Clinical and Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients With Coronary Artery Disease and/or Peripheral Artery Disease.

To address literature gaps on treatment with real-world evidence, this study compared effectiveness, safety, and cost outcomes in NVAF patients with coronary or peripheral artery disease (CAD, PAD) prescribed apixaban versus other oral anticoagulants. NVAF patients aged ≥65 years co-diagnosed with CAD/PAD initiating warfarin, apixaban, dabigatran, or rivaroxaban were selected from the US Medicare population (January 1, 2013 to September 30, 2015). Propensity score matching was used to match apixaban versus warfarin, dabigatran, and rivaroxaban cohorts. Cox models were used to evaluate the risk of stroke/systemic embolism (SE), major bleeding (MB), all-cause mortality, and a composite of stroke/myocardial infarction/all-cause mortality. Generalized linear and two-part models were used to compare stroke/SE, MB, and all-cause costs between cohorts. A total of 33,269 warfarin-apixaban, 9,335 dabigatran-apixaban, and 33,633 rivaroxaban-apixaban pairs were identified after matching. Compared with apixaban, stroke/SE risk was higher in warfarin (hazard ratio [HR]: 1.93; 95% confidence interval [CI]: 1.61 to 2.31), dabigatran (HR: 1.69; 95% CI: 1.18 to 2.43), and rivaroxaban (HR: 1.24; 95% CI: 1.01 to 1.51) patients. MB risk was higher in warfarin (HR: 1.67; 95% CI: 1.52 to 1.83), dabigatran (HR: 1.37; 95% CI: 1.13 to 1.68), and rivaroxaban (HR: 1.87; 95% CI: 1.71 to 2.05) patients vs apixaban. Stroke/SE- and MB-related medical costs per-patient per-month were higher in warfarin, dabigatran, and rivaroxaban patients versus apixaban. Total all-cause health care costs were higher in warfarin and rivaroxaban patients compared with apixaban patients. In conclusion, compared with apixaban, patients on dabigatran, rivaroxaban, or warfarin had a higher risk of stroke/SE, MB, and event-related costs.

Real-world cost-effectiveness of rivaroxaban compared with vitamin K antagonists in the context of stroke prevention in atrial fibrillation in France.

OBJECTIVE: The objective was to assess the real-world cost-effectiveness of rivaroxaban, versus vitamin K antagonists (VKAs), for stroke prevention in patients with atrial fibrillation (AF) from a French national health insurance perspective. METHODS: A Markov model was developed with a lifetime horizon and cycle length of 3 months. All inputs were drawn from real-world evidence (RWE) studies: data on baseline patient characteristics at model entry were obtained from a French RWE study, clinical event rates as well as persistence rates for the VKA treatment arm were estimated from a variety of RWE studies, and a meta-analysis provided comparative effectiveness for rivaroxaban compared to VKA. Model outcomes included costs (drug costs, clinical event costs, and VKA monitoring costs), quality-adjusted life-years (QALY) and life-years (LY) gained, incremental cost per QALY, and incremental cost per LY. Sensitivity analyses were performed to test the robustness of the model and to better understand the results drivers. RESULTS: In the base-case analysis, the incremental total cost was €714 and the total incremental QALYs and LYs were 0.12 and 0.16, respectively. The resulting incremental cost/QALY and incremental cost/LY were €6,006 and €4,586, respectively. The results were more sensitive to the inclusion of treatment-specific utility decrements and clinical event rates. CONCLUSIONS: Although there is no official willingness-to-pay threshold in France, these results suggest that rivaroxaban is likely to be cost-effective compared to VKA in French patients with AF from a national insurance perspective.

Evidence on the magnitude of the economic, health and population effects of palm cooking oil consumption: an integrated modelling approach with Thailand as a case study.

