Prediction of Cardiovascular Disease by the Framingham‐REGICOR Equation in the High‐Risk PREDIMED Cohort: Impact of the Mediterranean Diet Across Different Risk Strata
Authors: Amor Antonio J. , Serra‐Mir Mercè , Martínez‐González Miguel A. , Corella Dolores , Salas‐Salvadó Jordi , Fitó Montserrat , Estruch Ramón , Serra‐Majem Lluis , Arós Fernando , Babio Nancy , Ros Emilio , Ortega Emilio , 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. 
Published: March 2017

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.