Mortality is higher with drug eluting stents than with uncoated stents, studies find

The safety of drug eluting stents has been called into question by two meta-analyses of their long term effects. The results of the studies were presented at the World Congress of Cardiology in Barcelona last week.

Both studies showed that the risk of death and of Q wave myocardial infarction, a clinical surrogate of stent thrombosis, was higher with drug eluting stents than with bare metal or uncoated stents.

The use by cardiologists of the first generation of drug eluting stents—the sirolimus (Cypher) and the paclitaxel (Taxus) stents—has risen rapidly since they were introduced. Currently around six million people worldwide have had a drug eluting stent fitted.

Their widespread uptake came after promising early data from a study published in the New England Journal of Medicine (2002;346:1773-80). This study showed that the rate of re-stenosis was zero at six months after implantation of drug eluting stents but 26% after implantation of bare metal stents. Other early studies indicated that stent thrombosis was not a problem with drug eluting stents.

However, four years later case reports of late stent thrombosis and delayed healing in patients fitted with …