Cost-effectiveness of Contemporary Statin Use Guidelines With or Without Coronary Artery Calcium Assessment in African American Individuals.

Importance: Clinical and economic consequences of statin treatment guidelines supplemented by targeted coronary artery calcium (CAC) assessment have not been evaluated in African American individuals, who are at increased risk for atherosclerotic cardiovascular disease and less likely than non-African American individuals to receive statin therapy. Objective: To evaluate the cost-effectiveness of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guideline without a recommendation for CAC assessment vs the 2018 ACC/AHA guideline recommendation for use of a non-0 CAC score measured on one occasion to target generic-formulation, moderate-intensity statin treatment in African American individuals at risk for atherosclerotic cardiovascular disease. Design, Setting, and Participants: A microsimulation model was designed to estimate life expectancy, quality of life, costs, and health outcomes over a lifetime horizon. African American-specific data from 472 participants in the Jackson Heart Study (JHS) at intermediate risk for atherosclerotic cardiovascular disease and other US population-specific data on individuals from published sources were used. Data analysis was conducted from November 11, 2018, to November 1, 2019. Main Outcomes and Measures: Lifetime costs and quality-adjusted life-years (QALYs), discounted at 3% annually. Results: In a model-based economic evaluation informed in part by follow-up data, the analysis was focused on 472 individuals in the JHS at intermediate risk for atherosclerotic cardiovascular disease; mean (SD) age was 63 (6.7) years. The sample included 243 women (51.5%) and 229 men (48.5%). Of these, 178 of 304 participants (58.6%) who underwent CAC assessment had a non-0 CAC score. In the base-case scenario, implementation of 2013 ACC/AHA guidelines without CAC assessment provided a greater quality-adjusted life expectancy (0.0027 QALY) at a higher cost ($428.97) compared with the 2018 ACC/AHA guideline strategy with CAC assessment, yielding an incremental cost-effectiveness ratio of $158 325/QALY, which is considered to represent low-value care by the ACC/AHA definition. The 2018 ACC/AHA guideline strategy with CAC assessment provided greater quality-adjusted life expectancy at a lower cost compared with the 2013 ACC/AHA guidelines without CAC assessment when there was a strong patient preference to avoid use of daily medication therapy. In probability sensitivity analyses, the 2018 ACC/AHA guideline strategy with CAC assessment was cost-effective compared with the 2013 ACC/AHA guidelines without CAC assessment in 76% of simulations at a willingness-to-pay value of $100 000/QALY when there was a preference to lose 2 weeks of perfect health to avoid 1 decade of daily therapy. Conclusions and Relevance: A CAC assessment-guided strategy for statin therapy appears to be cost-effective compared with initiating statin therapy in all African American individuals at intermediate risk for atherosclerotic cardiovascular disease and may provide greater quality-adjusted life expectancy at a lower cost than a non-CAC assessment-guided strategy when there is a strong patient preference to avoid the need for daily medication. Coronary artery calcium testing may play a role in shared decision-making regarding statin use.

Effects and costs of real-time cardiac telerehabilitation: randomised controlled non-inferiority trial.

OBJECTIVE: Compare the effects and costs of remotely monitored exercise-based cardiac telerehabilitation (REMOTE-CR) with centre-based programmes (CBexCR) in adults with coronary heart disease (CHD). METHODS: Participants were randomised to receive 12 weeks of telerehabilitation or centre-based rehabilitation. REMOTE-CR provided individualised exercise prescription, real-time exercise monitoring/coaching and theory-based behavioural strategies via a bespoke telerehabilitation platform; CBexCR provided individualised exercise prescription and coaching via established rehabilitation clinics. Outcomes assessed at baseline, 12 and/or 24 weeks included maximal oxygen uptake (V̇O2max, primary) modifiable cardiovascular risk factors, exercise adherence, motivation, health-related quality of life and programme delivery, hospital service utilisation and medication costs. The primary hypothesis was a non-inferior between-group difference in V̇O2max at 12 weeks (inferiority margin=-1.25 mL/kg/min); inferiority margins were not set for secondary outcomes. RESULTS: 162 participants (mean 61±12.7 years, 86% men) were randomised. V̇O2 max was comparable in both groups at 12 weeks and REMOTE-CR was non-inferior to CBexCR (REMOTE-CR-CBexCR adjusted mean difference (AMD)=0.51 (95% CI -0.97 to 1.98) mL/kg/min, p=0.48). REMOTE-CR participants were less sedentary at 24 weeks (AMD=-61.5 (95% CI -117.8 to -5.3) min/day, p=0.03), while CBexCR participants had smaller waist (AMD=1.71 (95% CI 0.09 to 3.34) cm, p=0.04) and hip circumferences (AMD=1.16 (95% CI 0.06 to 2.27) cm, p=0.04) at 12 weeks. No other between-group differences were detected. Per capita programme delivery (NZD1130/GBP573 vs NZD3466/GBP1758) and medication costs (NZD331/GBP168 vs NZD605/GBP307, p=0.02) were lower for REMOTE-CR. Hospital service utilisation costs were not statistically significantly different (NZD3459/GBP1754 vs NZD5464/GBP2771, p=0.20). CONCLUSION: REMOTE-CR is an effective, cost-efficient alternative delivery model that could-as a complement to existing services-improve overall utilisation rates by increasing reach and satisfying unique participant preferences.

