Background: In unselected patients, the incidence of restenosis is lower after placement of drug-eluting stents (DES) than bare-metal stents (BMS) without difference in safety at a time horizon of 4 years. However, DES appears less effective in “off label” patients.

Objectives: The aim of the study was to assess available evidence of DES efficacy and safety by patient category to establish when DES placement may be recommended for reimbursement by the French national health insurance.

Methods: Based on a systematic review by patient category (January 2002 to August 2009), two health technology assessment (HTA) reports and thirty-eight clinical studies not covered by the HTA reports (eleven meta-analysis including ours, eleven randomized trials and sixteen cohort studies) were selected. After assessment of the methodological quality, the studies mostly comparing DES with BMS were reviewed by a panel of health professionals who defined a priori the most relevant end points of safety and efficacy.

Results: Seven to fourteen patients treated with DES were needed to avoid one target lesion revascularization (TLR) in patients with lesions >15 mm long, vessel diameter <3 mm, or diabetes, and with some complex lesions (total coronary occlusion, BMS in-stent restenosis multivessel disease, unprotected left main stenosis). DES appeared as safe as other alternatives over a follow-up of up to 4 years when dual antiplatelet therapy was continued for at least 1 year, but statistical power remains limited to conclude for some clinical features.

Conclusions: For reimbursement, DES use should be limited to certain categories of patients. Treatment of particular cases requires a multidisciplinary approach.

Objectives: Recent concerns have been raised for the safety after drug-eluting stents (DES) implantation compared with the use of bare-metal stents (BMS) in patients with ST-elevation acute myocardial infarction (STEMI). The objective of this study was to estimate the relative impact of DES versus BMS on mortality, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis (ST) in STEMI patients by performing comprehensive meta-analyses of randomized controlled trials (RCTs) and observational studies.

Methods: We performed an electronic search and manual search of studies presented through September 2009, without language restrictions. An approach of “using systematic reviews” was used. Two independent reviewers extracted prespecified data from each study. A random-effects model was used to combine trials and to perform stratified analyses based on study designs and the duration of follow-up.

Results: Fourteen RCTs were identified (N = 7,654). Compared with BMS, DES significantly reduced TVR (risk ratio [RR], 0.48; 95 percent confidence interval [CI], 0.41–0.56) and MI (RR, 0.77; 95 percent CI, 0.61–0.97), without increasing mortality (RR, 0.88; 95 percent CI, 0.70–1.10) and ST (RR, 0.93; 95 percent CI, 0.72–1.21). Among 35 observational studies (N = 44,849), the use of DES was associated with a significant reduction in mortality (RR, 0.85; 95 percent CI, 0.79–0.91) and TVR (RR, 0.61; 95 percent CI, 0.48–0.77). MI and ST were significantly lower in the DES group within 1-year follow-up, but there were no differences within 2 years of follow-up. There was no evidence of statistical heterogeneity and publication bias.

Conclusions: These data in aggregate suggest that using DES in STEMI patients is safe and efficacious, but there are differences between RCT and observational data comparing DES and BMS.

Objectives: The aim of this study was to analyze and describe process and outcomes of two pilot assessments based on the HTA Core Model, discuss the applicability of the model, and explore areas of development.

Methods: Data were gathered from HTA Core Model and pilot Core HTA documents, their validation feedback, questionnaires to investigators, meeting minutes, emails, and discussions in the coordinating team meetings in the Finnish Office for Health Technology Assessment (FINOHTA).

Results: The elementary structure of the HTA Core Model proved useful in preparing HTAs. Clear scoping and good coordination in timing and distribution of work would probably help improve applicability and avoid duplication of work.

Conclusions: The HTA Core Model can be developed into a platform that enables and encourages true HTA collaboration in terms of distribution of work and maximum utilization of a common pool of structured HTA information for national HTA reports.

Objectives: To determine the cost-effectiveness (CE) and cost-utility (CU) of drug-eluting stents (DES) compared to bare metal stents (BMS) in Ontario using a large prospective “real-world” cohort study and determine the extent to which results vary by patient risk subgroups.

Methods: A field evaluation was conducted based on all stent procedures in the province of Ontario between December 1, 2003, and March 31, 2005, with a minimum subject follow-up of 1 year. Effectiveness data from the study using a propensity-score matched cohort were combined with resource utilization and cost data and quality of life (QOL) data from the published literature in a decision analytic modeling framework to determine 2-year cost-effectiveness (cost per revascularization avoided) and cost-utility (cost per quality-adjusted life-year ([QALY] gained). Stochastic model parameter uncertainty was expressed using probability distributions and analyzed using a probabilistic model. Modeling assumptions were assessed using traditional deterministic sensitivity analysis.

Results: Significant differences in revascularization rates were found for patients with two or more high risk factors. Despite these differences, the CE and CU of DES remained high (e.g., $419,000 per QALY gained in the most favorable patient risk subgroup). In sensitivity analysis, the difference in cost between DES and BMS had an impact on the CE and CU results. For example, at a price differential of $500, the CU of DES was $20,000/QALY for one patient subgroup and DES was dominant (i.e., less costly and more effective) in another.

Conclusions: At current prices, the CE/CU of DES compared with BMS is high even in patient high risk subgroups. As the relative price of DES decrease, the value for money attractiveness of DES increases, especially for selected high risk patients.

Objectives: To assess the impact of the availability of drug-eluting stents (DES) in April 2002 in Emilia-Romagna (a four-million resident Italian region), on the rate of use of revascularization procedures. DES are expected to influence the rate of use of coronary artery bypass graft (CABG) and percutaneous coronary interventions (PCI). However, to date, little empirical information is available on the actual impact of this innovation on clinical practice.

Methods: A time series regression analysis of the monthly number of procedures (PCI and CABG) performed between January 1998 and March 2003.

Results: DES availability was associated with statistically significant changes in the use of revascularization procedures, although the size of the effect was always small or moderate. PCI increased only by 0.36 more procedures per month (approximately four per year), whereas more evident was the concurrent reduction of isolated CABG (4.15 fewer per month, that is fifty fewer per year). Overall, considering all the surgical revascularizations (i.e., CAGB both isolated and associated with other interventions), there was a reduction of 2.52 procedures per month (thirty less per year).

Conclusions: Despite DES being at a very early stage of their diffusion process, our results indicate that they are already having an impact, although moderate, on the use of revascularization procedures. If these findings will be confirmed, they will have a substantial influence on the patterns of care for patients with coronary artery disease and relevant policy implications for health services.