BackgroundA Mediterranean diet is favourable for cardiometabolic risk.ObjectiveTo examine the residual effect of a green Mediterranean diet, further enriched with green plant-based foods and lower meat intake, on cardiometabolic risk.MethodsFor the DIRECT-PLUS parallel, randomised clinical trial we assigned individuals with abdominal obesity/dyslipidaemia 1:1:1 into three diet groups: healthy dietary guidance (HDG), Mediterranean and green Mediterranean diet, all combined with physical activity. The Mediterranean diets were equally energy restricted and included 28 g/day walnuts. The green Mediterranean diet further included green tea (3–4 cups/day) and a Wolffia globosa (Mankai strain; 100 g/day frozen cubes) plant-based protein shake, which partially substituted animal protein. We examined the effect of the 6-month dietary induction weight loss phase on cardiometabolic state.ResultsParticipants (n=294; age 51 years; body mass index 31.3 kg/m2; waist circumference 109.7 cm; 88% men; 10 year Framingham risk score 4.7%) had a 6-month retention rate of 98.3%. Both Mediterranean diets achieved similar weight loss ((green Mediterranean −6.2 kg; Mediterranean −5.4 kg) vs the HDG group −1.5 kg; p<0.001), but the green Mediterranean group had a greater reduction in waist circumference (−8.6 cm) than the Mediterranean (−6.8 cm; p=0.033) and HDG (−4.3 cm; p<0.001) groups. Stratification by gender showed that these differences were significant only among men. Within 6 months the green Mediterranean group achieved greater decrease in low-density lipoprotein cholesterol (LDL-C; green Mediterranean −6.1 mg/dL (−3.7%), −2.3 (-0.8%), HDG −0.2 mg/dL (+1.8%); p=0.012 between extreme groups), diastolic blood pressure (green Mediterranean −7.2 mm Hg, Mediterranean −5.2 mm Hg, HDG −3.4 mm Hg; p=0.005 between extreme groups), and homeostatic model assessment for insulin resistance (green Mediterranean −0.77, Mediterranean −0.46, HDG −0.27; p=0.020 between extreme groups). The LDL-C/high-density lipoprotein cholesterol (HDL-C) ratio decline was greater in the green Mediterranean group (−0.38) than in the Mediterranean (−0.21; p=0.021) and HDG (−0.14; p<0.001) groups. High-sensitivity C-reactive protein reduction was greater in the green Mediterranean group (−0.52 mg/L) than in the Mediterranean (−0.24 mg/L; p=0.023) and HDG (−0.15 mg/L; p=0.044) groups. The green Mediterranean group achieved a better improvement (−3.7% absolute risk reduction) in the 10-year Framingham Risk Score (Mediterranean−2.3%; p=0.073, HDG−1.4%; p<0.001).ConclusionsThe green MED diet, supplemented with walnuts, green tea and Mankai and lower in meat/poultry, may amplify the beneficial cardiometabolic effects of Mediterranean diet.Trial registration numberThis study is registered under ClinicalTrials.gov Identifier no NCT03020186.
Funding Acknowledgements Type of funding sources: None. Background Atrial fibrillation (AF) is associated with an increased risk of stroke and mortality. Pulmonary vein isolation (PVI) is the most effective treatment to reduce AF burden and is associated with a reduced risk of stroke and death. Differences in long-term clinical outcomes following PVI between sexes are debatable. Purpose We aimed to explore the sex differences in outcomes following PVI in a contemporary population of AF patients. Methods This is a historical population-based study including all adult patients of the largest health maintenance organization in Israel who were first diagnosed with AF between January 1st, 2010, and January 1st, 2020. Patients with congenital heart disease, significant mitral stenosis, or who underwent valvular surgery were excluded. The primary outcomes were stroke and all-cause death after PVI. Early (30-day) outcomes were compared using logistic regression, and late (3-year) outcomes were assessed using multivariable survival analyses with Cox regression. Results Of 94,612 patients diagnosed with incident AF during the study period, 4593 (4.85%) underwent PVI, of whom 1892 (38.2%) were women. Women were older (65±12 vs. 63±13) and less likely to be smokers (15.0% vs. 33.0%). Women had higher body-mass-index (30.26±6.58 vs. 29.14±4.86) and higher rates of hypertension (66.4% vs. 63.2%) but had lower rates of known coronary or peripheral vascular disease and congestive heart failure (p<0.05 for all). The CHA2DS2-VASc score was higher among women compared to men [median 3 (IQR 2-4) vs. median 2 IQR (1-3), p<0.001). Compared to men, women were treated more often with beta-blockers (74.5% vs. 69.4%), non-dihydropyridine calcium channel blockers (6.5% vs. 3.0%), and class 1c antiarrhythmic drugs (19.4% vs. 12.8%; p<0.001 for all), but were treated less with amiodarone (14.2% vs. 18.1%, p<0.001). In the 30 days following CA, stroke occurred in 8 (0.2%) patients, and 26 (0.6%) patients died (p>0.1 for both). Three-year mortality was lower in women than in men (6.2%% vs. 8.6%, p=0.003), while stroke rates were similar in women (1.0%) and men (1.5%, p>0.1). In multivariable survival models, adjusting for potential confounders, women had a lower risk of mortality [aHR 0.72 95%CI (0.56-0.92), p=0.009]. Conversely, the risk of stroke was similar in women and men [aHR 0.62 95%CI (0.33-1.12), p=0.114]. The results were similar in propensity-adjusted models accounting for all differences between men and women. Conclusions In this contemporary AF population, short-term stroke and mortality rates after PVI were very low and similar in men and women. The risk of long-term stroke following PVI was relatively low and similar across sex criteria. Women had a lower risk of long-term mortality than men following PVI despite undergoing the procedure at an older age and after adjusting for comorbidities and background medical therapy, suggesting possible sex differences in long-term mortality after PVI.
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