Sham surgery trials prove that procedures like nonemergency stents offer no benefit for angina pain—only risk to millions of patients.
Do Heart Stent Procedures Work for Angina Chest Pain?
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Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.
Angioplasty and stents for non-emergency coronary artery disease is one of the most common invasive procedures performed in the United States. Though it appeared to offer immediate relief of angina chest pain in stable patients with coronary artery disease, it didn’t actually translate into a lower risk of heart attack or death. This is because the atherosclerotic plaques that narrow blood flow tend not to be the ones that burst and kill you. But hey, symptom control is important—that’s much of what we do in medicine. But cardiology has a bad track record when it comes to performing procedures that don’t actually end up helping at all.
Case in point: internal mammary artery ligation. Though it didn’t make much anatomical sense, why tying off arteries to the chest wall and breast would somehow improve coronary artery circulation, it worked like a charm. Immediate improvement in 95 percent of hundreds of patients. Could it have been just some elaborate placebo effect, and they were cutting into people for nothing? There’s only one way to find out. You cut into people for nothing.
They randomized people to get the actual surgery or a fake surgery where they cut you open and get to the last step, but don’t actually tie off those arteries. And … the patients who underwent the fake surgery experienced the same relief. Check out the testimonials. “[I]mmediately, I felt better.” “ …95 percent better.” “No chest trouble even with exercise.” “ … I’m cured!” And these are all people who got the sham surgery. So, it was just an extravagant placebo effect. Think about it. Some frightened, poorly-informed man with angina chest pain, winding himself tighter and tighter, sensitizing himself to every twinge of chest discomfort, who then comes into the environment of a great medical center and a powerful, positive, paternalistic personality and hears how great it’s going to be, goes through the whole operation and leaves a new man with his trademark scar.
One sham patient was actually cured though. “The patient is optimistic and says he feels much better.” Office note the next day: Patient dropped dead. So, no more chest pain!
This has happened over and over. I’ve got an idea! How about we burn holes in the heart muscle with lasers to create channels for blood flow. Worked great, until it was proven that it doesn’t work at all. Cutting the nerves to your kidneys was heralded as a cure for hard-to-treat high blood pressure until sham surgery proved the procedure itself was a sham. The necessity for placebo-controlled trials has been rediscovered several times in cardiology, typically to considerable surprise. Before they are debunked, often the therapy is thought to be so beneficial that a placebo-controlled trial is deemed unnecessary and perhaps even unethical. That was the case with stents.
Hundreds of thousands of angioplasties and stents are done every year, yet placebo-controlled trials had never been done. Why? Because cardiologists were so unquestionably sure it worked that it would be unethical to perform a fake procedure to prove something we already know is true. When patients are aware that they have had a stent, they have a clear reduction in angina and improved quality of life. But what if they weren’t aware? Would it still work?
Enter the ORBITA trial. After all, anti-angina medication is only taken seriously if there is blinded evidence of symptom relief against a placebo pill; so, why not pit stents against a placebo procedure. In both groups, doctors threaded a catheter through the groin or wrist of the patient, and with X-ray guidance, went up to the blocked artery, and then either inserted a stent or just pulled the catheter back out.
They had problems even getting the study funded. They were told we already know the answer to this question—of course, stents work—and that’s even what the researchers themselves thought. They were interventional cardiologists themselves. They just wanted to prove it. Boy, were they surprised. Even in patients with severe coronary artery narrowing, angioplasty and stents did not increase exercise time more than the fake procedure.
“Unbelievable” read the New York Times headline, remarking that the results “stunned leading cardiologists by countering decades of clinical experience.” In response to the blowback, the researchers wrote that they sympathize with everyone’s shock and disbelief. Yes, we could have tried to spin it somehow, but they had a duty to preserve scientific integrity.
While some commended them for challenging the existing dogma around a procedure that has become so routine, ingrained, and profitable, others questioned their ethics. After all, four patients in the placebo group had complications from the guide wire insertion and required emergency measures to seal the tear they made in the artery. There were also three major bleeding events in the placebo group; so, they suffered risks without even a chance of benefit. But “[f]ar from demonstrating the risks of sham-controlled trials, this demonstrates exactly what patients are being subjected to on a routine basis” for nothing.
