Long term risk and costs of bleeding in men and women treated with triple antithrombotic therapy-An observational study.

OBJECTIVES: Bleeding is the most common non-ischemic complication in patients with coronary revascularisation procedures, associated with prolonged hospitalisation and increased mortality. Many factors predispose for bleeds in these patients, among those sex. Anyhow, few studies have characterised the population receiving triple antithrombotic therapy (TAT) as well as long term bleeds from a sex perspective. We investigated the one year rate of bleeds in patients receiving TAT, potential sex disparities and premature discontinuation of TAT. We also assessed health care costs in bleeders vs non-bleeders. SETTING: Three hospitals in the County of Östergötland, Sweden during 2009-2015. PARTICIPANTS: All patients discharged with TAT registered in the SWEDEHEART registry. PRIMARY AND SECONDARY OUTCOME MEASURES: All bleeds receiving medical attention during one-year follow-up were collected by retrieving relevant information about each patient from medical records. Resource use associated with bleeds was assigned unit cost to estimate the health care costs associated with bleeding episodes. RESULTS: Among 272 patients, 156 bleeds occurred post-discharge, of which 28.8% were gastrointestinal. In total 54.4% had at least one bleed during or after the index event and 40.1% bled post discharge of whom 28.7% experienced a TIMI major or minor bleeding. Women discontinued TAT prematurely more often than men (52.9 vs 36.1%, p = 0.01) and bled more (48.6 vs. 37.1%, p = 0.09). One-year mean health care costs were EUR 575 and EUR 5787 in non-bleeding and bleeding patients, respectively. CONCLUSION: The high bleeding incidence in patients with TAT, especially in women, is a cause of concern. There is a need for an adequately sized randomised, controlled trial to determine a safe but still effective treatment for these patients.

Subcategorizing the Expected Value of Perfect Implementation to Identify When and Where to Invest in Implementation Initiatives.

Purpose. Clinical practice variations and low implementation of effective and cost-effective health care technologies are a key challenge for health care systems and may lead to suboptimal treatment and health loss for patients. The purpose of this work was to subcategorize the expected value of perfect implementation (EVPIM) to enable estimation of the absolute and relative value of eliminating slow, low, and delayed implementation. Methods. Building on the EVPIM framework, this work defines EVPIM subcategories to estimate the expected value of eliminating slow, low, or delayed implementation. The work also shows how information on regional implementation patterns can be used to estimate the value of eliminating regional implementation variation. The application of this subcategorization is illustrated by a case study of the implementation of an antiplatelet therapy for the secondary prevention after myocardial infarction in Sweden. Incremental net benefit (INB) estimates are based on published cost-effectiveness assessments and a threshold of SEK 250,000 (£22,300) per quality-adjusted life year (QALY). Results. In the case study, slow, low, and delayed implementation was estimated to represent 22%, 34%, and 44% of the total population EVPIM (2941 QALYs or SEK 735 million), respectively. The value of eliminating implementation variation across health care regions was estimated to 39% of total EVPIM (1138 QALYs). Conclusion. Subcategorizing EVPIM estimates the absolute and relative value of eliminating different parts of suboptimal implementation. By doing so, this approach could help decision makers to identify which parts of suboptimal implementation are contributing most to total EVPIM and provide the basis for assessing the cost and benefit of implementation activities that may address these in future implementation of health care interventions.

Clinical decision support for stroke prevention in atrial fibrillation (CDS-AF): Rationale and design of a cluster randomized trial in the primary care setting.

BACKGROUND: Atrial fibrillation (AF) is associated with substantial morbidity, in particular stroke. Despite good evidence for the reduction of stroke risk with anticoagulant therapy, there remains a significant undertreatment. The main aim of the current study is to investigate whether a clinical decision support tool for stroke prevention (CDS) integrated in the electronic health record can improve adherence to guidelines for stroke prevention in patients with AF. METHODS: We will conduct a cluster randomized trial where 43 primary care clinics in the county of Östergötland, Sweden (population 444,347), will be randomized to be part of the CDS intervention or serve as controls. The CDS will alert responsible physicians of patients with AF and increased risk for thromboembolism according to the CHA2DS2VASc (Congestive heart failure, Hypertension, Age ≥ 74 years, Diabetes mellitus, previous Stroke/TIA/thromboembolism, Vascular disease, Age 65-74 years, Sex category (i.e. female sex)) algorithm without anticoagulant therapy. The primary end point will be adherence to guidelines after 1 year. CONCLUSION: The present study will investigate whether a clinical decision support system integrated in an electronic health record can increase adherence to guidelines regarding anticoagulant therapy in patients with AF.

