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Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA): a pragmatic, open-label, randomised controlled trial.
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- Author(s): Näslund, Ulf; Ng, Nawi; Lundgren, Anna; Fhärm, Eva; Grönlund, Christer; Johansson, Helene; Lindahl, Bernt; Lindahl, Bertil; Lindvall, Kristina; Nilsson, Stefan K.; Nordin, Maria; Nordin, Steven; Nyman, Emma; Rocklöv, Joacim; Vanoli, Davide; Weinehall, Lars; Wennberg, Patrik; Wester, Per; Norberg, Margareta; VIPVIZA trial group (CORPORATE AUTHOR)
- Source:
Lancet. 1/12/2019, Vol. 393 Issue 10167, p133-142. 10p. - Source:
- Additional Information
- Subject Terms: CARDIOVASCULAR disease prevention; ATHEROSCLEROSIS; PRIMARY care; PHYSICIANS; ULTRASONIC imaging; CAROTID artery; COMPARATIVE studies; HEALTH behavior; HEALTH promotion; LIPIDS; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; PREVENTIVE health services; RESEARCH; RISK assessment; EVALUATION research; RANDOMIZED controlled trials; CAROTID intima-media thickness
- Abstract:
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. [ABSTRACT FROM AUTHOR] - Abstract: Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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