双对吻挤压术与预扩张支架术治疗左主干远端分叉病变的随机对照研究（DKCRUSH-V 研究）
Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial.
机构信息
Division of Cardiology, Nanjing First Hospital and Key Laboratory of Targeted Intervention of Cardiovascular Disease, Collaboratory Innovation Center for Cardiovascular Disease Translational Medicine, Nanjing Medical University, Nanjing, China.
Division of Cardiology, Nanjing First Hospital and Key Laboratory of Targeted Intervention of Cardiovascular Disease, Collaboratory Innovation Center for Cardiovascular Disease Translational Medicine, Nanjing Medical University, Nanjing, China.
出版信息
J Am Coll Cardiol. 2017 Nov 28;70(21):2605-2617. doi: 10.1016/j.jacc.2017.09.1066. Epub 2017 Oct 30.
BACKGROUND
Provisional stenting (PS) is the most common technique used to treat distal left main (LM) bifurcation lesions in patients with unprotected LM coronary artery disease undergoing percutaneous coronary intervention. The double kissing (DK) crush planned 2-stent technique has been shown to improve clinical outcomes in non-LM bifurcations compared with PS, and in LM bifurcations compared with culotte stenting, but has never been compared with PS in LM bifurcation lesions.
OBJECTIVES
The authors sought to determine whether a planned DK crush 2-stent technique is superior to PS for patients with true distal LM bifurcation lesions.
METHODS
The authors randomized 482 patients from 26 centers in 5 countries with true distal LM bifurcation lesions (Medina 1,1,1 or 0,1,1) to PS (n = 242) or DK crush stenting (n = 240). The primary endpoint was the 1-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Routine 13-month angiographic follow-up was scheduled after ascertainment of the primary endpoint.
RESULTS
TLF within 1 year occurred in 26 patients (10.7%) assigned to PS, and in 12 patients (5.0%) assigned to DK crush (hazard ratio: 0.42; 95% confidence interval: 0.21 to 0.85; p = 0.02). Compared with PS, DK crush also resulted in lower rates of target vessel myocardial infarction I (2.9% vs. 0.4%; p = 0.03) and definite or probable stent thrombosis (3.3% vs. 0.4%; p = 0.02). Clinically driven target lesion revascularization (7.9% vs. 3.8%; p = 0.06) and angiographic restenosis within the LM complex (14.6% vs. 7.1%; p = 0.10) also tended to be less frequent with DK crush compared with PS. There was no significant difference in cardiac death between the groups.
CONCLUSIONS
In the present multicenter randomized trial, percutaneous coronary intervention of true distal LM bifurcation lesions using a planned DK crush 2-stent strategy resulted in a lower rate of TLF at 1 year than a PS strategy. (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 [DKCRUSH-V]; ChiCTR-TRC-11001213).
背景
在接受经皮冠状动脉介入治疗的无保护左主干（LM）冠状动脉疾病患者中，临时支架置入术（PS）是治疗远端 LM 分叉病变最常用的技术。与 PS 相比，双吻（DK）挤压计划的 2 支架技术已显示出可改善非 LM 分叉病变的临床结果，与 culotte 支架相比，在 LM 分叉病变中也显示出改善，但从未与 LM 分叉病变中的 PS 进行比较。
目的
作者旨在确定计划的 DK 挤压 2 支架技术是否优于 PS 治疗真正的远端 LM 分叉病变患者。
方法
作者从 5 个国家的 26 个中心随机分配了 482 名真正的远端 LM 分叉病变（Medina 1,1,1 或 0,1,1）患者进行 PS（n=242）或 DK 挤压支架置入术（n=240）。主要终点是 1 年复合靶病变失败率（TLF）：心源性死亡、靶血管心肌梗死或临床驱动的靶病变血运重建。在确定主要终点后，计划进行常规的 13 个月血管造影随访。
结果
PS 组有 26 例（10.7%）患者在 1 年内发生 TLF，DK 挤压组有 12 例（5.0%）患者发生 TLF（风险比：0.42；95%置信区间：0.21 至 0.85；p=0.02）。与 PS 相比，DK 挤压还导致靶血管心肌梗死发生率较低（I 型：2.9% vs. 0.4%；p=0.03）和明确或可能的支架血栓形成（3.3% vs. 0.4%；p=0.02）。临床驱动的靶病变血运重建（7.9% vs. 3.8%；p=0.06）和 LM 复合体的血管造影再狭窄（14.6% vs. 7.1%；p=0.10）也倾向于 DK 挤压组比 PS 组更少。两组之间的心脏死亡率没有显著差异。
结论
在这项多中心随机试验中，使用计划的 DK 挤压 2 支架策略对真正的远端 LM 分叉病变进行经皮冠状动脉介入治疗，与 PS 策略相比，1 年内 TLF 发生率较低。（双吻和双挤压与临时 T 支架置入术治疗无保护的远端左主干真性分叉病变的比较：一项随机、国际、多中心临床试验[DKCRUSH-V]；ChiCTR-TRC-11001213）。
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