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The National Institute for Health and Clinical Excellence NICE guidance on the use of drug-eluting stents (DES) was published in July 2008.1 The guidance replaces sections 1.2–1.4 of NICE technology appraisal guidance number 71, which was published in 2003.2 This part-review indicates under what circumstances drug-eluting stents are recommended as a cost effective use of NHS resources in England and Wales.
Drug-eluting stents are recommended for use in percutaneous coronary intervention for the treatment of coronary artery disease, within their instructions 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.
DEVELOPMENT OF THE GUIDANCE
The appraisal committee considered the evidence on the clinical effectiveness of DES in the treatment of coronary heart disease (CHD). The meta-analysis of the clinical trials, conducted by the assessment group,3 showed that the use of DES reduced the rate of revascularisation in the target lesions and the target vessels, at all follow-up time points up to three years, compared with bare-metal stents (BMS). This reduced rate of revascularisation was not, however, accompanied by a reduction in mortality. The committee additionally took into account the ongoing international debate regarding the possible adverse effects of DES on the longer-term risks of myocardial infarction and mortality. It accepted the findings of the Food and Drug Administration review4 and agreed that the most reasonable view at present is that DES conferred no statistically significant benefits or harms in mortality or acute myocardial infarction (MI) rates in the longer term over BMS, when used within their indications for use (that is, in line with their CE markings). The overall conclusion therefore was that the key benefit of …