The People's Perspective on Medicine

Beware Routine Stents or Bypass Surgery for Stable Heart Disease

Heart patients have been told for years that stents or bypass surgery prevent heart attacks and prolong life. A $100 million study contradicts that belief.
Angioplasty and stent concept as a heart disease treatment symbol with an implant in an artery that has cholesterol plaque blockage being opened for increased blood flow as a 3D illustration.

Reader Alert: I am not an impartial observer of the latest study on stents or bypass surgery. Although my 92-year-old mother (Helen Graedon) did not suffer symptoms of angina, she was talked into angioplasty on December 13, 1996. The cardiologists were impressed that four of her coronary arteries were “clean.” One, however, had a partial blockage.

She was told that angioplasty would be beneficial. She died the morning after her procedure. Several serious medical mistakes led to her horrific death, but had she arrived at this prominent hospital today I would like to believe the cardiologists would not have recommended angioplasty, stents or bypass surgery!

Why the Caution About Stents or Bypass Surgery?

New research challenges the wisdom of routine angioplasty, stent placement or bypass surgery for stable coronary disease. This $100 million study called “ISCHEMIA” involved over 5,000 patients. They all had substantial heart disease.

These high-risk patients were randomized to get either surgery or drugs and lifestyle interventions. After four years, the investigators found that there was no difference in the likelihood of sudden cardiac death, heart attacks or heart failure between the two groups.

Are Cardiologists Salesmen for Stents or Bypass Surgery?

No doubt this important finding will come as a shock to the millions of heart patients who have already had angioplasty, stents or bypass surgery. That’s because such patients have been told for decades that opening a partially blocked coronary artery could save their lives.

A prominent cardiologist we know called this the “oculostenotic reflex.” That’s an insider doctor joke. A commentary in JAMA Internal Medicine (Oct. 2014) titled “Fighting the Oculostenotic Reflex” describes it this way:

“Many physicians are influenced by the so-called oculostenotic reflex, in which any significant stenosis seen during the catheterization is subject to treatment, even if evidence suggests no benefit.”

That’s doctorspeak. What it means in normal language is that if a doctor sees (oculo) some blockage (stenosis) in a coronary artery he is likely to reflexively tell the patient it needs to be treated. And when an interventional cardiologist shows the patient and his family the blockage and adds the overwhelming words: “you’re a heart attack waiting to happen,” most people are easily convinced that they need stents or bypass surgery pronto. That’s even true if they have no symptoms of heart disease.

Why Don’t Cardiologists Believe in COURAGE?

This is not the first time that stenting has fallen short for people with stable heart disease. A study more than a decade ago called COURAGE stunned interventional cardiologists. The researchers randomized 2,287 patients to receive either angioplasty with stent placement or drug therapy and lifestyle changes.

People who got stents to open clogged arteries did not live longer or have fewer heart attacks or strokes than those on medications alone (New England Journal of Medicine, April 12, 2007).  This was after five years.

Not surprisingly, many interventional cardiologists objected. After all, this trial challenged a basic premise of cardiology: revascularization by opening clogged coronary arteries was supposed to 1) reduce the risk of a heart attack or stroke and 2) extend life.

Most doctors pride themselves on practicing evidence-based medicine. That means that they do things for which there is solid scientific evidence and avoid things that lack such evidence. One might have imagined that the COURAGE trial would have had a dramatic impact upon the placement of stents or bypass surgery.

Ignoring COURAGE?

Investigators wanted to assess the impact of COURAGE upon interventional cardiology (JAMA, May 11. 2011). They reviewed the medical records of roughly 500,000 patients who had experienced angina because of blockage in their coronary arteries. These people had what is referred to as stable heart disease. That means people experience chest pain or tightness after physical activity or emotional stress. It is “stable” because the discomfort is familiar and is not getting worse. 

What the researchers discovered was that only 44% of the patients scheduled for stents or bypass surgery were given what was considered optimal medical therapy (OMT aka drugs and lifestyle interventions). In other words, many interventional cardiologists were ignoring the results of the COURAGE trial and proceeding with a surgical intervention as usual.

In their own words, the authors state:

“Our study demonstrated that less than half of patients undergoing PCI [percutaneous coronary intervention aka angioplasty with stents] are taking OMT before their procedure, despite the guideline-based recommendations to maximize OMT and the clinical logic of doing so before PCI so that the need for additional symptom relief from revascularization can be appreciated. Even after publication of the COURAGE trial, little change in this practice pattern was observed.”