An alternative approach identified optimal risk thresholds for treatment indication: an illustration in coronary heart disease.

OBJECTIVES: Treatment thresholds based on risk predictions can be optimized by considering various health (economic) outcomes and performing marginal analyses, but this is rarely performed. We demonstrate a general approach to identify treatment thresholds optimizing individual health (economic) outcomes, illustrated for statin treatment based on 10-year coronary heart disease (CHD) risk predicted by the Framingham risk score. STUDY DESIGN AND SETTING: Creating a health economic model for a risk-based prevention strategy, risk thresholds can be evaluated on several outcomes of interest. Selecting an appropriate threshold range and decrement size for the thresholds and adapting the health economic model accordingly, outcomes can be calculated for each risk threshold. A stepwise, or marginal, comparison of clinical as well as health economic outcomes, that is, comparing outcomes using a specific threshold to outcomes of the former threshold while gradually lowering the threshold, then takes into account the balance between additional numbers of individuals treated and their outcomes (additional health effects and costs). In our illustration, using a Markov model for CHD, we evaluated risk thresholds by gradually lowering thresholds from 20% to 0%. RESULTS: This approach can be applied to identify optimal risk thresholds on any outcome, such as to limit complications, maximize health outcomes, or optimize cost-effectiveness. In our illustration, keeping the population-level fraction of statin-induced complications <10% resulted in thresholds of T = 6% (men) and T = 2% (women). Lowering the threshold and comparing quality-adjusted life-years (QALYs) after each 1% decrease, QALYs were gained down to T = 1% (men) and T = 0% (women). Also accounting for costs, net health benefits were favorable down to T = 3% (men) and T = 6% (women). CONCLUSION: Using a stepwise risk-based approach to threshold optimization allows for preventive strategies that optimize outcomes. Presenting this comprehensive overview of outcomes will better inform decision makers when defining a treatment threshold.

[A pilot study to evaluate the DMP for coronary heart disease - Development of a methodology and first results]. / Pilotstudie zur Evaluation des DMP Koronare Herzkrankheit - Entwicklung einer Methodik und erste Ergebnisse.

Regarding the effectiveness of disease management programs (DMPs) in Germany, several studies have been published on the DMP for type 2 diabetes. This pilot study provides methodological insights into evaluating the DMP for coronary heart disease (CHD), which currently includes 1.7 million participants, and reveals trends in healthcare outcomes for mortality, guideline adherent prescribing and costs. Major methodological challenges that need to be considered for the development of an appropriate matching method for this indication have been identified. The results show positive trends in favor of the DMP regarding mortality, costs and medication according to guidelines. A matching design is applicable to the CHD indication; the knowledge gained regarding the quality of care can be used for a targeted development of the program.

From Science to Finance-A Tool for Deriving Economic Implications from the Results of Dietary Supplement Clinical Studies.

This article examines evidence showing that the use of key dietary supplements can reduce overall disease treatment-related hospital utilization costs associated with coronary heart disease (CHD) in the United States among those at a high risk of experiencing a costly, disease-related event. Results show that the potential avoided hospital utilization costs related to the use of omega-3 supplements at preventive intake levels among the target population can be as much as $2.06 billion on average per year from 2013 to 2020. The potential net savings in avoided CHD-related hospital utilization costs after accounting for the cost of omega-3 dietary supplements at preventive daily intake levels would be more than $3.88 billion in cumulative health care cost savings from 2013 to 2020. Furthermore, the use of folic acid, B6, and B12 among the target population at preventive intake levels could yield avoided CHD-related hospital utilization costs savings of an average savings of $1.52 billion per year from 2013 to 2020. The potential net savings in avoided CHD-related health care costs after accounting for the cost of folic acid, B6, and B12 utilization at preventive daily intake levels would be more than $5.23 billion in cumulative health care cost net savings during the same period. Thus, targeted dietary supplement regimens are recommended as a means to help control rising societal health care costs, and as a means for high-risk individuals to minimize the chance of having to deal with potentially costly events and to invest in increased quality of life.