BACKGROUND: Palm oil's high yields, consequent low cost and highly versatile properties as a cooking oil and food ingredient have resulted in its thorough infiltration of the food sector in some countries. Longitudinal studies have associated palm oil's high saturated fatty acid content with non-communicable disease, but neither the economic or disease burdens have been assessed previously. METHODS: This novel palm oil-focussed disease burden assessment employs a fully integrated health, macroeconomic and demographic Computable General Equilibrium Model for Thailand with nine regional (urban/rural) households. Nutritional changes from food consumption are endogenously translated into health (myocardial infarction (MI) and stroke) and population outcomes and are fed back into the macroeconomic model as health and caregiver-related productive labour supply effects and healthcare costs to generate holistic 2016-2035 burden estimates. Model scenarios mirror the replacement of palm cooking oil with other dietary oils and are compared with simulated total Thai health and macroeconomic burdens for MI and stroke. RESULTS: Replacing consumption of palm cooking oil with other dietary oils could reduce MI/stroke incident cases by 8280/2639 and cumulative deaths by 4683/894 over 20 years, removing approximately 0.5% of the total Thai burden of MI/stroke. This palm cooking oil replacement would reduce consumption shares of saturated/monounsaturated fatty acids in Thai household consumption by 6.5%/3% and increase polyunsaturated fatty acid consumption shares by 14%, yielding a 1.74% decrease in the population-wide total-to-HDL cholesterol ratio after 20 years. The macroeconomic burden that would be removed is US$308mn, approximately 0.44% of the total burden of MI/stroke on Thailand's economy or 0.003% of cumulative 20-year GDP. Bangkok and Central region households benefit most from removal of disease burdens. CONCLUSIONS: Simulations indicate that consumption of palm cooking oil, rather than other dietary oils, imposes a negative health burden (MI and stroke) and associated economic burden on a high consuming country, such as Thailand. Integrated sectoral model frameworks to assess these burdens are possible, and burden estimates from our simulated direct replacement of palm cooking oil indicate that using these frameworks both for broader analyses of dietary palm oil use and total burden analyses of other diseases may also be beneficial.

Effectiveness and cost-effectiveness of a Yoga-based Cardiac Rehabilitation (Yoga-CaRe) program following acute myocardial infarction: Study rationale and design of a multi-center randomized controlled trial.

BACKGROUND: Cardiac rehabilitation (CR) is a standard treatment for secondary prevention of acute myocardial infarction (AMI) in high income countries (HICs), but it is inaccessible to most patients in India due to high costs and skills required for multidisciplinary CR teams. We developed a low-cost and scalable CR program based on culturally-acceptable practice of yoga (Yoga-CaRe). In this paper, we report the rationale and design for evaluation of its effectiveness and cost-effectiveness. METHODS: This is a multi-center, single-blind, two-arm parallel-group randomized controlled trial across 22 cardiac care hospitals in India. Four thousand patients aged 18-80 years with AMI will be recruited and randomized 1:1 to receive Yoga-CaRe program (13 sessions supervised by an instructor and encouragement to self-practice daily) or enhanced standard care (3 sessions of health education) delivered over a period of three months. Participants will be followed 3-monthly till the end of the trial. The co-primary outcomes are a) time to occurrence of first cardiovascular event (composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and emergency cardiovascular hospitalization), and b) quality of life (Euro-QoL-5L) at 12 weeks. Secondary outcomes include need for revascularization procedures, return to pre-infarct activities, tobacco cessation, medication adherence, and cost-effectiveness of the intervention. CONCLUSION: This trial will alone contribute >20% participants to existing meta-analyses of randomized trials of CR worldwide. If Yoga-CaRe is found to be effective, it has the potential to save millions of lives and transform care of AMI patients in India and other low and middle income country settings.

Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial.

INTRODUCTION: Emergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial. METHODS AND ANALYSIS: The economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients' characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country's national health services, where costs will be expressed in euros adjusted for purchasing power parity. ETHICS AND DISSEMINATION: Ethical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of the concerned literature and communicated through the profiles of the authors at www.twitter.com and www.researchgate.net. TRIAL REGISTRATION NUMBER: NCT01927549; Pre-results.