Long-term resource use patterns and healthcare costs after myocardial infarction in a clinical practice setting: results from a contemporary nationwide registry study.

Aims: Long-term contemporary nationwide data on resource use and healthcare costs after myocardial infarction (MI) in a clinical practice setting are not widely studied, and the aim of this study was to investigate resource use patterns and healthcare costs in patients with MI in a nationwide clinical practice setting. Methods and results: This retrospective cohort study included all patients identified in the compulsory Swedish nationwide patient register with a diagnosis of MI between 1 July 2006 and 30 June 2011. Cardiovascular hospitalization and outpatient visits data from the patient register were combined with data from the cause of death register and the drug utilization register. For a subset of patients, data were also available from a primary care register. Healthcare resource use patterns and annual costs [reported in 2014 euros (€) converted from Swedish kronor (SEK) using the exchange rate €1 = SEK 9.33)] were estimated for the year prior to the occurrence of MI as well as for a maximum follow-up period of 6 years post-MI. The study included 97 252 patients with a diagnosis of MI with a total number of 285 351 observation years. The majority of healthcare consumption occurred within the first year of MI where patients were on average hospitalized 1.55 times, made 1.08 outpatient care visits, and 3.80 primary care visits. In the long term, for the majority of resource use categories, average consumption was higher in the years after MI compared with the year prior to MI. Healthcare costs at 6 years of follow-up were approximately €20 000 of which €12 460 occurred in the first year, and the major part was attributed to hospitalizations. Conclusion: For patients with 6 years of follow-up after MI, healthcare costs were approximately €20 000. The major part of costs occurred in the first year after MI and was driven by hospitalizations. ClinicalTrials.gov identifier: NCT01984307.

Economic analysis of ticagrelor therapy from a U.S. perspective: results from the PLATO study.

BACKGROUND: Based on results of the PLATO (Platelet Inhibition and Patient Outcomes) trial comparing ticagrelor with clopidogrel therapy, the U.S. Food and Drug Administration approved ticagrelor in 2011 for reducing thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) with the proviso that it be taken with low-dose aspirin. OBJECTIVES: This study sought to assess the cost and cost effectiveness of ticagrelor therapy relative to clopidogrel in treating ACS patients from the perspective of the U.S. health care system. METHODS: We estimated within-trial resource use and costs using U.S. low-dose aspirin patients in PLATO (n = 547). Quality-adjusted life expectancy was estimated using the total PLATO population (n = 18,624), combined with baseline risk and long-term survival data from an external ACS patient cohort. Study drugs were valued at current costs. Cost effectiveness was assessed, as was the sensitivity of results to sampling and methodological uncertainties. RESULTS: One year of ticagrelor therapy, relative to that of generic clopidogrel, cost $29,665/quality-adjusted life-year gained, with 99% of bootstrap estimates falling under a $100,000 willingness-to-pay threshold. Results were robust to extensive sensitivity analyses, including variations in clopidogrel cost, exclusion of costs in extended years of life, and a recalibrated estimate of survival reflecting a lower underlying mortality risk in the United States. CONCLUSIONS: For PLATO-eligible ACS patients, a U.S. perspective comparison of the current standard of dual antiplatelet therapy of aspirin with clopidogrel versus aspirin plus ticagrelor showed that the ticagrelor regimen increased life expectancy at an incremental cost well within accepted benchmarks of good value for money. (A Comparison of Ticagrelor [AZD6140] and Clopidogrel in Patients With Acute Coronary Syndrome [PLATO]; NCT00391872).

The cost-effectiveness of radiofrequency catheter ablation as first-line treatment for paroxysmal atrial fibrillation: results from a MANTRA-PAF substudy.

