Mini Crush or Double Kissing Crush Stenting Techniques for Complex Left Main Bifurcation Lesions: the EVOLUTE-CRUSH Left Main Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 531
- 试验地点
- 1
- 主要终点
- Major cardiovascular events (MACE)
研究概览
简要总结
The Crush technique has evolved significantly since its introduction to the literature by Colombo et al in 2003, with multiple iterations including mini-crush (MC) and double kissing-crush (DKC) stenting techniques. The main principle of crush techniques for complex bifurcation lesions is to protrude the side branch (SB) stent towards the main branch to adequately cover the SB ostium and minimize the risk of SB ostium restenosis. It was noticed that the 4-5 mm protrusion of the SB stent resulted in a large volume of the crushed stent and the technique was modified into MC which aimed for approximately 1-2 mm protrusion by Galassi et al in 2007. Despite all the disadvantages of the crush technique, the final kissing balloon inflation (KBI) rate of this technique, along with several iterations has been up to 98%. Moreover, a recent meta-analysis showed that MC was associated with a reduction in risk of major cardiovascular events compared to provisional stenting, crush, and culotte techniques. The DKC is a planned 2-stent technique introduced by Chen et al. The ultimate innovation of this approach is that it is designed to increase the success rate of the final KBI. Provided recrossing of the crushed stent occurs through the proximal cell: another advantage of the DKC technique is to improve the success of KBI. The DKC significantly reduced major cardiovascular events (MACE) compared to provisional stenting, crush, TAP, and culotte. Until now, no clinical investigation has compared the DKC and MC in patients with complex left main bifurcation lesions. Therefore, this study sought to determine the clinical results of DKC and MC stenting techniques under long-term follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •true complex left main bifurcation lesions
- •stenting with double kissing-crush or mini-crush as a 2-stent strategy
- •participation in regular clinical follow-up
排除标准
- •prior history of coronary artery bypass grafting
- •cardiogenic shock
- •end-stage liver or kidney disease
- •allergy to antiplatelet therapy or contrast media
- •inappropriate dual antiplatelet therapy
- •critically ill with < 1-year life expectancy
- •absence of all medical records
- •PCI for ST-segment elevation myocardial infarction or in-stent restenosis
- •non-complex bifurcation lesions
- •treated with a bare metal stent
结局指标
主要结局
Major cardiovascular events (MACE)
时间窗: 12 months
Cardiac death, clinically-driven target lesion revascularization, target vessel myocardial infarction
次要结局
未报告次要终点
研究者
Ahmet Guner
Associate Professor of Cardiology
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
