Mumbai: The recent findings of a safety analysis study on use of stents in heart patients published in The Lancet, a respected medical journal, is likely for come as a relief to at least a dozen post-marketing trials of such products currently going on in India.
The global meta-analysis study (an analysis of several previous studies combined), which was initiated by a team of scientists at the Institute of Social and Preventive Medicine of the University of Bern, Switzerland, analysed 38 different clinical trials covering some 18,000 patients worldwide.
This study has now established that the drug-eluting stents were associated with lower risk of heart attack and deaths.
“Even though a meta-analysis will not provide any new data pertaining to safety and efficacy, it would help in drawing some conclusion on the comparative risk-benefit studies on different types of stents available in the market,” said India’s drug controller general M. Venkateswarlu.
Since heart disease is one of the fastest growing disease segments in India, such stents have been one of the most preferred options even as their safety is not fully established.
Making way: Boston Scientific Corp.’s Taxus stent, a tiny mesh tube used to keep arteries from reclogging following angioplasties, is pictured over an angioplasty balloon in this undated company photo.
Stents are tiny wire mesh tubes that act as scaffolding inside plaque-congested arteries to keep them open. The drug coating on these stents helps prevent the artery from reclogging.
Currently, at least five leading medical companies including the US drug major Johnson & Johnson Inc., Medtronic Inc., Boston Scientific Corp. and a couple of local players are selling heart stents in India.
There are mainly two types of cardiac stents—drug-eluting and bare-metal are available in the market now, even as the drug release mechanism of the drug-eluting stents as well as the safety of both kinds of devices are still under debate.
The Lancet report says the mortality risks associated with drug-eluting and bare-metal stents used for coronory revascularization (block removal mechanism) are similar, even as the drug-eluting stents are associated with a lower risk of heart attack than bare-metal stents.
In India, heart stents are approved for marketing after limited trials based on foreign studies and all the manufacturers are asked to submit side effect data within a period of six months and two years for non-CE (European quality assurance) and CE marked products, respectively.
Following the recent debate on increased risk of death and other side effects, the drug controller general of India imposed a strict adverse monitoring for these products. Johnson & Johnson, the leader in cardiac stent market in India, meanwhile, had withdrawn its drug-infused stent known as CoStar from the world market, including India, following the failure of the product in clinical trials.
In the drug-eluting stent market, J&J’s brand Cypher is the market leader with almost a 40% share. The domestic market demand for drug-eluting stent is estimated to be 6,500 units.
Says Ramkumar Vyas, a leading cardiologist in Mumbai: “Out of the total 280 patients treated in our hospital in the last one year, more than 90% were implanted with Cypher stent and there were hardly any recurring blocks reported in these patients.”
Adds Venkateswarlu: “So far, we have not received any serious adverse reports from the post-market studies that are going on in the country.”