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Online Appendix for the following JACC articleTITLE: Prognostic Value of Stress Myocardial Perfusion Positron Emission Tomography:Results From a Multicenter Observational RegistryAUTHORS: Sharmila Dorbala, MD, MPH, Marcelo F. Di Carli, MD, Rob S. Beanlands, MD, Michael E. Merhige, MD, Brent A. Williams, PhD, Emir Veledar, PhD, Benjamin J. W. Chow, MD, James K. Min, MD, Michael J. Pencina, PhD, Daniel S. Berman, MD, Leslee J. Shaw, PhDPET Registry Methods: Four centers participated in this multi-center PET registry and enrolled 7,061 patients. Each center enrolled a patients clinically referred for a pharmacological stress Rubidium-82 (Rb-82) MPI. Patients were enrolled between January 2000 to July 2009 [n=3,635, n=1,424, n=1,024 and n=978], consecutively over a variable time period (1- 6 years at each site). Demographic, historical information and stress hemodynamic data were systematically recorded as per site specific protocols. Risk factors are described based on historical information and verified by medical records whenever feasible. Myocardial perfusion imaging methodsRb-82 (40 -60 mCi) was infused intravenously and images were acquired at rest and following vasodilator stress using site-specific imaging and stress protocols. Rb-82 MPI was acquired using a dedicated PET (ECAT ART; Siemens-CTI, Knoxville, TN; Posicam HZL/R, Positron Corporation, Houston, TX) or a hybrid PET/CT scanner [Discovery Rx or STE Light Speed (16, 64 slice CT), GE Healthcare, Milwaukee, WI; Biograph 64, Siemen’s, Knoxville, TN]. Vasodilator stress with intravenous dipyridamole (142 mcg/kg/min for 4-5 minutes) or adenosine (140 mcg/kg/min for 4-6 minutes) was used. Rb-82 was injected ~ 7 minutes after the start of the dipyridamole infusion and at the mid-point of the adenosine infusion. Attenuation correction was performed using a radionuclide line source or using a low dose chest CT scan. The estimated effective radiation dose to the subjects from the rest and stress Rb-82 study ranged from 4.4 to 6.4 mSV. Percent (%) myocardium abnormal, scarred or ischemic were computed based on visual scoring (3 sites) (summed stress, summed rest and summed differences scores, respectively, divided by 68 and multiplied by 100) or generated by software (1 site) as described previously and multiplied by 100 to obtain percentages.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TZHJpbmdvbGE8L0F1dGhvcj48WWVhcj4yMDA2PC9ZZWFy

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ADDIN EN.CITE.DATA (3) Although vasodilator stress may not always produce ischemia, for ease of interpretation, the term ischemia is used in this manuscript to represent reversible perfusion defects. When stress myocardial perfusion was normal, the rest perfusion was assumed to be normal as well. Follow-up methodsCardiac death was the primary end-point and all-cause death the secondary endpoint of this study. The ascertainment of mortality status was performed by trained study coordinators supervised by the site clinical investigators. The study coordinators used telephone contact with the patients with scripted patient interviews and reviewed electronic medical records. In the advent of acknowledged death status, source documents (i.e., patient’s medical record, verbal confirmation by the patient’s primary care physician or review of death certificates) were used for confirmation. Additionally, the National Death Index was applied for confirmatory purposes at all US sites to identify patients dying during follow-up. At one center, the standard procedure was to collect all-cause death only and support for expanded data collection was not available. Statistical AnalysisSurvival Analyses and Prognostic Value:Cox Proportional hazards models: For model development, model over-fitting was considered by limiting variables to only 1 for every 10 deaths. The proportional hazards assumption was met for every model. We identified a few variables a priori to note traditional measures to reflect pretest CAD likelihood and to maintain efficiency and parsimony in model development. Interactions between variables (e.g., female and diabetes, female and age) were tested and found to be non-significant. From the Cox models, hazard ratios and 95% confidence intervals were calculated.Reclassification indices: The sum of the correct reclassifications in patients with and without events is reported as the NRI. Integrated discrimination improvement which compares the average difference in the predicted risk for the models without and with PET MPI variables was also computed. The NRI methodologies of Pencina were applied including both categorical and continuous estimates, ADDIN EN.CITE <EndNote><Cite><Author>Pencina</Author><Year>2008</Year><RecNum>10</RecNum><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="x5rtzrz92srzr4e2rpappvzsrps9w5vsa9f5">10</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pencina, M. J.