39 Comments

It's quite simple: DES reduced restenosis rates SIGNIFICANTLY compared to BMS. This is a massive advantage. Previous to DES, we were seeing patients every 6 months with recurrent angina due to restenosis, necessitating multiple re-cath, re-stent, rotoblator, procedures & admissions, added risk etc. Not to mention the terrible drain on physicians and patients alike. This factor alone makes DES the clear winner. Further, duration of DAPT is much shorter now with the latest DES.

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This whole area is a scandal. I described it in my book, Survival in an overmedicated world: Look up the evidence yourself:

Do stents improve survival in those who need them? That is difficult to find out, because

the many trials that have been performed compare stents with something else, like bypass or

balloon angioplasty, not with doing nothing. How do you search on doing nothing? That is really

difficult. I decided to cut this Gordian Knot which, to me, always means Google: do stents improve mortality. It worked. A paper in New York Times described what we need to know with reference to a recent meta-analysis.16

The researchers reviewed eight randomized trials (7,229 patients) comparing percutaneous

coronary intervention (PCI) with standard medical care. Aha, there it was. Remember that. Try the

phrase standard medical care or standard care on Google when you do not know what to do

about studies without placebos.

Three trials enlisted stable patients after myocardial infarction, and five trials enlisted

patients with stable angina and/or ischaemia on stress testing.17 Interesting. I finally found

patients like me.

“Prescribing beta blockers, ACE inhibitors, statins and daily aspirin — now standard for

treatment of stable coronary artery disease — was just as effective as stent implantation for

prevention of chest pain, heart attack, the need for a future PCI and death.”16

One of the authors of the meta-analysis said that more than half patients with stable

coronary artery disease are implanted with stents without even trying drug treatment. They

believed the reason was financial.17 “In many hospitals, the cardiac service line generates 40%

percent of the total hospital revenue, so there’s incredible pressure to do more procedures ...

When you put in a stent, everyone is happy — the hospital is making more money, the doctor is

making more money — everybody is happier except the health care system as a whole, which is

paying more money for no better results.”

The cost of the procedure varies from about $30,000 to $50,000, and more than one million

are performed every year in the United States. That makes a total of around $40 billion a year for

doing something unnecessary that can kill you. The risk of death is about one in a thousand.16

Dr. Harlan Krumholz, a cardiology professor at Yale who was not involved in the study, said

that the findings contain a lesson for doctors treating heart patients. “When people are making

decisions, it’s important to disclose to them that this procedure - outside of an emergency - is not known to be lifesaving or to prevent heart attacks ... The vast majority of people who have this procedure have the expectation that it will help them live longer. That belief is out of alignment with the evidence.”

Angina is often the symptom that convinces doctors and patients that medical therapy is

not enough and that a stent is required. Yet, in this review, 29% of people who had a PCI still had

angina, compared to 33% of those on medication - an insignificant difference.16 One of the authors declared that, “interventional cardiologists use the analogy of a pipe blocked in a house — it’s a terrible analogy, but patients accept it. It’s simplistic and erroneous.”

But what about those who really, really need stents - those with seriously blocked

coronaries? Well, again the data are disappointing. The first truly placebo controlled trial was

published in November 2017.18 Researchers inserted catheters in all 200 patients but only stented half of them. All patients had severe (≥70%) single-vessel stenoses. The primary outcome was quite ridiculous: exercise time. Yet that utterly irrelevant outcome is recommended by both the US and the European drug regulator. Stenting was not beneficial. The exercise time increased a little more in the stent group, but the difference was not statistically significant, 16.6 seconds (95% CI –8.9 to 42.0, P = 0.20). Moreover, the average exercise time was 510 seconds, or 8.5 minutes, before the intervention, which increased by half a minute in the stent group and by a quarter of a minute in the placebo group. So what?

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I think the combo of stable CAD and ACS pts makes it a bit challenging to discern the net benefit of DES vs BMS. Given what we know about stable CAD, it is not surprising that there would be no hard outcome benefits with PCI regardless of what type of metal one sticks in there.

That expected null effect in the stable population may have obscured any possible benefit of DES just in the ACS cohort.

