Randomized clinical trial to assess the efficacy of a comprehensive programme of secondary prevention of cardiovascular disease in general practice: the PREseAP study.

INTRODUCTION AND OBJECTIVES: To assess the efficacy of a comprehensive program of secondary prevention of cardiovascular disease in general practice. METHODS: A cluster randomized clinical trial was carried out in a regular general practice setting. Male and female patients aged under 86 years with a diagnosis of ischemic heart disease, stroke or peripheral artery disease were recruited between January 2004 and May 2005. Study participants were seen at 42 health centers throughout the whole of Spain. The primary endpoint was the combination of all-cause mortality and hospital cardiovascular readmission at 3-year follow-up. RESULTS: In total, 1224 patients were recruited: 624 in the intervention group and 600 in the control group. The primary endpoint was observed in 29.9% (95% confidence interval [CI], 25.5-34.8%) in the intervention group and 25.6% (22.3-29.2%) in the control group (P=.15). At the end of follow-up, 8.5% (6.3-11.3%) in the intervention group and 11% (7.4-16%) in the control group were smokers (P=.07). The mean waist circumference of patients in the intervention and control groups was 100.44 cm (95% CI, 98.97-101.91 cm) and 102.58 cm (95% CI, 100.96-104.21 cm), respectively (P=.07). Overall, 20.9% (15.6-27.7%) of patients in the intervention group and 29.6% (23.9-36.1%) in the control group suffered from anxiety (P=.05), and 29.6% (22.4-37.9%) in the intervention group and 41.4% (35.8-47.3%) in the control group had depression (P=.02). CONCLUSIONS: A comprehensive program of secondary prevention of cardiovascular disease in general practice was not effective in reducing cardiovascular morbidity and mortality. However, some factors associated with a healthy lifestyle were improved and anxiety and depression were reduced.

Ensayo clínico aleatorizado para evaluar la eficacia de un programa integral de prevención secundaria de las enfermedades cardiovasculares en atención primaria: estudio PREseAP / Randomized clinical trial to assess the efficacy of a comprehensive programme of secondary prevention of cardiovascular disease in general practice: the PREseAP study

Introducción y objetivos. Evaluar la eficacia de un programa integral de prevención secundaria de las enfermedades cardiovasculares en atención primaria. Métodos.Ensayo clínico aleatorizado, pragmático, por conglomerados realizado en atención primaria. Eran pacientes elegibles varones y mujeres menores de 86 años, diagnosticados de cardiopatía isquémica, accidente cerebrovascular o enfermedad arterial periférica entre enero de 2004 y mayo de 2005. Participaron en el estudio pacientes visitados en 42 centros de salud de todo el estado español. La variable de resultado fue la combinación de la mortalidad total y los reingresos hospitalarios por causa cardiovascular a los 3 años de seguimiento. Resultados. Se reclutó a 1.224 pacientes, 624 en el grupo intervención y 600 en el grupo control. La variable principal de resultado se observó en el 29,9% (intervalo de confianza del 95%, 25,5-34,8) en el grupo intervención y en el 25,6% (22,3-29,2) en el grupo control (p=0,15). Al final del seguimiento un 8,5% (6,3-11,3) del grupo intervención y un 11% (7,4-16) del grupo control eran fumadores (p=0,07). El perímetro abdominal del grupo intervención fue 100,44 (98,97-101,91) cm y el del grupo control, 102,58 (100,96-104,21) cm (p=0,07). El 20,9% (15,6-27,7) de los pacientes del grupo intervención y el 29,6% de los pacientes del grupo control (23,9-36,1) tenían ansiedad (p=0,05), y el 29,6% (22,4-37,9) del grupo intervención y el 41,4% (35,8-47,3) del grupo control tenían depresión (p=0,02). Conclusiones. Un programa integral de prevención secundaria no es eficaz para reducir la morbimortalidad cardiovascular, pero sí en mejorar algunos aspectos relacionados con los hábitos saludables y en reducir la ansiedad y la depresión (AU)

Introduction and objectives: To assess the efficacy of a comprehensive programof secondary prevention of cardiovascular disease in general practice. Methods: A cluster randomized clinical trial was carried out in a regular general practice setting. Male and female patients aged under 86 years with a diagnosis of ischemic heart disease, stroke or peripheral artery disease were recruited between January 2004 and May 2005. Study participants were seen at 42 health centers throughout the whole of Spain. The primary endpoint was the combination of all-cause mortality and hospital cardiovascular readmission at 3-year follow-up. Results: In total, 1224 patients were recruited: 624 in the intervention group and 600 in the control group. The primary endpoint was observed in 29.9% (95% confidence interval [CI], 25.5–34.8%) in the intervention group and 25.6% (22.3–29.2%) in the control group (P = .15). At the end of follow-up, 8.5% (6.3–11.3%) in the intervention group and 11% (7.4–16%) in the control group were smokers (P = .07). The mean waist circumference of patients in the intervention and control groups was 100.44 cm (95% CI, 98.97–101.91 cm) and 102.58 cm (95% CI, 100.96–104.21 cm), respectively (P = .07). Overall, 20.9% (15.6–27.7%) of patients in the intervention group and 29.6% (23.9–36.1%) in the control group suffered from anxiety (P = .05), and 29.6% (22.4–37.9%) in the intervention group and 41.4% (35.8–47.3%) in the control group had depression (P = .02). Conclusions: A comprehensive program of secondary prevention of cardiovascular disease in general practice was not effective in reducing cardiovascular morbidity and mortality. However, some factors associated with a healthy lifestyle were improved and anxiety and depression were reduced (AU)