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The Pot Calling the Kettle Black: The Death of Angioplasty in Stable Coronary Disease.

I was reading the February 12, 2018 online edition of the New York Times when I stumbled across the article "Heart Stents are Useless for Most Stable Patients. They're Still Widely Used." (1) I fervently read the article with incredulous disbelief. Here was an expose about the use of percutaneous coronary angioplasty in stable patients with cardiovascular disease. The article highlighted a double-blind placebo-controlled study published in the January 2018 edition of The Lancet, which concluded that percutaneous coronary intervention or angioplasty, was no better than placebo in relieving symptoms associated with coronary artery disease. The study showed that optimizing medical treatment through medication was just as effective in relieving symptoms in patients with stable coronary artery disease. I couldn't believe what I was reading. Here was a cornerstone of modern cardiology, performed on millions of patients, by thousands of cardiologists. Now new evidence shows that it is basically no better than placebo. Wow!!! This is a classic case of the proverbial idiom "the pot calling the kettle black."

As an alternative medical practitioner, I have constantly endured the wrath and scorn of the mainstream medical establishment with many procedures and treatments that I have used to treat cardiovascular disease. I am a practicing naturopathic physician who graduated from Bastyr College (now Bastyr University) in Seattle in 1991. I have utilized alternative procedures and treatments to try to help patients with cardiovascular disease for over 25 years. Some of these treatments include natural supplements and chelation therapy, in addition to diet and lifestyle modification. Medical practitioners who ardently adhere to the dogma of the mainstream medical establishment would frequently rebuff alternative and natural therapies. A constant retort would be that "there is no scientific evidence that it works." Now here is a prime example of blatant hypocrisy in the mainstream medical establishment. How can they criticize alternative treatments when their own treatment doesn't really work? After reading this article, the hypocrisy is almost laughable. This reminds me of the biblical hypocrite who worries about a speck of dust in their friend's eye when they have a log in their own eye. It is time to take the blinders off.

Of course, if you think linearly and within the box, it makes sense. Coronary arteries supply blood to the heart muscle. When they become clogged with cholesterol and plaque, blood flow is reduced. Angina or chest pain in the heart occurs because of this reduced blood flow. The more clogged the artery was, the more negative symptoms the patient would have. If you perform a delicate surgical procedure whereby you remove the atherosclerotic buildup, you restore blood flow. The patient feels better, and the angina goes away. Sounds like a fairy tale story, except now it is more like fable that is not true in patients with stable coronary artery disease.

ORBITA or percutaneous coronary intervention in stable angina; a double blind placebo controlled trial was a multicentre, randomized double-blinded placebo-controlled trial done at five study sites in the UK between January 2014 and August 2017. Two hundred patients were selected who had at least one coronary vessel with at least 70% atherosclerotic blockage and angina symptoms with exertion. All patients were evaluated at the beginning of the study with exercise stress testing, symptom questionnaire and Doppler echocardiography. All patients had what was called "optimised medical therapy" before the study was started that included anti-anginal drugs, anti-platelet medication, beta-blockers, calcium channel antagonists and lipid lowering medicine; 105 patients underwent percutaneous coronary angioplasty with drug eluting stents being placed and 95 patients underwent a sham surgery. The control group was anesthetized and had catheters inserted in their arteries like the treatment group but had no angioplasty procedure at all. They simply laid on the surgical table unconscious for approximately 15 minutes and had no medical intervention. All patients were evaluated six weeks post operation and repeated the stress testing, symptom questionnaire, and echocardiography. The end points of the study were to evaluate whether there was a difference in subjective symptoms of chest pain, quality of life symptoms and aforementioned objective stress echocardiography measurements. The data showed there was no statistically significant difference in measureable end points between the placebo and treated groups. There was no significant difference in terms of exercise time on the treadmill, time for 1 mm ST segment depression on EKG, peak oxygen uptake, or Seattle anginal questionnaire symptoms. The only demonstrable difference was better peak heart wall motion index score in the PCI treated group. The authors concluded that although symptomatic relief is the primary goal of percutaneous coronary intervention in stable angina and is commonly observed clinically, there is no evidence from blinded, placebo-controlled randomized trials to show its efficacy. In this watershed study, percutaneous angioplasty showed that it was no better than placebo in relieving symptoms in patients with stable coronary artery disease. (23)

