Reaching cardiovascular prevention guideline targets with a polypill-based approach: a meta-analysis of randomised clinical trials.

OBJECTIVE: The aim of this study was to determine the effect of polypill-based care on the achievement of 2016 European Society of Cardiology (ESC) guideline targets for blood pressure (BP), low-density lipoprotein (LDL) cholesterol and antiplatelet therapy. METHODS: We conducted an individual participant data meta-analysis of three randomised clinical trials that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior cardiovascular disease (CVD) event or who were at high risk of their first event. Overall, the trials included 3140 patients from Australia, England, India, Ireland, the Netherlands and New Zealand (75% male, mean age 62 years and 76% with a prior CVD event). The primary outcome for this study was the proportion of people achieving ESC guideline targets for BP, LDL and antiplatelet therapy. RESULTS: Those randomised to polypill-based care were more likely than those receiving usual care to achieve recommended targets for BP (62% vs 58%, risk ratio (RR) 1.08, 95% CI 1.02 to 1.15), LDL (39% vs 34%, RR 1.13, 95% CI 1.02 to 1.25) and all three targets for BP, LDL and adherence to antiplatelet therapy (the latter only applicable to those with a prior CVD event) simultaneously (24% vs 19%, RR 1.27, 95% CI 1.10 to 1.47) at 12 months. There was no difference between groups in antiplatelet adherence (96% vs 96%, RR 1.00, 95% CI 0.98 to 1.01). There was heterogeneity by baseline treatment intensity such that treatment effects increased with the fewer the number of treatments being taken at baseline: for patients taking 3, 2 and 0-1 treatment modalities the RRs for reaching all three guideline goals simultaneously were 1.10 (95% CI 0.94 to 1.30, 22% vs 20%), 1.62 (95% CI 1.09 to 2.42, 27% vs 17%) and 3.07 (95% CI 1.77 to 5.33, 35% vs 11%), respectively. CONCLUSIONS: Polypill-based therapy significantly improved the achievement of all three ESC targets for BP, LDL and antiplatelet therapy compared with usual care, particularly among those undertreated at baseline.

Healthcare expenditure on Indigenous and non-Indigenous Australians at high risk of cardiovascular disease.

BACKGROUND: In spite of bearing a heavier burden of death, disease and disability, there is mixed evidence as to whether Indigenous Australians utilise more or less healthcare services than other Australians given their elevated risk level. This study analyses the Medicare expenditure and its predictors in a cohort of Indigenous and non-Indigenous Australians at high risk of cardiovascular disease. METHODS: The healthcare expenditure of participants of the Kanyini Guidelines Adherence with the Polypill (GAP) pragmatic randomised controlled trial was modelled using linear regression methods. 535 adult (48% Indigenous) participants at high risk of cardiovascular disease (CVD) were recruited through 33 primary healthcare services (including 12 Aboriginal Medical Services) across Australia. RESULTS: There was no significant difference in the expenditure of Indigenous and non-Indigenous participants in non-remote areas following adjustment for individual characteristics. Indigenous individuals living in remote areas had lower MBS expenditure ($932 per year P < 0.001) than other individuals. MBS expenditure was found to increase with being aged over 65 years ($128, p = 0.013), being female ($472, p = 0.003), lower baseline reported quality of life ($102 per 0.1 decrement of utility p = 0.004) and a history of diabetes ($324, p = 0.001), gout ($631, p = 0.022), chronic obstructive pulmonary disease ($469, p = 0.019) and established CVD whether receiving guideline-recommended treatment prior to the trial ($452, p = 0.005) or not ($483, p = 0.04). When controlling for all other characteristics, morbidly obese patients had lower MBS expenditure than other individuals (-$887, p = 0.002). CONCLUSION: The findings suggest that for the majority of participants, once individuals are engaged with a primary care provider, factors other than whether they are Indigenous determine the level of Medicare expenditure for each person. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN 126080005833347.

The Irish National Adverse Events Study (INAES): the frequency and nature of adverse events in Irish hospitals-a retrospective record review study.

