Prediction of Cardiovascular Disease by the Framingham‐REGICOR Equation in the High‐Risk PREDIMED Cohort: Impact of the Mediterranean Diet Across Different Risk Strata

Author:

Amor Antonio J.12,Serra‐Mir Mercè12,Martínez‐González Miguel A.23,Corella Dolores24,Salas‐Salvadó Jordi25,Fitó Montserrat26,Estruch Ramón72,Serra‐Majem Lluis28,Arós Fernando29,Babio Nancy25,Ros Emilio12,Ortega Emilio12,Pérez‐Heras A.,Viñas C.,Casas R.,de Santamaría L.,Romero S.,Sacanella E.,Chiva G.,Valderas P.,Arranz S.,Baena J. M.,García M.,Oller M.,Amat J.,Duaso I.,García Y.,Iglesias C.,Simón C.,Quinzavos Ll.,Parra Ll.,Liroz M.,Benavent J.,Clos J.,Pla I.,Amorós M.,Bonet M. T.,Martin M. T.,Sánchez M. S.,Altirriba J.,Manzano E.,Altés A.,Sala‐Vila A.,Cofán M.,Valls‐Pedret C.,Freitas‐Simoes T. M.,Doménech M.,Gilabert R.,Bargalló N.,Bulló M.,Basora J.,González R.,Díaz‐López A.,Molina C.,Mena G.,Márquez F.,Martínez P.,Ibarrola N.,Sorli M.,García Roselló J.,Martín F.,Tort N.,Isach A.,Salas‐Huetos A.,Becerra‐Tomás N.,Rosique Esteban N.,Cabré J. J.,Mestres G.,Paris F.,Llaurado M.,Pedret R.,Basells J.,Vizcaino J.,Segarra R.,Hernandez‐Alonso P.,Giardina S.,Ferreira‐Pego C.,Papandreou C.,Camacho L.,Toledo E.,Buil‐Cosiales P.,Ruiz‐Canela M.,Martínez J. A.,Sanjulian B.,Sánchez‐Tainta A.,Diez‐Espino J.,Razquin C.,Garcia‐Arellano A.,Goni E.,Vazquez Z.,Berrade N.,Extremera‐Urabayen V.,Eguaras S.,Marti A.,Arroyo‐Azpa C.,García‐Pérez L.,Villanueva Telleria J.,Cortés Ugalde F.,Sagredo Arce T.,de la Noceda Montoy M. D. García,Vigata López M. D.,Arceiz Campo M. T.,Urtasun Samper A.,Gueto Rubio M. V.,Sola A.,Goñi N.,Lecea O.,Tello S.,Vila J.,de la Torre R.,Muñoz‐Aguayo D.,Elosua R.,Marrugat J.,Schröder H.,Molina N.,Maestre E.,Castañer O.,Rovira A.,Farre M.,Sorli J. V.,Zanon‐Moreno V.,Carrasco P.,Ortega‐Azorín C.,Asensio E. M.,Osma R.,Barragán R.,Francés F.,Guillén M.,González J. I.,Saiz C.,Portolés O.,Giménez F. J.,Coltell O.,Guillem‐Saiz P.,Quiles L.,Pascual V.,Riera C.,Pages M. A.,Godoy D.,Carratala‐Calvo A.,Martín‐Rillo M. J.,Llopis‐Osorio E.,Ruiz‐Baixauli J.,Bertolín‐Muñoz A.,Salaverría I.,del Hierro T.,Algorta J.,Francisco S.,Alonso‐Gómez A.,Sanz E.,Rekondo J.,Bello M. C.,Loma‐Osorio A.,Gómez‐Gracia E.,Warnberg J.,Benítez Pont R.,Bianchi Alba M.,Gómez‐Huelgas R.,Martínez‐González J.,Velasco García V.,de Diego Salas J.,Baca Osorio A.,Gil Zarzosa J.,Sánchez Luque J. J.,Vargas López E.,Ruiz‐Gutiérrez V.,Sánchez Perona J.,Montero Romero E.,García‐García M.,Jurado‐Ruiz E.,Fiol M.,García‐Valdueza M.,Moñino M.,Proenza A.,Prieto R.,Frontera G.,Ginard M.,Fiol F.,Jover A.,Romaguera D.,García J.,Lapetra J.,Santos‐Lozano J. M.,Ortega‐Calvo M.,Mellado L.,Leal M.,Martínez E.,José García F.,Román P.,Iglesias P.,Corchado Y.,Miró L.,Domínguez C.,Lozano J. M.,Mayoral E.,Lamuela‐Raventós R. M.,López‐Sabater M. C.,Castellote‐Bargallo A. I.,Tresserra‐Rimbau A.,Álvarez‐Pérez J.,Díaz‐Benítez E. M.,Bautista Castaño I.,Sánchez‐Villegas A.,Fernández‐Rodríguez M. J.,Casanas Quintana T.,Pérez‐Cabrera J.,Nissensohn M.,Díaz‐González V.,Ruano‐Rodríguez C.,Ortiz‐Andrelluchi A. P.,Macías Gutiérrez B.,Santana‐Santana A. J.,Pintó X.,de la Cruz E.,Galera A.,Soler Y.,Trias F.,Sarasa I.,Padres E.,Corbella E.,Cabezas C.,Vinyoles E.,Rovira M. A.,García L.,Flores G.,Verdú J. M.,Baby P.,Ramos A.,Mengual L.,Roura P.,Yuste M. C.,Guarner A.,Rovira A.,Santamaría M. I.,Mata M.,de Juan C.,Brau A.,Tur J. A.,Portillo M. P.,Sáez G.,Aldamiz M.,Alonso A.,Berjón J.,Forga L.,Gallego J.,Larrauri A.,Portu J.,Timiraos J.,Serrano‐Martínez M.,

