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The safety of drug-eluting stents (DES) has been called into question by studies suggesting a predisposition to late stent thrombosis—an uncommon but potentially fatal complication.1–4 Consequently, balancing the risks and benefits of DES use in an individual patient undergoing percutaneous coronary intervention (PCI) is challenging, particularly as studies have often been unrepresentative of routine practice, underpowered, prone to bias or used inconsistent definitions of stent thrombosis.
WHAT ARE THE BENEFITS?
DES have been studied widely in patients undergoing single vessel PCI for stable or unstable angina. “On-label” use of both sirolimus-eluting and paclitaxel-eluting stents is defined by the inclusion criteria for their respective pivotal randomised clinical trials (RCTs).5 6 In patients randomised to DES there was an approximate 10% absolute reduction in the need for target lesion revascularisation at 9 months; this benefit was sustained to at least 4 years of follow-up.5–7 Subsequent studies have demonstrated the efficacy of DES in a variety of angiographic subgroups.8–10 However, within RCTs, comparator bare-metal stents (BMS) were often inferior to those used in contemporary practice, and angiography mandated by the study protocols artificially inflated the absolute benefit of DES owing to the well-described “oculo-stenotic” reflex.11 Despite these limitations, the clinical efficacy of DES in reducing restenosis is not in doubt.
WHAT ARE THE RISKS?
DES may be associated with late stent thrombosis, which usually results in myocardial infarction …