The Century Health Trial A Comprehensive Integrated Strategy For Managing CAD K. Lance Gould, M.D. Martin Bucksbaum Distinguished University Chair, Professor of Cardiovascular Medicine and Executive Director, Weatherhead P.E.T. Center for Preventing and Reversing Atherosclerosis University of Texas Medical School – Houston No Conflict of Interest

16% risk reduction 22% risk reduction From Jones PH. LDL-C and Cardiovascular Disease. High vs low dose statins vs LDL and CV events: Highest dose and lowest LDL had best outcomes

Very Low Levels of Atherogenic Lipoproteins & Risk for CV Events at 4 yrs: Meta-Analysis of High Dose Statin Trials Distribution of achieved on-statin LDL-C levels (dark blue curve; right y- axis) and the risk of major cardiovascular events (light blue line; left y- axis). HR = hazard ratio. J Am Coll Cardiol. 2014;64(5): N = 38,153 with 155,573 person-yrs f/u

Postprandial Lipid Surge Associated with CAD After fats & carbohydrates Predicts progression of CAD Genetic sensitivity to fat and CBHT foods, DM, CAD Not altered by statins alone Reduced by EXERCISE before or after meal FOOD - Low fat, low CBHT Lean protein Fish or fish oil Small meals

Lyon Diet heart Study Randomized Mediterranean Diet after first MI. de Lorgeril Circ1999;99:779 & Lancet 1994;343:1454 (n = 605) Indo-Mediterranean Diet Singh et al Lancet 2002;360:1455 Randomized dietary advice, patients with MI, angina or high risk factors N = 1000 Endpoints: MI, Cardiac deaths P =

Intense, Comprehensive, Integrated Individually Tailored Food and Exercise, Medications to Strict Risk Factor Goals Monthly f/u & as needed 24/7 for 5 years PET Scan at baseline, 2 years and 5 years Randomized to AHA Standard community care or Comprehensive Management for max risk factor control of food, weight, exercise, BP, lipids, HbA1c, smoking, max dose medications, tailored/person. Blinded objective entry of quantitative data, and Scored for adherence to each goal above and Composite integrated total risk score for feedback. Outcomes: risk factor changes angiograms, stents, CAB, MI, death.

Standard Care at baseline and at 2 years Better P = Much Better P = Better P = Much Better P = Worse P = 0.03 Better P = Better P = No difference Comprehensive Care at baseline and at 2 years P = for all differences between the changes of each outcome

Total Modifiable Risk Factor Score Low riskHigh risk Much Better P = Minimally Better P = 0.02 Standard Care at baseline and 24 mo Comprehensive Care at baseline and 24 mo P= for the difference in the changes of each group

K. Lance Gould Precise Artery-Flow Map 1088 patients with coronary arteriograms and PET imaging Nakagawa et al. Jour Nucl Cardiol 2001;8:580 Demer et al. Circulation 1989;79:825 Sdringola et al. J Am Coll Cardiol 2003;41:263 Sdringola et al. J Nucl Medicine 2006;47:1-9.

70% of 2 nd opinion cases do not need recommended procedures 76 year old asymptomatic yo man with abnormal stress SPECT imaging & angiogram reportedly with “severe” Left Main 70% DS, LAD 80%, D1 80%, OM1 70%, RCA 70% + 80%, LCx moderate stenosis. EF 60%. Coronary Bypass Surgery was recommended, patient came to PET Center for 2nd opinion. PET flow excellent, No CAB indicated

The Ischemic Flow Action Threshold Johnson & Gould JACC Imag 2012;5: cc/min/gm and CFR 1.7

Standard Care Comprehensive Care

Unique in literature as strategy for CAD. World leader in quantitative imaging. Inventor of CFR, FFR, pharmacologic stress imaging, improved CAD perfusion. Randomized, comprehensive, integrated, individually tailored lifestyle & meds to strict risk factor goals with world’s most advanced quantitative imaging to guide only essential procedures, eliminating unnecessary ones. Highly significant Interim data on 900 of 1300 protocol goal. Privately funded with $30M since 2009 now ending. Continued funding over 7.5 years needed to finish project. Nearly guaranteed statistically positive outcomes and Favorable cost-benefit for health improvements. Scientific and Public Relations Value for Food and Tech industries or Health Care Systems