A 2007 study reported in The New England Journal of Medicine examined the difference between optimal medical therapy with or without percutaneous coronary intervention for stable coronary artery disease. Between 1999 and 2004 at 50 US and Canadian centers, 2287 patients with myocardial ischemia and significant coronary artery disease were involved in a randomized controlled trial; 1149 patients had PCI surgery plus optimal drug therapy, and 1138 patients had optimal drug therapy alone. The primary endpoints of the study were to evaluate differences in non-fatal myocardial infarctions and patient death. The patients were followed for between 2.5 and 7 years. There were 211 events in the PCI treated group and 202 events in the medical therapy group. This translated to a 19.0% event rate in the PCI treated group and an 18.5% event rate in the medical therapy group. The researchers observed there was no statistically significant difference between the PCI group and the drug therapy alone group in terms of non-fatal MIs, stroke and death. The authors concluded the percutaneous angioplasty did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal therapy alone. (4)

The authors further hypothesized that different plaque morphology and blood vessel vasculature accounted for the apparent differences in atherosclerosis and atheroma formation. Vulnerable plaque was more likely to be involved in a cardiovascular event than stable or non-vulnerable plaque. Vulnerable plaque had a thin fibrous cap, large lipid core, fewer smooth muscles, more macrophages and decreased collagen when compared to stable plaque. Also vulnerable plaque was more involved in outward blood vessel expansion and had less remodeling at the arterial wall causing less stenosis inwardly. Vulnerable plaque did not cause significant stenosis before rupture causing a cardiovascular event. (4)

A 2012 review article in JAMA or the Journal of the American Medical Association, evaluated coronary stent implantation with medical therapy versus medical therapy alone for stable coronary artery disease. (5) This meta-analysis searched Medline databases between 1976 and 2011 for randomized controlled trials. A total of eight trials with 7229 patients were identified in this analysis. The researchers discovered that coronary stent implantation with medical therapy coronary artery disease was not associated with any significant reduction in mortality compared with medical therapy alone. The authors further concluded that the failure of stent implantation to reduce deaths due to myocardial infarction reinforces the underlying pathophysiology of plaque formation with different arterial inflammation that gives rise to vulnerable plaque.

It is time for a paradigm shift that includes the alternative ideas of atherosclerosis and an integrative approach to heart disease treatment. These ideas would include the difference between stable and unstable vulnerable plaque, arterial inflammation, and intimal and lipid oxidation. This would also include a holistic treatment incorporating diet and lifestyle factors, stress reduction, optimal nutritional supplementation, blood pressure and lipid management, and perhaps chelation therapy. I believe that alternative natural therapies coupled with conventional therapies would provide additional benefit in reducing the rate of cardiovascular events in individuals with stable coronary artery disease.

Cigarette smoking has been shown to be directly related to an increased risk of coronary heart disease. Compared to non-smokers, daily smokers had a 60% increased risk of developing heart disease. Decreasing the number of cigarettes smoked and smoking cessation dramatically decreased these risk factors. (6)

A healthy diet rich in whole, unprocessed foods, fruits and vegetables, whole grains, fish and dairy products coupled with other lifestyle factors including no smoking, regular moderate exercise and keeping weight at a favorable body mass index, reduced the incidence of coronary heart disease by at least 46%, especially in higher risk patients. A healthy diet involved avoiding processed grains, processed meats, unprocessed red meat, sugar-sweetened beverages, trans fats and sodium. (7)

Emotional stress has long been associated with an increased risk of cardiovascular events. Perceived emotional stress increases the incidence of cardiovascular disease and coronary events. Stress was perceived to increase arterial inflammation and c-reactive protein levels. (8,9)

Regular moderate aerobic exercise has been associated with a decreased risk of cardiovascular disease and coronary events. Benefits of regular exercise include improved physical function and well being, lessening of cardiovascular symptoms, enhanced quality of life, improved coronary risk profile, improved muscle and aerobic fitness, and overall less mortality. (10)

