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Risks, rewards associated with drug-coated stents

December 10, 2006|by CANDICE BOSELY

TRI-STATE - As Jim Laidlaw was walking home less than a block from a friend's dinner party a week ago Saturday, he started to feel an intense pressure - not pain - in his chest that went through to his back.

He knew right away it was heart-related and was taken to the emergency room, where dye and X-rays showed that one of his coronary arteries was 90 percent obstructed.

"When you're having a problem with chest pain that's related to the heart, you want to control it, and you have a couple of options," said Laidlaw, 69, a retired physician of internal medicine who works with the physician assistants program at Shenandoah University in Winchester, Va.

Laidlaw's possible options were to treat the condition with prescription medications, have bypass surgery or have an angioplasty procedure done.

His doctors, including his primary doctor, cardiologist Neal Gaither, agreed angioplasty would be the best option, and a drug-eluting stent was placed in Laidlaw's blocked artery during an hour-long procedure on Monday.

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Drug-eluting stents have come under scrutiny recently, with questions about long-term risks and whether those who have them face a higher risk of clotting, heart attacks and death.

Study inconclusive



A federal panel met Thursday and Friday to study the issue, but nothing conclusive was announced. Patients with drug-coated stents face an increased risk of heart attacks and death, but it's not clear whether their already poor health or the devices are to blame, the federal health advisers said.

Laidlaw, of Winchester, was well aware of the risks, but decided to go forward with having the drug-eluting stent implemented. His other option was to have a bare-metal stent put in place.

What they are



Stents are tiny slotted metal tubes placed in arteries to prevent them from collapsing. Bare-metal stents are, as the name implies, made simply of metal, while drug-eluting stents are impregnated with a drug that slowly leaches out to help reduce the chance of the artery reclosing, said Gaither, who practices in Martinsburg, W.Va., and Winchester.

Like others who have a drug-eluting, sometimes called a drug-coated stent, in place, Laidlaw is taking the medication Plavix, which is believed to help prevent clotting.

Laidlaw believed the drug-eluting stent was the best option because he feels there is a lower risk of a problem occurring.

"My feeling was that I wanted to have something I wouldn't always have to worry about," he said.

With a bare-metal stent, there is a much higher chance that the artery would clog again.

"(The drug-eluting stent) reduces the chance," Laidlaw said. "It does, however, have its own risk, and that's the risk of a blood clot."

The first stent was introduced in 1994, seven years after Gaither began doing coronary intervention.

"That was a delightful thing to be able to work with," Gaither said.

However, those bare-metal stents carried about a one in four chance of a partial obstruction developing - which was their "Achilles heel," Gaither said.

Drug-eluting stints first were used on humans in Brazil in 2002, and gained the approval of the U.S. Food and Drug Administration in April 2003.

Scar tissue or clot



While the chances of an obstruction forming over months and caused by scar tissue is reduced with the drug-eluting stents, the chance of a sudden clot forming at any moment increases.

"What is unique about this is the risk of having something happening to you is less, but it extends out over time," Gaither said. "This was not a problem we weren't used to dealing with. We just transferred the worry to another area."

When the clot could form isn't known, but if one does form, a major health problem similar to a heart attack could happen within minutes.

About half of the people who have such a problem die, Gaither said.

Overall, though, there's about a 2 percent chance of a serious problem happening, said Gaither, who estimated he has placed 2,000 to 3,000 stents in patients.

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