Sirolimus-eluting stents with ultrathin struts versus everolimus-eluting stents for patients undergoing percutaneous coronary intervention: final three-year results of the TALENT trial
Sirolimus-eluting stents with ultrathin struts versus everolimus-eluting stents for patients undergoing percutaneous coronary intervention: final three-year results of the TALENT trial
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DOI：
10.4244/eij-d-21-00766
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发表时间：
2022-08-01
期刊：
影响因子：
6.2
通讯作者：
Serruys, Patrick W.
中科院分区：
文献类型：
--
作者：
de Winter, Robbert J.;Zaman, Azfar;Serruys, Patrick W.
背景：在TALENT研究中，西罗莫司洗脱超薄支架Supraflex在12个月时对于器械导向复合终点（DoCE：定义为心脏性死亡、靶血管心肌梗死[TV - MI]或临床指征的靶病变血运重建[CI - TLR]）不劣于XIENCE支架。目的：本研究调查了TALENT试验的3年结果以及与XIENCE依维莫司洗脱薄支架相比，超薄药物洗脱支架（DES）的长期影响。方法：TALENT试验是一项前瞻性、多中心、随机的所有患者入选试验，比较了Supraflex西罗莫司洗脱支架和XIENCE依维莫司洗脱支架，并计划随访3年。结果：TALENT试验招募了1435名患者（Supraflex组n = 720，XIENCE组n = 715），Supraflex组97.8%的患者有3年随访数据，XIENCE组98.9%的患者有3年随访数据。在3年时，Supraflex组有57名患者（8.1%）发生DoCE，XIENCE组有66名患者（9.4%）发生DoCE（p = 0.406）。心脏性死亡、TV - MI或CI - TLR的发生率在两组之间无显著差异。明确或可能的支架血栓形成率较低且两组间相似（1.1%对1.4%；p = 0.640）。在一项长期随访（3 - 5年）的荟萃分析中，与较厚支架的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之间心脏性死亡以及明确或可能的支架血栓形成风险相似。结论：在3年随访中，在所有患者人群中，Supraflex支架的使用至少与XIENCE支架一样安全有效。ClinicalTrials.gov：NCT02870140
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 fol-low-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