Medical cost savings in Sakado City and worldwide achieved by preventing disease by folic acid fortification.

The introduction of mandatory fortification of grains with folate in 1998 in the United States resulted in 767 fewer spina bifida cases annually and a cost saving of $603 million per year. However, far more significant medical cost savings result from preventing common diseases, including myocardial infarction, stroke, dementia and osteoporosis. A cost-effectiveness analysis showed a gain of 266 649 quality-adjusted life-years and $3.6 billion saved annually, mainly due to the reduction of cardiac infarction. The recommended folate intake in Japan is 240 µg/day whereas it is 400 µg/day internationally. Our Sakado Folate Project targeted individuals with genetic polymorphism of methylenetetrahydrofolate reductase or with hyperhomocysteinemia. Using, for example, folate-fortified rice, resulted in an increase in serum folate and a decrease in serum homocysteine in the participants, and reduced medical costs were achieved by decreasing myocardial infarction, stroke, dementia and fracture. Due to the small population of Sakado City (approximately 101 000) and small number of births (693) in 2015, a decrease in spina bifida could not be confirmed but there was a significant decrease in the number of very low birthweight infants. The genome notification of subjects was effective in motivating intake of folate, but the increase in serum folate (from 17.4 to 22.5 nmol/L, 129%) was less than that observed following compulsory folic acid fortification of cereals in the USA (from 12.1 to 30.2 nmol/L, 149.6%). Mandatory folic acid fortification is cheap in decreasing medical costs and is thus recommended in Japan.

CYP2C19 LOF and GOF-Guided Antiplatelet Therapy in Patients with Acute Coronary Syndrome: A Cost-Effectiveness Analysis.

PURPOSE: This study aimed to examine the cost-effectiveness of CYP2C19 loss-of-function and gain-of-function allele guided (LOF/GOF-guided) antiplatelet therapy in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). METHODS: A life-long decision-analytic model was designed to simulate outcomes of three strategies: universal clopidogrel (75 mg daily), universal alternative P2Y12 inhibitor (prasugrel 10 mg daily or ticagrelor 90 mg twice daily), and LOF/GOF-guided therapy (LOF/GOF allele carriers receiving alternative P2Y12 inhibitor, wild-type patients receiving clopidogrel). Model outcomes included clinical event rates, quality-adjusted life-years (QALYs) gained and direct medical costs from perspective of US healthcare provider. RESULTS: Base-case analysis found nonfatal myocardial infarction (5.62%) and stent thrombosis (1.2%) to be the lowest in universal alternative P2Y12 inhibitor arm, whereas nonfatal stroke (0.72%), cardiovascular death (2.42%), and major bleeding (2.73%) were lowest in LOF/GOF-guided group. LOF/GOF-guided arm gained the highest QALYs (7.5301 QALYs) at lowest life-long cost (USD 76,450). One-way sensitivity analysis showed base-case results were subject to the hazard ratio of cardiovascular death in carriers versus non-carriers of LOF allele and hazard ratio of cardiovascular death in non-carriers of LOF allele versus general patients. In probabilistic sensitivity analysis of 10,000 Monte Carlo simulations, LOF/GOF-guided therapy, universal alternative P2Y12 inhibitor, and universal clopidogrel were the preferred strategy (willingness-to-pay threshold = 50,000 USD/QALY) in 99.07%, 0.04%, and 0.89% of time, respectively. CONCLUSIONS: Using both CYP2C19 GOF and LOF alleles to select antiplatelet therapy appears to be the preferred antiplatelet strategy over universal clopidogrel and universal alternative P2Y12 inhibitor therapy for ACS patients with PCI.

Comparison of differences in medical costs when new oral anticoagulants are used for the treatment of patients with non-valvular atrial fibrillation and venous thromboembolism vs warfarin or placebo in the US.

