TA152 Coronary artery disease - drug-eluting stents: guidance

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Transcript of TA152 Coronary artery disease - drug-eluting stents: guidance

  • 1. Issue date: July 2008Review date: April 2009Drug-eluting stents for thetreatment of coronary arterydisease Part review of NICEtechnology appraisal guidance 71NICE technology appraisal guidance 152
  • 2. NICE technology appraisal guidance 152Drug-eluting stents for the treatment of coronary artery disease(part review of NICE technology appraisal guidance 71)Ordering informationYou can download the following documents from www.nice.org.uk/TA152 The full guidance (this document). A quick reference guide for healthcare professionals. Information for people with coronary artery disease and their carers (Understanding NICE guidance). Details of all the evidence that was looked at and other background information.For printed copies of the quick reference guide or Understanding NICEguidance, phone NICE publications on 0845 003 7783 or emailpublications@nice.org.uk and quote: N1636 (quick reference guide) N1637 (Understanding NICE guidance).This guidance is written in the following contextThis guidance represents the view of the Institute, which was arrived at aftercareful consideration of the evidence available. Healthcare professionals areexpected to take it fully into account when exercising their clinical judgement. Theguidance does not, however, override the individual responsibility of healthcareprofessionals to make decisions appropriate to the circumstances of the individualpatient, in consultation with the patient and/or guardian or carer.Implementation of this guidance is the responsibility of local commissionersand/or providers. Commissioners and providers are reminded that it is theirresponsibility to implement the guidance, in their local context, in light of theirduties to avoid unlawful discrimination and to have regard to promoting equality ofopportunity. Nothing in this guidance should be interpreted in a way which wouldbe inconsistent with compliance with those duties. National Institute for Health and Clinical Excellence MidCity Place 71 High Holborn London WC1V 6NA www.nice.org.uk National Institute for Health and Clinical Excellence, 2008. All rights reserved. This materialmay be freely reproduced for educational and not-for-profit purposes. No reproduction by orfor commercial organisations, or for commercial purposes, is allowed without the expresswritten permission of the Institute.
  • 3. ContentsContents ...........................................................................................................31 Guidance.........................................................................................................42 Clinical need and practice...............................................................................43 The technologies.............................................................................................74 Evidence and interpretation..........................................................................105 Implementation ............................................................................................346 Recommendations for further research........................................................357 Related NICE guidance................................................................................368 Review of guidance.......................................................................................36Appendix A: Appraisal Committee members and NICE project team............36Appendix B: Sources of evidence considered by the Committee..................41
  • 4. NOTE: This guidance replaces sections 1.21.4 of NICE technologyappraisal guidance 71 (2003).Sections 1.1 and 1.5 of technology appraisal guidance 71 recommend whento use a stent. This part review recommends under what circumstances adrug-eluting stent should be used.1 GuidanceDrug-eluting stents are recommended for use in percutaneous coronaryintervention for the treatment of coronary artery disease, within theirinstructions for use, only if: the target artery to be treated has less than a 3-mm calibre or the lesion is longer than 15 mm, and the price difference between drug-eluting stents and bare-metal stents is no more than 300.2 Clinical need and practiceCoronary artery disease is also known as coronary heart disease (CHD) andischaemic heart disease. It is narrowing (stenosis) of the coronary arteries asa result of deposition of atherosclerotic plaque, which results in an insufficientsupply of oxygen to the heart muscle. CHD may affect one or more arteries,which may be of different diameters (calibres). The stenosis of arteries maybe partial or total. Coronary artery stenosis may be asymptomatic or may leadto angina chest pain that may be severe enough to restrict or preventexertion. A critical reduction of the blood supply to the heart may result inmyocardial infarction (MI) or death.Mortality rates from CHD are decreasing but CHD remains the most commoncause of mortality in the UK. It accounted for nearly 117,500 deaths in the UKin 2002 (about 103,000 deaths in England and Wales). CHD is also the causeof considerable morbidity and loss of ability to lead a normal life. In the UK,annually, approximately 259,500 people experience an acute MI andapproximately 341,500 new cases of angina (the most common form of CHDNICE technology appraisal guidance 152 4
  • 5. morbidity) are reported. In Europe, CHD has been estimated to account for9.7% of total disability-adjusted life years lost.Mortality and morbidity rates associated with CHD vary by socioeconomicgroup (rates are higher in lower socioeconomic groups), by geographical area(rates are highest in Wales, North West England, and the Northern Englandand Yorkshire regions, and lowest in South East England) and by ethnicgroup (for example, CHD rates are highest among people from the Indiansubcontinent living in the UK). The prevalence of CHD also increases withage and is higher in men than women. The disease is more common inpeople with high serum cholesterol and/or high blood pressure, in people whohave type 1 or type 2 diabetes mellitus, in people who smoke, and in peoplewho are physically inactive and/or obese.The symptoms and health risks associated with a stenosed artery may betreated medically, by modifying risk factors (for example, smoking,hyperlipidaemia, obesity and hyperglycaemia) and/or by drug treatment (forexample, beta-adrenergic blockers, nitrates, calcium-channel blockers,antiplatelet agents and/or statins).If these medical treatments fail or are inappropriate, two invasive therapiesare available. The first, coronary artery bypass grafting (CABG), involvesmajor cardiac surgery. The second, balloon angioplasty (or percutaneoustransluminal coronary angioplasty) involves a widening from within the arteryusing a balloon catheter, which is inserted through a femoral artery. Wheninflated, the balloon increases the calibre of the artery. Most percutaneoustransluminal coronary angioplasty procedures involve the use of stents. Astent is a thin wire-mesh tube loaded over an angioplasty balloon. When theballoon inflates, the stent expands like a scaffold to hold the vessel open, andis left behind after the balloon is deflated and withdrawn. Percutaneouscoronary intervention (PCI) is a generic term that encompasses percutaneoustransluminal coronary angioplasty with or without stenting. The comparison ofCABG with PCI including coronary artery stents (bare-metal and drug-eluting)was covered by NICE technology appraisal guidance 71 and is not dealt within this appraisal.NICE technology appraisal guidance 152 5
  • 6. One of the criteria for comparing the clinical effectiveness of PCI with stentswith standard PCI (without stents) is the incidence of subsequent attacks ofangina and major adverse coronary events (MACEs), which include death, MIand the need for further revascularisation procedures (CABG or repeat PCI).A number of problems with PCI may occur. Recoil of the artery whichhappens when the balloon is deflated, usually occurs immediately or within24 hours of completing the procedure, and may be associated with acuteocclusive dissection of the vessel and require emergency CABG. In themedium term restenosis of the artery after the procedure may occur and hastwo main causes: contraction of the outer layer of the artery secondary to aninjury reaction (36 months after the procedure) and proliferation of smoothmuscle cells within the arterial wall (46 months after the procedure), leadingto intimal hyperplasia. As a consequence of restenosis, a repeat proceduremay be required and the rate of reintervention is greater in patients who havearteries of small calibre (small vessels less than 3 mm in calibre),saphenous vein grafts and long lesions (longer than 15 mm) or totalocclusions. People with diabetes, who commonly have arteries affected byatherosclerosis, also have a higher rate of restenosis.Stent technology (type and platform, including the design, alloy used and strutthickness) has developed rapidly, and recent advances aim to reduce thelikeliho