Control of cardiovascular risk factors with tailored recommendations: A randomized controlled trial.

This study analyzed the efficacy of tailored recommendations to control cardiovascular risk factors at 1-year follow-up in a population-based randomized controlled trial in individuals aged 35-74 years with no history of cardiovascular disease at baseline. Total, low-density lipoprotein (LDL), and high-density lipoprotein cholesterol and systolic and diastolic blood pressure (BP) were measured at baseline and at 1-year follow-up. The primary outcome was the quantitative change in total cholesterol. To estimate the differences within and between groups, McNemar and Student t-tests were applied according to an intention-to-treat strategy. We enrolled 955 individuals [52.3% women; mean age, 50 years (standard deviation 10)]. Finally, 1 participant in each group presented a cardiovascular event and 768 were reexamined at 1-year follow-up. Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively]. Men in the intervention group showed significant decreases in systolic and diastolic BP [117.2 (14.6) to 115.6 mmHg (14.1) and 77.9 (9.7) to 76.5 mmHg (9.7), respectively]; no changes were found in the rates of total cholesterol <5.2 mmol/L and LDL cholesterol <3.0 mmol/L. In the control group, both values were significantly decreased (43.5 to 36.4% and 26.4 to 20.8%, respectively) in men. In the stratified analysis, women showed no differences in any of the outcomes. In conclusion, an intervention with tailored recommendations increased mean total cholesterol values. The intervention effect was higher in men who maintained blood lipids at optimal levels and had decreased BP values.

Efficacy of tailored recommendations to promote healthy lifestyles: a post hoc analysis of a randomized controlled trial.

Prevention is the key to stopping the ravages of cardiovascular diseases, the main cause of death worldwide. The objective was to analyze the efficacy of tailored recommendations to promote healthy lifestyles. Parallel-arm randomized controlled trial with 1 year follow-up. Individuals aged 35-74 years from Girona (Spain) randomly selected from a population with no cardiovascular diseases at baseline were included. Participants in the intervention group received a brochure with tailored healthy choices according to the individual risk profile and a trained nurse explained all recommendations in detail in a 30 min consultation. One year changes in smoking, Mediterranean diet adherence, physical activity, and weight were analyzed with McNemar, Student's t, Wilcoxon, and Fisher exact tests according to an intention-to-treat strategy. Of 955 individuals (52.3% women; mean age 50 [±10] years) randomly allocated to the intervention or control group, one participant in each group presented a cardiovascular event and 768 (81%) were reexamined at 1 year follow-up. The prevalence of nonsmokers increased in both the intervention and control groups (78.1%-82.5%, p = <.001, and 76.7% to 78.8%, p = .015, respectively); however, significance persisted only in the intervention group when stratified by sex, age group, and educational level. Adherence to a Mediterranean diet increased in the intervention group (22.3%-26.5%, p = .048). In conclusion, a brief personalized intervention with science-based recommendations according to individual risk profiles appears to improve healthy lifestyles, particularly nonsmoking and adherence to a Mediterranean diet. This promising intervention system offers evidence-based recommendations to develop healthy lifestyles.

Why should population attributable fractions be periodically recalculated? An example from cardiovascular risk estimation in southern Europe.

OBJECTIVE: To determine the effect of age and study period on coronary heart disease (CHD) risk attributable to cardiovascular risk factors. METHODS: A cohort of cardiovascular disease (CVD)-free randomly participants from Girona (Spain) aged 35-74 years recruited in 1995 and 2000 and followed for an average of 6.9 years. A survey conducted in the same area in 2005 was also used for the analysis. Smoking, hypertension, diabetes, sedentary lifestyle, obesity, total cholesterol > or = 240 mg/dl, low-density lipoprotein (LDL) cholesterol > or = 160 mg/dl, and high-density lipoprotein cholesterol <40 mg/dl were the risk factors considered. The composite end-point included myocardial infarction, angina pectoris, and CHD death. RESULTS: LDL cholesterol had the highest potential for CHD prevention between 35 and 74 years [42% (95% Confidence Interval: 23,58)]. The age-stratified analysis showed that the population attributable risk (PAF) for smoking was 64% (30,80) in subjects < 55 years; for those > or = 55 years, the PAF for hypertension was 34% (1,61). The decrease observed between 1995 and 2005 in the population's mean LDL cholesterol level reduced that PAF in all age groups. CONCLUSION: Overall, LDL cholesterol levels had the highest potential for CHD prevention. Periodic PAF recalculation in different age groups may be required to adequately monitor population trends.