Clinical and economic outcomes of liberal versus selective drug-eluting stent use: insights from temporal analysis of the multicenter Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry.

BACKGROUND: Although the benefits of drug-eluting stents (DES) for reducing restenosis after percutaneous coronary intervention are well established, the impact of alternative rates of DES use on population-level outcomes is unknown. METHODS AND RESULTS: We used data from the Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry to examine the clinical impact and cost-effectiveness of varying DES use rates in routine care. Between 2004 and 2007, 10,144 patients undergoing percutaneous coronary intervention were enrolled in the EVENT registry at 55 US centers. Clinical outcomes and cardiovascular-specific costs were assessed prospectively over 1 year of follow-up. Use of DES decreased from 92 in 2004 to 2006 (liberal use era; n=7587) to 68 in 2007 (selective use era; n=2557; P<0.001). One-year rates of death or myocardial infarction were similar in both eras. Over this time period, the incidence of target lesion revascularization increased from 4.1 to 5.1, an absolute increase of 1.0 (95 confidence interval, 0.1 to 1.9; P=0.03), whereas total cardiovascular costs per patient decreased by $401 (95 confidence interval, 131 to 671; P=0.004). The risk-adjusted incremental cost-effectiveness ratio for the liberal versus selective DES era was $16,000 per target lesion revascularization event avoided, $27,000 per repeat revascularization avoided, and $433 000 per quality-adjusted life-year gained. CONCLUSIONS: In this prospective registry, a temporal reduction in DES use was associated with a small increase in target lesion revascularization and a modest reduction in total cardiovascular costs. These findings suggest that although clinical outcomes are marginally better with unrestricted DES use, this approach represents a relatively inefficient use of healthcare resources relative to several common benchmarks for cost-effective care.

[Analysis of Brazilian Public Health System values for complete percutaneous myocardial revascularization in multi-arterial patients]. / Análise dos valores SUS para a revascularização miocárdica percutânea completa em multiarteriais.

BACKGROUND: The Brazilian Public Health System (SUS, acronym in Portuguese) establishes that coronary angioplasty with the double implant stent must not exceed 20% of the angioplasties, resulting in the need of assigning most of the procedures in patients with multiarterial disease. OBJECTIVE: The objective of the present study was to assess the paid values by the SUS in order to obtain the complete percutaneous myocardial revascularization in the SUS patients with the multiarterial disease, related to the number of necessary procedures and of implanted stents. METHODS: A total of 141 patients with multiarterial coronary disease, submitted to a successful complete revascularization, were included by the stent implant with coronariography in a 6-month period of post-implant. The complete revascularization was defined as the percutaneous treatment of all stenosis > 70% in vessels with diameter > 2 mm. For the costs analysis, the values from the Sistema de Informações Hospitalares (SIH) of the SUS table were considered as R$ 2,263.77, for the procedure; and R$ 2,034.23, per implanted stent. RESULTS: In the period from 7/2006 to 12/2007, 416 stents were implanted in 141 patients. The mean age was of 59.7 +/- 9.9 years old, prevailing the male sex (68.1%). The number of vessels was 356 and the lesions number corresponded to 416. In order to obtain the complete revascularization by the coronary stent implant, it was necessary to stagger in up to four procedures. The mean time between the 1st and 2nd, 2nd and 3rd and 3rd and 4th angioplasties was of 45.8 +/- 37.7; 55.4 +/- 55.3 and 33.5 +/- 19.1 days, respectively. CONCLUSION: The complete percutaneous revascularization in patients from the SUS with the multiarterial coronary disease, carried out in most of them staggered, causes considerable elevation of public expenses due to the increase of procedures' number.

