The historic approach to invasive management of stable coronary artery disease in the United States (U. S.) is one reason why U. S. healthcare costs are nearly twice those of any other developed nation and U. S. longevity is the poorest among all of those countries. Another is that the U. S. has one of the most sedentary, obese populations in the world, in part, because U. S. medical schools do such a terrible job teaching medical students about exercise and nutrition, the 2 most important therapeutic interventions in medicine, and physician have inadequate knowledge about those topics. Also, no other nation in the world uses the Relative Value Unit (RVU) System, which should be demolished. The RVU Update Committee, which determines RVUs, is heavily "stacked" with procedurists; hence procedures such as coronary artery revascularization and pharmacologic stress tests, are reimbursed far out of proportion to their effect (or lack thereof) on clinical outcome. The U. S. healthcare system is designed to maximize profits for providers and healthcare institutions and not clinical outcome and, for some reason, most patients, Congress and Medicare can't seem to understand that. However, great over-valued bubbles such as the U. S. healthcare system generally come to an end, often rather abruptly, such as the internet bubble in 2000, the housing bubble in 2008 and the artificial intelligence bubble now.
There should be a journal club with these three articles (COURAGE ORBITA ISCHEMIA) twice during cardiology fellowship. One on the first day, and one on the last day.
A small note on the statistical methodology: the hazard ratio (reported to be 0.93 for the primary outcome) is calculated on the assumption that the hazard of failure in one group (i.e., the failure rate at a specific point in time) is a constant multiple of the hazard in the other group. When the failure curves cross (as in this case and as noted by John) it is impossible for the hazards to be proportional. In this case, the intervention arm has failures at a greater rate earlier on and a slower rate later on than the conservative therapy arm. This means that the hazard ratio isn't measuring a quantity that describes the overall relative effectiveness of the two arms across the length of the study. And as a result, the statistical test and resulting p-value are meaningless.
There is no mystery as to why Stress Testing has not decreased since Courage, Ischemia and ORBITAL;
Specifically, POS revenue, Downstream revenue (cath,PCI, CABG), patients' expectations and Med Mal concerns. These will never change until ACC and AHA shout from the rooftops to physicians and the public that looking for and treating ischemia in minimally or a-symptomatic stable patients is of little benefit.
I don't fully understand all the technical jargon, but after a positive stress test about 2 years ago, the cardiologist was in somewhat of a hurry to get me in for a catherization and probably a stent or two. There was no explanation of the results of the stress test, no informed consent about having a catherization and stents (risk assessment), or no talk about the risk of having the procedure verses not having it. No options for other testing or evaluations or other possible solutions or courses of action.
I imagine this is pretty much standard in the cardio business. Pack 'em, rack 'em and stack 'em. I cannot blindly trust any doctor when they do not lay out the story in plain view, other than perhaps in a life threatening emergency...which is gonna come along how many times in a lifetime? Zero for me at age 73.
If I understand the trial correctly, there was virtually no difference in doing something verses not doing something. Looks to me that all this modern medicine is no more than a coin flip, which will only cost me a quarter if that is what I choose to flip. I figured the cost for the procedure and the stents would be somewhere between $30-50,000. Totally ridiculous.
Why has Ischemia trial not caused a sea-change in cardiology practice? One needs to look no further than at the ….umm…. disparities in incentives…..ie reimbursement. Catheter pushers are remunerated for pushing catheters. So they will continue to push for pushing more of them, with latex and cobalt chromium chasers. Things have changed a bit more in Canada, thankfully.
Excluding LM was an unfortunate concession in trial design….probably for medico-legal reasons. But as you know, more contemporary trials like Noble and Excel for LM disease did not have a medical therapy arm. I wonder if such a trial will ever be done.
Just in the last week or 2, there were 2 more Ischemia sub-studies published in JACC, regarding the cohort of pts who received anatomic or functional complete revascularization. And again, it seems no one asked how one would know who would potentially be able to have “complete revasc”….a priori to the angiogram. It would have required randomization post diagnostic angiography…but as you noted….that trial has already been done (ie Courage). So it will be that there will be constant pushing and prodding by those with incentives to do so, and the real change needs to take hold upstream of the Cath lab, among non-invasive cardiologists.
There are fifteen studies that prove opening arteries provides no benefit for people with stable angina beyond that provided by optimal medical therapy alone. Our entire system is still designed to find blockages and open them and very few patients receive best practice medical treatment. That is part of the reason that our health care costs twice as much and citizens of other developed countries live longer. Optimal medical therapy first is the way they do business in Great Britain. It is all about the money in the US. Use your influence to change our system so that we treat chronic diseases more effectively.
