Chen Xiang, Li Xiaobo, Zhang Jun-Jie, Han Yaling, Kan Jing, Chen Lianglong, Qiu Chunguang, Santoso Teguh, Paiboon Chootopol, Kwan Tak W, Sheiban Imad, Leon Martin B, Stone Gregg W, Chen Shao-Liang
Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Division of Cardiology, Shenyang Northen Hospital, Shenyang, China.
JACC Cardiovasc Interv. 2019 Oct 14;12(19):1927-1937. doi: 10.1016/j.jcin.2019.04.056. Epub 2019 Sep 11.
The present study aimed to investigate the difference in target lesion failure (TLF) at 3 years after double kissing (DK) crush stenting versus provisional stenting (PS) for unprotected left main distal bifurcation (UPLMb) lesions.
The multicenter and randomized DKCRUSH-V (Double Kissing Crush versus Provisional Stenting for Left Main Distal Bifurcation Lesions: The DKCRUSH-V Randomized Trial) study showed fewer 1-year TLF after DK crush for UPLMb lesions compared with PS. The study reports the 3-year clinical outcome of the DKCRUSH-V study.
A total of 482 patients with UPLMb lesions who were randomly assigned to either the DK crush group (DK group) or PS group in the DKCRUSH-V study were followed for 3 years. The primary endpoint was the occurrence of a TLF at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by lesion's complexity and NERS (New Risk Stratification) II or SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score.
At 3 years, TLF occurred in 41 (16.9%) patients in the PS group and in 20 (8.3%) patients in the DK group (p = 0.005), mainly driven by increased target vessel myocardial infarction (5.8% vs. 1.7%; p = 0.017) and target lesion revascularization (10.3% vs. 5.0%; p = 0.029). Definite or probable ST rate at 3 years was 4.1% in the PS group and 0.4% in the DK group (p = 0.006). Notably, DK crush was associated with a significant reduction in both primary and secondary endpoints for patients with complex lesions or at high risk.
Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up. Further randomized study is warranted to confirm the benefits of DK crush stenting for complex UPLMb lesions. (Double Kissing and Double Crush versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial; ChiCTR-TRC-11001213).
本研究旨在探讨双吻(DK)挤压支架置入术与临时支架置入术(PS)治疗无保护左主干远端分叉(UPLMb)病变3年后靶病变失败(TLF)的差异。
多中心随机DKCRUSH-V(左主干远端分叉病变双吻挤压与临时支架置入术:DKCRUSH-V随机试验)研究表明,与PS相比,DK挤压治疗UPLMb病变1年后的TLF更少。本研究报告了DKCRUSH-V研究的3年临床结果。
DKCRUSH-V研究中共有482例UPLMb病变患者被随机分配至DK挤压组(DK组)或PS组,随访3年。主要终点为3年时TLF的发生情况。支架血栓形成(ST)为安全性终点。根据病变复杂性和NERS(新风险分层)II或SYNTAX(紫杉醇药物洗脱支架与心脏手术的协同作用)评分对患者进行分类。
3年时,PS组41例(16.9%)患者发生TLF,DK组20例(8.3%)患者发生TLF(p = 0.005),主要原因是靶血管心肌梗死增加(5.8%对1.7%;p = 0.017)和靶病变血运重建(10.3%对5.0%;p = 0.029)。3年时PS组明确或可能的ST发生率为4.1%,DK组为0.4%(p = 0.006)。值得注意的是,对于复杂病变或高危患者,DK挤压与主要和次要终点的显著降低相关。
在3年的随访中,UPLMb病变的临时支架置入术与TLF和ST发生率显著增加相关。有必要进行进一步的随机研究以证实DK挤压支架置入术对复杂UPLMb病变的益处。(双吻与双挤压对比临时T支架置入技术治疗无保护左主干远端真性分叉病变:一项随机、国际、多中心临床试验;ChiCTR-TRC-11001213)