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Signs of Subclinical Coronary Atherosclerosis Measured as Coronary Artery Calcification Improve Risk Prediction of Hard Events Beyond Traditional Risk Factors in an Unselected General Population:  The Heinz Nixdorf Recall Study – 5-Year Outcome Data  Raimund Erbel  1 ,   Stefan Möhlenkamp  1 , Susanne Moebus  1 , Axel Schmermund  4 , Nils Lehmann  1 ,  Nico Dragano  3 , Andreas Stang  5 , Dietrich Grönemeyer  2 , Rainer Seibel  2 , Hagen Kälsch  1 , Martina Bröcker-Preuß  1 , Klaus Mann  1 , Johannes Siegrist  3 , Karl-Heinz Jöckel  1 ,  for the Heinz Nixdorf Recall Study Investigative Group 1 University Duisburg-Essen,  2   University Witten-Herdecke,  3  University Düsseldorf,  4  Cardioangiological Center Bethanien,  Frankfurt,  5  University Halle-Wittenberg, Germany
Presenter Disclosure Information < Raimund Erbel, MD, FACC, FESC, FAHA > The following relationships exist related to this presentation: Research Grant  Company Imatron-GE  modest level
Background ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Background: Risk Classification Greenland P et al  Circulation 104:1863-1867, 2001 Grundy SM  JACC 46: 173 – 5, 2005 FRS/NCEP ATP III 35 %   Low Risk  40 % Intermediate risk 25 %  High Risk Diabetes, stroke, aortic aneurysma, PAD Hard CVE or all CV Events < 10% 10-year 10 – 20%  10-year > 20%  10- year ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Life Style Change Reassessment after 5years INTENSIFIED THERAPY of all  risk factors + -
Electron-beam Computed Tomography for Non-Invasive Imaging of Subclinical Coronary Atherosclerosis -  < 20 s scan time -  1-1.3 mSv X-ray exposure -  100 ms acquisition time -  standardized protocols: Agatston-Score -  15-20 min total time -  0.94 Kappa value for inter- institutional variation Imaging of coronary artery calcification as  a specific sign of  atherosclerosis Agatston et al.  JACC 15:827-32, 1990    Hunold P et al  Radiology  226:145-52, 2003     Schmermund et al .  Z Kardiol 92:I/385,2003
Aim of the Study Funded by the Heinz Nixdorf Foundation  (chairman: G Schmidţ) International Advisory Board: Th Meinertz, (chair)  supported by German Foundation of Research … coronary calcium as a sign of subclinical coronary atherosclerosis improves risk prediction for cardiovascular events in comparison to risk factors Heinz Nixdorf Recall Study (HNR) R isk Factors,  E valuation of Coronary  Cal cium  and  L ifestyle Initiated in 1999 and started in 2000
Schmermund A et al  Am Heart J 144:212-18, 2002 Stang A et al  Eur J Epidemiol 20: 489-96, 2005 Dragano N et al  Eur J Cardvasc Prev Rehab  14:568-74, 2007  Methods I: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Stang A et al    Am J Epidemiol 164:85-94, 2006 Erbel R et al  Atherosclerosis 197:662-72, 2008 Schmermund A et  Atherosclerosis 185:177-82, 2006 Greenland P et al  Circulation  115:402-26, 2007 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Methods II: Risk Factors and CAC
