Evaluating the impact of population and high-risk strategies for the primary prevention of cardiovascular disease. Lifestyle‐Based Prediction Model for the Prevention of CVD: The Healthy Heart Score Rationale and design of the Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): a factorial, cluster-randomized trial of 2 practical cardiovascular disease prevention strategies developed for rural Andhra Pradesh, India. Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour Evaluating the use of mobile phone technology to enhance cardiovascular disease screening by community health workers An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial Global Risk Assessment to Guide Blood Pressure Management in Cardiovascular Disease Prevention Effectiveness of a preventive cardiology programme for high CVD risk persistent smokers: the EUROACTION PLUS varenicline trial. A multifaceted quality improvement intervention for CVD risk management in Australian primary healthcare: a protocol for a process evaluation Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. Estimating the benefits of modifying risk factors of cardiovascular disease: a comparison of primary vs secondary prevention. The systematic coronary risk evaluation (SCORE) for the prevention of cardiovascular diseases. Does evidence exist for its effectiveness? A systematic review Nut Consumption in Relation to Cardiovascular Disease Incidence and Mortality Among Patients With Diabetes Mellitus Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. The International Polycap Study-3 (TIPS-3): Design, baseline characteristics and challenges in conduct Legacy Effect of Delayed Blood Pressure-Lowering Pharmacotherapy in Middle-Aged Individuals Stratified by Absolute Cardiovascular Disease Risk: Protocol for a Systematic Review Effects on cardiovascular disease risk of a web-based health risk assessment with tailored health advice: a follow-up study Mediterranean diet and the incidence of cardiovascular disease: a Spanish cohort. Intake of vegetables, legumes, and fruit, and risk for all-cause, cardiovascular, and cancer mortality in a European diabetic population. Effect of Collaborative Care for Depression on Risk of Cardiovascular Events: Data From the IMPACT Randomized Controlled Trial A Novel Family-Based Intervention Trial to Improve Heart Health: FIT Heart: Results of a Randomized Controlled Trial Predicting the 30-Year Risk of Cardiovascular Disease: The Framingham Heart Study Prospective Association Between the Dietary Inflammatory Index and Cardiovascular Diseases in the SUpplémentation en VItamines et Minéraux AntioXydants (SU.VI.MAX) Cohort
AIMS To estimate the potential effectiveness of different " high-risk " and " population " approaches to the primary prevention of  cardiovascular disease ( CVD ) in middle-aged British men , after correction for regression dilution bias . METHODS AND RESULTS We used a combination of cohort and r and omised controlled trial evidence to estimate the effectiveness of high-risk strategies , based on the identification of high-risk factors or high absolute risk , and strategies based on population -wide reductions in cholesterol and blood pressure . High-risk strategies were potentially effective but would need to be used widely to have a substantial effect on CVD in the population . Aggressive pharmacological treatment ( using statins , beta-blockers , ACE-inhibitors and aspirin ) in individuals with a 10-year Framingham event risk of > or=30 % ( 6 % of population ) would have reduced major CVD by at most 11 % . This figure increased to 34 % at a > or=20 % treatment threshold ( 26 % of population ) . In contrast , modest downwards shifts in the population distributions of serum total cholesterol and systolic blood pressure led to marked expected reductions in major CVD . Taking regression dilution bias into account , 10 % reductions in long-term mean blood cholesterol and blood pressure could have reduced major CVD by 45 % . CONCLUSIONS If high-risk strategies are to have a major impact on CVD in the population , they need to be more widely used than previously envisaged . Population -wide reduction of major risk factors is needed if CVD is to be substantially reduced Background Clinical practice focuses on the primary prevention of  cardiovascular ( CV ) disease ( CVD ) through the modification and pharmacological treatment of elevated risk factors . Prediction models based on established risk factors are available for use in the primary prevention setting . However , the prevention of risk factor development through healthy lifestyle behaviors , or primordial prevention , is of paramount importance to achieve optimal population ‐wide CV health and minimize long‐term CVD risk . Methods and Results We developed a  lifestyle‐based CVD prediction model among 61 025 women in the Nurses ’ Health Study and 34 478 men in the Health Professionals Follow‐up Study , who were free of chronic disease in 1986 and followed for ≤24 years .  Lifestyle factors  were assessed by question naires in 1986 . In the derivation step , we used the Bayes Information Criterion to create parsimonious 20‐year risk prediction models among a r and om two thirds of participants in each cohort separately . The scores were vali date d in the remaining one third of participants in each cohort . Over 24 years , there were 3775 cases of CVD in women and 3506 cases in men . The Healthy Heart Score included age , smoking , body mass index , exercise , alcohol , and a composite diet score . In the validation cohort , the risk score demonstrated good discrimination ( Harrell 's C‐index , 0.72 ; 95 % confidence interval [ CI ] , 0.71 , 0.74 [ women ] ; 0.77 ; 95 % CI , 0.76 , 0.79 [ men ] ) , fit , and calibration , particularly among individuals without baseline hypertension or hypercholesterolemia . Conclusions The Healthy Heart Score accurately identifies individuals at elevated risk for CVD and may serve as an important clinical and public health screening tool for the primordial prevention of CVD BACKGROUND Developing