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The boom in drug-eluting stents (DES), which was noted in the United Kingdom despite initial restrictions by the National Institute for Health and Clinical Excellence (NICE), was stopped by first reports about an increased risk of late stent thrombosis and related cardiac death or myocardial infarction (MI) several months to years after DES implantation.1 2 Although this finding was confirmed in many analyses,3–5 its clinical relevance remained disputed: since it was not associated with increased rates of death or MI,3 6 it was considered “irrelevant” by many, whereas others—like NICE—were impressed by the severity of its consequences and opted to ban DES entirely. In July 2007, NICE released a new draft guidance on the use of DES stating that “DES are not recommended for use in percutaneous coronary intervention in patients with coronary artery disease (CAD)”. This recommendation led to extensive debates among interventional cardiologists, other healthcare professionals and industry and to new long-term data and meta-analyses.
A large network meta-analysis including 38 randomised DES trials concluded that up to four years, the risks of mortality associated with DES and bare-metal stents (BMS) are similar.7 Still, the problem of late stent thrombosis persisted, with an incidence of 0.6% per year8 if only angiographically documented cases were considered, but at a rate of 2–3% if target-vessel MIs and unexpected late cardiac death were also counted.2 9 10 This did not translate into an overall increased mortality mainly for two reasons: (1) restenosis may also lead to MI or death6 and is significantly reduced by DES in all studies, and (2) there seem to be certain groups of patients who clearly benefit from DES, such as those with stenting of small vessels, long lesions, diabetes or bypass grafts; whereas …