The highly anticipated results from the CORAL clinical trial wasn’t great news for renal stents, as researchers reported that renal-artery stenting offered "no benefits" over drugs alone in treating patients with atherosclerotic renal-artery stenosis and elevated blood pressure, chronic kidney disease, or both.
Renal stenting is becoming ever less common in practice but CORAL trial investigators pointed to their results as clear evidence that the devices need to take a back seat to drug therapy.
"I don’t think that anybody should consider renal stenting as a 1st-line treatment for patients with hypertension and renal artery stenosis, I think that’s what CORAL tells us," investigator Dr. Michael Jaff, chair of Massachusetts General Hospital Institute for Heart, Vascular & Stroke Care, told MassDevice.com today. "And that’s where the conclusions should literally stop, because CORAL does not look at what happens to patients who fail medical therapy; it doesn’t look at patients who have much more severe kidney disease, much worse heart failure, things like that."
And that’s the way many doctors are practicing already, thanks to a couple of smaller, less robust studies published in 2009. The new results are less overhaul and more validation, Jaff said. Those sentiments were reiterated by Dr. John Bittl, who wrote an editorial accompanying the CORAL publication.
"Renal-artery stenting is futile for the target population enrolled in the study," Bittl wrote. "The trial results send a clear message to patients and referring physicians. Until new treatments are found to be safe and effective, patients in everyday practice who have moderately severe atherosclerotic renovascular disease and either hypertension or stage 3 chronic kidney disease should receive medical therapy to control blood pressure and prevent the progression of atherosclerosis but should not be corralled into getting a renal-artery stent."
There’s still a place for renal stenting in fighting renal artery disease, Jaff noted, but primarily as a back-up plan and not a 1st choice.
"It’s not the end of renal stenting, it’s an appropriate use of renal stenting," Jaff told us.
Previous smaller studies had come to a similar conclusion, but CORAL trial included nearly 950 participants and more rigorous methodology designed to suss out the outcomes associated with treatment with and without renal stenting.
"We found no benefit of stenting with respect to the rate of the composite primary end point or any of its individual components, including death from cardiovascular or renal causes, stroke, myocardial infarction, congestive heart failure, progressive renal insufficiency, and the need for renal-replacement therapy," the authors wrote in a study published today in the New England Journal of Medicine. "It is clear that medical therapy without stenting is the preferred management strategy for the majority of people with atherosclerotic renal-artery stenosis."
The devices did spur a modest 2.3 mmHG drop in blood pressure, they researchers added, but that didn’t translate into any clinical benefits during the course of the study.
Patients in the CORAL study were randomized to treatment with drugs alone or treatment with renal stenting in addition to drug therapy. The stenting arm received a Palmaz Genesis stent, manufactured by Cordis Corp., the stent-making arm of Johnson & Johnson(NYSE:JNJ), according to the published study. The participants were followed for 43 months, with researchers reporting a 35.1% rate of cardiovascular and renal events in the stent group compared with 35.8% in the non-stented group.