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

J Vasc Interv Radiol. 2014 Apr;25(4):511-20. doi: 10.1016/j.jvir.2013.09.018. Epub 2013 Dec 8.


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: NCT00081731.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon* / adverse effects
  • Angioplasty, Balloon* / instrumentation
  • Atherosclerosis / diagnosis
  • Atherosclerosis / physiopathology
  • Atherosclerosis / therapy*
  • Blood Pressure
  • Clinical Competence
  • Databases, Factual
  • Female
  • Glomerular Filtration Rate
  • Humans
  • Hypertension / diagnosis
  • Hypertension / physiopathology
  • Hypertension / therapy
  • Kidney / physiopathology
  • Male
  • Middle Aged
  • Outcome and Process Assessment, Health Care*
  • Patient Selection
  • Renal Artery Obstruction / diagnosis
  • Renal Artery Obstruction / physiopathology
  • Renal Artery Obstruction / therapy*
  • Renal Insufficiency, Chronic / diagnosis
  • Renal Insufficiency, Chronic / physiopathology
  • Renal Insufficiency, Chronic / therapy
  • Severity of Illness Index
  • Stents
  • Time Factors
  • Treatment Outcome

Associated data