INTRODUCTION: Irish healthcare has undergone extensive change recently with spending cuts and a focus on quality initiatives; however, little is known about adverse event occurrence. OBJECTIVE: To assess the frequency and nature of adverse events in Irish hospitals. METHODS: 1574 (53% women, mean age 54 years) randomly selected adult inpatient admissions from a sample of eight hospitals, stratified by region and size, across the Republic of Ireland in 2009 were reviewed using two-stage (nurse review of patient charts, followed by physician review of triggered charts) retrospective chart review with electronic data capture. Results were weighted to reflect the sampling strategy. The impact on adverse event rate of differing application of international adverse event criteria was also examined. RESULTS: 45% of charts were triggered. The prevalence of adverse events in admissions was 12.2% (95% CI 9.5% to 15.5%), with an incidence of 10.3 events per 100 admissions (95% CI 7.5 to 13.1). Over 70% of events were considered preventable. Two-thirds were rated as having a mild-to-moderate impact on the patient, 9.9% causing permanent impairment and 6.7% contributing to death. A mean of 6.1 added bed days was attributed to events, representing an expenditure of €5550 per event. The adverse event rate varied substantially (8.6%-17.0%) when applying different published adverse event eligibility criteria. CONCLUSIONS: This first study of adverse events in Ireland reports similar rates to other countries. In a time of austerity, adverse events in adult inpatients were estimated to cost over €194 million. These results provide important baseline data on the adverse event burden and, alongside web-based chart review, provide an incentive and methodology to monitor future patient-safety initiatives.

Polypill-based therapy likely to reduce ethnic inequities in use of cardiovascular preventive medications: Findings from a pragmatic randomised controlled trial.

OBJECTIVE: The purpose of this study was to investigate the consistency of the proportional effect of fixed-dose combination therapy (the 'polypill') on the use of recommended cardiovascular preventative medications among indigenous Maori and non-indigenous adults in New Zealand. METHODS: We randomised Maori and non-Maori primary care patients at high risk of cardiovascular disease (either because of a prior event or with an estimated 5-year risk of a first event of at least 15%) to a polypill (containing aspirin, statin and two antihypertensives) or usual care for a minimum of 12 months. All patients had indications for all polypill components according to their general practitioner, and all medications (including the polypill) were prescribed by the patient's general practitioner and dispensed at community pharmacies. The main outcome for this study was the use of all recommended medications (antiplatelet, statin and two antihypertensives) at 12 months. Heterogeneity in the effect of polypill-based care compared with usual care on this outcome by ethnicity was assessed by logistic regression. RESULTS: Baseline use of recommended medications was 36% (93/257) among Maori and 51% (130/156) among non-Maori participants. Polypill-based care was associated with an increase in the use of recommended medications among Maori (relative risk [RR]: 1.87; 95% confidence interval [CI]: 1.50-2.34) and non-Maori (RR: 1.66; 95% CI: 1.37-2.00) when compared with usual care at 12 months, and there was no statistically significant heterogeneity in this outcome by ethnicity (p = 0.92). CONCLUSION: Polypill-based care is likely to reduce absolute inequities between Maori and non-Maori in the use of recommended cardiovascular preventative medications given baseline absolute differences and the consistency of the proportional effect of this intervention by ethnicity in this pragmatic trial in primary care.

Do polypills lead to neglect of lifestyle risk factors? Findings from an individual participant data meta-analysis among 3140 patients at high risk of cardiovascular disease.

AIM: The aim of this study was to investigate whether polypill-based care for the prevention of cardiovascular disease (CVD) is associated with a change in lifestyle risk factors when compared with usual care, among patients with CVD or high calculated cardiovascular risk. METHODS: We conducted an individual participant data meta-analysis of three trials including patients from Australia, England, India, Ireland, the Netherlands and New Zealand that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior CVD event or who were at high risk of their first event. Analyses investigated any differential effect on anthropometric measures and self-reported lifestyle behaviours. RESULTS: Among 3140 patients (75% male, mean age 62 years and 76% with a prior CVD event) there was no difference in lifestyle risk factors in those randomised to polypill-based care compared with usual care over a median of 15 months, either across all participants combined, or in a range of subgroups. Furthermore, narrow confidence intervals (CIs) excluded any major effect; for example differences between the groups in body mass index was -0.1 (95% CI -0.2 to 0.1) kg/m(2), in weekly duration of moderate intensity physical activity was -2 (-26 to 23) minutes and the proportion of smokers was 16% vs 17% (RR 0.98, 0.84 to 1.15) at the end of trial. DISCUSSION: This analysis allays concern that polypill-based care may lead to neglect of lifestyle risk factors, at least among high-risk patients. Maximally effective preventive approaches should address lifestyle factors alongside pharmaceutical interventions, as recommended by major international guidelines.

