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Study finds strong evidence that stents are being used needlessly

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04 November 2017

A groundbreaking new experiment reveals that stents - mesh wire tubes inserted into narrow or weak arteries to widen them and increase blood flow - are no more effective than treating people with medicine when it comes to relieving stable angina, or chest pain.

As Dr Max Gomez, CBS News medical correspondent put it, the key is why you're putting in a stent,

While stents can save lives in the aftermath of a heart attack, the results from the new study suggest people who get them inserted for chest pain - estimated at over 500,000 people every year around the globe - may be benefiting more from a placebo effect than from the device itself.

Stents are used to open up clogged arteries in the heart. When a patient is having a heart attack, stents are clearly life savers. But many stents are put in for chest pain, called angina. Those are now being called into question by the study, published in The Lancet.

Experts praised the study, saying it highlights just how crucial it is to test certain therapies with a placebo group, even if that placebo treatment may mean a minimally invasive sham procedure.

The placebo effect is created when a patient is given fake 'treatment' like a sugar pill and starts feeling better because of the psychological effect. It is particularly potent when it comes to the perception of pain.

In the experiment, patients who received the stent didn't show any difference in chest pain symptoms or enhanced exercise performance compared to patients who underwent a sham procedure.

While the experiment, which was conducted in the UK, only followed up with participants after six weeks ? a relatively short time when it comes to evaluating a chronic condition ? experts expect the results may influence cardiologists in other countries like the US to recommend that patients who can control their pain symptoms with anti-anginal medication should hold off on a stent insertion.

''It's a really interesting trial and it should make people pause,'' said Dr James Slater, an interventional cardiologist at NYU Langone Health who estimates that he performs hundreds of stent insertions every year. ''For the knee-jerk stenters out there, it's just one more piece of evidence that maybe they should be a little more reluctant to do that.''

''It'll change me somewhat because for some of those people where I'm on the fence, I think I will move toward not doing as much,'' said Dr. Paul Thompson, chief of cardiology at Hartford Hospital in Connecticut. ''Even though I don't think I've been aggressive about it anyway, I would move toward not recommending it.''

While the study could lead to a change in how American cardiologists approach angina treatment, arguably more important than the results of the study is the way the experiment itself was conducted, said Dr. Deepak Bhatt, a spokesman with the American Heart Association.

When people think about placebos and the ''placebo effect'', they're generally thinking of a drug trial that tests an experimental medicine against a harmless sugar pill. In this scenario, the sugar pill presents virtually no risk to the study participant who swallows it, and scientists go on to compare their results with people who received the active medicine, in the hope of being able to separate its true physical effect from its placebo effect.

But to test the effectiveness of a device inserted into the body against a placebo, patients who receive the placebo treatment must be led to believe that they could have been operated on ? what's known as a ''sham'' procedure. And, that's exactly what happened in the stent experiment.

Participants who were randomly picked to receive the placebo were sedated, and a catheter really was inserted into their body, up a blood vessel close to their heart. But instead of depositing the stent, doctors instead just withdrew the catheter. Some may consider this kind of ''deception'' in the name of science to be unethical, Bhatt said.

''Since we don't have a good word for a placebo device, 'sham' is used, and thaA groundbreaking new experiment reveals that stents - mesh wire tubes inserted into narrow or weak arteries to widen them and increase blood flow - are no more effective than treating people with medicine when it comes to relieving stable angina, or chest pain.

As Dr Max Gomez, CBS News medical correspondent put it, the key is why you're putting in a stent,

While stents can save lives in the aftermath of a heart attack, the results from the new study suggest people who get them inserted for chest pain - estimated at over 500,000 people every year around the globe - may be benefiting more from a placebo effect than from the device itself.

Stents are used to open up clogged arteries in the heart. When a patient is having a heart attack, stents are clearly life savers. But many stents are put in for chest pain, called angina. Those are now being called into question by the study, published in The Lancet.

