Universität zu Köln

Gysan, Detlef Bernd, Millentrup, Stefanie, Albus, Christian, Bjarnason-Wehrens, Birna, Latsch, Joachim, Gohlke, Helmut, Herold, Gerd, Wegscheider, Karl, Heming, Christian, Seyfarth, Melchior and Predel, Hans-Georg (2017). Substantial improvement of primary cardiovascular prevention by a systematic score-based multimodal approach: A randomized trial: The PreFord-Study. Eur. J. Prev. Cardiol., 24 (14). S. 1544 - 1555. LONDON: SAGE PUBLICATIONS LTD. ISSN 2047-4881

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Abstract

Trial design Prospective randomized multicentre interventional study. Methods Individual cardiovascular risk assessment in Ford Company, Germany employees (n=4.196), using the European Society of Cardiology-Systematic Coronary Risk Evaluation (ESC-SCORE) for classification into three risk groups. Subjects assigned to ESC high-risk group (ESC-SCORE5%), without a history of cardiovascular disease were eligible for randomization to a multimodal 15-week intervention programme (INT) or to usual care and followed up for 36 months. Objectives Evaluation of the long-term effects of a risk-adjusted multimodal intervention in high-risk subjects. Primary endpoint: reduction of ESC-SCORE in INT versus usual care. Secondary endpoints: composite of fatal and non-fatal cardiovascular events and time to first cardiovascular event. Statistical analysis: intention-to-treat and per-protocol analysis. Results Four hundred and forty-seven subjects were randomized to INT (n=224) or to usual care (n=223). After 36 months ESC-SCORE development favouring INT was observed (INT: 8.70% to 10.03% vs. usual care: 8.49% to 12.09%; p=0.005; net difference: 18.50%). Moreover, a significant reduction in the composite cardiovascular events was observed: (INT: n=11 vs. usual care: n=27). Hazard ratio of intervention versus control was 0.51 (95% confidence interval 0.25-1.03; p=0.062) in the intention-to-treat analysis and 0.41 (95% confidence interval 0.18-0.90; p=0.026) in the per-protocol analysis, respectively. No intervention-related adverse events or side-effects were observed. Conclusions Our results demonstrate the efficiency of identifying cardiovascular high-risk subjects by the ESC-SCORE in order to enrol them to a risk adjusted primary prevention programme. This strategy resulted in a significant improvement of ESC-SCORE, as well as a reduction in predefined cardiovascular endpoints in the INT within 36 months. (ISRCTN 23536103.)

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Gysan, Detlef Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Millentrup, Stefanie UNSPECIFIED UNSPECIFIED UNSPECIFIED Albus, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Bjarnason-Wehrens, Birna UNSPECIFIED UNSPECIFIED UNSPECIFIED Latsch, Joachim UNSPECIFIED UNSPECIFIED UNSPECIFIED Gohlke, Helmut UNSPECIFIED UNSPECIFIED UNSPECIFIED Herold, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Wegscheider, Karl UNSPECIFIED UNSPECIFIED UNSPECIFIED Heming, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Seyfarth, Melchior UNSPECIFIED UNSPECIFIED UNSPECIFIED Predel, Hans-Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-218659
DOI:	10.1177/2047487317718081
Journal or Publication Title:	Eur. J. Prev. Cardiol.
Volume:	24
Number:	14
Page Range:	S. 1544 - 1555
Date:	2017
Publisher:	SAGE PUBLICATIONS LTD
Place of Publication:	LONDON
ISSN:	2047-4881
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language HEART-DISEASE; RISK-FACTORS; MYOCARDIAL-INFARCTION; MORTALITY; FITNESS; PROJECT Multiple languages Cardiac & Cardiovascular Systems Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/21865