Endpoint committee: C Bode, Freiburg (chairman) K. Berger, Münster; HR. Figulla, Jena; C. Hamm,  Bad Nauheim; P. Hanrath, Aachen ; W. Köpcke,  Münster; Ringelstein, Münster, C. Weimar, Essen;  A. Zeiher, Frankfurt ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Methods III: Sample Size Calculation and Statistical Methods
0.8 % lost to follow-up  1.9 % alive, no information about AMI n = 4487 without CAD 4370 study cohort: 4137   participants (53% females) missing values for Framingham risk factors, ATPIII variables and calcium scores  (n=233) Study Cohort Median observation time:  5.03 yrs (mean: 5.12  ±  0.26 yrs)
no primary endpoint  n=4044 (53% females) primary endpoint  n=93   (30% females) non-fatal MI : n=64   (30% females) * coronary death: n=29   (31% females) *: MI-Group includes 1 subject who survived  sudden cardiac death (died 2 days later from cerebral bleeding) Study Cohort 4137  (53% females) n=107 non-coronary deaths (43% females) 450/100.000  per year  observed versus  300 – 500/100.000 predicted based on German PROCAM / MONICA data Primary Endpoints
Age [yrs] Systolic BP [mmHg] Total Cholesterol [mmol/l] HDL-Cholesterol [mmol/l] Smoking (active or former) [%] Diabetes [%] ATP III  <10% 10-20% >20% 62±8 145±25 6.1±0.9 1.3±0.4 70.8% 16.9% 15.4% 38.5% 46.1% 59±8* 138±19* 5.9±1.0 1.3±0.4 70.0% 8.5%* 30.0% 38.6% 31.4% Men Women events n=65 no events n=1891 64±8 135±23 6.5±1.1 1.6±0.5 42.9% 17.9% 42.8% 28.6% 28.6% 59±8* 128±21 6.1±1.0* 1.7±0.4 43.6% 6.0%* 71.5% 20.0% 8.5% events n=28 no events n=2153 Demographics / Risk Factors * * * : p < 0.05 Data = mean±SD or %
ATP III Categories Data = Event Rates (95%CI) Event Rates stratified by  ATP III Categories 0 8 12 20 Event Rate in 5 Years [%] 16 4 low inter- mediate high All Subjects low inter- mediate high Men Women low inter- mediate high p=0.0003 P<0.0001 p=0.03 p=0.08 P=0.003 p=0.17 p=0.06 P=0.0007 p=0.10 51.5% 28.8% 19.7% 29.6% 38.6% 31.9% 71.2% 20.1% 8.8%
CAC Categories Data = Event Rates (95%CI) Event Rates stratified by  CAC Score Categories 72.9% 16.8% 10.3% 85.0% 10.5% 4.5% 0 8 12 20 Event Rate in 5 Years [%] 16 4 <100 100-399 ≥ 400 Men <100 100-399 ≥ 400 Women <100 100-399 ≥ 400 All Subjects p=0.0002 p<0.0001 p=0.0004 p=0.002 p<0.0001 p=0.02 p=0.48 p<0.0001 p=0.004 59.4% 23.8% 16.8%
Relative Risks (Men) * adjusted for  ATP III category CAC Score Categories  Crude Relative  Risk (95%CI) Adjusted* Relative  Risk (95%CI) 0-99 1.00 1.00 100-399 2.77 (1.48-5.19) 2.53 (1.35-4.74)  400 5.31 (2.96-9.53) 4.65 (2.60-8.30) Doubling of CAC Scores   (Log 2 (CAC+1)) 1.32 (1.20-1.45) 1.30 (1.18-1.43) Quartiles of  CAC Scores   1st (0-4.4) 1.00 2nd (4.4-55.55) 3.39 (0.94-12.24) 3.16 (0.88-11.29) 3rd (55.55-239.2) 6.39 (1.90-21.44) 5.69 (1.72-18.80) 4th (>239.2) 11.09 (3.42-35.92) 9.48 (2.97-30.22)
Relative Risks (Women) * adjusted for  ATP III category CAC Score  Categories  Crude Relative Risk (95%CI) Adjusted* Relative Risk (95%CI) 0-99 1.00 1.00 100-399 1.42 (0.42-4.81) 1.07 (0.29-3.97)  400 8.90 (3.94-20.11) 5.89 (2.46-14.08) Doubling of CAC  Scores  (log 2 (CAC+1)) 1.25 (1.11-1.42) 1.20 (1.06-1.37) Quartiles of  CAC Scores  1st  (=0) 1.00 2nd + 3rd (>0-37.9) 1.12 (0.39-3.23) 0.90 (0.31-2.61) 4th (>37.9) 3.16 (1.33-7.48) 2.12 (0.81-5.55)
