Sources
All information has been taken from an upcoming video series to be published on NutritionFacts.org. All citations and source material will be available once the videos are published.
Is Elective PCI Effective?
In 2007, the COURAGE study was published. Its goal, by randomizing thousands of patients, was to determine whether elective PCI reduced the odds of death or future occurrences of MI. The study almost never happened because of the difficulty in funding it. Everyone was so convinced of the effectiveness of PCI, that this study was generally regarded as a waste of time and money. Even the authors admitted the intent was to give additional credibility to the procedure. The result? PCI had no impact either on the patient’s longevity or reduction in future occurrences of MI. The only benefit that COURAGE found was relief from angina. These results were in line with a study done 12 years earlier, the MASS trial, which looked specifically at angioplasty. It also showed no benefit whatsoever in terms of mortality or MI rates between those electing to have angioplasty and those forgoing the procedure.
Ten years later in 2017, the ORBITA study was published that showed even the angina relief shown in COURAGE to be in doubt. ORBITA was a double-blind RCT to study the effectiveness of symptom relief gained from elective PCI. Think about this for a minute. What exactly is a control for surgery? Believe it or not, a “sham surgery” meaning, that the actual PCI-like surgery was performed but at the last minute, patients were randomly chosen either to have the stent or angioplasty balloon inserted or not. The result? Those who got the sham surgery performed just as well as those with the real surgery on subsequent tests designed to stress and measure angina.
These results were later repeated with 10 different prospective RCTs with almost 7,000 patients. All 10 results were the same: No benefit in terms of MI, mortality, or reduction of angina. Further studies also examined high-risk subsets of patients (like those with diabetes or completely blocked arteries) and the results were the same.
When taken together, COURAGE and ORBITA show that elective PCI has no benefit at all. There is no reduction in death rates, no reduction of occurrence in future MIs, and no symptom relief. This opens so many questions: hundreds of thousands of people are having PCI for nothing? Why are people agreeing to do this? Why doesn’t PCI work? How do doctors and hospitals justify these procedures?
Why Doesn’t Elective PCI Work?
How is it possible that elective PCI offers no benefits? Isn’t a PCI physically opening a diseased artery to increase blood flow? Two reasons: 1. In thousands of autopsies performed on those with heart disease, not once was there found even a 5mm segment of coronary arteries without plaque. The idea of plaque being localized instead of systemic is a myth. Meaning, it is wrong to think about heart disease in terms of this or that artery is having a problem. The whole cardio-vascular system is affected by plaque. 2. Most of the plaques that kill you are from vessels with less than 50% blockages.
These small blockages are not visible in an angiogram, so they are not being treated by stents/angioplasty. Instead of thinking about coronary artery disease (CAD) as being a slow narrowing of arteries over time, think of it as a disease of inflammation where the cholesterol being placed in artery walls causes an inflammatory reaction, much like a pimple. When that pimple bursts, blood clotting starts to heal this injury. It is these blood clots that actually cause the MI.
Because CAD is systemic, no wonder elective PCI fails as a treatment. The only viable treatment is to address the cause and keep LDL cholesterol low.
How Safe is PCI?
In 1997, the RITA-2 study was published. It was a randomized trial of more than 1,000 patients, and was aimed to measure the effectiveness of angioplasty specifically. The result? The group randomized to have angioplasty had twice the risk of death or MI as compared to the group randomized not to have the procedure.
Why Do Patients Agree to Elective PCI?
In 2014 a study was published in JAMA which sought to explore this topic. When the issue of cardiologist communications with patients was studied, it was discovered that despite cardiologists being aware of the effectiveness of elective PCI, 95% of them did not inform their patient that elective PCI would not lower the risk of death, MI, or long term symptom relief.
Why is there this communication gap? A quote from the study: “Current reimbursement favors procedures over medication and lifestyle change, and it is possible that reimbursement may influence physicians’ recommendations.” In other words, doctors are paid more for PCI than for medication and lifestyle treatments.
As for the patients’ beliefs, 78% believed that elective PCI would extend life expectancy, and 71% believed it would reduce their risk of future MI.
Simply stated, patients agree to elective PCI because they are not informed of the lack of benefit, and because patients generally have a high degree of trust in the medical community’s duty of care. It would seem obvious that any fully informed patient, based on findings from COURAGE and ORBITA would not agree to elective PCI with the hope of gaining zero benefits.
Why Is Elective PCI Recommended At All?
