A New Intervention for

Coronary Artery Disease

Columbus D Batiste, MD, FACC, FSCAI

In just one year Heart Disease claims more lives in the United States than all Americans lost in

the wars of the past century

Permanent Disability

European Heart Journal – Quality of Care and Clinical Outcomes

(2017) 3, 101–106

(S)

Endothelial cells serve multiple functions.

The vascular endothelium serves multiple functions:1) Itregulates fluid and molecule traffic between blood and tissues

2) It is an anti-coagulantsurface

3) It contributes to vascular homeostasis andrepair

4) It plays a vital role in vascular tone and blood flow regulation ***

Assessing this function is the most practical way of measuring

endothelial function.

BASELINE POST OCCLUSION

Brachial Artery Ultrasound with FMD

Prediction of Future CV Events by

Measurement of Endothelial Function

Endothelial Function and Risk of Developing

Hypertension

Endothelial Function and Risk of Developing

Diabetes

Fatal thrombus

Plaque rupture site

Collagenous fibrous cap

Thrombogeniclipid core

Ischemic Heart Disease

Acute Coronary Syndrome

Stable Coronary Syndrome

Goals of Therapy

Decrease

SymptomsProlong Life

Decrease Heart Attacks

Medical Therapy

William Murrell

Nitroglycerin

Sir John Black

Beta Blockers

Akira Endo

Statins

Pioneers in Pharmaceuticals

Revascularization

Pioneers in Revascularization

PCI

Gruentzig

CABG

Favoloro

Treatment for Acute Myocardial Infarction

Doesn’t Equal Treatment for Stable Ischemic Heart

Disease

MEDICATIONS

Aspirin in SIHD

• ARRIVE trial revealed no benefit in patients with moderate risk

• ASCEND revealed bot a benefit and heightened risk balance in Diabetics

Beta Blockers in SIHD

• Do NOT decrease

incidence of Myocardial

Infarction

• Do NOT prolong survival

Statin Therapy in SIHD• 75 percent of heart attack

patients fell within targets for

LDL cholesterol

• Risk of Diabetes

• Risk of hepatotoxicity

• Risk of Muscle Symptoms

STENTS & SURGERY

BARI 2D TRIAL

Among patients with diabetes and stable coronary

artery disease, a strategy of revascularization by PCI or CABG failed to demonstrate superiority to medical therapy over a mean of 5.3 years

BARI 2D Study Group NEJM 2009; 360:2503

COURAGE TRIAL

“As an initial management strategy in patients with

stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to

optimal medical therapy…..”

N Engl J Med 2007; 356; 1503-1516

Initial Coronary Stent Implantation with

Medical Therapy vs Medical Therapy Alone for

SIHDMetanalysis of 8 trials and over 7000 patients initial

stent implantation for stable CAD showed no evidence of benefit compared with initial medical

therapy for prevention of death, nonfatal MI,

unplanned revascularization, or angina.

Arch Intern Med. 2012;172(4):312-319

ORBITA

First randomized SHAM procedure trial

🚫 No improvement in symptoms

🚫 Improvement in quality of life

🚫 No improvement in exercise time

Honorable Mention

FAME 1 showed stenting blockages with decreased

flow was better than treating all blockages

FAME 2 showed improved outcomes with

stenting blockages with decreased flow was better

than medical therapy

PCI in SIHD

💔PCI reduces the incidence of angina.

💔PCI has not been demonstrated to improve

survival in SIHDpatients.

💔PCI may increase the short-term risk ofMI.

💔PCI does not lower the long-term risk ofMI.

Revascularization in SIHDSYNTAX 5 YrFollow-Up

💔CABG: 49.4% of follow-up deaths were cardiovascular

(CHF, Arrhythmia, and Other).

💔PCI: 68% of the deaths after PCI were also cardiovascular

in origin, but these deaths were driven by fatalMI.

💔The rates of MI-related deaths were striking; there was a

10-fold higher rate in PCI-treated patients(4.1%) compared

with CABG-treated patients (0.4%).