Be that as it may, the real benefit of DES is in reducing neointimal hyperplasia and ISR…which is akin to stable CAD. I would have had a pessimistic prior for it to show hard outcome benefits.

In this case, particularly when it comes to cost, I think it would be relevant to consider the cost of recurrent and TL revasc vs the upfront cost penalty in using the more expensive DES.

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Create the condition and or ‘catastrophize’ a known condition and market the hell out of it along with the ‘new’ and fantastic solution. Worked for a med device company. :).

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Greatly appreciate and enjoy your articles. On this rare occasion we might have to disagree. UK interventional cardiologist here with some historical perspective. Benefits of drug eluting stents (DES) were never about reducing incidence of death or non-fatal heart attacks, the primary endpoint of NORSTENT. Prior to DES, the Achilles heel of PCI was instent restenosis (ISR) to the extent that PCI would be avoided in those patients with lesions most likely to restenose, typically diabetics with small vessels needing long stents. ISR was a huge issue in the era of bare metal stents (BMS) with masses of research into treatments- remember the use of brachytherapy? DES revolutionised practice and patients who would not have been offered PCI previously are now treated routinely with good outcomes.

The patients included in NORSTENT are probably not typical of those treated today- the data provided is limited but there seem to have been more patients than we see today in whom restenosis rates would be predicted to be low- focal disease in fairly large vessels and remarkably few diabetics.

I would suggest that NORSTENT was not primarily designed as a restenosis/revascularisation trial but even so there was a significant difference in revascularisation rates favouring DES. Should we be surprised the difference was not greater? I suggest not- many factors influence the decision to offer repeat coronary angiography, a necessary prelude before repeat PCI. In general repeat revascularisation is for treatment of angina (much less often for heart attack/unstable angina), and as you argue so elegantly in previous articles, PCI does not confer any prognostic benefit (ie reduction in death or heart attack) over optimal medical therapy and risk factor control in chronic stable angina.

Not all cardiologists went to universal immediate adoption of DES when they were introduced. For many years there was concern about the risk of late stent thrombosis compared to BMS, so that DES were sometimes avoided in patients at high bleeding risk who might not tolerate prolonged anti platelet therapy especially for those less likely to develop ISR. However the costs of DES have reduced remarkably since introduction and for whatever reasons, the risks of late stent thrombosis appear to have been over-stated (at least in contemporary practice), hence the universal adoption of DES.

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Thank you very much, sir, for your comment.

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In April 2023, my IC placed a 10 mm, BMS in my left inferior pulmonary vein after it had almost totally occluded following a catheter ablation for AF. My understanding after searching the literature then was that most evidence showed no benefit to using DES for pulmonary vein stenosis—as long as the BMS is at least 10 mm diameter, there is a low rate of restenosis. I certainly hope this is true. I realize that coronary arteries and pulmonary veins are not the same environment, but it would seem that the size of the coronary stent would also play a large part in outcomes.

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Ontario examined the effectiveness and safety of DES.

Tu JV, Bowen J, Chiu M, Ko DT, Austin PC, He Y, Hopkins R, Tarride JE, Blackhouse G, Lazzam C, Cohen EA, Goeree R. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med. 2007 Oct 4;357(14):1393-402. doi: 10.1056/NEJMoa071076. PMID: 17914040.

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I eschewed stents when the cardio guy wanted me to have them installed 3.5 years ago after a mild heart attack. Of course, no one in the medical world would explain exactly what happened and what the stress test revealed. No informed consent whatsoever. It was that they needed to do a catherization ASAP. And of course there were going to be statins and other heart drugs prescribed and I said no to those also.

I am nearing 75 and am using herbs and hi-potency cayenne tincture with no further problems. You guys are missing the boat. You cannot prove that having stenting ensures a longer life or that not having stenting condemns you to death. You can't even decide which forms of stents are best to use. Good grief and you wonder why (smart) patients run for the hills.

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We must remember, Crixcyon, that we may be statistical outliers, at least to some degree. In my case, it was acute cardiogenic shock from a 100% occlusion of the left anterior descending artery at the pivotal juncture; the classic "widow maker."

