Last week an expert panel of the US Food and Drug Administration (FDA) recommended that the FDA should issue warnings to doctors and patients about drug eluting coronary stents. The safety of such stents is unclear except in low risk patients. Furthermore, patients with drug eluting stents should take antiplatelet therapy for at least one year after insertion.

Percutaneous coronary intervention is the dominant treatment for patients with coronary artery disease; 73 000 procedures were performed in the United Kingdom in 2005, compared with 25 000 coronary artery bypass operations. Drug eluting stents have been part of the procedure since 2002 as they reduce the risk of in-stent restenosis.

In-stent restenosis, caused by injury induced cell proliferation and scar tissue formation, requires repeat intervention in 12-20% of patients receiving a bare metal (non-drug eluting) stent.1 Randomised trials have shown that drug eluting stents, which are coated with agents such as sirolimus or paclitaxel that inhibit such local smooth muscle proliferation, reduce the need for repeat procedures to about 5%.2 3

Do drug eluting stents …