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Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA): A pragmatic, open-label, randomised controlled trial

The Lancet Dec 08, 2018

Näslund U, et al. - In this pragmatic, open-label, randomised controlled trial, researchers examined whether ultrasound-based pictorial information on subclinical carotid atherosclerosis, which targets both primary care physicians and individuals, improves prevention. This investigation shows the contribution of the pictorial presentation of silent atherosclerosis to cardiovascular disease prevention. It supports the further development of methods to reduce the major problem of low adherence to medication and changes in lifestyle.

Methods
  • Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) is a pragmatic, open-label, randomised controlled trial included in the Västerbotten Intervention Programme, an ongoing population-based cardiovascular disease prevention programme in northern Sweden.
  • Participants of 40, 50, or 60 years of age with one or more conventional risk factors were eligible.
  • Clinical examination, blood sampling and ultrasound assessment of carotid intima media wall thickness and plaque formation were conducted by participants.
  • For this investigation, participants were randomly assigned 1:1 with a computer-generated randomisation list to an intervention group (pictorial representation of carotid ultrasound plus a nurse phone call to confirm understanding) or a control group (not informed).
  • The primary results, Framingham risk score (FRS) and European systematic coronary risk evaluation (SCORE), were evaluated after 1 year among the follow-up participants.

Results
  • Between 29 April 2013 and 7 June 2016, 3532 individuals were enrolled, of which 1783 were randomly assigned to the control group and 1749 were assigned to the intervention group.
  • The1-year follow - up was completed by 3175 participants.
  • FRS and SCORE varied significantly between groups (FRS 1·07 [95% CI 0·11 to 2·03, p=0·0017] and SCORE 0·16 [0·02 to 0·30, p=0·0010]) at the 1-year follow-up.
  • In the intervention group, FRS decreased from baseline to the 1-year follow-up and increased in the control group (−0·58 [95% CI −0·86 to −0·30] vs 0·35 [0·08 to 0·63]).
  • In both groups (0·13 [95% CI 0·09 to 0·18] vs 0·27 [0·23 to 0·30]), SCORE increased.
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