Elsevier

The Lancet

Volume 393, Issue 10167, 12–18 January 2019, Pages 133-142
The Lancet

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

https://doi.org/10.1016/S0140-6736(18)32818-6Get rights and content

Summary

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.

Introduction

Smoking cessation, physical activity, statins, and antihypertensive medication to prevent cardiovascular disease are among the most evidence-based and cost-effective treatments in health care. However, in the real world, prevention fails because of low and non-sustained adherence to prevention guidelines among practitioners and individuals.1, 2 Statistical modelling based on clinical risk factors is recommended for risk assessment of cardiovascular disease, and the Framingham risk score (FRS) and the European systematic coronary risk evaluation (SCORE) are the most widely used measures.3, 4 Evidence showing that use of these scores translates into reduction of cardiovascular disease morbidity or mortality is scarce.5 These risk scores might be too abstract and therefore fail to communicate risk in order to stimulate appropriate pharmacological prescription and enhanced motivation for a healthier lifestyle.

Information alone rarely leads to rational behavioural modification.6 The recall of advice regarding exercise and diet is poorer than advice to take medications.7 The risk of cardiovascular disease is usually communicated to individuals verbally;8 visual tools are seldom used.9, 10 A more person-centred approach by adding pictorial information about the individual's atherosclerosis would increase motivation and adherence to guidelines.11 It could be argued that this is as important as development of new treatment modalities for prevention of cardiovascular disease. Providing information to physicians concerning their patients' risk of cardiovascular disease has been found to increase prescription of lipid-lowering and blood pressure medication, with the greatest effect in those with the highest risk.12, 13

Research in context

Evidence before this study

Physical activity, smoking cessation, and treatment of hypertension and hypercholesterolaemia are among the most effective, cost-effective, and evidence-based therapies for non-communicable diseases. However, prevention of cardiovascular disease fails, largely because of low adherence to guidelines and recommendations for lifestyle change and pharmacological treatment by individuals and health-care professionals. Risk assessment, risk communication, and motivation for a change in lifestyle are all targets to improve adherence to prevention measures. Pictorial representation of the risk factor burden might improve risk perception and motivation, but few studies have investigated this hypothesis, and no systematic reviews are published. Vascular ultrasound of atherosclerotic plaques and intima media wall thickness is an established diagnostic tool to assess atherosclerosis, but the effects on adherence to healthy lifestyle and drug therapy have not previously been studied in randomised controlled trials.

Added value of this study

This pragmatic, open-label, randomised controlled trial, targeting both physicians and individuals, aimed at improved efficacy and adherence to prevention measures in an asymptomatic population, showed significant benefits with respect to lowering the risk factor burden for cardiovascular disease in participants given a pictorial representation of their atherosclerotic plaques and intima media wall thickness, presented as vascular age, compared with participants who received routine care, with no pictorial information (Framingham risk score 1·07 [95% CI 0·11 to 2·03, p=0·0017] and systematic coronary risk evaluation [SCORE] 0·16 [0·02 to 0·30, p=0·0010]).

Implications of all the available evidence

This study provides further evidence on the contributory role of pictorial representations and dialogue about silent atherosclerosis for primary prevention of cardiovascular disease, which are valid for clinical practice. Whether the results are sustainable for more than 1 year and lead to reduction of cardiovascular disease events warrant long-term follow-up.

However, results on the contributory impact of image-based information about silent atherosclerosis on adherence to prevention are inconsistent.14, 15 Therefore, additional large-scale randomised controlled trials are needed.1, 16, 17

The primary aim of this study was to investigate the impact of pictorial information about individuals' atherosclerosis, as demonstrated by carotid ultrasound, in comparison with traditional risk factor-based risk communication.

Section snippets

Study design and participants

Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) is a pragmatic, open-label, randomised controlled trial with masked evaluators (PROBE) integrated in the Västerbotten Intervention Programme (VIP), a population-based cardiovascular disease screening and prevention programme in Sweden. VIP was initiated in the 1990s and has been described in detail.18 In VIP, an invitation is sent to all Västerbotten County inhabitants at the of age 40, 50, or

Results

3532 participants were enrolled between April 29, 2013, and June 7, 2016, of which 1783 were randomly assigned to the control group and 1749 to the intervention group. 3175 participants completed the 1-year follow-up (figure 2). The dropout analysis showed no differences between dropouts and participants in baseline FRS or SCORE in both the control and the intervention groups (appendix). For individual components of risk scores and other risk factors, there were no differences in the control

Discussion

In this pragmatic, open-label, randomised controlled trial, the most important result was that a low-intensity intervention with pictorial information of atherosclerosis followed by a nurse-led telephone call reduced the cardiovascular disease risk factor burden at the 1-year follow-up. This intervention was given in addition to an effective prevention programme managed by local health-care centres.19, 26 Of note, these results were obtained in a middle-aged population with low to moderate

Data sharing

Study protocol and several other sets of information are available at https://clinicaltrials.gov/ct2/show/NCT01849575. Furthermore, information will be available at the VIPVIZA website from December, 2018, or January, 2019. VIPVIZA is a study programme with a steering group, principal investigator, and co-principal investigator. We are interested in research collaboration with other groups in the field of prevention of cardiovascular disease, behaviour medicine, vascular ultrasound, and

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