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Renovascular hypertension 2014: what have we learned from CORAL?

Journal of Human Hypertension volume 29, pages 141–142 (2015)Cite this article

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The Cardiovascular Outcomes of Renal Atherosclerotic Lesions (CORAL) trial was funded by the NHLBI to define the management of renovascular disease (RVD)1 during a time when angiographic imaging and stenting for RVD were rising exponentially.2 Much of the expanded use of these procedures was based on classical views favoring improved blood pressure control for renovascular hypertension, lowering cardiovascular risk and improving endovascular technical results.3 CORAL sought to establish what renal revascularization adds to current optimal medical therapy utilizing ‘hard’ end points based on cardiovascular or renal death, stroke, myocardial infarction, hospitalization for congestive heart failure, progressive renal insufficiency or the need for renal replacement therapy. Outcomes of CORAL were uniformly negative in that none of these end points differed between treatment arms. Combined with earlier results from ASTRAL and STAR,4 one might understandably conclude that renal revascularization should be abandoned.

Our center (Mayo Clinic) was a participant in CORAL and was listed as one of the top three enrolling sites. A stated goal was to require precisely defined vascular occlusion in candidates with atherosclerotic RVD using trans-lesional gradients and core laboratory confirmation of vessel measurements. Each site was required to have an experienced interventionalist with demonstrated skill and compliance with protocol requirements and a separate clinician dedicated to ongoing medical management of hypertension and cardiovascular risk (that is, lipids, blood pressure, glucose, smoking, and so on). Initially, each site was required to demonstrate adequate experience using an embolic protection device (Angiogard, Cordis Corporation, Bridgewater, NJ, USA) that was later discontinued. The preparation and requirements for this study were arduous and controversial. Many active vascular intervention centers declined to participate. In the final tally, patients were entered from more than 100 sites, with nearly as many sites having either been disqualified or withdrawn. Regrettably, limited patient recruitment eventually undermined this trial, leading to relaxed eligibility criteria and modified protocols.

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Acknowledgements

Grant support was provided by NHLBI, NIDDK and Stealth Peptides.

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  1. Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, USA

    S C Textor

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Correspondence to S C Textor.

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Textor, S. Renovascular hypertension 2014: what have we learned from CORAL?. J Hum Hypertens 29, 141–142 (2015). https://doi.org/10.1038/jhh.2014.51

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