• National Institute for Health and Clinical Excellence (NICE). Drug-eluting stents for the treatment of coronary artery disease. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Jul. 48 p. (Technology appraisal guidance; no. 152).

This is the current release of the guideline.

Coronary artery disease

Assessment of Therapeutic Effectiveness
Treatment

Cardiology
Internal Medicine
Thoracic Surgery

Advanced Practice Nurses
Nurses
Physician Assistants
Physicians

To evaluate the clinical effectiveness and cost-effectiveness of drug-eluting stents for the treatment of coronary artery disease

Adults with coronary artery disease undergoing percutaneous coronary intervention (PCI)

Drug-eluting stents (DES)

• Clinical effectiveness
  • Combined event rate (major adverse cardiac events, target vessel failure) or event free survival
  • Mortality (all cause and cardiac)
  • Acute myocardial infarction
  • Target lesion revascularization
  • Target vessel revascularization
  • Repeat revascularization (percutaneous coronary intervention [PCI]/stent, other PCI or coronary artery bypass grafting [CABG])
  • Adverse effects (thrombosis, mal-absorption; incomplete stent apposition; device failures/defects)
  • Angiographic binary restenosis
  • Late loss
  • Health-related quality of life
• Cost-effectiveness

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Clinical Effectiveness

• Seventeen randomised controlled trials (RCTs) (reported in 58 records) comparing drug-eluting stent (DES) with bare-metal stent (BMS) were included.
• Eight RCTs (reported in 11 records) comparing DES with other DES were identified.
• Twenty-seven non-RCTs for assessment of new and existing DES were identified.

Cost-Effectiveness

• A total of 10 full economic evaluations were included
• Seven manufacturers' submissions were provided

Expert Consensus

Not applicable

Meta-Analysis
Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Note from the National Guideline Clearinghouse (NGC): The National Institute for Health and Clinical Excellence (NICE) commissioned an independent academic centre to perform a systematic literature review on the technology considered in this appraisal and prepare an assessment report. The assessment report for this technology appraisal was prepared by the Liverpool Reviews and Implementation Group, University of Liverpool (see the "Availability of Companion Documents" field).

Clinical Effectiveness

Data Extraction

Data extraction for the review of clinical effectiveness was carried out by two reviewers. Data were independently abstracted by one reviewer into pretested data extraction forms created within the Access database application, Microsoft Corporation, and then checked for accuracy by a second reviewer.

Data presented from multiple reports of single trials were extracted onto a single data extraction record.

Quality Assessment

Two of three reviewers independently evaluated the included studies for methodological quality (utilising forms created in Access) using criteria based on Centre for Reviews and Dissemination, Report 4 (refer to Appendix 2 of the Assessment Report [see the "Availability of Companion Documents" field]). Any discrepancies in quality grading were resolved through discussion.

Outcomes/Data Analysis

Outcome data from trials comparing drug-eluting stent (DES) with bare-metal stent (BMS) are presented in Table 3 in Appendix 3 of the Assessment Report (see the "Availability of Companion Documents" field). Meta-analysis is presented for mortality, acute myocardial infarction (AMI), composite event rate (major adverse coronary and cerebrovascular events [MACE], target vessel failure [TVF]), target lesion revascularisation, target vessel revascularisation, angiographic binary restenosis rates and late luminal loss.

Data in the form of odds ratio (OR) and 95% confidence intervals (CI) were analysed using the Mantel-Haenszel method, fixed-effect model provided by the RevMan Analyses 1.0 application within RevMan 4.2. Similarly, for continuous outcomes, weighted mean difference (WMD) was analysed.

Heterogeneity was tested by the chi-squared test and the I² statistic was obtained to describe the proportion of the variability using RevMan Analyses 1.0. Where quantitative heterogeneity was indicated, analysis using a random-effects model was conducted for comparison with results of fixed-effect-based analysis.

For convenience, studies are grouped according to drug eluted in the meta-analysis. Pooled estimates (OR 95%CI) are provided for each 'eluted drug' subgroup. Pooled effect estimate incorporating available data for all DES analysed are presented in Table 4-3 of the Assessment Report (see the "Availability of Companion Documents" field).

Refer to Section 4 of the Assessment Report (see the "Availability of Companion Documents" field) for more information.

Cost-Effectiveness

Quality of Economic Literature

Ten studies were quality assessed against a standard checklist. In general the quality of data was reasonably high (see Table 6-6 of the Assessment Report [see the "Availability of Companion Documents" field]), except in four key areas. Firstly, the resource use was only reported separately from costs in four of the studies, making it impossible to validate underlying assumptions. Secondly, a discount rate was not applied by one study, and no explanation was given as to why not. Furthermore, the sensitivity analysis was not fully explained or justified in that study. Finally and most importantly, the modelling methodology was poorly described by seven of the studies, making it difficult to access the credibility of their models.