John, your last paragraph may be your most important. It shouldn't take a generation to adapt to the best available evidence, yet practice patterns resist change for a variety of reasons, not all altruistic. Some orthopedic surgeons continue to administer hyaluronic acid injections though not covered by insurance, not recommended and not supported by evidence. In every field of medicine we do things of questionable value. As an Internist I performed hundreds of requested pre-op surgical clearance consultations for patients scheduled for uncomplicated cataract surgery, an exceedingly safe procedure for patients who would benefit, are not in distress, have a pulse and the ability to cooperate during surgery. Resistance to change deeply held beliefs, fear of litigation, financial incentives, inertia all play a role.
I’m a retired physician with all the ABIM baubles that go with it. The way you delve into methodology, pointing out the details of the interpretation are invaluable.
This Stack could take a year off the two years of Med School Basic Science.
I send my patients with heavy plaque burden (3 vessel disease, left main disease, or score over 400) to cardiology. Everyone else I put on lifestyle changes and a statin. I have found more restraint by the cardiologists in the past few years even for those with a positive stress test. And yes, what about preop in major surgery for those with positive ST?
You do such a wonderful job of explaining medical jargon in simple terms, Dr. M. If all cardiologists would do the same with each patient in this situation, it would lead to truly informed shared decision making. It would probably be even better if a diverse cardiology team were involved (see link below). As my PCP told me years ago when referring me to a non-surgical orthopedist first, he said if I went to a surgeon first, the recommendation would no doubt be surgery because when you have a hammer, everything looks like a nail. As an aside, in addition to the placebo effect, I wonder if learning you have clogged arteries leads to greater changes in behavior? It would scare the bejesus out of me!
Who do I speak to about getting CME credit? But seriously, What’s an anesthesiologist to do with a patient for major abdominal surgery and a positive stress test? Tough to answer without another study, I suppose.
The historic approach to invasive management of stable coronary artery disease in the United States (U. S.) is one reason why U. S. healthcare costs are nearly twice those of any other developed nation and U. S. longevity is the poorest among all of those countries. Another is that the U. S. has one of the most sedentary, obese populations in the world, in part, because U. S. medical schools do such a terrible job teaching medical students about exercise and nutrition, the 2 most important therapeutic interventions in medicine, and physician have inadequate knowledge about those topics. Also, no other nation in the world uses the Relative Value Unit (RVU) System, which should be demolished. The RVU Update Committee, which determines RVUs, is heavily "stacked" with procedurists; hence procedures such as coronary artery revascularization and pharmacologic stress tests, are reimbursed far out of proportion to their effect (or lack thereof) on clinical outcome. The U. S. healthcare system is designed to maximize profits for providers and healthcare institutions and not clinical outcome and, for some reason, most patients, Congress and Medicare can't seem to understand that. However, great over-valued bubbles such as the U. S. healthcare system generally come to an end, often rather abruptly, such as the internet bubble in 2000, the housing bubble in 2008 and the artificial intelligence bubble now.
Wade Martin, MD, FACC, FACP, FACSM
There should be a journal club with these three articles (COURAGE ORBITA ISCHEMIA) twice during cardiology fellowship. One on the first day, and one on the last day.
A small note on the statistical methodology: the hazard ratio (reported to be 0.93 for the primary outcome) is calculated on the assumption that the hazard of failure in one group (i.e., the failure rate at a specific point in time) is a constant multiple of the hazard in the other group. When the failure curves cross (as in this case and as noted by John) it is impossible for the hazards to be proportional. In this case, the intervention arm has failures at a greater rate earlier on and a slower rate later on than the conservative therapy arm. This means that the hazard ratio isn't measuring a quantity that describes the overall relative effectiveness of the two arms across the length of the study. And as a result, the statistical test and resulting p-value are meaningless.
Given the financial incentives, it will never change imo
Great work John. I hope Dr. Eric Williams is a subscriber. He would be proud as would Dr. Knoebel.
There is no mystery as to why Stress Testing has not decreased since Courage, Ischemia and ORBITAL;
Specifically, POS revenue, Downstream revenue (cath,PCI, CABG), patients' expectations and Med Mal concerns. These will never change until ACC and AHA shout from the rooftops to physicians and the public that looking for and treating ischemia in minimally or a-symptomatic stable patients is of little benefit.