A meta-analysis of 10 randomized controlled trials with 14,727 patients showed that fish oils reduced the incidence of myocardial infarction by 24% and all causes of mortality by 16%. Fish oils decreased cholesterol and triglyceride levels, decreased inflammation, increased endothelial function and increased vasodilation, decreased platelet aggregation, and improved blood rheology. (11) Experts recommend consuming fish at least twice per week or taking a fish oil supplement. It is noted that this has been shown to have minimal adverse effects and is a safe adjunct to lipid lowering medicine. (12,13)

Garlic has been show to lower blood pressure, reduce cholesterol and triglyceride levels, inhibit platelet aggregation, increase fibrinolytic activity and prevent the formation of atherosclerosis. (14)

Polyphenols such as resveratrol, epigallocatechin, and curcumin have been acknowledged to have beneficial effects in cardiovascular health. The consumption of dark berries, which contained these flavonoids, and wine, particularly red wine, are believed to lower the risk of cardiovascular disease. (15)

Capsaicinoids from a variety of different pepper plants including cayenne pepper have been shown to improve cardiovascular parameters. Some of these effects include decreased oxidative stress, decreased inflammation, improved endothelial function, decreased blood pressure, decreased endothelial cytokines, decreased cholesterol, decreased blood sugar, and decreased LDL oxidation. (16)

A high-dose multivitamin and mineral supplement helped to decrease cardiovascular events in stable, post myocardial infarction patients not taking statin medicine. (17)

Selenium and co-enzyme Q10 have shown to lower the risk of cardiovascular disease. A Swedish study of 443 elderly citizens showed that selenium and CoQ10 supplementation significantly reduced the risk of cardiovascular mortality in this group. (18)

Vitamin E has shown some observational benefits when used as a supplement. (19) Other studies with vitamin E, vitamin C and both vitamin E and C together have been less encouraging. (20,21)

Intravenous chelation therapy has shown some modest benefit in preventing cardiovascular events in patients with previous myocardial infarction. The Trial to Assess Chelation Therapy (TACT) was a double-blind, placebo-controlled randomized trial at 134 US and Canadian Sites involving 1708 patients conducted from 2003 to 2010. Patients were randomized to receive 40 intravenous infusions of EDTA or placebo over a concurrent period of time. The primary end points of the study were all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. The study showed a cumulative decrease of 18% in the EDTA treated group compared to placebo. The effects appeared to be more pronounced in the diabetic sub-group of the treated population. (22,23)

The use of percutaneous coronary intervention or angioplasty in patients with stable coronary artery disease appears to be no better than placebo and optimal medical drug therapy alone. In other severe cases of unstable angina, however, it can be lifesaving. However, for most people with stable disease it appears to be useless. The use of conventional medical drug therapy can improve symptoms and decrease cardiovascular events. The addition of alternative therapies in the form of diet and lifestyle changes, stress reduction, exercise, nutritional supplementation, and possibly chelation therapy may provide added benefit. These natural therapies appear to be safe and effective.

References

(1.) Carroll AE. Heart Stents are Useless for Most Stable Patients. They're Still Widely Used. The New York Times. The Upshot. Online edition. Feb 12, 2018.

(2.) Rasha AI-L et al. Percutaneous Coronary Intervention in stable angina (ORBITA): a double-blind, randomized controlled trial. The Lancet. January 6-12, 2018; 391 (10115): 31-40.

(3.) Brown DL, Redberg RF. Last Nail in the coffin for PCI in stable angina. The Lancet. January 6-12, 2018; 391 (10115):3-4.

(4.) Boden WE, et al. Optimal Medical Therapy with or without PCI for Stable Coronary Disease. N Engl J Med. 2007;356:1503-1516.

(5.) Stergiopoulos K, Brown DL. Initial Coronary Stent Implantation With Medical Therapy vs Medical Therapy Alone for Stable Coronary Artery Disease. Meta-analysis of Randomized Controlled Trials. JAMA Int Med. 2012 Feb 27;172(4):312-9.

