Calcified Plaque or Soft Plaque, Which One to Believe? by Jeffrey Dach MD
Calcified Coronary Plaque, Not Soft Plaque, Predicts Future Heart Attacks in Diabetic Patients
Jim is a 56 year old stock broker and has type two diabetes, and takes a statin drug for a cholesterol level of 235. Jim’s coronary artery calcium score (CAC) of 12 Agatson units, indicates Jim is at very low risk for coronary artery disease, and the statin drug is of no clinical benefit. Jim’s cardiologist is an old friend of mine from the old days when I worked in the hospital as a radiologist, and I explained that Jim’s statin drug could be safely discontinued. His cardiologist disagreed and said he was still concerned about the soft plaque, and intended to continue the statin drug.
For decades, cardiologists have told us that the soft, lipid-rich, “vulnerable” plaque inside the coronary arteries is the real danger. The theory goes that these soft plaques rupture, cause clots, and trigger heart attacks. Hard, calcified plaque was considered “stable” and less worrisome. No doubt this does occur. However there is more to the story. It turns out the calcific plaque is more predictive of heart attack risk than is the soft plaque.
Rocking the Foundation of Statin Drug paradigm
The foundation of the statin drug paradigm was shaken when studies made it obvious that statin drugs increase the progression of coronary calcification. In 2015, Dr. Michael Henein comes up with the magical thinking that the increased arterial calcification while on a statin drug somehow indicates “arterial plaque repair”, writing:
Despite a greater CAC [Coronary Artery Calcium Score] increase with high dose and long-term statin therapy, events did not occur more frequently in statin treated patients. This suggests that CAC growth under treatment with statins represents plaque repair rather than continuing plaque expansion. (11-12)
Magical Thinking Shown False
Mainstream cardiology needed to preserve the statin drug paradigm, so they came up with magical thinking. This magical thinking says that increasing coronary calcification on a statin drug is somehow “protective arterial repair” and it is the soft plaque and not the calcified plaque that is important. This magical thinking was shown false by the 2004 study by Dr. Paolo Raggi, and by the more recent 2017 study by Dr. Farangis Lavasani. (1) (8) (10)
Header Image: Low magnification micrograph of the distal right coronary artery with complex atherosclerosis and luminal narrowing. Masson’s trichrome. The tunica intima is severely thickened; it measures up to approximately 1/3 of a millimetre. Normally, it is one cell layer thick (approximately 10 micrometres). There is fragmentation of the internal elastic lamina (a very thin black wavy layer) between the intima and media. Author: Nephron. CC 3.0. RCA artery wikimedia commons
The FACTOR-64 Trial
In 2017, Dr. Farangis Lavasani and colleagues at the Intermountain Medical Center Heart Institute, Johns Hopkins and the NIH, analyzed detailed CT coronary angiography data from 224 asymptomatic patients with diabetes who were part of the FACTOR-64 trial. Using sophisticated software, they broke down plaque into soft (non-calcified), fibrous, and calcified components and followed these patients for an average of nearly seven years to see who actually had heart attacks, unstable angina, or cardiac death. The results were unexpected and, in my view, potentially game-changing. In 2017, Dr. Farangis Lavasani writes:
In asymptomatic diabetic patients undergoing CTCA, CAC score and calcified plaque burden were the plaque compositional variables most predictive of future MACE. Soft plaque compositional variables did not predict future risk. These findings provide further evidence of the relationship between coronary calcium and cardiovascular risk.(1) Note: CTCA = cat scan coronary angiography. CAC= Coronary Artery Calcification. MACE= Major Adverse Coronary Event.
Soft Plaque Has No Predictive Value Whatsoever!
In the FACTOR-64 trial, patients who experienced major adverse cardiovascular events (MACE) had dramatically higher coronary artery calcium (CAC) scores (605 vs. 50 in those without events, p=0.008). The people who experienced a major cardiac event had 12 times higher calcium score than those who did not have a major cardiac event! The amount of calcified plaque seen on imaging with on CAT Scan angiography was the strongest predictor of future heart attack risk. In contrast, the quantity of soft, lipid-laden plaque showed no predictive value whatsoever. Dr. Farangis Lavasani writes:
Median follow-up was 6.6 years. Total MACE included 18(8.0%) patients. The median CAC for patients with and without MACE was 605 versus 50 respectively (P=0.008). (1)
In plain English: the hard, calcified plaque, not the soft stuff, was the marker that best predicted future cardiac events.This reinforces observed in clinical practice: the coronary calcium score remains the most powerful predictor of future cardiac events, especially in higher-risk groups like diabetics. A zero calcium score is essentially a five-year warranty against heart attack, even in patients with elevated LDL cholesterol.
