Original title: Stenting and Medical Therapy for Atherosclerotic Renal-Artery Stenosis. CORAL trial. Reference: Christopher J. Cooper et al. DOI: 10.1056/NEJMoa1310753
Between 1 and 5% of the hypertensive population has renal artery stenosis and in general, this is combined with peripheral and coronary vascular disease. The renal artery stenosis may result in hypertension, ischemic nephropathy, and multiple long-term complications.
The CORAL study (The Cardiovascular Outcomes in Renal Atherosclerotic Lesions ) was a multicenter, randomized, open, controlled trial comparing medical therapy alone versus medical therapy plus renal angioplasty. Patients with renal artery injury plus experiencing hypertension with a systolic of 155 mm Hg or more despite receiving at least 2 drugs were eligible. Injury greater than 80% and less than 100% or between 60% and 80 % when associated with a gradient of at least 20 mmHg was defined as severe. Patients with fibromuscular dysplasia, renal insufficiency of other causes than the ischemic, level greater than 4 mg / dl , kidney smaller than 7 cm or injury requiring more than one stent, were excluded.
The primary end point of the study was a composite of major cardiovascular and renal events (death from cardiovascular or renal disease, stroke, myocardial infarction, hospitalization for heart failure, progression of renal failure or need for dialysis). Between 2005 and 2010, 5322 patients of whom 947 were randomized (467 patients in the renal angioplasty branch plus medical treatment and 480 patients in the medical treatment branch only). The baseline characteristics of both groups were well balanced and the average follow-up was 43 months (range 31-55). No significant differences in the rate of the primary end point among patients who received angioplasty and those who received only medical treatment were observed (35.1 % versus 35.8 % , HR 0.94 , 95% CI 0.76 to 1.17 , P = 0.58 ). Considering separately the components of the primary end point, no significant differences were observed as in mortality from any cause. While the systolic pressure decreased in both groups compared to baseline, this decrease was higher in the angioplasty group (-2.3 mmHg, 95% CI -4.4 to -0.2 mmHg, P = 0.03).
Conclusion:
Renal angioplasty does not provide a significant benefit in terms of clinical events compared with medical treatment alone in patients with atherosclerotic stenosis of the renal artery, associated with hypertension or renal failure.
Editorial comment:
A striking difference catches our attention between the numbers of patients who were eligible and those who were finally randomized. The main reason was that the treating physician opined that it was not proper to perform medical treatment only for his patient. This situation probably does not allow participating in the study those patients who will benefit more from the process (mainly those with more severe injuries). Despite the above, in the analysis performed considering only patients with injury greater than 80%, no significant differences were observed.
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