Bernhard Bornschein

Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study.

OBJECTIVES The purpose of this study was to investigate the 2-year outcome of percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) in patients with multivessel coronary artery disease (CAD). BACKGROUND In patients with multivessel CAD undergoing PCI, coronary angiography is the standard method for guiding stent placement. The FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study showed that routine FFR in addition to angiography improves outcomes of PCI at 1 year. It is unknown if these favorable results are maintained at 2 years of follow-up. METHODS At 20 U.S. and European medical centers, 1,005 patients with multivessel CAD were randomly assigned to PCI with drug-eluting stents guided by angiography alone or guided by FFR measurements. Before randomization, lesions requiring PCI were identified based on their angiographic appearance. Patients randomized to angiography-guided PCI underwent stenting of all indicated lesions, whereas those randomized to FFR-guided PCI underwent stenting of indicated lesions only if the FFR was <or=0.80. RESULTS The number of indicated lesions was 2.7+/-0.9 in the angiography-guided group and 2.8+/-1.0 in the FFR-guided group (p=0.34). The number of stents used was 2.7+/-1.2 and 1.9+/-1.3, respectively (p<0.001). The 2-year rates of mortality or myocardial infarction were 12.9% in the angiography-guided group and 8.4% in the FFR-guided group (p=0.02). Rates of PCI or coronary artery bypass surgery were 12.7% and 10.6%, respectively (p=0.30). Combined rates of death, nonfatal myocardial infarction, and revascularization were 22.4% and 17.9%, respectively (p=0.08). For lesions deferred on the basis of FFR>0.80, the rate of myocardial infarction was 0.2% and the rate of revascularization was 3.2 % after 2 years. CONCLUSIONS Routine measurement of FFR in patients with multivessel CAD undergoing PCI with drug-eluting stents significantly reduces mortality and myocardial infarction at 2 years when compared with standard angiography-guided PCI. (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation [FAME]; NCT00267774).

Clinical ResearchInterventional CardiologyFractional Flow Reserve Versus Angiography for Guiding Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease: 2-Year Follow-Up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) Study

OBJECTIVES The purpose of this study was to investigate the 2-year outcome of percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) in patients with multivessel coronary artery disease (CAD). BACKGROUND In patients with multivessel CAD undergoing PCI, coronary angiography is the standard method for guiding stent placement. The FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study showed that routine FFR in addition to angiography improves outcomes of PCI at 1 year. It is unknown if these favorable results are maintained at 2 years of follow-up. METHODS At 20 U.S. and European medical centers, 1,005 patients with multivessel CAD were randomly assigned to PCI with drug-eluting stents guided by angiography alone or guided by FFR measurements. Before randomization, lesions requiring PCI were identified based on their angiographic appearance. Patients randomized to angiography-guided PCI underwent stenting of all indicated lesions, whereas those randomized to FFR-guided PCI underwent stenting of indicated lesions only if the FFR was <or=0.80. RESULTS The number of indicated lesions was 2.7+/-0.9 in the angiography-guided group and 2.8+/-1.0 in the FFR-guided group (p=0.34). The number of stents used was 2.7+/-1.2 and 1.9+/-1.3, respectively (p<0.001). The 2-year rates of mortality or myocardial infarction were 12.9% in the angiography-guided group and 8.4% in the FFR-guided group (p=0.02). Rates of PCI or coronary artery bypass surgery were 12.7% and 10.6%, respectively (p=0.30). Combined rates of death, nonfatal myocardial infarction, and revascularization were 22.4% and 17.9%, respectively (p=0.08). For lesions deferred on the basis of FFR>0.80, the rate of myocardial infarction was 0.2% and the rate of revascularization was 3.2 % after 2 years. CONCLUSIONS Routine measurement of FFR in patients with multivessel CAD undergoing PCI with drug-eluting stents significantly reduces mortality and myocardial infarction at 2 years when compared with standard angiography-guided PCI. (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation [FAME]; NCT00267774).

