Ben van Hout

Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)

BACKGROUNDnThe multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more.nnnMETHODSn827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat.nnnFINDINGSnFour patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US

Modelling in Ecomomic Evaluation: An Unavoidable Fact of Life

1020) per patient.nnnINTERPRETATIONnOver 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.

Hip Fracture Prediction in Elderly Men and Women: Validation in the Rotterdam Study

The role of modelling in economic evaluation is explored by discussing, with examples, the uses of models. The expanded use of pragmatic clinical trials as an alternative to models is discussed. Some suggestions for good modelling practice are made.

Cost-effectiveness of drotrecogin alfa (activated) in the treatment of severe sepsis

The aim of our study was to validate a hip fracture risk function, composed of age and femoral neck bone mineral density (BMD). This estimate of the 1‐year cumulative risk was previously developed on the basis of Dutch hip fracture incidence data and BMD in men and women. A cohort of 7046 persons (2778 men) aged 55 years and over was followed for an average of 3.8 years. The 1‐year hip fracture risk estimate was calculated for each participant according to the risk function and categorized as low (<0.1%), moderate (0.1 to <1%), or high (≥1%). Observed first hip fracture incidence was then analyzed for each of these risk categories by age and gender. Additionally, we calculated the relative risk per standard deviation (SD) decrease in femoral neck BMD in this population. At baseline, 2360 individuals were categorized as low risk, 2567 as moderate risk, and 378 as high risk. During follow‐up, 110 first hip fractures were observed corresponding to an incidence rate of 4.1/1000 person‐years (pyrs) (95% confidence interval 3.4–5.0). The observed incidence rate in the low risk group was 0.2/1000 pyrs (0.1–0.9), 2.7/1000 pyrs (1.8–3.9) in the moderate risk group, and 18.4/1000 pyrs (12.4–27.2) in the high risk group. Below the age of 70 years, incidence was low in all categories, and very few individuals were considered at high risk. Above the age of 70 years, the observed incidence was high in the high risk group, while in the low and moderate risk groups, the incidence remained low even over 80 years of age. In women, the age‐adjusted relative risk for hip fractures was 2.5 per SD decrease in femoral neck BMD (1.8–3.6), while in men this relative risk was 3.0 per SD (1.7–5.4). In conclusion, we observed a similar relation of hip fracture with femoral neck BMD in men and women and were able to predict accurately hip fracture rates over a period of almost 4 years.

Relationship Between Seizure Frequency and Costs and Quality of Life of Outpatients with Partial Epilepsy in France, Germany, and the United Kingdom

ObjectiveTo assess the cost-effectiveness of drotrecogin alfa (activated) therapy, which was recently shown to reduce mortality in severe sepsis. DesignEstimates of effectiveness and resource use were based on data collected prospectively as part of a multicenter international trial. Estimates of hospital costs were based on a subset of the patients treated in the United States (33% of all enrolled patients). Lifetime projections were modeled from published sources and tested in sensitivity analyses. Analyses were conducted from the United States societal perspective, limited to healthcare costs, and using a 3% annual discount rate. SettingA total of 164 medical institutions in 11 countries. PatientsAdults ≥18 yrs of age with severe sepsis. InterventionsEligible patients were randomly assigned to receive a 96-hr intravenous infusion of drotrecogin alfa (acti-vated) at 24 &mgr;g/kg/hr (n = 850) or placebo (n = 840). Measurements and Main ResultsBase Case: incremental short-term (days 1–28) healthcare costs per day-28 survivor; Panel on Cost-Effectiveness in Health and Medicine Reference Case: incremental lifetime healthcare costs per quality-adjusted life-year. Over the first 28 days (short-term Base Case), drotrecogin alfa (activated) increased the costs of care by

A cost-effective analysis of primary coronary angioplasty versus thrombolysis for acute myocardial infarction

9,800 and survival by 0.061 lives saved per treated patient. Thus, drotrecogin alfa (activated) cost

DISCOUNTING COSTS AND EFFECTS : A RECONSIDERATION

160,000 per life saved (with 84.7% probability that ratio is <

Current Issues in the Management of Epilepsy: The Impact of Frequent Seizures on Cost of Illness, Quality of Life, and Mortality

250,000 per life saved). Projected to lifetime (lifetime Reference Case), drotrecogin alfa (activated) increased the costs of care by

Estimating parametric relationships between health description and health valuation with an application to the EuroQol EQ-5D

16,000 and quality-adjusted survival by 0.33 quality-adjusted life-years per treated patient. Thus, drotrecogin alfa (activated) cost

Heart transplantation in the Netherlands; costs, effects and scenarios☆

48,800 per quality-adjusted life-year (with 82% probability that ratio is <