Key result
Supraflex sirolimus-eluting stents match XIENCE stents for device-oriented composite endpoints at three years.
Why the study?
To evaluate the 3-year outcomes of the TALENT trial and investigate the long-term impact of ultrathin strut DES compared to the thin strut XIENCE stent following 12-month non-inferiority.
Does a sirolimus-eluting ultrathin strut stent improve long-term outcomes compared to an everolimus-eluting thin stent in all-comers patients undergoing percutaneous coronary intervention?
RCT (n=1,435)
randomised
Yes
Does a sirolimus-eluting ultrathin strut stent improve long-term outcomes compared to an everolimus-eluting thin stent in all-comers patients undergoing percutaneous coronary intervention?
The ultrathin strut sirolimus-eluting stent is as safe and efficacious as the everolimus-eluting stent at 3 years in an all-comers PCI population.
Supraflex provides a noninferior stent option for routine PCI; extends randomized 3-year data on ultrathin sirolimus-eluting platforms.
BACKGROUND: In the TALENT study, the sirolimus-eluting ultrathin strut Supraflex stent was non-inferior to the XIENCE stent for a device-oriented composite endpoint (DoCE: defined as cardiac death, target vessel myocardial infarction [TV-MI], or clinically indicated target lesion revascularisation [CI-TLR]) at 12 months. AIMS: This study investigated the 3-year outcomes of the TALENT trial and long-term impact of ultrathin drug-eluting stents (DES), compared to the XIENCE everolimus-eluting thin stent. METHODS: The TALENT trial is a prospective, multicentre, randomised all-comers trial comparing the Supraflex sirolimus-eluting stent with the XIENCE everolimus-eluting stent, with planned follow-up for 3 years. RESULTS: The TALENT trial enrolled 1,435 patients (Supraflex n=720, XIENCE n=715) with 3-year follow-up data available in 97.8% in the Supraflex group, and in 98.9% in the XIENCE group. At 3 years, DoCE occurred in 57 patients (8.1%) in the Supraflex group, and in 66 patients (9.4%) in the XIENCE group (p=0.406). There were no significant between-group differences in rates of cardiac death, TV-MI or CI-TLR. The rates of definite or probable stent thrombosis were low and similar between groups (1.1% vs 1.4%; p=0.640). In a meta-analysis of long-term follow-up (3-5 years), ultrathin strut DES tended to reduce DoCE (relative risk 0.89 [0.79-1.01]; p=0.068), compared to thicker strut DES. The risks for cardiac death and definite or probable stent thrombosis were similar between ultrathin strut DES and thicker strut DES. CONCLUSIONS: At 3-year follow-up, the use of the Supraflex stent was at least as safe and efficacious as the XIENCE stent in an all-comers population. CLINICALTRIALS: gov: NCT02870140.
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Winter et al. (2022) conducted an RCT in percutaneous coronary intervention (n=1,435). Supraflex sirolimus-eluting ultrathin strut stent vs. XIENCE everolimus-eluting thin stent was evaluated on device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularisation) (p=0.406). The Supraflex sirolimus-eluting ultrathin strut stent was at least as safe and efficacious as the XIENCE stent for the device-oriented composite endpoint at 3 years (8.1% vs 9.4%; p=0.406).
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