Refer to Sections 6 and 7 of the Assessment Report (see the "Availability of Companion Documents" field) for more information.

Expert Consensus

Considerations

Technology appraisal recommendations are based on a review of clinical and economic evidence.

Technology Appraisal Process

The National Institute for Health and Clinical Excellence (NICE) invites 'consultee' and 'commentator' organisations to take part in the appraisal process. Consultee organisations include national groups representing patients and carers, the bodies representing health professionals, and the manufacturers of the technology under review. Consultees are invited to submit evidence during the appraisal and to comment on the appraisal documents.

Commentator organisations include manufacturers of the products with which the technology is being compared, the National Health Service (NHS) Quality Improvement Scotland and research groups working in the area. They can comment on the evidence and other documents but are not asked to submit evidence themselves.

NICE then commissions an independent academic centre to review published evidence on the technology and prepare an 'assessment report'. Consultees and commentators are invited to comment on the report. The assessment report and the comments on it are then drawn together in a document called the evaluation report.

An independent Appraisal Committee then considers the evaluation report. It holds a meeting where it hears direct, spoken evidence from nominated clinical experts, patients and carers. The Committee uses all the evidence to make its first recommendations, in a document called the 'appraisal consultation document' (ACD). NICE sends all the consultees and commentators a copy of this document and posts it on the NICE website. Further comments are invited from everyone taking part.

When the Committee meets again it considers any comments submitted on the ACD; then it prepares its final recommendations in a document called the 'final appraisal determination' (FAD). This is submitted to NICE for approval.

Consultees have a chance to appeal against the final recommendations in the FAD. If there are no appeals, the final recommendations become the basis of the guidance that NICE issues.

Who is on the Appraisal Committee?

NICE technology appraisal recommendations are prepared by an independent committee. This includes health professionals working in the NHS and people who are familiar with the issues affecting patients and carers. Although the Appraisal Committee seeks the views of organisations representing health professionals, patients, carers, manufacturers and government, its advice is independent of any vested interests.

Not applicable

Consideration of the Evidence

After agreeing on the parameters to use in the Assessment Group's model, the Committee discussed the resulting incremental cost-effectiveness ratios (ICERs) for the base case and risk groups, assuming:

• The absolute risk of revascularization with bare-metal stents (BMSs) for the total population is 11%, with resulting risks of revascularization for small vessels of 19% and for long lesions of 11.7%
• The mean number of stents per patient is 1.571
• The relative risk reduction with drug-eluting stents (DESs) for the base case is 55% for the total population, and 65% for patients with small vessels and long lesions
• Price differences of DESs over BMSs of 600 and 300 pounds sterling

At a relative risk reduction of 55% with DESs, the resulting ICER for the total population of patients was associated with a cost per quality-adjusted life year (QALY) of approximately 171,000 pounds sterling at a price difference of 600 pounds sterling and 74,000 pounds sterling at a price difference of 300 pounds sterling. For the higher risk groups of patients (that is, those with long lesions and those with small vessels) using a DES, with a relative risk reduction of 65%, the resulting ICERs were associated with costs per QALYs of 126,000 pounds sterling and 95,000 pounds sterling, respectively, at a price difference of 600 pounds sterling and 47,000 pounds sterling and 25,000 pounds sterling, respectively, at a price difference of 300 pounds sterling.

The Committee agreed that DESs could not be considered a cost-effective use of National Health Service (NHS) resources at a price difference of 600 pounds sterling. After considering the alternative parameter values presented by the Assessment Group and British Cardiovascular Intervention Society (BCIS), the Committee concluded that on balance at a price difference between DESs and BMSs of not more than 300 pounds sterling, DESs could be considered a cost effective option in patients with small vessels and long lesions.

Refer to Section 4 of the original guideline document for information on the economic analyses provided by the manufacturers, the Assessment Group, and the Appraisal Committee considerations.

External Peer Review

Consultee organizations from the following groups were invited to comment on the draft scope, Assessment Report and the Appraisal Consultation Document (ACD) and were provided with the opportunity to appeal against the Final Appraisal Determination.

• Manufacturer/sponsors
• Professional/specialist and patient/carer groups
• Commentator organisations (without the right of appeal)

In addition, individuals selected from clinical expert and patient advocate nominations from the professional/specialist and patient/carer groups were also invited to comment on the ACD.