The Scandalous ORBITA Study:

But wait…there’s more! British scientists conducted a study called ORBITA (Objective Randomised Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina). It was published in The Lancet (Jan. 6, 2018).  This study would not have been conducted in the U.S. That’s because most cardiologists would have considered it unethical.

Here’s what the British cardiologists did. They recruited 200 patients suffering from severely clogged coronary arteries. These people experienced chest pain after exercise. All patients were prescribed medications to enhance their heart function. They then were randomized to receive either angioplasty with stents or sham surgery. Yes, you read right. Sham surgery!

How did the Brits perform this sham surgery? The British cardiologists threaded a catheter all the way to the coronary artery and then immediately pulled it out again. There was no angioplasty and no stent inserted in the artery. While it was true that the patients who got angioplasty and stents had better blood flow to the heart, they did not experience less chest pain or better exercise tolerance than the group that got placebo surgery. You can read more details about this extraordinary research at this link:

The Shocking Results of a Heart Stent Experiment

Fast Forward to 2019:

At the American Heart Association Meetings on November 16, 2019, another shoe dropped on the cardiology community. The ISCHEMIA study we described at the top of this post cost $100 million. This was your tax dollars at work.

It demonstrated that stents or bypass surgery do not guarantee protection against heart attacks. Nor do such procedures lead to longer life. Unlike the ORBITA trial, though, there was a difference in quality of life. The group that received revascularization had less chest pain on exertion.

The People’s Pharmacy Perspective:

The ISCHEMIA trial was well done. No doubt some cardiologists will find fault. Keep in mind that interventional cardiologists perform 500,000 stent procedures annually.

Some are absolutely necessary. That is especially true when someone has unstable angina. It can precede a heart attack. Symptoms are worse than usual and include increasing chest tightness, pressure or pain, shortness of breath, sweating, dizziness or nausea. When in doubt, call 911 or go to an emergency department! Further tests will reveal if a heart attack is imminent. In such a situation, stents or bypass surgery may well be called for.

The Death of Helen Graedon:

You can read more details about my mother’s death after angioplasty in our book, Top Screwups Doctors Make and How to Avoid Them. Find out how to prevent diagnostic disasters, prescribing problems, drug interactions and the top screwups in common conditions. Learn how to ask your doctor about the scientific evidence before undergoing procedures. 

Helen Graedon was a vibrant, engaged and intellectually curious woman right up until the day she died in one of the best hospitals in the United States. We hope no other family has to experience the horror that we went through during this medical misadventure.

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    About the Author
    Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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    Citations
    • Borden, W. B., et al, "Patterns and Intensity of Medical Therapy in Patients Undergoing Percutaneous Coronary Intervention," JAMA, May 11, 2011, doi:10.1001/jama.2011.601
    • Brown, D. L. and Redberg, R. F., "Last nail in the coffin for PCI in stable angina?" Lancet, Jan. 6, 2018, DOI:https://doi.org/10.1016/S0140-6736(17)32757-5
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    I’m so sorry to read the news of your mother’s untimely death. Few experiences are sadder than a beloved parent leaving this life.

    When my mom had angina at the age of 78, the doctors diagnosed a possible mild heart attack and recommended 3 stent placements. She had the first and almost died from a bleed-out from the pseudoaneurysm that formed after her release home (a bubble that forms in the groin area where the stent was inserted.) Anyway, after that, she refused further stents. She died recently at 95, but not from heart problems.

    I had no symptoms but my artery was 100% clogged. I had angioplasty with two stents in Feb 2019. I hope it was necessary.

    100% blockage requires prompt action. For most of the studies that have looked at stents or bypass surgery researchers are referring to “stable angina.” In other words, symptoms upon exercise or emotional stress. With 100% blockage in two arteries we assume you were experiencing symptoms.

    I am sorry to disagree with some of your comments. But I am 92 years old, had CABG in 1982 at age 55 due to severe cardiac symptoms for 2 blocked arteries including the LAD (the widow’s artery). Had no further symptoms until 1997 when I had more symptoms continuously in spite of optimal medical treatment. I am a physician with careful lifestyle, diet, and taking medications properly. But I have had 16 angioplasties since 1997, as each time there was indication by performing Fractional Flow rate to indicate angioplasty.

    I am now 92 , Height 5′ 7,’ Wt 155 lbs, walk on treadmill 30 min daily, do yard work.
    Yet my brother died at age 64 with sudden MI, and he was being treated medically. So as the saying goes, each person is different, and not one person fits the issue written in books or articles

    In May I began to experience unusual symptoms while exercising on an elliptical exercise machine. My pulse increased to over 140 within 10 minutes instead of taking the usual 20 minutes. I began to sweat more than usual, and I had very mild pain in the floor of my mouth. At first I thought my discomfort was caused by acid indigestion, but it seemed to get worse each time I exercised.