Effectiveness of fixed dose combination medication ('polypills') compared with usual care in patients with cardiovascular disease or at high risk: A prospective, individual patient data meta-analysis of 3140 patients in six countries.

AIMS: To conduct a prospective, individual participant data (IPD) meta-analysis of randomised controlled trials comparing a polypill-based approach with usual care in high risk individuals. METHODS AND RESULTS: Three trials comparing polypill-based care with usual care in individuals with CVD or high calculated cardiovascular risk contributed IPD. Primary outcomes were self-reported adherence to combination therapy (anti-platelet, statin and ≥ two blood pressure (BP) lowering agents), and difference in mean systolic BP (SBP) and LDL-cholesterol at 12 months. Analyses used random effects models. Among 3140 patients from Australia, England, India, Ireland, New Zealand and The Netherlands (75% male, mean age 62 years), median follow-up was 15 months. At baseline, 84%, 87% and 61% respectively were taking a statin, anti-platelet agent and at least two BP lowering agents. At 12 months, compared to usual care, participants in the polypill arm had higher adherence to combination therapy (80% vs. 50%, RR 1.58; 95% CI, 1.32 to 1.90; p < 0.001), lower SBP (-2.5 mmHg; 95% CI, -4.5 to -0.4; p = 0.02) and lower LDL-cholesterol (-0.1 mmol/L; 95% CI, -0.2 to 0.0; p = 0.04). Baseline treatment levels were a major effect modifier for adherence and SBP (p-homog < 0.0001 and 0.02 respectively) with greatest improvements seen among those under-treated at baseline. CONCLUSIONS: Polypill therapy significantly improved adherence, SBP and LDL-cholesterol in high risk patients compared with usual care, especially among those who were under-treated at baseline.

The Effect of a Cardiovascular Polypill Strategy on Pill Burden.

AIMS: Recent trials of cardiovascular polypills in high-risk populations show improvements in the use of cardiovascular preventive treatments, compared to usual care. We describe patterns of pill burden in Australian practice, define the impact of polypill therapy on pill burden, and explore how physicians add medication to polypill therapy. METHODS: The Kanyini Guidelines Adherence with the Polypill Study was an open-label trial involving 623 participants in Australia which randomized participants to a polypill strategy (containing a statin, antiplatelet agent, and two blood-pressure-lowering medications) or usual care. Participants either had established cardiovascular disease or were at high calculated risk (≥15% over 5 years). Current medications, daily pill burden, and self-reported use of combination treatment were recorded prior to randomization and at study end. Median pill burden at baseline and study end was compared in both arms. Subgroup analysis of the polypill strategy on trial primary outcomes was conducted by pill burden at baseline. RESULTS: Median total and cardiovascular pill burdens of the polypill group decreased from 7 to 5 and from 4 to 2, respectively (median change -2; IQR -3, 0), with no change in the usual care group (comparison of change; P < 0.001). No change was seen for noncardiovascular medications. Of those still using the polypill at study end, 43.8% were prescribed additional medications; 84.5% of these additional medications were blood-pressure-lowering medications. Within the polypill group, lower pill burden at baseline was associated with greater increases in the use of indicated cardiovascular preventive medications at study end compared to those with higher pill burdens. No trend was observed between the level of baseline pill burden and the effect of poylpill treatment on systolic blood pressure or total cholesterol. CONCLUSION: A cardiovascular polypill in contemporary Australian practice reduces cardiovascular and total pill burdens, despite frequent prescription of additional medications.

A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk.