</author><author>D&apos;Agostino, R. B., Sr.</author><author>D&apos;Agostino, R. B., Jr.</author><author>Vasan, R. S.</author></authors></contributors><auth-address>Department of Mathematics and Statistics, Framingham Heart Study, Boston University, Boston, MA 02215, USA. mpencina@bu.edu</auth-address><titles><title>Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond</title><secondary-title>Stat Med</secondary-title></titles><periodical><full-title>Stat Med</full-title></periodical><pages>157-72; discussion 207-12</pages><volume>27</volume><number>2</number><edition>2007/06/15</edition><keywords><keyword>Area Under Curve</keyword><keyword>Cardiovascular Diseases/*etiology</keyword><keyword>Humans</keyword><keyword>Models, Statistical</keyword><keyword>*ROC Curve</keyword><keyword>Risk Assessment/*classification/statistics &amp; numerical data</keyword><keyword>*Risk Factors</keyword><keyword>United States</keyword></keywords><dates><year>2008</year><pub-dates><date>Jan 30</date></pub-dates></dates><isbn>0277-6715 (Print)&#xD;0277-6715 (Linking)</isbn><accession-num>17569110</accession-num><urls><related-urls><url>;(9) using SAS methods for calculating the NRI for survival data. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZW5jaW5hPC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48

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ADDIN EN.CITE.DATA (9,14) In 2,102 patients with rest left ventricular ejection fraction data, we explored the incremental prognostic value of PET MPI to a clinical model incorporating rest left ventricular ejection fraction. Results:The study cohort comprised of 7, 061 patients undergoing Rb-82 PET scans for clinical reasons. During follow-up, the overall cardiac death rate was 2.8 % (169/6, 037) and all-cause death rate was 8.1 % (570/7, 061). In this registry, there were 48% women (3,378/7,061). More than 60% of the patients complained of angina (dyspnea or chest pain). As expected, there was a higher risk factor burden and fewer women in the patients with ≥ 20% abnormal myocardium. Also, the frequency of patients with prior coronary revascularization gradually increased from normal to severely abnormal MPI. However, the frequency of angina was lowest in patients with ≥20% abnormal myocardium. The frequency of % myocardium scarred increased gradually and was highest in patients with ≥ 20% abnormal myocardium.Univariable associations between cardiovascular risk factors, Rb-82 PET MPI and outcomesThe univariable clinical and PET MPI predictors of all-cause death are listed in Appendix Table 1. In addition to the expected findings for higher hazard of cardiac and all-cause death (age, coronary risk factors, rest heart rate and PET MPI variables), of note, female sex, history of dyslipidemia, history of angina, and body mass index were associated with a lower hazard of cardiac death and all-cause death, and beta-blocker use was associated with a higher hazard. These findings suggest expected findings as in lower hazard with female sex and likely more aggressive treatment of patients with dyslipidemia and angina, and the survival advantage for patients with higher BMI. The cumulative unadjusted hazard of all-cause death or the % myocardium abnormal at stress is plotted in Figure 1B. Overall, the crude Kaplan Meier survival rate at 5 years ranged 91.6% to 70.3% from normal to severely abnormal myocardium at stress (p<0.0001). Compared to patients with normal stress PET MPI (0% abnormal myocardium), the relative hazard of all-cause death was 1.4 (95% CI 1.1-1.7, P=0.001), 2.8 (95% CI 2.1-3.6, P<0.0001) and 3.8 (95% CI 3.0-4.8, P<0.0001), respectively, for patients with 0.1-9.9%, 10-19.9%, and ≥20% of the myocardium abnormal at stress (Figure 1B).Multivariable Cox Models for the estimation of cardiac deathThe independent predictors of cardiac death (N=6, 037, Table 3,) and all-cause death (N=7, 061, appendix Table 2) were determined using separate multivariable Cox-proportional hazards models. Older age, history of diabetes, history of smoking and higher rest heart rate were independently associated with a higher hazard of cardiac death even after accounting for % myocardium ischemic and % myocardium scarred. In