The TALENT trial was conducted across seven countries in Europe at 23 renowned centers with a sample size of 1435 patients
Supraflex, a cardiac drug eluting stent designed and manufactured in India has been confirmed to be at par with Abbott’s Xience through an investigators-driven study called ‘TALENT’.
Dr Patrick Serruys, a renowned cardiology researcher was the chair for the TALENT trial. The findings of the TALENT trial were presented at the ‘late breaking trial session’ at Transcatheter Cardiovascular Therapeutics 2018 (TCT), the largest global conference of cardiologist currently underway in San Diego, USA. This study was conducted in seven countries – United Kingdom, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria – across 23 renowned centres with a sample size of 1435 patients. Xience is regarded as global standard in safety and efficacy for drug eluting stents.
Over 5,00,000 stents are used in India every year. A cardiac stent is a device used to unblock clogged arteries. Drug eluting stents are coated with medicines that help lower recurrence chances of an artery narrowing after corrective surgery.
Presenting the findings of TALENT trial, Dr Serruys, said, “Safety and efficacy of Supraflex SES with ultra thin struts and biodegradable polymer were compared with Xience EES in all comers population. Supraflex was found to be non-inferior to the Xience for DOCE (device oriented end points) at 12 months in an all comer-population with a lower rate of CI-TLR in the per protocol analysis.”
Dr Upendra Kaul, a cardiologist from India was the co-chair of the TALENT Study. Commenting on the study, Dr Kaul said, “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. TALENT is the first such trial to yield positive results and stands out with a far better efficacy compared to the competitors.”
Prof R de Winter, MD, Academisch Medisch Centrum, Amsterdam,The Netherlands and A Zaman, MD, Cardiac Catheter Laboratories, Royal Freeman, Newcastle, UK, were the Principal Investigators for the TALENT trial.
The TALENT trial included mean patient age of 65 years, and about three-quarters were men, with about 40 per cent of patients presenting with stable angina and 60 per cent with Acute Coronary Syndromes (ACS). The rate of a device-oriented composite endpoint of cardiac death, target-vessel MI, and clinically indicated TLR at 12 months was 4.9 per cent with Supraflex and 5.3 per cent with Xience, a difference that met criteria for non-inferiority (P< 0.001).
Ganesh Sabat, CEO, SMT said, “The result of the TALENT study is significant for the coronary stent industry. The success of this study resonates well with make in India. We are proud to establish India name in such a complicated and high end life-saving technology industry.”
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