July 29th, 2011

Less May Be More, But Stents Are Neither Good Nor Bad

A few days ago, the distinguished healthcare writer Shannon Brownlee wrote a provocative blog post  about the overuse of stents. A key piece of evidence that she used was a paper co-authored by Grace Lin and Rita Redberg, in which focus groups of cardiologists cheerfully admitted that they would give stents to hypothetical patients who were, according to the current guidelines, not eligible for stents. Here’s a paragraph from her post:

The really unsettling part of Lin and Redberg’s paper? The conversation they quote among the cardiologists from one of the focus groups that suggests that once a patient is in their clutches, he or she is going to get a procedure. One cardiologist says, “There’s no chance of escaping.” Another responds, “That’s the end of it. He [the patient] is not going to get out […] without a stent.”

But when I looked at the original Archives paper, I saw that it had been published in 2007.  I follow cardiology fairly closely, and it’s my impression that much, but certainly not everything, has changed since 2007, which happened to be a very important year for cardiology: several months before the Archives paper was published, the groundbreaking COURAGE trial was published in the New England Journal of Medicine. 

COURAGE provoked a long and complex debate in the cardiology world. This debate is by no means over, but it is fair to say that almost no one doubts the main conclusion of the trial today, which is that stents are no better than optimal medical therapy (drugs and lifestyle changes) in people with stable chronic angina for delivering important long-term health benefits, like reducing death, heart attacks, or other adverse cardiovascular events.

COURAGE provided the intellectual basis for a less aggressive approach to interventions. One Wall Street analyst who follows the stent market told me that PCI volume dropped about 10% in the year after COURAGE. Now that may not sound like a lot, but since non-urgent PCI for stable angina composes about 40% of the market, the 10% overall drop likely translates to a 25% reduction in non-urgent, elective procedures, which is where the overuse was most likely to occur.

And then the Mark Midei case came along.

As the magnitude and implications of the case filtered through the cardiology community (and as other similar cases appeared, along with numerous lawsuits and government investigations), the culture of cardiology began to change even more. I don’t know what the numbers are now, but it’s clear that interventional cardiologists as a group are aware that they are subject to far more scrutiny than they were in the past. I would imagine that the voices coming out of a focus group today would sound very different than those cynical voices in 2007.

I certainly don’t want to leave the impression that I believe there are no remaining serious problems in interventional cardiology. A recent study in JAMA provided perhaps our best look yet at this issue. A nuanced view of this study in context suggests that overuse of stents remains a problem, but that much progress has been made. No doubt the overwhelming influence of industry on physicians, journals, and medical culture in general remains a serious problem, and no doubt interventional cardiologists, like everyone else (except journalists), will find ways to justify behaviors that align so neatly with financial rewards. But it is a mistake to say that the situation in 2011 is the same as the situation in 2007.

Less Is More

One more point about Brownlee’s post. She defends the “Less Is More” series in Archives of Internal Medicine, which, it turns out, is supported by a $50,000 grant from a small nonprofit organization, the Parsemus Foundation. The president of the foundation is Elaine Lissner, who became interested in the topic when she consulted Redberg, a cardiologist who is now the editor of Archives, after her father was scheduled to receive an angiogram. (He skipped the angiogram and is doing well today.) Writes Brownlee:

Apparently, this donation is not sitting well with some cardiologists. Lissner’s experience and the donation from the Parsemus Foundation appeared in a story in TheHeart.org, an online source of information for cardiologists published by WebMD. The story quotes Arjay Kirtane, a cardiologist at Columbia University, in New York, who takes offense at the idea of a medical journal taking money from a foundation that has the gall to suggest that there’s a lot of unnecessary cardiology procedures being done, that maybe cardiologists are doing things to patients they shouldn’t.

Brownlee dismisses Kirtane’s response:

C’mon. According to two recent papers, about 1 in 8 angioplasties and stents done in the U.S. are performed on inappropriate patients – patients who by cardiologists’ own studies and by their own guidelines don’t stand a ghost of a chance of benefiting from the procedure, but who are nevertheless exposed to its risks. Those risks aren’t high, but they’re serious, including heart attack, stroke and death. Not to mention the fact that we’re spending more than $3 billion a year (that’s billion with a B) on those unnecessary procedures.

I think Brownlee oversteps here, at least a bit. Given the tidal shift in recent years toward full disclosure of conflicts of interest, it only seems fair to insist that Archives play by the same rules. Perhaps it didn’t want to publicize the fact that, as reported in the story on TheHeart.Org,

the wording about the angioplasty initiative on the Parsemus Foundation website changed in the last year: while they now support ending “inappropriate angioplasty use,” the former title of this effort was known as the “antiangioplasty project.”

So here’s the danger: It’s one thing to raise concerns about “inappropriate angioplasty use,” it’s another thing entirely to become aligned with medical Luddites who stand against one of the most important advances in modern medicine, even with all its real faults. I’m a big fan of “less is more,” both the concept and the Archives series, but the ideal of “less is more” is betrayed by the lack of disclosure of financial support and the crude partisan tone of the term “antiangioplasty project.”

By itself, angioplasty isn’t “good” or “bad.” A well-performed procedure in a properly selected and educated patient is one of the miracles of modern medicine, and should be celebrated as such. In contrast are procedures performed in poorly selected and educated patients, either out of pure greed or out of the overweening self-delusion of the physician who thinks he can heal the world. A balanced view of the picture needs to encompass both perspectives.

One Response to “Less May Be More, But Stents Are Neither Good Nor Bad”

  1. Anil Virmani, MD, DRM says:

    I couldn’t agree more. It’s never a procedure or a drug that has failed, it’s always a judicious selection of patients for that particular treatment that has a actual bearing on the end-result. The stories with thalidomide / Metformin / Glitazones etc. are there for all to see.

    Competing interests pertaining specifically to this post, comment, or both: