Substantial improvement of primary cardiovascular prevention by a systematic score-based multimodal approach: A randomized trial: The PreFord-Study

Detlef Bernd Gysan, Stefanie Millentrup, Christian Albus, Birna Bjarnason-Wehrens, Joachim Latsch, Helmut Gohlke, Gerd Herold, Karl Wegscheider, Christian Heming, Melchior Seyfarth, Hans Georg Predel

Research output: Contribution to journalArticlepeer-review

20 Scopus citations


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-SCORE ≥ 5%), 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.)

Original languageEnglish
Pages (from-to)1544-1554
Number of pages11
JournalEuropean Journal of Preventive Cardiology
Issue number14
StatePublished - 1 Sep 2017
Externally publishedYes


  • Primary prevention
  • cardiovascular diseases
  • risk stratification
  • risk-adjusted multimodal intervention


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