Those few complications in the trial are dwarfed by the thousands that have been killed or maimed by the procedure over the years. You want unethical? How about the fact that an invasive procedure has been performed on millions of people before it was ever actually put to the test? Maybe we should consider the absence, not the presence, of sham control trials to be the greater injustice.
When a former FDA commissioner was asked at the American Heart Association meeting whether sham controls should be required for the approval of all devices, he replied, “Do you want to get the truth or not?”
Please consider volunteering to help out on the site.
- Fernandez A. Improving the quality of informed consent: it is not all about the risks. Ann Intern Med. 2010;153(5):342-3.
- Rothberg MB. PCI for stable angina: a missed opportunity for shared decision-making. Cleve Clin J Med. 2018;85(2):105-21.
- Khot UN. Having the COURAGE to include PCI in shared decision-making for stable angina. Cleve Clin J Med. 2018;85(2):124-7.
- DE BAKEY ME, HENLY WS. Surgical treatment of angina pectoris. Circulation. 1961;23:111-20.
- GLOVER RP, KITCHELL JR, KYLE RH, DAVILA JC, TROUT RG. Experiences with myocardial revascularization by division of the internal mammary arteries. Dis Chest. 1958;33(6):637-57.
- BATTEZZATI M, TAGLIAFERRO A, CATTANEO AD. Clinical evaluation of bilateral internal mammary artery ligation as treatment coronary heart disease. Am J Cardiol. 1959;4(2):180-3.
- DIMOND EG, KITTLE CF, CROCKETT JE. Comparison of internal mammary artery ligation and sham operation for angina pectoris. Am J Cardiol. 1960;5:483-6.
- Leon MB, Kornowski R, Downey WE, et al. A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. J Am Coll Cardiol. 2005;46(10):1812-9.
- Mearns BM. Hypertension: is renal denervation a cure for drug-resistant disease? Nat Rev Cardiol. 2011;8(1):2.
- Bhatt DL, Kandzari DE, O'Neill WW, et al. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014;370(15):1393-401.
- Al-Lamee R, Thompson D, Dehbi HM, et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018;391(10115):31-40.
- Al-Lamee RK, Nowbar AN, Francis DP. Percutaneous coronary intervention for stable coronary artery disease. Heart. 2019;105(1):11-19.
- Kolata G. ‘Unbelievable’: heart stents fail to ease chest pain. The New York Times. November 2, 2017.
- Al-Lamee R, Francis DP. Swimming against the tide: insights from the ORBITA trial. EuroIntervention. 2017;13(12):e1373-5.
- Gelman A, Carlin JB, Nallamothu BK. Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina (ORBITA) and coronary stents: a case study in the analysis and reporting of clinical trials. Am Heart J. 2019;214:54-9.
- Francis D. Percutaneous coronary intervention for stable angina in ORBITA. Lancet. 2018;392:28-30.
- Brown DL, Redberg RF. Last nail in the coffin for PCI in stable angina? Lancet. 2018;391(10115):3-4.
- Zaman AG. ORBITA - much ado about nothing? J R Coll Physicians Edinb. 2018;48(1):40-3.
- Warriner DR, O'Sullivan JW. Has too much cardiology been sent into the appropriateness ORBITA? BMJ Evid Based Med. 2018;23(2):48-9.
- Konigstein M, Ben-Yehuda O. The ORBITA trial and the future of percutaneous coronary intervention for stable angina. Coron Artery Dis. 2018;29(6):447-50.
- Prasad V, Cifu AS. The Necessity of Sham Controls. Am J Med. 2019;132(2):e29-30.
- Ward T. ORBITA: sham PCI trial sends stents and CardioTwitter reeling. Medscape. December 12, 2017.
Video production by Glass Entertainment
Motion graphics by Avocado Video
Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.
Angioplasty and stents for non-emergency coronary artery disease is one of the most common invasive procedures performed in the United States. Though it appeared to offer immediate relief of angina chest pain in stable patients with coronary artery disease, it didn’t actually translate into a lower risk of heart attack or death. This is because the atherosclerotic plaques that narrow blood flow tend not to be the ones that burst and kill you. But hey, symptom control is important—that’s much of what we do in medicine. But cardiology has a bad track record when it comes to performing procedures that don’t actually end up helping at all.
