Stent carries a little something extra to protect arteries

Drug coating helps retard scarring after angioplasty

Medicine & Science

April 28, 2003|By David Kohn | David Kohn,SUN STAFF

Rob Alford, veteran heart patient, became a pioneer last week when tiny tubes were threaded into his clogged arteries. Doctors believe the devices could transform cardiac medicine.

On Thursday, the U.S. Food and Drug Administration approved a new drug-coated stent that keeps scar tissue from choking newly unclogged arteries. The next day, Alford, a 50-year-old Bel Air resident, became one of the first patients in the country outside a clinical trial to get the new treatment.

"This is the hottest thing in cardiology in years," said Dr. Mark Midei, the St. Joseph Medical Center physician who treated Alford. In an hourlong angioplasty procedure, he inserted stents - tiny metal tubes just a few millimeters wide - into several of Alford's heart arteries.

Stents have been used for more than a decade. But the new version, called a Cypher stent, has an extra feature: a coating of an anti-inflammatory drug that keeps scar tissue from forming. Studies showed that the new stents cut the need for additional treatments, including bypass surgery, by more than half, compared to the nondrug-coated version.

In one study, more than 1,000 patients were given either the Cypher stent or a plain stent. Doctors tracked how many suffered a heart attack or needed additional treatment to clear a reclog: a quarter of the plain-stent recipients compared with 10 percent of those given the new device.

St. Joseph was among the hospitals that participated in the studies. In clinical trials over the past two years, Midei and other cardiologists at the Towson hospital have inserted the new devices into the arteries of more than 200 patients.

In an angioplasty, doctors thread a balloon into a blocked artery to clear the obstruction, and they often insert a stent to keep the pathway open. But in 15 percent to 30 percent of patients, scar tissue forms around the stent, reclogging the artery.

To avoid this, the Cypher stent is coated with a drug called Sirolimus, which restricts scar tissue growth. For about a month after insertion, the stent releases the drug, ensuring that the artery gets a steady supply. "Patients with these stents have no scar tissue," Midei says.

Alford, the business manager of St. Margaret's Church in Bel Air, has suffered from heart disease for six years. Because of multiple clogs, he received four stents last week. With so many blockages, he faced a high risk of problems with scarring had normal stents been used.

"He is an ideal patient for a Cypher stent," Midei said.

Doctors will likely be using the new stent in many of the 800,000 angioplasties done annually in this country. At about $3,100, it costs about two to three times as much as other stents. But the more expensive device will likely decrease the number of restentings, and also of open-heart bypasses - a pricier, more risky procedure often used in cases of reclogged arteries.

In one study, more than 1,000 patients were given either the Cypher stent or a plain stent. Doctors tracked how many suffered a heart attack or needed additional treatment to clear a reclog: a quarter of the plain-stent recipients compared with 10 percent of those given the new device.

Besides the Cypher, several other anti-scarring stents are being tested at medical centers, including Baltimore's Sinai Hospital. None has yet received FDA approval.

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