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Local Research Study Gets National Attention



A study conducted at Central Baptist Hospital (now Baptist Health Lexington) more than 15 years ago to determine the best therapy for patients with carotid artery disease is still getting attention, much of it on a national scale.

The original study was conducted beginning in 1998 by neurosurgeon Dr. William H. Brooks, interventional cardiologist Dr. Rick R. McClure, interventional cardiologist Dr. Michael R. Jones, neurologist Dr. Timothy C. Coleman and clinical research nurse, Linda Breathitt. The study sought to compare two treatments for a common cause of stroke called carotid stenosis. Carotid stenosis occurs when there is an accumulation of a fatty substance called ‘plaque’ in the large arteries that supply blood to the brain. This causes narrowing of those arteries and increases the risk for stroke.

The longstanding treatment for significant carotid stenosis has been to perform a surgery called carotid endarterectomy in which the artery is opened and the plaque is stripped from the vessel. The alternative treatment, carotid stenting, offers patients a minimally invasive alternative to major surgery which can be performed in a similar manner to stents for the heart. Physicians go through the groin with a catheter, which is threaded to the area affected by stenosis. A balloon is inflated to open the vessel, and a stent is placed there which holds the vessel open permanently.

The original study’s results were published in 2001 in the prestigious journals, Journal of the American College of Cardiology (JACC) and Neurosurgery. The study showed that carotid stenting was equally effective as carotid endarterectomy in reducing carotid stenosis without an increased risk for major complications of stroke and death. Over the years, this study has been referred to in scientific circles as “The Kentucky Study.”

In February 2014, JACC Cardiovascular Interventions published the 10-year follow-up results of the Kentucky study. Patients were followed for 10 years after receiving either the stent or the surgery and watched for both fatal and non-fatal stroke and myocardial infarction (heart attack) incidence.

The follow-up showed that there was no difference in the incidence of stroke regardless of which procedure the patient had. Thus, even at 10 years out, stenting was equally effective to surgery. Interestingly though, patients who had the surgery did have a 2.3 times higher risk of fatal and non-fatal heart attack. It is not clear why, but may be related to cardiac damage precipitated by the surgical procedure itself.

Both the original study and its follow-up results caught the eye of elite physicians who are editors for the aforementioned JACC medical journal. In a 2001 JACC editorial, Dr. Christopher J. White, chairman of the department of cardiology at Ochsner Clinic and Foundation in New Orleans, lauded the original study as “the largest randomized carotid artery stent versus carotid endarterectomy trial published to date.“ He went on to describe the study as “an excellent example of team building with a surgeon, a cardiologist and a neurologist working together to optimize patient care.”

In an editorial in the February 2014 JACC Cardiovascular Interventions issue, Dr. Robert D. Safian with Beaumont Health System in Royal Oak, Michigan, suggested that – based on the Kentucky trial’s follow-up report – all carotid trials may need to be extended to 5 to 10 years of follow-up.

This type of research is often thought of as occurring only in academic medical centers. It is unusual for a non-academic community hospital such as Baptist Health Lexington to conduct the caliber of cardiovascular and neurological research that it does, but because heart disease and stroke are so prevalent in Central and Eastern Kentucky, the hospital and many of physicians practicing there have devoted themselves for more than 20 years to serious, original research and participation in clinical trials.

“This study really opens a door that everybody else is going to have to look into because the data is good, and it’s the first data on this subject that’s this long-term,” said Dr. Michael R. Jones, one of the principal investigators in both studies.

“I also think this type of national attention shines a spotlight on the superior neurological and cardiovascular services that are available at Baptist Health Lexington, a community hospital that isn’t tied to an academic institution,” Jones said. “None of us are university professors. We’re just physicians who are committed to seeking better treatments not only for our patients, but for patients everywhere who may ultimately benefit from this research.”

 

Click on Clinical Research Center to learn more about research studies at Baptist Health Lexington.