左心室射血分数对左主干冠状动脉血运重建术后临床结局的影响：随机EXCEL试验结果
Impact of left ventricular ejection fraction on clinical outcomes after left main coronary artery revascularization: results from the randomized EXCEL trial.
作者信息
Thuijs Daniel J F M, Milojevic Milan, Stone Gregg W, Puskas John D, Serruys Patrick W, Sabik Joseph F, Dressler Ovidiu, Crowley Aaron, Head Stuart J, Kappetein A Pieter
机构信息
Department of Cardiothoracic Surgery, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands.
Division of Cardiology, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA.
出版信息
Eur J Heart Fail. 2020 May;22(5):871-879. doi: 10.1002/ejhf.1681. Epub 2020 Feb 11.
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 (P = 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 Identifier NCT01205776.
目的
在EXCEL试验中，评估左心室射血分数（LVEF）对接受经皮冠状动脉介入治疗（PCI）或冠状动脉旁路移植术（CABG）的左主干冠状动脉疾病（LMCAD）患者3年预后的影响。
方法与结果
EXCEL试验将LMCAD患者随机分为接受依维莫司洗脱支架PCI组（n = 948）或CABG组（n = 957）。在1804例已知基线LVEF的患者中，74例（4.1%）LVEF<40%[射血分数降低的心力衰竭（HFrEF）]，152例（8.4%）LVEF为40 - 49%[射血分数中等范围的心力衰竭（HFmrEF）]，1578例（87.5%）LVEF≥50%（射血分数保留的心力衰竭）。与HFmrEF和射血分数保留的患者相比，HFrEF患者术后住院时间更长（9.0天对7.0天对6.0天，P = 0.02），CABG术后围手术期并发症更多，而PCI术后住院时间不受LVEF影响（1.5天对2.0天对1.0天，P = 0.20）。3年时死亡、卒中或心肌梗死的复合主要终点在HFrEF患者中PCI组为29.3%，CABG组为27.6%；HFmrEF患者中分别为16.2%和15.0%；射血分数保留的患者中分别为14.5%和14.6%（P = 0.90）。样条平滑分析表明，无论接受CABG还是PCI的患者，LVEF降低时全因死亡的3年风险均增加。
结论
在EXCEL试验中，HFrEF患者3年时死亡、卒中或心肌梗死的复合发生率显著高于HFmrEF或射血分数保留的患者，这是由全因死亡率增加所致。在HFrEF、HFmrEF和射血分数保留的患者中，未观察到PCI与CABG术后有显著差异。长期随访可能会为随时间推移可能出现的临床结局差异提供重要见解。
临床试验注册
ClinicalTrials.gov标识符NCT01205776。
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