HEART SURGERY

Drug-releasing stents help prevent repeat surgery, but some call for more research.
By SALLY SQUIRES
WASHINGTON POST
Helen Rehak of Indiatlantic, Fla., carries the recent history of innovations in heart care in her body.
Over the past 25 years, she's had almost every procedure cardiology can offer. Surgeons first cut open her chest on three separate occasions to perform open-heart surgery, grafting vessels from her legs to bypass clogged ones.
When her arteries began to fill in again a few years later, cardiologists used tiny tools to ream out the blockages. Then, as technology improved and angioplasty developed, they opened the vessels with small balloons.
In 2001, when the blockages re-formed, stents were implanted. These tiny metal scaffolds kept her vessels propped open for another year.
In May 2002, Rehak's arteries narrowed around the site of her stents, a phenomenon called restenosis, which is experienced by about a third of those who get stents and requires about 15 percent to have their vessels cleaned out again.
Experimental option
That's when doctors offered the 75-year-old grandmother the latest option: a then-experimental drug-coated, or drug-eluting, stent that slowly releases medication designed to help prevent restenosis.
A year after two of the experimental stents were slipped inside her old stents, Rehak's arteries remain open. "I'm feeling better," said Rehak, who celebrated her 55th wedding anniversary this year. "I'm not having the chest pain that I had before."
The drug-coated stents, known by the brand name Cypher, reached a milestone this year, too. On April 24, the Food and Drug Administration (FDA) approved their use as the first drug-coated stents in the United States.
Since then, the stent's maker, Johnson and Johnson's Cordis Corp., has been scrambling to meet demand -- and create it. In four months, Cypher has captured 55 percent of the stent market in the United States, where about 800,000 people get the devices every year while undergoing balloon angioplasty.
On average, about two stents are implanted per patient. At $3,100 per Cypher, the cost is nearly quadruple that of standard bare-metal stents, although the company has recently offered hospitals discounts that could drop the price to $2,400. Medicare has agreed to reimburse some of its costs.
Drug-eluting stents "hold the promise of reducing restenosis," said Lowell Satler, associate director of the Washington Hospital Center's Cardiac Catheterization Lab. "There's a lot of data to support that."
Curbing repeat surgery
By tackling restenosis -- what some call the soft underbelly of one of the most commonly performed procedures in the world -- the new stents may expand the universe of candidates for angioplasty.
Studies suggest that by reducing the inflammation and scarring that often follows removal of a blockage, the stents can cut the need for repeat procedures in half.
The hope is that they can also help keep some people from going to the operating room for more invasive, expensive and dangerous bypass surgery.
Need for research?
What troubles cardiologists is that the rapid shift to drug-eluting stents is occurring before there's solid evidence -- and, in some cases, any evidence at all -- for their safety and effectiveness in treating some of the most common types of blockages.
The clinical trials of Cypher have been limited to people with shorter blockages that fill most of the artery's diameter and have not been treated previously.
In one study, none of those who received Cyphers had any restenosis, compared with 27 percent of those who got the bare stents. In another, 9 percent of the Cypher group developed new blockages, compared with 36 percent of participants who received standard stents.
Still to be proved, however, is whether the stents are beneficial if implanted during a heart attack -- a common practice with bare-metal stents. Will the drug-eluting stents work on blockages at branched arteries, in small arteries and in vessels that are completely blocked? Can they keep open bypass grafts that have re-clogged?
Are they safe and effective when placed inside other stents that have re-clogged -- a use the FDA has sanctioned, but only on a case-by-case basis as part of a compassionate-use experimental trial? What about blockages in the vital left main artery? And can the stents be used safely in people with multiple clogged vessels, especially those who have diabetes?
"There are a lot of places where they have not been tested," Dr. Satler says, noting that is why the Washington Hospital Center has decided not to venture into off-label uses of the stents, as many hospitals have.
Of the 400 or so stents implanted monthly at the Hospital Center, about 270 are drug-eluting stents, according to Dr. Satler.
Cost is a big issue. In Europe, doctors limit use of drug-eluting stents to about 20 percent of patients.
In August, a report by Moody's Investors Service concluded that drug-coated stents "are good for patients, but bad" for the financial health of hospitals.