countries are experiencing increasing levels of cardiovascular disease ( CVD ) . Although there is a good underst and ing of how to deliver CVD prevention programs in developed countries , there are few data regarding strategies for CVD prevention in re source -poor setting s. This study aim ed to implement and evaluate a CVD prevention program in a rural area of India . METHODS The 2 strategies of CVD prevention to be investigated are an algorithm-based care approach and a health-promotion campaign . A factorial , cluster-r and omized trial design will be used to evaluate these , in which villages will be exposed to one , both , or neither of the interventions for a period of about 12 months . Surveys of households in every village will be used to assess outcomes in all high-risk individuals and a sample of the general adult population . RESULTS The primary outcome of the algorithm-based component of this study will be the percentage of high-risk individuals that have been " identified"-defined as having received a cardiovascular-risk assessment in the last 12 months . The primary outcome for the health-promotion component will be the percentage of the adult population with correct knowledge about the effects of 6 behavioral determinants of cardiovascular risk ( green-leafy vegetables , fruits , oily foods , salt , smoking , physical activity ) . Secondary outcomes include a range of measures defining uptake of different preventive strategies . CONCLUSIONS This study will provide evidence about the effectiveness of a simple practical mechanism of CVD preventive care specifically design ed for delivery in a re source -poor area in India Background Cardiovascular disease ( CVD ) remains the leading cause of death globally . Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions . An integral part of this approach is the use of CVD risk scores . Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies . We aim to evaluate short-term effects of providing different types of information about coronary heart disease ( CHD ) risk , alongside lifestyle advice , on health-related behaviours . Methods / Design In a parallel-group , open r and omised trial , we are allocating 932 male and female blood donors with no previous history of CVD aged 40–84 years in Engl and to either no intervention ( control group ) or to one of three active intervention groups : i ) lifestyle advice only ; ii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics ; and iii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics . The primary outcome is change in objective ly measured physical activity . Secondary outcomes include : objective ly measured dietary behaviours ; cardiovascular risk factors ; current medication and healthcare usage ; perceived risk ; cognitive evaluation of provision of CHD risk scores ; and psychological outcomes . The follow-up assessment takes place 12 weeks after r and omisation . The experiences , attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups . Discussion The INFORM study has been design ed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours . Trial registration Current Controlled Trials IS RCT N17721237 . Registered 12 January 2015 BACKGROUND Primary prevention of cardiovascular disease (CVD),by identifying individuals at risk is a well-established , but costly strategy when based on measurements that depend on laboratory analyses . A non-laboratory , paper-based CVD risk assessment chart tool has previously been developed to make screening more affordable in developing countries . Task shifting to community health workers ( CHWs ) is being investigated to further scale CVD risk screening . This study aim ed to develop a mobile phone CVD risk assessment application and to evaluate its impact on CHW training and the duration of screening for CVD in the community by CHWs . METHODS A feature phone application was developed using the open source online platform , CommCare ( © ) . CHWs ( n=24 ) were trained to use both paper-based and mobile phone CVD risk assessment tools . They were r and omly allocated to using one of the risk tools to screen 10 - 20 community members and then crossed over to screen the same number , using the alternate risk tool . The impact on CHW training time , screening time and margin of error in calculating risk scores was recorded . A focus group discussion evaluated experiences of CHWs using the two tools . RESULTS The training time was 12.3h for the paper-based chart tool and 3h for the mobile phone application . 537 people were screened . The mean screening time was 36 min ( SD=12.6 ) using the paper-base chart tool and 21 min ( SD=8.71 ) using the mobile phone application , p=<0.0001 . Incorrect calculations ( 4.3 % of average systolic BP measurements , 10.4 % of BMI and 3.8 % of CVD risk score ) were found when using the paper-based chart tool while all the mobile phone calculations were correct . Qualitative findings from the focus group discussion corresponded with the findings of the pilot study . CONCLUSION The reduction in CHW training time , CVD risk screening time , lack of errors in calculation of a CVD risk score and end user satisfaction when using a mobile phone application , has implication s in terms of adoption and sustainability of this primary prevention strategy to identify people with high CVD risk who can be referred for appropriate diagnoses and treatment Background Cardiovascular diseases ( CVD ) are responsible for significant morbidity , premature mortality , and economic burden . Despite established evidence that supports the use of preventive medications among patients at high CVD risk , treatment gaps remain . Building on prior evidence and a theoretical framework , a complex intervention has been design ed to address these gaps among high-risk , under-treated patients in the Australian primary care setting . This intervention comprises a general practice quality improvement tool incorporating clinical decision support and audit/feedback capabilities ; availability of a range of CVD polypills ( fixed-dose