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The article presents a study on one-year cardiovascular (CV) event rates in patients with established CV disease or with multiple CV risk factors. The study involved 2,873 patients at high risk of atherothrombosis presenting to 273 Australian general practitioners as part of the international REACH Registry. It finds that the rate of clinical events in community-based patients with stable atherothrombotic disease increases with the severity of disease and number of vascular beds involved.

Background: Cardiovascular disease (CVD) remains a leading cause of death across the world and poses a significant economic burden. Research regarding per-person use and cost of cardiovascular pharmaceuticals in Australia, as well as potential predictors of pharmaceutical costs in populations using the 'bottom up' costing approach, is limited. Previous studies have adopted 'top down' costing approaches and have been based largely on hypothetical examples and considered only inpatient settings. Objective: To determine the distribution of pharmaceutical costs (from a governmental perspective) related to each cardiovascular risk factor for individuals with, or at high risk of, CVD by analysing data for Australian participants enrolled in the Reduction of Atherothrombosis for Continued Health (REACH) Registry. Methods: 2873 participants were recruited for the REACH Registry through 273 general (primary care) practices in Australia. Included among data collected at baseline was a cardiovascular medicines review. Average weighted costs per person were estimated using Government-reimbursed prices (2007). Annual costs were stratified by sex, age, disease group and other co-morbidities. A multivariate linear regression model was utilized to reveal the predictors of the pharmaceutical costs. Results: The average annual median cost of cardiovascular pharmaceuticals per person was Australian dollars ($A)1310. Use of lipid-lowering agents, non-aspirin (acetylsalicylic acid) antiplatelet agents and thiazolidinediones (glitazones) added significantly to the average annual per-person costs. The multivariate regression model showed that the predictors of annual pharmaceutical costs were dyslipidemia (b coefficient value [marginal annual cost associated with a condition] $A691; p < 0.001), hypertension ($A346; p < 0.001), vascular disease ($A340; p < 0.001), diabetes mellitus ($A298; p < 0.001), and obesity ($A52; p = 0.03). The same predictors, together with sex, were shown to have an impact on the number of medicines used. Conclusions: Among community-based Australians with, or at risk of, CVD, independent drivers of annual cardiovascular pharmaceutical costs are dyslipidemia (which accounts for half of perperson costs), followed by hypertension, established CVD, and diabetes. Obesity also independently adds to the cost of cardiovascular pharmaceuticals in community-based Australians with, or at risk of, CVD. [ABSTRACT FROM AUTHOR]

Australia's Pharmaceutical Benefits Scheme supports the use of effective drugs for the prevention and control of cardiovascular risk factors. However, there are little data available describing per person costs of medication in primary prevention and secondary prevention in the community. We aim to understand annual expenditure on cardiovascular medicines according to the level and extent of cardiovascular disease, using participants enrolled in the Reduction of Atherothrombosis for Continued Health (REACH) registry. 2873 participants were recruited into the REACH registry through 273 Australian general practices. Cardiovascular medicines review was undertaken at baseline. Average weighted costs of medications were estimated using government-reimbursed prices. Annual costs were stratified by disease extent and location. The annual mean cost of pharmaceuticals per person was AU$1307. The average reported medicine use per person across all states and participants groups varied significantly. Participants with cerebrovascular or peripheral arterial disease were prescribed less cardiovascular medication than those with coronary artery disease (CAD) (mean number of drugs 3.5 vs. 4.5, P < 0.0001) and (3.6 vs. 4.5, P < 0.0001), while those with risk factor alone had the same medication use as those with CAD (mean number 4.5). Medication use was lower in Western Australia in comparison to eastern States. Participants with existing cerebrovascular disease and peripheral vascular disease receive less preventive therapy than those with CAD or even risk factors alone. This observation is consistent across all mainland states. Given the evidence of the effectiveness and cost-effectiveness of treating all types of vascular diseases, the present study suggests that there is scope to improve the treatment of these high-risk participants in Australia. [ABSTRACT FROM AUTHOR]