Análise dos valores SUS para a revascularização miocárdica percutânea completa em multiarteriais / Analysis of Brazilian Public Health System values for complete percutaneous myocardial revascularization in multi-arterial patients

FUNDAMENTO: O Sistema Único de Saúde (SUS) estabelece que a angioplastia coronariana com o implante de duplo stent não deve exceder 20 por cento das angioplastias, resultando na necessidade de escalonar a maioria dos procedimentos nos pacientes com doença multiarterial. OBJETIVO: O objetivo do presente estudo foi avaliar os valores remunerados pelo SUS para a obtenção da revascularização miocárdica percutânea completa em pacientes do SUS com doença multiarterial relacionados ao número de procedimentos necessários e de stents implantados. MÉTODOS: Foram incluídos 141 pacientes com doença coronariana multiarterial, submetidos à revascularização completa com sucesso pelo implante de stent, com coronariografia aos 6 meses pós-implante. A revascularização completa foi definida como o tratamento percutâneo de todas as lesões com percentual de estenose > 70 por cento, em vasos com diâmetro > 2 mm. Para análise dos custos, foram considerados os valores da Tabela SIH/SUS de R$ 2.263,77 para o procedimento e R$ 2.034,23 por stent implantado. RESULTADOS: No período de 07/2006 a 12/2007 foram implantados 416 stents em 141 pacientes. A idade média foi de 59,7 ± 9,9 anos, com predomínio do sexo masculino (68,1 por cento). O número de vasos foi 356 e o número de lesões 416. Para a obtenção da revascularização completa pelo implante de stent coronáriano foi necessário o escalonamento em até 4 procedimentos. O tempo médio entre a 1ª e 2ª, 2ª e 3ª e 3ª e 4ª angioplastias foi de 45,8 ± 37,7, 55,4 ± 55,3 e 33,5 ± 19,1 dias, respectivamente. CONCLUSÃO: A revascularização percutânea completa em pacientes do SUS com doença coronariana multiarterial, realizada em sua grande maioria de forma escalonada, ocasiona considerável elevação de gastos públicos devido ao aumento do número de procedimentos.

BACKGROUND: The Brazilian Public Health System (SUS, acronym in Portuguese) establishes that coronary angioplasty with the double implant stent must not exceed 20 percent of the angioplasties, resulting in the need of assigning most of the procedures in patients with multiarterial disease. OBJECTIVE: The objective of the present study was to assess the paid values by the SUS in order to obtain the complete percutaneous myocardial revascularization in the SUS patients with the multiarterial disease, related to the number of necessary procedures and of implanted stents. METHODS: A total of 141 patients with multiarterial coronary disease, submitted to a successful complete revascularization, were included by the stent implant with coronariography in a 6-month period of post-implant. The complete revascularization was defined as the percutaneous treatment of all stenosis > 70 percent in vessels with diameter > 2 mm. For the costs analysis, the values from the Sistema de Informações Hospitalares (SIH) of the SUS table were considered as R$ 2,263.77, for the procedure; and R$ 2,034.23, per implanted stent. RESULTS: In the period from 7/2006 to 12/2007, 416 stents were implanted in 141 patients. The mean age was of 59.7 ± 9.9 years old, prevailing the male sex (68.1 percent). The number of vessels was 356 and the lesions number corresponded to 416. In order to obtain the complete revascularization by the coronary stent implant, it was necessary to stagger in up to four procedures. The mean time between the 1st and 2nd, 2nd and 3rd and 3rd and 4th angioplasties was of 45.8 ± 37.7; 55.4 ± 55.3 and 33.5 ± 19.1 days, respectively. CONCLUSION: The complete percutaneous revascularization in patients from the SUS with the multiarterial coronary disease, carried out in most of them staggered, causes considerable elevation of public expenses due to the increase of procedures' number.

Patients' views on the UK policy of prescription charges-Insights from qualitative interviews.

BACKGROUND: Some UK evidence exists, which suggests that the cost of prescription charges can pose a barrier to accessing medication. However, little evidence exists on patients' more general views on the policy of prescription charges. OBJECTIVES: The aim of this study was to explore the views of nonexempt patients, suffering from chronic conditions requiring regular medication, on the UK policy of prescription charges and how this could be improved. METHODS: Patients aged between 18 and 59 years (ie, potentially paying charges) were approached through 6 General Practices in Northwest England. Thirty asthma, 8 coronary heart disease, and 23 hypertension patients were interviewed in depth. RESULTS: Numerous interviewees were appreciative of the National Health Service, recognized its cost pressures and accepted paying toward medication in principle. A few though disagreed with charges on top of national insurance contributions. Many felt the level of the charge was too high. To protect population groups potentially vulnerable to issues of affordability, interviewees suggested that 2 principles should underpin any prescription charges policy: People on low incomes and essential medication treating chronic conditions should be exempt or subsidized. There was extensive discussion on the current grounds for medical exemption, which many viewed as not meeting these principles well or fairly, as well as the grounds for age-related exemptions. CONCLUSIONS: This study has highlighted a number of principles and options that should be considered by the UK Governments when reviewing the prescription charges policy. It puts these in context of the ongoing public consultations commissioned by UK Governments.