Validity of a method for the self-screening of cardiovascular risk.

BACKGROUND: The validity of a cardiovascular risk self-screening method was assessed. The results obtained for self-measurement of blood pressure, a point-of-care system's assessment of lipid profile and glycated hemoglobin, and a self-administered questionnaire (sex, age, diabetes, tobacco consumption) were compared with the standard screening (gold standard) conducted by a health professional. METHODS: Crossover clinical trial on a population-based sample from Girona (north-eastern Spain), aged 35-74, with no cardiovascular disease at recruitment. Participants were randomized to one of the two risk assessment sequences (standard screening followed by self-screening or vice versa). Cardiovascular risk was estimated with the Framingham-REGICOR function. Concordance between methods was estimated with the intraclass correlation coefficient (ICC). Sensitivity, specificity, and positive and negative predictive values were estimated, considering 5% cardiovascular risk as the cutoff point. ClinicalTrials.gov Registration #NCT02373319. Clinical Research Ethic Committee of the Parc de Salut Mar Registration #2014/5815/I. RESULTS: The median cardiovascular risk in men was 2.56 (interquartile range: 1.42-4.35) estimated by standard methods and 2.25 (1.28-4.07) by self-screening with ICC=0.92 (95% CI: 0.90-0.93). In women, the cardiovascular risk was 1.14 (0.61-2.10) by standard methods and 1.10 (0.56-2.00) by self-screening, with ICC=0.89 (0.87-0.90). The sensitivity, specificity, and positive and negative predictive values for the self-screening method were 0.74 (0.63-0.82), 0.97 (0.95-0.99), 0.86 (0.77-0.93), and 0.94 (0.91-0.96), respectively, in men. In women, these values were 0.50 (0.30-0.70), 0.99 (0.98-1), 0.81 (0.54-0.96), and 0.97 (0.95-0.99), respectively. CONCLUSION: The self-screening method for assessing cardiovascular risk provided similar results to the standard method. Self-screening had high clinical performance to rule out intermediate or high cardiovascular risk.

Validity of an adaptation of the Framingham cardiovascular risk function: the VERIFICA Study.

BACKGROUND: To assess the reliability and accuracy of the Framingham coronary heart disease (CHD) risk function adapted by the Registre Gironí del Cor (REGICOR) investigators in Spain. METHODS: A 5-year follow-up study was completed in 5732 participants aged 35-74 years. The adaptation consisted of using in the function the average population risk factor prevalence and the cumulative incidence observed in Spain instead of those from Framingham in a Cox proportional hazards model. Reliability and accuracy in estimating the observed cumulative incidence were tested with the area under the curve comparison and goodness-of-fit test, respectively. RESULTS: The Kaplan-Meier CHD cumulative incidence during the follow-up was 4.0% in men and 1.7% in women. The original Framingham function and the REGICOR adapted estimates were 10.4% and 4.8%, and 3.6% and 2.0%, respectively. The REGICOR-adapted function's estimate did not differ from the observed cumulated incidence (goodness of fit in men, p = 0.078, in women, p = 0.256), whereas all the original Framingham function estimates differed significantly (p<0.001). Reliabilities of the original Framingham function and of the best Cox model fit with the study data were similar in men (area under the receiver operator characteristic curve 0.68 and 0.69, respectively, p = 0.273), whereas the best Cox model fitted better in women (0.73 and 0.81, respectively, p<0.001). CONCLUSION: The Framingham function adapted to local population characteristics accurately and reliably predicted the 5-year CHD risk for patients aged 35-74 years, in contrast with the original function, which consistently overestimated the actual risk.

[Coronary risk estimation in Spain using a calibrated Framingham function]. / Estimación del riesgo coronario en España mediante la ecuación de Framingham calibrada.