Left Image: Figure 1. Examples of Coronary Artery Scans. (Left) Normal scan without calcified plaque. (Middle) Moderate calcified plaque in the left anterior descending and left circumflex coronary arteries. (Right) Severe calcified plaque involving the left main, left anterior descending, and left circumflex coronary arteries. Courtesy of Hecht, Harvey S. “Coronary artery calcium scanning: past, present, and future.” JACC: Cardiovascular Imaging (2015). (7)
Serum Cholesterol Has No Predictive Value and Does Not Correlate with Calcium Score and
In 2001, Dr. Harvey Hecht did calcium score study on 930 asymptomatic people with no history coronary artery disease, and not taking statins. Dr. Hecht found there was no correlation between calcium score and the serum cholesterol level. The cholesterol level has virtually no predictive value and does not correlate with calcium score. (6)
Why this Matters for Statin Therapy
The conventional cardiology approach has been to treat elevated serum cholesterol aggressively with statin drugs in diabetic patients regardless of any other clinical findings. Yet this study raises an important question: if the calcium score is zero with no measurable atherosclerosis, and no plaque on CT angiography, is lifelong statin therapy really necessary? Obviously not.
Calcium Score is a Key Decision Tool
In my own office practice we use the coronary calcium score as a key decision-making tool. When the calcium score is zero, patients can avoid unnecessary statin therapy. When the score is high, above 100, aggressive lifestyle and dietary modification, and blood pressure control is warranted. For calcium score over 100, there is a measurable benefit from a statin drug prescribed by the cardiologist, as shown in 2018 by Dr. Joshua Mitchell using the Walter Reed Registry. (9)
Annual Progression of Calcium Score
Another useful strategy for high risk patients is serial calcium score every year or two. This is based on the 2004 study by Dr. Paolo Raggi who found annual progression of calcium score below 15% regardless of high initial score, has a good prognosis, while those patients with annual progression of calcium score greater than 15% are high risk for near term heart attack. Dr. Raggi’s 2004 study again shows that calcium score progression while on a statin drug is not a benign event, and is actually a flashing red light on the dashboard, indicating very high risk for heart attack in the near future.
Grouping of All Calcium Scores Together on Left Chart
Another useful finding made by Dr. Raggi is shown in the left chart below of patients with less than 15% annual progression of calcium score. Notice all the colored coded lines indicating starting calcium scores were all grouped at the top of the Left chart, indicating good prognosis regardless of high starting calcium score. (see left chart below). On the Right chart however, all the color coded calcium scores are separated indicating higher starting calcium score associated with worse prognosis when progression is greater than 15%. (8)
Figure 5. Progression of CAC and Risk of First MI in 495 Asymptomatic Patients Receiving Cholesterol-Lowering Therapy.
Left Chart: CAC progression of <15% per year is associated with a benign prognosis irrespective of the baseline CAC, implying stabilization of the atherosclerotic process.
Right Chart: CAC progression of >15% per year is associated with a poor prognosis directly related to the baseline CAC, implying new plaque formation and inadequacy of treatment. CAC = coronary artery calcium; MI = myocardial infarction. (7-8) Courtesy of Paolo Raggi et al 2004. and Hecht, Harvey 2015.
Calcium Score Under 100
In 2018, Dr. Joshua Mitchell used the Walter Reed Hospital registry to show that calcium score under 100 identifies low-risk patients who may safely avoid statin drugs, even with high serum cholesterol levels. Dr. Joshua Mitchell showed statin drugs have no cardiac benefit for calcium score under 100, in which case the NNT = 100 (NNT=number needed to treat). When calcium score is greater than 100, the NNT drops to 12, a more favorable number. The amount of atherosclerosis identified by calcium score, not the serum cholesterol level, should determine who to treat with a statin drug. See data chart below. (9)
Cumulative Incidence of MACE (Major Adverse Cardiac Event) Stratified by Statin Treatment and CAC (Calcium Score) Severity. Benefit of statin therapy was significantly related to CAC group (p<0.0001 for interaction), with benefit in patients with CAC >100 but not in patients with CAC < 100. aSHR – adjusted subhazard ratio. MACE – major adverse cardiovascular event. CAC – coronary artery calcium. Courtesy of Mitchell, Joshua D., et al. “Impact of statins on cardiovascular outcomes following coronary artery calcium scoring.” Journal of the American College of Cardiology 72.25 (2018): 3233-3242. (9)
Our Calcium Score Protocol
For those who with calcium score over 100 who cannot tolerate the adverse effects of a statin drug prescribed by the cardiologist, we have devised our own calcium score protocol, a basket of supplements in addition to diet and lifestyle modification (a Gluten-free, plant based diet, and daily exercise). This basket includes: Magnesium, Aged Garlic, Vitamin C, Tocotrienol Vitamin E, Vitamin K (MK7), Nattokinase and/or Lumbrokinase as described in my book, Heart Book. Additional Supplements are optional: Berberine and Probiotics.
