Clinical trial studies carotid stent

By LAURIE SMITH ANDERSON

When Cheryl Hartenstein suffered from a blocked artery on the left side of her neck earlier this year, her doctor refused to operate on her.

Despite the fact the blocked artery could have caused a stroke, she was at even greater risk of death or complications from major surgery because she also had heart disease, diabetes and high blood pressure.

The 66-year-old great-grandmother from Walker was referred to Dr. Albert D. Sam II of Vascular Surgery Associates, who recommended placement of a carotid stent in her neck instead.

The less-invasive procedure is now being investigated in a clinical trial funded by the National Institutes of Health to determine whether it is as effective as surgery. Sam currently has five patients enrolled in the trial and could enroll as many as 100.

"I knew I didn't want to have the operation again," said Hartenstein, who underwent surgery seven years ago when she suffered a blockage in the right side of her neck. "But, I was scared about getting the stent too. There was no comparison. My recovery from the stent was so much easier."

Carotid endarterectomy surgery has been in common use since the 1950s for treating blocked neck arteries. The procedure significantly lowers the chances of stroke in patients with serious blockages.

Carotid stenting (the less-invasive placement of a tube in the artery to restore blood flow) has been shown to be as effective as surgery so far, but remains an investigational procedure as equipment and techniques are improved, guidelines for patient selection are established, and long-term outcomes and risks become known.

CREST (the Carotid Revascularization Endarderectomy v. Stenting Trial) is investigating the efficacy of both procedures. The trial is randomized which means half of the patients will receive one procedure and half the other.

Eligibility requirements call for patients to be age 18 or older with a 50 percent or more carotid blockage and have experienced a nondisabling stroke or transient ischemic attack or loss of vision in the past six months.

Sam said he believes carotid stents will replace surgery as the gold standard of care for blocked neck arteries in the next five years, although there will always be some patients who will still need to undergo surgery.

Stenting involves inserting a long, thin catheter tube into an artery in the leg and threading the catheter through the vascular system into the narrowed carotid artery in the neck. Once the catheter is in place, the stent is inflated with a balloon on the tip of the catheter.

Carotid stenting is more expensive than traditional surgery at this time, although there are some potential advantages, primarily that it is easier on the patient before, during and after the procedure, he said.

Previous studies showed a lower incidence of stroke and death following carotid stenting, as well as a reduction in the incidence of major side effects. There is also reduced pain, reduced procedure time and anesthesia risk, and reduced scarring.

Hartenstein said she couldn't speak or swallow after her first surgery and spent six months in therapy to deal with that. After the stent placement; however, she went home the next day and suffered no such complications.

"I was so excited. I would recommend it (stenting) to anyone," she said. "It was awesome. I'll always be thankful that Dr. Sam took a chance on me -- even if he does look like Doogie Howser."

A boyish grin broke across Sam's face upon hearing his patient's remark. "I've been in practice here two years now and I still hear that. I'm not as young as I look."

Originally from New Orleans, Sam went to Duke University Medical School and Northwestern University Feinberg School of Medicine, where he did research in vascular surgery. He was considering academic medicine when Vascular Surgery Associates here enticed him to practice and continue his research by participating in clinical trials.

"We're committed" to doing clinical trials, he said. "They are good for us because we can improve our skills as physicians and help advance the practice of medicine and they're good for our patients as well." Sam also teaches surgical residents at LSU's School of Medicine, and his office is involved in several other national clinical trials.

For more information about the CREST trial, visit the NIH Web site at http://www.nih.gov or the Vascular Surgery Associates Web site at http://www.brvsa.com.

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