Cardiac rehabilitation coordinators' perceptions of patient-related barriers to implementing cardiac evidence-based guidelines.

BACKGROUND: Coronary heart disease remains the leading cardiovascular cause of mortality and morbidity globally. Implementing evidence-based guidelines after a coronary event is vital to prevent recurrence of an acute episode. However, various barriers to guideline implementation have been identified. OBJECTIVE: This article presents the perspective of cardiac rehabilitation (CR) coordinators regarding patient-related barriers to implementing the evidence-based guidelines after an acute cardiac event. METHODS: Twenty CR coordinators from 4 geographic regions of New South Wales, Australia, participated in the study. A semistructured interview using open-ended questions was used to obtain the CR coordinator's perspectives of the patient-related barriers to guideline implementation. Interviews were transcribed, and content analysis was undertaken. FINDINGS: The most frequently identified patient-related barriers were (a) coming to terms with a diagnosis of heart disease, (b) challenges in changing behavior, (c) having heart disease is costly, and (d) other personal barriers. CONCLUSIONS: Despite CR coordinators having positive attitudes toward implementing evidence-based guidelines, several patient-related barriers were identified that obstructed the implementation process. The findings have important implications for nursing practice in terms of directing efforts at increasing participation in CR and engaging commitment of the patient to behavior change. Changes to health service policies that address identified barriers could further facilitate the provision of evidence-based care to patients with coronary heart disease.

Atorvastatin: a pharmacoeconomic review of its use in the primary and secondary prevention of cardiovascular events.

Atorvastatin is a lipid-lowering agent that has been evaluated in a number of primary and secondary intervention studies. In the primary prevention trials ASCOT-LLA and CARDS, atorvastatin 10 mg/day significantly reduced cardiovascular events compared with placebo. A prospectively conducted economic analysis of the 3.3-year ASCOT-LLA trial showed that atorvastatin was associated with incremental cost-effectiveness ratios (ICERs) of euro11,693 (UK) and euro12,673 (Sweden) per event avoided (2002 values). Longer-term modelled analyses using data from CARDS showed ICERs of euro8046 (Spain) and 6471pound (UK) per QALY gained (2003/2004 values), and a US analysis showed atorvastatin was dominant versus no statin when modelled over the lifetime of a representative US diabetic primary prevention population. In a modelled analysis based on results of the IDEAL trial, which showed significant reductions in cardiovascular endpoints with high-dose atorvastatin (80 mg/day) compared with conventional-dose simvastatin in patients with stable coronary heart disease, ICER values were below the commonly used cost-effectiveness threshold of euro50,000 per QALY gained in Norway, Sweden and Denmark, but were above this threshold in Finland (2005 values). A modelled US analysis that also included data from IDEAL and other sources showed an ICER of $US33,400 per QALY gained, assuming the incremental difference in acquisition cost between high-dose atorvastatin and conventional-dose simvastatin was $US1.40/day (2005 value). Most cost-effectiveness analyses with atorvastatin in patients with acute coronary syndrome used data from the 16-week MIRACL study, which showed a significant reduction in cardiovascular events with high-dose atorvastatin compared with placebo. Analyses were conducted in North America and Europe and showed that 31-86% of the acquisition cost of high-dose atorvastatin was offset by reductions in costs associated with cardiovascular events. Across five countries, ICER values ranged from approximate $US850 to $US4100 per event avoided (2000/2001 values). Another analysis conducted in the US used longer-term data and showed that high-dose atorvastatin versus conventional-dose statin was associated with an ICER of $US12,900 per QALY gained, assuming the daily difference in acquisition cost was $US1.40 (2005 value). In conclusion, atorvastatin has demonstrated beneficial effects on various cardiovascular endpoints in large, well designed primary and secondary intervention trials. These benefits in moderate- to high-risk patients were achieved at a relatively low incremental cost and, across the economic analyses, a substantial proportion of atorvastatin acquisition costs was offset by reductions in healthcare resource use associated with cardiovascular events. Cost-effectiveness analyses based on major clinical trials comparing atorvastatin with placebo, usual medical care, simvastatin or pravastatin have generally shown that atorvastatin is associated with favourable ICER values, often well below commonly used cost-effectiveness thresholds. These modelled analyses have the inherent limitation that projecting long-term outcomes beyond the time period of a clinical trial imparts a degree of uncertainty to the results. Nevertheless, while some findings were sensitive to changes in model assumptions, such as the long-term benefits of statin therapy, most sensitivity analyses showed that results of the base-case analyses were robust to plausible changes in key parameters. Although a clear pattern is not evident from available data, intuitively, the value of atorvastatin would be expected to increase with the patient's risk for serious cardiovascular events.

