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February 20, 2018

Thousands of patients get heart stents they don't need, Carroll argues

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    New research suggests heart stents might not be any better than a placebo for most stable patients with severe coronary disease, and patient should be aware of this when they agree to having a stent placed, Aaron Carroll writes for the New York Times' "The Upshot."

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    According to Carroll, stents for decades have been a common treatment for angina, and cardiologists have reported that patients who received stents appeared healthier and said they felt better. Many doctors thought stents could help prevent heart attack and possibly death. Over time, the percutaneous coronary intervention—a stent placement procedure—has become popular, Carroll writes.

    Stents comparable to placebos, research suggests

    However, a randomized control trial published in The New England Journal of Medicine in 2007 found that stents did not make a significant difference beyond medical treatment in preventing heart attack or death in patients with stable coronary disease, Carroll writes.

    The findings were "hard to believe," Carroll writes, so scientists conducted follow-up studies. One meta-analysis published in JAMA Internal Medicine—which included three studies of patients who were stable after a heart attack and five studies of patients who had not had a heart attack but had stable angina or ischemia—concluded stents did not afford a benefit beyond just medical therapy for preventing heart attack or death among patients with stable coronary heart disease.

    But some doctors still argued that stents improved patients' pain levels and bolstered their overall quality of life. So researchers conducted a double-blind trial in which neither patients nor their doctors knew which patients had received stents and which had not—over the objections of some doctors, who argued that stents were so clearly valuable that even conducting such a study would be unethical. But in the end, researchers found no difference in outcomes in the two groups: Stents were not tied to a reduction in pain.

    That said, Carroll notes that the study had a few limitations: Patients had received medication treatment ahead of the study, which meant their condition had improved; the study lasted just six weeks, so the long-term outcomes have yet to be seen; and all patients had stable angina, so stents may provide more benefits for patients who are sicker.

    'Many, if not most, patients probably don't need' stents

    All this research demonstrates that "many, if not most, patients probably don't need" stents, Carroll writes. He acknowledges that the concept "is hard for patients and physicians to wrap their heads around," since their personal experience suggests "patients who got stents got better." But those benefits, according to Carroll, "appears to be because of the placebo effect, not any physical change from improved blood flow."

    While the placebo effect may offer real benefits, stent placement comes with medical risks and financial costs, Carroll explains. In double-blind study, 2% of patients experienced a major bleeding event, Carroll notes, pointing out that "hundreds of thousands of stents are placed every year" and "can add at least $10,000 to the cost of therapy."

    Ultimately, Carroll says, "stents still have a place in care, but much less of one than we used to think."

    And Carroll adds that stents are likely not the only medical procedure that providers and patients incorrectly believe lead to improvements in health—particularly as the United States doesn't hold medical devices to the same standard of assessment as it does drugs, which must demonstrate better performance than a placebo before approval. He cites a 2014 piece in The New England Journal of Medicine that found just 1% of approved medical devices gained approval through a process that requires clinical data to be submitted—and that data is nearly always from a small trial without much follow-up. 

    "There seems to be a strong argument that we should be more conscious of what we are willing to risk, and what we are willing to pay, for a placebo effect," Carroll writes. And in the meantime, and when it comes to stents, patients "should at least know what they're paying for" (Carroll, "The Upshot," New York Times, 2/12).

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