Coral trial - renal artery stenting

Importantly, urine albumin to creatinine ratio appears to different subjects that may benefit from stent intervention versus subjects that are unlikely to achieve any benefit. In addition, there was a trend toward increase benefit in subjects with greater percent stenosis.

Stenting was associated with a modest improvement in systolic blood pressure during follow-up In an editorial comment, John A. The trial results send a clear message to patients and referring physicians This trial was devised to try and solve some of the limitations and criticisms of the previous studies. The patients were randomized to medical therapy, or stenting with medical therapy, for a median of 43 months. The primary endpoint was a composite of death from cardiovascular or renal causes, stroke, myocardial infarction hospitalization for congestive heart failure, progressive loss of eGFR, or need for permanent dialysis.

Despite even more comprehensive clinical enrollment criteria, there was no difference in occurrence of the primary composite endpoint or any individual components. A correspondence in NEJM was published four months later that looked at patients with uncontrolled hypertension.

All three trials have been criticized for not including enough high-risk patients. Unfortunately, it would not be expected that revascularization would improve blood pressure or reverse renal disease in these individuals given the extent of their disease states and morbidity. Two subsequent randomized trials of stenting did not show a benefit with respect to kidney function. At the time of the CORAL trial, no studies had been designed specifically to assess clinical outcomes.

Given the prevalence of atherosclerotic renal-artery stenosis, this condition is an important public health issue. If stenting prevents the progression of chronic kidney disease and lowers blood pressure, it has the potential to prevent serious health consequences, including adverse cardiovascular and renal events.

In contrast, if stenting confers neither of these benefits, it is likely to incur substantial cost without a public health advantage. Therefore, CORAL researchers performed a randomized clinical trial to determine the effects of renal-artery stenting on the incidence of important cardiovascular and renal adverse events.

Individuals with severe renal-artery stenosis were eligible if they had hypertension with a systolic blood pressure of mm Hg or higher while receiving two or more antihypertensive medications. Severe renal-artery stenosis could be identified with the use of duplex ultrasonography, magnetic resonance angiography, or computed tomographic angiography.

A total of patients were screened, and were randomly assigned to stenting plus medical therapy subjects or medical therapy alone subjects. Subjects were randomly assigned in a ratio to either medical therapy alone or stenting plus medical therapy.