Nifedipine Gastrointestinal Therapeutic System (GITS) in the treatment of coronary heart disease and hypertension.

Since the 1960s, calcium antagonists have been available for the treatment of angina pectoris and hypertension. The first of this class, nifedipine, was introduced and readily accepted as the third treatment option for angina, alongside beta-blockers and nitrates. However, the short-acting formulations of nifedipine had pharmacokinetic properties that were far from ideal and in 1995, several studies involving various dosing regimens reported possible dangerous effects in secondary prevention. Since then, large-scale, randomized controlled trials with new controlled-released formulations of nifedipine have demonstrated the effectiveness and safety of this drug. As a consequence of these results, guidelines for both hypertension and angina pectoris have been recently reconsidered, and have put the modern formulations of calcium channel blockers in a pole position. Within this group of therapeutics, nifedipine gastrointestinal therapeutic system has a unique position and it cannot be replaced by other controlled-release formulations of nifedipine, the pharmaceutical properties of which have yet to be tested in large-scale outcome trials.

Plant stanol esters are potentially cost-effective in the prevention of coronary heart disease in men: Bayesian modelling approach.

BACKGROUND: Plant stanol esters in spreads have demonstrated efficacy in reducing serum cholesterol. The cost-effectiveness of plant stanol esters in the prevention of coronary heart disease, however, has remained unevaluated. DESIGN: A Bayesian modelling approach was applied to synthesize clinical evidence and evaluate the cost-effectiveness (Euro/quality-adjusted life years) of plant stanol esters in spread in the prevention of coronary heart disease based on published FINRISK and 4S risk functions. RESULTS: The regular use of plant stanol esters reduced total serum cholesterol by -0.362 mmol/l [95% credibility interval (CrI) -0.31 to -0.41]. The corresponding placebo-adjusted reduction attributable to stanol esters when combined with statin was -0.385 mmol/l (95% CrI -0.18 to -0.61). The cost-effectiveness estimations were assessed for men and women separately at four different initial ages at which the regular use of stanol esters was assumed to be started. The base case cost per quality-adjusted life years gained by using stanol esters regularly ranged from 7436 to 20,999 Euro in men and from 34,327 to 112,151 Euro in women based on the initial starting age. According to uncertainty analysis, there is over a 90% probability that the use of plant stanol esters is cost-effective for men inclusively and for 60-year-old and older women assuming that decision-makers' maximum willingness to pay per quality-adjusted life year is 50,000 Euro. CONCLUSIONS: A recommendation that plant stanol ester-containing spreads be used as a part of daily diet replacing regular spread could be viewed as potentially cost-effective public health policy in the prevention of CHD in all adult men and in older age-groups of women with total serum cholesterol levels of 5 mmol/l or greater.

Economic analysis of treatments reducing coronary heart disease mortality in England and Wales, 2000-2010.

BACKGROUND: Coronary heart disease (CHD) in the UK affects approximately 3 million people, with >100,000 deaths annually. Mortality rates have halved since the 1980s, but annual NHS treatment costs for CHD exceed 2 billion pounds. AIM: To examine the cost-effectiveness of specific CHD treatments in England and Wales. METHODS: The IMPACT CHD model was used to calculate the number of life-years gained (LYG) from specific cardiological interventions from 2000 to 2010. Cost-effectiveness ratios (costs per LYG) were generated for each specific intervention, stratified by age and sex. The robustness of the results was tested using sensitivity analyses. RESULTS: In 2000, medical and surgical treatments together prevented or postponed approximately 25,888 deaths in CHD patients aged 25-84 years, thus generating approximately 194,929 extra life-years between 2000 and 2010 (range 143,131-260,167). Aspirin and beta-blockers for secondary prevention following myocardial infarction or revascularisation, for angina and heart failure were highly cost-effective (< 1000 pounds per LYG). Other secondary prevention therapies, including cardiac rehabilitation, ACE inhibitors and statins, were reasonably cost-effective (1957 pounds, 3398 pounds and 4246 pounds per LYG, respectively), as were CABG surgery (3239 pounds-4601 pounds per LYG) and angioplasty (3845 pounds-5889 pounds per LYG). Primary angioplasty for myocardial infarction was intermediate (6054 pounds-12,057 pounds per LYG, according to age), and statins in primary prevention were much less cost-effective (27,828 pounds per LYG, reaching 69,373 pounds per LYG in men aged 35-44). Results were relatively consistent across a wide range of sensitivity analyses. DISCUSSION: The cost-effectiveness ratios for standard CHD treatments varied by over 100-fold. Large amounts of NHS funding are being spent on relatively less cost-effective interventions, such as statins for primary prevention, angioplasty and CABG surgery. This merits debate.