OBJECTIVE: Medical costs that may be avoided when any of the four new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban, and edoxaban, are used instead of warfarin for the treatment of non-valvular atrial fibrillation (NVAF) were estimated and compared. Additionally, the overall differences in medical costs were estimated for NVAF and venous thromboembolism (VTE) patient populations combined. METHODS: Medical cost differences associated with NOAC use vs warfarin or placebo among NVAF and VTE patients were estimated based on clinical event rates obtained from the published trial data. The clinical event rates were calculated as the percentage of patients with each of the clinical events during the trial periods. Univariate and multivariate sensitivity analyses were conducted for the medical-cost differences determined for NVAF patients. A hypothetical health plan population of 1 million members was used to estimate and compare the combined medical-cost differences of the NVAF and VTE populations and were projected in the years 2015-2018. RESULTS: In a year, the medical-cost differences associated with NOAC use instead of warfarin were estimated at -$204, -$140, -$495, and -$340 per patient for dabigatran, rivaroxaban, apixaban, and edoxaban, respectively. In 2014, among the hypothetical population, the medical-cost differences were -$3.7, -$4.2, -$11.5, and -$6.6 million for NVAF and acute VTE patients treated with dabigatran, rivaroxaban, apixaban, and edoxaban, respectively. In 2014, for the combined NVAF, acute VTE, and extended VTE patient populations, medical-cost differences were -$10.0, -$10.9, -$21.0, and -$21.0 million for dabigatran, rivaroxaban, 2.5 mg apixaban, and 5 mg apixaban, respectively. Medical-cost differences associated with use of NOACs were projected to steadily increase from 2014 to 2018. CONCLUSIONS: Medical costs are reduced when NOACs are used instead of warfarin/placebo for the treatment of NVAF or VTE, with apixaban being associated with the greatest reduction in medical costs.

Percutaneous cardiac assist devices compared with surgical hemodynamic support alternatives: cost-effectiveness in the emergent setting.

UNLABELLED: This study evaluates the cost-effectiveness of percutaneous cardiac assist device (pVAD) therapy in the emergent setting compared with traditional surgical hemodynamic support alternatives. BACKGROUND: Previous research has demonstrated the cost-effectiveness of pVAD hemodynamic support for patients undergoing high-risk percutaneous coronary intervention. For patients in cardiogenic shock (CS), use of pVAD therapy has been shown to reduce length of stay (LOS). METHODS: National utilization and outcome data from the 2010-2011 MedPAR and state-sponsored all-payer databases were collected for patients with an acute myocardial infarction complicated by CS who were treated with either a pVAD (n = 883) or with traditional surgical hemodynamic support alternatives (ECMO and extracorporeal VAD) (n = 305). RESULTS: Discharge survival was greater with pVADs than with surgical alternatives (56% vs. 42%, P < 0.001) and was achieved with a strong trend toward reduced LOS (13.2 and 17.9 days, respectively, P = 0.055) and a significantly lower cost of the index admission ($90,929 and $144,257, respectively, P < 0.001). Cost-effectiveness analysis based on the national data demonstrated that pVAD achieved improved outcomes at lower cost. Data were also collected for similar patients who underwent protocol-guided pVAD therapy (using Impella 2.5) at PinnacleHealth, between 2009 and 2011 (n = 30). At this site, the survival rate increased to 60%, length of hospitalization was shortened to 6 days, and admission costs were lowered to $53,850 relative to the surgical alternatives strategy. CONCLUSIONS: For patients in CS requiring emergent hemodynamic support, pVAD therapy offers a less invasive alternative that can be deployed sooner, resulting in better outcomes, shorter LOS, lower costs and with no incremental cost, and a survival benefit when compared with traditional surgical hemodynamic support alternatives. PVAD therapy (and Impella 2.5 in particular) is emerging as a dominant strategy for this challenging patient population.

