Hyderabad: Stents grabbed the limelight in July last year when government regulators brought them under the National List of Essential Medicines, in a bid to make them more accessible and affordable to the people.
They are back in the limelight again after a recent review published in Journal of Medicine revea-led that completely bio-absorbable stents have a higher risk of forming blot clots in the arteries and leading to heart attacks.
This has prompted the US Food and Drug Administration (FDA) to ask all stent manufacturing companies making bio-absorbable stents to issue warnings and state that these can’t be used for small arteries and for very thick/large blood clots.
Senior cardiologist Dr Sunil Kapoor explained, “The order from the US FDA has come in only last week. This was because patients who had got totally absorbable stents fitted had very severe heart atta-cks. This is called device thrombosis where blood clot forms on the stent. Presently, the best stents that must be used for patients are thin strut stents with a bio-degradable polymer and drug elu-ting stents to clear blockages. These stents have shown least incidence of clotting.”
The Hyderabad data of bio-absorbable stents has not been released yet hence assessing the impact locally is not feasible, explained cardiologists.
A senior cardiologist, seeking anonymity, explained, “Bio-absorbable stents are expensive and hence not accessible to all patients in India. This review has now opened them up for further scrutiny as it has shown a device side-effect. Also, these stents do not fall in the category of the price structure which has been fixed by the government.”
Earlier bare metal stents were used but metal in the hearts would affect the blood vessel lining and hence the drug eluting stents with polymers were introduced.
Dr Debabrata Mukherjee, who has reviewed the study, says, “Bio-absorbab-le stents were introduced to do away with the side-effects of metallic stents. But this review shows that the device has a dangerous side-effect. The blood clot forms on the stent itself, which is not a good sign.”
The review recommended that the current generation of drug eluting stents in the present format is best for patients and that there must be more clinical trials on bio-absorbable stents. The study mentioned that bio-absorbable stents are a good idea in theory and can be a device for future use after improvements are carried out.
Cardiologists, meanwhile, recommend that stent manufacturers focus on creating stents with quicker reabsorption rates, thinner struts and improved strength.
