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Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA): a pragmatic, open-label, randomised controlled trial
Umeå Univ, Heart Ctr, Umeå, Sweden; Umeå Univ, Dept Publ Hlth & Clin Med, Umeå, Sweden.
Umeå Univ, Unit Epidemiol & Global Hlth, Umeå, Sweden.
Umeå Univ, Unit Epidemiol & Global Hlth, Umeå, Sweden.
Umeå Univ, Unit Family Med, Umeå, Sweden.
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2019 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 393, no 10167, p. 133-142, article id S0140-6736(18)32818-6Article in journal (Refereed) Published
Abstract [en]

Background: Primary prevention of cardiovascular disease often fails because of poor adherence among practitioners and individuals to prevention guidelines. We aimed to investigate whether ultrasound-based pictorial information about subclinical carotid atherosclerosis, targeting both primary care physicians and individuals, improves prevention.

Methods: Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) is a pragmatic, open-label, randomised controlled trial that was integrated within the Västerbotten Intervention Programme, an ongoing population-based cardiovascular disease prevention programme in northern Sweden. Individuals aged 40, 50, or 60 years with one or more conventional risk factors were eligible to participate. Participants underwent clinical examination, blood sampling, and ultrasound assessment of carotid intima media wall thickness and plaque formation. 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 outcomes, Framingham risk score (FRS) and European systematic coronary risk evaluation (SCORE), were assessed after 1 year among participants who were followed up. This study is registered with ClinicalTrials.gov, number NCT01849575.

Findings: 3532 individuals were enrolled between April 29, 2013, and June 7, 2016, of which 1783 were randomly assigned to the control group and 1749 were assigned to the intervention group. 3175 participants completed the 1-year follow-up. At the 1-year follow-up, FRS and SCORE differed 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]). FRS decreased from baseline to the 1-year follow-up in the intervention group and increased in the control group (−0·58 [95% CI −0·86 to −0·30] vs 0·35 [0·08 to 0·63]). SCORE increased in both groups (0·13 [95% CI 0·09 to 0·18] vs 0·27 [0·23 to 0·30]).

Interpretation: This study provides evidence of the contributory role of pictorial presentation of silent atherosclerosis for prevention of cardiovascular disease. It supports further development of methods to reduce the major problem of low adherence to medication and lifestyle modification.

Funding: Västerbotten County Council, the Swedish Research Council, the Heart and Lung Foundation, the Swedish Society of Medicine, and Carl Bennet Ltd, Sweden.

Place, publisher, year, edition, pages
2019. Vol. 393, no 10167, p. 133-142, article id S0140-6736(18)32818-6
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:uu:diva-374210DOI: 10.1016/S0140-6736(18)32818-6ISI: 000455437100026PubMedID: 30522919OAI: oai:DiVA.org:uu-374210DiVA, id: diva2:1280389
Funder
Swedish Research Council, Dnr 521-2013-2708; 2016-01891Swedish Heart Lung Foundation, Dnr 20150369; 20170481Swedish Society of MedicineAvailable from: 2019-01-18 Created: 2019-01-18 Last updated: 2019-02-05Bibliographically approved

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