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使用血管内超声(IVUS)评估新型超薄可生物降解聚合物Tetriflex(西罗莫司洗脱支架)在短冠状动脉病变(≤20mm)与长冠状动脉病变(≥20mm)中的优化:Tetriflex IVUS研究。

Evaluation of novel ultrathin, biodegradable polymer tetriflex (sirolimus-eluting stent) optimization using intravascular ultrasound (IVUS) in short coronary lesion (≤ 20mm) vs. long coronary lesion (≥ 20mm): Tetriflex IVUS study.

作者信息

Sofi Najeeb Ullah, Sachan Mohit, Sinha Santosh Kumar, Jha Mukesh J, Pandey Umeshwar, Razi Mahmodullah, Sharma Awadesh K, Aggarwal Puneet, Shukla Praveen, Varma Rakesh

机构信息

Department of Cardiology, LPS Institute of Cardiology, G.S.V.M. Medical College, Kanpur, Uttar Pradesh, India.

Department of Cardiology, RML Institute of Medical Science, New Delhi, India.

出版信息

ARYA Atheroscler. 2025;21(1):22-35. doi: 10.48305/arya.2024.41978.2912.

Abstract

BACKGROUND

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) is useful for stent optimization. Outcomes of the ultrathin Supralimus Tetriflex stent (Sahajanand Medical Technologies Pvt. Ltd., India) using IVUS were evaluated among patients with short (≤ 20 mm) versus long lesions (≥ 20 mm).

METHODS

A total of 207 patients underwent PCI, and IVUS was performed post-deployment. The primary outcome was optimal stent deployment, defined as (a) mean surface area (MSA) >5.0 mm²; (b) plaque burden <50%; (c) complete apposition; and (d) no edge dissection. Secondary outcomes were target lesion failure (TLF)-a composite of cardiac death, target vessel myocardial infarction (TVMI), and target lesion revascularization (TLR)-stent thrombosis, and major adverse cardiovascular events (MACE; a composite of death, MI, stent thrombosis, and repeat revascularization).

RESULTS

Suboptimal deployment was significantly more frequent among patients with longer lesions (30.1% vs. 23.3%; p=0.03) due to higher rates of malapposition (17.3% vs. 10.6%) and MSA <5 mm² (9.6% vs. 7.7%). Following post-dilatation, suboptimal deployment was observed in 7.6% and 5.8% of patients, respectively. Residual plaque burden was 4.5% and 5.7%, respectively. The MSA in both groups was 6.3 mm² and 6.5 mm². Minimum and mean stent expansions were 82.1% versus 81.7% and 106.3% versus 109.8%, respectively, with no significant differences. TLF and stent thrombosis were observed in 0.9% versus 0.9% and 2.9% versus 3.8% of patients, respectively, with no significant differences. However, MACE was significantly higher (10.5% vs. 8.7%; p=0.05) among patients with longer lesions.

CONCLUSION

Supralimus Tetriflex stent has very good optimal deployment based on angiogram and becomes better with IVUS imaging, making it safe among long lesions (≥ 20mm).

摘要

背景

血管内超声(IVUS)引导下的经皮冠状动脉介入治疗(PCI)有助于优化支架植入。对使用IVUS的超薄Supralimus Tetriflex支架(印度Sahajanand医疗技术有限公司)在短病变(≤20 mm)与长病变(≥20 mm)患者中的疗效进行了评估。

方法

共有207例患者接受了PCI治疗,并在支架植入后进行了IVUS检查。主要结局为最佳支架植入,定义为:(a)平均表面积(MSA)>5.0 mm²;(b)斑块负荷<50%;(c)完全贴壁;(d)无边缘夹层。次要结局包括靶病变失败(TLF)——心脏性死亡、靶血管心肌梗死(TVMI)和靶病变血运重建(TLR)的复合终点,支架血栓形成,以及主要不良心血管事件(MACE;死亡、心肌梗死、支架血栓形成和再次血运重建的复合终点)。

结果

由于贴壁不良率(17.3%对10.6%)和MSA<5 mm²(9.6%对7.7%)较高,长病变患者中支架植入欠佳的情况明显更常见(30.1%对23.3%;p=0.03)。球囊后扩张后,分别有7.6%和5.8%的患者出现支架植入欠佳。残余斑块负荷分别为4.5%和5.7%。两组的MSA分别为6.3 mm²和6.5 mm²。最小和平均支架扩张率分别为82.1%对81.7%和106.3%对109.8%,无显著差异。分别有0.9%对0.9%和2.9%对3.8%的患者发生TLF和支架血栓形成,无显著差异。然而,长病变患者中的MACE明显更高(10.5%对8.7%;p=0.05)。

结论

基于血管造影,Supralimus Tetriflex支架具有很好的最佳植入效果,在IVUS成像下效果更佳,使其在长病变(≥20mm)中使用安全。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e8e/12091251/d39891a18c9c/ARYA-21-022-g001.jpg

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