ROC Curve Analysis / C-Statistics ATPIII categories log(CAC+1) ATPIII cat. + log(CAC+1) All Subjects **: p=0.0001 versus ATPIII *: p=0.009 versus ATPIII Sensitivity 1 - Specificity 0.0 0.2 0.4 0.6 0.8 1.0 0.0 0.2 0.4 0.6 0.8 1.0 ATPIII log(CAC+1) ATPIII + log(CAC+1) 0.754 ** 0.740 * 0.667
ROC Curve Analysis / C-Statistics **: p < 0.0001 vs ATPIII *: p = 0.004 vs ATPIII Men **: p = 0.18 vs ATPIII *: p = 0.80 vs ATPIII Women Men Women 0.0 0.2 0.4 0.6 0.8 1.0 0.0 0.2 0.4 0.6 0.8 1.0 Sensitivity 1 - Specificity ATPIII log(CAC+1) ATPIII + log(CAC+1) 0.727 ** 0.724 * 0.602 0.0 0.2 0.4 0.6 0.8 1.0 0.0 0.2 0.4 0.6 0.8 1.0 1 - Specificity ATPIII log(CAC+1) ATPIII + log(CAC+1) 0.660 0.677 * 0.723 ** Sensitivity
Events Stratified by ATP III & CAC Categories All Subjects Data = Event Rates (95%CI) Low risk Intermediate risk High risk ATP III  CAC  87.3% 9.3% 3.4% 62.9% 23.1% 14.1% 49.8% 27.4% 22.9% 51.5% 28.8% 19.7% 0 8 12 20 Event Rate in 5 Years [%] 16 4 <100 100-399 ≥ 400 <100 100-399 ≥ 400 <100 100-399 ≥ 400
0  10  20  % 10-year risk ATPIII Score Risk Assessment  CAC Score  high risk  Intermediate risk  low risk Reclassification of ATP III Risk  Categories Using CAC Scheme according to Wilson PWF et al  JACC 41:1889 – 1906, 2003 with HNR data 23.1 % 51.5% 28.8% 19.7% 62.9 % 14.1 %
Conclusion ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Funded by the Heinz Nixdorf Foundation  (chairman: G Schmidt) International Advisory Board: T Meinertz, (chair),  by the German Foundation of Research, DFG. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
„ ...  we are still living in a world where almost 1/3 of the patients who die ... die suddenly before we were even aware that these people were ill or that their lives were in jeopardy. So it seems to me   that   the most important problem we face is to find a way of recognizing these people before they drop dead and tell us that they were sick “ In: Coronary Heart Disease, 3rd Int. Symposium  Frankfurt, Kaltenbach M, Lichtlen P, Balcon R,  Bussmann WD (eds) Thieme, Stuttgart  1978; 83  Mason Sones in  Frankfurt 1978 Risk factors alone seem not be reliable enough

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Heinz Nixdorf Erbel

  • 1. Signs of Subclinical Coronary Atherosclerosis Measured as Coronary Artery Calcification Improve Risk Prediction of Hard Events Beyond Traditional Risk Factors in an Unselected General Population: The Heinz Nixdorf Recall Study – 5-Year Outcome Data Raimund Erbel 1 , Stefan Möhlenkamp 1 , Susanne Moebus 1 , Axel Schmermund 4 , Nils Lehmann 1 , Nico Dragano 3 , Andreas Stang 5 , Dietrich Grönemeyer 2 , Rainer Seibel 2 , Hagen Kälsch 1 , Martina Bröcker-Preuß 1 , Klaus Mann 1 , Johannes Siegrist 3 , Karl-Heinz Jöckel 1 , for the Heinz Nixdorf Recall Study Investigative Group 1 University Duisburg-Essen, 2 University Witten-Herdecke, 3 University Düsseldorf, 4 Cardioangiological Center Bethanien, Frankfurt, 5 University Halle-Wittenberg, Germany
  • 2. Presenter Disclosure Information < Raimund Erbel, MD, FACC, FESC, FAHA > The following relationships exist related to this presentation: Research Grant Company Imatron-GE modest level
  • 3.
  • 4.
