Cardiovascular Diseases Clinical Trial
Official title:
Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)
This study will compare medical therapy plus stenting of hemodynamically significant renal artery stenoses versus medical therapy alone in patients with systolic hypertension and renal artery stenosis.
BACKGROUND:
Atherosclerotic renal artery stenosis is a common problem for which there is no clear
consensus on diagnosis or therapy. There likely exists a progression in which renal ischemia
leads to neuroendocrine activation, hypertension, and renal insufficiency resulting in
acceleration of atherosclerosis, further renal dysfunction, and development of left
ventricular hypertrophy. These events in turn lead to adverse clinical events.
Renal artery stenosis is one of the two major known causes of hypertension and occurs in
1-5% of hypertensive patients. In patients with accelerated hypertension, the prevalence of
renal artery stenosis is much higher, ranging from 10-40%. Renal artery stenosis, when
occurring bilaterally, or in a solitary kidney, is a significant cause for end-stage renal
disease, accounting for several percent of patients with end-stage renal disease.
Clinically, atherosclerotic renal artery stenosis is a major problem primarily in older
patients, and is often seen in long-standing hypertensives whose blood pressure becomes very
difficult to control. Of major significance is the progressive nature of atherosclerotic
renal artery stenosis, progressing at the rate of about 10% per year (45-60% progression
rate in 4-7 year follow-ups). Over this time period, 10-15% of patients develop total renal
artery occlusion. If the renal artery stenosis is greater than 75% when detected, 40% of
patients develop total occlusion. Due to the progressive nature of atherosclerotic lesions,
the decline in renal function in some individuals, and difficult-to-control hypertension,
the medical community has sought to detect those patients in whom intervention would be
beneficial. This has been extremely difficult to achieve and tests to date have not been
uniformly predictive, including peripheral vein plasma renin activity, renal vein renin
activity, captopril-stimulated nuclear medicine renal scans, etc.
Since approximately 50% of patients with unilateral renal artery stenosis of significant
degree (definitions vary) benefit from surgical intervention, enthusiasm has continued with
the advent of renal artery angioplasty. The entire field is moving very quickly. However,
there are neither current data nor prospective studies indicating the benefit of renal
artery angioplasty plus stents. Studies over the last decade have shown that balloon
angioplasty alone is associated with a high rate of recurrence in patients with
atherosclerotic renal artery stenosis. In the present climate, there is great enthusiasm to
perform angioplasty plus stent placement in atherosclerotic renal artery stenosis, without
supporting data for efficacy compared to medical management alone. Angioplasty and stent
placement in the renal arteries had been the domain of interventional radiologists, but
recently, interventional cardiologists are also performing these procedures. The questions
as to who will benefit from intervention and which intervention to use have not been
answered. Renal artery angioplasty and stent placement subjects the patient to procedural
risks, as well as increased cost, when compared to aggressive antihypertensive medication
and risk factor medication and therapy.
DESIGN NARRATIVE:
This randomized, multicenter clinical trial will contrast the effect of optimal medical
therapy alone to stenting with optimal medical therapy, on a composite of cardiovascular and
renal endpoints: cardiovascular or renal death, myocardial infarction, hospitalization for
congestive heart failure, stroke, doubling of serum creatinine level, and need for renal
replacement therapy. These endpoints will be evaluated by a clinical events committee masked
to treatment assignment. The secondary endpoints will 1) evaluate the mechanisms linked to
clinical events; 2) describe differential effectiveness in critical end-organs; 3) determine
the value of stenting from the patient and the health policy perspectives, measured as
quality of life and cost-effectiveness; and 4) evaluate for clinically relevant differences
in treatment effectiveness within the primary endpoint.
Patients will undergo a baseline evaluation to determine eligibility. Approximately 1,080
patients will be randomized to optimal medical therapy alone or to stenting with optimal
medical therapy at an estimated 100 clinical sites. Initially, patients will be followed at
2-week intervals, until blood pressure is at target or up to 2 months. Follow-up visits will
be mandated at 2 weeks, every 3 months for the first year and annually thereafter.
Coordinator visits will also occur semi-annually.
The CORAL Study Chair is Lance Dworkin, MD, Brown University, Providence, RI. The CORAL
Study Co-Chair is William Henrich, MD, University of Texas, San Antonio, TX. The Principal
Investigators of the CORAL Clinical Coordinating Center are Christopher Cooper, MD,
University of Toledo Health Science Campus, Toledo OH, and Timothy Murphy, MD, Brown
University, Providence, RI.
The Principal Investigator of the Angiographic Core Laboratory is Alan Matsumoto, MD,
University of Virginia, Charlottesville, VA. The Principal Investigator of the GFR and
Biochemistry Core Laboratory is Michael Steffes, MD, University of Minnesota, Minneapolis,
MN. The Principal Investigator of the Economics and Quality of Life Core Laboratory is David
Cohen, MD, Mid-America Heart Institute, St. Luke's Hospital, Kansas City, MO. The Principal
Investigator of the Data Coordinating Center is Donald Cutlip, MD, Beth Israel Deaconess
Medical Center, Boston, MA. For additional information about the CORAL trial, please refer
to the CORAL website (link given below).
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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