Mediterranean Diet Decreases the Initiation of Use of Vitamin K Epoxide Reductase Inhibitors and Their Associated Cardiovascular Risk: A Randomized Controlled Trial

Q: What is the clinical evidence from this study?

Study design: RCT. Population: High cardiovascular risk without baseline cardiovascular disease (n=6772). Intervention: Mediterranean diet enriched with extra-virgin olive oil or nuts vs. Low-fat control diet. Primary outcome: Initiation of vitamin K epoxide reductase inhibitors (acenocoumarol/warfarin) (HR 0.68, 95% CI 0.46-0.998, p=0.049).

Q: What does this research mean for the field?

A Mediterranean diet enriched with extra-virgin olive oil reduces the risk of initiating vitamin K epoxide reductase inhibitors by 32% in older adults at high cardiovascular risk compared to a low-fat control diet. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Sara Castro‐Barquero; Margarita Ribó-Coll; Camille Lassale; Anna Tresserra‐Rimbau; Olga Castañer; Xavier Pintó; Miguel Ángel Martínez‐González; José V. Sorlí; Jordi Salas‐Salvadó; José Lapetra; Enrique Gómez‐Gracia; Ángel M. Alonso‐Gómez; Miquel Fiol; Lluís Serra‐Majem; Emilio Sacanella; Francisco Javier Basterra-Gortari; Olga Portolés; Nancy Babió; Montserrat Cofán; Emilio Ros; Ramón Estruch; Álvaro Hernáez

doi:10.3390/nu12123895

Key result

Mediterranean diet with olive oil cuts vitamin K antagonist initiation ~32% vs. low-fat diet.

HR 0.68
95% CI 0.46-0.998
P=0.049
n=6,772

Figures

Why the study?

It was unknown whether following a Mediterranean Diet decreases the risk of initiating antithrombotic therapies and the cardiovascular risk associated with their use in older individuals at high cardiovascular risk.

Does following a Mediterranean diet enriched with extra-virgin olive oil or nuts reduce the initiation of antithrombotic therapies and attenuate the cardiovascular risk associated with their use in older adults at high cardiovascular risk?

Key Points

To assess whether following a Mediterranean diet decreases the initiation of antithrombotic therapies and modifies the cardiovascular risk associated with their use in older adults at high cardiovascular risk.
Secondary analysis of the PREDIMED randomized trial evaluating older individuals (average age 67 years) assigned to a Mediterranean diet enriched with extra-virgin olive oil, a Mediterranean diet with nuts, or a low-fat control diet.
Tracked incident initiation of vitamin K epoxide reductase inhibitors (n = 6772), acetylsalicylic acid (n = 5662), and other antiplatelet drugs (n = 6768) among baseline non-users over median follow-ups of 4.5, 4.0, and 4.6 years, respectively.
Allocation to the Mediterranean diet enriched with extra-virgin olive oil reduced the risk of initiating vitamin K epoxide reductase inhibitors compared to the control diet (HR: 0.68 [95% CI: 0.46–0.998], p = 0.049; absolute incidence difference: 0.66%).
After excluding incident atrial fibrillation cases, the Mediterranean diet with extra-virgin olive oil decreased initiation risk by 47% (HR: 0.53 [95% CI: 0.32; 0.88], p = 0.014), whereas no intervention effect was found for acetylsalicylic acid initiation.
Baseline use of vitamin K epoxide reductase inhibitors showed a stronger link to cardiovascular disease in the control group (HR: 4.22 [95% CI: 1.92–9.30], p < 0.001) than in the Mediterranean diet groups (HR: 1.71 [95% CI: 0.83–3.52], p = 0.137; p-interaction = 0.052).

Study Design

Type

RCT (n=6,772)

Randomization

1:1:1

Multicenter

Yes

Structured PICO

Does following a Mediterranean diet enriched with extra-virgin olive oil or nuts reduce the initiation of antithrombotic therapies and attenuate the cardiovascular risk associated with their use in older adults at high cardiovascular risk?

P

Population

6,772 older adults in Spain (mean age 67 years, 58-59% women) at high cardiovascular risk without baseline cardiovascular disease or antithrombotic use, followed for a median of 4.5 years.

I

Intervention

Mediterranean Diet enriched with extra-virgin olive oil (MedDiet-EVOO, provided 1 L/week of virgin olive oil) or enriched with mixed nuts (MedDiet-Nuts, provided 210 g/week of mixed nuts), promoting fruits, vegetables, pulses, nuts, fish, olive oil, and poultry over red/processed meats and sweets.

