Are further studies or new warnings needed on the safety of coated stents? Practitioners and patients await the outcome of the FDA’s meetings planned for this Thursday and Friday.

Coated stents, also known as drug-eluting coronary stents, have until recently been seen as a cost-effective way to keep clogged arteries open after being cleared. However, new studies revealed at a conference in Barcelona in September suggest that a very small proportion (less than 1 per cent) of patients develop blood clots when they come off anti-clotting medication up to three years later.

Some hospitals have reduced their use of coated stents in favour of bare metal ones as a precaution while they await the outcome of further research, notwithstanding the FDA’s deliberations. Others urge their patients to stay on the anti-clotting medication longer, which of course increases the cost of post-op treatment. One such drug (clopigorel, marketed as Plavix) costs in the region of 120 US dollars a month.

In the US alone, over 2 million people have a coated stent implant.

The alternative to a coated stent is the bare metal stent, which is not as effective at preventing the formation of the scar tissue that causes the artery wall to thicken and risk of blockage to develop anew at the site of implant. However, these new developments have upset the balance of pros and cons of coated versus uncoated stents and reopened the safety debate.

Click here for safety information on coronary stents, MHRA (UK).

Written by: Catharine Paddock
Writer: Medical News Today