I don't fully understand all the technical jargon, but after a positive stress test about 2 years ago, the cardiologist was in somewhat of a hurry to get me in for a catherization and probably a stent or two. There was no explanation of the results of the stress test, no informed consent about having a catherization and stents (risk assessment), or no talk about the risk of having the procedure verses not having it. No options for other testing or evaluations or other possible solutions or courses of action.
I imagine this is pretty much standard in the cardio business. Pack 'em, rack 'em and stack 'em. I cannot blindly trust any doctor when they do not lay out the story in plain view, other than perhaps in a life threatening emergency...which is gonna come along how many times in a lifetime? Zero for me at age 73.
If I understand the trial correctly, there was virtually no difference in doing something verses not doing something. Looks to me that all this modern medicine is no more than a coin flip, which will only cost me a quarter if that is what I choose to flip. I figured the cost for the procedure and the stents would be somewhere between $30-50,000. Totally ridiculous.
Why has Ischemia trial not caused a sea-change in cardiology practice? One needs to look no further than at the ….umm…. disparities in incentives…..ie reimbursement. Catheter pushers are remunerated for pushing catheters. So they will continue to push for pushing more of them, with latex and cobalt chromium chasers. Things have changed a bit more in Canada, thankfully.
Excluding LM was an unfortunate concession in trial design….probably for medico-legal reasons. But as you know, more contemporary trials like Noble and Excel for LM disease did not have a medical therapy arm. I wonder if such a trial will ever be done.
Just in the last week or 2, there were 2 more Ischemia sub-studies published in JACC, regarding the cohort of pts who received anatomic or functional complete revascularization. And again, it seems no one asked how one would know who would potentially be able to have “complete revasc”….a priori to the angiogram. It would have required randomization post diagnostic angiography…but as you noted….that trial has already been done (ie Courage). So it will be that there will be constant pushing and prodding by those with incentives to do so, and the real change needs to take hold upstream of the Cath lab, among non-invasive cardiologists.
There are fifteen studies that prove opening arteries provides no benefit for people with stable angina beyond that provided by optimal medical therapy alone. Our entire system is still designed to find blockages and open them and very few patients receive best practice medical treatment. That is part of the reason that our health care costs twice as much and citizens of other developed countries live longer. Optimal medical therapy first is the way they do business in Great Britain. It is all about the money in the US. Use your influence to change our system so that we treat chronic diseases more effectively.
https://www.ajmc.com/view/aug08-3509p521-528
John, your last paragraph may be your most important. It shouldn't take a generation to adapt to the best available evidence, yet practice patterns resist change for a variety of reasons, not all altruistic. Some orthopedic surgeons continue to administer hyaluronic acid injections though not covered by insurance, not recommended and not supported by evidence. In every field of medicine we do things of questionable value. As an Internist I performed hundreds of requested pre-op surgical clearance consultations for patients scheduled for uncomplicated cataract surgery, an exceedingly safe procedure for patients who would benefit, are not in distress, have a pulse and the ability to cooperate during surgery. Resistance to change deeply held beliefs, fear of litigation, financial incentives, inertia all play a role.
I’m a retired physician with all the ABIM baubles that go with it. The way you delve into methodology, pointing out the details of the interpretation are invaluable.
This Stack could take a year off the two years of Med School Basic Science.
Fascinating - thank you!
I send my patients with heavy plaque burden (3 vessel disease, left main disease, or score over 400) to cardiology. Everyone else I put on lifestyle changes and a statin. I have found more restraint by the cardiologists in the past few years even for those with a positive stress test. And yes, what about preop in major surgery for those with positive ST?
You do such a wonderful job of explaining medical jargon in simple terms, Dr. M. If all cardiologists would do the same with each patient in this situation, it would lead to truly informed shared decision making. It would probably be even better if a diverse cardiology team were involved (see link below). As my PCP told me years ago when referring me to a non-surgical orthopedist first, he said if I went to a surgeon first, the recommendation would no doubt be surgery because when you have a hammer, everything looks like a nail. As an aside, in addition to the placebo effect, I wonder if learning you have clogged arteries leads to greater changes in behavior? It would scare the bejesus out of me!
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1440300/
Who do I speak to about getting CME credit? But seriously, What’s an anesthesiologist to do with a patient for major abdominal surgery and a positive stress test? Tough to answer without another study, I suppose.