Case in point: internal mammary artery ligation. Though it didn’t make much anatomical sense, why tying off arteries to the chest wall and breast would somehow improve coronary artery circulation, it worked like a charm. Immediate improvement in 95 percent of hundreds of patients. Could it have been just some elaborate placebo effect, and they were cutting into people for nothing? There’s only one way to find out. You cut into people for nothing.
They randomized people to get the actual surgery or a fake surgery where they cut you open and get to the last step, but don’t actually tie off those arteries. And … the patients who underwent the fake surgery experienced the same relief. Check out the testimonials. “[I]mmediately, I felt better.” “ …95 percent better.” “No chest trouble even with exercise.” “ … I’m cured!” And these are all people who got the sham surgery. So, it was just an extravagant placebo effect. Think about it. Some frightened, poorly-informed man with angina chest pain, winding himself tighter and tighter, sensitizing himself to every twinge of chest discomfort, who then comes into the environment of a great medical center and a powerful, positive, paternalistic personality and hears how great it’s going to be, goes through the whole operation and leaves a new man with his trademark scar.
One sham patient was actually cured though. “The patient is optimistic and says he feels much better.” Office note the next day: Patient dropped dead. So, no more chest pain!
This has happened over and over. I’ve got an idea! How about we burn holes in the heart muscle with lasers to create channels for blood flow. Worked great, until it was proven that it doesn’t work at all. Cutting the nerves to your kidneys was heralded as a cure for hard-to-treat high blood pressure until sham surgery proved the procedure itself was a sham. The necessity for placebo-controlled trials has been rediscovered several times in cardiology, typically to considerable surprise. Before they are debunked, often the therapy is thought to be so beneficial that a placebo-controlled trial is deemed unnecessary and perhaps even unethical. That was the case with stents.
Hundreds of thousands of angioplasties and stents are done every year, yet placebo-controlled trials had never been done. Why? Because cardiologists were so unquestionably sure it worked that it would be unethical to perform a fake procedure to prove something we already know is true. When patients are aware that they have had a stent, they have a clear reduction in angina and improved quality of life. But what if they weren’t aware? Would it still work?
Enter the ORBITA trial. After all, anti-angina medication is only taken seriously if there is blinded evidence of symptom relief against a placebo pill; so, why not pit stents against a placebo procedure. In both groups, doctors threaded a catheter through the groin or wrist of the patient, and with X-ray guidance, went up to the blocked artery, and then either inserted a stent or just pulled the catheter back out.
They had problems even getting the study funded. They were told we already know the answer to this question—of course, stents work—and that’s even what the researchers themselves thought. They were interventional cardiologists themselves. They just wanted to prove it. Boy, were they surprised. Even in patients with severe coronary artery narrowing, angioplasty and stents did not increase exercise time more than the fake procedure.
“Unbelievable” read the New York Times headline, remarking that the results “stunned leading cardiologists by countering decades of clinical experience.” In response to the blowback, the researchers wrote that they sympathize with everyone’s shock and disbelief. Yes, we could have tried to spin it somehow, but they had a duty to preserve scientific integrity.
While some commended them for challenging the existing dogma around a procedure that has become so routine, ingrained, and profitable, others questioned their ethics. After all, four patients in the placebo group had complications from the guide wire insertion and required emergency measures to seal the tear they made in the artery. There were also three major bleeding events in the placebo group; so, they suffered risks without even a chance of benefit. But “[f]ar from demonstrating the risks of sham-controlled trials, this demonstrates exactly what patients are being subjected to on a routine basis” for nothing.
Those few complications in the trial are dwarfed by the thousands that have been killed or maimed by the procedure over the years. You want unethical? How about the fact that an invasive procedure has been performed on millions of people before it was ever actually put to the test? Maybe we should consider the absence, not the presence, of sham control trials to be the greater injustice.
When a former FDA commissioner was asked at the American Heart Association meeting whether sham controls should be required for the approval of all devices, he replied, “Do you want to get the truth or not?”
Please consider volunteering to help out on the site.
- Fernandez A. Improving the quality of informed consent: it is not all about the risks. Ann Intern Med. 2010;153(5):342-3.
- Rothberg MB. PCI for stable angina: a missed opportunity for shared decision-making. Cleve Clin J Med. 2018;85(2):105-21.
- Khot UN. Having the COURAGE to include PCI in shared decision-making for stable angina. Cleve Clin J Med. 2018;85(2):124-7.
