Indigenous coronary stents on par with US makes: Study

A Made-in-India cardiac stent performed on a par with top-line stents manufactured by a foreign multinational, finds the world’s longest study backed by 10-year follow data.

The study, public health campaigners said, can take the wind out of the argument of trans-national firms that lobby for a higher price for their products claiming superior performance.

The study findings are based on the examination of 2,603 patients by cardiologists at German Heart Centre, Munich over a decade.

The patients received one of the three types of stents - Yukon Choice PC made by Indian firm Translumina at its Dehradun and Hechingen (Germany) plants, Xience manufactured by Abbott and Cypher produced by Cordis Corporation.

While Yukon and Xience are new generation drug-eluting stents, Cypher is older generation stent of similar category

At 10-year follow-up, 1,827 patients (70.2%) were alive but mortality rates were significantly different among the three groups.

Both Yukon Choice PC and Xience stents showed significantly better results than the Cypher stent with regard to major adverse cardiac events, with a risk reduction of 18% and 21% and mortality risk reduction of 18% and 22% respectively.

Equal outcomes

There were no significant differences between Yukon Choice PC and Xience stents regarding these outcomes.

The Yukon Choice PC showed the lowest rate of definite or probable stent thrombosis with a significant risk reduction than the Cypher stent (50% reduction) and 29% lower rate when compared to Xience stent. Another important finding is comparative efficacy of the two new-generation DES outcomes at 10 years does not seem to be impacted by whether the polymer is of a biodegradable or permanent nature, the team reported in the journal Circulation.

The data was also presented at the American Heart Association scientific sessions at Chicago earlier this week.

In February 2017, the National Pharmaceutical Pricing Authority put an upper ceiling on the prices of coronary stents by slashing their maximum retail price by over 70%. Since then the MNCs were not only lobbying for revocation of the decision but also demanding higher price.

A year later, the cost of drug-eluting stents was fixed at Rs 27,890, less by more than Rs 2,200 than the previous ceiling price.

The cost of bare metal stents too was enhanced to Rs 7,660.

The new price ceiling would be in place till March 31, 2019, when it would be reviewed again.