Background: Compared with other manifestations of cardiovascular disease, peripheral arterial disease (PAD) is under-diagnosed. This study aims to investigate the prevalence, risk profile and cardiovascular outcomes of undiagnosed PAD in Australian general practices.Method: A sub-study of the Australian Reduction of Atherothrombosis for Continued Health (REACH) Registry, a prospective cohort study of patients at high risk of atherothrombosis recruited from Australian general practices. Eligible patients for this study had no previous clinical diagnosis of PAD and had an ankle-brachial index (ABI) ≤1.4 at recruitment.Results: Peripheral arterial disease was undiagnosed in 34% Australian REACH participants, 28% patients had low ABI (ABI<0.9) and 11% had intermittent claudication (IC) based on responses to the Edinburgh Claudication Questionnaire (ECQ). We found no significant differences in risk factor control between patient with or without PAD. Intermittent claudication patients had higher risks of non-fatal cardiovascular events and PAD interventions at one year, whereas all-cause mortality rate was higher among patients with ABI<0.9, especially in those who also reported IC. Finally, an ABI<0.9, together with poorly controlled risk factors were independent predictors of incident IC at one year.Conclusions: This study suggests a high rate of undiagnosed PAD among high risk patients in Australian primary health care. These patients are at high risk of events and therefore would potentially benefit from better secondary prevention measures. [ABSTRACT FROM AUTHOR]

Abstract: Background: Although few cardiovascular registries report the costs of illness or cost-effectiveness of health interventions, such information is critical to inform the effective and cost-effective management of cardiovascular disease, particularly if drawn from population-based registries, which more accurately reflect clinical practice and follow up patients for much longer than clinical trials. Objective: The goal of this study was to estimate the cost-effectiveness of closing the statin “treatment gap” in the secondary prevention of coronary artery disease (CAD) in Australia. Methods: A decision analysis Markov model was developed with yearly cycles and the health states of alive or dead. Using data from the Australian Reduction of Atherothrombosis for Continued Health Registry, the model compared current statin coverage (82%) in the secondary prevention of CAD (the current group) with a hypothetical situation of 100% coverage (the improved group). The 18% gap was filled with use of generic statins. Data from a recent meta-analysis were used to estimate the benefits of statin use in terms of reducing recurrent cardiovascular events and death. Government reimbursement data from 2011 were used to calculate direct health care costs. The cost of the intervention to improve statin coverage was assumed to be $250 per person. Years of life lived and costs were discounted at 5% annually. All values are given in Australian dollars. Results: Among the 2058 subjects in the current group, the model estimated that there would be 106 nonfatal myocardial infractions, 68 nonfatal strokes, and 275 deaths over 5 years. In the improved group, all of whom took statins, the corresponding numbers were 101, 65, and 259, equating to numbers needed to treat of 426, 639, and 127, respectively. Over the 5 years, there would be 0.018 life-years gained (discounted) at a net cost of $546 (discounted) per person. These equated to an incremental cost-effectiveness ratio of $29,717 per life-year gained. Conclusion: The results suggest that for patients with CAD, maximizing coverage with statins, in line with evidence-based recommendations, represents a cost-effective means of secondary prevention. [Copyright &y& Elsevier]

Background: The management of atherothrombotic disease is responsible for a large proportion of direct medical costs in most countries, imposing a substantial financial burden on health care payers. There is limited knowledge about direct per-person medical costs using a “bottom-up” approach. Objective: This study was designed to estimate the per-person direct medical costs incurred by communitybased subjects in Australia who have or are at high risk for atherothrombotic disease. The perspective was a governmental one, at the federal level for pharmaceuticals and at the state level for hospitalizations. Methods: One-year follow-up data were obtained for Australian participants in the international REACH (Reduction of Atherothrombosis for Continued Health) Registry who were aged ≥45 years and had either established atherothrombotic disease (coronary artery disease, cerebrovascular disease, or peripheral artery disease [PAD]) or ≥3 risk factors for atherothrombotic disease. Information was extracted on the use of cardiovascular medications, hospitalizations, general practice visits, clinical pathology and imaging studies, and use of rehabilitation services. Bottom-up costing was undertaken by assigning unit costs to each health care item, based on Australian government reimbursement data for 2006–2007. Costs were estimated in Australian dollars. Results: Data for 2873 Australian participants in the REACH Registry were included in the analysis. Mean (SD) annual pharmaceutical costs per person were A$1388 (A$645). Mean ambulatory care costs per person were A$704 (A$492), and mean hospitalization costs were A$10,711 (A$10,494). Compared with participants with ≥3 risk factors (adjusted for age and sex), participants with 2 to 3 affected vascular territories incurred A$160 more in mean pharmaceutical costs (95% CI, 78 to 256) and A$181 more in ambulatory care costs (95% CI, 107 to 252). Mean ambulatory care costs were A$132 greater among participants with PAD only relative to those with ≥3 risk factors (95% CI, 19 to 272). Hospital costs were not significantly increased with an increasing number of affected vascular territories. The greatest difference in direct hospital costs (A$943) was between participants with PAD relative to those with ≥3 risk factors (95% CI, −564 to 3545). Conclusions: From the government perspective, management of atherothrombotic disease in Australia was costly during the period studied, particularly among those with PAD only or disease affecting 2 to 3 vascular territories. Hospitalization accounted for the majority of health care expenditure associated with atherothrombotic disease, although the number of hospitalized participants was relatively small. [Copyright &y& Elsevier]