combinations of two blood pressure lowering agents , a statin ± aspirin ) for prescription when appropriate ; and access to a pharmacy-based program to support long-term medication adherence and lifestyle modification . Methods Following a systematic development process , the intervention will be evaluated in a pragmatic cluster r and omized controlled trial including 70 general practice s for a median period of 18 months . The 35 general practice s in the intervention group  will work with a nominated partner pharmacy , whereas those in the control group will provide usual care without access to the intervention tools . The primary outcome is the proportion of patients at high CVD risk who were inadequately treated at baseline who achieve target blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) levels at the study end . The outcomes will be analyzed using data from electronic medical records , utilizing a vali date d extraction tool . Detailed process and economic evaluations will also be performed . Discussion The study intends to establish evidence about an intervention that combines technological innovation with team collaboration between patients , pharmacists , and general practitioners ( GPs ) for CVD prevention . Trial registration Australian New Zeal and Clinical Trials Registry Elevated blood pressure ( BP ) is a causal risk factor for cardiovascular disease ( CVD ) . Epidemiological analyses have established the grade d and continuous association between higher BP and CVD . Moreover , r and omized clinical trials among individuals with hypertension have demonstrated , in aggregate , a reduction in CVD events by 20 % , coronary heart disease ( CHD ) by 17 % , stroke by 27 % , and heart failure by 28 % for every 10 mm Hg systolic BP ( SBP ) lowering with medical therapy.1 Therefore , prevention , detection , treatment , and control of elevated BP , and its clinical correlate hypertension , is an important public health priority and a primary target for CVD prevention . Although national health surveys have demonstrated improvements in hypertension awareness and treatment , strategic opportunities to improve the efficiency and efficacy of applying BP-lowering therapy in patients most likely to benefit remain.2 Global CVD risk assessment , using multivariable prediction models that estimate absolute CVD risk from routinely measured clinical variables , has been promulgated in several CVD prevention guidelines for cholesterol management to target the most intensive preventive therapies to those at highest absolute CVD risk.3–5 Hypertension guidelines , however , have instead relied solely on isolated BP thresholds and BP goals to guide treatment initiation and intensity . In this review , we provide a rationale for incorporating global CVD risk assessment in BP treatment decision-making and propose a framework to guide its implementation in future CVD prevention guidelines . Epidemiological analyses have firmly established that CVD is a multifactorial condition and that modest increases of several CVD risk factors can often lead to greater overall risk than a severe elevation of a AIM The EUROACTION PLUS trial measured the effectiveness of a nurse-led preventive cardiology programme ( EUROACTION ) offering intensive smoking cessation PLUS optional varenicline for persistent high CVD risk smokers to reduce overall cardiovascular risk compared with usual care ( UC ) in general practice ( GP ) . METHODS AND RESULTS A parallel group r and omized controlled trial in 20 GP in Italy , Netherl and s , Spain , and UK . Six hundred and ninety-six current smokers , ( 137 vascular disease and 559 high total CVD risk ) , were r and omized 350 to EUROACTION PLUS ( EA+ ) and 346 to UC . Specially , trained nurses offered the EUROACTION preventive cardiology programme addressing smoking cessation , diet , physical activity , and risk factor management to reduce overall cardiovascular risk . The primary endpoint was 7 day point prevalence of self-reported abstinence ( vali date d breath carbon monoxide < 10 p.p.m . ) at 16 weeks . Secondary outcomes included dietary habits , physical activity , weight , blood pressure ( BP ) , lipid , and glucose management . One hundred and seventy-seven ( 51 % ) EA+ patients ( 91 % opted to use varenicline ) were abstinent vs. 63 ( 19 % ) in UC ; OR 4.52 ( 95 % CI : 3.20 - 6.39 ) . The Mediterranean diet score of ≥9 in 149 ( 52 % ) EA+ patients vs. 97 ( 37 % ) in UC ; OR 1.84 ( 95 % CI : 1.31 - 2.59 ) . Physical activity target achieved in 46 ( 16 % ) EA+ patients vs. 19 ( 7 % ) in UC ; OR 2.48 ( 95 % CI : 1.41 - 4.36 ) . Target BP ( < 140/90 mm Hg ) achieved in 150 ( 52 % ) EA+ patients vs. 112 ( 43 % ) in UC , OR 1.47 ( 95 % CI : 1.05 - 2.06 ) with no difference in antihypertensive drugs . There were no differences in management of cholesterol or glucose . CONCLUSIONS The EUROACTION preventive cardiology programme in high CVD risk smokers using optional varenicline substantially increased smoking abstinence over 16 weeks and also reduced overall cardiovascular risk compared with UC . REC reference : 09/H0402/85 ; EudraCT number : 2009 - 012451 - 18 ; http://www.controlled-trials.com/IS RCT N22073647 , 12 February 2014 , date last accessed Background Cardiovascular disease ( CVD ) is the leading cause of death and disability worldwide . Despite the widespread availability of evidence -based clinical guidelines and vali date d risk predication equations for prevention and management of CVD , their translation into routine practice is limited . We developed a multifaceted quality improvement intervention for CVD risk management which incorporates electronic decision support , patient risk communication tools , computerised audit and feedback tools , and monthly , peer-ranked performance feedback via a web portal . The intervention was implemented in a cluster r and omised controlled trial in 60 primary healthcare services in Australia . Overall , there were improvements in risk factor recording and in prescribing of recommended treatments