Stent controversy: The scrutiny continues to expand

April 19, 2011
by Sruthi Valluri, DOTmed News
This report originally appeared in the April 2011 issue of DOTmed Business News

When Bill Clinton received two stents to treat a blocked coronary artery last year, the world took notice—not just due to his celebrity, but because stenting has become one of the most controversial procedures in the United States.

The issue has experienced renewed interest in recent months. In early March, two western Pennsylvania doctors voluntarily resigned after investigation into their practices involving the procedure. Drs. Ehab Morcos and George Bou Samra, cardiologists at Westmoreland Hospital in Greensburg, Penn., were found to have implanted stents—thin wire scaffolds that unclog and prop open blocked arteries—in 141 patients who may not have needed them.

Meanwhile, in Baltimore, courtroom drama is unfolding around Dr. Mark G. Midei, who is accused of falsifying hundreds of medical records at St. Joseph Medical Center and inserting stents into patients who did not need them. Midei gained notoriety when the Senate released a report in December 2010, detailing his relationship with Abbott Laboratories, a stent manufacturer.

The report contended that Midei may have implanted 585 medically unnecessary stents between 2007 and 2009. The estimated cost of the unnecessary procedures topped out at $6.6 million, with Medicare picking up $3.6 million of the tab. The report also found that Abbott Labs rewarded Midei with thousands of dollars in perks. In one of the more infamous instances, Midei was found to have implanted 30 stents in a single day. Two days later, Abbott Labs spent $2,159 to host a celebratory dinner at Midei’s house.

But the issue is not just limited to litigations. Dr. Gerry Gacioch, head of cardiology at Rochester General Hospital in Rochester, N.Y., says that details can often be lost in the drama of courtroom disputes. “The more the people understand the nuances, the better,” Gacioch says.

Placing a stent in a patient is a complicated process, according to Gacioch, one that requires balancing existing protocol with the individuality of each patient. A patient being considered for a stent is first assessed using either a stress test or a heart scan to determine if any heart muscle is being deprived of oxygen.

If the artery is blocked, a catheter tipped with a deflated balloon, surrounded by a stent in a compressed form, is threaded into the patient’s circulatory system. Once the stent is in place, a balloon is inflated to expand the stent and to push the plaque against the walls of the artery to clear the blockage.

But this depends on the severity of the blockage, the location and the patient’s individual history. Several societies, including the American College of Cardiology (ACC) and the Society of Cardiovascular Angiography and Interventions (SCAI), have guidelines in place for interventional cardiologists to follow.

“In a hypothetical case, it’s very clear-cut. There are people who absolutely need stents, and people who absolutely don’t,” says Gacioch. “The place where there’s been controversy is in between.”

Dr. Christopher White, president-elect of SCAI, also agrees that the guidelines aren’t specific to all the cases he sees. “There’s black and white, and then there’s that gray zone,” says White. “As physicians, we need to be careful about what we do in the gray zone.”

Physicians like Midei, Morcos and Bou Samra are alleged to have breached protocol in this gray zone. The allegations have cast a shadow on the profession, according to Gacioch.

“Even if the allegations turn out to be completely false, it has still hurt our reputation,” he says. “And it’s going to take a while to come back.”

But Gacioch also sees the controversy as something that goes beyond the doctor’s office. He says there are several levels of controversy happening at once — one in the scientific community, another in the political community, and a third in the public. For the controversy to see any resolution, Gacioch says, everyone needs to be on the same page.

Dr. William Boden, clinical chief of the division of cardiovascular medicine at the University of Buffalo, is familiar with the controversy in scientific circles. In fact, he is partly responsible for starting it. His study, called Courage, cast doubt on the effectiveness of stents in patients suffering from chronic chest pain and focused national attention on the popular procedure.

After following 2,287 patients for five years, Boden and his colleagues found that stents are not necessarily more effective than drug therapy in patients with chronic stable angina. The study, which appeared in an April 2007 issue of the New England Journal of Medicine, created a furor.

Nearly all major news organizations picked up the story, which made the front page of the New York Times and The Wall Street Journal. Dr. Steve Nissen, chairman of the ACC, called Courage a “practice-changing,” “blockbuster” study. The ripple effects were far-reaching: the day the news broke, shares for Boston Scientific Corp., a leading stent maker, plummeted in anticipation of the fallout.

“It was a major shot across the bow,” says Boden, recalling the immediate reaction to the study. “It polarized the community for several months.”

Courage was closely followed by other studies, which continued to undermine the popularity of stents. In 2009, a National Institute of Health study titled BARI 2D, found that among some patients, bypass surgery yields far better results than stents. That same year, Boston Scientific Corp. sponsored a study that found surgery should be the standard of care in patients with severe coronary artery disease because there are fewer adverse effects experienced than with procedures involving stents.

