Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension: Rationale and design of the CORAL trial

Christopher J. Cooper, Timothy P. Murphy, Alan Matsumoto, Michael Steffes, David J. Cohen, Michael Jaff, Richard Kuntz, Kenneth Jamerson, Diane Reid, Kenneth Rosenfield, John Rundback, Ralph D. Agostino, William L Henrich, Lance Dworkin

Research output: Contribution to journalArticle

261 Citations (Scopus)

Abstract

Background: Atherosclerotic renal artery stenosis is a problem with no consensus on diagnosis or therapy. The consequences of renal ischemia are neuroendocrine activation, hypertension, and renal insufficiency that can potentially result in acceleration of atherosclerosis, further renal dysfunction, myocardial infarction, heart failure, stroke, and death. Whether revascularization improves clinical outcomes when compared with optimum medical therapy is unknown. Methods: CORAL is a randomized clinical trial contrasting optimum medical therapy alone to stenting with optimum medical therapy on a composite cardiovascular and renal end point: cardiovascular or renal death, myocardial infarction, hospitalization for congestive heart failure, stroke, doubling of serum creatinine, and need for renal replacement therapy. The secondary end points evaluate the effectiveness of revascularization in important subgroups of patients and with respect to all-cause mortality, kidney function, renal artery patency, microvascular renal function, and blood pressure control. We will also correlate stenosis severity with longitudinal renal function and determine the value of stenting from the perspectives of quality of life and cost-effectiveness. The primary entry criteria are (1) an atherosclerotic renal stenosis of ≥60% with a 20 mm Hg systolic pressure gradient or ≥80% with no gradient necessary and (2) systolic hypertension of ≥155 mm Hg on ≥2 antihypertensive medications. Randomization will occur in 1080 subjects. The study has 90% power to detect a 28% reduction in primary end point hazard rate. Conclusions: CORAL represents a unique opportunity to determine the incremental value of stent revascularization, in addition to optimal medical therapy, for the treatment of atherosclerotic renal artery stenosis.

Original languageEnglish (US)
Pages (from-to)59-66
Number of pages8
JournalAmerican Heart Journal
Volume152
Issue number1
DOIs
StatePublished - Jul 2006
Externally publishedYes

Fingerprint

Renal Artery Obstruction
Stents
Hypertension
Kidney
Pathologic Constriction
Therapeutics
Heart Failure
Stroke
Myocardial Infarction
Blood Pressure
Renal Replacement Therapy
Renal Artery
Random Allocation
Antihypertensive Agents
Cost-Benefit Analysis
Renal Insufficiency
Creatinine
Atherosclerosis
Hospitalization
Ischemia

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension : Rationale and design of the CORAL trial. / Cooper, Christopher J.; Murphy, Timothy P.; Matsumoto, Alan; Steffes, Michael; Cohen, David J.; Jaff, Michael; Kuntz, Richard; Jamerson, Kenneth; Reid, Diane; Rosenfield, Kenneth; Rundback, John; Agostino, Ralph D.; Henrich, William L; Dworkin, Lance.

In: American Heart Journal, Vol. 152, No. 1, 07.2006, p. 59-66.

Research output: Contribution to journalArticle

Cooper, CJ, Murphy, TP, Matsumoto, A, Steffes, M, Cohen, DJ, Jaff, M, Kuntz, R, Jamerson, K, Reid, D, Rosenfield, K, Rundback, J, Agostino, RD, Henrich, WL & Dworkin, L 2006, 'Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension: Rationale and design of the CORAL trial', American Heart Journal, vol. 152, no. 1, pp. 59-66. https://doi.org/10.1016/j.ahj.2005.09.011
Cooper, Christopher J. ; Murphy, Timothy P. ; Matsumoto, Alan ; Steffes, Michael ; Cohen, David J. ; Jaff, Michael ; Kuntz, Richard ; Jamerson, Kenneth ; Reid, Diane ; Rosenfield, Kenneth ; Rundback, John ; Agostino, Ralph D. ; Henrich, William L ; Dworkin, Lance. / Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension : Rationale and design of the CORAL trial. In: American Heart Journal. 2006 ; Vol. 152, No. 1. pp. 59-66.
@article{8df10bcb2cee4a7c91557205e675fdf5,
title = "Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension: Rationale and design of the CORAL trial",
abstract = "Background: Atherosclerotic renal artery stenosis is a problem with no consensus on diagnosis or therapy. The consequences of renal ischemia are neuroendocrine activation, hypertension, and renal insufficiency that can potentially result in acceleration of atherosclerosis, further renal dysfunction, myocardial infarction, heart failure, stroke, and death. Whether revascularization improves clinical outcomes when compared with optimum medical therapy is unknown. Methods: CORAL is a randomized clinical trial contrasting optimum medical therapy alone to stenting with optimum medical therapy on a composite cardiovascular and renal end point: cardiovascular or renal death, myocardial infarction, hospitalization for congestive heart failure, stroke, doubling of serum creatinine, and need for renal replacement therapy. The secondary end points evaluate the effectiveness of revascularization in important subgroups of patients and with respect to all-cause mortality, kidney function, renal artery patency, microvascular renal function, and blood pressure control. We will also correlate stenosis severity with longitudinal renal function and determine the value of stenting from the perspectives of quality of life and cost-effectiveness. The primary entry criteria are (1) an atherosclerotic renal stenosis of ≥60{\%} with a 20 mm Hg systolic pressure gradient or ≥80{\%} with no gradient necessary and (2) systolic hypertension of ≥155 mm Hg on ≥2 antihypertensive medications. Randomization will occur in 1080 subjects. The study has 90{\%} power to detect a 28{\%} reduction in primary end point hazard rate. Conclusions: CORAL represents a unique opportunity to determine the incremental value of stent revascularization, in addition to optimal medical therapy, for the treatment of atherosclerotic renal artery stenosis.",
author = "Cooper, {Christopher J.} and Murphy, {Timothy P.} and Alan Matsumoto and Michael Steffes and Cohen, {David J.} and Michael Jaff and Richard Kuntz and Kenneth Jamerson and Diane Reid and Kenneth Rosenfield and John Rundback and Agostino, {Ralph D.} and Henrich, {William L} and Lance Dworkin",
year = "2006",
month = "7",
doi = "10.1016/j.ahj.2005.09.011",
language = "English (US)",
volume = "152",
pages = "59--66",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "1",