Interventional management of acute coronary syndromes: applying the lessons of ST-elevation services to non-ST-elevation myocardial infarction.

Many countries have embarked on national strategies to translate evidence from trials of reperfusion therapy for ST-elevation myocardial infarction (STEMI) into clinical practice. Primary angioplasty has become the dominant mode of reperfusion, but the best outcomes depend on appropriate service re-configurations to ensure rapid, effective and comprehensive treatment. Although there are many differences in the treatment of STEMI and non-STEMI acute coronary syndromes (ACS), there are many parallels. Many of the changes in the system of care for STEMI patients could now be applied to the non-STEMI ACS population, providing faster and more efficient care and promising to deliver better outcomes. This article highlights additional changes to healthcare services that should be considered.

Systems of care for ST-segment-elevation myocardial infarction: a report From the American Heart Association's Mission: Lifeline.

BACKGROUND: National guidelines call for participation in systems to rapidly diagnose and treat ST-segment-elevation myocardial infarction (STEMI). In order to characterize currently implemented STEMI reperfusion systems and identify practices common to system organization, the American Heart Association surveyed existing systems throughout the United States. METHODS AND RESULTS: A STEMI system was defined as an integrated group of separate entities focused on reperfusion therapy for STEMI within a geographic region that included at least 1 hospital that performs percutaneous coronary intervention and at least 1 emergency medical service agency. Systems meeting this definition were invited to participate in a survey of 42 questions based on expert panel opinion and knowledge of existing systems. Data were collected through the American Heart Association Mission: Lifeline website. Between April 2008 and January 2010, 381 unique systems involving 899 percutaneous coronary intervention hospitals in 47 states responded to the survey, of which 255 systems (67%) involved urban regions. The predominant funding sources for STEMI systems were percutaneous coronary intervention hospitals (n = 320, 84%) and /or cardiology practices (n = 88, 23%). Predominant system characteristics identified by the survey included: STEMI patient acceptance at percutaneous coronary intervention hospital regardless of bed availability (N = 346, 97%); single phone call activation of catheterization laboratory (N = 335, 92%); emergency department physician activation of laboratory without cardiology consultation (N = 318, 87%); data registry participation (N = 311, 84%); and prehospital activation of the laboratory through emergency department notification without cardiology notification (N = 297, 78%). The most common barriers to system implementation were hospital (n = 139, 37%) and cardiology group competition (n = 81, 21%) and emergency medical services transport and finances (n = 99, 26%). CONCLUSIONS: This survey broadly describes the organizational characteristics of collaborative efforts by hospitals and emergency medical services to provide timely reperfusion in the United States. These findings serve as a benchmark for existing systems and should help guide healthcare teams in the process of organizing care for patients with STEMI.

[Costs of the chain of treatment procedures in acute myocardial infarction in Brazilian reference and specialized hospitals]. / Custos da cadeia de procedimentos no tratamento do infarto agudo do miocárdio em hospitais Brasileiros de excelência e especializados.

OBJECTIVE: To present the methodology and the results of a field survey to assess the chain costs of procedures for treatment of acute myocardial infarction (AMI), carried out in 11 Brazilian reference and specialized hospitals. METHODS: The cost assessment used the cost per procedure and per pathology systems. The procedures associated with the treatment of AMI were organized and their logical sequence (protocols) was used to create a flowchart. Data collection tools gathered information on prices and quantities in 2008 (private, health insurance, SUS, and Brazilian Medical Association - AMB price lists), as well as the applicable costs. RESULTS: Overall, the total cost of the procedures involving the 'standard treatment' of AMI was R$ 12,873.69, if percutaneous coronary intervention (PCI) did not involve stent use. If the stent becomes necessary, the cost increases to R$ 23,461.87. CONCLUSION: Among the results, we emphasize the fact that the costs of the more expensive procedures did not present statistically significant variations between hospitals, regardless of their location, predominant clientele or legal nature, and the fact that hospitals that treat predominantly users of the Brazilian Unified Health System registered the lowest costs, albeit not statistically significant regarding the entire chain of procedures associated with the pathology.