  • 5. Electron-beam Computed Tomography for Non-Invasive Imaging of Subclinical Coronary Atherosclerosis - < 20 s scan time - 1-1.3 mSv X-ray exposure - 100 ms acquisition time - standardized protocols: Agatston-Score - 15-20 min total time - 0.94 Kappa value for inter- institutional variation Imaging of coronary artery calcification as a specific sign of atherosclerosis Agatston et al. JACC 15:827-32, 1990 Hunold P et al Radiology 226:145-52, 2003 Schmermund et al . Z Kardiol 92:I/385,2003
  • 6. Aim of the Study Funded by the Heinz Nixdorf Foundation (chairman: G Schmidţ) International Advisory Board: Th Meinertz, (chair) supported by German Foundation of Research … coronary calcium as a sign of subclinical coronary atherosclerosis improves risk prediction for cardiovascular events in comparison to risk factors Heinz Nixdorf Recall Study (HNR) R isk Factors, E valuation of Coronary Cal cium and L ifestyle Initiated in 1999 and started in 2000
  • 7.
  • 8.
  • 9.
  • 10. 0.8 % lost to follow-up 1.9 % alive, no information about AMI n = 4487 without CAD 4370 study cohort: 4137 participants (53% females) missing values for Framingham risk factors, ATPIII variables and calcium scores (n=233) Study Cohort Median observation time: 5.03 yrs (mean: 5.12 ± 0.26 yrs)
  • 11. no primary endpoint n=4044 (53% females) primary endpoint n=93 (30% females) non-fatal MI : n=64 (30% females) * coronary death: n=29 (31% females) *: MI-Group includes 1 subject who survived sudden cardiac death (died 2 days later from cerebral bleeding) Study Cohort 4137 (53% females) n=107 non-coronary deaths (43% females) 450/100.000 per year observed versus 300 – 500/100.000 predicted based on German PROCAM / MONICA data Primary Endpoints
  • 12. Age [yrs] Systolic BP [mmHg] Total Cholesterol [mmol/l] HDL-Cholesterol [mmol/l] Smoking (active or former) [%] Diabetes [%] ATP III <10% 10-20% >20% 62±8 145±25 6.1±0.9 1.3±0.4 70.8% 16.9% 15.4% 38.5% 46.1% 59±8* 138±19* 5.9±1.0 1.3±0.4 70.0% 8.5%* 30.0% 38.6% 31.4% Men Women events n=65 no events n=1891 64±8 135±23 6.5±1.1 1.6±0.5 42.9% 17.9% 42.8% 28.6% 28.6% 59±8* 128±21 6.1±1.0* 1.7±0.4 43.6% 6.0%* 71.5% 20.0% 8.5% events n=28 no events n=2153 Demographics / Risk Factors * * * : p < 0.05 Data = mean±SD or %
  • 13. ATP III Categories Data = Event Rates (95%CI) Event Rates stratified by ATP III Categories 0 8 12 20 Event Rate in 5 Years [%] 16 4 low inter- mediate high All Subjects low inter- mediate high Men Women low inter- mediate high p=0.0003 P<0.0001 p=0.03 p=0.08 P=0.003 p=0.17 p=0.06 P=0.0007 p=0.10 51.5% 28.8% 19.7% 29.6% 38.6% 31.9% 71.2% 20.1% 8.8%
  • 14. CAC Categories Data = Event Rates (95%CI) Event Rates stratified by CAC Score Categories 72.9% 16.8% 10.3% 85.0% 10.5% 4.5% 0 8 12 20 Event Rate in 5 Years [%] 16 4 <100 100-399 ≥ 400 Men <100 100-399 ≥ 400 Women <100 100-399 ≥ 400 All Subjects p=0.0002 p<0.0001 p=0.0004 p=0.002 p<0.0001 p=0.02 p=0.48 p<0.0001 p=0.004 59.4% 23.8% 16.8%