[Attempt to exclude invasive cardiology services in Poland--rationing, national sovereignty and European Union law]. / Próba wylaczenia swiadczen kardiologii inwazyjnej z finansowaniaze srodków publicznych--racjonowanie w swietle suwerennosci panstwowej i prawa Europejskiego.

One of the guiding principles of health policy in many European countries is equitable access to health care services. One of the life saving procedures is percutaneous transluminal coronary angioplasty (PTCA) performed after coronary angiography. Introducing payment for these procedures would limit access for low-income patients. Fortunately, despite political debate, invasive cardiology develops well in Poland. It is important to notice that within the European Union Polish citizens would be able to receive this treatment in other member states and, according to a European Court of Justice ruling, the costs would have to be reimbursed by the National Health Fund. The wider implication is that the 10 new EU member states now have to realise that health care is no longer a matter of national sovereignty - a fact legislators and health care managers in the 15 member states of the pre-accession EU are still struggling with.

Cost effectiveness of paclitaxel-eluting stents for patients undergoing percutaneous coronary revascularization: results from the TAXUS-IV Trial.

OBJECTIVES: This study sought to compare aggregate medical care costs for patients undergoing percutaneous coronary intervention with paclitaxel-eluting stents (PES) and bare-metal stents (BMS) and to formally evaluate the incremental cost effectiveness of PES for patients undergoing single-vessel percutaneous coronary intervention. BACKGROUND: Although the cost effectiveness of SES has been studied in both clinical trials and decision-analytic models, few data exist on the cost effectiveness of alternative drug-eluting stent (DES) designs. In addition, no clinical trials have specifically examined the cost effectiveness of DES among patients managed without mandatory angiographic follow-up. METHODS: We performed a prospective economic evaluation among 1,314 patients undergoing percutaneous coronary revascularization randomized to either PES (N = 662) or BMS (N = 652) in the TAXUS-IV trial. Clinical outcomes, resource use, and costs (from a societal perspective) were assessed prospectively for all patients over a 1-year follow-up period. Cost effectiveness was defined as the incremental cost per target vessel revascularization (TVR) event avoided and was analyzed separately among cohorts assigned to mandatory angiographic follow-up (n = 732) or clinical follow-up alone (n = 582). RESULTS: The PES reduced TVR by 12.2 events per 100 patients treated, resulting in a 1-year cost difference of 572 dollars per patient with incremental cost-effectiveness ratios of 4,678 dollars per TVR avoided and 47,798 dollars/quality-adjusted life year (QALY) gained. Among patients assigned to clinical follow-up alone, the net 1-year cost difference was 97 dollars per patient with cost-effectiveness ratios of 760 dollars per TVR event avoided and $5,105/QALY gained. CONCLUSIONS: In the TAXUS-IV trial, treatment with PES led to substantial reductions in the need for repeat revascularization while increasing 1-year costs only modestly. The cost-effectiveness ratio for PES in the study population compares reasonably with that for other treatments that reduce coronary restenosis, including alternative drug-eluting stent platforms.

Clopidogrel used in combination with aspirin compared with aspirin alone in the treatment of non-ST-segment-elevation acute coronary syndromes: a systematic review and economic evaluation.

