Are Coronary Stents Killing People?
New research seriously challenges the safety of most stenting procedures
It’s two days after election 2024, and Trump has won. Perhaps (and I’m thinking of my mother) it’s a good time to discuss the best treatment for heart attacks.
So here’s a question that for the past 40 years has rarely been asked: Should doctors open acutely clogged arteries? It’s an age-old question, and a new study asked it in age-old people, based on age-old data.
Let’s briefly review the history.
From huge trials in the 1980s we learned clot-busting drugs, when given in the throes of a major heart attack, can open freshly clotted arteries and save lives. This was revolutionary, ushering in the era of cardiologist-as-plumber—clear out the clogs!
Less remembered, however, is that it only helped people with ‘ST-elevation’ patterns on their EKG, a minority of heart attacks. People with the more common ‘acute coronary syndrome’ or ACS, were unhelped by the drugs and, in some cases (like ST-depression EKG patterns) seemed to die more often with the drugs. Nevertheless, the drugs were soon standard treatment for ST-elevation heart attacks.
Later, as techniques improved, trials showed that angioplasty or stents (small metal scaffolds snaked into the coronary arteries) opened arteries better and saved more lives than clot-buster drugs. The procedure had to done within 2 hours of pain onset and the difference was small, about 2%. But stents quickly took over as the preferred treatment for ST-elevation heart attacks.
And not just ST-elevation heart attacks. Stents became preferred for just about any narrowed heart artery. They were put in for chronic clots with no heart attack, for people without symptoms, and even (forgetting the dangerous history) for ACS. Soon, cardiologists were to stents as Oprah was to cars: You get a stent! YOU get a stent! EVERYONE gets a stent!!
But the benefits had been proven only in a narrow group, ST-elevation heart attacks, i.e. big fresh clots. Research in other conditions was lagging, but the procedure still metastasized throughout the medical world. And like most surgeries, it was lucrative. At roughly $30,000 a pop, and about 1 million placed per year in the US alone, a $30 billion stent economy developed.
But, predictably, as the research trickled in it became clear that opening arteries wasn’t saving lives. Study after study showed that, other than for ST-elevation heart attacks, stents weren’t preventing deaths or even future heart attacks. They did, however, seem to improve chest pains. And… presto! Chest pain soon became the justification for most stent procedures.
Then ORBITA happened, the first sham-controlled trial of cardiac stenting. Participants with chest pain and a narrowed artery were randomly assigned to either have a stent placed, or have a sham. In the sham group people underwent sedation and catheterization, a wire snaked into their heart arteries—but, unbeknownst to patients and their cardiologists outside the room, no stent was placed. Then, six weeks later, a battery of tests was performed. For many, the results were unfathomable: stents were exactly as good as the fake procedure. Pain, ability to exercise, and quality of life were identical.1
Meanwhile, the most common reason for stents other than chest pain was ACS, acute coronary syndromes. But by 2010 large reviews and meta-analyses agreed that stents don’t save lives in ACS. At best, some optimistic analyses (written by interventional cardiologists) suggested they might prevent a small number of future, nonfatal heart attacks.
Which brings us to yesterday’s bombshell, a trial that randomly assigned more than 1,500 older adults with an ACS heart attack to stenting or no stenting. At four years, the rate of death or a second heart attack was measured, and found to be 26%—in both groups. No difference. In other words, stents didn’t help.
But there’s an ominous twist buried in the paper. The 26% number represents deaths or heart attacks, a common tactic in cardiology research that is, IMHO, real weird. Because deaths and nonfatal heart attacks are very different outcomes of hugely different importance to people. And yet they’re combined in the same number, obscuring different values people place on them.
And, as if attempting to prove the misleading nature of their own outcome, in the discussion section of the paper the study authors unironically tout the fact that they found 3% fewer heart attacks in the stent group—but fail to mention they found 4% more deaths.2
Bury the lead, much???
But there are other, more foundational problems for this study. For instance it was a study of older people (75+) with ACS and it was conceived on a dubious assumption: that people generally benefit from stents in ACS. That’s not only unproven, early studies suggested the drugs might increase deaths in ACS. The study’s related assumption was that being older or frail might lead to complications that could neutralize the benefits of stenting.
And yet complications occurred in less than 1% of people in the study. Moreover, the results were the same among participants judged to be frail as those who were judged healthy. Which means complications and frailty cannot explain why the death rate was 4% higher in the stent group.
By any sane measure, opening arteries in this group didn’t help and it probably hurt—just like in the 1980s studies.3 And since this is among the first and best modern tests of stenting vs no stenting for ACS, the most appropriate response should be a moratorium on stenting worldwide other than for ST-elevation heart attacks. No more stents to relieve symptoms, no more stents for ACS. Until large trials prove there’s a second group for whom stents are safe and effective, it’s time to stop.4
Yes, that’s a tall order. For decades the cardiology establishment has been ideologically and financially committed to plumbing, which works great for big fresh clots in the first minutes of massive heart attacks. But even good plumbers know forcing open clogs that were slowly built over years is a risky quick-fix—and it doesn’t heal the pipes. For people with heart disease that’s a long term project that includes reducing inflammation, exercise to improve blood flow, and diet changes to prevent future attacks. Each of these is proven to be a far more powerful healing technique than any pill or procedure ever invented, and they are infinitely safer.
With yesterday’s new data showing they may be killers, it’s time to ban stents for anything other than the one condition they’re proven to help.
The results shouldn’t have shocked anyone—the history of medicine is flush with sham procedures for heart disease that improved symptoms just as effectively as real procedures.
In Table 3 note "Nonfatal MI” was 12.7% vs 15%; while “Death from any cause” was 36.1% vs 32.3%.
The study authors might point to the fact that the 3% drop in heart attacks was ‘statistically significant’ while the 4% increase was not. This is baloney. That distinction can be very important for primary outcomes. But when assessing secondary outcomes like these the distinction is a judgment call, and it is simply nutty to look at an all-cause mortality increase which is greater than the decrease in heart attacks, and cry ‘statistical significance!’. Finally, in this case the statistical difference is nominal, with confidence intervals that are extremely similar. The increase in deaths very nearly reaches the threshold they would use for statistical significance.
Stents are routinely used to replace bypass surgery and there’s reasonable data to support this, therefore I’m excepting these much less common stenting procedures. Presuming a baseline belief in the life-saving impact of bypass surgery (different issue for a different day, peruse here if you’re curious), these stents have been tested and proven in large randomized trials.
This is huge. I was always suspicious of all the stenting. I've known a couple of people who had chest pain, went to the doctor, got a stent. Hard decision without much information.