Coronary Artery Disease: Bagust A

Daemen J, Simoons ML, Wijns W, Bagust A, Bos G, Bowen JM, Braunwald E, Camenzind E, Chevaliers B, DiMario C, Fajadeto J, Gitt A, Guagliumi G, Hillege HL, James S, Jüni P, Kastrati A, Kloth S, Kristensen SD, Krucoff M, Legrand V, Pfisterer M, Rothman M, Serruys PW, Silber S, Steg PG, Tariah I, Wallentin L, Windecker SW, Aimonetti A, Allocco D, Berenger M, Boam A, Calle JP, Campo G, Carlier S, de Schepper J, Di Bisceglie G, Dobbels H, Farb A, Ghislain JC, Hellbardt S, ten Hoedt R, Isaia C, de Jong P, Lekehal M, LeNarz L, Mhullain FN, Nagai H, Patteet A, Paunovic D, Potgieter A, Purdy I, Raveau-Landon C, Ternstrom S, Van Wuytswinkel J, Waliszewski M, Anonymous00071. · Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. · EuroIntervention. · Pubmed #19284063 No free full text.

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Hill RA, Boland A, Dickson R, Dündar Y, Haycox A, McLeod C, Mujica Mota R, Walley T, Bagust A. · Liverpool Reviews and Implementation Group, University of Liverpool, UK. · Health Technol Assess. · Pubmed #17999841 links to  free full text

Abstract: OBJECTIVES: To assess the effectiveness and cost-effectiveness of the use of drug-eluting coronary artery stents in percutaneous coronary intervention (PCI) in patients with coronary artery disease. DATA SOURCES: Bibliographic databases, including MEDLINE, EMBASE and the Cochrane Library, were searched from December 2002 to August 2005. Hand-searching was also done. REVIEW METHODS: A systematic literature review of effectiveness was conducted focusing primarily on randomised controlled trials (RCTs). Full economic evaluations that compared two or more options and considered both costs and consequences were eligible for inclusion in the economics review. A critique of manufacturer submissions to the National Institute for Health and Clinical Excellence and an economic evaluation in the form of cost-utility analysis were also carried out. RESULTS: In the 17 RCTs of drug-eluting stents (DES) versus bare metal stents (BMS), no statistically significant differences in mortality or myocardial infarction (MI) were identified up to 3 years. Significant reductions in repeat revascularisations were determined for DES compared with BMS [for example, at 1 year: target lesion revascularisation (TLR) relative risk 0.24; 95% confidence interval (CI) 0.19 to 0.31; and target vessel revascularisation (TVR) relative risk 0.43; 95% CI 0.33 to 0.55]. This estimated benefit appears to be stable from 1 to 3 years. Binary restenosis and late luminal loss also favoured DES. In the eight RCTs of DES versus DES, no statistically significant differences in mortality or MI were detected between DES designs. In meta-analyses of TLR, TVR and composite event rate, marginal improvement in efficacy of Cypher trade mark over Taxus trade mark was observed. These results await confirmation beyond 1 year and differences in study design may have influenced reporting of outcomes. Ten full economic evaluations were included in the review and the balance of evidence indicated that DES are more cost-effective in higher risk patients. The review of submitted models confirmed the view that DES may be cost-effective only under very limited circumstances when realistic assumptions and data values were used. In the cost-utility analysis of DES versus BMS, the use of DES appears to reduce the rate of repeat revascularisations; benefit estimates used in the economic assessment are defined as 'broad' (i.e. cases involving any TLR/TVR irrespective of any other lesions/vessels undergoing revascularisation) and 'narrow' (i.e. cases involving TLR/TVR only). The incremental benefit to the patient is therefore described as the loss of quality-adjusted life-years (QALYs) avoided by not having to undergo a repeat revascularisation. Univariate sensitivity analysis and extreme values analysis indicate that the price premium, numbers of stents used in the index procedure and absolute risk reduction in repeat interventions most significantly influence the cost-effectiveness ratios. Sensitivity analyses also permit a range of values for efficacy and effectiveness to be considered for individual designs of DES. The cost-effectiveness results reveal that, all patients considered together, the calculated cost per QALY ratios are high (183,000-562,000 pounds) and outside the normal range of acceptability. Cost-effectiveness is only achieved for those non-elective patients who have undergone a previous coronary artery bypass graft and have small vessels. 'Real-world' data show that patient numbers in this latter group are very small (one in 3100 of all patients treated with PCI). CONCLUSIONS: The conclusions of the assessment are that the use of DES would be best targeted at the subgroups of patients with the highest risks of requiring reintervention, and could be considered cost-effective in only a small percentage of such patents. This is similar to the conclusion of our previous assessment. Trials of DES compared with new generation BMS and with DES would be useful, as would further evaluation of newer BMS in combination with drug administration.