AIM: The aim of this prospective substudy was to estimate the cost-effectiveness of treating paroxysmal atrial fibrillation (AF) with radiofrequency catheter ablation (RFA) compared with antiarrhythmic drugs (AADs) as first-line treatment. METHODS AND RESULTS: A decision-analytic Markov model, based on MANTRA-PAF (Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation) study data, was developed to study long-term effects and costs of RFA compared with AADs as first-line treatment. Positive clinical effects were found in the overall population, a gain of an average 0.06 quality-adjusted life years (QALYs) to an incremental cost of €3033, resulting in an incremental cost-effectiveness ratio of €50 570/QALY. However, the result of the subgroup analyses showed that RFA was less costly and more effective in younger patients. This implied an incremental cost-effectiveness ratio of €3434/QALY in ≤50-year-old patients respectively €108 937/QALY in >50-year-old patients. CONCLUSION: Radiofrequency catheter ablation as first-line treatment is a cost-effective strategy for younger patients with paroxysmal AF. However, the cost-effectiveness of using RFA as first-line therapy in older patients is uncertain, and in most of these AADs should be attempted before RFA (MANTRA-PAF ClinicalTrials.gov number; NCT00133211).

Cost consequences of point-of-care troponin T testing in a Swedish primary health care setting.

OBJECTIVE: To evaluate the safety and cost-effectiveness of point-of-care troponin T testing (POCT-TnT) for the management of patients with chest pain in primary care. DESIGN: Prospective observational study with follow-up. SETTING: Three primary health care (PHC) centres using POCT-TnT and four PHC centres not using POCT-TnT in south-east Sweden. PATIENTS: All patients ≥ 35 years of age, contacting one of the PHC centres for chest pain, dyspnoea on exertion, unexplained weakness and/or fatigue, with no other probable cause than cardiac, were included. Symptoms must have commenced or worsened during the previous seven days. MAIN OUTCOME MEASURES: Emergency referral rates, diagnoses of acute myocardial infarction (AMI) or unstable angina (UA), and costs were collected for 30 days after the patient sought care at the PHC centre. RESULTS: A total of 196 patients with chest pain were included: 128 in PHC centres with POCT-TnT and 68 in PHC centres without POCT-TnT. Fewer patients from the PHC centres with POCT-TnT (n = 32, 25%) were emergently referred to hospital than from centres without POCT-TnT (n = 29, 43%; p = 0.011). Eight patients (6.2%) from PHC centres with POCT-TnT were diagnosed with AMI or UA compared with six patients (8.8%) from centres without POCT-TnT (p = 0.565). Two patients with AMI or UA were classified as missed cases from PHC centres with POCT-TnT and there were no missed cases from PHC centres without POCT-TnT. SKr290 000 was saved per missed case of AMI or UA. CONCLUSION: The use of POCT-TnT in primary care may be cost saving but at the expense of missed cases.

Use of cost-effectiveness data in priority setting decisions: experiences from the national guidelines for heart diseases in Sweden.

BACKGROUND: The inclusion of cost-effectiveness data, as a basis for priority setting rankings, is a distinguishing feature in the formulation of the Swedish national guidelines. Guidelines are generated with the direct intent to influence health policy and support decisions about the efficient allocation of scarce healthcare resources. Certain medical conditions may be given higher priority rankings i.e. given more resources than others, depending on how serious the medical condition is. This study investigated how a decision-making group, the Priority Setting Group (PSG), used cost-effectiveness data in ranking priority setting decisions in the national guidelines for heart diseases. METHODS: A qualitative case study methodology was used to explore the use of such data in ranking priority setting healthcare decisions. The study addressed availability of cost-effectiveness data, evidence understanding, interpretation difficulties, and the reliance on evidence. We were also interested in the explicit use of data in ranking decisions, especially in situations where economic arguments impacted the reasoning behind the decisions. RESULTS: This study showed that cost-effectiveness data was an important and integrated part of the decision-making process. Involvement of a health economist and reliance on the data facilitated the use of cost-effectiveness data. Economic arguments were used both as a fine-tuning instrument and a counterweight for dichotomization. Cost-effectiveness data were used when the overall evidence base was weak and the decision-makers had trouble making decisions due to lack of clinical evidence and in times of uncertainty. Cost-effectiveness data were also used for decisions on the introduction of new expensive medical technologies. CONCLUSION: Cost-effectiveness data matters in decision-making processes and the results of this study could be applicable to other jurisdictions where health economics is implemented in decision-making. This study contributes to knowledge on how cost-effectiveness data is used in actual decision-making, to ensure that the decisions are offered on equal terms and that patients receive medical care according their needs in order achieve maximum benefit.

Ticagrelor treatment in patients with acute coronary syndrome is cost-effective in Sweden and Denmark.