Prevalence and incidence of Parkinson's disease in Europe

OBJECTIVE To provide an overview on the prevalence and incidence of Parkinsons disease (PD) in selected European countries. BACKGROUND PD is a common disease of unknown etiology. Accurate information on the epidemiology of PD is critical to inform health policy. An aging population will lead to more patients with PD; thus, the high financial burden PD places on society will increase. MATERIAL AND METHODS A systematic literature search was performed to identify studies on the prevalence and incidence of PD in the following European countries: Austria, the Czech Republic, France, Germany, Italy, The Netherlands, Portugal, Spain, Sweden and United Kingdom. Only published studies were included. Abstracts, reviews, meta-analyses and letters to the editor were excluded. There were no language restrictions. Data were extracted using a standardized assessment form, and evidence tables were used to systematically report and compare the data. RESULTS Of 39 identified studies, most (87%) reported estimates of PD prevalence rates, while only a few (13%) reported estimates of PD annual incidence rates. Crude prevalence rate estimates ranged from 65.6 per 100,000 to 12,500 per 100,000 and annual incidence estimates ranged from 5 per 100,000 to 346 per 100,000. No publications could be identified for Austria or the Czech Republic. DISCUSSION AND CONCLUSION The observed variations in prevalence and incidence rates may result from environmental or genetic factors, but might also be a consequence of differences in methodologies for case ascertainment, diagnostic criteria, or age distributions of the study populations. The comparability of existing studies is limited.

Economic Evaluation of Fractional Flow Reserve–Guided Percutaneous Coronary Intervention in Patients With Multivessel Disease

Background— The Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) study demonstrated significantly improved health outcomes at 1 year in patients randomized to multivessel percutaneous coronary intervention guided by fractional flow reserve (FFR) compared with percutaneous coronary intervention guided by angiography alone. The economic impact of routine measurement of FFR in this setting is not known. Methods and Results— In this study, 1005 patients were randomly assigned to FFR-guided or angiography-guided percutaneous coronary intervention and followed up for 1 year. A prospective cost-utility analysis comparing costs and quality-adjusted life-years was performed with a time horizon of 1 year. Quality-adjusted life-years were calculated with the use of utilities determined by the EuroQuol 5 dimension health survey with US weights. Direct medical costs included those of the index procedure and hospitalization and costs for major adverse cardiac events during follow-up. Confidence intervals for both quality-adjusted life-years and costs were estimated by the bootstrap percentile method. Major adverse cardiac events at 1 year occurred in 13.2% of those in the FFR-guided arm and 18.3% of those in the angiography-guided arm (P=0.02). Quality-adjusted life-years were slightly greater in the FFR-guided arm (0.853 versus 0.838; P=0.2). Mean overall costs at 1 year were significantly less in the FFR-guided arm (

Cost of Illness and its Predictors for Parkinson's Disease in Germany

14 315 versus

Rate of clinical progression in Parkinson's disease. A prospective study

16 700; P<0.001). Bootstrap simulation indicated that the FFR-guided strategy was cost-saving in 90.74% and cost-effective at a threshold of US

Cost-Effectiveness of Deep Brain Stimulation in Patients With Parkinson's Disease

50 000 per quality-adjusted life-years in 99.96%. Sensitivity analyses demonstrated robust results. Conclusion— Economic evaluation of the FAME study reveals that FFR-guided percutaneous coronary intervention in patients with multivessel coronary disease is one of those rare situations in which a new technology not only improves outcomes but also saves resources. Clinical Trial Registration— URL: http://ClinicalTrials.gov. Unique identifier: NCT00267774.

Dopamine transporter imaging and SPECT in diagnostic work‐up of Parkinson's disease: A decision‐analytic approach