BACKGROUND: Most individuals at high cardiovascular disease (CVD) risk worldwide do not receive any or optimal preventive drugs. We aimed to determine whether fixed dose combinations of generic drugs ('polypills') would promote use of such medications. METHODS: We conducted a randomized, open-label trial involving 623 participants from Australian general practices. Participants had established CVD or an estimated five-year CVD risk of ≥15%, with indications for antiplatelet, statin and ≥2 blood pressure lowering drugs ('combination treatment'). Participants randomized to the 'polypill-based strategy' received a polypill containing aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg. Participants randomized to 'usual care' continued with separate medications and doses as prescribed by their doctor. Primary outcomes were self-reported combination treatment use, systolic blood pressure and total cholesterol. RESULTS: After a median of 18 months, the polypill-based strategy was associated with greater use of combination treatment (70% vs. 47%; relative risk 1.49, (95% confidence interval (CI) 1.30 to 1.72) p < 0.0001; number needed to treat = 4.4 (3.3 to 6.6)) without differences in systolic blood pressure (-1.5 mmHg (95% CI -4.0 to 1.0) p = 0.24) or total cholesterol (0.08 mmol/l (95% CI -0.06 to 0.22) p = 0.26). At study end, 17% and 67% of participants in polypill and usual care groups, respectively, were taking atorvastatin or rosuvastatin. CONCLUSION: Provision of a polypill improved self-reported use of indicated preventive treatments. The lack of differences in blood pressure and cholesterol may reflect limited study power, although for cholesterol, improved statin use in the polypill group counter-balanced use of more potent statins with usual care.

An economic case for a cardiovascular polypill? A cost analysis of the Kanyini GAP trial.

OBJECTIVE: To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease (CVD) or at similarly high cardiovascular risk. DESIGN: A within-trial cost analysis of polypill-based care versus usual care with separate medications, using data from the Kanyini Guidelines Adherence with the Polypill (GAP) trial and linked health service and medication administrative claims data. PARTICIPANTS: Kanyini GAP participants who consented to Australian Medicare record access. MAIN OUTCOME MEASURES: Mean health service and pharmaceutical expenditure per patient per year, estimated with generalised linear models. Costs during the trial (randomisation January 2010 - May 2012, median follow-up 19 months, maximum follow-up 36 months) were inflated to 2012 costs. RESULTS: Our analysis showed a statistically significantly lower mean pharmaceutical expenditure of $989 (95% CI, $648-$1331) per patient per year in the polypill arm compared with usual care (P < 0.001; adjusted, excluding polypill cost). No significant difference was shown in health service expenditure. CONCLUSIONS: This study provides evidence of significant cost savings to the taxpayer and Australian Government through the introduction of a CVD polypill strategy. The savings will be less now than during the trial due to subsequent reductions in the costs of usual care. Nonetheless, given the prevalence of CVD in Australia, the introduction of this polypill could increase considerably the efficiency of health care expenditure in Australia. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN126080005833347.

Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk: the SPACE Collaboration.

BACKGROUND: An international collaboration of investigators will assess the benefits and risks of fixed dose combination (FDC) based care compared with usual care in populations at high risk of cardiovascular disease (CVD). Several trials are being conducted, as the effectiveness and economic impact of a FDC-based strategy may vary substantially between countries, given the varying influence of the health-care system within which the intervention is delivered. METHODS: Individual patient data (IPD) will be provided by participating trials for combined IPD meta-analysis. RESULTS: Primary outcomes will include self-reported current use of antiplatelet, statin, and combination (≥ 2) blood pressure lowering therapies at 12 months, and change in systolic blood pressure (SBP) and LDL cholesterol from baseline to 12 months. Non-inferiority margins of 3 mm Hg for SBP and 0.3 mmol/L for LDL cholesterol have been pre-specified. Secondary outcomes will include change in cholesterol fractions, diastolic blood pressure and creatinine from baseline to 12 months, quality of life, new onset diabetes mellitus, mortality (cardiovascular, non-cardiovascular and all cause) and a composite outcome of cardiovascular events (including all coronary heart disease events, heart failure events leading to death or requiring hospital admission, cerebrovascular events and peripheral arterial events). CONCLUSION: The SPACE group of trials will assess, in a variety of healthcare settings, whether a FDC strategy for delivery of preventive medication has the potential to significantly improve prevention of cardiovascular disease in patients at high risk.