Affiliation:

1. Lipid Clinic, Department of Endocrinology and Nutrition, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic, University of Barcelona, Spain

2. Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain

3. Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain

4. Genetic and Molecular Epidemiology Unit, Department of Preventive Medicine and Public Health, School of Medicine, University of Valencia, Spain

5. Human Nutrition Unit, Faculty of Medicine and Health Sciences, IISPV, Universitat Rovira i Virgili, Reus, Spain

6. Cardiovascular Risk and Nutrition Research (REGICOR Group), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain

7. Department of Internal Medicine, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic, University of Barcelona, Spain

8. Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Las Palmas, Spain

9. Department of Cardiology, University Hospital of Alava, Vitoria, Spain

Abstract

Background The usefulness of cardiovascular disease ( CVD ) predictive equations in different populations is debatable. We assessed the efficacy of the Framingham‐ REGICOR scale, validated for the Spanish population, to identify future CVD in participants, who were predefined as being at high‐risk in the PRE vención con DI eta MED iterránea (PREDIMED) study—a nutrition‐intervention primary prevention trial—and the impact of adherence to the Mediterranean diet on CVD across risk categories. Methods and Results In a post hoc analysis, we assessed the CVD predictive value of baseline estimated risk in 5966 PREDIMED participants (aged 55–74 years, 57% women; 48% with type 2 diabetes mellitus). Major CVD events, the primary PREDIMED end point, were an aggregate of myocardial infarction, stroke, and cardiovascular death. Multivariate‐adjusted Cox regression was used to calculate hazard ratios for major CVD events and effect modification from the Mediterranean diet intervention across risk strata (low, moderate, high, very high). The Framingham‐ REGICOR classification of PREDIMED participants was 25.1% low risk, 44.5% moderate risk, and 30.4% high or very high risk. During 6‐year follow‐up, 188 major CVD events occurred. Hazard ratios for major CVD events increased in parallel with estimated risk (2.68, 4.24, and 6.60 for moderate, high, and very high risk), particularly in men (7.60, 13.16, and 15.85, respectively, versus 2.16, 2.28, and 3.51, respectively, in women). Yet among those with low or moderate risk, 32.2% and 74.3% of major CVD events occurred in men and women, respectively. Mediterranean diet adherence was associated with CVD risk reduction regardless of risk strata ( P >0.4 for interaction). Conclusions Incident CVD increased in parallel with estimated risk in the PREDIMED cohort, but most events occurred in non–high‐risk categories, particularly in women. Until predictive tools are improved, promotion of the Mediterranean diet might be useful to reduce CVD independent of baseline risk. Clinical Trial Registration URL : http://www.Controlled-trials.com . Unique identifier: ISRCTN 35739639.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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