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Trans-Atlantic Network to study Stepwise Non-invasive Imaging as a tool for CVD Prognosis and prevention - TANSNIP-PESA
Contribution To Literature:
The TANSNIP-PESA trial showed improvement in a cardiovascular risk score at 1 year from comprehensive lifestyle intervention; however, this benefit dissipated at 3 years.
Description:
The goal of the trial was to evaluate comprehensive lifestyle intervention compared with control among asymptomatic individuals.
Study Design
- Randomization
- Parallel
- Stratification
Eligible middle-aged asymptomatic subjects from the PESA (Progression of Early Subclinical Atherosclerosis) cohort in Spain were stratified by baseline subclinical atherosclerosis (low atherosclerosis burden = 720; high atherosclerosis burden = 300). Subclinical atherosclerosis was detected in the carotid, iliofemoral, and aortic arteries with vascular ultrasound and by coronary artery calcification with computed tomography. Subjects were randomized (1:1) to comprehensive lifestyle intervention versus control.
The lifestyle intervention consisted of 12 individual motivational sessions (nine at baseline, then three more between years 1–3), physical activity (PA) tracker, and a sit-stand workstation.
- Total number of enrollees: 1,020
- Duration of follow-up: 3 years
- Mean patient age: 50 years
- Percentage female: 31%
Inclusion criteria:
- Asymptomatic subjects 40–54 years of age
- Completed all baseline assessments (wearing an activPAL PA monitor for 7 consecutive days, providing a blood sample, and completing the study questionnaires)
- Valid imaging results from PESA for stratification into low or high subgroups
Exclusion criteria:
- Previous cardiovascular disease, cancer, or any other disease expected to shorten life span or influence protocol adherence
- No plaque burden, a normal body mass index (BMI, 18.5–25 kg/m2), and a healthy lifestyle
Principal Findings:
The primary outcome, change (intervention vs. control) in a prespecified adaptation of the Fuster-BEWAT score at 1 year, was 0.83 (95% confidence interval [CI] 0.52-1.15, p < 0.001) and at 3 years 0.24 (95% CI -0.10 to 0.59, p = 0.16).
Secondary outcomes:
Low atherosclerosis burden
Change (intervention vs. control) in a prespecified adaptation of the Fuster-BEWAT score at 1 year was 1.01 (95% CI 0.63-1.39, p < 0.001) and at 3 years 0.34 (95% CI -0.07 to 0.76, p = 0.11).
High atherosclerosis burden
Change (intervention vs. control) in a prespecified adaptation of the Fuster-BEWAT score at 1 year was 0.38 (95% CI -0.20 to 0.95, p = 0.20) and at 3 years 0.03 (95% CI -0.57 to 0.63, p = 0.93).
Note: BEWAT = Blood pressure, Exercise (objectively measured PA and sedentary time), Weight (BMI), Alimentation (fruit and vegetable consumption), and Tobacco.
Interpretation:
Among asymptomatic middle-aged individuals, comprehensive lifestyle intervention compared with control improved a cardiovascular risk score at 1 year (Fuster-BEWAT score); however, this benefit was no longer seen at 3 years. This overall finding was mirrored among those with low atherosclerosis burden at baseline. Among those with high atherosclerosis burden, there was no benefit at either time point.
References:
Garcia-Lunar I, van der Ploeg HP, Fernández Alvira JM, et al. Effects of a comprehensive lifestyle intervention on cardiovascular health: the TANSNIP-PESA trial. Eur Heart J 2022;43:3732-45.
Clinical Topics: Cardiovascular Care Team, Diabetes and Cardiometabolic Disease, Dyslipidemia, Noninvasive Imaging, Prevention, Computed Tomography, Echocardiography/Ultrasound, Nuclear Imaging, Diet, Exercise
Keywords: Atherosclerosis, Blood Pressure, Body Mass Index, Diagnostic Imaging, Diet, Dyslipidemias, Exercise, Heart Disease Risk Factors, Healthy Lifestyle, Life Style, Primary Prevention, Risk Factors, Sedentary Behavior, Tobacco, Tomography, Tomography, X-Ray Computed, Ultrasonography, Vascular Calcification
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