contrast, history of angina, female sex and history of dyslipidemia were associated independently with a lower hazard of cardiac death in the multivariable clinical model and after the addition of % myocardium ischemic and % myocardium scarred. These findings suggest expected findings as in lower hazard with female sex and likely more aggressive treatment of patients with dyslipidemia and angina, and the survival advantage for patients with higher BMI. Multivariable Cox Models for the estimation of all-cause deathThe % myocardium ischemic and % myocardium scarred were independent predictors of all-cause death. As shown in Table 4, older age, history of hypertension, history of diabetes, beta-blocker use, and higher rest heart rate were also independently associated with a higher hazard of all-cause death, while, female sex, higher BMI, history of dyslipidemia, history of angina and beta-blocker use were associated with a lower hazard of all-cause death, likely for the same reasons discussed previously. For each 10% increase in % myocardium ischemic and % myocardium scarred, the hazard of all-cause mortality increased by 16%, and 32% respectively. Figure 2B plots cumulative risk-adjusted hazard of all-cause death as a function of the % myocardium abnormal at stress. After adjustment for the listed covariates, compared to patients with normal stress PET MPI, the relative hazard of all-cause death was 1.3 (95% CI=1.1-1.6, p=0.016), 1.7 (95% CI=1.2-2.2, p=0.001), and 1.8 (95% CI=1.3-2.6, p=0.001), respectively, for patients with 0.1-9.9%, 10-19.9%, and ≥20% of the myocardium abnormal at stress.Reclassification of all-cause deathFor all-cause death, the NRI results also showed added value of risk classification with PET MPI, although the magnitude of reclassification was lower than for cardiac death. For all-cause death, the IDI was 0.007 (95% CI 0.002-0.012), with a relative IDI of 7% (95% CI 2.0%-12.4%). The continuous NRI was 19.9 % (95% CI 10.1%-28.6%), for annual risk categories of <2.5%, 2.5-7.4% and ≥ 7.5%, NRI was 3.6% (95% CI, 3.0%-6.9%). The addition of % myocardium ischemic and % myocardium scarred to the clinical model more correctly reclassified all-cause death in about 4% of patients.Tables:Appendix Table 1. Univariable Hazard Ratios for All-Cause Death (N=7, 061)ALL-CAUSE DEATHVariablesHR95.0% CI for HRP-ValueAge*2.001.70-2.30<0.0001Female sex0.710.59-0.84<0.0001Hx Hypertension1.481.22-1.81<0.0001Hx Diabetes2.221.61-3.06<0.0001Hx Dyslipidemia0.660.56-0.79<0.0001Hx Smoking1.260.84-1.890.263Hx Angina 0.700.59-0.83<0.0001Body mass index (BMI)0.950.93-0.96<0.0001Hx PCI0.490.87-1.350.5Hx CABG1.981.61-2.45<0.0001Aspirin1.230.90-1.700.2Beta-blockers1.461.23-1.73<0.0001Rest heart rate*1.301.20-1.40<0.0001% Myo abnormal*1.401.30-1.50<0.0001% Myo scarred*1.601.50-1.70<0.0001% Myo ischemic*1.401.30-1.50<0.0001Hx = history of; sites = sites where test was performed; PCI = percutaneous coronary intervention; CABG = coronary artery bypass surgery; myo = myocardium; * per 10 unit change.Appendix Table 2. Multivariable Cox Proportional Hazards Models Estimating All-cause Death (N=7,061)CLINICAL MODELCLINICAL + PET MODELVariablesHR95% CI for HRp-ValueHR95% CI for HRp-ValueAge in deciles1.711.57-1.85<0.00011.691.57-1.83<0.0001Female sex0.670.56-0.80<0.00010.720.61-0.860.0007Body mass index (BMI)0.950.94-0.97<0.00010.960.94-0.97<0.0001Hx Hypertension1.271.04-1.560.021.301.07-1.590.01Hx Diabetes1.981.67-2.36<0.00011.911.60-2.28<0.0001Hx Dyslipidemia0.610.51-0.72<0.00010.590.50-0.70<0.0001Hx Smoking1.241.00-1.540.051.230.99-1.520.06Hx Angina 0.730.62-0.870.00010.760.64-0.900.001Beta-blocker1.401.18-1.670.00021.331.12-1.590.001Rest heart rate*1.411.33-1.49<0.00011.381.20-1.46<0.0001Hx PCI1.130.91-1.410.291.060.85-1.320.60Hx CABG1.210.98-1.490.081.040.84-1.290.70% Myo ischemic* 1.161.04-1.290.006% Myo scarred*1.321.21-1.44<0.0001Comparison of the clinical and clinical + PET models for all-cause deathCLINICAL MODELCLINICAL+PET MODELAIC90048970Chi square value575625C-Statistic0.777 (0.758-0.796)0.788 (0.769-0.807)IDI0.007 (0.002-0.012)Relative IDI0.069 (0.020-0.124)NRI-continuous0.199 (0.101-0.286)NRI-categories0.036 (0.003-0.069)HR = hazard ratio; CI = confidence interval; yr = year; Hx = history of; PCI = percutaneous coronary intervention; CABG = coronary artery bypass grafting; Myo=myocardium; bpm= beats per minute.* per 10 unit change. AIC = Akaike information criterion, IDI = integrated discrimination improvement, NRI = net reclassification improvement. ................
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