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Published on June 04, 2002

Press Release

Trials May Help Hearts

Hospital takes part in artery study

By Sara Michael, Journal staff writer

The 78-year-old woman moved her leg slightly under the blue sheet, as the doctor meticulously directed a tiny tube to the blocked artery in her heart.

In the dim room, the surgeon watched the monitors magnifying her arteries, while he guided the tube to the clog.

"Hang in there, we're doing good stuff here," Dr. Mark Turco told his patient.

What they are doing at Washington Adventist Hospital in Takoma Park is work that could solve a common problem for patients who have their arteries cleared: reblockage.

Turco and his small team of nurses and technicians performed an angioplasty Wednesday to unblock a clogged artery.

After clearing the artery of tissue, the surgeon inserted a stent, much like a miniature mesh tube, to hold the artery open.

Stents are commonly used in angioplasty. But at Washington Adventist, 40 patients are being given stents as part of a study.

Half will be given stents coated with a cancer-fighting drug, which doctors hope will ward off reblockage. The others will receive uncoated stents - and doctors then will compare the results.

"What we think will happen is the reblockage rates will be significantly lower than in the non-drug-coated stent group," said Turco, who is the director of the Center for Cardiac and Vascular Research at the hospital.

After stent procedures, arteries can reclog by 15 percent to 40 percent. The clinical trial at Adventist, part of a national study, aims to cut down on regrowth, which leads to repeat procedures, and eventually bypass surgery.

Frances Miller, 76, had about a 70 percent blockage in an artery when he joined the trial and had the surgery. While he and his doctor do not know whether the stent he received was drug-coated, he said he was willing to take a chance.

"Before I retired, I was a scientist, so it was an opportunity to help advance a program and help some people," Miller said. "If the coated stent works, it may prevent [blockage]."

He said the hourlong procedure early last month was painless, and he stayed in the hospital for one night.

In the noninvasive procedure, a doctor feeds a 3 millimeter-wide catheter into the artery through a small incision in the groin area. A thin wire is guided through the catheter to the blocked area, where a balloon - covered by the tiny cylindrical stent - is inflated to hold open the artery.

The stent expands in place, and when the balloon is deflated, the stent stays as a permanent bridge.

Time will tell whether the procedure will benefit him, Miller said.

"I think I am still experiencing some shortness of breath that led to the procedure in the first place," said Miller, who lives in Leisure World in Silver Spring. "That may or may not be related [to the surgery]."

Forty patients have been enrolled in the trial at Washington Adventist, one of 80 centers in the United States participating in the clinical trial. About 2,000 people undergo the angioplasty procedure at the hospital each year, and 80 percent to 90 percent of those receive a stent, Turco said.

The 40 patients who will participate in the drug-coated-stent trial are being drawn from a pool of patients with more than 50 percent artery blockage, documented chest pain and an abnormal exercise stress test.

After about nine months, the patients will return, and Turco will re-examine the artery to see if the stent worked.

In this trial, the stent is coated with Taxol, a drug used to treat breast cancer. When diluted and delivered locally, the drug should have few or no side effects, Turco said, and serve to stunt the growth of tissue around the stent.

A prior trial, not at Adventist, involving 400 patients and a similar drug, found that after nine months, a reblockage occured in only 2 percent of the cases, Turco said.

"This gives a little more validation to this drug," Turco said.

But the American Heart Association is less optimistic about the procedure.

According to spokeswoman Sabriya Ellis, the association's researchers released a report last month concluding that while the procedure delivered positive results for six months, after a year, the drug-coated stent wasn't holding up.

In a trial using a drug that blocks cancer cell growth, 13 percent of the patients experienced reblockage after six months, and after one year, more than half the patients had reblockage - and one patient had another heart attack.

A representative of the association was unavailable for further comment Friday.

The trials at Washington Adventist will continue for about another month, and preliminary findings will be released this fall.

"Patients have been very pleased," Turco said. "Patients have been extremely excited about the opportunity to participate in a very, very important clinical trial."

copyright 2002 Montgomery Journal, reprinted with permission

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