Cost-effectiveness of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitor in the treatment of acute ST-segment elevation myocardial infarction.

OBJECTIVE: To assess the cost-effectiveness of bivalirudin versus heparin and glycoprotein IIb/IIIa inhibitor (H-GPI) in patients undergoing primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction (STEMI), from a UK health service perspective. DESIGN: Cost-utility analysis with life-long time horizon. MAIN OUTCOME MEASURES: Costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness. METHODS: Event risks and medical resource use data derived from the HORIZONS-AMI trial were entered into a decision analytic model. Clinical events until the end of year 1 (main model) or year 3 (alternative model) were modelled in detail. Adjustments were applied to approximate UK routine practice characteristics. Life expectancy of 1-year or 3-year survivors, health-state utilities, initial hospitalisation length of stay in the comparator strategy and unit costs were based on UK sources. Costs and effects were discounted at 3.5%. RESULTS: The main model predicted bivalirudin and H-GPI patients to survive 11.52 and 11.35 (undiscounted) years on average, respectively, and to accrue 6.26 and 6.17 QALYs. Patient lifetime costs were £267 lower in the bivalirudin strategy (£12 843 vs £13 110). Extensive sensitivity and scenario analyses confirmed these results to be robust. In probabilistic analysis, quality-adjusted survival was higher and costs were lower with bivalirudin in 95.0% of simulation runs. In 99.2%, cost-effectiveness was better than £20 000 per QALY gained. Results from the alternative model were fully consistent. CONCLUSION: The use of bivalirudin instead of H-GPI in STEMI patients undergoing PPCI is cost-effective, and offers a high probability of dominance. Background treatment with aspirin and clopidogrel is assumed.

Custos da cadeia de procedimentos no tratamento do infarto agudo do miocárdio em hospitais brasileiros de excelência e especializados / Costs of the chain of treatment procedures in acute myocardial infarction in Brazilian reference and specialized hospitals

OBJETIVO: Apresenta a metodologia e os resultados de uma pesquisa de campo para avaliar os custos da cadeia de procedimentos para tratamento do Infarto Agudo do Miocárdio (IAM), realizada em 11 hospitais brasileiros de excelência e especializados. MÉTODOS: A apuração do custo utilizou o sistema de custo por procedimento e o sistema por patologia. Os procedimentos associados ao tratamento do IAM foram organizados com sua sequência lógica (protocolos), dando origem a um fluxograma. Os instrumentos de coleta da pesquisa contemplavam informações relativas aos preços e as quantidades (particular, convênios, tabela SUS e Associação Médica Brasileira - AMB), praticados no ano de 2008, bem como os custos pertinentes. RESULTADOS: De forma geral, o custo total dos procedimentos que integram o "tratamento-padrão" do IAM, totalizou R$ 12.873,69 se a intervenção coronária percutânea (ICP) não envolver utilização de stent. Caso este se torne necessário, o custo se eleva para R$ 23.461,87. CONCLUSÃO: Entre os resultados obtidos destacam-se: o fato de os valores dos procedimentos mais caros não apresentarem variações estatísticas significativas entre os hospitais, independentemente de sua localização, clientela predominante ou natureza jurídica; e o fato de os hospitais, que tratam predominantemente de usuários do Sistema Único de Saúde, registrar custos menores, mas não estatisticamente significativos, para toda a cadeia de procedimentos associada à patologia.