There are wild variations of presentation and existing arterial occlusion, along with other confounding factors. Having just concluded year four post-STEMI, and desisting from lipid and beta-adrenergic therapy at year 2.5, an unmedicated EF of 55% and BP of 117/74 is anomalous.

In both your case and mine, lifestyle changes have proven sufficient. Few are conscientious adherents to such changes, and that is a factor in prescribing these pharmaceutical horrors; it's a utilitarian calculus that "paints by numbers" without considering individual circumstance, and that's the core of the problem.

All the best to you and congratulations on your recovery. I was denied revascularization of secondary occlusions of no minor significance, on the basis of flawed trials such as ISCHEMIA and a few others. Statistically, this inverts the reported trial outcomes in another year, but that's okay, gotta die sometime and my number would already have been up, had I not been four minutes away from a trauma center with an empty cath lab and a renowned surgeon standing by.

For anyone critical of my characterization of ISCHEMIA and the other studies, I refer you to the inclusion/exclusion criteria, end point dismissiveness of basic functionality as "quality of life" and endpoint inversion at the five-year mark. The data was manipulated before ever it was accrued, by the simple mechanism of trial subject gerrymandering.

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I forgot to mention that all the trials comparing different types of stents with one another diverts attention from the fact that stents offer no benefits over "optimal medical therapy" for those with stable coronary artery disease and debatable benefits for those with unstable disease.

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Look a bit more deeply into the trials and research papers, Mr. Curtis. You may find reason for dismay at the conclusions.

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Wow! This is really challenging fundamental dogma in the interventional community. Despite my innate skepticism of new devices in cardiology I had never questioned the superiority of the DES over the bare metal ones.

One thing I have observed in last 3 decades is that in the era of DES we rarely see restenosis except in those who are noncompliant/ and/or smoke cigarettes. I assumed that a lot of this improvement was due to DES but it may have been other factors such as more effective lipid lowering therapy, DAPT, etc.

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Had no idea millions of stents are placed yearly. Are preventive efforts for vascular disease not working?

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Preventive medicine for vascular disease has a long and unbroken history of failure. The diets, drugs, and stents may not work for the patients, but they work great for the manufacturers of the drugs and devices and the doctors that prescribe and use them.

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Are you joking? The drugs ain't gettin' it.

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Marketing, lobbying, and complete take-over of "expert panels" that establish guidelines for treatment. Same m.o. that has proven successful for statin drugs and numerous other drugs and devices.

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Just from a cost point of view, it matters how much more expensive a a DES is (both stent cost and extended duration of DAPT).

Google says a DES is $1K more than a BMS. So if you place 100 stents it will cost you an additional $100K not counting DAPT.

However, you are saving five stent revisions. How much do those cost? (Need to include costs of placement, repeat DAPT, and whatever additional follow-up is required.)

This is a back-of-the-envelope model, but it's worth figuring out carefully before deciding that DES are more expensive to the system. And, you're saving five patients a procedure, and that matters to them.

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Great reminder. Other reasons: Peer pressure fueled by marketing. Minimal restenosis=a happier patient that doesn’t have to come back for procedures (a form of loss aversion or risk bias where the times that a patient with a BMS has any problem is weighed more than the same in a DES patient) ; a happier referring doctor whose patient doesn’t come back with angina and therefore refers more patients; IC see a “nicer” angiographic result on repeat procedures and are framed to choose DES despite lack of hard point clinical benefit—another consequence of the well described oculostenotic reflex.

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Oculostenotic reflex. I havent heard that one before, but I love it!!!!

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Now just a dang minute! Interventional guy (ret) here. True the evidence has come to show no benefit in major clinical outcomes with drug-eluting stents, but it also has very solidly established no safety concerns like early or late stent thrombosis or bleeding. That I would say has been the general understanding for decades. The repeat revascularization issue is not trivial. Nobody wants to come back to the cath lab who doesn’t have to. And more who received bare-metal stents will come back. I’ll offer that it is this secondary advantage to DES that is the reason for their popularity, and it’s a perfectly good reason.

Let me also point out that while more patients with BMS are revascularized, the clinical reason for that does not show up in the clinical endpoint findings. Yet there is a reason and it operates in all comparisons of the two classes of stents.

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Incredible and stunning - hard not to get completely discouraged on so many levels...

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