Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Newcastle Freeman Hospital, Newcastle University, and Newcastle upon Tyne Hospitals NHS Trust, Newcastle, United Kingdom.
EuroIntervention. 2022 Aug 19;18(6):492-502. doi: 10.4244/EIJ-D-21-00766.
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.
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.
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.
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.
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.
gov: NCT02870140.
在 TALENT 研究中,与 XIENCE 支架相比,西罗莫司洗脱超亲水性支架 Supraflex 在 12 个月时的以器械为导向的复合终点(DoCE:定义为心脏死亡、靶血管心肌梗死[TV-MI]或临床指示的靶病变血运重建[CI-TLR])方面非劣效。
本研究旨在探讨 TALENT 试验的 3 年结果,并比较超亲水性药物洗脱支架(DES)与 XIENCE 依维莫司洗脱薄支架的长期影响。
TALENT 试验是一项前瞻性、多中心、随机、所有患者入组的试验,比较了 Supraflex 西罗莫司洗脱支架与 XIENCE 依维莫司洗脱支架,计划随访 3 年。
TALENT 试验共纳入 1435 例患者(Supraflex 组 720 例,XIENCE 组 715 例),Supraflex 组 97.8%的患者和 XIENCE 组 98.9%的患者获得了 3 年随访数据。在 3 年时,Supraflex 组有 57 例(8.1%)患者发生 DoCE,XIENCE 组有 66 例(9.4%)患者发生 DoCE(p=0.406)。两组间心脏死亡、TV-MI 或 CI-TLR 的发生率无显著差异。确定或可能的支架血栓形成发生率较低,且两组间相似(1.1%比 1.4%;p=0.640)。在对长期随访(3-5 年)的荟萃分析中,与较厚支架 DES 相比,超薄支架 DES 倾向于降低 DoCE(相对风险 0.89 [0.79-1.01];p=0.068)。超薄支架 DES 和较厚支架 DES 之间的心脏死亡和确定或可能的支架血栓形成风险相似。
在 3 年随访时,Supraflex 支架在所有患者人群中的安全性和疗效至少与 XIENCE 支架相当。
gov:NCT02870140。