(6.) Sheilds M, Wilkins K. Smoking, smoking cessation and heart disease risk; A 16 year follow-up study. Health Rep. 2013 Feb;24(2):12-22.

(7.) Khera AV, et al. Genetic Risk, Adherence to a Healthy Lifestyle and Coronary Disease. N Engl J Med. 2016; 375:2349-2358.

(8.) Tawakol A, et al. Relation between resting amygdala activity and cardiovascular events: a longitudinal and cohort study. The Lancet. February 25, 2017; 389 (10071): 834-845.

(9.) Dimsdale JE. Psychological Stress and Cardiovascular Disease. J Am Coll Cardiol. 2008 Apr. 1;51(13):1237-1246.

(10.) Briffa TG, et al. Physical activity for people with cardiovascular disease: recommendations of the National Heart Foundation of Australia. Med J Aust. 2006 Jan 16;184(2):71-75.

(11.) Yzebe D, Lievre M. Fish oils in the care of coronary heart disease patients: a met-analysis of randomized controlled trials. Fundam Clin Pharmacol. 2004 Oct;18(5):581-92.

(12.) Kromhout D, et al. Fish oil and omega-3 fatty acids in cardiovascular disease: do they really work. Eur Heart J. 2012 Feb;33(4): 436-443.

(13.) Weitz D, et al. Fish Oil for the Treatment of Cardiovascular Disease, Cardiol Rev. 2010 Sept-Oct 18(5):258-263.

(14.) Bayan L, et al. Garlic: a review of potential therapeutic effects. Avicenna J Phytomed. 2014. Jan-Feb;4(1):1-14.

(15.) Khurana S, et al. Polyphenols: Benefits to the Cardiovascular System in Health and Aging. Nutrients. 2013 Oct;5(10):3779-3827.

(16.) Vijaya J. Capsinoids Modulatiing Cardiometabolic Syndrome Risk Factors: Current Perspectives. J Nutr Metab. May 23, 2016.

(17.) Issa OM, et al. Effect of high dose oral multivitamin and mineral in participants not treated with statins in the randomized trial to assess chelation therapy (TACT). Am Heart J. 2018. Jan;195:70-77.

(18.) Alehagen U, et al. Selenium and Co-enzyme Q10 for Four Years: Follow-up Results of a Prospective Randomized Double Blind Placebo-Controlled Trial in Elderly Citizens. PLOS One. 2015;10(12):e0141641.

(19.) Dietrich M, et al. Vitamin E Supplement Use and the Incidence of Cardiovascular Disease and All-Cause Mortality in the Framingham Heart Study: Does the Underlying Health Status Play a Rote? Atherosclerosis. 2009 Aug: 205(2):549-553.

(20.) Sesso HD, et al. Vitamin E and C in the Prevention of Cardiovascular Disease in Men: The Physicians Health Study II Randomized Trial. JAMA. 2008 Nov 12:300(18):2123-2133.

(21.) Khudairy AI, et al. vitamin C supplementation for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2017 Mar. 16:3; cd 011114.

(22.) Lamas GA, et al. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013 Mar 27; 309(12):1241-1250.

(23.) Lamas GE, et al. Design and Methodology of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan; 163(1):7-12.

by Dr. Douglas Lobay, BSc, ND

Douglas G. Lobay is a practicing naturopathic physician in Kelowna, British Columbia. Dr. Lobay graduated with a bachelor of science degree from the University of British Columbia in 1987. He then attended Bastyr College of Health Sciences in Seattle, Washington, and graduated with a doctorate of naturopathic medicine in 1991. While attending Bastyr College, he began researching the scientific information on the use of food, nutrition, and natural healing. Dr. Lobay enjoys research, writing, and teaching others about good health and good nutrition. He is the author of four books and numerous articles in magazines. He also enjoys hockey, skiing, hiking, tennis, and playing guitar.
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Author:Lobay, Douglas
Publication:Townsend Letter
Article Type:Clinical report
Date:Dec 1, 2018
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