This New York Times story describes startling news that a very common procedure–inserting a stent to open a blocked blood vessel–does not add benefit over medication in patients with angina. Angina is chest pain due to blocked heart arteries, and is common among people with heart disease.
Sourcing is a strong point for this story: It features perspective from many American cardiologists who were shocked to learn of the negative results from this study. However, two important potential conflicts of interest among the sources were not disclosed.
In addition, the story contains lots of helpful detail on the limitations of the study, the possibility that placebo effects are at play, and how medical practice may or may not change as a result. It also discussed the costs and potential harms of stenting procedures. That said, the story could have provided more information on what the study itself measured–and what, precisely, the results were. The Wall Street Journal story, which we also reviewed, was stronger on this point.
Heart disease is still the leading killer of Americans so any news about treating aspects of heart disease, such as blocked arteries, is newsworthy. In addition, this story suggests that stenting — common, but expensive — is a prime example of over-treatment. Also the procedure carries some risk and may be causing complications if overused.
The story says the procedure to insert stents costs from $11,000 to $41,000 in the U.S.
The story makes clear there was no significant difference between a sham procedure or stent insertion, but it only describes the benefit as “less pain.” We would like to see how the pain was measured, some numbers on how much pain was reduced, and how many patients benefitted in each group.
The story briefly mentions there are potential harms, including death.
The story describes the study’s methods in some detail — the sham surgery of the control group, for instance — and mentions the size of the study and the characteristics of the subjects. It adds heft to the sense that this was a very good study with multiple reactions from expert sources — “humbling,” “unbelievable,” “impressive” and “very well conducted.” Importantly, it quotes one source describing a few desired measures that the study didn’t address, such as whether stents would be more effective in patients with more severe disease or who were studied for a longer period of time. The story could have done a better job of explicitly calling attention to the relatively small number of participants and the need for confirmatory follow-up studies.
Heart disease is very common in our society and opening up blocked arteries is a common almost routine procedure. No disease mongering occurred in the article.
We were pleased to see discussion from many experts, however, the story left out two important potential conflicts of interest. The story states that:
Dr. William E. Boden, a cardiologist and professor of medicine at Boston University School of Medicine, called the results “unbelievable.”
Readers should have been informed that Boden has received fees from Abbott, a major stent device maker.
Also, the story states that:
Dr. David Maron, a cardiologist at Stanford University, praised the new study as “very well conducted” but said that it left some questions unanswered. The participants had a profound blockage but only in one artery, he noted, and they were assessed after just six weeks.
The story didn’t disclose that Dr. Maron is an “employee of and stockholder in Cardiovascular Services of America, which provides outpatient cardiac catheterization and computed tomography angiography services,” which was disclosed here.
The story (and the study) suggest that medication can manage pain from blocked arteries.
Stenting procedures are clearly widely available in the U.S. and across the world. What’s less clear, the story says, is whether guidelines or practice for stenting will change in the U.S.: “The idea that stenting relieves chest pain is so ingrained that some experts said they expect most doctors will continue with stenting, reasoning that the new research is just one study.” We thought this was an interesting point and are glad it was included.
The many expressions of surprise by practicing cardiologists makes clear that the study offers a novel finding.
The story did not rely on the news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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