OBJECTIVES: To evaluate the cost-effectiveness of treating patients with acute coronary syndromes (ACS) for 12 months with ticagrelor compared with generic clopidogrel in Sweden and Denmark. DESIGN: Decision-analytic model to estimate lifetime costs, life-expectancy, and quality-adjusted life years (QALYs) with ticagrelor and clopidogrel. Event rates, healthcare resource use, and health-related quality of life during 12 months of therapy were estimated from the PLATelet inhibition and patient Outcomes (PLATO) trial. Beyond 12 months, quality-adjusted survival and costs were estimated conditional on events occurring during the 12 months of therapy. When available, country-specific data were employed in the analysis. Incremental cost-effectiveness ratios are presented from a healthcare perspective and a broader societal perspective including costs falling outside the healthcare sector in 2010 local currency. RESULTS: The cost per QALY with ticagrelor compared with generic clopidogrel was SEK 25 022 and DKK 26 892 for Sweden and Denmark, respectively, from a healthcare perspective. The cost per QALY from a broader societal perspective was SEK 24 290 and DKK 25 051 for Sweden and Denmark, respectively. CONCLUSION: The cost per QALY of treating ACS-patients with ticagrelor compared with generic clopidogrel is below the conventional thresholds of cost-effectiveness in Sweden and Denmark.

Abciximab bolus with optional infusion in intervention for ST-elevation myocardial infarction.

OBJECTIVES: The standard abciximab regimen is a bolus dose followed by a 12-h infusion. Whether the bolus dose alone is sufficient for ST-elevation myocardial infarction patients receiving a high loading dose of clopidogrel is unknown. DESIGN: In an observational study, 693 consecutive patients were treated with abciximab during percutaneous coronary intervention for ST-elevation myocardial infarction. Totally 354 patients received standard strategy of abciximab bolus and infusion followed by 339 patients that recieved abciximab bolus only (271 patients) or bolus and infusion if suboptimal result (68 patients) in combination with a higher loading dose of clopidogrel (600 mg) - the modified strategy. RESULTS: The two groups were similar regarding baseline characteristics and in hospital bleeding events. At 30 days, the composite of death, re-infarction or target vessel revascularization was 9.1% in the standard and 7.5% in the modified strategy (p = 0.45). The rate of stent thrombosis was lower in the modified strategy group with 0% and 2.3% in the standard group (p < 0.001) and the mean total medical cost was lower in the modified strategy group with €8032 and €8665 in the standard group (p < 0.001). CONCLUSIONS: In primary percutaneous coronary intervention with a loading dose of 600 mg clopidogrel, it seems safe and cost-saving to give abciximab bolus with optional infusion.

Cost-effectiveness of ticagrelor in acute coronary syndromes.

Ticagrelor is a reversibly binding oral P2Y(12) inhibitor, which belongs to a novel chemical class of antiplatelet agents named cyclopentyl-triazolo-pyrimidines. Ticagrelor administered with acetylsalicylic acid has been shown to reduce the rate of the composite end point of death from vascular causes, myocardial infarction or stroke without an increase in the rate of overall major bleeding compared with clopidogrel plus acetylsalicylic acid in patients with acute coronary syndromes. In addition to these clinical findings, it has been shown that the cost per quality-adjusted life year with ticagrelor is below the generally acceptable thresholds for cost-effectiveness compared with clopidogrel. Healthcare decision-makers need to consider the costs and cost-effectiveness when prioritizing treatments among scarce healthcare resources. This is of particular importance in cases similar to ticagrelor, where the novel treatment is expected to improve effectiveness at a higher acquisition cost. In this article, the authors review and discuss the health-economic evidence of ticagrelor.

Cost-effectiveness of dabigatran compared with warfarin for patients with atrial fibrillation in Sweden.