among under-treated individuals , but it is unclear how this intervention was used in practice and what factors promoted or hindered its use . This information is necessary to optimise intervention impact and maximally implement it in a post-trial context . In this study protocol , we outline our methods to conduct a theory-based , process evaluation of the intervention . Our aims are to underst and how , why , and for whom the intervention produced the observed outcomes and to develop effective strategies for translation and dissemination . Methods / Design We will conduct four discrete but inter-related studies taking a mixed methods approach . Our quantitative studies will examine ( 1 ) the longer term effectiveness of the intervention post-trial , ( 2 ) patient and health service level correlates with trial outcomes , and ( 3 ) the health economic impact of implementing the intervention at scale . The qualitative studies will ( 1 ) identify healthcare provider perspectives on implementation barriers and enablers and ( 2 ) use video ethnography and patient semi-structured interviews to underst and how cardiovascular risk is communicated in the doctor/patient interaction both with and without the use of intervention . We will also assess the costs of implementing the intervention in Australian primary healthcare setting s which will inform scale-up considerations . Discussion This mixed methods evaluation will provide a detailed underst and ing of the process of implementing a  quality improvement intervention and identify the factors that might influence scalability and sustainability . Trials registration 12611000478910 AIMS Cardiovascular disease ( CVD ) is the leading cause of morbidity and mortality in people with diabetes in South Asia . The CARRS Translation Trial tests the effectiveness , cost-effectiveness , and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan . METHODS We r and omly assigned 1146 adults with diabetes recruited from 10 urban clinic sites , to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention . The intervention involves electronic health record management , decision-support prompts to the healthcare team , and the support of a care coordinator to actively facilitate patient and provider adherence to evidence -based guidelines . The primary outcome is a composite of multiple CVD risk factor control ( blood glucose and either blood pressure or cholesterol , or all three ) . Other outcomes include control of the individual CVD risk factors , process and patient-centered measures , cost-effectiveness , and acceptability/feasibility . CONCLUSION The CARRS Translation Trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients ( clinical trials.gov number : NCT01212328 ) OBJECTIVES To compare the potential years of life saved ( YOLS ) associated with risk factor modification in the primary and secondary prevention of cardiovascular disease ( CVD ) . METHODS The CVD life expectancy model estimates the risk of death due to coronary disease , stroke , and other causes based on the levels of independent risk factors ( such as age , blood pressure , and blood lipid levels ) found in the cohort of the Lipid Research Clinics . The model was vali date d by comparing its predictions with the observed fatal outcomes of 9 r and omized clinical trials . We then estimated the YOLS associated with treating hyperlipidemia or hypertension among hypothetical patient groups with and without CVD at baseline . We defined high-risk patients as those with 3 risk factors ( hyperlipidemia , cigarette smoking , and hypertension ) and low-risk patients as those with isolated hypertension or hyperlipidemia . RESULTS The fatal events predicted by the model were consistent with the clinical trial results . Among men and women with hyperlipidemia without CVD , the forecasted benefits of lipid therapy  were substantially greater among high-risk groups vs low-risk groups ( 4.74 - 0.78 YOLS vs 2.50 - 0.25 YOLS , respectively ) . Among those with CVD , the forecasted benefits of treatment were similar for both high-risk and low-risk groups ( 4.65 - 0.65 YOLS vs 3.84 - 0.58 YOLS , respectively ) . The results for  hypertension  therapy also demonstrated greater benefits for high-risk vs low-risk patients undergoing primary prevention therapy ( 1.34 - 0.29 YOLS vs 0.85 - 0.13 YOLS , respectively ) , and the forecasted benefits in secondary prevention were similar ( 1.26 - 0.23 YOLS vs 1.00 - 0.23 YOLS , respectively ) . CONCLUSIONS The clinical approach to risk factor modification in primary prevention should be different from that in secondary prevention . The forecasted benefits of therapy among patients without CVD are greatest in the presence of other risk factors . Among those with CVD , the benefits of therapy are equivalent , thereby obviating the need to target high-risk patients Objectives : The SCORE model predicts the ten-year risk of cardiovascular mortality but it is still unknown whether applying the SCORE in clinical practice subsequently improves cardiovascular disease ( CVD ) outcomes . The objective of this study is to assess the effect of total cardiovascular risk estimation using the SCORE in preventing serious cardiovascular events in European adults without prior CVD . Methods and results : Data sources : eight bibliographical data bases ( 2003 – August 2015 ) , other internet sources and reference lists of articles were checked . This was supplemented by contact with the board members of the European Society of Cardiology ( ESC ) and the authors of the SCORE model . Study eligibility criteria : all prospect i ve studies in any language investigating the effect of using the SCORE on the clinical outcome ( CVD death , major events and adverse outcomes ) in an adult population were examined . Two review ers assessed the studies independently ( titles , abstract s , full texts ) . After removal of duplicates , 5,256 records were screened and 14 full text papers considered . No eligible studies were identified . An extensive literature search revealed no r and