Roll-in experience from the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study

Abstract

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 = 161) did not show any clinical benefit over nonuse of such devices (n = 78) in this small series. At 9 months, there were significantly more endpoints reported by site in subjects with bilateral renal artery stenosis (P = .01) and prior history of stroke (P = .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.

Trial registration: ClinicalTrials.gov NCT00081731.

© 2013 Published by SIR on behalf of The Society of Interventional Radiology.

Figures

Figure 1

Plot of the change in GFR and baseline eGFR. Kidney function MDRD eGFR change score (from the baseline value to the short-term (2–4 week) value) is used as dependent variable. The largest cluster is centered around zero, and those at the lower end of the baseline eGFR range have less change than those with baseline eGFRs over 60 ml/min/1.73 m2.

Figure 2

Scatter plot of % stenosis as interpreted by the angiographic core laboratory on the x-axis and corresponding mean pressure gradients on the y-axis (r=0.21, p=0.06).