INTRODUCTION AND OBJECTIVES: The Framingham coronary heart disease (CHD) functions overestimate the risk of CHD in countries with a low incidence. Consequently, these functions should be calibrated for the purpose of primary prevention. Calibrated Framingham function charts of overall CHD risk for the Spanish population are presented. Patients and methods. The Framingham functions were calibrated by substituting the prevalence of CHD risk factors and incidence found in Framingham with the same values for Spain. The Framingham function that included high-density lipoprotein (HDL) cholesterol was used. The 10-year probability of developing a CHD event was estimated for several combinations of risk factors and HDL levels ranging from 35 to 59 mg/dl. Color-coded charts were prepared that show the exact probability of CHD corresponding to each combination of risk factors, shown in separate cells on the chart. RESULTS: The event rate and prevalence of CHD risk factors differed considerably between Girona and Framingham. HDL < 35 mg/dL increased risk by approximately 50% and HDL > 60 mg/dL reduced it by 50%. The proportion of cells in which the 10-year probability of developing a CHD event was > 9% was 2.3 times higher and that of cells with a probability > 19% was 13 times lower in the chart calibrated for Spain than in the original Framingham charts. CONCLUSIONS: The calibrated Framingham function may help to more accurately estimate the overall risk of CHD in the Spanish population for primary prevention purposes. The calibrated function should be validated, and the development of functions for the Spanish population should be promoted.

[Comparison of population coronary heart disease risk estimated by the Framingham original and REGICOR calibrated functions]. / Comparación de la función de Framingham original y la calibrada del REGICOR en la predicción del riesgo coronario poblacional.

BACKGROUND AND OBJECTIVE: The therapeutic consequences of using the Framingham function calibrated by the REGICOR and Framingham investigators (Framingham-REGICOR) in the Spanish population are unknown. The objective of this study was to determine the differences in the classification of the population coronary risk when using the classical Framingham function (Framingham-Wilson) and that calibrated, and its consequences on the theoretical indication of lipid-lowering treatment. PATIENTS AND METHOD: The classification into the < 2%, 2-4,9%, 5-9,9%, 10-19,9%, 20-39,9%, and >= 40% risk categories observed by the two functions was compared in 3.270 individuals aged 35 to 74 years with no history of ischaemic heart disease or lipid-lowering drug treatment, recruited in two population samples representative of Girona between 1994 and 2001. The number of lipid-lowering treatment candidates was estimated applying the most recent guidelines for clinical practice, according to the risk level obtained with both functions. RESULTS: The proportion of patients excluded owing to the fact that they already were on lipid-lowering treatment was 6.2%. The Framingham-REGICOR assigned 54.2% of women and 67.9% of men to a lower level of risk as compared to the Framingham-Wilson function. In 0.2% of women and 21.2% of men the decrease was two categories of risk. The figures in diabetic participants were 75.7 and 18.5%, respectively. When the European recommendations published in 2003 were applied, lipid-lowering treatment would have been indicated in 14.5% and in 4.4% of non-diabetic participants by the Framingham-Wilson and the Framingham-REGICOR, respectively. CONCLUSIONS: The calibrated Framingham-REGICOR function assigns a lower coronary risk category in more than 50% of women and almost 90% of men than the uncalibrated Framingham function. The calibrated function is more suitable for risk estimation in primary prevention than the original function in Spain.

Derivation and validation of REASON: a risk score identifying candidates to screen for peripheral arterial disease using ankle brachial index.

BACKGROUND: The recommendation of screening with ankle brachial index (ABI) in asymptomatic individuals is controversial. The aims of the present study were to develop and validate a pre-screening test to select candidates for ABI measurement in the Spanish population 50-79 years old, and to compare its predictive capacity to current Inter-Society Consensus (ISC) screening criteria. METHODS AND RESULTS: Two population-based cross-sectional studies were used to develop (n = 4046) and validate (n = 3285) a regression model to predict ABI < 0.9. The validation dataset was also used to compare the model's predictive capacity to that of ISC screening criteria. The best model to predict ABI < 0.9 included age, sex, smoking, pulse pressure and diabetes. Assessment of discrimination and calibration in the validation dataset demonstrated a good fit (AUC: 0.76 [95% CI 0.73-0.79] and Hosmer-Lemeshow test: χ(2): 10.73 (df = 6), p-value = 0.097). Predictions (probability cut-off value of 4.1) presented better specificity and positive likelihood ratio than the ABI screening criteria of the ISC guidelines, and similar sensitivity. This resulted in fewer patients screened per diagnosis of ABI < 0.9 (10.6 vs. 8.75) and a lower proportion of the population aged 50-79 years candidate to ABI screening (63.3% vs. 55.0%). CONCLUSION: This model provides accurate ABI < 0.9 risk estimates for ages 50-79, with a better predictive capacity than that of ISC criteria. Its use could reduce possible harms and unnecessary work-ups of ABI screening as a risk stratification strategy in primary prevention of peripheral vascular disease.

