Indigenously made coronary stents are as good as those manufactured in other countries by multinational companies, according to a recent scientific study. The study's findings were presented at the prestigious international conference on Non Surgical Cardiac interventions -- TCT (Trans Catheter Interventions) -- on September 22 in San Diego, USA.
The study, which involved around 1,500 patients, was conducted in various countries of Europe and monitored by an international reputed clinical research organisation (CRO), Cardialysis.
The scientific study had the acronym TALENT.
The study dispels the perception among many doctors and patients that stents made in India may not be as safe and efficacious as those manufactured in foreign countries.
The TALENT trial was conceived by Prof Upendra Kaul, a well known interventional cardiologist who is currently the chairman of Batra Heart Centre, New Delhi, and Prof Patrick Serruys, an internationally acclaimed researcher in this field from the Netherlands.
Coronary stents are devices made of metal, usually chromium cobalt and coated with polymers and drug to treat blocked coronary arteries and also with a good and safe long term performance.
In the recently conducted randomised trial to compare an India made stent Supraflex with the world leader Xience stent from Abbott Vascular, the Supraflex sirolimus-eluting coronary stent manufactured by SMT in Surat emerged to be as good as the Xience stent made in Europe and the USA.
The study was sufficiently powered to give the final answer regarding non-inferiority of the Supraflex sirolimus-eluting stent versus the best-in class Xience stent from Abbott. The study was done in all comers with no exclusions, Prof Kaul said.
"The aim of the study was to test the hypothesis that both stents are equal in performance and safety. To dispel the belief that imported coronary devices are better, it needed a scientific study without any bias," he explained.
In February, last year, when the Indian government decided to cap the prices of coronary stents, there was a dramatic reduction in prices from an average of USD 1,800 for the drug-eluting stent (DES) to USD 480 irrespective of the country they were manufactured in.
This resulted in increase in the usage of domestic stents because they offered it at lower prices, Dr Kaul said.
"However, the users still had the belief that India made stents may not be as good (as the imported ones). This required an acceptable scientific trial to draw a comparison between the two stents," he claimed.
"The study was done in Europe to remove any bias and it was monitored by an international clinical research organisation (CRO), Cardialysis, which is world reputed," Dr Kaul added.
The study the showed that the composite end points consisting of cardiac death, target-vessel MI and clinically indicated repeat procedures at 12 months were similar for both.
Thus proving that the India made stent Supraflex was as good as the market leader Xinence, Dr Kaul claimed.
The study has important economic implications in countries where cost of the stent is an important issue. The full paper of this trial will soon be published in the Lancet, he said.
Dr Kaul further called upon other Indian manufacturers to do similar clinical trials to prove that their devices are worthy competitors to those made abroad. These trials should be published in peer reviewed journals.
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