Background: Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs., Methods: In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing., Findings: Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; p non-inferiority =0·034, p superiority =0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; p non-inferiority =0·0058, p superiority =0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups., Interpretation: The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves., Funding: Abbott., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Objectives: The aim of this study was to compare intravenous (IV) sodium bicarbonate with IV sodium chloride and oral acetylcysteine with placebo for the prevention of contrast-associated acute kidney injury (CAAKI) and intermediate-term adverse outcomes., Background: Data are conflicting on the optimal strategy to reduce CAAKI and related complications after percutaneous coronary intervention (PCI)., Methods: The PRESERVE (Prevention of Serious Adverse Events Following Angiography) trial used a 2 × 2 factorial design to randomize 5,177 patients with stage III or IV chronic kidney disease undergoing angiography to IV 1.26% sodium bicarbonate or IV 0.9% sodium chloride and 5 days of oral acetylcysteine or placebo. A subgroup analysis was conducted of the efficacy of these interventions in patients who underwent PCI during the study angiographic examination. The primary endpoint was a composite of death, need for dialysis, or persistent kidney impairment at 90 days; CAAKI was a secondary endpoint., Results: A total of 1,161 PRESERVE patients (mean age 69 ± 8 years) underwent PCI. The median estimated glomerular filtration rate was 50.7 ml/min/1.73 m 2 (interquartile range: 41.7 to 60.1 ml/min/1.73 m 2 ), and 952 patients (82%) had diabetes mellitus. The primary endpoint occurred in 15 of 568 patients (2.6%) in the IV sodium bicarbonate group and 24 of 593 patients (4.0%) in the IV sodium chloride group (odds ratio: 0.64; 95% confidence interval: 0.33 to 1.24; p for interaction = 0.41) and in 23 of 598 patients (3.8%) in the acetylcysteine group and 16 of 563 patients (2.8%) in the placebo group (odds ratio: 1.37; 95% confidence interval: 0.71 to 2.62; p for interaction = 0.29). There were no significant between-group differences in the rates of CAAKI., Conclusions: Among patients with CKD undergoing PCI, there was no benefit of IV sodium bicarbonate over IV sodium chloride or of acetylcysteine over placebo for the prevention of CAAKI or intermediate-term adverse outcomes., (Published by Elsevier Inc.)

Background: Atherothrombotic diseases are the leading health problems in the world, both in terms of morbidity and mortality. This study aimed to identify and quantify the predictors of medication, hospital and outpatient service use among patients with or at high risk of atherothrombotic disease., Methods: Two-year follow-up data were analyzed for 2873 Australian participants of the Reduction of Atherothrombosis for Continued Health (REACH) registry. The analysis was performed using generalized linear models with Poisson and Gamma distributions and log link function., Results: Participants with hypercholesterolemia, diabetes, hypertension, atrial fibrillation (AF), and history of coronary artery disease (CAD) used more medications (p<0.0001). The presence of diabetes predicted higher number of outpatient visits (RR=1.09, 95% CI: 1.07-1.11), as did AF (RR=1.10, 95% CI: 1.08-1.12). The presence of peripheral artery disease (PAD) regardless of ankle brachial index (ABI) status (abnormal or normal) increased the use of outpatient visits (RR=1.24, 95% CI: 1.20-1.29 and RR=1.12, 95% CI: 1.08-1.15), compared to those without PAD. Similarly, the presence of PAD regardless of ABI status increased the risk of vascular interventions, including coronary angioplasty, carotid surgery, amputation affecting lower-limb and peripheral bypass graft (RR=3.64, 95% CI: 2.01-6.60) (RR=2.8, 95% CI: 1.6-4.92) compared to patients without PAD., Conclusions: The presence of PAD regardless of ABI status predicts a higher number of outpatient visits, non-fatal cardiovascular endpoints and vascular-interventions, while diabetes predicts higher pharmaceutical use and outpatient visits. AF predicts the higher number of outpatient visits and non-fatal cardiovascular events., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Objective: The aim of the study is to determine the extent of lost therapeutic benefit (LTB) in the hypertensive patients, and to determine the relationship between the presence of LTB and clinical outcomes., Methods: Prospective-cohort study of n = 2856 patients with or at high risk of atherothrombosis. LTB was calculated as the proportion of patients receiving blood pressure medication who were not attaining guideline blood pressure (BP) control targets (<140/90 mmHg). Logistic regression analysis was performed to identify predictors of LTB at baseline, and propensity score matching (PSM) was undertaken to estimate the treatment effects by matching case LTB and control non-LTB cohorts based on the nearest neighbor matching., Results: Of the total sample of 2856, 45.6% had uncontrolled BP, and LTB was present in 46.7% patients. The likelihood of LTB was less in males (OR = 0.78 [95% CI; 0.64-0.97]), and those with a previous myocardial infarction (OR = 0.66 [0.53-0.81]) or heart failure (OR = 0.58 [0.42-0.82]). LTB was more common in those with diabetes (OR = 1.44 [1.16-1.79]), aged >65 years (OR = 1.36 [1.06-1.75]) and having an ABI < 0.09 in either leg at rest (OR = 1.30 [1.02-1.75]). Following PSM, the combination of ischemic events (55-64 age category) was more likely to occur in the LTB compared with non-LTB group (4.38% and 0.68%, respectively [P = 0.046])., Conclusion: Presence of HF, previous MI and being male decreased the likelihood of LTB, while presence of diabetes, age > 65 and ABI < 0.09 increased the risk of LTB. Patients with LTB in age category 55-64 had higher incidence of vascular events compared with those with non-LTB., (© 2013 John Wiley & Sons Ltd.)

