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
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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
1University 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
Acute onset of coronary syndromes still combined with
- up to 50 % rate of sudden deaths
Fox CS et al Circulation 110: 522-7, 2004
AHA: Heart Disease and Stroke Update 2009 at a glance
- 60 % of deaths outside the hospital with no improvement over
the last 10 years (MONICA/KORA)
Löwel H et al Dtsch Ärztebl 103:A616-22, 2006
- prevention at top of list of measures to reduce case fatality from CAD
Chambless et al (MONICA study) Circulation 96: 3849-59,1997
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 RiskDiabetes, stroke,aortic aneurysma, PAD
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 coronaryartery 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 Schmid )ţInternational 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)
Risk Factors, Evaluation of Coronary Calcium and Lifestyle
Initiated in 1999 and started in 2000
Schmermund A et al Am Heart J 144:212-18, 2002Stang A et al Eur J Epidemiol 20: 489-96, 2005Dragano N et al Eur J Cardvasc Prev Rehab 14:568-74, 2007
Methods I:
- prospective, population-based cohort study according to GEP
- random samples from resident registration offices
- 4814 men and women, aged 45 – 75 years (response: 56%)
between 12/2000 and 6/2003
- urban population with 1.5 million inhabitants in an big city area
of 8 million people
- study certified and recertified according to ISO 9001:2000
Stang A et al Am J Epidemiol 164:85-94, 2006Erbel R et al Atherosclerosis 197:662-72, 2008Schmermund A et Atherosclerosis 185:177-82, 2006Greenland P et al Circulation 115:402-26, 2007
- blood pressure measurement [OMRON 705CP]
- blood samples taken for measurement of total cholesterol,LDL-C, HDL-C (enzymatic methods),
- ATP III: low, intermediate and high risk categories <10%, 10–20%, >20% 10-year risk for hard events,
- electron beam CT (GE-Imatron, San Francisco),
- coronary artery calcification scoring (Agatston score) for low, intermediate and high risk categories: < 100, 100 – 399, ≥ 400 calcium score.
EBCT results not open to participants or physicians
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
- Primary hypothesis: > 2.5 relative risk of 4th versus 1st quartile of coronary artery calcification
- Primary endpoint: fatal and non fatal myocardial infarction
- Pre-specified follow-up time: 5 years
- one-sided test; α: 5% , β: 10%
- calculation of means, relative risk with 2-sided 95%CI and c-statistics (ROC/AUC)
Reclassification of ATP III Risk Categories Using CAC
51.5% 28.8% 19.7%
Scheme according to Wilson PWF et al JACC 41:1889 – 1906, 2003 with HNR data
62.9 %
23.1 %
14.1 %
Conclusion
Coronary Artery Calcium Score
- is a strong predictor of acute coronary events,
- improves risk prediction beyond traditional risk factors,
- may be valid more in men than in women,
- can be used for reclassification of individuals at intermediate ATP III risk,
- is not recommended in ATP III graded low risk subjects,
- may improve risk prediction in ATPIII high risk individuals
Funded by the Heinz Nixdorf Foundation (chairman: G Schmidt)International Advisory Board: T Meinertz, (chair), by the German Foundation of Research, DFG.
University Clinic Essen, University Duisburg-Essen• Department of Cardiology (R Erbel, Chairman, S Möhlenkamp)
• IMIBE (KH Jöckel, Vicechairman, S Moebus: study coordinator)
• Department of Endocrinology (K Mann)
• Division of Laboratory Research (K Mann, M Bröcker-Preuß)
• Institute of Health Economics (J Wasem)
University Düsseldorf• Institute of Medical Sociology ( J Siegrist, N Dragano)
Alfried Krupp Hospital (Th Budde)
University Witten/Herdecke - Bochum/Mülheim/R• Institute of Radiology and Microtherapy (D Grönemeyer)
• Institute of Diagnostic and Interventional Radiology (R Seibel)
„... 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“