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Off-label use, complex trials affect renal artery stenting
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Experts said there is not enough published data to guide physicians on whether stenting the renal artery makes a difference in the outcomes of patients with hypertension.
But is off-label use of available stents and complicated trial designs keeping new indications or new products from development?
“Off-label use of commercially available devices limits the incentives for physicians and patients to participate in current clinical trials,” David Buckles, PhD, deputy division chief of the Peripheral Vascular Devices Branch of the FDA, said. “Physicians can use a legally-marketed device off-label for a patient or can enroll patients in a clinical trial, but with all the overhead that comes with that, frequently in our experience the choice is made simply to use the off-label [device].”
Buckles and John Kaufman, MD, Frederick S. Keller Professor of Interventional Radiology and chief of vascular and interventional radiology at Oregon Health and Science University, Portland, provided perspectives on the hot topic at the recent Vascular Interventional Advances meeting held here.
Questions and few answers
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Source: Oregon Health and Science University |
There’s currently only one clinical trial – CORAL – testing the clinical outcomes of renal artery stenting. The CORAL study will compare medical therapy in combination with stenting of hemodynamically significant renal artery stenoses vs. medical therapy alone in patients with systolic hypertension and renal artery stenosis. The study is expected to be completed in 2010.
Buckles said there are two devices with premarket approval, but the data for those devices is from trials that started five to eight years ago and the clinical relevance collected by these clinical trials is limited. He said the FDA wants to see clinical trials happen that would result in a therapeutic indication and not just a functional indication (ie, patency of a renal artery) for treating hypertension.
“We do not have at present an approved device for primary or direct stenting,” Buckles said.
Buckles said he wants to know how physicians can identify patients that would clinically benefit from stenting, as well as those who would not. “What practical, doable, financially viable clinical trial model would leadto a therapeutic indication – not just a functional indication – for renal artery stenting as a treatment option?”
Everyone shares the blame
Kaufman said everyone – industry, physicians, patients, health insurers and regulatory agencies – is to blame for the lack of evidence in renal artery stenting.
Renal artery revascularization is essential, Kaufman said, and the area needs dedicated devices with experienced operators.
“Our obligation of course is to always treat our patients with the best care possible and to treat only symptomatic renal artery stenosis that has really failed, we feel, on maximum optimal medical therapy,” Kauffman said.
“We should really encourage trials to be done and to try to participate in these trials. Above all, keep an open and honest mind; as the data comes through, it is possible that renal artery stenting in the majority of patients … may not be that good, or it might be great. That data is still unresolved.” – by Judith Rusk
For more information:
- Buckles D., Kaufman J. Who is to blame for the precarious state of renal artery stenting? FDA perspective (Buckles) and Pphysician’s perspective (Kaufman). Presented: VIVA 2008; Sept. 22-26, 2008; Las Vegas.
It’s clear to me that both the FDA and Centers for Medicare and Medicaid Services are demanding better quality scientific data. If that does not come, I think CMS will revisit the noncoverge decision and restrict reimbursement for renal artery intervention, which may have disastrous consequences. Having said that, we have all dropped the ball on providing the high quality science needed. So my hope is that the next trials that are done prior to CORAL being finished will add important scientific end points that will allow us to make better decisions for our patients.
– Michael R. Jaff, DO
Cardiology Today Editorial Board Member