A critical analysis of the non-inferiority design of TALENT trial

Publication date: Available online 14 February 2020Source: Indian Heart JournalAuthor(s): S. Saha, P. Kerkar, N.J. GogtayAbstractIn recent years, regulatory approval of stents has been based on studies that have a non-inferiority design, which has its own inherent complexities. We critically appraise in this paper, the TALENT trial which established the non-inferiority of Indian manufactured Supraflex stent (a third generation, sirolimus-eluting stent with an ultra-thin strut thickness) compared to the Xience stent – (an internationally available,everolimus-eluting stent with a thicker strut) for a device-oriented composite endpoint at the end of 12 months. Our analysis shows that ifrisk ratio rather than absolute risk difference were used to calculate the non-inferiority margin, we would obtain a value of 1.48 for the risk ratio. Supraflex would then be non-inferior to Xience by 0.92 [95% CI 0.59 to 1.47]. The upper bound of the 95% CI of 1.47 is dangerously close to 1.48 indicating that the TALENT trial would just about manage to prove non-inferiority.
Source: Indian Heart Journal - Category: Cardiology Source Type: research