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DK Crush 与 Culotte 支架术治疗左主干远端分叉病变的临床结果:DKCRUSH-III 研究的 3 年随访结果。

Clinical Outcome After DK Crush Versus Culotte Stenting of Distal Left Main Bifurcation Lesions: The 3-Year Follow-Up Results of the DKCRUSH-III Study.

机构信息

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

Beijing Fuwai Cardiovascular Hospital, Beijing, China.

出版信息

JACC Cardiovasc Interv. 2015 Aug 24;8(10):1335-1342. doi: 10.1016/j.jcin.2015.05.017.

Abstract

OBJECTIVES

The present study aimed to investigate the difference in major adverse cardiac events (MACE) at 3 years after double-kissing (DK) crush versus culotte stenting for unprotected left main distal bifurcation lesions (LMDBLs).

BACKGROUND

The multicenter and randomized DKCRUSH-III (Comparison of double kissing crush versus culotte stenting for unprotected distal left main bifurcation lesions: results from a multicenter, randomized, prospective study) showed that DK crush stenting was associated with fewer MACE at 1-year follow-up in patients with LMDBLs compared with culotte stenting. Here, we report the 3-year clinical outcome of the DKCRUSH-III study.

METHODS

A total of 419 patients with LMDBLs who were randomly assigned to either the DK crush or culotte group in the DKCRUSH-III study were followed for 3 year. The primary endpoint was the occurrence of a MACE at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by simple and complex LMDBLs according to the DEFINITION (Definition and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) study criteria.

RESULTS

At 3 years, MACE occurred in 49 patients the culotte group and in 17 patients in the DK crush group (cumulative event rates of 23.7% and 8.2%, respectively; p < 0.001), mainly driven by increased myocardial infarction (8.2% vs. 3.4%, respectively; p = 0.037) and target-vessel revascularization (18.8% vs. 5.8%, respectively; p < 0.001) between groups. Definite ST rate was 3.4% in the culotte group and 0% in the DK crush group (p = 0.007). Complex LMDBLs were associated with a higher rate of MACE (35.3%) at 3 years compared with a rate of 8.1% in patients with simple LMDBLs (p < 0.001), with an extremely higher rate in the culotte group (51.5% vs. 15.1%, p < 0.001).

CONCLUSIONS

Culotte stenting for LMDBLs was associated with significantly increased rates of MACE and ST. (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-11001877).

摘要

目的

本研究旨在探讨无保护左主干远端分叉病变(LMDBL)患者行双吻挤压(DK)与 Culotte 支架术后 3 年主要不良心脏事件(MACE)的差异。

背景

多中心随机 DKCRUSH-III(比较双吻挤压与 Culotte 支架治疗无保护左主干远端分叉病变的效果:多中心、随机、前瞻性研究)显示,与 Culotte 支架相比,DK 挤压支架治疗 LMDBL 患者 1 年后的 MACE 发生率更低。在此,我们报告了 DKCRUSH-III 研究的 3 年临床结果。

方法

共有 419 例 LMDBL 患者被随机分配至 DKCRUSH-III 研究中的 DK 挤压组或 Culotte 组,随访 3 年。主要终点是 3 年时发生 MACE。支架血栓形成(ST)是安全性终点。根据 DEFINITION(经皮冠状动脉介入治疗中使用药物洗脱支架后复杂分叉病变对临床结局的定义和影响)研究标准,将患者分为简单和复杂 LMDBL。

结果

3 年时,Culotte 组有 49 例患者和 DK 挤压组有 17 例患者发生 MACE(累积事件发生率分别为 23.7%和 8.2%,p < 0.001),主要原因是心肌梗死(8.2%对 3.4%,p = 0.037)和靶血管血运重建(18.8%对 5.8%,p < 0.001)增加。Culotte 组的明确 ST 发生率为 3.4%,DK 挤压组为 0%(p = 0.007)。与简单 LMDBL 患者的 8.1%相比,复杂 LMDBL 患者 3 年时的 MACE 发生率更高(35.3%,p < 0.001),Culotte 组的发生率更高(51.5%对 15.1%,p < 0.001)。

结论

LMDBL 患者行 Culotte 支架治疗后 MACE 和支架血栓形成的发生率明显增加。(双吻挤压[DK]与 Culotte 支架治疗无保护左主干远端分叉病变的疗效比较:DKCRUSH-III,双支架技术的多中心随机研究;ChiCTR-TRC-11001877)。

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