Heart doctors 'held back stent death data'(bbc.com)
bbc.com
Heart doctors 'held back stent death data'
https://www.bbc.com/news/health-51539112
33 comments
Here is a better written article with some of the controversy over the EXCEL trial. Medical decision making is something of a mess.
https://www.dicardiology.com/content/excel-trial-authors-say...
Agreed. It isn’t clear what the issue is here.
If the research protocol states 3 years of data collection it’s technically unethical, without submitting an amendment, to collect data beyond 3 years as the patient hasn’t agreed to this. Sure, in hindsight the data should have been collected for longer but at the time of study design 3 years probably seemed appropriate. It’s really difficult to say how long to follow up - forever? Sure, but would be financially unfeasible.
We do have a yellow carding system in the UK - the medicine and health regulatory authority (MHRA) run this and it’s for submission of adverse drug reactions as well device issues. But again, not sure how helpful it would have been for the instances of participant death after 3 years. Seems harsh on the doctors who carried out the research, unless I’m not reading this correctly.
They were already collecting data past 3 years.
The doctors who carried out this research are, it sounds, blatantly in the wrong, for they withheld the data that appears to make clear that stents have worse outcomes past year 3 until after the guidelines were written while they had already gathered this data before the guidelines were written.
Sure they cannot openly share all their data because it is private, but it is very suspect that they do not share the external review that found them at fault
As Prof John Ioannadis points out in the article, there are wide systemic issues in the trials and guidelines process.
The doctors who carried out this research are, it sounds, blatantly in the wrong, for they withheld the data that appears to make clear that stents have worse outcomes past year 3 until after the guidelines were written while they had already gathered this data before the guidelines were written.
Sure they cannot openly share all their data because it is private, but it is very suspect that they do not share the external review that found them at fault
As Prof John Ioannadis points out in the article, there are wide systemic issues in the trials and guidelines process.
> Sure they cannot openly share all their data because it is private
Couldn't they just anonymize the data?
Couldn't they just anonymize the data?
This depends on jurisdiction of course, but in a lot of cases you can't share data that wasn't consented for that use originally - anonymized, de-identified, or otherwise.
Chasing down previous patients for retrospective consent would be difficult to impossible.
Chasing down previous patients for retrospective consent would be difficult to impossible.
Exactly, the last two year survival of control group may be artificially enhanced because the ones that were going to die were already dead in the first three.
Why would they compare the death rate in just the fourth year between the two groups instead of doing a normal survival analysis?
That's what the article seemed to imply. That mortality was higher after year 3 in the intervention group compared to the control group.
This is pretty well-known phenomenon to vascular practitioners...
Interventional cardiologists chronically low-ball the dangers of stents and gloss-over their well-known short-term performance. Who'd a thunk that jamming a foreign body in a small artery ends up making it worse in the long-term?
Patients with coronary bypass often have a better long-term outlook, but in many cases the cardiologists simply don't refer to cardiac surgeons to line their own pockets (and admit "defeat").
Interventional cardiologists chronically low-ball the dangers of stents and gloss-over their well-known short-term performance. Who'd a thunk that jamming a foreign body in a small artery ends up making it worse in the long-term?
Patients with coronary bypass often have a better long-term outlook, but in many cases the cardiologists simply don't refer to cardiac surgeons to line their own pockets (and admit "defeat").
This isn’t really true. Stents in patients with heart attacks have a clear mortality benefit except in certain high risk situations when bypass surgery has better outcomes.
Stents are quite routine and much, much, much easier to do than bypass surgery.
The problem is that outside of heart attacks, there isn’t good evidence for a mortality benefit from stents. So cardiologists are constantly searching for additional evidence that justifies stent use. And there isn’t much mortality benefit yet, but lots of other reasons why they might get used. But in those cases (like stable angina), almost no one would do bypass surgery, except for patients at very high risk of having a deadly heart attack.
So criticize indication creep but there are many clear times when stents absolutely should be used.
Stents are quite routine and much, much, much easier to do than bypass surgery.
The problem is that outside of heart attacks, there isn’t good evidence for a mortality benefit from stents. So cardiologists are constantly searching for additional evidence that justifies stent use. And there isn’t much mortality benefit yet, but lots of other reasons why they might get used. But in those cases (like stable angina), almost no one would do bypass surgery, except for patients at very high risk of having a deadly heart attack.
So criticize indication creep but there are many clear times when stents absolutely should be used.
I’m not a medical expert but your hand waving of stents feels off to me. Yes, it’s not surprising that stents can be dangerous, but the alternative is open heart surgery. Which sounds pretty damn risky too.
Is the choice really that simple?
Is the choice really that simple?
I've followed news about stents for decades.
They're about $5,000 each.
A couple times per year there is some news report similar to this story.
I have a feeling that, just like hip replacements took decades to find the right combination of materials to not disintegrate or be rejected, we're still researching what to make stents from and when to use them.
The problem is that patients aren't told they're guinea pigs, and stents aren't that reliable. Oh and doctors get to bill a fortune per operation regardless.
Regarding this particular story, rather than be outraged, we should have cardiac experts and statisticians sit down and figure out what's real and what isn't. There is valuable data in there somewhere.
They're about $5,000 each.
A couple times per year there is some news report similar to this story.
I have a feeling that, just like hip replacements took decades to find the right combination of materials to not disintegrate or be rejected, we're still researching what to make stents from and when to use them.
