Roll-in Experience from the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) Study

Purpose: To describe the experience and results from the roll-in phase of the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study. Materials and Methods: The CORAL roll-in database was used to describe the baseline characteristics of the patients in the roll-in cohort, all of whom underwent renal artery stent placement; to evaluate CORAL site performance; to compare estimates of lesion (stenosis) severity made by site interventionalists with the central CORAL angiographic core laboratory readings; and to report outcomes after renal artery stent placement. During the roll-in phase, 239 patients (mean age, 70.2 y _ 9.0; 49% male) underwent renal artery stent procedures. Angiographic core laboratory analysis of renal arteriograms was done, and participants were followed at 1 month and 9 months. Results: Major angiographic complications were identified in 28 (13%) subjects. Kidney function remained unchanged at the short (2–4 weeks) follow-up interval. Improvement in systolic blood pressure with use of distal embolic protection devices (n ¼161) did not show any clinical benefit over nonuse of such devices (n ¼ 78) in this small series. At 9 months, there were significantly more endpoints reported by site in subjects with bilateral renal artery stenosis (P ¼ .01) and prior history of stroke (P ¼ .03). Conclusions: In the roll-in phase of the CORAL study, a significant number of angiographic complications were identified. No effect was seen on estimated glomerular filtration rate after renal artery stent placement, but systolic blood pressure decreased significantly