  • 15. Relative Risks (Men) * adjusted for ATP III category CAC Score Categories Crude Relative Risk (95%CI) Adjusted* Relative Risk (95%CI) 0-99 1.00 1.00 100-399 2.77 (1.48-5.19) 2.53 (1.35-4.74)  400 5.31 (2.96-9.53) 4.65 (2.60-8.30) Doubling of CAC Scores (Log 2 (CAC+1)) 1.32 (1.20-1.45) 1.30 (1.18-1.43) Quartiles of CAC Scores 1st (0-4.4) 1.00 2nd (4.4-55.55) 3.39 (0.94-12.24) 3.16 (0.88-11.29) 3rd (55.55-239.2) 6.39 (1.90-21.44) 5.69 (1.72-18.80) 4th (>239.2) 11.09 (3.42-35.92) 9.48 (2.97-30.22)
  • 16. Relative Risks (Women) * adjusted for ATP III category CAC Score Categories Crude Relative Risk (95%CI) Adjusted* Relative Risk (95%CI) 0-99 1.00 1.00 100-399 1.42 (0.42-4.81) 1.07 (0.29-3.97)  400 8.90 (3.94-20.11) 5.89 (2.46-14.08) Doubling of CAC Scores (log 2 (CAC+1)) 1.25 (1.11-1.42) 1.20 (1.06-1.37) Quartiles of CAC Scores 1st (=0) 1.00 2nd + 3rd (>0-37.9) 1.12 (0.39-3.23) 0.90 (0.31-2.61) 4th (>37.9) 3.16 (1.33-7.48) 2.12 (0.81-5.55)
  • 17. ROC Curve Analysis / C-Statistics ATPIII categories log(CAC+1) ATPIII cat. + log(CAC+1) All Subjects **: p=0.0001 versus ATPIII *: p=0.009 versus ATPIII Sensitivity 1 - Specificity 0.0 0.2 0.4 0.6 0.8 1.0 0.0 0.2 0.4 0.6 0.8 1.0 ATPIII log(CAC+1) ATPIII + log(CAC+1) 0.754 ** 0.740 * 0.667
  • 18. ROC Curve Analysis / C-Statistics **: p < 0.0001 vs ATPIII *: p = 0.004 vs ATPIII Men **: p = 0.18 vs ATPIII *: p = 0.80 vs ATPIII Women Men Women 0.0 0.2 0.4 0.6 0.8 1.0 0.0 0.2 0.4 0.6 0.8 1.0 Sensitivity 1 - Specificity ATPIII log(CAC+1) ATPIII + log(CAC+1) 0.727 ** 0.724 * 0.602 0.0 0.2 0.4 0.6 0.8 1.0 0.0 0.2 0.4 0.6 0.8 1.0 1 - Specificity ATPIII log(CAC+1) ATPIII + log(CAC+1) 0.660 0.677 * 0.723 ** Sensitivity
  • 19. Events Stratified by ATP III & CAC Categories All Subjects Data = Event Rates (95%CI) Low risk Intermediate risk High risk ATP III CAC 87.3% 9.3% 3.4% 62.9% 23.1% 14.1% 49.8% 27.4% 22.9% 51.5% 28.8% 19.7% 0 8 12 20 Event Rate in 5 Years [%] 16 4 <100 100-399 ≥ 400 <100 100-399 ≥ 400 <100 100-399 ≥ 400
  • 20. 0 10 20 % 10-year risk ATPIII Score Risk Assessment CAC Score high risk Intermediate risk low risk Reclassification of ATP III Risk Categories Using CAC Scheme according to Wilson PWF et al JACC 41:1889 – 1906, 2003 with HNR data 23.1 % 51.5% 28.8% 19.7% 62.9 % 14.1 %
  • 21.
  • 22.
  • 23. „ ... we are still living in a world where almost 1/3 of the patients who die ... die suddenly before we were even aware that these people were ill or that their lives were in jeopardy. So it seems to me that the most important problem we face is to find a way of recognizing these people before they drop dead and tell us that they were sick “ In: Coronary Heart Disease, 3rd Int. Symposium Frankfurt, Kaltenbach M, Lichtlen P, Balcon R, Bussmann WD (eds) Thieme, Stuttgart 1978; 83 Mason Sones in Frankfurt 1978 Risk factors alone seem not be reliable enough