Experts praised the study, saying it highlights just how crucial it is to test certain therapies with a placebo group, even if that placebo treatment may mean a minimally invasive sham procedure.

The placebo effect is created when a patient is given fake 'treatment' like a sugar pill and starts feeling better because of the psychological effect. It is particularly potent when it comes to the perception of pain.

In the experiment, patients who received the stent didn't show any difference in chest pain symptoms or enhanced exercise performance compared to patients who underwent a sham procedure.

While the experiment, which was conducted in the UK, only followed up with participants after six weeks ? a relatively short time when it comes to evaluating a chronic condition ? experts expect the results may influence cardiologists in other countries like the US to recommend that patients who can control their pain symptoms with anti-anginal medication should hold off on a stent insertion.

''It's a really interesting trial and it should make people pause,'' said Dr James Slater, an interventional cardiologist at NYU Langone Health who estimates that he performs hundreds of stent insertions every year. ''For the knee-jerk stenters out there, it's just one more piece of evidence that maybe they should be a little more reluctant to do that.''

''It'll change me somewhat because for some of those people where I'm on the fence, I think I will move toward not doing as much,'' said Dr. Paul Thompson, chief of cardiology at Hartford Hospital in Connecticut. ''Even though I don't think I've been aggressive about it anyway, I would move toward not recommending it.''

While the study could lead to a change in how American cardiologists approach angina treatment, arguably more important than the results of the study is the way the experiment itself was conducted, said Dr. Deepak Bhatt, a spokesman with the American Heart Association.

When people think about placebos and the ''placebo effect'', they're generally thinking of a drug trial that tests an experimental medicine against a harmless sugar pill. In this scenario, the sugar pill presents virtually no risk to the study participant who swallows it, and scientists go on to compare their results with people who received the active medicine, in the hope of being able to separate its true physical effect from its placebo effect.

But to test the effectiveness of a device inserted into the body against a placebo, patients who receive the placebo treatment must be led to believe that they could have been operated on ? what's known as a ''sham'' procedure. And, that's exactly what happened in the stent experiment.

Participants who were randomly picked to receive the placebo were sedated, and a catheter really was inserted into their body, up a blood vessel close to their heart. But instead of depositing the stent, doctors instead just withdrew the catheter. Some may consider this kind of ''deception'' in the name of science to be unethical, Bhatt said.

''Since we don't have a good word for a placebo device, 'sham' is used, and that just puts people in a bad frame of mind already, because it sounds like something illicit is going on,'' said Bhatt.

Another reason US scientists and institutions are reluctant to approve experiments with sham procedures is that they are still real, invasive procedures. This means they expose the patient to a slight risk with arguably no payoff, as they aren't receiving the actual treatment, the Huffington Post reports.

Indeed, in this stent experiment, four of the 95 participants who were supposed to get the sham procedure ended up experiencing artery disruption during the insertion, which required doctors to insert the stent anyway, even though it was unplanned.

Despite the complications, the stent experiment reveals there's a dire need for scientists to figure out if certain devices or operations really are delivering the results promised to patients ? or whether it's just a placebo effect due to undergoing some kind of procedure.t just puts people in a bad frame of mind already, because it sounds like something illicit is going on,'' said Bhatt.

Another reason US scientists and institutions are reluctant to approve experiments with sham procedures is that they are still real, invasive procedures. This means they expose the patient to a slight risk with arguably no payoff, as they aren't receiving the actual treatment, the Huffington Post reports.

Indeed, in this stent experiment, four of the 95 participants who were supposed to get the sham procedure ended up experiencing artery disruption during the insertion, which required doctors to insert the stent anyway, even though it was unplanned.

Despite the complications, the stent experiment reveals there's a dire need for scientists to figure out if certain devices or operations really are delivering the results promised to patients ? or whether it's just a placebo effect due to undergoing some kind of procedure.





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