AIMS: Patients with atrial fibrillation have a significantly increased risk of thromboembolic events such as ischaemic stroke, and patients are therefore recommended to be treated with anticoagulation treatment. The most commonly used anticoagulant consists of vitamin K antagonist such as warfarin. A new oral anticoagulation treatment, dabigatran, has recently been approved for stroke prevention among patients with atrial fibrillation. The purpose of this study was to estimate the cost-effectiveness of dabigatran as preventive treatment of stroke and thromboembolic events compared with warfarin in 65-year-old patients with atrial fibrillation in Sweden. METHODS AND RESULTS: A decision analytic simulation model was used to estimate the long-term (20-year) costs and effects of the different treatments. The outcome measures are the number of strokes prevented, life years gained, and quality-adjusted life years (QALYs) gained. Costs and effect data are adjusted to a Swedish setting. Patients below 80 years of age are assumed to start with dabigatran 150 mg twice a day and switch to 110 mg twice a day at the age of 80 years due to higher bleeding risk. The price of dabigatran in Sweden is €2.82 (Swedish kronor 25.39) per day for both doses. The cost per QALY gained for dabigatran compared with warfarin is estimated at €7742, increasing to €12 449 if dabigatran is compared with only well-controlled warfarin treatment. CONCLUSION: Dabigatran is a cost-effective treatment in Sweden, as its incremental cost-effectiveness ratio is below the normally accepted willingness to pay limit.

Cost-effectiveness of treating acute coronary syndrome patients with ticagrelor for 12 months: results from the PLATO study.

AIMS: The efficacy and safety of ticagrelor vs. clopidogrel in patients with acute coronary syndromes (ACS) are well documented in the PLATelet inhibition and patient Outcomes trial (PLATO). The aim of this study was to assess the long-term cost-effectiveness of treating ACS patients for 12 months with ticagrelor compared with generic clopidogrel. METHODS AND RESULTS: Event rates, health-care costs, and health-related quality of life during 12 months of therapy with either ticagrelor or generic clopidogrel were estimated from PLATO. Beyond 12 months, quality-adjusted survival and costs were estimated conditional on whether a non-fatal myocardial infarction (MI), a non-fatal stroke, or no MI or stroke occurred during the 12 months of therapy. Lifetime costs, life expectancy, and quality-adjusted life years (QALYs) were estimated for both treatment strategies. Incremental cost-effectiveness ratios were presented from a health-care perspective in 2010 Euros (€) applying unit costs and life tables from a Swedish setting in the base-case analysis. Treatment with ticagrelor was associated with increased health-care costs of €362 and a QALY gain of 0.13 compared with generic clopidogrel, yielding a cost per QALY gained with ticagrelor of €2753. The cost per life year gained was €2372. The results were consistent in major subgroups. Sensitivity analyses showed a cost per QALY gained with ticagrelor of ∼€7300 under certain scenarios. CONCLUSION: Based on clinical and health-economic evidence from the PLATO study, treating ACS patients with ticagrelor for 12 months is associated with a cost per QALY below generally accepted thresholds for cost-effectiveness. ClinicalTrials.gov Identifier: NCT00391872.

Compilation of cost-effectiveness evidence for different heart conditions and treatment strategies.

OBJECTIVES: Despite the continuing interest in health economic research, we could find no accessible data set on cost-effectiveness, useful as practical information to decision makers who must allocate scarce resources within the cardiovascular field. The aim of this paper was to present cost-effectiveness ratios, based on a systematic literature search for the treatment of heart diseases. DESIGN: A comprehensive literature search on cost-effectiveness analyses of intervention strategies for the treatment of heart diseases was conducted. We compiled available cost-effectiveness ratios for different heart conditions and treatment strategies, in a cost-effectiveness ranking table. The cost-effectiveness ratios were expressed as a cost per quality adjusted life year (QALY) or life year gained. RESULTS: Cost-effectiveness ratios, ranging from dominant to those costing more than 1,000,000 Euros per QALY gained, and bibliographic references are provided for. The table was categorized according to disease group, making the ranking table readily available. CONCLUSIONS: Cost-effectiveness ranking tables provide a means of presenting cost-effectiveness evidence. They provide valid information within a limited space aiding decision makers on the allocation of health care resources. This paper represents an extensive compilation of health economic evidence for the treatment of heart diseases.

The Cost of Thromboembolic Events and their Prevention among Patients with Atrial Fibrillation.