More Calcium Score Studies
In 2008, Dr. Detrano conducted the Multi-Ethnic Study of Atherosclerosis (MESA) following 6,700 asymptomatic adults with coronary artery calcium score (CAC), showing CAC is a powerful, independent predictor of coronary events across all racial and ethnic groups. (2)
In 2013, Dr. Agarwal conduct the PREDICT study in type 2 diabetes patients demonstrating that coronary calcium score strongly predicts cardiovascular mortality, confirming its utility in the very population studied in FACTOR-64. (3)
In 2022, Dr. Al-Kindi conducted the CLARIFY Registry analysis showing higher coronary calcium levels are independently associated with major adverse cardiovascular events in patients with diabetes, thus leading to more intensification of preventive therapy.(4)
In 2017, Dr. Gupta did a systematic review and meta-analysis finding that identifying calcified coronary plaque on imaging significantly increases the likelihood that physicians will initiate and continue statin and lifestyle therapies. This is what most cardiologists will follow in real-world practice. (5)
Bottom Line: The old dogma that “soft plaque ruptures and kills you” while calcified plaque is benign needs serious re-examination. In asymptomatic diabetic patients, calcified plaque burden and the coronary calcium score are the strongest predictors of who will actually have a future heart attack. This 2017 study from the FACTOR-64 investigators, along with the supportive literature, provides strong evidence that we should be focusing more on actual atherosclerotic burden, measured by calcium scoring and CT angiography and less concerned about serum cholesterol levels alone.
Heart Book: How to Keep Your Heart Healthy by Jeffrey Dach MD
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Heart Book is a journey through the confusing maze of literature on coronary artery disease, the number-one killer in America. With his years of practice in vascular radiology, Dr. Dach has the background, credentials, and experience to transform your understanding of heart disease. The old medical paradigms have been upended, yet mainstream cardiology clings to these tired dogmas as if nothing has changed. Be prepared to be shocked, amazed, provoked, and gratified as this book empowers you to take control of your own heart health.
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Coronary Artery Disease: Questions and Answers
Does Cholesterol Cause Coronary Artery Disease ?
Calcium Score Determines Who to Treat with Statin Drug
Calcium Score Diabetes and Statin Drugs
Plant Based Diet, Health Benefits for Coronary Artery Disease
LDL-Cholesterol Does Not Cause Coronary Artery Disease
Low Level Endotoxemia, Depression, Endocrinopathy and Coronary Artery Disease
Fibrinolytic Enzymes, Nattokinase, Lumbrokinase Prevent and Reverse Atherosckerosis
Reverse Heart Disease with Coronary Calcium Score
Low Level Endotoxemia LPS Theory of Coronary Artery Disease
Calcium Score Paradigm Shift in Cardiology
Coronary Calcium Score Benefits of Aged Garlic
The Art of the Curb Side Cholesterol Consult
Cholesterol and Atherosclerosis:Autopsy Studies Show No Correlation
Statin Denialism Internet Cult with Deadly Consequences
Defending the Cholesterol Hypothesis in the Elderly
Does High Cholesterol Cause Heart Disease ?
Familial Hypercholesterolemia and Statin Drugs
Donating Blood Prevents Heart Disease
Does Cholesterol Cause Heart Disease ? Part two
Atherosclerotic Plaque as Infected Biofilm on Electron Microscopy
Coronary Calcium Score Paradigm Shift Podcast
Jeffrey Dach MD
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References:
1) Lavasani F, May HT, Kwan AC, et al. Prediction of Future Cardiovascular Risk by Analysis of Various CT Coronary Angiography-Determined Quantitative Plaque Compositional Characteristics among Patients with Diabetes Enrolled in the FACTOR-64 Study: The Importance of the Calcified Coronary Plaque. Journal of the American College of Cardiology. 2017;69(11_Supplement):1592.