OBJECTIVES: To review systematically the clinical effectiveness and the cost-effectiveness of clopidogrel used in combination with standard therapy including aspirin, compared with standard therapy alone for the treatment of non-ST-segment elevation acute coronary syndromes (ACS). DATA SOURCES: Electronic databases. Manufacturers' submissions. REVIEW METHODS: Studies were selected using rigorous criteria. The quality of randomised controlled trials (RCTs) was assessed according to criteria based on NHS CRD Report No. 4, and the quality of systematic reviews was assessed according to the guidelines for the Database of Reviews of Effect (DARE) criteria. The quality of economic evaluations was assessed according to a specifically tailored checklist. The clinical effectiveness and cost-effectiveness of clopidogrel in combination with standard therapy compared with standard therapy alone were synthesised through a narrative review with full tabulation of the results of the included studies. In the economic evaluations, a cost-effectiveness model was constructed using the best available evidence to determine cost-effectiveness in a UK setting. RESULTS: One RCT (the CURE trial) was a randomised, double-blind, placebo-controlled trial of high quality and showed that clopidogrel in addition to aspirin was significantly more effective than placebo plus aspirin in patients with non-ST-segment elevation ACS for the composite outcome of death from cardiovascular causes, non-fatal myocardial infarction or stroke over the 9-month treatment period. However, clopidogrel was associated with a significantly higher number of episodes of both major and minor bleeding. The results from the five systematic reviews that assessed the adverse events associated with long-term aspirin use showed that aspirin was associated with a significantly higher incidence of haemorrhagic stroke, extracranial haemorrhage and gastrointestinal haemorrhage compared with placebo. Of the cost-effectiveness evidence reviewed, only the manufacturer's submission was considered relevant from the perspective of the NHS. The review of this evidence highlighted potential limitations within the submission in its use of data and in the model structure used. These limitations led to the development of a new model with the aim of providing a more reliable estimate of the cost-effectiveness from the perspective of the UK NHS. This model indicated that clopidogrel appears cost-effective compared with standard care alone in patients with non-ST-elevation ACS as long as the NHS is willing to pay GBP6078 per quality of life year (QALY). The results were most sensitive to the inclusion of additional strategies that assessed alternative treatment durations with clopidogrel. Although treatment with clopidogrel for 12 months remained cost-effective for the overall cohort, provisional findings indicate that the shorter treatment durations may be more cost-effective in patients at low risk. CONCLUSIONS: The results of the CURE trial indicate that clopidogrel in combination with aspirin was significantly more effective than placebo combined with aspirin in a wide range of patients with ACS. This benefit was largely related to a reduction in Q-wave myocardial infarction. There was no statistically significant benefit in relation to mortality. The trial data suggested that a substantial part of the benefit derived from clopidogrel is achieved by 3 months, with a further small benefit over the remaining 9 months of chronic treatment. The results from the base-case model suggest that treatment with clopidogrel as an adjunct to standard therapy (including aspirin) for 12 months, compared with standard therapy alone, is cost-effective in non-ST elevation ACS patients as long as the health service is willing to pay GBP6078 per additional QALY. However, although treatment with clopidogrel for 12 months remained cost-effective for the overall cohort, provisional findings indicate that the shorter treatment durations may be more cost-effective in patients at low risk. To estimate the exact length of time that clopidogrel in addition to standard therapy should be prescribed for patients with non-ST-segment ACS would require a prospective trial that randomised patients to various durations of therapy. This would accurately assess whether a 'rebound' phenomenon occurs in patients if clopidogrel were stopped after 3 months of treatment.

[Economic evaluation of off-pump coronary artery bypass grafting; compared to conventional coronary artery bypass grafting].

This study was undertaken to compare economic outcomes of off-pump coronary artery bypass grafting (off-pump CABG: OPCAB) and conventional CABG (CCABG). We reviewed the medical records of 5 patients with ischemic coronary disease (IHD) who underwent OPCAB and 5 patients with IHD who underwent CCABG. A hospital income which was based on a current Japanese health insurance system was indicated. There were significant differences in total cost (OPCAB = 208,200 +/- 7,383 yen versus CCABG = 324,300 +/- 10,290 yen, 35.8% decreased), costs of medical materials and transfusions (OPCAB = 14,760 +/- 3,270 yen versus CCABG = 87,540 +/- 3,326, 81.3% decreased) and charges of surgery and anesthesia (OPCAB = 130,400 +/- 1,853 yen versus CCABG = 147,650 +/- 4,167 yen, 12% decreased) OPCAB markedly reduces the cost of hospitalization. But charges of surgery and anesthesia of OPCAB seems to be valued properly in a current Japanese health insurance system.

Burden of coronary heart disease on the Iranian oil industry (1999-2000).

To estimate the direct cost of coronary heart disease (CHD) to the Iranian oil industry, we calculated the cost of essential services for 1253 CHD patients admitted to the National Iranian Oil Corporation (NIOC) Central Hospital. The direct cost of CHD at the Hospital was 10940 million rials (US$ 1 = 8000 rials), or 8.7 million rials per patient. The direct cost of CHD to the Iranian oil industry was estimated at 22 770 million rials. Working days lost to workers hospitalized for CHD amounted to 62 832. The heavy burden of CHD on the Iranian oil industry necessitates the introduction of an industry-wide prevention programme.