omized control trial or other prospect i ve study comparing significant clinical outcomes between groups that used the SCORE and those who did not . Conclusions : The effect of using the SCORE ( with or without subsequent intervention ) on CVD death , all-cause mortality , major CVD events like myocardial infa rct ion and stroke , as well as adverse outcomes , is still unknown . A cluster r and omised controlled trial is warranted to evaluate the use of the SCORE on important outcomes Rationale : The evidence regarding the potential health benefits of nut consumption among individuals with type 2 diabetes mellitus is limited . Objective : To examine intake of total and specific types of nuts , including tree nuts and peanuts , in relation to subsequent risk of cardiovascular disease ( CVD ) , including coronary heart disease and stroke , and all-cause and cause-specific mortality among individuals with diabetes mellitus . Methods and Results : This prospect i ve analysis included 16 217 men and women with diabetes mellitus at baseline or diagnosed during follow-up ( Nurses ’ Health Study : 1980–2014 , Health Professionals Follow-Up Study : 1986–2014 ) .  Nut consumption was assessed using a vali date d food frequency question naire and up date d every 2 to 4 years . During 223 682 and 254 923 person-years of follow-up , there were 3336 incident CVD cases and 5682 deaths , respectively . Higher total nut consumption was associated with a lower risk of CVD incidence and mortality . The multivariate-adjusted hazard ratios ( 95 % CIs ) for participants who consumed 5 or more servings of total nuts per week ( 1 serving=28 g ) , compared with those who consumed < 1 serving per month , were 0.83 ( 0.71–0.98 ; P trend=0.01 ) for total CVD incidence , 0.80 ( 0.67–0.96 ; P trend=0.005 ) for coronary heart disease incidence , 0.66 ( 0.52–0.84 ; P trend < 0.001 ) for CVD mortality , and 0.69 ( 0.61–0.77 ; P trend < 0.001 ) for all-cause mortality .  Total nut consumption was not significantly associated with risk of stroke incidence or cancer mortality . For specific types of nuts , higher tree nut consumption was associated with lower risk of total CVD , coronary heart disease incidence , and mortality because of CVD , cancer , and all causes , whereas peanut consumption was associated with lower all-cause mortality only ( all P trend < 0.001 ) . In addition , compared with participants who did not change the consumption of total nuts from pre- to post-diabetes mellitus diagnosis , participants who increased consumption of total nuts after diabetes mellitus diagnosis had an 11 % lower risk of CVD , a 15 % lower coronary heart disease risk , a 25 % lower CVD mortality , and a 27 % lower all-cause mortality . The associations persisted in subgroup analyses stratified by sex/cohort , body mass index at diabetes mellitus diagnosis , smoking status , diabetes mellitus duration , nut consumption before diabetes mellitus diagnosis , or diet quality . Conclusions : Higher consumption of nuts , especially tree nuts , is associated with lower CVD incidence and mortality among participants with diabetes mellitus . These data provide novel evidence that supports the recommendation of incorporating nuts into healthy dietary patterns for the prevention of CVD complications and premature deaths among individuals with diabetes mellitus Most patients with type 2 diabetes mellitus develop cardiovascular disease ( CVD ) , with substantial loss of life expectancy . Nonfatal CVD contributes greatly to excess healthcare costs and decreased quality of life in patients with diabetes . The current epidemic of obesity has raised expectations that CVD associated with type 2 diabetes will become an even greater public health challenge . Despite the importance of this health problem , there is a lack of definitive data on the effects of the intensive control of glycemia and other CVD risk factors on CVD event rates in patients with type 2 diabetes . The Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) trial is a r and omized , multicenter , double 2 x 2 factorial design study involving 10,251 middle-aged and older participants with type 2 diabetes who are at high risk for CVD events because of existing CVD or additional risk factors . ACCORD is testing the effects of 3 medical treatment strategies to reduce CVD morbidity and mortality . All participants are in the glycemia trial , which is testing the hypothesis that a therapeutic strategy that targets a glycosylated hemoglobin ( HbA1c ) level of < 6.0 % will reduce the rate of CVD events more than a strategy that targets an HbA1c level of 7.0%-7.9 % . The lipid trial includes 5,518 of the participants , who receive either fenofibrate or placebo in a double-masked fashion to test the hypothesis of whether , in the context of good glycemic control , a therapeutic strategy that uses a fibrate to increase high-density lipoprotein cholesterol and lower triglyceride levels together with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor ( statin ) to lower low-density lipoprotein cholesterol will reduce the rate of CVD events compared with a strategy that uses a statin plus a placebo . The blood pressure trial includes the remaining 4,733 participants and tests the hypothesis that a therapeutic strategy that targets a systolic blood pressure of < 120 mm Hg in the context of good glycemic control will reduce the rate of CVD events compared with a strategy that targets a systolic blood pressure of < 140 mm Hg . The primary outcome measure for all 3 research questions is the first occurrence of a major CVD event , specifically nonfatal myocardial infa rct ion , nonfatal stroke , or cardiovascular death . Upon the expected completion of participant follow-up in 2009 , the ACCORD trial should document for the first time the benefits and risks of intensive glucose control , intensive blood pressure control , and the combination of fibrate and statin drugs in managing blood lipids in high-risk patients with type 2 diabetes Background It is hypothesized that in individuals