Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial. Issue 10338 (14th May 2022)

• Record Type: Journal Article
• Authors: Delgado-Lista, Javier; Alcala-Diaz, Juan F; Torres-Peña, Jose D; Quintana-Navarro, Gracia M; Fuentes, Francisco; Garcia-Rios, Antonio; Ortiz-Morales, Ana M; Gonzalez-Requero, Ana I; Perez-Caballero, Ana I; Yubero-Serrano, Elena M; Rangel-Zuñiga, Oriol A; Camargo, Antonio; Rodriguez-Cantalejo, Fernando; Lopez-Segura, Fernando; Badimon, Lina; Ordovas, Jose M; Perez-Jimenez, Francisco; Perez-Martinez, Pablo; Lopez-Miranda, Jose; Alcala-Diaz, Juan F; Almaden Peña, Yolanda; Aranda, Enrique; Arenas de Larriva, Antonio P; Badimon, Lina; Badimon, Juan J; Blanco-Molina, Angeles; Blanco-Rojo, Ruth; Bolivar-Muñoz, Julia; Caballero-Villarraso, Javier; Camargo, Antonio; Chica, Javier; Corina, Andreea; Criado-Garcia, Juan; Cruz-Teno, Cristina; Daponte-Codina, Antonio; de Teresa Galvan, Eduardo; Delgado-Casado, Nieves; Delgado-Lista, Javier; Estruch, Ramon; Fernandez, Juan M; Fernandez-Gandara, Carolina; Fuentes-Jimenez, Francisco; Garcia-Carpintero Fernandez-Pacheco, Sonia; Garcia-Rios, Antonio; Gomez-Delgado, Francisco; Gomez-Garduño, Angela; Gomez-Luna, Purificacion; Gomez-Luna, Maria J; Gonzalez-Guardia, Lorena; Gonzalez-Requero, Ana I.; Gutierrez-Mariscal, Francisco M; Haro-Mariscal, Carmen M; Jimenez-Lucena, Rosa; Jimenez-Morales, Ana I.; Leon-Acuña, Ana; Lopez-Miranda, Jose; Lopez-Segura, Fernando; Marin-Hinojosa, Carmen; Meneses Alvarez, Maria E; Mesa-Luna, Dolores; Moya-Garrido, Maria N; Muñoz-Carvajal, Ignacio; Navarro-Martos, Vanessa; Ochoa, Juan J; Ordovas, Jose M; Ortiz-Minuesa, Juan A; Ortiz-Morales, Ana M; Pan, Manuel; Peña-Orihuela, Patricia; Perez-Caballero, Ana I; Perez-Corral, Isabel; Perez-Jimenez, Francisco; Perez-Martinez, Pablo; Pi-Sunyer, Francesc X; Quintana-Navarro, Gracia M; Ramirez-Lara, Irene; Rangel-Zuñiga, Oriol A; Rodriguez-Artalejo, Fernando; Rodriguez-Cantalejo, Fernando; Romero, Miguel A; Roncero-Ramos, Irene; Ruano-Ruiz, Juan A.; Ruiz de Castroviejo, Joaquin; Sanchez-Villegas, Pablo; Suarez de Lezo, Jose; Suarez de Lezo, Javier; Torres-Peña, Jose D; Vals-Delgado, Cristina; Valverde, Roberto; Visioli, Francisco; Yubero-Serrano, Elena M;
• Is Part Of: Lancet. Volume 399:Issue 10338(2022)
• Page Start: 1876
• Page End: 1885
• Publication Date: 2022-05-14
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Medicine; Electronic journals; Periodicals; 610.5
• DOI: 10.1016/S0140-6736(22)00122-2
• Languages: English
• ISSNs: 0140-6736

Abstract

Summary: Background: Mediterranean and low-fat diets are effective in the primary prevention of cardiovascular disease. We did a long-term randomised trial to compare the effects of these two diets in secondary prevention of cardiovascular disease. Methods: The CORDIOPREV study was a single-centre, randomised clinical trial done at the Reina Sofia University Hospital in Córdoba, Spain. Patients with established coronary heart disease (aged 20–75 years) were randomly assigned in a 1:1 ratio by the Andalusian School of Public Health to receive a Mediterranean diet or a low-fat diet intervention, with a follow-up of 7 years. Clinical investigators (physicians, investigators, and clinical endpoint committee members) were masked to treatment assignment; participants were not. A team of dietitians did the dietary interventions. The primary outcome (assessed by intention to treat) was a composite of major cardiovascular events, including myocardial infarction, revascularisation, ischaemic stroke, peripheral artery disease, and cardiovascular death. This study is registered with ClinicalTrials.gov, NCT00924937 . Findings: From Oct 1, 2009, to Feb 28, 2012, a total of 1002 patients were enrolled, 500 (49·9%) in the low-fat diet group and 502 (50·1%) in the Mediterranean diet group. The mean age was 59·5 years (SD 8·7) and 827 (82·5%) of 1002 patients were men. The primary endpoint occurred in 198 participants: 87 in the Mediterranean diet group and 111 in the low-fat group (crude rate per 1000 person-years: 28·1 [95% CI 27·9–28·3] in the Mediterranean diet group vs 37·7 [37·5–37·9] in the low-fat group, log-rank p=0·039). Multivariable-adjusted hazard ratios (HRs) of the different models ranged from 0·719 (95% CI 0·541–0·957) to 0·753 (0·568–0·998) in favour of the Mediterranean diet. These effects were more evident in men, with primary endpoints occurring in 67 (16·2%) of 414 men in the Mediterranean diet group versus 94 (22·8%) of 413 men in the low-fat diet group (multiadjusted HR 0·669 [95% CI 0·489–0·915], log-rank p=0·013), than in 175 women for whom no difference was found between groups. Interpretation: In secondary prevention, the Mediterranean diet was superior to the low-fat diet in preventing major cardiovascular events. Our results are relevant to clinical practice, supporting the use of the Mediterranean diet in secondary prevention. Funding: Fundacion Patrimonio Comunal Olivarero; Fundacion Centro para la Excelencia en Investigacion sobre Aceite de Oliva y Salud; local, regional, and national Spanish Governments; European Union.