“It is difficult to get a man to understand something, when his salary depends upon his not understanding it” - Upton Sinclair
In 2008, a study was performed to answer this very question. It consisted of focus groups of both cardiologists and primary care physicians who make referrals. From the study, “Acknowledging the tension between the available evidence and their feelings of what was best, physicians tended to justify a non-evidence based approach (“I know the data shows there is no benefit, but …”) by focusing on the ease of PCI and the belief that an open artery was better while minimizing the risks of PCI.”
As for stent manufacturers, they, too, know the lack of benefit. Their response? “If prolongation of life was a sine-qua-non of medical interventions, most of them would no longer be supported and entire disciplines would dwindle or even disappear, such as dermatology, ophthalmology, orthopedic surgery, and dentistry.” The difference of course, is the disconnect between these medical disciplines and patient expectations. Rarely does a patient headed to the dentist do so with the expectation of extending longevity. Furthermore, patients also rightly believe they have a better than 1 in 150 chance of surviving a cavity filling.
The profitability of PCI cannot be overlooked, either. Even our favorite Dr. Shalz has told our group directly that cardiac care is easily the most profitable practice for St. Lukes.
When thousands of physicians were surveyed, 71% of them believe that doctors knowingly provide unnecessary procedures when they profit from them. The data bears out this belief. When a quantitative economic analysis was done on what recommendations were made for different chemotherapy drugs for breast cancer, it was discovered that when a physician’s margin on a particular drug increased by 10%, the rate of prescribing that drug increased up to 177%.
Likewise, when physicians are paid per procedure as opposed to a capitation basis (number of patients), surgery rates increase 78%. The US is the only developed country that provides a per procedure payment system that encourages this type of behavior, so is it a coincidence that the US performs 101% more angioplasties than any other developed country?
Because the medical community is now aware of just how ineffective PCI is for stable patients, guidelines are being put in place so that these procedures should be used only in emergency situations. However, once these guidelines went into effect, classifications of PCI as being used in emergency or unstable situations dramatically increased. For example, in New York state, this rate increased 14 times. Since the underlying biology hasn’t changed when the guidelines went into effect, this indicates that the system is being gamed, so these highly profitable procedures can continue.
How Effective Are Diet and Lifestyle Changes for Heart Disease?
The COURAGE trial did more than just show that elective PCI offered no benefit to extending a patient’s life. It also measured improved survivability as a function of how many risk factors can be controlled. Specifically, if patients did the following:
Lower blood pressure (< 130mm Hg)
Lower cholesterol (LDL < 70)
Lower BMI
Stop smoking
Improve diet (COURAGE specifically calls out the American Heart Association diet)
Increase levels of activity
then the odds were 5x higher to survive another 14 years, than those who did not.
Of course, the reason why diet and lifestyle changes are so effective is because these actually treat the condition rather than just the symptoms. Dr. Caldwell Esselstyn writes:
“These mechanical interventions treat only the symptoms, not the disease. It is therefore not surprising that patients who receive these interventions often experience progressive disease, graft shutdown, restenosis, more procedures, progressive disability and death from disease. Thus, the leading killer of men and women in Western civilization is being left untreated. What is being practiced is ‘palliative cardiology’: non treatment of heart disease leading to disease extension and frequently an eventual fatal outcome.”
90% of cardiologists report receiving no nutritional information during their training. This, despite the fact that WFPB nutrition (WFPBN) has been shown to treat 75-80% of cardiovascular patients at minimal cost with no side effects. Speaking of cardiologists, Dr. Esselstyn further writes,
“why do they resist WFPBN? Cardiovascular medicine practitioners receive essentially no nutrition education in medical school or postgraduate training. Therefore, they lack not only the skill set needed to help their patients modify their diets but also a basic awareness that plant-based nutrition can halt and reverse CVD. I recall a lawyer with CAD and angina who rapidly improved following WFPBN. He became quite angry after a follow-up visit to his cardiologist who said he knew WFPBN might be successful. The lawyer asked, “Why didn't you offer it to me many months ago?” and the cardiologist replied, “In my experience patients won't follow that program.” Where upon the lawyer stated, “That must be my decision, not yours.” It is not the message that is wrong but how and if the message is articulated that determines adherence and success.
In summary, current palliative cardiovascular medicine consisting of drugs, stents, and bypass surgery cannot cure or halt the vascular disease epidemic and is financially unsustainable. WFPB can restore the ability of endothelial cells to produce nitric oxide,[28] which can halt and reverse disease without morbidity, mortality, or added expense. As powerful as the data are, it is unconscionable not to inform the cardiovascular disease patient of this option for disease resolution. To begin to eliminate chronic illness, the public needs to be made aware that a pathway to this goal is through WFPBN.”