    For several years I had been exercising on an elliptical machine for 38 minutes three times a week. The first time the discomfort occurred after 20 minutes. It went away, and I continued to exercise for the full 38 minutes. To me this confirmed that my discomfort was not due to a heart problem. However, the discomfort kept getting worse, and in June I had to quit after 20 minutes and by July I could only go for 15 minutes. As soon as I stopped exercising I felt fine. I took a stress echcocardiogram a few weeks later. The test was cut short, and I was admitted to the hospital. I had 3 stents placed, and now I can exercise 38 minutes without discomfort.

    I had a full body scan which showed heavy calcification near the ‘widow maker’ area of my heart. My walking had become very labored and a bit painful. I had a stress test, followed by a heart attack in March. Stent inserted. I’m walking farther, faster and without chest pain. I take 12.5 mg of Metoprolol, Plavix, Low Dose Aspirin and 20Mg Lipitor. Doing great!

    In view of the study, even though I’ve had a stent for the last ten years, with no pain or problems, I would seriously question the value of having any more. It should be pointed out that my wife and I exercise regularly and are very careful about what we eat. Incidentally, I also have a pacemaker and AFIB.

    My husband had some aching in his upper arm after exercise and was sent to a cardiovascular surgeon whose care he has had for some time. Two 90 % blockages and one 60% blockage were discovered. The two 90 % blockages were stented and he was given exercise and diet information to deal with the 60% blockage. He has neuropathy in his legs and feet and some knee problems. Instead of learning and using the diet and exercise routine, he sits much of the time and is not losing the extra weight either. I believe he should have been kept in rehab for a much longer period of time and been required to meet regularly with a dietitian with updated knowledge and the ability to get sedentary people on their feet and making changes in their eating habit. I never have thought that stents did much good. But lifelong bad eating and exercise habits are very difficult to change.

    In 1996, I, a 55 year-old man with a family history of coronary arteriole sclerosis, had angioplasty, with stent, following shortness of breath and chest pain. I immediately returned to my active life, trouble-free, but thinner. In 2010, chest pain returned with shortness of breath. After angioplasty verified my clogged arteries, I had quadruple bypass surgery. To this day, I live a normal, active life, while watching my diet and on a daily regimen of blood-pressure, cholesterol-lowering, blood thinner and joint pain tablets. I’m convinced I would long be dead without my angioplasty, stent and bypass surgery accomplishments. My slightly obese dad died at 48, two years after his initial clogged-artery heart attack. He only had nitroglycerin tablets available to him back then.

    Thanks for the information and the courage to speak up. I sincerely believe that diet is an important corrective procedure to prevent and reverse disease. If everyone would stop eating so much animal products we would all be healthier. With a veggie and fruit diet and some nuts (limited and hopefully NO meats and other animal products) maybe we could reverse most/all diseases. I believe this but admit that is hard to do.

    Another example of where people take the easy way out rather than do life style changes for safer and better outcomes.

    Since health care makes up almost 20% of the US economy, you wouldn’t want to see doctors and support staff out of work. Thus, you have all kinds of unnecessary and useless procedures being performed at high costs so the medical system can support the luscious lifestyles of medical practitioners. The same goes for drug sales. Heart disease starts before you reach 20 in most people. It usually takes decades to become a minor or a major problem. I believe it can be thwarted or delayed with preventative measures you will not hear from your doctor.

    My dad had bypass surgery in 1988. The doctor had told him it wasn’t an emergency. He had no symptoms. He died 3 days later from horrible complications-he had developed a UTI, had high cever, blood in his urine, and the hospital sent him home anyway. They told him his insurance had run out. My dad was only 68 years old. This was an unnecessary procedure. Thank you for validating

    I’m not privy to the cost of stent placement, but I’m guessing whatever it is, multiplying it times 500,000 adds up to a hefty chunk of change. I’ve noted that cardiologist seem to among the worst at refusing new data (especially if it involves less expensive options), and I find myself wondering if it’s because they get more kickbacks and incentives than most.

    Thanks for publishing this important story. I doubt if the profession will thank you. I currently live in a small country in which all but the easiest procedures are unavailable and only a few can afford to travel. Nevertheless. Visiting doctors tell me the health of the population seems excellent.

    * Be nice, and don't over share. View comment policy^