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雷帕霉素洗脱支架与依维莫司洗脱支架治疗初发长冠状动脉病变患者的比较:一项随机LONG-DES VI试验

Comparison of Resolute zotarolimus-eluting and Xience everolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES VI trial.

作者信息

Kang Do-Yoon, Lee Cheol Hyun, Lee Pil Hyung, Ahn Jung-Min, Lee Seung-Whan, Kim Young-Hak, Park Seong-Wook, Nam Chang Wook, Choi Yun Seok, Rha Seung-Woon, Cho Jang Hyun, Kim Weon, Her Sung-Ho, Jeong Myung Ho, Yang Joo-Young, Lee Bong-Ki, Park Hun Sik, Park Duk-Woo, Park Seung-Jung

机构信息

Asan Medical Center, Heart Institute, University of Ulsan College of Medicine.

Department of Medicine, Keimyung University Dongsan Medical Center.

出版信息

Coron Artery Dis. 2019 Jan;30(1):59-66. doi: 10.1097/MCA.0000000000000680.

DOI:10.1097/MCA.0000000000000680
PMID:30507632
Abstract

BACKGROUND

Outcomes for stent-based coronary intervention of lesions with long diseased segments remain relatively unfavorable. This study sought to compare the efficacy of Resolute zotarolimus-eluting stents (R-ZES) and Xience everolimus-eluting stents (EES) for very long coronary lesions.

METHODS AND RESULTS

This randomized, multicenter, prospective trial compared the use of R-ZES with EES for very long (≥50 mm) native coronary lesions. The primary end point was in-segment late luminal loss at 12-month angiographic follow-up. A total of 400 patients were needed to assess the primary end point. However, owing to very slow enrollment of patients, this trial was early terminated (302 patients were enrolled), and thus, this report provides descriptive information on primary and secondary end points. The R-ZES and EES groups had similar baseline characteristics. Lesion length was 49.6±10.2 and 50.6±13.3 mm in the R-ZES and EES groups, respectively (P=0.47). The number of stents used at the target lesion was 2.1±0.3 and 2.2±0.5, respectively. Twelve-month angiographic follow-up was performed in 50% of eligible patients. In-segment late luminal loss did not significantly differ between the R-ZES and EES groups (0.17±0.57 vs. 0.09±0.43 mm, P=0.32). In-segment binary restenosis rates were 8.1 and 5.3% in the R-ZES and EES groups, respectively (P=0.49). There were no significant between-group differences in the rate of adverse events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes).

CONCLUSION

For patients with very long native coronary artery disease, R-ZES and EES implantation showed comparable angiographic and clinical outcomes through 1 year of follow-up.

摘要

背景

对于长病变节段的支架置入冠状动脉介入治疗,其结果仍相对不理想。本研究旨在比较雷帕霉素洗脱支架(R-ZES)和依维莫司洗脱支架(EES)治疗极长冠状动脉病变的疗效。

方法与结果

这项随机、多中心、前瞻性试验比较了R-ZES与EES用于极长(≥50毫米)的自身冠状动脉病变的情况。主要终点是12个月血管造影随访时节段内晚期管腔丢失。共需要400例患者来评估主要终点。然而,由于患者入组非常缓慢,该试验提前终止(入组了302例患者),因此,本报告提供了关于主要和次要终点的描述性信息。R-ZES组和EES组具有相似的基线特征。R-ZES组和EES组的病变长度分别为49.6±10.2毫米和50.6±13.3毫米(P = 0.47)。靶病变处使用的支架数量分别为2.1±0.3个和2.2±0.5个。50%的符合条件患者进行了12个月的血管造影随访。R-ZES组和EES组的节段内晚期管腔丢失无显著差异(0.17±0.57毫米对0.09±0.43毫米,P = 0.32)。R-ZES组和EES组的节段内二元再狭窄率分别为8.1%和5.3%(P = 0.49)。不良事件发生率(死亡、心肌梗死、支架血栓形成、靶病变血管重建和复合结局)在组间无显著差异。

结论

对于患有极长自身冠状动脉疾病的患者,R-ZES和EES植入在1年的随访中显示出相当的血管造影和临床结果。

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