C

Comparator

Low-fat control diet with recommendations to promote fruits, vegetables, pulses, lean fish, and low-fat dairy, and to decrease intake of vegetable oils (including olive oil), nuts, red/processed meat, fatty fish, and sweets.

O

Outcome

Initiation of antithrombotic therapies among baseline non-users: (1) vitamin K epoxide reductase inhibitors (acenocoumarol/warfarin) over median 4.5 years; (2) acetylsalicylic acid over median 4.0 years; (3) other antiplatelet drugs (cilostazol, clopidogrel, dipyridamole, ditazol, ticlopidine, triflusal) over median 4.6 years.surrogate

Main Result

Hazard Ratio: 0.68 (95% CI 0.46–0.998)

Absolute Risk Reduction: 0.66%

p-value: p=0.049

Adherence to a Mediterranean diet enriched with extra-virgin olive oil reduces the need to initiate vitamin K antagonist therapy by 32% and blunts the heightened cardiovascular event risk observed in patients taking these anticoagulants.

Limitations

Onset of antithrombotic medication was not a predetermined endpoint in the PREDIMED study (exploratory analysis)
Extremely scarce use of direct oral anticoagulants during the 2003-2010 follow-up period
Limited generalizability beyond older individuals at high cardiovascular risk
Self-reported covariates such as leisure-time physical activity may imply residual confounding
Only categorical information on drug use/non-use was collected, preventing assessment of dose changes
Use of direct oral anticoagulants (dabigatran, apixaban, rivaroxaban, edoxaban) was extremely scarce during 2003-2010 follow-up
Study sample of older individuals at high cardiovascular risk limits generalizability
Self-reported covariates such as leisure-time physical activity may cause residual confounding
Only categorical drug use/non-use data collected, precluding assessment of dose changes

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Implication

Mediterranean diet with extra-virgin olive oil may delay vitamin K antagonist initiation in high-risk older adults; extends RCT evidence for its role in cardiovascular prevention.

Abstract

Our aim is to assess whether following a Mediterranean Diet (MedDiet) decreases the risk of initiating antithrombotic therapies and the cardiovascular risk associated with its use in older individuals at high cardiovascular risk. We evaluate whether participants of the PREvención con DIeta MEDiterránea (PREDIMED) study allocated to a MedDiet enriched in extra-virgin olive oil or nuts (versus a low-fat control intervention) disclose differences in the risk of initiation of: (1) vitamin K epoxide reductase inhibitors (acenocumarol/warfarin; n = 6772); (2) acetylsalicylic acid as antiplatelet agent (n = 5662); and (3) other antiplatelet drugs (cilostazol/clopidogrel/dipyridamole/ditazol/ticlopidine/triflusal; n = 6768). We also assess whether MedDiet modifies the association between the antithrombotic drug baseline use and incident cardiovascular events. The MedDiet intervention enriched with extra-virgin olive oil decreased the risk of initiating the use of vitamin K epoxide reductase inhibitors relative to control diet (HR: 0.68 [0.46–0.998]). Their use was also more strongly associated with an increased risk of cardiovascular disease in participants not allocated to MedDiet interventions (HRcontrol diet: 4.22 [1.92–9.30], HRMedDiets: 1.71 [0.83–3.52], p-interaction = 0.052). In conclusion, in an older population at high cardiovascular risk, following a MedDiet decreases the initiation of antithrombotic therapies and the risk of suffering major cardiovascular events among users of vitamin K epoxide reductase inhibitors.

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Cite This Study

Castro‐Barquero et al. (2020) conducted an RCT in High cardiovascular risk without baseline cardiovascular disease (n=6,772). Mediterranean diet enriched with extra-virgin olive oil or nuts vs. Low-fat control diet was evaluated on Initiation of vitamin K epoxide reductase inhibitors (acenocoumarol/warfarin) (HR 0.68, 95% CI 0.46-0.998, p=0.049). Mediterranean diet enriched with extra-virgin olive oil reduced the risk of initiating vitamin K epoxide reductase inhibitors by 32% compared to a low-fat diet.

synapsesocial.com/papers/6a8969475c4c6b099dec6cde https://doi.org/10.3390/nu12123895

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Mediterranean Diet Decreases the Initiation of Use of Vitamin K Epoxide Reductase Inhibitors and Their Associated Cardiovascular Risk: A Randomized Controlled Trial

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Mediterranean Diet Decreases the Initiation of Use of Vitamin K Epoxide Reductase Inhibitors and Their Associated Cardiovascular Risk: A Randomized Controlled Trial

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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