In asymptomatic diabetic patients undergoing CTCA, CAC score and calcified plaque burden were the plaque compositional variables most predictive of future MACE. Soft plaque compositional variables did not predict future risk. These findings provide further evidence of the relationship between coronary calcium and cardiovascular risk.
2) Detrano R, Guerci AD, Carr JJ, et al. Coronary Calcium as a Predictor of Coronary Events in Four Racial or Ethnic Groups. New England Journal of Medicine. 2008;358(13):1336-1345.
3) Agarwal S, Cox AJ, Herrington DM, et al. Coronary Calcium Score Predicts Cardiovascular Mortality in Diabetes: The PREDICT Study. Diabetes Care. 2013;36(4):972-977.
4) Al-Kindi S, Dong T, Chen W, et al. Relation of coronary calcium scoring with cardiovascular events in patients with diabetes: The CLARIFY Registry. Journal of Cardiovascular Computed Tomography. 2022.
5) Gupta A, Lau E, Varshney R, et al. The Identification of Calcified Coronary Plaque Is Associated With Initiation and Continuation of Pharmacological and Lifestyle Preventive Therapies: A Systematic Review and Meta-Analysis. JACC: Cardiovascular Imaging. 2017;10(8):833-842.
6) Hecht, Harvey S., et al. “Relation of coronary artery calcium identified by electron beam tomography to serum lipoprotein levels and implications for treatment.” The American journal of cardiology 87.4 (2001): 406-412.
7) Hecht, Harvey S. “Coronary artery calcium scanning: past, present, and future.” JACC: Cardiovascular Imaging 8.5 (2015): 579-596.
Figure 5. Progression of CAC and Risk of First MI in 495 Asymptomatic Patients Receiving Cholesterol-Lowering Therapy
(Left) CAC progression of <15% per year is associated with a benign prognosis irrespective of the baseline CAC, implying stabilization of the atherosclerotic process. (Right) CAC progression of >15% per year is associated with a poor prognosis directly related to the baseline CAC, implying new plaque formation and inadequacy of treatment. CAC = coronary artery calcium; MI = myocardial infarction.
8) Raggi, Paolo, Tracy Q. Callister, and Leslee J. Shaw. “Progression of coronary artery calcium and risk of first myocardial infarction in patients receiving cholesterol-lowering therapy.” Arteriosclerosis, thrombosis, and vascular biology 24.7 (2004): 1272-1277.
9) Mitchell, Joshua D., et al. “Impact of statins on cardiovascular outcomes following coronary artery calcium scoring.” Journal of the American College of Cardiology 72.25 (2018): 3233-3242.
Cumulative Incidence of MACE Stratified by Statin Treatment and CAC Severity. Benefit of statin therapy was significantly related to CAC group (p<0.0001 for interaction), with benefit in patients with CAC >100 but not in patients with CAC < 100. aSHR – adjusted subhazard ratio. MACE – major adverse cardiovascular event. CAC – coronary artery calcium.
10) Muhlestein, Joseph B., et al. “Effect of screening for coronary artery disease using CT angiography on mortality and cardiac events in high-risk patients with diabetes: the FACTOR-64 randomized clinical trial.” Jama 312.21 (2014): 2234-2243.
11) Henein, Michael, et al. “High dose and long-term statin therapy accelerate coronary artery calcification.” International journal of cardiology 184 (2015): 581-586.
Conclusions: Despite a greater CAC increase with high dose and long-term statin therapy, events did not occur more frequently in statin treated patients. This suggests that CAC growth under treatment with statins represents plaque repair rather than continuing plaque expansion.
12) Dykun, Iryna, et al. “Statin medication enhances progression of coronary artery calcification: the Heinz Nixdorf Recall Study.” Journal of the American College of Cardiology 68.19 (2016): 2123-2125.
Disclaimer: individual decisions should be made with your personal physician after a full discussion of risks and benefits.
Jeffrey Dach MD
7450 Griffin Road, Suite 190
Davie, Fl 33314
954-792-4663
my web site: https://drjeffreydachmd.com/
my personal blog: www.jeffreydachmd.com
Bioidentical Hormones 101 Second Edition
Menopausal Hormone Replacement, Health Benefits
Natural Thyroid Toolkit by Jeffrey Dach MD
Cracking Cancer Toolkit ebook
Cracking Cancer Toolkit print version
Heart Book by Jeffrey Dach MD
www.naturalmedicine101.com
www.bioidenticalhormones101.com
www.truemedmd.com
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