Hill R, Bagust A, Bakhai A, Dickson R, Dündar Y, Haycox A, Mujica Mota R, Reaney A, Roberts D, Williamson P, Walley T. · Liverpool Reviews and Implementation Group, Liverpool, UK. · Health Technol Assess. · Pubmed #15361315 links to  free full text

Abstract: OBJECTIVES: To assess the effectiveness and cost-effectiveness of the use of coronary artery stents in patients with coronary heart disease (CHD). DATA SOURCES: Electronic databases. REVIEW METHODS: The review was conducted following accepted guidelines for conducting systematic reviews. Randomised controlled trials that include comparisons of percutaneous transluminal coronary angioplasty (PTCA) versus PTCA with stent, stent versus coronary artery bypass graft (CABG), and drug-eluting stents (DES) versus non-DES in patients with CAD in native or graft vessels and those with stable angina or acute coronary syndrome (ACS) and unstable angina were also included. Data on the following outcome measures were included in the review: combined event rate or event-free survival, death, acute myocardial infarction, target vessel revascularisation, repeat treatment (PTCA, stent or CABG) and binary restenosis. An economic model was developed based on extrapolation of trends in mortality and revascularisation from clinical trials data to a 5-year time horizon. RESULTS: The inclusion criteria were fulfilled by 50 studies comparing the use of stents with PTCA, six comparing stents with CABG and 12 comparing DES eluting stents with non-DES. No studies were identified that compared DES with PTCA or DES with CABG. Existing quality of life data suggest that revascularisation procedures reduce the patient's quality of life for a short period only. Stents were found to be more effective than PTCA in preventing adverse events and revascularisations. In multiple-vessel disease there was no evidence of a difference in mortality (at 1 year) between patients treated surgically and those receiving a stent. Patients treated surgically required fewer revascularisations. There is no evidence of a difference in mortality between patients receiving DES and those treated with bare metal stents at 1 year. A reduction in event rate at 9 and 12 months was found in patients treated with DES. This event rate is primarily made up of increased revascularisation rates in patients treated with bare metal stents. Two-year outcome data from one study indicate that this benefit of DES continues over the longer term. The economic model proved sufficient to indicate long-term trends in cost-effectiveness. CABG was found initially to be more expensive than bare metal stenting in multivessel disease and may have higher immediate risks, but over time the cost differential is reduced and long-term outcomes favour CABG over stenting. A similar situation was found for DES versus CABG in multiple-vessel disease. However, DES may not generally be considered a cost-effective alternative to bare metal stenting in single-vessel disease by policy makers as substantially higher costs are involved with a very small outcome benefit. CONCLUSIONS: DES might be considered cost-effective if the additional cost (compared with ordinary stents) was substantially reduced, the outcome benefits from the use of DES were much improved, and/or its use were targeted on the subgroups of patients with the highest risks of requiring reintervention. Long-term clinical studies are needed that focus on significant outcomes such as mortality. Further research should consider: the differences among plain stents; head-to-head comparisons within DES, CABG compared with DES; and the evaluation of newer non-DES against DES. Evaluation of the effects of revascularisation procedures and especially repeat revascularisation procedures on the patient's quality of life would also be useful, as would the development and testing of risk assessment tools to identify patients likely to need further revascularisations.

Bagust A, Grayson AD, Palmer ND, Perry RA, Walley T. · University of Liverpool Management School, Liverpool, UK. · Heart. · Pubmed #15831599 links to  free full text

Abstract: OBJECTIVE: To assess the cost effectiveness of drug eluting stents (DES) compared with conventional stents for treatment of symptomatic coronary artery disease in the UK. DESIGN: Cost-utility analysis of audit based patient subgroups by means of a simple economic model. SETTING: Tertiary care. PARTICIPANTS: 12 month audit data for 2884 patients receiving percutaneous coronary intervention with stenting at the Cardiothoracic Centre Liverpool between January 2000 and December 2002. MAIN OUTCOME MEASURES: Risk of repeat revascularisation within 12 months of index procedure and reduction in risk from use of DES. Economic modelling was used to estimate the cost-utility ratio and threshold price premium. RESULTS: Four factors were identified for patients undergoing elective surgery (n = 1951) and two for non-elective surgery (n = 933) to predict risk of repeat revascularisation within 12 months. Most patients fell within the subgroup with lowest risk (57% of the elective surgery group with 5.6% risk and 91% of the non-elective surgery group with 9.9% risk). Modelled cost-utility ratios were acceptable for only one group of high risk patients undergoing non-elective surgery (only one patient in audit data). Restricting the number of DES for each patient improved results marginally: 4% of stents could then be drug eluting on economic grounds. The threshold price premium justifying 90% substitution of conventional stents was estimated to be 112 pound sterling (212 USD, 162 pound sterling) (sirolimus stents) or 89 pound sterling (167 USD, 130 pound sterling) (paclitaxel stents). CONCLUSIONS: At current UK prices, DES are not cost effective compared with conventional stents except for a small minority of patients. Although the technology is clearly effective, general substitution is not justified unless the price premium falls substantially.