Recruiting equal numbers of indigenous and non-indigenous participants to a 'polypill' randomized trial.

INTRODUCTION: Maori are disproportionately affected by cardiovascular disease (CVD), which is the main reason for the eight year difference in life expectancy between Maori and non-Maori. The primary care-based IMPACT (IMProving Adherence using Combination Therapy) trial evaluates whether fixed dose combination therapy (a "polypill") improves adherence to guideline-based therapy compared with current care among people at high risk of CVD. Interventions shown in trials to be effective do not necessarily reduce ethnic disparities, and may in fact widen them. Indigenous populations with poorer health outcomes are often under-represented in trials so the effect of interventions cannot be assessed for them, specifically. Therefore, the IMPACT trial aimed to recruit as many Maori as non-Maori to assess the consistency of the effect of the polypill. This paper describes the methods and results of the recruitment strategy used to achieve this. METHODS: Experienced Maori researchers were involved in trial governance throughout trial development and conduct. The trial Steering Committee included leading Maori researchers and was committed to equal recruitment of Maori and non-Maori. Additional funding and Maori research nurses were sought to allow home-based assessment, establishment of the relationship between research nurse and participant, more family involvement prior to enrollment, continuity of the research nurse-participant relationship, and acknowledgement of other Maori culturally important procedures, interactions, language and manners. Primary care practices with high enrollment of Maori were targeted, with over-sampling of potentially eligible Maori patients, lower thresholds for screening of Maori and 6 months continued Maori recruitment after non-Maori recruitment had finished. RESULTS: A total of 257 Maori and 256 non-Maori participants were randomized. Four Maori and eight non-Maori participants were randomized per research nurse per month. Potentially eligible Maori were more likely than non-Maori to proceed to subsequent stages of recruitment. Differences between randomized Maori and non-Maori were evident (e.g. Maori were less likely to have established coronary artery disease). CONCLUSIONS: Recruitment of equal numbers of indigenous and non-indigenous participants is possible if it is prioritised, adequately resourced and self-determination is supported. TRIAL REGISTRATION: The trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN12606000067572.

IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death, and principal reason for the large difference in life expectancy between indigenous Maori and the non-indigenous population in New Zealand. CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin, blood pressure lowering and lipid lowering therapies. However, prescribing and adherence rates are low and CVD events remain high. AIM: To assess whether a medication strategy using a fixed dose combination pill ('polypill') could improve prescribing and adherence to recommended medications, lower blood pressure and improve lipids compared with current care over 12 months. METHODS: IMProving Adherence using Combination Therapy (IMPACT) is an open-label randomised controlled trial comparing a once-daily polypill containing four preventive medications with usual care. Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled, including 300 Maori. Participants are identified, enrolled and prescribed either the polypill or current medications at their usual primary health care practice, with medications (including the polypill) dispensed through local community pharmacies. The polypill contains 75 mg aspirin, 40 mg simvastatin, 10mg lisinopril and either 12.5mg hydrochlorothiazide or 50mg atenolol. Primary outcomes are adherence to guidelines-recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months. Secondary outcomes include other lipids, medication dispensing, barriers to adherence, CVD and other serious adverse events, quality of life and prescriber acceptability. The trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12606000067572).

An international randomised placebo-controlled trial of a four-component combination pill ("polypill") in people with raised cardiovascular risk.