None provided

The type of evidence supporting the recommendations is not specifically stated.

Appropriate use of drug-eluting stents for the treatment of coronary artery disease

There is a risk of stent thrombosis associated with the use of both types of stent (drug-eluting stents [DESs] and bare-metal stents [BMSs]).

For details of side effects and specific contraindications for DESs, refer to the instruction for use (IFU) document attached to each DES.

For details of side effects and specific contraindications for drug-eluting stents (DESs) refer to the instruction for use (IFU) document attached to each DES.

• This guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. The guidance does not, however, override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
• Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.

Getting Better
Living with Illness

Effectiveness
Patient-centeredness

• National Institute for Health and Clinical Excellence (NICE). Drug-eluting stents for the treatment of coronary artery disease. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Jul. 48 p. (Technology appraisal guidance; no. 152).

Not applicable: The guideline was not adapted from another source.

2008 Jul

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

National Institute for Health and Clinical Excellence (NICE)

Appraisal Committee

Committee Members: Professor Keith Abrams, Professor of Medical Statistics, University of Leicester; Dr Darren Ashcroft, Senior Clinical Lecturer, School of Pharmacy and Pharmaceutical Sciences, University of Manchester; Dr Jeffrey Aronson, Reader in Clinical Pharmacology, University Department of Clinical Pharmacology, Radcliffe Infirmary; Professor David Barnett, Professor of Clinical Pharmacology, University of Leicester; Dr Peter Barry, Consultant in Paediatric Intensive Care, Leicester Royal Infirmary; Mr Brian Buckley, Lay Member; Professor Stirling Bryan, Director, Health Economics Facility, University of Birmingham; Professor John Cairns, Public Health and Policy, London School of Hygiene and Tropical Medicine; Professor Mike Campbell, Statistician, University of Sheffield; Professor David Chadwick, Professor of Neurology, Walton Centre for Neurology and Neurosurgery; Dr Mark Chakravarty, Industry Member; Dr Peter I Clark, Consultant Medical Oncologist, Clatterbridge Centre for Oncology, Merseyside; Dr Mike Davies, Consultant Physician, University Department of Medicine and Metabolism, Manchester Royal Infirmary; Professor Jack Dowie, Health Economist, London School of Hygiene; Ms Lynn Field, Nurse Director, Pan Birmingham Cancer Network; Professor Christopher Fowler, Professor of Surgical Education and Honorary Consultant Urologist; Mrs Barbara Gerggains, Lay Member; Dr Fergus Gleeson, Consultant Radiologist, The Churchill Hospital, Oxford; Ms Sally Gooch, Independent Healthcare Consultant; Mr Sanjay Gupta, Stroke Services Manager, Basildon and Thurrock University Hospitals NHS Trust; Professor Philip Home, Professor of Diabetes Medicine, University of Newcastle upon Tyne; Dr Peter Jackson, Clinical Pharmacologist, University of Sheffield; Professor Peter Jones, Professor of Statistics and Dean, Faculty of Natural Sciences, Keele University; Dr Mike Laker, Medical Director, Newcastle Hospitals NHS Trust; Dr George Levvy, Chief Executive, Motor Neurone Disease Association, Northampton; Ms Rachel Lewis, Nurse Advisor to the Department of Health; Mr Terence Lewis, Lay Member; Professor Gary McVeigh, Professor of Cardiovascular Medicine, Queen's University Belfast; Professor Jonathan Michaels, Professor of Vascular Surgery, University of Sheffield; Dr Neil Milner, General Practitioner, Sheffield; Dr Ruairidh Milne, Senior Lecturer in Health Technology Assessment, National Coordinating Centre for Health Technology; Dr John Pounsford, Consultant Physician, Frenchay Hospital, Bristol; Dr Rosalind Ramsay, Consultant Psychiatrist, Adult Mental Health Services, Maudsley Hospital; Dr Stephen Saltissi, Consultant Physician, The Royal Liverpool University Hospital; Mr Miles Scott, Chief Executive, Bradford Teaching Hospitals NHS Foundation Trust; Dr Lindsay Smith, General Practitioner, East Somerset Research Consortium; Mr Roderick Smith, Director of Finance, Adur, Arun and Worthing PCT; Mr Cliff Snelling, Lay Member; Dr Ken Stein, Senior Lecturer, Peninsula Technology Assessment Group (PenTAG), University of Exeter; Professor Andrew Stevens (Chair), Professor of Public Health, University of Birmingham

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

This is the current release of the guideline.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.