). Rates of the individual endpoints and all-cause mortality also did not significantly differ.
Cooper and colleagues did observe a modest reduction in systolic BP for stenting (–2.3 mm Hg; P=.03).
Safety data revealed one stroke in the medical therapy only population resulting in death on the day of randomization. No participant required dialysis within 30 days of randomization, Cooper said. Between 30 and 90 days of randomization, dialysis was initiated in only one patient in the stenting group. – by Brian Ellis
For more information:
Cooper CJ. LBCT.04. Therapeutic advances in coronary and peripheral vascular disease. Presented at: the American Heart Association Scientific Sessions; Nov. 16-20, 2013; Dallas.
Disclosure: Cooper reports receiving research grant support from AstraZeneca, Cordis and Pfizer. The study was sponsored by the NIH.