CORAL study on renal artery stenting

CORAL study on renal artery stenting

In the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study, 947 patients who had atherosclerotic renal artery stenosis and either systolic hypertension while taking two or more antihypertensive medications or chronic kidney disease were evaluated. It was a multi-center, open-label, randomized, controlled trial. Patients were randomized to either medical therapy plus renal artery stenting or medical therapy alone [1].

Previous randomized trials on renal angioplasty had failed to show significant benefit in control of blood pressure [2,3]. Another two randomized trials checking the effect of renal artery stenting in atherosclerotic renal artery stenosis did not show any benefit with respect to kidney function [4.5].

Adverse cardiovascular and renal events were checked in the CORAL study. Composite end point was death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency or need for renal replacement therapy. Median follow up period in the trial was 43 months [1]. There were no significant differences in all cause mortality or the individual components of the primary composite endpoint between the study and control groups. There was a modest decrease of systolic blood pressure in the stenting group (mean 2.3 mm Hg). Final data reported was from 931 participants, after excluding one center due to quality issues.

Authors were considering whether the medical therapy given to CORAL participants can be replicated in clinical practice to reap similar benefits. The medical therapy in the study included angiotensin receptor blocker with or without a thiazide diuretic and amlodipine for control of blood pressure. The patients received antiplatelet agents and atorvastatin also [1]. The trial had enrolled patients with renal artery stenosis of 60% or more. Though this might be considered as a limitation, there was no benefit among the participants with more than 80% stenosis either. Another potential issue was the 210 patients excluded by the physicians. It is likely that physicians felt that they may benefit from stenting due to the severity of the disease.

CORAL study complements the findings of ASTRAL [4] and STAR [5] trials, which did not find a benefit on kidney function from renal artery stenting in atherosclerotic renal artery stenosis.

References

1. Cooper CJ, Murphy TP, Cutlip DE, Jamerson K, Henrich W, Reid DM, Cohen DJ, Matsumoto AH, Steffes M, Jaff MR, Prince MR, Lewis EF, Tuttle KR, Shapiro JI, Rundback JH, Massaro JM, D’Agostino RB Sr, Dworkin LD; CORAL Investigators. Stenting and medical therapy for atherosclerotic renal-artery stenosis. N Engl J Med. 2014 Jan 2;370(1):13-22.
2. van Jaarsveld BC, Krijnen P, Pieterman H, Derkx FH, Deinum J, Postma CT, Dees A, Woittiez AJ, Bartelink AK, Man in ‘t Veld AJ, Schalekamp MA. The effect of balloon angioplasty on hypertension in atherosclerotic renal-artery stenosis. Dutch Renal Artery Stenosis Intervention Cooperative Study Group. N Engl J Med. 2000 Apr 6;342(14):1007-14.
3. Plouin PF, Chatellier G, Darné B, Raynaud A. Blood pressure outcome of angioplasty in atherosclerotic renal artery stenosis: a randomized trial. Essai Multicentrique Medicaments vs Angioplastie (EMMA) Study Group. Hypertension. 1998 Mar;31(3):823-9.
4. ASTRAL Investigators, Wheatley K, Ives N, Gray R, Kalra PA, Moss JG, Baigent C, Carr S, Chalmers N, Eadington D, Hamilton G, Lipkin G, Nicholson A, Scoble J. Revascularization versus medical therapy for renal-artery stenosis. N Engl J Med. 2009 Nov 12;361(20):1953-62.
5. Bax L, Woittiez AJ, Kouwenberg HJ, Mali WP, Buskens E, Beek FJ, Braam B, Huysmans FT, Schultze Kool LJ, Rutten MJ, Doorenbos CJ, Aarts JC, Rabelink TJ, Plouin PF, Raynaud A, van Montfrans GA, Reekers JA, van den Meiracker AH, Pattynama PM, van de Ven PJ, Vroegindeweij D, Kroon AA, de Haan MW, Postma CT, Beutler JJ. Stent placement in patients with atherosclerotic renal artery stenosis and impaired renal function: a randomized trial. Ann Intern Med. 2009 Jun 16;150(12):840-8, W150-1.