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Impact of left ventricular ejection fraction on clinical outcomes after left main coronary artery revascularization: results from the randomized EXCEL trial.
European Journal of Heart Failure ( IF 16.9 ) Pub Date : 2020-02-11 , DOI: 10.1002/ejhf.1681
Daniel J F M Thuijs 1 , Milan Milojevic 1 , Gregg W Stone 2, 3 , John D Puskas 4 , Patrick W Serruys 5 , Joseph F Sabik 6 , Ovidiu Dressler 3 , Aaron Crowley 3 , Stuart J Head 1 , A Pieter Kappetein 1
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AIM To evaluate the impact of left ventricular ejection fraction (LVEF) on 3-year outcomes in patients with left main coronary artery disease (LMCAD) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the EXCEL trial. METHODS AND RESULTS The EXCEL trial randomized patients with LMCAD to PCI with everolimus-eluting stents (n = 948) or CABG (n = 957). Among 1804 patients with known baseline LVEF, 74 (4.1%) had LVEF <40% [heart failure with reduced ejection fraction (HFrEF)], 152 (8.4%) LVEF 40-49% [heart failure with mid-range ejection fraction (HFmrEF)] and 1578 (87.5%) LVEF ≥50% (heart failure with preserved ejection fraction). Patients with HFrEF vs. HFmrEF vs. preserved LVEF experienced a longer postoperative hospital stay (9.0 vs. 7.0 vs. 6.0 days, P = 0.02) with greater peri-procedural complications after CABG, while hospital stay after PCI was unaffected by LVEF (1.5 vs. 2.0 vs. 1.0 days, P = 0.20). The composite primary endpoint of death, stroke, or myocardial infarction at 3 years was 29.3% (PCI) vs. 27.6% (CABG) in patients with HFrEF, 16.2% vs. 15.0% in patients with HFmrEF, and 14.5% vs. 14.6% in those with preserved LVEF, respectively (Pinteraction = 0.90). Smoothing spline analysis demonstrated that the 3-year risk of all-cause death increased when LVEF decreased, both in patients undergoing CABG and PCI. CONCLUSION In the EXCEL trial, the composite rate of death, stroke or myocardial infarction at 3 years was significantly higher in patients with HFrEF compared with HFmrEF or preserved LVEF, driven by an increased rate of all-cause death. No significant differences after PCI vs. CABG were observed among patients with HFrEF, HFmrEF and preserved LVEF. Longer-term follow-up could provide important insights on differences in clinical outcomes that might emerge over time. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov ID NCT01205776.

中文翻译:

左主冠状动脉血运重建后左心室射血分数对临床结局的影响:来自随机EXCEL试验的结果。

目的在EXCEL试验中评估左心室射血分数(LVEF)对左主冠状动脉疾病(LMCAD)接受经皮冠状动脉介入治疗(PCI)或冠状动脉搭桥术(CABG)的患者3年结局的影响。方法和结果EXCEL试验将依维莫司洗脱支架(n = 948)或CABG(n = 957)的LMCAD患者随机分配至PCI。在已知基线LVEF的1804名患者中,74例(4.1%)的LVEF <40%[射血分数降低的心力衰竭],152例(8.4%)LVEF 40-49%[中度射血分数的心力衰竭( HFmrEF)]和1578(87.5%)LVEF≥50%(保留射血分数的心力衰竭)。HFrEF vs. HFmrEF vs LVEF保留的患者术后住院时间更长(9.0 vs. 7.0 vs. 6.0天,P = 0。02)CABG术后围手术期并发症更大,而PCI后的住院时间不受LVEF影响(1.5天,2.0天,1.0天,P = 0.20)。HFrEF患者在3年时死亡,中风或心肌梗死的综合主要终点为29.3%(PCI)对27.6%(CABG),HFmrEF患者为16.2%对15.0%,14.5%对14.6 LVEF保留者中的百分比分别为(%= 0.90)。平滑样条分析表明,在接受CABG和PCI的患者中,LVEF降低时,3年全因死亡的风险增加。结论在EXCEL试验中,由于全因死亡率增加,HFrEF患者3年的死亡,中风或心肌梗死的综合发生率明显高于HFmrEF或LVEF保留的患者。PCI与PCI后无明显差异。在HFrEF,HFmrEF和保留的LVEF患者中观察到CABG。长期的随访可以提供有关随时间推移可能出现的临床结果差异的重要见解。临床试验注册ClinicalTrials.gov ID NCT01205776。
更新日期:2020-02-11
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