Aim: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. People with AF have a significantly increased risk of thromboembolic events, including stroke, and the main treatment is therefore aimed at preventing thromboembolic events via anticoagulation with warfarin or acetylsalicylic acid. However, the development of new anticoagulation treatments has prompted a need to know the current cost of AF-related thromboembolic events, for future cost-effectiveness comparisons with the existing treatments. In this study, we estimated the cost of thromboembolic events and their prevention among Swedish AF patients in 2010. Methods: The relevant costs were identified, quantified, and valued. The complications included were ischaemic and haemorrhagic stroke, gastrointestinal bleeding, and other types of major bleeding caused by AF. Treatments intended to lower the risk of ischaemic stroke were also included. A societal perspective was used, including productivity loss due to morbidity. Patients with a CHADS2 score of 1 or higher were included. Results: Among the 9 340 682 inhabitants of Sweden, there are 118 000 patients with AF and at least one more risk factor for stroke, comprising 1.26% of the population. Of these patients, 43.3% are treated with warfarin, 28.3% use acetylsalicylic acid, and 28.3% are assumed to have no anticoagulation treatment. The cost of AF-related complications and its prevention in Sweden was estimated at €437 million for 2010, corresponding to €3 712 per AF patient per year. The highest cost was caused by stroke, and the second highest by the cost of monitoring the warfarin treatment. As the prevalence of AF is expected to increase in the future, AF-related costs are also expected to rise. Conclusion: Thromboembolic events cause high costs. New, easily-administered treatments that could reduce the risk of stroke have the potential to be cost-effective.

Cost and health outcome of primary percutaneous coronary intervention versus thrombolysis in acute ST-segment elevation myocardial infarction-Results of the Swedish Early Decision reperfusion Study (SWEDES) trial.

BACKGROUND: In ST-elevation myocardial infarction, primary percutaneous coronary intervention (PCI) has a superior clinical outcome, but it may increase costs in comparison to thrombolysis. The aim of the study was to compare costs, clinical outcome, and quality-adjusted survival between primary PCI and thrombolysis. METHODS: Patients with ST-elevation myocardial infarction were randomized to primary PCI with adjunctive enoxaparin and abciximab (n = 101), or to enoxaparin followed by reteplase (n = 104). Data on the use of health care resources, work loss, and health-related quality of life were collected during a 1-year period. Cost-effectiveness was determined by comparing costs and quality-adjusted survival. The joint distribution of incremental costs and quality-adjusted survival was analyzed using a nonparametric bootstrap approach. RESULTS: Clinical outcome did not differ significantly between the groups. Compared with the group treated with thrombolysis, the cost of interventions was higher in the PCI-treated group ($4,602 vs $3,807; P = .047), as well as the cost of drugs ($1,309 vs $1,202; P = .001), whereas the cost of hospitalization was lower ($7,344 vs $9,278; P = .025). The cost of investigations, outpatient care, and loss of production did not differ significantly between the 2 treatment arms. Total cost and quality-adjusted survival were $25,315 and 0.759 vs $27,819 and 0.728 (both not significant) for the primary PCI and thrombolysis groups, respectively. Based on the 1-year follow-up, bootstrap analysis revealed that in 80%, 88%, and 89% of the replications, the cost per health outcome gained for PCI will be <$0, $50,000, and $100,000 respectively. CONCLUSION: In a 1-year perspective, there was a tendency toward lower costs and better health outcome after primary PCI, resulting in costs for PCI in comparison to thrombolysis that will be below the conventional threshold for cost-effectiveness in 88% of bootstrap replications.

Costs of bleeds relating to acute coronary syndrome therapies.

UNLABELLED: To estimate the costs to manage selected types of bleeding complications in patients with acute coronary syndrome (ACS) treated with antithrombotics, including antiplatelet, and fibrinolytic therapies: decrease in haemoglobin >3 g/dL, puncture site, and bleeding requiring transfusion of blood products. METHODS: Retrospective chart reviews of ACS patients experiencing decrease in Hb, puncture site, or bleeding requiring transfusion were conducted in hospitals in France, Germany, Italy, Spain and Sweden to determine the total length of stay (LOS), stay post-bleeding, procedures to identify the extent of bleeding, number and types of transfusion products, patient demographics, reason for hospital admission and disposition upon discharge. Country-specific costs were applied to estimate the average cost per patient by type of bleeding event. RESULTS: Records of 158 ACS patients with the bleeding complications were examined (26.9% decrease in Hb, 35.5% puncture site, and 37.8% transfusion). The average LOS was 10.6 days for decreasing Hb, 7.7 days for puncture site bleeding, and 11.3 days for patients receiving transfusions due to these bleeding events. The average costs per patient ranged between €3,986 and €10,252. The LOS ranged widely both within and across countries. LIMITATIONS: The study has a small sample size and costs are confounded by co-morbidities. CONCLUSIONS: The estimated costs for decreasing Hb, puncture site bleeding and bleeding resulting in transfusions provide a tool for researchers to conduct economic analyses of bleeding events associated with therapies for ACS.

