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韩国双药洗脱支架治疗初发冠状动脉病变的疗效与安全性——效应试验

Efficacy and Safety of Dual-Drug-Eluting Stents for de Novo Coronary Lesions in South Korea-The Effect Trial.

作者信息

Cha Jung-Joon, Kim Gi Chang, Hur Seung Ho, Bae Jang Ho, Choi Jae Woong, Jin Dong-Kyu, Woo Seong Il, Lee Seung Uk, Park Jong Seon, Cho Yun-Hyeong, Choi Cheol Ung, Lim Do-Sun, Ahn Tae Hoon

机构信息

Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul 02841, Korea.

Department of Cardiology, Shihwa General Hospital, Siheung 15034, Korea.

出版信息

J Clin Med. 2020 Dec 27;10(1):69. doi: 10.3390/jcm10010069.

Abstract

BACKGROUND

Drug-eluting stents (DESs) are commonly used in percutaneous coronary intervention (PCI) procedures; however, complications including in-stent restenosis and stent thrombosis are significant challenges. The dual-DES is a stent that elutes two drugs to target various stages of the restenosis reaction. This study investigated the safety and efficacy of dual-DES in clinical practice.

METHODS

This study included 375 patients who underwent PCI with Cilotax or DXR dual-DESs at one of 13 centers in South Korea. The primary endpoint was target lesion failure (TLF) within 1 year. The secondary endpoints were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis.

RESULTS

The rates of TLF in dual-DESs (3.7%) were comparable to those reported in conventional DES. In addition, the DXR group had a significantly lower rate of TLF than the Cilotax group. In multivariate analysis, the DXR group had a lower risk of TLF (adjusted hazard ratio (HR) 0.30, 95% CI 0.09-0.92, = 0.036) and MI (adjusted HR 0.16, 95% CI 0.03-0.82, = 0.027) than the Cilotax group.

CONCLUSION

Dual-DESs had similar clinical outcomes regarding efficacy and safety as conventional DES. Among the dual-DES, the DXR stent as a new generation dual-DES had more favorable clinical outcomes than the Cilotax stent.

摘要

背景

药物洗脱支架(DESs)常用于经皮冠状动脉介入治疗(PCI)手术;然而,包括支架内再狭窄和支架血栓形成在内的并发症是重大挑战。双药物洗脱支架是一种能洗脱两种药物以针对再狭窄反应不同阶段的支架。本研究调查了双药物洗脱支架在临床实践中的安全性和有效性。

方法

本研究纳入了375例在韩国13个中心之一接受使用西罗莫司或多西紫杉醇双药物洗脱支架进行PCI的患者。主要终点是1年内的靶病变失败(TLF)。次要终点是心源性死亡、心肌梗死(MI)、靶病变血运重建(TLR)和支架血栓形成。

结果

双药物洗脱支架的TLF发生率(3.7%)与传统DES报道的发生率相当。此外,多西紫杉醇组的TLF发生率显著低于西罗莫司组。在多变量分析中,多西紫杉醇组发生TLF(调整后风险比(HR)0.30,95%置信区间0.09 - 0.92,P = 0.036)和MI(调整后HR 0.16,95%置信区间0.03 - 0.82,P = 0.027)的风险低于西罗莫司组。

结论

双药物洗脱支架在疗效和安全性方面的临床结果与传统DES相似。在双药物洗脱支架中,新一代双药物洗脱支架多西紫杉醇支架的临床结果比西罗莫司支架更有利。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d82/7795129/5b3198ce752c/jcm-10-00069-g001.jpg

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