without clinical cardiovascular disease ( CVD ) , but at increased CVD risk , a 50 % to 60 % reduction in CVD risk could be achieved using fixed dose combination ( FDC ) therapy ( usually comprised of multiple blood‐pressure agents and a statin [ with or without aspirin ] ) in a single “ polypill ” . However , the impact of a polypill in preventing clinical CV events has not been evaluated in a large r and omized controlled trial . Methods TIPS‐3 is a 2x2x2 factorial r and omized controlled trial that will examine the effect of a FDC polypill on major CV outcomes in a primary prevention population . This study aims to determine whether the Polycap ( comprised of atenolol , ramipril , hydrochlorothiazide , and a statin )  reduces CV events in persons without a history of CVD , but who are at least at intermediate CVD risk . Additional interventions in the factorial design of the study will compare the effect of ( 1 ) aspirin versus placebo on CV events ( and cancer ) , ( 2 ) vitamin D versus placebo on the risk of fractures , and ( 3 ) the combined effect of aspirin and the Polycap on CV events . Results The study has r and omized 5713 participants across 9 countries . Mean age of the study population is 63.9 years , and 53 % are female . Mean INTERHEART risk score is 16.8 , which is consistent with a study population at intermediate CVD risk . Conclusion Results of the TIP‐3 study will be key to determining the appropriateness of FDC therapy as a strategy in the global prevention of CVD Background Many national and international guidelines recommend that the initiation of blood pressure (BP)-lowering drug treatment for the primary prevention of cardiovascular disease ( CVD ) should no longer be based on BP level alone , but on absolute cardiovascular risk . While BP-lowering drug treatment is beneficial in high-risk individuals at any level of elevated BP , clinicians are concerned about legacy effects on patients with low-to-moderate risk and mildly elevated BP who remain “ untreated ” . Objective We aim to investigate the legacy effect of delayed BP-lowering pharmacotherapy in middle-aged individuals ( 45 - 65 years ) with mildly elevated BP ( systolic BP 140 - 159 mmHg and /or diastolic BP 90 - 99 mmHg ) stratified by absolute risk for primary prevention of CVD , but particularly in the low-risk ( < 10 % five-year absolute risk ) group . Methods R and omized trials of BP-lowering therapy versus placebo or pretreated subjects in active comparator studies with posttrial follow-up will be identified using a 2-step process . First , r and omized trials of BP-lowering therapy will be identified by ( 1 ) retrieving the references of trials included in published systematic review s of BP-lowering therapy , ( 2 ) retrieving studies published by the Blood Pressure Lowering Treatment Trialists ’ Collaboration ( BPLTTC ) , and ( 3 ) checking studies referenced in the 1993 World Health Organization/International Society of Hypertension meeting memor and um on BP management . Posttrial follow-up studies will then be identified by forward citation search ing the r and omized trials identified in step 1 through Web of Science . The search will include r and omized controlled trials with at least 1-year in-trial period and a posttrial follow-up phase . Age is the major determinant of absolute cardiovascular risk , so the participants in our review will be restricted to middle-aged adults who are more likely to have a lower cardiovascular risk profile . The primary outcome will be all-cause mortality . Secondary outcomes will include cardiovascular mortality , fatal stroke , fatal myocardial infa rct ion , and death due to heart failure . Results The search es for existing systematic review s and BPLTTC studies were piloted and modified . The study is expected to be completed before June 2018 . Conclusions The findings of this study will contribute to the body of knowledge concerning the beneficial , neutral , or harmful effects of delayed BP-lowering drug treatment on the primary prevention of CVD in patients with mildly elevated BP and low-to-moderate CVD risk . Trial Registration PROSPERO International Prospect i ve Register of Systematic Review s : CRD42017058414 ; https://www.crd.york.ac.uk/ PROSPERO /display_record.asp?ID = CRD42017058414 ( Archived by WebCite ® at http://www.webcitation.org/6t6sa8O2Q Introduction : A large proportion of the cardiovascular disease ( CVD ) burden can potentially be prevented by primary prevention programs addressing major causal risk factors . A Web-based health risk assessment ( HRA ) with tailored feedback for individual health promotion is a promising strategy . We evaluated the effect on CVD risk of such a program among employees of a Dutch worksite . Methods : We conducted a prospect i ve follow-up study among 368 employees who voluntarily participated in a Web-based HRA program at a single Dutch worksite in 2008 . The program included a multicomponent HRA through a Web-based electronic question naire , biometrics , and laboratory evaluation . The results were combined with health behavior change theory to generate tailored motivational and educational health advice . On request , a health counseling session with the program physician was available . Follow-up data on CVD risk were collected 1 year after initial participation . The primary outcome was a change in Framingham CVD risk at 6 months relative to baseline . We checked for a possible background effect of an increased health consciousness as a consequence of program introduction at the worksite by comparing baseline measurements of early program participants with baseline measurements of participants who completed the program 6 months later . Results : A total of 176 employees completed follow-up measurements after a mean of 7 months . There was a grade d relation between CVD risk changes and baseline risk , with a relative reduction of 17.9 % ( P = 0.001 ) in the high-risk category ( baseline CVD risk ≥20 % ) . Changes were not explained by additional health counseling , medication , or an increase in health consciousness within the company . Conclusions : Voluntary participation in a Web-based HRA with tailored feedback at the worksite reduced CVD risk by nearly 18 % among participants at high CVD risk and by nearly 5 % among all participants . Web-based HRA could improve CVD risk in similar population s. Future research should focus on the persistence of the effects underlying the CVD risk reduction BACKGROUND AND AIM The Mediterranean diet is considered a model for healthy eating . However , prospect i ve evidence in Mediterranean countries evaluating the relationship between this dietary pattern and non-fatal cardiovascular events is scarce . The aim of the present study was to evaluate the association between the adherence to the Mediterranean diet and the incidence of fatal and non-fatal cardiovascular events among initially healthy middle-aged adults from the Mediterranean area . METHODS AND RESULTS We followed-up 13,609 participants ( 60 percent women , mean age : 38 years ) initially free of cardiovascular disease ( CVD ) during 4.9 years . Participants were part of a prospect i ve cohort study of university graduates from all regions of Spain .  Baseline diet  was assessed using a vali date d 136-item food-frequency question naire . A 9-point score was used to appraise adherence to the Mediterranean diet . Incident clinical events were confirmed by a review of medical records . We observed 100 incident cases of CVD . In multivariate analyses , participants with the highest adherence to the Mediterranean diet ( score>6 ) exhibited a lower cardiovascular risk ( hazard ratio=0.41 , 95 % confidence interval [ CI ] : 0.18 - 0.95 ) compared to those with the lowest score ( <3 ) . For each 2-point increment in the score , the adjusted hazard ratios were 0.80 ( 95 % CI : 0.62 - 1.02 ) for total CVD and 0.74 ( 0.55 - 0.99 ) for coronary heart disease . CONCLUSIONS There is an inverse association between adherence to the Mediterranean diet and the incidence of fatal and non-fatal CVD in initially healthy middle-aged adults We examined the associations of intake of vegetables , legumes and fruit with all-cause and cause-specific mortality in a population with prevalent diabetes in Europe . A cohort of 10,449 participants with self-reported diabetes within the European Prospect i ve Investigation into Cancer and Nutrition study was followed for a mean of 9 y. Intakes of vegetables , legumes , and fruit were assessed at baseline between 1992 and 2000 using vali date d country-specific question naires . A total of 1346 deaths occurred . Multivariate relative risks ( RR ) for all-cause mortality were estimated in Cox regression models and RR for cause-specific mortality were derived in a competing risk model . An increment in intake of total vegetables , legumes , and fruit of 80 g/d was associated with a RR of death from all causes of 0.94 [ 95 % CI 0.90 - 0.98 ] . Analyzed separately , vegetables and legumes were associated with a significantly reduced risk , whereas nonsignificant inverse associations for fruit intake were observed . Cardiovascular disease ( CVD ) mortality and mortality due to non-CVD/non-cancer causes were significantly inversely associated with intake of total vegetables , legumes , and fruit ( RR 0.88 [ 95 % CI 0.81 - 0.95 ] and 0.90 [ 0.82 - 0.99 ] , respectively ) but not cancer mortality ( 1.08 [ 0.99 - 1.17 ] ) . Intake of vegetables , legumes , and fruit was associated with reduced risks of all-cause and CVD mortality in a diabetic population . The findings support the current state of evidence from general population studies that the protective potential of vegetable and fruit intake is larger for CVD than for cancer and suggest that diabetes patients may benefit from a diet high in vegetables and fruits Objective Although depression is a risk and prognostic factor for cardiovascular disease ( CVD ) , depression trials involving cardiac patients have not observed the anticipated cardiovascular benefits . To test our hypothesis that depression treatment delivered before clinical CVD onset reduces risk of CVD events , we conducted an 8-year follow-up study of the Indiana sites of the Improving Mood-Promoting Access to Collaborative Treatment ( IMPACT ) r and omized controlled trial . Methods Participants were 235 primary care patients 60 years or older with major depression or dysthymia who were r and omized to a 12-month collaborative care program involving antidepressants and psychotherapy ( 85 without and 35 with baseline CVD ) or usual care ( 83 without and 32 with baseline CVD ) . Hard CVD events ( fatal/nonfatal ) were identified using electronic medical record and Medicare/Medicaid data . Results A total of 119 patients ( 51 % ) had a hard CVD event . As hypothesized , the treatment × baseline CVD interaction was significant ( p = .021 ) . IMPACT patients without baseline CVD had a 48 % lower risk of an event than did usual care patients ( 28 % versus 47 % , hazard ratio = 0.52 , 95 % confidence interval = 0.31–0.86 ) . The number needed to treat to prevent one event for 5 years was 6.1 . The likelihood of an event did not differ between IMPACT and usual care patients with baseline CVD ( 86 % versus 81 % , hazard ratio = 1.19 , 95 % confidence interval , 0.70–2.03 ) . Conclusions Collaborative depression care delivered before CVD onset halved the excess risk of hard CVD events among older , depressed patients . Our findings raise the possibility that the IMPACT intervention could be used as a CVD primary prevention strategy . Trial Registration : clinical trials.gov Identifier : NCT01561105 Background —Family members of patients with cardiovascular disease ( CVD ) may be at increased risk due to shared genes and lifestyle . Hospitalization of a family member with CVD may represent a “ motivational moment ” to take preventive action . Methods and Results —A r and omized , controlled clinical trial was conducted in healthy adult family members ( N=501 ; 66 % female ; 36 % nonwhite ; mean age , 48 years ) of patients hospitalized