Assessing the cost effectiveness of using prognostic biomarkers with decision models: case study in prioritising patients waiting for coronary artery surgery.

OBJECTIVE: To determine the effectiveness and cost effectiveness of using information from circulating biomarkers to inform the prioritisation process of patients with stable angina awaiting coronary artery bypass graft surgery. DESIGN: Decision analytical model comparing four prioritisation strategies without biomarkers (no formal prioritisation, two urgency scores, and a risk score) and three strategies based on a risk score using biomarkers: a routinely assessed biomarker (estimated glomerular filtration rate), a novel biomarker (C reactive protein), or both. The order in which to perform coronary artery bypass grafting in a cohort of patients was determined by each prioritisation strategy, and mean lifetime costs and quality adjusted life years (QALYs) were compared. DATA SOURCES: Swedish Coronary Angiography and Angioplasty Registry (9935 patients with stable angina awaiting coronary artery bypass grafting and then followed up for cardiovascular events after the procedure for 3.8 years), and meta-analyses of prognostic effects (relative risks) of biomarkers. RESULTS: The observed risk of cardiovascular events while on the waiting list for coronary artery bypass grafting was 3 per 10,000 patients per day within the first 90 days (184 events in 9935 patients). Using a cost effectiveness threshold of pound20,000- pound30,000 (euro22,000-euro33,000; $32,000-$48,000) per additional QALY, a prioritisation strategy using a risk score with estimated glomerular filtration rate was the most cost effective strategy (cost per additional QALY was < pound410 compared with the Ontario urgency score). The impact on population health of implementing this strategy was 800 QALYs per 100,000 patients at an additional cost of pound 245,000 to the National Health Service. The prioritisation strategy using a risk score with C reactive protein was associated with lower QALYs and higher costs compared with a risk score using estimated glomerular filtration rate. CONCLUSION: Evaluating the cost effectiveness of prognostic biomarkers is important even when effects at an individual level are small. Formal prioritisation of patients awaiting coronary artery bypass grafting using a routinely assessed biomarker (estimated glomerular filtration rate) along with simple, routinely collected clinical information was cost effective. Prioritisation strategies based on the prognostic information conferred by C reactive protein, which is not currently measured in this context, or a combination of C reactive protein and estimated glomerular filtration rate, is unlikely to be cost effective. The widespread practice of using only implicit or informal means of clinically ordering the waiting list may be harmful and should be replaced with formal prioritisation approaches.

How to set up an effective national primary angioplasty network: lessons learned from five European countries.

AIMS: Percutaneous coronary interventions (PCI) are used to treat acute and chronic forms of coronary artery disease. While in chronic forms the main goal of PCI is to improve the quality of life, in acute coronary syndromes (ACS) timely PCI is a life-saving procedure - especially in the setting of ST-elevation myocardial infarction (STEMI). The aim of this study was to describe the experience of countries with successful nationwide implementation of PCI in STEMI, and to provide general recommendations for other countries. METHODS AND RESULTS: The European Association of Percutaneous Cardiovascular Interventions (EAPCI) recenty launched the Stent For Life Initiative (SFLI). The initial phase of this pan-European project was focused on the positive experience of five countries to provide the best practice examples. The Netherlands, the Czech Republic, Sweden, Denmark and Austria were visited and the logistics of ACS treatment was studied. Public campaigns improved patient access to acute PCI. Regional networks involving emergency medical services (EMS), non-PCI hospitals and PCI centres are useful in providing access to acute PCI for most patients. Direct transfer from the first medical contact site to the cathlab is essential to minimise the time delays. Cathlab staff work is organised to provide acute PCI services 24 hours a day / seven days a week (24/7). Even in those regions where thrombolysis is still used due to long transfer distances to PCI, patients should still be transferred to a PCI centre (after thrombolysis). The highest risk non-ST elevation acute myocardial infarction patients should undergo emergency coronary angiography within two hours of hospital admission, i.e. similar to STEMI patients. CONCLUSIONS: Three realistic goals for other countries were defined based on these experiences: 1) primary PCI should be used for >70% of all STEMI patients, 2) primary PCI rates should reach >600 per million inhabitants per year and 3) existing PCI centres should treat all their STEMI patients by primary PCI, i.e. should offer a 24/7 service.