Indian made stents seem to be a safe and effective alternative to stents of global standard, reports a study in the Lancet.
The study compared Surat-based stent manufacturer Sahajanand Medical Technologies's Supraflex with US-based Abott's Xience -- regarded as the global standard in safety and efficacy for drug-eluting stents.
While Supraflex is a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts, Xience is an everolimus-eluting stent with a durable polymer coating.
"Supraflex seems a safe and effective alternative drug-eluting stent to other stents in clinical practice," the report stated.
The international team, including an Indian team of doctors led by Upendra Kaul, cardiologist at the Batra Hospital here, examined 1,435 patients from seven countries -- UK, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria.
They randomly assigned patients to implantation of either a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts (Supraflex) or an everolimus eluting stent with a durable polymer coating (Xience).
The results indicated that repeat percutaneous or surgical revascularization at 12 months was 4.9 per cent with Indian-made and 5.3 per cent with global peers, a difference that met criteria for non-inferiority.
"The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population," the report stated.
"There remained a perception that stents produced outside of India were superior to homegrown devices. There were demands from Indian manufacturers to prove that their devices are comparable to those made elsewhere in robust clinical trials," Kaul said in a statement.
Supraflex stents, which is available in 65 countries across the world, has advanced features like biodegradable polymer and ultrathin strut (60 micrometre) thickness, compared to strut thickness and biostable polymer coating of Xience (81 micrometre).
--IANS
rt/mag/bg
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