The problem is that patients aren't told they're guinea pigs, and stents aren't that reliable. Oh and doctors get to bill a fortune per operation regardless.
Regarding this particular story, rather than be outraged, we should have cardiac experts and statisticians sit down and figure out what's real and what isn't. There is valuable data in there somewhere.
> The problem is that patients aren't told they're guinea pigs
Here's the thing. Every patient is a guinea pig in one way or another. Every medication has side-effects both known and unknown.
But yeah, maybe stents need to be replaced before 3 years or some better materials need to be found, and maybe they are used in situation where they're not really needed.
Still better than bypass surgery which is a very invasive surgery.
Here's the thing. Every patient is a guinea pig in one way or another. Every medication has side-effects both known and unknown.
But yeah, maybe stents need to be replaced before 3 years or some better materials need to be found, and maybe they are used in situation where they're not really needed.
Still better than bypass surgery which is a very invasive surgery.
Ok, but Google says open heart surgery costs $324,000! Which is probably a huge variance number...
My point is not that stents > open heart surgery, but rather that they’re not at all easy to compare.
My point is not that stents > open heart surgery, but rather that they’re not at all easy to compare.
Open-heart surgery is certainly no picnic, I'm not suggesting that it is. It depends on who the patient is. If you're talking about an 82yo man with renal insufficiency, that's not exactly a person you're going to rush into surgery. But if you are a relatively healthy 67yo who smoked for a decade but not actively smoking, getting a stent is likely not your best option because your expected life expectancy is still fairly decent. The point is that many people are not getting both sides of the story because cardiologists act as both the gatekeepers and the interventionalists.
Any mention of these things and death is pretty frightening. I've got two of the damn things in me. However, the article is baffling in the extreme. It sure appears to be written to alarm, and doesn't provide enough detail. I will definitely bring it up with the cardiologist in a few weeks and see what he says.
If this helps put your mind at rest, I have had a couple of them for twenty-two years without any problems. They have allowed me to continue an active lifestyle.
it does actually. I'm also very eager to get off the #%@#%ing blood thinners and get back to my normal life.
From what I've read over the years, it's pretty clear that stents are a con game. And from what I know personally about Abbott, I'm not at all surprised that they'd bribe researchers to yield the results that they wanted.
In a 2018 article in the New York Times, Marcia Angell wrote:
> Second, there’s good evidence that drug company involvement biases research in ways that are not always obvious, often by suppressing negative results.
And as I recall, her 2005 book The Truth About the Drug Companies discussed research which showed that the geographic distribution of stent usage correlated with the geographic distribution of capacity to do stents. With evidence, as I recall, that facilities basically bribed local cardiologists for referrals.
In a 2018 article in the New York Times, Marcia Angell wrote:
> Second, there’s good evidence that drug company involvement biases research in ways that are not always obvious, often by suppressing negative results.
And as I recall, her 2005 book The Truth About the Drug Companies discussed research which showed that the geographic distribution of stent usage correlated with the geographic distribution of capacity to do stents. With evidence, as I recall, that facilities basically bribed local cardiologists for referrals.
I can accept a % of fluff in any industry, but in the medical field, especially cardiovascular.. it stings a bit. How much more bs is there ? Should it be investigated ?
It's obvious that it doesn't work every time and some people try to get stents instead of a open-heart surgery which leads to many devastating things.
The main article picture, from "Getty Images", is of a heart in the exact middle of a human chest.
WTF? That is not where the human heart is located. :(
WTF? That is not where the human heart is located. :(
I'm not sure that is correct -
https://biology.stackexchange.com/questions/60718/why-is-the...
https://biology.stackexchange.com/questions/60718/why-is-the...
Interesting. I'd learned early on that the heart is on the left side, but it looks like it's more centrally located than that. eg 2/3 on the left, with 1/3 on the right.
This is terrifying. Does anybody know of any alternative that would work well in long-term? Asking for a relative who just had a mild heart attack.
See also: https://eu.usatoday.com/story/news/nation/2018/03/09/cardiol...
Patients are more likely to survive heart attacks while the cardiologists are all away at a conference, because that means the cardiologists are less able to interfere.
Patients are more likely to survive heart attacks while the cardiologists are all away at a conference, because that means the cardiologists are less able to interfere.
They were still treated by a cardiologist, just not the “preeminent” doctors as they were all at the conference.
This effect has alternatively been written as an effect arising from the fact that “lesser” doctors would tend to follow established, standardized practices, be open to other opinions etc. while the higher status doctors may be less so
This effect has alternatively been written as an effect arising from the fact that “lesser” doctors would tend to follow established, standardized practices, be open to other opinions etc. while the higher status doctors may be less so
Didn’t stents become popular before doing any real clinical trials?
"sponsored by US stent manufacturer" and people are gobsmacked that this happened.
Stents do help and are good medical tools but they certainly can cause problems.
Is this about some specific heart problems?
Because anecdotically I know 2 people with stents that are just fine(tm) after more than 3 years. I don’t know the specifics of their conditions though.
Because anecdotically I know 2 people with stents that are just fine(tm) after more than 3 years. I don’t know the specifics of their conditions though.
I had to read the article twice to understand the main point. Sentences like this make me scratch my head: "The data suggested more people fitted with stents were dying after three years."