BACKGROUND: There has been widespread interest in the potential of combination cardiovascular medications containing aspirin and agents to lower blood pressure and cholesterol ('polypills') to reduce cardiovascular disease. However, no reliable placebo-controlled data are available on both efficacy and tolerability. METHODS: We conducted a randomised, double-blind placebo-controlled trial of a polypill (containing aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg and simvastatin 20 mg) in 378 individuals without an indication for any component of the polypill, but who had an estimated 5-year cardiovascular disease risk over 7.5%. The primary outcomes were systolic blood pressure (SBP), LDL-cholesterol and tolerability (proportion discontinued randomised therapy) at 12 weeks follow-up. FINDINGS: At baseline, mean BP was 134/81 mmHg and mean LDL-cholesterol was 3.7 mmol/L. Over 12 weeks, polypill treatment reduced SBP by 9.9 (95% CI: 7.7 to 12.1) mmHg and LDL-cholesterol by 0.8 (95% CI 0.6 to 0.9) mmol/L. The discontinuation rates in the polypill group compared to placebo were 23% vs 18% (RR 1.33, 95% CI 0.89 to 2.00, p = 0.2). There was an excess of side effects known to the component medicines (58% vs 42%, p = 0.001), which was mostly apparent within a few weeks, and usually did not warrant cessation of trial treatment. CONCLUSIONS: This polypill achieved sizeable reductions in SBP and LDL-cholesterol but caused side effects in about 1 in 6 people. The halving in predicted cardiovascular risk is moderately lower than previous estimates and the side effect rate is moderately higher. Nonetheless, substantial net benefits would be expected among patients at high risk. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12607000099426.

Gaps in primary care documentation of cardiovascular risk factors.

BACKGROUND: New Zealand guidelines recommend that cardiovascular risk management should be informed by the absolute risk of a cardiovascular event. This requires knowledge of a person's age, sex, ethnicity, medical and family history, blood pressure, total and HDL cholesterol, diabetes, and smoking status. AIM: To establish the extent of primary care documentation of cardiovascular risk factors. METHODS: An audit of electronic patient records was conducted in practices affiliated with an Auckland primary care organisation (ProCare Health Ltd). The audited population were patients eligible for risk assessment (all Maori and a random sample of non-Maori) who had a consultation with their general practitioner during a four week study period (1 year before the doctor first used cardiovascular electronic clinical decision support software). Audit nurses searched for risk factors documented prior to the study period. RESULTS: The records of 1680 individuals from 84 doctors were audited. The study periods prior to which the records were inspected ranged from August 2001 to June 2003. The proportions of records with risk factors documented were: blood pressure 81.8%, cholesterol 62.4%, smoking status 41.5%, diabetes status 16.1%, all these risk factors 6.8%. Recording of blood pressure and of cholesterol was higher in those with cardiovascular disease or diabetes. Recording of blood pressure increased with increasing age, then levelled off at about age 60 years. Documentation of cholesterol was lowest in the oldest and youngest age groups, and in women (at all ages) compared to men. CONCLUSIONS: Primary care documentation of cardiovascular risk factors was incomplete. Whilst many doctors may know whether patients are smokers or have diabetes, systematic documentation of these factors in particular, is not occurring. In order to realise the large potential benefits associated with population-based cardiovascular risk assessment and management, a substantial investment by government, healthcare organisations, health professionals, and patients is required to collect and record this information.

Will a web-based cardiovascular disease (CVD) risk assessment programme increase the assessment of CVD risk factors for Maori?

BACKGROUND: Maori suffer disproportionately from cardiovascular disease despite the national priority of reducing inequalities. National guidelines on the clinical management of CVD risk recommend a comprehensive risk assessment be completed as a prerequisite for identifying patients most likely to benefit from treatment. METHODS: A retrospective audit of GPs using PREDICT-CVD (an electronic risk assessment and management tool) was designed with adequate explanatory power for Maori to determine if it could increase CVD risk assessment without increasing inequalities. 1680 electronic medical records (EMRs) prior to implementation and 1884 after implementation of PREDICT were audited. RESULTS: Documentation of CVD risk increased from 3.2% of EMRs to 14.7% of EMRs in Maori, and from 2.8% to 10.5% in non-Maori. The documentation of individual CVD risk factors also increased post-implementation of the tool. CONCLUSIONS: The implementation of PREDICT-CVD was as likely to increase documentation of CVD risk assessment and risk factors in Maori as in non-Maori. However documentation was still low in Maori despite known high prevalence of CVD risk factors. A comprehensive quality-driven implementation programme is recommended, including targeting risk assessment for those most in need.