Zhang Jun-Jie, Ye Fei, Xu Kai, Kan Jing, Tao Ling, Santoso Teguh, Munawar Muhammad, Tresukosol Damras, Li Li, Sheiban Imad, Li Feng, Tian Nai-Liang, Rodríguez Alfredo E, Paiboon Chotnoparatpat, Lavarra Francesco, Lu Shu, Vichairuangthum Kitigon, Zeng Hesong, Chen Lianglong, Zhang Ruiyan, Ding Shiqin, Gao Fengtang, Jin Zening, Hong Lang, Ma Likun, Wen Shangyu, Wu Xueming, Yang Song, Yin Wei-Hsian, Zhang Jun, Wang Yan, Zheng Yonghong, Zhou Lei, Zhou Limin, Zhu Yuansheng, Xu Tan, Wang Xin, Qu Hong, Tian Yulong, Lin Song, Liu Lijun, Lu Qinghua, Li Qihua, Li Bo, Jiang Qing, Han Leng, Gan Guojun, Yu Mengyue, Pan Defeng, Shang Zhenglu, Zhao Yanfang, Liu Zhizhong, Yuan Ye, Chen Cynthia, Stone Gregg W, Han Yaling, Chen Shao-Liang
Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China.
Division of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.
Eur Heart J. 2020 Jul 14;41(27):2523-2536. doi: 10.1093/eurheartj/ehaa543.
The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions.
In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-stent technique (two-stent group) or provisional stenting (provisional group). The primary endpoint was the composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR). The safety endpoint was definite or probable stent thrombosis. At the 1-year follow-up, TLF occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and two-stent groups, respectively [77.8%: double-kissing crush; hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30-0.90; P = 0.019], largely driven by increased TVMI (7.1%, HR 0.43, 95% CI 0.20-0.90; P = 0.025) and clinically driven TLR (5.5%, HR 0.43, 95% CI 0.19-1.00; P = 0.049) in the provisional group. At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772).
For DEFINITION criteria-defined complex coronary bifurcation lesions, the systematic two-stent approach was associated with a significant improvement in clinical outcomes compared with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting.
http://www.clinicaltrials.com; Identifier: NCT02284750.
本研究旨在评估双支架技术对符合DEFINITION标准的复杂冠状动脉分叉病变患者的益处。
共有来自49个国际中心的653例复杂分叉病变患者被随机分配接受系统性双支架技术（双支架组）或临时支架置入术（临时组）。主要终点是1年随访时的靶病变失败（TLF）复合终点，包括心源性死亡、靶血管心肌梗死（TVMI）和临床驱动的靶病变血运重建（TLR）。安全性终点是明确或可能的支架血栓形成。在1年随访时，临时组和双支架组分别有37例（11.4%）和20例（6.1%）患者发生TLF[77.8%：双吻挤压术；风险比（HR）0.52，95%置信区间（CI）0.30 - 0.90；P = 0.019]，主要是由于临时组中TVMI增加（7.1%，HR 0.43，95% CI 0.20 - 0.90；P = 0.025）和临床驱动的TLR增加（5.5%，HR 0.43，95% CI 0.19 - 1.00；P = 0.049）。在索引手术1年后，临时组的心源性死亡发生率为2.5%，与双支架组的2.1%无显著差异（HR 0.86，95% CI 0.31 - 2.37；P = 0.772）。
对于符合DEFINITION标准的复杂冠状动脉分叉病变，与临时支架置入术相比，系统性双支架方法与临床结局的显著改善相关。迫切需要进一步研究以确定导致临时支架置入术后TVMI发生率增加的机制。
