3-Year Outcomes After 2-Stent With Provisional Stenting for Complex Bifurcation Lesions Defined by DEFINITION Criteria,JACC: Cardiovascular Interventions

当前位置： X-MOL 学术 › JACC Cardiovasc. Inte. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

3-Year Outcomes After 2-Stent With Provisional Stenting for Complex Bifurcation Lesions Defined by DEFINITION Criteria
JACC: Cardiovascular Interventions ( IF 11.7 ) Pub Date : 2022-07-04 , DOI: 10.1016/j.jcin.2022.05.026
Jing Kan ₁ , Jun-Jie Zhang ₁ , Imad Sheiban ₂ , Teguh Santoso ₃ , Muhammad Munawar ₄ , Damras Tresukosol ₅ , Kai Xu ₆ , Gregg W Stone ₇ , Shao-Liang Chen ₈ ,

Affiliation

Background

The multicenter and randomized DEFINITION II (Two-Stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions) trial showed less 1-year target lesion failure (TLF) after a 2-stent approach for complex coronary bifurcation lesions compared with provisional stenting (PS). The authors report the 3-year clinical outcome of the DEFINITION II trial.

Objectives

The aim of the present study was to investigate the difference in TLF at 3 years after a planned 2-stent approach vs PS for complex coronary bifurcation lesions stratified by DEFINITION (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) criteria.

Methods

A total of 653 patients with complex coronary bifurcation lesions were randomly assigned to either the 2-stent group or the PS group in the DEFINITION II trial and were followed for 3 years. The primary endpoint was the occurrence of TLF at 3 years. Stent thrombosis was the safety endpoint.

Results

At 3 years, TLF had occurred in 52 patients (16.0%) in the PS group and in 34 (10.4%) patients in the 2-stent group (HR: 0.63; 95% CI: 0.41-0.97; P = 0.035), driven mainly by increased target vessel myocardial infarction (8.0% vs 3.7%; HR: 0.45; 95% CI: 0.23-0.89; P = 0.022) and target lesion revascularization (8.3% vs 4.3%; HR: 0.50; 95% CI: 0.26-0.96; P = 0.038). There was no difference in TLF between the 2 groups between year 1 and year 3.

Conclusions

For patients with complex coronary bifurcations who reach 1-year postprocedure without experiencing endpoint events, there is still a risk for future events. The type of procedure performed initially is no longer a future event risk determinant. (Two-Stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions; NCT02284750)

中文翻译：

定义标准定义的复杂分叉病变临时支架置入 2 支架后的 3 年结果

背景

多中心和随机 DEFINITION II（复杂冠状动脉分叉病变患者的双支架与临时支架技术）试验显示，与临时支架相比，2 支架入路治疗复杂冠状动脉分叉病变后的 1 年靶病变失败（TLF）更少。 PS）。作者报告了 DEFINITION II 试验的 3 年临床结果。

目标

本研究的目的是研究计划的 2 支架入路后 3 年 TLF 与 PS 治疗按定义分层的复杂冠状动脉分叉病变（复杂分叉病变对经皮冠状动脉介入治疗后的临床结果的定义和影响药物）的差异-洗脱支架）标准。

方法

在 DEFINITION II 试验中，共有 653 名患有复杂冠状动脉分叉病变的患者被随机分配到 2 支架组或 PS 组，并随访 3 年。主要终点是 3 年时 TLF 的发生。支架血栓形成是安全终点。

结果

3 年时，PS 组 52 名患者（16.0%）和 2 支架组 34 名（10.4%）患者发生 TLF（HR：0.63；95% CI：0.41-0.97；P = 0.035），主要由靶血管心肌梗死增加（8.0% vs 3.7%；HR：0.45；95% CI：0.23-0.89；P = 0.022）和靶病变血运重建（8.3% vs 4.3%；HR：0.50；95% CI： 0.26-0.96；P = 0.038)。在第 1 年和第 3 年，两组之间的 TLF 没有差异。