Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial

医学 经皮冠状动脉介入治疗 临床终点 靶病变 支架 西罗莫司 内科学 心肌梗塞 外科 置信区间 入射(几何) 随机对照试验 危险系数 心脏病学 光学 物理
作者
Lars Jakobsen,Evald Høj Christiansen,Phillip Freeman,Johnny Kahlert,Karsten Tange Veien,Michael Mæng,Bent Raungaard,Julia Ellert,Anton Boel Villadsen,Steen Dalby Kristensen,Martin Kirk Christensen,Christian Juhl Terkelsen,Jens Aarøe,Troels Thim,Jens Flensted Lassen,Mikkel Hougaard,Ashkan Eftekhari,Rebekka Vibjerg Jensen,Nicolaj Brejnholt Støttrup,Jørgen Gulddahl Rasmussen,Anders Junker,Svend Eggert Jensen,Henrik Steen Hansen,Lisette Okkels Jensen
出处
期刊:Eurointervention [European Association of Percutaneous Cardiovascular Interventions]
卷期号:19 (8): 676-683
标识
DOI:10.4244/eij-d-23-00330
摘要

Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing.We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention.The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR).A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups.At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years.gov: NCT03216733.
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