Gaurang Shah Volume: 36 (14/02/2007)
According to five parallel studies published in the latest online issue of the New England Journal of Medicine drug-eluting stents are no better off at protecting the heart and reducing the risk of fatal late stent thrombosis than bare metal ones. The studies found that the risk of late stent thrombosis is actually higher with drug-eluting stents as compared to bare metal stents.
Heart stents have been at the centre of a number of controversies – recently and over the last several years. The introduction of drug-eluting stents (special stents that are coated in medications) a couple of years back added to these controversies. Stents of both types have been associated with fatal or near fatal thrombosis and heart attacks.
A number of studies have been conducted to test the efficacies of these stents. However not many studies have directly compared effects of drug-eluting stents with those of bare metal stents. Now five parallel studies conducted by researchers in different countries have come up with some surprisingly similar results.
Two of the five studies were conducted in the US while the remaining three were respectively in Sweden, the Netherlands and Germany. In each of the studies, researchers conducted randomized clinical trials to evaluate the safety of drug-eluting stents in comparison to bare-metal stents. More than 36,200 heart patients were enrolled in the studies across the four countries.
Researchers in the respective studies pooled and analysed the data collected during an average follow-up period of more than four years for all patients. In each of the studies researchers found that after one year, the risk of stent thrombosis was higher for patients who were treated with drug-eluting stents as compared to those treated with bare metal stents.
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Risk of late stent thrombosis is actually higher with drug-eluting stents than with bare-metal ones
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Even in the long term follow-up, the four year survival rate of patients with drug-eluting stents was 93.3% as compared to 94.6% for patients with bare metal stents. According to the researchers, the studies clearly show that there is no significant difference in short or long term survival rates between the two stent types.
The studies also indicate that drug-eluting stents actually increase the risk of death as compared to bare metal stents. The trend appears after six months when the risk of death increases by 0.5%. A composite of death or myocardial infarction increases by 0.5% to 1% point with each passing year for drug-eluting stents.
In the opinion of the researchers, these study findings make it necessary for large, randomized trials to be conducted to perfectly evaluate the long-term safety of drug-eluting stents.