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Yale-New Haven Hospital
20 York Street
New Haven, CT
06510-3202
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January 18, 2000
News this month Several recent studies have focused on the effectiveness of stents, the tiny metal mesh tubes used to keep blocked arteries open after angioplasty. Angioplasty is a relatively common procedure in which a catheter is threaded into blocked arteries in the heart and then expanded to restore blood flow. Stents are permanently placed inside the treated arteries to keep them open. Medicare study Overall results show a clear decrease
in hospital deaths and emergency bypass surgeries among those patients
with stents.
In this study, researchers studied the medical records of 367,526 patients 65 and older who received balloon angioplasty from 1994 to 1996, the first year the coronary stent code was used. Nearly 75,000 received stents. The overall results show a clear decrease in hospital deaths and emergency bypass surgeries among those patients with stents. Patients admitted with a heart attack who were given stents were 71 percent less likely to undergo bypass surgery during the same hospital admission than those who did not undergo stenting. Patients admitted with diagnoses other than heart attack were 58 percent less likely to undergo same-admission bypass surgery. The study also found that patients who received stents had better outcomes at hospitals that perform many of these procedures. "Every study published so far shows a clear-cut association between the number of cases and the outcome," Dr. Richie said. EPISTENT study Patients undergoing angioplasty do best
when treated with stents and the antiplatelet drug abciximab. .
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In 63 hospitals in the U.S. and Canada, 2,399 patients received either stenting and abciximab, stenting with an inactive placebo or angioplasty but no stenting with abciximab. Researchers also investigated the one-year cost effectiveness of combined stenting with abciximab therapy. After one year, lead author Dr. Eric J. Topol of the Cleveland Clinic Foundation reported a 57 percent reduction in death in the stenting/abciximab group compared with stenting alone. Eight (1.0 %) of 794 patients in the stent plus abciximab group had died compared with 19 (2.4 %) of 809 in the stent plus placebo group and 2.2 percent in the angioplasty group. Although the drug/stent treatment increased costs overall, Topol and his colleagues report "it was economically favorable by conventional cost-effectiveness." The cost-effectiveness ratio was $5,291 for balloon angioplasty plus abciximab and $6,213 for stenting plus abciximab per added life-year. "With lower device and drug costs, the combination of stenting and abciximab could be an economically dominant strategy by lowering the cost of acute care and extending life expectancy," the authors predict in the journal. Benefits of the combined therapy were demonstrated among all types of patients, but diabetics were shown to benefit most. Among the 489 diabetic patients in the study, the incidence of death, heart attack or need for repeat operations decreased by more than 50 percent. Kansas City study Study results showed the restenosis rate (renarrowing) six months after treatment was half for the abciximab and stenting group compared with the other two groups. NEJM studies Stenting reduces complications but may
not reduce death among heart attack patients.
In one study of 900 volunteers who had suffered heart attacks and were treated with angioplasty, doctors found 11 percent of the stent recipients suffered chest pain after six months compared to 17 percent who did not get stents. Blood vessels narrowed in 34 percent of the nonstented patients compared to 20 percent of those with stents. The stent proved to be a better choice when looking at the combined outcomes of death, another heart attack, stroke or the need for another heart procedure; however, the death rate after six months was 4.2 percent for stent recipients compared with 2.7 percent for nonstented patients. "This is not statistically significant," said Dr. Cindy Grines, lead author of the study and chief of the cardiac catheterization laboratory at William Beaumont Hospital in Royal Oak, Michigan, "but these studies may raise more questions about the appropriate use of stents than they answer." Stenting reduced the need for additional
procedures to keep arteries open and blood flowing to the heart.
In another study reported in the journal, Dr. James Rankin of Vancouver General Hospital and colleagues from British Columbia also found that stenting reduced the need for additional procedures to keep arteries open and blood flowing to the heart. The researchers followed the course of nearly 10,000 patients. In an accompanying editorial, Dr. Alice Jacobs, professor of medicine
at Boston University, Boston Medical Center, said: "Stents
will most assuredly be viewed as one of the most important advances
in cardiovascular medicine in this decade. Although it has
yet to be shown that it can save lives, it is likely that they will
have a favorable, albeit moderate, influence on mortality."
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Stents: Benefits outweigh negatives for most patients When we began using stents with angioplasty in investigational trials in the late 1980s, we had no idea their use would become as explosive as it has. We currently use stents in about 75 percent of our cases at Yale-New Haven Hospital. The devices used today bear little resemblance to the earlier versions. Later models have become much more flexible and can be successfully maneuvered around vessels, which was not the case in the early days. The FDA approved the use of stents in the mid 1990s, and the devices have successfully addressed the two biggest problems we’ve had with balloon angioplasty alone:
Before the advent of stents, 3 - 5 percent of angioplasty patients required emergency surgery. Angioplasty actually injures arteries by causing a controlled tear to dislodge the built-up plaque. Occasionally the tear causes the artery to close. Stents effectively prevent this from happening, and the need for bypass surgery has dropped dramatically to less than 1 percent. With stents, the [vessel reclosure]
rate has been reduced from approximately one in three to one in
five.
Before stents were widely used, 30 - 50 percent of angioplasty patients experienced restenosis or renarrowing of the affected artery. The higher percentage applied to diabetic patients who have smaller vessels to begin with. With stents, the restenosis rate has been reduced from approximately one in three to one in five. When we do intra-arterial ultrasounds on these patients, we see the stent in place with scar tissue building up inside it. For these patients, we can repeat the angioplasty and use a rotoblator to pulverize the obstructing material. New trials using radiation on the arterial walls may also prove to be effective. The downside Medications are proving to be very helpful in treating this. Previously, a combination of anticlotting medications were used such as aspirin, Coumadin and heparin. The problem was it could take three to four days for the Coumadin to become effective. During this time, patients needed to be hospitalized. The time in the hospital for the medications to become active and the time needed to recover from the stent procedure itself resulted in a four- to five-day hospital stay making the procedure more expensive. The use of new medications has reduced
that length of stay to less than a full day.
Now, the use of new medications has reduced that length of stay to less than a full day. We are using a combination of antiplatelet drugs. Aspirin and ticlopidine have been shown to be most effective in reducing the risk of clotting from 3 - 4 percent to .8 percent. The drug clopidogrel (Plavix®), much like ticlopidine but with fewer side affects, is now the standard regimen for a month following stenting. Patients remain on aspirin therapy indefinitely. Medication therapy has continued to improve outcomes. The EPISTENT trial demonstrated the effectiveness of administering the antiplatelet drug abciximab at the time of coronary stenting. This drug is very expensive and stenting itself is an expensive procedure. Stents cost between $1,500 and $2,000, and some patients require stents in more than one site. The EPISTENT trial also showed, however, that when all factors are considered—improved outcomes and fewer repeat procedures—this combination of stenting and abciximab is the best, most cost-efficient treatment. This is particularly true of our diabetic patients who are at higher risk for complications of heart disease. Not for everyone All in all, stents have made it possible to perform angioplasties
in more patients. They have actually reduced the time and discomfort
of the procedure since arteries are blocked for less time–reducing
blood flow to the heart for a shorter period of time resulting
in less chest pain. Because of the higher risk of emergency bypass
surgery with angioplasties alone, we often wouldn’t advise
the procedure for higher risk patients. Stenting with its very
low risk of surgery has made it possible to effectively treat
many of these high-risk patients. Dr. Cabin is a professor of cardiology at the Yale School of Medicine and an attending cardiologist at the Yale-New Haven Heart Center.
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