AbstractObjective: To prospectively evaluate the health economic burden of patients with Parkinson’s disease (PD) in Germany over a 6-month observation period and to identify the predictors of these costs. Study design and methods: Direct and indirect costs were evaluated in 145 patients with PD (mean age 67.3 ± 9.6 years). PD patients were recruited from an outpatient department for movement disorders, a specialised PD clinic, two office-based neurologists and general practitioners, all located in Germany, and were enrolled between January and June 2000. Relevant economic data were documented in a patient diary over the 6-month period. Clinical evaluations (Unified Parkinson’s Disease Rating Scale [UPDRS]) were performed at baseline and at 3 and 6 months. Costs were derived from various German medical economic resources. Costs were calculated from the perspective of healthcare and transfer payment providers and the individual patient. Indirect costs for lost productivity were also calculated. Costs are presented as means ± standard deviation (SD). Multivariate regression analyses were performed to identify independent cost predictors. Costs are in year 2000–02 values. Results: We estimated average per patient direct, indirect and total costs for the 6-month observation period. The costs from the perspective of statutory health insurance (Gesetzliche Krankenkversicherung [GKV]) consisted of direct medical costs €1370 ± €3240, including rehabilitation (€420 ± €1630), hospitalisation (€710 ± €2520), outpatient treatment (€40 ± €30), ancillary treatment (€190 ± €280) and ambulatory diagnostic procedures (€10 ± €30). In addition, parkinsonian drug costs were €1520 ± €1250. Non-medical direct costs calculated from the GKV perspective were estimated to be €480 ± €1710, which included transportation (€10 ± €20), special equipment (€420 ± €1640), social/home-help services (€10 ± €110) and sickness benefit (€40 ± €540). The total medical (including drug costs) and non-medical direct costs for the GKV were €3380 ± €4230. Univariate predictors for GKV direct costs included occurrence of motor complications and falls, disease severity, nightmares and dementia. However, multivariate analyses only suggested disease severity and health-related quality of life as significant predictors. For nursing insurance, payments of €1330 ± €2890 were calculated. For retirement insurance, payments were €650 ± €1510 and there were patient (or caregiver) costs of €1490 ± €2730. Total indirect costs amounted to €3180 ± €6480. Conclusion: According to our study, PD puts a high financial burden on society and underscores the need for further economic and medical research to optimise treatment for PD.

Systematic overview of cost–effectiveness thresholds in ten countries across four continents

Few prospective data on the clinical progression of Parkinsons disease (PD) in patient groups outside treatment trials in selected patients are available, and controversy exists on the rate of clinical disease progression with advancing disease. In this study, we investigated the rate of clinical progression of PD in a clinic‐based sample of 145 patients over 1 year and in a community‐based sample of 124 patients over 4 years. Depending on the sample and clinical scale used, mean deterioration of motor and disability scores ranged from 2.4 to 7.4% of the maximum possible score per year, and standard deviations indicated that there was considerable variability of progression rates between individuals. The progression of motor scores decreased with follow‐up over 4 years and significantly decreased in more advanced disease stages. Deterioration of disability scores did not differ between disease stages; this may reflect the increasing rate of disease complications, which contribute to increasing disability in addition to motor impairment alone, in more advanced disease. Thus, motor fluctuations, hallucinations, depression, memory problems, and bladder symptoms were all reported more often at follow‐up in the community‐based sample (all P < 0.01), and dyskinesias, motor fluctuations, falls, and hallucinations were more common and cognitive and depression scores worse in higher disease stages in the clinic‐based sample (all P < 0.001). We conclude that progression of motor scores in PD decreases with advancing disease in PD. However, disability continues to deteriorate with advancing disease and with the development of disease complications that are likely to be related to additional extrastriatal pathology.

Modelling the cost effectiveness of treatments for Parkinson's disease: a methodological review.

In addition to medical treatment, deep brain stimulation has become an alternative therapeutic option in advanced Parkinsons disease. High initial costs of surgery have to be weighted against long‐term gains in health‐related quality of life. The objective of this study was to assess the cost‐effectiveness of deep brain stimulation compared with long‐term medical treatment. We performed a cost‐utility analysis using a lifetime Markov model for Parkinsons disease. Health utilities were evaluated using the EQ‐5D generic health status measure. Data on effectiveness and adverse events were obtained from clinical studies, published reports, or meta‐analyses. Costs were assessed from the German health care provider perspective. Both were discounted at 3% per year. Key assumptions affecting costs and health status were investigated using one‐way and two‐way sensitivity analyses. The lifetime incremental cost‐utility ratio for deep brain stimulation was €6700 per quality‐adjusted life year (QALY) and €9800 and €2500 per United Parkinsons Disease Rating Scale part II (motor experiences of daily living) and part III (motor examination) score point gained, respectively. Deep brain stimulation costs were mainly driven by the cost of surgery and of battery exchange. Health status was improved and motor complications were reduced by DBS. Sensitivity analysis revealed that battery life time was the most influential parameter, with the incremental cost‐utility ratio ranging from €20,000 per QALY to deep brain stimulation dominating medical treatment. Deep brain stimulation can be considered cost‐effective, offering a value‐for‐money profile comparable to other well accepted health care technologies. Our data support adopting and reimbursing deep brain stimulation within the German health care system.