To file in the “First, Do No Harm” file. Or the “Follow the Money” file. You decide. I’ve discussed some of the hesitations about coronary stents here, and here.
We learned that the FDA “endangered countless patients’ lives when it stopped enforcing 30-year-old requirements that medical device makers meet federal lab standards before testing their products on humans.” We also learned that the procedures could cost $30,000 to $50,000 per procedure, so no one wanted to stop that gravy train. There was a study published in 2007 in NEJM showing that many patients given stents would fare just as well without them. So this is nothing new. There are a number of forces at work here. Following the money is big, but also the tyranny of doing a procedure that makes sense, even though the data doesn’t support it. I talked about “believing in treatments that don’t work” here.
Talked about better mental models for treatment here.
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No Extra Benefits Are Seen in Stents for Coronary Artery Disease
The common practice of inserting a stent to repair a narrowed artery has no benefit over standard medical care in treating stable coronary artery disease, according to a new review of randomized controlled trials published on Monday…
Some of these devices, called drug-eluting stents, are coated with medicine that helps to keep the artery open. The cost of the procedure varies from about $30,000 to $50,000, and more than one million are performed every year in the United States.
The procedure has certain risks. According to Dr. David L. Brown, an author of the analysis, the risk for death is about one in a thousand, and complications can include stroke, heart attack, bleeding, kidney damage and serious allergic reactions. But those events are rare, and the review did not detect any increased risk in P.C.I. compared with medical treatment…
The researchers reviewed eight randomized trials comparing P.C.I. with standard medical care. Combining data from all the studies, the researchers found that prescribing beta blockers, ACE inhibitors, statins and daily aspirin — now standard for treatment of stable coronary artery disease — was just as effective as stent implantation for prevention of chest pain, heart attack, the need for a future P.C.I. and death.
More than half of patients with stable coronary artery disease are now implanted with stents without even trying drug treatment, Dr. Brown said. The reason, he believes, is financial.
“In many hospitals, the cardiac service line generates 40 percent of the total hospital revenue, so there’s incredible pressure to do more procedures,” he said.
“When you put in a stent, everyone is happy — the hospital is making more money, the doctor is making more money — everybody is happier except the health care system as a whole, which is paying more money for no better results.”
Angina is often the symptom that convinces doctors and patients that medical therapy is not enough and that a stent is required. But in this analysis, 29 percent of people who had P.C.I. still had angina, compared with 33 percent of those on medicine, an insignificant difference.
These results support the current concept of coronary artery disease, the authors wrote — that it is a systemic inflammatory disease of the arteries that cannot be successfully treated by surgical intervention at a particular site on one artery.
According to Dr. Brown, a professor of medicine at Stony Brook University, many doctors cannot accept this. Instead, he said, “interventional cardiologists use the analogy of a pipe blocked in a house — it’s a terrible analogy, but patients accept it. It’s simplistic and erroneous.”