Trends in cardiovascular risk factor prevalence (1995-2000-2005) in northeastern Spain.

BACKGROUND: High prevalence of cardiovascular risk factors has been observed in Spain along with low incidence of acute myocardial infarction. Our objective was to determine the trends of cardiovascular risk factor prevalence between 1995 and 2005 in the 35-74-year-old population of Gerona, Spain. DESIGN: Comparison of cross-sectional studies were conducted in random population samples in 1995, 2000, and 2005 at Gerona, Spain. METHODS: An electrocardiogram was obtained, along with standardized measurements of body mass index, lipid profile, systolic and diastolic blood pressure, glycaemia, energy expenditure in physical activity, smoking, use of lipid-lowering and antihypertensive medications, and cardiovascular risk. Prevalence of diabetes, hypertension, and obesity was calculated and standardized for age. RESULTS: A total of 7571 individuals (52.0% women) were included (response rate 72%). Low-density lipoprotein cholesterol >3.4 mmol/l (130 mg/dl) (49.7%) and hypertension (39.1%) were the most prevalent cardiovascular risk factors. In 1995, 2000 and 2005, low-density lipoprotein cholesterol decreased in both men and women: 4.05-3.91-3.55 mmol/l (156-151-137 mg/dl) and 3.84-3.81-3.40 mmol/l (148-147-131 mg/dl), respectively. Increases were observed in lipid-lowering drug use (5.7-6.3-9.6% in men and 4.0-5.8-8.0% in women), controlled hypertension (14.8-35.4-37.7% in men and 21.3-36.9-45.0% in women); (all P-trends <0.01), and obesity (greatest for men: 17.5-26.0-22.7%, P-trends=0.020). Prevalence of myocardial infarction or possibly abnormal Q waves in electrocardiogram also increased significantly (3.9-4.7-6.4%, P-trends=0.018). CONCLUSIONS: The cardiovascular risk factor prevalence change in Gerona was marked in this decade by a shift of total cholesterol and low-density lipoprotein cholesterol distributions to the left, independent of the increase in lipid-lowering drug use, and better hypertension control with increased use of antihypertensive drugs.

[Estimating cardiovascular risk in Spain using different algorithms]. / Rendimiento de la estimación del riesgo cardiovascular en España mediante la utilización de distintas funciones.

INTRODUCTION AND OBJECTIVES: Although its incidence is low, cardiovascular disease is the most common cause of morbidity and mortality in Spain. A number of different algorithms can be used to calculate cardiovascular disease risk for primary prevention, but their ability to identify patients who will experience a cardiovascular event is not well understood. The objective of this study was to compare the results of using the original Framingham algorithm and two adaptations for low-risk countries: the REGICOR (Registre Gironí del cor) and SCORE (Systematic COronary Risk Evaluation) algorithms. METHODS: All cardiovascular events during 5-year follow-up in a cohort of patients without coronary disease in nine autonomous Spanish regions were recorded. The levels of different cardiovascular risk factors were measured between 1995 and 1998. Participants were considered high-risk if their 10-year risk was >or=20% with the Framingham algorithm, >or=10%, >or=15% or >or=20% with REGICOR, and >or=5% with SCORE. RESULTS: In total, 180 (3.1%) coronary events (112 in men and 68 in women) occurred among the 5732 (57.3% female) participants during follow-up. Of these, 43 died from cerebrovascular disease, and 24 had a non-coronary vascular event. The REGICOR algorithm had the highest positive predictive value for coronary and cardiovascular disease in all age groups. Moreover, with a 10-year risk limit of 10%, it classified less of the population aged 35-74 years as high-risk (i.e., 12.4%) than the Framingham algorithm (i.e., 22.4%). The SCORE and Framingham algorithms classified 8.4% and 16.6% of the population aged 35-64 years, respectively, as having a high cardiovascular disease risk; with REGICOR, the figure was 7.5%. CONCLUSIONS: The REGICOR adapted algorithm was the best predictor of cardiovascular events and classified a smaller proportion of the Spanish population aged 35-74 years as high risk than alternative algorithms.