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CORAL: Renal stenting fails to reduce clinical events vs. medical therapy
DALLAS — Among patients with atherosclerotic renal artery stenosis, renal stenting did not confer a benefit with regard to a reduction in clinical events as compared with multifactorial medical therapy, according to results of the CORAL trial.
There were also no significant reductions in the individual endpoints with renal stenting.
Christopher J. Cooper, MD, with the University of Toledo in Ohio, presented the data from CORAL and explained at a press conference that stenting was safe, resulting in limited peri-procedural clinical complications. He also added that renal stenting did result in a significant reduction of BP, although this did not translate into difference in clinical events.
In the study, Cooper and fellow investigators randomly assigned 947 patients (50% women; mean age, 69 years) with atherosclerotic renal artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal stenting or to medical therapy alone.
Patients presented with a mean systolic BP of 150 ± 23 mm Hg and mean glomerular filtration rate of 58 ± 22 mL/min. Inclusion criteria were an atherosclerotic renal stenosis of at least 60% and hypertension despite being on at least two antihypertensive medications and/or at least stage III chronic kidney disease.
Investigators examined the occurrence of adverse CV and renal events, the study’s primary endpoint, which was defined as a composite of death from CV or renal causes, MI, stroke, hospitalization for congestive HF, progressive renal insufficiency or the need for renal replacement therapy. The statistical plan of the study included a sample size that was selected to provide 90% power to test the hypothesis that stenting reduced the incidence of the primary endpoint by 25%, Cooper said.
During follow-up (median, 43 months), the rate of the primary composite endpoint was comparable between patients in both groups (renal stenting, 35.1% vs. medical therapy alone, 35.8%; HR=0.94; P=.58). Rates of the individual endpoints and all-cause mortality also did not significantly differ.
Cooper and colleagues did observe a modest reduction in systolic BP for stenting (–2.3 mm Hg; P=.03).
Safety data revealed one stroke in the medical therapy only population resulting in death on the day of randomization. No participant required dialysis within 30 days of randomization, Cooper said. Between 30 and 90 days of randomization, dialysis was initiated in only one patient in the stenting group. – by Brian Ellis
For more information:
Cooper CJ. LBCT.04. Therapeutic advances in coronary and peripheral vascular disease. Presented at: the American Heart Association Scientific Sessions; Nov. 16-20, 2013; Dallas.
Cooper CJ. N Engl J Med. 2013;doi:10.1056/nejmoa1310753.
Disclosure: Cooper reports receiving research grant support from AstraZeneca, Cordis and Pfizer. The study was sponsored by the NIH.
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The key takeaway is that fully effective medical therapy could now be delivered to every patient with hypertension, whether associated with renal artery stenosis or not. After all, there are 100s of studies that definitively demonstrate this benefit and reproducible efficacy in lowering CV risk. In contrast, the evidence base that metal stent implantation is required to achieve beneficial real world clinical outcomes for patients with high grade renal artery stenosis is utterly lacking.
It always amazes me how difficult it is to achieve rapid practice change. Utilizing high quality data, such as has been provided by the CORAL investigators, change should be easy. This benefit may not be achieved if the clearcut clinical practice implications are ignored or denigrated by a culture that often disrespects scientific evidence. This study could easily be championed by the public, primary care and renal medicine specialists, and wizened endovascular colleagues.
Patients often very much appreciate the life-saving benefits of drug therapy. This approach is "minimally invasive" and represents a healthcare miracle that definitively improves the outcomes that matter: rates of heart attack, stroke, progressive kidney disease and death. Yet, it is true that delivery of medications effectively to the affected public would require a health system that provides access to drugs, and a supportive healthcare environment within which long-term compliance can be maintained. But in the absence of any data that endovascular therapy is required or superior for nearly all of these patients, it would seem logical for healthcare payers, policymakers and others to create an environment where these medical interventions could be easily offered and sustained. The ecosystem of healthcare delivery in homes and communities could be as robust as what has traditionally been aggressively promoted in the catheterization lab. This merely requires us to read the evidence base and then apply what we know to be true. We must begin to deploy adequate resources to accomplish the health goals that are needed in our communities.
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The results are definitive and do not surprise me. There was no benefit to renal artery stenting in any outcome results. It showed that just because you can put in a stent doesn’t mean that you should.
The next chapter in renal-related therapy is denervation. The data look good so far, but we need other data to determine if it actually makes people better. BP is a surrogate; it is nowhere near as serious as a heart attack or a stroke. Eventually, what happens with those outcomes will determine what happens with that procedure.