Background:Patients with significant (≥50%) left main disease (LMD) have a high risk of cardiovascular events, and guidelines recommend revascularization to improve survival. However, the impact of intermediate LMD (stenosis, 25%–49%) on outcomes is unclear.Methods:Randomized ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) participants who underwent coronary computed tomography angiography at baseline were categorized into those with (25%–49%) and without (<25%) intermediate LMD. The primary outcome was a composite of cardiovascular mortality, myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. The primary quality of life outcome was the Seattle Angina Questionnaire summary score.Results:Among the 3699 participants who satisfied the inclusion criteria, 962 (26%) had intermediate LMD. Among invasive strategy participants with intermediate LMD on coronary computed tomography angiography, 49 (7.0%) had significant (≥50% stenosis) left main stenosis on invasive angiography. Patients with intermediate LMD had a higher risk of cardiovascular events in the unadjusted but not in the fully adjusted model compared with those without intermediate LMD. An invasive strategy increased procedural MI and decreased nonprocedural MI with no significant difference for other outcomes including the primary end point. There was no meaningful heterogeneity of treatment effect based on intermediate LMD status except for nonprocedural MI for which there was a greater absolute reduction with invasive management in the intermediate LMD group (−6.4% versus −2.0%; P_interaction=0.049). The invasive strategy improved angina-related quality of life and the benefit was durable throughout follow-up without significant heterogeneity based on intermediate LMD status.Conclusions:In the ISCHEMIA trial, there was no meaningful heterogeneity of treatment benefit from an invasive strategy regardless of intermediate LMD status except for a greater absolute risk reduction in nonprocedural MI with invasive management in those with intermediate LMD. An invasive strategy increased procedural MI, reduced nonprocedural MI, and improved angina-related quality of life.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

中文翻译：

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中间左主干疾病的结果：缺血试验的分析

背景：患有显着（≥50%）左主干疾病（LMD）的患者发生心血管事件的风险很高，指南建议进行血运重建以提高生存率。然而，中等 LMD（狭窄，25%–49%）对结果的影响尚不清楚。方法：随机 ISCHEMIA（医疗和侵入性方法比较健康有效性国际研究）参与者在基线时接受冠状动脉计算机断层扫描血管造影，分为那些有（25%–49%）和没有（<25%）中间LMD的人。主要结局是心血管死亡率、心肌梗死（MI）或因不稳定心绞痛住院、心力衰竭或复苏性心脏骤停的综合结果。主要的生活质量结果是西雅图心绞痛问卷总结评分。结果：在满足纳入标准的 3699 名参与者中，962 名（26%）患有中等 LMD。在冠状动脉计算机断层扫描血管造影中 LMD 为中等的侵入性策略参与者中，49 名 (7.0%) 的侵入性血管造影显示左主干显着狭窄（≥50% 狭窄）。与没有中间 LMD 的患者相比，有中间 LMD 的患者在未调整模型中但在完全调整模型中心血管事件的风险较高。侵入性策略增加了手术性心肌梗死，减少了非手术性心肌梗死，但包括主要终点在内的其他结果没有显着差异。基于中间 LMD 状态的治疗效果没有有意义的异质性，但非手术性 MI 除外，在中间 LMD 组中，侵入性治疗的绝对减少幅度更大（-6.4% 与 -2.0%；P 交互作用 = 0.049 _）。侵入性策略改善了心绞痛相关的生活质量，并且在整个随访过程中获益持久，没有基于中间 LMD 状态的显着异质性。结论：在 ISCHEMIA 试验中，无论中间 LMD 状态如何，侵入性策略的治疗益处不存在有意义的异质性。 LMD 状态，但对于中等 LMD 的患者，通过侵入性治疗可显着降低非手术性 MI 的绝对风险。侵入性策略增加了手术性心肌梗死，减少了非手术性心肌梗死，并改善了心绞痛相关的生活质量。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT01471522。