Following a major controversy about the quality of stents manufactured in India, yet another study comparing an Indian stent with…
At the Scientific Session of the American Heart Association in Chicago, cardiologists from Germany presented the results of a prolonged follow-up of 2,603 patients randomized to treatment with two new generation genes ̵
1; everolimus eluting Xience and sirolimus eluting Yukon Choice – and a first-generation sirolimus that elutes Cypher stent. Cypher is not on the market anymore. The study published in AHA’s journal showed that there was no difference in the outcome between the two new generation stents.
In February 2017, the government had reduced the price of stents
+ which results in a three-thirds reduction in the prices of drugs that elute stents. Several multinational stent companies had threatened to withdraw their stents from India, claiming they were superior to Indian and thus deserved a higher price. Several cardiologists also questioned the quality of Indian stents. But with studies showing that Indian stents are as good as foreign, cardiologists seem to have changed thanks.
“This is the type of study we need – large, randomized, long-term studies. More Indian companies should do such studies to establish their credibility internationally.” Each of the stent needs to be proven, “says Dr. Ashok Seth, Cardiologist for Fortis- the group at the hospital. He added that the study showed that there was no difference between biodegradable polymer coating stents and permanent polymer coating added to the argument that biodegradable polymer-coated stents would get a higher price.
Dr Upendra Kaul, president of Batra Heart Center, who initiated the previous year study compared Supra Flex to Xience together with Prof. Patrick Serruys from the Netherlands, pointed out that even with good new generation stents 3% of patients still had heart attacks and needed restenosis every year. “Further research is being done to reduce this 3%,” says Dr. Kaul.
Yukon stents are made in India from German technology, while Supra Flex is a completely domestic stent, Dr. Kaul pointed out. In an editorial journal of the Euro Intervention magazine last year, Dr Kaul wrote: “There is an opinion in the heart of cardiologists, transferred to patients that imported stents are superior.” He added that it was time for Indian companies to prove that cardiologists and patients that their products were as safe and effective as in multinational companies.
Until now, no brand of drug-destructive stents anywhere in the world has proven to be superior to other brands in the market, as Dr. Kaul and Dr. Seth pointed out.