Milojevic et al. J Am Coll Cardiol2016;67:42–55)

“Here’s to the crazy ones. The misfits. The rebels. The

troublemakers. The round pegs in square holes. The ones who see

things differently. ”

“... They are not found of rules. And they have no respect for the status quo. You can quote them,

glorify or vilify them. ”

“…. About the only thing you can’t do is ignore them. Because they push the human race forward and while some see them as crazy We see them as genius”

Nathan Pritikin Dean Ornish Caldwell Esselstyn

T. Colin Campbell John McDougall Neil Barnard

Heart DiseaseCancer Diabetes Mellitus

Obesity Hypertension

Hyperlipidemia Autoimmune

Stroke Allergies

Standard American Diet

Poor Sleep Dehydration

Endothelial Damage

StressPoor Relationships

Endothelial Damage

Inflammation

Artery Response

Symptoms

Effect of Intensive Lifestyle

Changes on Endothelial Function

and Inflammatory Markers of

Atherosclerosis

EVADE CAD

1

1.05

1.1

1.15

1.2

1.25

BASELINE 8 WEEKS

WFPB AHA

Endothelial Damage

Inflammation

Artery Response

Symptoms

Effect of Intensive Lifestyle Changes on

Endothelial Function and Inflammatory

Markers of Atherosclerosis

0.02

0.07

0.04

0.03

0

0.01

0.02

0.03

0.04

0.05

0.06

0.07

0.08

Baseline 3 months

Experimental Control

Comparative Effects of 3 Popular Diets on

Lipids, Endothelial Function and C-Reactive

Protein during Weight Maintenance

• Ornish Diet associated with higher FMD compared to Atkins

• Inverse correlation between FMD

and saturated fat

Saturated Fat

FM

D

J Am Diet Assoc 2009 Apr 109 (4); 713-717

Omnivore

Vegetarian

4.42

4.21

3.13

13.78

13.78

21.99

VASODILATORY FUNCTIONS OF VEGETARIANS COMPARED WITH

OMNIVORES

NTG induced dilataton Flow-mediated dilatation Baseline size

DECREASE ISCHEMIA

Endothelial Damage

Inflammation

Artery Response

Symptoms

Weight Reduction

• reduces ROS, Lipid

profiles, and BP

• Improves exercise

capacity

Reduce BP

-improve vascular function

-reduced inflammation

-reduced ROS

-Enhanced NO utilizationImprove Vascular Function

-reduce inflammation

-improve platelet function

-enhance NO ablation

Reduce Oxidative Stress

- Reduce LDL oxidation

- Improve anti oxidant

- Reduce ROS

Improve Lipid Profile

- Reduced LDLc, TG &

TC

- Increase HDL

- Reduce LDL oxidation

Decrease Events

Decrease Ischemia

Improve Dilation

Repair Endothelium

Class I

Benefit >>> Risk

Procedure/ TreatmentSHOULD be

performed/ administered

Benefit >> Risk Additional studies with focused objectives needed

IT IS REASONABLE to

perform procedure/administer treatment

Benefit ≥ Risk Additional studies withbroad objectives needed;

Additional registry data would be helpful

Procedure/TreatmentMAY BE CONSIDERED

Class IIa Class IIb Class III

Risk ≥ BenefitNo additional studies needed

Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL

should

is recommended is indicatedis useful/effective/

beneficial

is reasonable

can be useful/effective/ beneficial

is probably recommended orindicated

may/might be considered may/might be reasonable usefulness/effectiveness is

unknown /unclear/uncertain or not well established

is not recommended is not indicated should notis not

useful/effective/beneficial may be harmful

Classification and Level of Evidence

Level of Evidence

Level of Evidence A: Data derived from

multiple randomized clinical trials or meta-analyses.

Level of Evidence B: Data derived

from a single randomized trial, or

nonrandomized studies.

Level of Evidence C:

Only

consensus opinion

of experts, case

studies, or

standard

of

care.

Clinical Practice Guidelines💔“Should do, should not do”

💔Class I is do and Class III is don’t do

💔In the 16 guidelines

💔19% of class I guidelines are LOE A

💔48% of recommendations are LOE C

Cardiologist

Lifestyle Specialist

Interventional Cardiologist

Initial Treatment Strategy

for Patients

Transition to a Whole Food Plant Based Diet

I IIa IIb III

B

Patients identified as having stable ischemic

heart disease should be referred to cardiac

rehab

Patients should have medications adjusted as lifestyle is increased

Initial Treatment Strategy for

Patients

I IIa IIb III

I IIa IIb III

B

B

QUESTIONS