Level 2: Mid-level evidence
Drug-eluting stents are used to reduce the risk of restenosis in patients having percutaneous coronary intervention. A Cochrane review has demonstrated that, compared with bare-metal stents, drug-eluting stents reduce the risk of target lesion revascularization.1
However, a large majority of patients with coronary artery disease (CAD) recruited for clinical studies are men, and these trials may not have been adequately powered to make similar conclusions in women. A recent pooled analysis of individual patient data has evaluated the long-term safety and efficacy of drug-eluting stents compared with bare-metal stents in a subgroup of female patients with CAD.2
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A systematic review identified 26 randomized trials comparing drug-eluting stents with bare-metal stents in 43,904 patients with CAD. Individual data from 11,557 women (26.3% of randomized patients) with a mean age of 67 years and a mean follow-up time of 2.9 years were included in the analysis.
Drug-eluting stents were classified as either newer-generation stents (including everolimus-eluting Xience and Promus stents, zotarolimus-eluting Endeavor and Resolute stents, biolimus-eluting Biomatrix and Nobori stents, and sirolimus-eluting Yukon stents) or early-generation stents (sirolimus-eluting Cypher stents and paclitaxel- eluting Taxus stents).
At baseline, women receiving drug-eluting stents had lower rates of diabetes and higher rates of previous MI compared with those receiving bare-metal stents. The minimum duration of dual antiplatelet therapy ranged from two months to 12 months.
The cumulative incidence of MI over three years was 4.8% in 6,278 women who received newer-generation drug-eluting stents, which was significantly lower than the rates in the other groups (6% of 4,171 women with early-generation drug-eluting stents and 7.7% of 1,108 women with bare-metal stents).
Similarly, the cumulative incidence of target lesion revascularization over three years was significantly reduced in the newer-generation drug-eluting stent group (6.3%) compared with the other groups (7.8% with early-generation and 18.6% with bare-metal stents).
Newer-generation drug-eluting stents were also associated with significantly lower rates of definite or probable stent thrombosis. The mortality rate was 5.7% overall, with no significant differences among treatment groups.
These results are consistent with previous findings observed for drug-eluting stents in trials evaluating populations of both women and men. Collectively, these data support the use of newer-generation drug-eluting stents compared with early-generation drug-eluting stents or bare-metal stents in women with coronary artery syndrome having percutaneous coronary intervention.
It is important to remember that drug-eluting stents are not the preferred option in patients unable to take dual antiplatelet therapy reliably for 12 months.3
Alan Ehrlich, MD, is a deputy editor for DynaMed, Ipswich, Mass., and assistant clinical professor in Family Medicine, University of Massachusetts Medical School in Worcester.
DynaMed is a database that provides evidence-based information on more than 3,000 clinical topics and is updated daily through systematic surveillance covering more than 500 journals. The most important evidence identified is summarized here.