SCAI’s White, who is also the principle investigator for a study on carotid stents sponsored by Boston Scientific Corp., points out that before Courage and the subsequent studies, interventional cardiology was aggressive in its treatment of blocked arteries. “At the time we thought that opening as many arteries as we possibly could, was the best way to treat patients, but Courage and the other [studies] made us understand that’s not the best thing.”

The U.S. Food and Drug Administration ratcheted up the controversy when it took on another dispute that was slowly unfolding: drug eluting stents, a new generation of stents coated with drugs to prevent arteries from re-clogging. The stents received a very warm reception upon their introduction in 2003. By 2004, Boston Scientific’s Taxus, for example, generated sales of more than $2 billion. By 2006, drug-eluting stents accounted for nearly 90 percent of all stent procedures, according to the American Heart Association.

But the rapid rise of drug-eluting stents was hobbled. In 2006, reports emerged of cases in which drug-eluting stents were found to have caused strokes. The FDA convened an emergency Advisory Panel to discuss the potential risk and make recommendations.

“Whenever something new comes out, it’s the best thing since sliced bread. Like drug-coated stents,” says Gacioch. “The pendulum swings in its favor, and then you figure out, it might not be the best thing. So the pendulum swings back.”

According to the AHA, drug-eluting stents now account for only 70 percent of stent procedures, a significant decline.

White, who also acts as the system chairman for cardiovascular diseases at the John Ochsner Heart & Vascular Institute in New Orleans, says that many of the patients who walk through his clinic’s door are initially scared.

“It’s the hyperboles that they hear,” says White, pointing out that the issue can seem alarming when many of the details are misunderstood.

Gacioch has noticed a similar pattern in his own practice. “When things first come out, there’s a fear factor that kicks in,” says Gacioch. “Some people get unnecessarily scared; some people might even avoid having things done that they should have done.”

But eventually, the dust settled. White, Gacioch and Boden all agree that what emerged from the fray is a more medically conservative field of interventional cardiologists.

At the University of Buffalo, Boden says he there has been a sustained 15 to 20 percent decline in the volume of cardiac catheterization requests and associated stents and angioplasties in the past few years.

In New Orleans, there is a similar downward trend. “Stents are absolutely being used less,” says White, a decline that has held steady for the past few years.

Boden’s and White’s observations might seem odd given the data, however. Stents remain a popular therapy choice. Although there was an initial drop in the rate of stent placements—nearly 13 percent nationwide in the months after Courage’s publication, according to Millennium Research Group—the number of stents has remained high.

The AHA, which keeps a tally of all heart procedures in the United States, mistakenly double-counted procedures until recently. Even with the figures adjusted for this error, the number of stents has consistently remained more than 500,000 per year.

White offers an explanation for this discrepancy in numbers: baby boomers. He points out that as the next generation of patients hits their 50s and beyond, the number of heart-associated diagnoses will increase as well. “We see more patients every year,” says White. “We’re seeing more people that need to be treated, but the percentage of stents [being used] is growing smaller.”

Stents continues to outpace other medical devices in the market as well, accounting for nearly $5 billion worldwide and making it one of the most popular medical devices globally. Joseph McGrath, a spokesman for Medtronic Inc., a Minneapolis-based stent manufacturer, predicts that the market will remain healthy.

“Stents are an example of an innovation that has absolutely changed the way coronary artery disease is treated,” says McGrath. “And it will continue to play a role in treatment.”

But McGrath is quick to point out that Medtronic Inc. only produces the stents. “We don’t practice medicine,” says McGrath. “Physicians have the latitude based on their discretion to use the device in a way that’s not on the label.”

According to White, a physician is almost entirely driven by evidence. “When there is data, we use evidence-based medicine,” he says. “But when there’s no evidence, that’s where the art of medicine comes in.”

Boden also points to larger, more systemic problems that might be driving aggressive use of medical procedures like stents. “In the United States, we reimburse physicians and hospitals on a fee-for-service basis,” Boden says. He points out that when incentives are in place, practices will become more common, even if they’re not necessarily in the best interest of the patient.

Gacioch thinks that defensive medicine also plays a role. The fear of potential lawsuits is a constant worry for physicians, especially interventional cardiologists. “Everybody in medicine is sort of defensive,” Gacioch says. “You’re always trying to do the best you can do, but I think everybody is baseline defensive. And I don’t think this is good for anyone but lawyers.”

White believes that reform and greater oversight are necessary. “Physicians have to regulate physicians,” says White. According to him, any change in the field—whether it is stricter guidelines in physician societies or new legislation, as the state of Maryland is currently pursuing—must be physician-driven to ensure that the patients’ best interest are still served.

Boden believes that while the past few years have been rocky for interventional cardiology, the results have been positive. “I think trends and patterns are beginning to change, especially with intensifying scrutiny at the national level,” says Boden. “We need to make sure that we’re doing what’s right for patients.”