OBJECTIVE: To present the methodology and the results of a field survey to assess the chain costs of procedures for treatment of acute myocardial infarction (AMI), carried out in 11 Brazilian reference and specialized hospitals. METHODS: The cost assessment used the cost per procedure and per pathology systems. The procedures associated with the treatment of AMI were organized and their logical sequence (protocols) was used to create a flowchart. Data collection tools gathered information on prices and quantities in 2008 (private, health insurance, SUS, and Brazilian Medical Association - AMB price lists), as well as the applicable costs. RESULTS: Overall, the total cost of the procedures involving the 'standard treatment' of AMI was R$ 12,873.69, if percutaneous coronary intervention (PCI) did not involve stent use. If the stent becomes necessary, the cost increases to R$ 23,461.87. CONCLUSION: Among the results, we emphasize the fact that the costs of the more expensive procedures did not present statistically significant variations between hospitals, regardless of their location, predominant clientele or legal nature, and the fact that hospitals that treat predominantly users of the Brazilian Unified Health System registered the lowest costs, albeit not statistically significant regarding the entire chain of procedures associated with the pathology.

Impact of free universal medical coverage on medical care and outcomes in low-income patients hospitalized for acute myocardial infarction: an analysis from the FrenchNational Health Insurance system.

BACKGROUND: The type of medical coverage in patients with acute myocardial infarction (AMI) may affect their treatment and outcome. METHODS AND RESULTS: We used the reimbursement database from the French National Health Insurance to determine the impact of full medical coverage (Couverture Médicale Universelle Complémentaire, CMUC), a free supplemental insurance for low-income earners <60 years of age, on treatment and outcomes of patients with AMI. The population comprised consecutive patients <60 years of age hospitalized for AMI from January to June 2006 in France. Of 4939 patients with AMI aged <60 years, 587 (12%) were on the CMUC. CMUC patients were younger, with more prior cardiovascular and comorbid conditions. CMUC and non-CMUC patients were admitted to the same types of institutions, including academic hospitals and private clinics. The use of cardiac catheterization and coronary interventions was similar (adjusted relative risk, 0.97; 95% confidence interval, 0.91-1.05; P=0.45). In-hospital mortality was also comparable (3.1% versus 2.8%, P=0.69). There was no difference in early use of secondary prevention medications after multivariate adjustment. At 30 months, survival and acute coronary syndrome-free survival were lower in CMUC patients (trend, not significant after adjustment). Long-term adherence to statin therapy was lower in CMUC patients (64% versus 77%; adjusted relative risk, 0.82; 95% confidence interval, 0.73-0.92). CONCLUSIONS: Free full coverage for socially deprived people levels inequalities in the acute and midterm treatment of AMI patients. However, full reimbursement per se is not sufficient to ensure optimal patient adherence to secondary prevention medications and may not be enough to prevent an excess of long-term events.

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.

Health and cost consequences of early versus late invasive strategy after thrombolysis for acute myocardial infarction.

UNLABELLED: The NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infarction showed an improved clinical outcome with early transfer for percutaneous coronary intervention (PCI) compared to a more conservative approach after thrombolysis. The aim of this substudy was to compare the 12-month quality-adjusted life years (QALYs) and costs of these alternative strategies. METHODS: Patients with ST-elevation myocardial infarction <6 h duration and >90 min expected delay to PCI, received full-dose tenecteplase and were randomized to either early or late invasive strategy (n = 266). Detailed quality of life and resource use data were registered prospectively for a period of 12 months. Health outcomes were measured as quality of life using a generic instrument (15D). Quality of life scores were translated into QALYs. Unit costs were based on hospital accounts, fee schedules, and market prices. RESULTS: After 12 months of follow-up, patients in the early invasive group had 0.008 (95% CI -0.027 to 0.043) more QALYs compared to the late invasive group. The mean total costs were €18,201 in the early versus €17,643 in the late invasive group, with a mean difference of €558 (95% CI -2258 to 3484). Cost/QALY was €69,750 while cost/avoided clinical endpoint was €5636. CONCLUSION: Early and late invasive strategies after thrombolysis resulted in similar quality of life and similar costs in ST-elevation myocardial infarction patients living far from a PCI centre (NCT00161005).