Southeastern Wisconsin cardiologists are raving about drug-coated stents, just one year after the U.S. Food and Drug Administration approved their use. Dr. Andy Feiring, director of cardiac catheterization at Columbia St. Mary’s Hospital in Milwaukee, said heart surgeries in his practice are down 30% in the last year, largely because of the drug-coated stent.
"This is the next major advance in the treatment of coronary heart disease," Feiring said. "This is one that has a significant potential for long-term benefit. Now there is little reason to send a patient to (open heart) surgery."
Stents are tiny metal sheaths, similar in size and appearance to a pen spring, that are inserted into arteries after they are unclogged by a balloon during an angioplasty procedure. Stents are supposed to prevent further blockages.
Some patients who received plain metal stents, which were introduced in the mid-1990s, experienced recurring blockages.
Each year, about 800,000 angioplasty procedures are performed in the United States.
In a U.S. clinical study, patients treated with a drug-coated stent had a recurring blockage rate of 8.9%, compared with 36.3% with an uncoated stent. Both the U.S. study and a study in Europe had fewer patients with drug-coated stents who needed additional procedures than patients with plain metal stents.
"Patients who receive (a drug-coated stent) will need fewer repeat operations to unclog arteries, which can make a real difference in the quality of their lives," U.S. Health and Human Services Secretary Tommy Thompson said in a prepared statement.
Cardiac surgeries at St. Luke’s Medical Center are down about 5% this year, said Dr. David Kress, chief of cardiothoracic surgery at St. Luke’s. Kress said the decline in cardiac surgeries is directly related to the introduction of the drug-coated stent.
"The long-term impact is still to be determined," Kress said. "But if you look at the studies in Europe, it looks promising."
Scar tissue that often forms on the stent is what causes the additional blockages for some patients who received plain metal stents. Patients who do not have scar tissue around a stent blocking their artery within the first year usually do not have any problems, said Dr. Imad Katib, a Waukesha Memorial Hospital cardiologist.
Katib was the first doctor in the state to use the drug-coated stent after its approval by the FDA, according to hospital officials. Katib said he has installed drug-coated stents in about 60 of his patients.
"Everybody I’ve done the (drug-coated) stents on, I’ve not had one return," he said. "It’s really a major breakthrough, in my opinion. With this new stent, we’re able to say this is a life-long solution."
Dr. Frank E. Cummins, a cardiologist at St. Joseph’s Hospital and the Wisconsin Heart Hospital, said he has installed drug-coated stents in about 100 patients and only one has had minor blockage.
"We’ve learned over the years to be a little skeptical about how a new product is going to perform," Cummins said. "They’re working quite well. We’re using them more commonly (now)."
The first drug-coated stent approved by the FDA was the Cypher Sirolimus-Eluting Coronary Stent, made by Cordis Corp., a Johnson & Johnson company, based in Miami Lakes, Fla. In March, the FDA approved another stent, called the Taxus stent and developed by Natick, Mass.-based Boston Scientific Corp. The Taxus stent contains a different type of drug.
At first, Cordis was not able to manufacture enough of its drug-coated stents to keep up with demand, Cummins said. The introduction of the Taxus stent and improvements in production by Cordis have eliminated that problem, he said.
"The availability of the stents has become less of an issue," Cummins said. "Boston Scientific has clearly cut into the market share."
The Taxus stent is more flexible and maneuverable and can be placed in hard-to-reach locations easier than the Cypher stent, Katib said.
"The Taxus stent is a little more deliverable," Feiring said. However, it may not be as affective as the Cypher stent, Feiring said.
Dr. David Rutlen, director of the Froedtert Memorial Lutheran Hospital and the Medical College of Wisconsin, said cardiologists at his facilities are using both the Taxus and Cypher stents.
Froedtert and the Medical College also use drug-coated stents to provide radiation treatment for cancer patients.
Rutlen said he expects recurring blockages to be dramatically reduced by the drug-coated stents.
"From a patient’s perspective, they’re delighted when this is done and they don’t have to come back again and have something else done," he said.
Other local hospitals are also using both the Taxus and the Cypher stents.
"We’re using both (stents)," Cummins said. "I don’t know that the drug compounds make any difference."
April 30, 2004 Small Business Times, Milwaukee
