Substantial Improvement of Primary Cardiovascular Prevention by a Systematic Score-based Multimodal Approach: A Randomized Trial: The PreFord-Study

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.).