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双对吻挤压技术与 Culotte 支架术治疗无保护左主干分叉病变的对比:来自多中心、随机、前瞻性 DKCRUSH-III 研究的结果。

Comparison of double kissing crush versus Culotte stenting for unprotected distal left main bifurcation lesions: results from a multicenter, randomized, prospective DKCRUSH-III study.

机构信息

Cardiological Department, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.

出版信息

J Am Coll Cardiol. 2013 Apr 9;61(14):1482-8. doi: 10.1016/j.jacc.2013.01.023. Epub 2013 Mar 10.

DOI:10.1016/j.jacc.2013.01.023
PMID:23490040
Abstract

OBJECTIVES

The study aimed to investigate the difference in major adverse cardiac event (MACE) at 1-year after double kissing (DK) crush versus Culotte stenting for unprotected left main coronary artery (UPLMCA) distal bifurcation lesions.

BACKGROUND

DK crush and Culotte stenting were reported to be effective for treatment of coronary bifurcation lesions. However, their comparative performance in UPLMCA bifurcation lesions is not known.

METHODS

A total of 419 patients with UPLMCA bifurcation lesions were randomly assigned to DK (n = 210) or Culotte (n = 209) treatment. The primary endpoint was the occurrence of a MACE at 1 year, including cardiac death, myocardial infarction, and target vessel revascularization (TVR). In-stent restenosis (ISR) at 8 months was secondary endpoint, and stent thrombosis (ST) served as a safety endpoint. Patients were stratified by SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) and NERS (New Risk Stratification) scores.

RESULTS

Patients in the Culotte group had significant higher 1-year MACE rate (16.3%), mainly driven by increased TVR (11.0%), compared with the DK group (6.2% and 4.3%, respectively; all p < 0.05). ISR rate in side branch was 12.6% in the Culotte group and 6.8% in the DK group (p = 0.037). Definite ST rate was 1.0% in the Culotte group and 0% in the DK group (p = 0.248). Among patients with bifurcation angle ≥70°, NERS score ≥20, and SYNTAX score ≥23, the 1-year MACE rate in the DK group (3.8%, 9.2%, and 7.1%, respectively) was significantly different to those in the Culotte group(16.5%, 20.4%, and 18.9%, respectively; all p < 0.05).

CONCLUSIONS

Culotte stenting for UPLMCA bifurcation lesions was associated with significantly increased MACEs, mainly due to the increased TVR. (Double Kissing [DK] Crush Versus Culotte Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions: DKCRUSH-III, a Multicenter Randomized Study Comparing Double-Stent Techniques; ChiCTR-TRC-00000151).

摘要

目的

本研究旨在探讨在治疗无保护左主干(UPLMCA)远端分叉病变时,双吻挤压(DK)与 Culotte 支架术 1 年后主要不良心脏事件(MACE)的差异。

背景

DK 挤压和 Culotte 支架术均被报道可有效治疗冠状动脉分叉病变。然而,它们在 UPLMCA 分叉病变中的对比表现尚不清楚。

方法

将 419 例 UPLMCA 分叉病变患者随机分为 DK 组(n = 210)或 Culotte 组(n = 209)。主要终点为 1 年时 MACE 的发生,包括心源性死亡、心肌梗死和靶血管血运重建(TVR)。次要终点为 8 个月时的支架内再狭窄(ISR),支架血栓形成(ST)为安全性终点。根据 SYNTAX(经皮冠状动脉介入治疗与心脏手术的协同作用)和 NERS(新风险分层)评分对患者进行分层。

结果

与 DK 组(分别为 6.2%和 4.3%)相比,Culotte 组 1 年 MACE 发生率(16.3%)显著升高,主要原因是 TVR 增加(11.0%和 4.3%;均 p < 0.05)。Culotte 组分支侧 ISR 发生率为 12.6%,DK 组为 6.8%(p = 0.037)。Culotte 组明确 ST 发生率为 1.0%,DK 组为 0%(p = 0.248)。在分叉角≥70°、NERS 评分≥20 和 SYNTAX 评分≥23 的患者中,DK 组(分别为 3.8%、9.2%和 7.1%)1 年 MACE 发生率明显低于 Culotte 组(分别为 16.5%、20.4%和 18.9%;均 p < 0.05)。

结论

对于 UPLMCA 分叉病变,Culotte 支架术与明显增加的 MACE 相关,主要原因是 TVR 增加。(双吻挤压(DK)与 Culotte 支架术治疗无保护左主干远端分叉病变的比较:DKCRUSH-III,一项比较双支架技术的多中心随机研究;ChiCTR-TRC-00000151)。

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