}

TY - JOUR

T1 - Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension

T2 - Rationale and design of the CORAL trial

AU - Cooper, Christopher J.

AU - Murphy, Timothy P.

AU - Matsumoto, Alan

AU - Steffes, Michael

AU - Cohen, David J.

AU - Jaff, Michael

AU - Kuntz, Richard

AU - Jamerson, Kenneth

AU - Reid, Diane

AU - Rosenfield, Kenneth

AU - Rundback, John

AU - Agostino, Ralph D.

AU - Henrich, William L

AU - Dworkin, Lance

PY - 2006/7

Y1 - 2006/7

N2 - Background: Atherosclerotic renal artery stenosis is a problem with no consensus on diagnosis or therapy. The consequences of renal ischemia are neuroendocrine activation, hypertension, and renal insufficiency that can potentially result in acceleration of atherosclerosis, further renal dysfunction, myocardial infarction, heart failure, stroke, and death. Whether revascularization improves clinical outcomes when compared with optimum medical therapy is unknown. Methods: CORAL is a randomized clinical trial contrasting optimum medical therapy alone to stenting with optimum medical therapy on a composite cardiovascular and renal end point: cardiovascular or renal death, myocardial infarction, hospitalization for congestive heart failure, stroke, doubling of serum creatinine, and need for renal replacement therapy. The secondary end points evaluate the effectiveness of revascularization in important subgroups of patients and with respect to all-cause mortality, kidney function, renal artery patency, microvascular renal function, and blood pressure control. We will also correlate stenosis severity with longitudinal renal function and determine the value of stenting from the perspectives of quality of life and cost-effectiveness. The primary entry criteria are (1) an atherosclerotic renal stenosis of ≥60% with a 20 mm Hg systolic pressure gradient or ≥80% with no gradient necessary and (2) systolic hypertension of ≥155 mm Hg on ≥2 antihypertensive medications. Randomization will occur in 1080 subjects. The study has 90% power to detect a 28% reduction in primary end point hazard rate. Conclusions: CORAL represents a unique opportunity to determine the incremental value of stent revascularization, in addition to optimal medical therapy, for the treatment of atherosclerotic renal artery stenosis.

AB - Background: Atherosclerotic renal artery stenosis is a problem with no consensus on diagnosis or therapy. The consequences of renal ischemia are neuroendocrine activation, hypertension, and renal insufficiency that can potentially result in acceleration of atherosclerosis, further renal dysfunction, myocardial infarction, heart failure, stroke, and death. Whether revascularization improves clinical outcomes when compared with optimum medical therapy is unknown. Methods: CORAL is a randomized clinical trial contrasting optimum medical therapy alone to stenting with optimum medical therapy on a composite cardiovascular and renal end point: cardiovascular or renal death, myocardial infarction, hospitalization for congestive heart failure, stroke, doubling of serum creatinine, and need for renal replacement therapy. The secondary end points evaluate the effectiveness of revascularization in important subgroups of patients and with respect to all-cause mortality, kidney function, renal artery patency, microvascular renal function, and blood pressure control. We will also correlate stenosis severity with longitudinal renal function and determine the value of stenting from the perspectives of quality of life and cost-effectiveness. The primary entry criteria are (1) an atherosclerotic renal stenosis of ≥60% with a 20 mm Hg systolic pressure gradient or ≥80% with no gradient necessary and (2) systolic hypertension of ≥155 mm Hg on ≥2 antihypertensive medications. Randomization will occur in 1080 subjects. The study has 90% power to detect a 28% reduction in primary end point hazard rate. Conclusions: CORAL represents a unique opportunity to determine the incremental value of stent revascularization, in addition to optimal medical therapy, for the treatment of atherosclerotic renal artery stenosis.

UR - http://www.scopus.com/inward/record.url?scp=33745659870&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33745659870&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2005.09.011

DO - 10.1016/j.ahj.2005.09.011

M3 - Article

C2 - 16824832

AN - SCOPUS:33745659870

VL - 152

SP - 59

EP - 66

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 1

ER -