- DE BAKEY ME, HENLY WS. Surgical treatment of angina pectoris. Circulation. 1961;23:111-20.
- GLOVER RP, KITCHELL JR, KYLE RH, DAVILA JC, TROUT RG. Experiences with myocardial revascularization by division of the internal mammary arteries. Dis Chest. 1958;33(6):637-57.
- BATTEZZATI M, TAGLIAFERRO A, CATTANEO AD. Clinical evaluation of bilateral internal mammary artery ligation as treatment coronary heart disease. Am J Cardiol. 1959;4(2):180-3.
- DIMOND EG, KITTLE CF, CROCKETT JE. Comparison of internal mammary artery ligation and sham operation for angina pectoris. Am J Cardiol. 1960;5:483-6.
- Leon MB, Kornowski R, Downey WE, et al. A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. J Am Coll Cardiol. 2005;46(10):1812-9.
- Mearns BM. Hypertension: is renal denervation a cure for drug-resistant disease? Nat Rev Cardiol. 2011;8(1):2.
- Bhatt DL, Kandzari DE, O'Neill WW, et al. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014;370(15):1393-401.
- Al-Lamee R, Thompson D, Dehbi HM, et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018;391(10115):31-40.
- Al-Lamee RK, Nowbar AN, Francis DP. Percutaneous coronary intervention for stable coronary artery disease. Heart. 2019;105(1):11-19.
- Kolata G. ‘Unbelievable’: heart stents fail to ease chest pain. The New York Times. November 2, 2017.
- Al-Lamee R, Francis DP. Swimming against the tide: insights from the ORBITA trial. EuroIntervention. 2017;13(12):e1373-5.
- Gelman A, Carlin JB, Nallamothu BK. Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina (ORBITA) and coronary stents: a case study in the analysis and reporting of clinical trials. Am Heart J. 2019;214:54-9.
- Francis D. Percutaneous coronary intervention for stable angina in ORBITA. Lancet. 2018;392:28-30.
- Brown DL, Redberg RF. Last nail in the coffin for PCI in stable angina? Lancet. 2018;391(10115):3-4.
- Zaman AG. ORBITA - much ado about nothing? J R Coll Physicians Edinb. 2018;48(1):40-3.
- Warriner DR, O'Sullivan JW. Has too much cardiology been sent into the appropriateness ORBITA? BMJ Evid Based Med. 2018;23(2):48-9.
- Konigstein M, Ben-Yehuda O. The ORBITA trial and the future of percutaneous coronary intervention for stable angina. Coron Artery Dis. 2018;29(6):447-50.
- Prasad V, Cifu AS. The Necessity of Sham Controls. Am J Med. 2019;132(2):e29-30.
- Ward T. ORBITA: sham PCI trial sends stents and CardioTwitter reeling. Medscape. December 12, 2017.
Video production by Glass Entertainment
Motion graphics by Avocado Video
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Title
Do Heart Stent Procedures Work for Angina Chest Pain?
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Content URLDoctor's Note
At this point, you may be thinking what a shameful, dark period of medical history. Millions of risky procedures were performed, killing people and causing strokes before it was actually put to the test. When it finally was, it was proven to offer to no benefit. Certainly, a cautionary tale for the future. In fact, they’re still being done. It’s still one of the most common invasive procedures performed in the United States. Why Are Stents Still Used if They Don’t Work? That’s the subject of the next video.
This is part of a seven-video series. If you need to catch up, here are the first four:
- Do Angioplasty Heart Stent Procedures Work?
- Why Angioplasty Heart Stents Don’t Work Better
- The Risks of Heart Stents
- Angioplasty Heart Stent Risks vs. Benefits
As I say over and over in this video series, during a heart attack, in an acute setting, angioplasty can be life-saving. As I reiterate, when I’m talking about stable CAD, I’m talking nonemergency situations. In an upcoming series I talk about pros and cons of statin drug therapy. Spoiler: If you have a history of heart disease or stroke, taking a statin is recommended. All of these videos, including the upcoming statin series, are available on a digital download of a webinar I did last year. You can find it here.
UPDATE: A new meta-analysis was just published last month and alas, there is still zero survival benefit to stent placement for stable coronary artery disease, but at least there were fewer heart attacks. Since this still didn’t translate into actually living any longer, the foundation of treatment remains medical and lifestyle management. Hat tip to Dr. Bitterman!
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