Aims: To describe aspirin use in primary and secondary prevention and to determine the incremental costs-effectiveness ratio (ICER) per life year gain (LYG) of aspirin use among subjects with, or at high risk of atherothrombotic disease., Design and Subjects: To project the cost-effectiveness of aspirin over 5 years of follow-up, a Markov state transition model was developed with yearly cycles and the following health states: "Alive" (post-CAD) and "Dead." The model compared current coverage observed among 2361 subjects using the prospective Australian subset of Reduction of Atherothrombosis for continued Health (REACH) registry, and hypothetical situation whereby all subjects assumed to be treated. Costs were calculated based on the Australian government reimbursed data for 2010., Main Outcome Measures: ICER per LYG for increased use of aspirin., Results: The use of aspirin in current group varied from 67% to 70%. The base-case analysis showed that increasing aspirin use among subjects with existing CAD in outpatient settings was cost saving, while increasing use of aspirin in primary prevention equated to an ICER of AUD 7126 per LYG., Conclusion: Among subjects with existing CAD aspirin use was shown to be a dominant choice of treatment. However, among patients without existing cardiovascular disease (primary prevention), increased uptake of aspirin was cost effective but with uncertain benefit, with two hemorrhagic bleeding events occurring for every life saved., (© 2011 Blackwell Publishing Ltd.)

Background and Purpose: Few practice-based studies have reported vascular outcome events among patients with cerebrovascular disease (CeVD). We describe 2-year vascular outcomes among symptomatic CeVD patients from the REduction of Atherothrombosis for Continued Health (REACH) Registry., Methods: Vascular events (stroke; myocardial infarction, MI; cardiovascular death, CV death; hospitalization) were studied among symptomatic CeVD patients from a prospective cohort of stable outpatients with established atherothrombosis or ≥3 atherothrombotic risk factors., Results: Of the 69,055 patients in REACH, 18,992 (28%) had symptomatic CeVD, of which outcome data were available for 18,189 patients. At 2 years, the frequency of non-fatal stroke was 5.93% (95% CI 5.22-6.64), non-fatal MI 2.21% (95% CI 1.65-2.76), CV death 4.45% (95% CI 3.66-5.22), combined vascular endpoint 11.48% (95% CI 10.46-12.49), and all deaths 7.39% (95% CI 6.34-8.42). The frequency of stroke, MI, CV death, or hospitalization for atherothrombotic events was 21.05% (95% CI 20.05-22.03). Event rates were lowest among patients with CeVD alone and highest among patients with CeVD, coronary artery disease, and peripheral artery disease. Other predictors of the primary outcome were increasing age, history of diabetes, current smoking, asymptomatic carotid stenosis, and carotid plaque. Outcomes were similar across geographical regions., Conclusions: Symptomatic CeVD patients encounter high vascular event rates despite treatment. Recurrent nonfatal stroke is more common than nonfatal MI., (Copyright © 2011 S. Karger AG, Basel.)