Effekte einer multimodalen Intervention auf das kardiovaskuläre Risikoprofil ausgewählter Hochrisikopatienten in der Primärprävention von Herz-Kreislauferkrankungen: Ergebnisse der PräFord-Studie

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Introduction: In Western industrialized countries, cardiovascular diseases are still the most frequent cause of death. Evidence- and science-based concepts regarding guidelines and standards for effective prevention programs do not exist yet. In addition, the monitoring of traditional risk factors in the primary prevention of cardiovascular disease is considered to be insufficient. The PreFord Study is a prospective, multicenter cohort study to assess the risk of an acute cardiovascular event (overall collective) as well as a prospective, randomized, controlled, multicenter clinical intervention study for the high-risk part of the cohort. The aim of this study was to evaluate whether a newly designed multimodal intervention program has a short- and long-term effect (two years) on risk factors and the ESC score for the sub-cohort with high cardiovascular risk profile in comparison to a control group. Methods: 286 patients with an ESC risk score ≥ 5% were evaluated in this study. After randomization, 142 patients were in the intervention group (IG: 124 m/18 f; 62.7 ± 6.9 years) and 144 patients in the control group (CG: 132 m/12 f; 60.9 ± 6.8 years). The IG participated in a 15-week (2,5-3 h twice a week) new, multimodal, outpatient intervention in conjunction with guideline-based medication. The program consisted of the modules nutrition advice, exercise, psychotherapy, health training and medical care. The CG received a detailed explanation on their cardiovascular risk factors profile from a cardiologist. Three patients discontinued the intervention prematurely. 14 patients reached secondary endpoints in the two-year observation period. The IG was significantly (p=0.026) older than the CG. No other major significant differences between the groups were observed. Results: As a result of the intervention, anthropometric data (body weight -2.6 kg; BMI -0.9 kg/m2; waist circumference -3.0 cm), systolic and diastolic resting blood pressure (-9.1 mmHg; -5.6 mmHg), labor parameters (total cholesterol -28.2 mg/dl; LDL cholesterol -22.5 mg/dl; triglycerides -37.0 mg/dl; HbA1c -0.14%) and the ESC score (-2.6%) improved significantly (p<0,001). The weight reduction was stabilized for two years (body weight -1.6 kg and BMI -0.5 kg/m2; p<0.001). Waist circumference was significantly reduced at the one-year follow-up (-2.1 cm; p<0.001). In the CG, no significant changes in anthropometric parameters were observed. The reduction of the lipid parameters could be significantly maintained for two years (total cholesterol -19.1 mg/dl, p<0.001; LDL cholesterol -18.0 mg/dl, p<0.001; triglycerides -20.7 mg/dl, p=0.002). In the CG, no significant changes were observed. Furthermore, the lipid parameters were significantly lower in the IG group compared to the CG at the one- and two-year follow-up. The systolic resting blood pressure was significantly reduced at the one-year follow-up in both groups (IG -6.3 mmHg, KG -1.7 mmHg; p<0,001). This was also true for the diastolic resting blood pressure at the two-year follow-up (IG -3.2 mmHg, KG -0.8 mmHg; p=0,019). Although, the change was higher in the IG, there was no significant difference between the groups. Smoking was almost completely stopped in both groups (non-smoker: IG 99.3%; CG 100%). In the IG, the left and right IMT showed a significant reduction at the two-year follow-up (-0.1 mm; p=0.035 and -0.11 mmHg; p=0.011) compared to the CG. In addition, the left IMT was significantly lower in the IG than in the CG at the two-year follow-up. The reduction of the ESC score could be maintained in the IG up to one year (-1.9%; p<0.001) compared to the CG. Discussion: The results confirm the short- and long-term efficacy of a multimodal intervention in reducing cardiovascular risks in high-risk patients. This is especially true for the short-term results as well as the one-year follow-up results. At the two-year follow-up, however, the effects on the ESC score and partly on the cardiovascular risk factors do not exist anymore. More intensive follow-up care and cluster programs could have improved the long-term results. These results highlight the importance of providing multimodal outpatient intervention programs in combination with consistent implementation of preventive arrangements to optimize cardiovascular risk reduction in patients with high-risk in developing cardiovascular disease.
Original languageGerman
PublisherDeutsche Sporthochschule Köln
Number of pages193
Publication statusPublished - 2014