Substantial improvement of primary cardiovascular prevention by a systematic score-based multimodal approach: A randomized trial: The PreFord-Study
| Autor: | G. Herold, D. B. Gysan, Melchior Seyfarth, Helmut Gohlke, Joachim Latsch, Birna Bjarnason-Wehrens, Christian Albus, Stefanie Millentrup, Christian Heming, Karl Wegscheider, Hans-Georg Predel |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Randomization Epidemiology 030204 cardiovascular system & hematology Risk Assessment law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Predictive Value of Tests Risk Factors law Germany Clinical endpoint Humans Medicine Prospective Studies 030212 general & internal medicine Prospective cohort study Intention-to-treat analysis Surrogate endpoint business.industry Multimodal therapy Middle Aged Combined Modality Therapy Intention to Treat Analysis Primary Prevention Treatment Outcome Cardiovascular Diseases Physical therapy Female Cardiology and Cardiovascular Medicine business Risk assessment |
| Zdroj: | European Journal of Preventive Cardiology. 24:1544-1554 |
| ISSN: | 2047-4881 2047-4873 |
| DOI: | 10.1177/2047487317718081 |
| Popis: | 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.) |
| Databáze: | OpenAIRE |
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