with CVD to evaluate a special intervention ( SI )  with personalized risk factor screening , therapeutic lifestyle-change counseling , and progress reports to physicians versus a control intervention ( CIN ) on the primary outcome , mean percent change in low-density lipoprotein cholesterol ( LDL-C ) , and other risk factors . Vali date d dietary assessment s and st and ardized risk factors were obtained at baseline and 1 year ( 94 % follow-up ) . At baseline , for 93 % of subjects , saturated fat comprised ≥7 % of total caloric intake , and 79 % had nonoptimal LDL-C levels ( of which 50 % were unaware ) . There was no difference in the SI versus the CIN with respect to the mean percent change in LDL-C ( −1 % versus −2 % , respectively ; P=0.64 ) , owing to a similar significant reduction in LDL-C in both groups ( −4.4 mg/dL and −4.5 mg/dL , respectively ) . Diet score significantly improved in the SI versus the CIN ( P=0.04 ) . High-density lipoprotein cholesterol declined significantly in the CIN but not in the SI ( −3.2 % [ 95 % CI , −5.1 to −1.3 ] versus + 0.3 % [ 95 % CI , −1.7 to + 2.4 ] ; P=0.01 ) . At 1 year , SI subjects were more likely than controls to exercise > 3 days per week ( P=0.04 ) . Conclusion —The SI was not more effective than the CIN in reducing the primary end point , LDL-C. The screening process identified many family members of hospitalized patients with CVD who were unaware of their risk factors , and further work is needed to develop and test interventions to reduce their CVD risk Background — Present cardiovascular disease ( CVD ) risk prediction algorithms were developed for a ≤10-year follow up period . Clustering of risk factors at younger ages and increasing life expectancy suggest the need for longer-term risk prediction tools . Methods and Results — We prospect ively followed 4506 participants ( 2333 women ) of the Framingham Offspring cohort aged 20 to 59 years and free of CVD and cancer at baseline examination in 1971–1974 for the development of “ hard ” CVD events ( coronary death , myocardial infa rct ion , stroke ) . We used a modified Cox model that allows adjustment for competing risk of noncardiovascular death to construct a prediction algorithm for 30-year risk of hard CVD . Cross-vali date d survival C statistic and calibration & khgr;2 were used to assess model performance . The 30-year hard CVD event rates adjusted for the competing risk of death were 7.6 % for women and 18.3 % for men . St and ard risk factors ( male sex , systolic blood pressure , antihypertensive treatment , total and high-density lipoprotein cholesterol , smoking , and diabetes mellitus ) , measured at baseline , were significantly related to the incidence of hard CVD and remained significant when up date d regularly on follow-up . Body mass index was associated positively with 30-year risk of hard CVD only in models that did not up date risk factors . Model performance was excellent as indicated by cross-vali date d discrimination C=0.803 and calibration & khgr;2=4.25 ( P=0.894 ) . In contrast , 30-year risk predictions based on different applications of 10-year functions proved inadequate . Conclusions — St and ard risk factors remain strong predictors of hard CVD over extended follow-up . Thirty-year risk prediction functions offer additional risk burden information that complements that of 10-year functions Background Cardiovascular diseases ( CVD ) are the leading cause of death in the world , and diet plays a major role in CVD incidence , especially through lipid oxidation mechanisms . This , in turn , leads to tissue inflammation and formation of atheromatous plaques . Methods and Results Our objective was to evaluate the association between the inflammatory potential of the diet and the incidence of overall CVD or its subclasses . We included 7743 participants from the Supplémentation en Vitamines et Minéraux AntioXydants ( SU.VI.MAX ) cohort . All cardiovascular events were recorded using self‐reported information or clinical visits , and were vali date d. The dietary inflammatory index ( DII ) was computed using repeated 24‐hour dietary records ( mean=9.5±3.4 records/subject ) . Hazard ratio and 95 % CI for outcomes ( CVD and subclasses ) were estimated across sex‐specific quartiles of the DII using Cox proportional hazard models . A total of 292 cardiovascular events were recorded and vali date d during an average of 11.4 years of follow‐up : 93 myocardial infa rct ions , 58 strokes , 128 angina pectoris and revascularization interventions , and 13 sudden deaths . When considering CVD subclasses , a diet with pro‐inflammatory properties , as expressed by higher DII scores , was significantly associated with a higher risk of myocardial infa rct ion ( hazard ratioQuartile 4 versus Quartile 1=2.24 , 95 % CI : 1.08–4.67 ) . No significant association was observed between the DII score and stroke or both angina pectoris and revascularization intervention . Conclusions A pro‐inflammatory diet , as measured by a higher DII score , was prospect ively associated with a higher risk of myocardial infa rct ion . Promotion of a diet exhibiting anti‐inflammatory properties may help prevent myocardial infa rct ions
Conclusions This review demonstrates the potential for multifactorial interventions aim ed at individuals selected by CVD risk scores for lowering CVD risk and mortality .
However , the majority of studies in this area do not provide an intensity of intervention which is sufficient in significantly reducing CVD mortality or vali date d CVD risk
Objectives The high prevalence of cardiovascular disease ( CVD ) and the increased cost of treatment have prompted strategies for the primary prevention of CVD in the UK to move towards the use of vali date d CVD risk scores to identify individuals at the highest risk .
There are no review s evaluating the effectiveness of this strategy as a means of reducing CVD risk or mortality .
This review summarizes current evidence for and against the use of vali date d CVD risk scores for the primary prevention of CVD .