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冠状动脉分叉病变双吻挤压术与临时支架置入术的临床结局:多中心随机DKCRUSH-II研究(冠状动脉分叉病变双吻挤压技术与临时支架置入技术的随机研究)的5年随访结果

Clinical Outcome of Double Kissing Crush Versus Provisional Stenting of Coronary Artery Bifurcation Lesions: The 5-Year Follow-Up Results From a Randomized and Multicenter DKCRUSH-II Study (Randomized Study on Double Kissing Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions).

作者信息

Chen Shao-Liang, Santoso Teguh, Zhang Jun-Jie, Ye Fei, Xu Ya-Wei, Fu Qiang, Kan Jing, Zhang Feng-Fu, Zhou Yong, Xie Du-Jiang, Kwan Tak W

机构信息

From the Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, China (S.-L.C., J.-J.Z., F.Y., J.K., F.-F.Z.); Division of Cardiology, Medistra Hospital, University of Indonesia Medical School, Jakarta (T.S.); Division of Cardiology, Shanghai 10th People's Hospital, China (Y.-W.X.); Division of Cardiology, Xuzhou Central Hospital, China (Q.F.); Division of Cardiology, Zhangjiagang People's Hospital, China (Y.Z.); Division of Cardiology, Huainan Xinhua Hospital, China (D.-J.X.); and Division of Cardiology, Beth Israel Hospital, New York, NY (T.W.K.).

出版信息

Circ Cardiovasc Interv. 2017 Feb;10(2):e004497. doi: 10.1161/CIRCINTERVENTIONS.116.004497.

Abstract

BACKGROUND

Provisional stenting is effective for anatomic simple bifurcation lesions. Double kissing crush stenting reduces the 1-year rate of target lesion revascularization. This study aimed to investigate the 5-year clinical results of the DKCRUSH-II study (Randomized Study on Double Kissing Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions).

METHODS AND RESULTS

A total of 370 patients with coronary bifurcation lesions who were randomly assigned to either the double kissing crush or provisional stenting group in the DKCRUSH-II study were followed for 5 years. The primary end point was the occurrence of a major adverse cardiac event at 5 years. Patients were classified by simple and complex bifurcation lesions according to the DEFINITION criteria (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents). At 5 years, the major adverse cardiac event rate (23.8%) in the provisional stenting group was insignificantly different to that of the double kissing group (15.7%; P=0.051). However, the difference in the target lesion revascularization rate between 2 groups was sustained through the 5-year follow-up (16.2% versus 8.6%; P=0.027). The definite and probable stent thrombosis rate was 2.7% in each group (P=1.0). Complex bifurcation was associated with a higher rate of target lesion revascularization (21.6%) at 5 years compared with 11.1% in patients with a simple bifurcation (P=0.037), with an extremely high rate in the provisional stenting group (36.8% versus 12.5%, P=0.005) mainly because of final kissing balloon inflation (19.4% versus 5.2%; P=0.036).

CONCLUSIONS

The double kissing crush stenting technique for coronary bifurcation lesions is associated with a lower rate of target lesion revascularization. The optimal stenting approach based on the lesions' complexity may improve the revascularization for patients with complex bifurcations.

CLINICAL TRIAL REGISTRATION

URL: http://www.chictr.org. Unique identifier: ChiCTR-TRC-0000015.

摘要

背景

临时支架置入术对解剖结构简单的分叉病变有效。双吻挤压支架置入术可降低1年靶病变血运重建率。本研究旨在调查DKCRUSH-II研究(冠状动脉分叉病变双吻挤压技术与临时支架置入技术的随机研究)的5年临床结果。

方法与结果

DKCRUSH-II研究中共有370例冠状动脉分叉病变患者被随机分配至双吻挤压组或临时支架置入组,并随访5年。主要终点为5年时主要不良心脏事件的发生情况。根据DEFINITION标准(复杂分叉病变的定义及其对使用药物洗脱支架的经皮冠状动脉介入治疗后临床结局的影响)将患者分为简单和复杂分叉病变。5年时,临时支架置入组的主要不良心脏事件发生率(23.8%)与双吻挤压组(15.7%)无显著差异(P=0.051)。然而,两组间靶病变血运重建率的差异在5年随访期间持续存在(16.2%对8.6%;P=0.027)。每组的明确和可能支架血栓形成率均为2.7%(P=1.0)。与简单分叉病变患者的11.1%相比,复杂分叉病变在5年时的靶病变血运重建率更高(21.6%)(P=0.037),临时支架置入组的发生率极高(36.8%对12.5%,P=0.005),主要原因是最终吻球囊扩张(19.4%对5.2%;P=0.036)。

结论

冠状动脉分叉病变的双吻挤压支架置入技术与较低的靶病变血运重建率相关。基于病变复杂性的最佳支架置入方法可能改善复杂分叉病变患者的血运重建。

临床试验注册

网址:http://www.chictr.org。唯一标识符:ChiCTR-TRC-0000015。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4118/5319391/f0673cb6afe8/hcv-10-e004497-g001.jpg

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