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左主干冠状动脉疾病患者行冠状动脉旁路移植术时,单支与双侧胸廓内动脉桥的外科血运重建效果:EXCEL 试验的见解†。

Outcomes following surgical revascularization with single versus bilateral internal thoracic arterial grafts in patients with left main coronary artery disease undergoing coronary artery bypass grafting: insights from the EXCEL trial†.

机构信息

Department of Cardiothoracic Surgery, Erasmus MC, University Medical Centre, Rotterdam, Netherlands.

Department of Cardiology, Columbia University Medical Center, New York-Presbyterian Hospital, Cardiovascular Research Foundation, New York, NY, USA.

出版信息

Eur J Cardiothorac Surg. 2019 Mar 1;55(3):501-510. doi: 10.1093/ejcts/ezy291.

Abstract

OBJECTIVES

Observational data suggest that the use of a single internal thoracic artery (SITA) may result in inferior outcomes compared with bilateral internal thoracic artery (BITA) use for coronary artery bypass grafting (CABG)-a finding not yet supported by randomized trial outcomes. However, the optimal number of internal thoracic artery grafts in patients with left main coronary artery disease has not been investigated.

METHODS

The EXCEL trial randomized 1905 patients with left main coronary artery disease to percutaneous coronary intervention with everolimus-eluting stents versus CABG. Among the 905 patients undergoing CABG, 688 (76.0%) received SITA and 217 (24.0%) received BITA. Differences in clinical event rates were estimated using the Kaplan-Meier method and compared with the log-rank test. Multivariable Cox regression was used to adjust for differences in baseline covariates.

RESULTS

Compared to SITA, patients treated with BITA were younger (66.1 ± 9.5 vs 64.5 ± 9.3 years, P = 0.020), were less likely female (24.3% vs 14.3%, P = 0.002) and diabetic (28.8% vs 15.2%, P < 0.001), and had a lower prevalence of peripheral vessel disease (10.2% vs 5.5%, P = 0.040). The unadjusted 3-year composite primary endpoint of death, stroke or myocardial infarction (MI) occurred in 15.6% of SITA vs 11.6% of BITA patients (P = 0.17). The SITA group tended to have a higher 3-year rate of all-cause death compared with the BITA group (6.7% vs 3.3%; P = 0.070). Stroke, MI and ischaemia-driven revascularization outcomes were not significantly different between groups. After adjusting for baseline differences, neither the composite of death, stroke or MI [hazard ratio (HR) 1.12, 95% confidence interval (CI) 0.71-1.78; P = 0.62] nor mortality (HR 1.36, 95% CI 0.60-3.12; P = 0.46) was significantly higher with SITA. The rehospitalization rate after 3 years was higher in the SITA group (35.8% vs 26.0%, P = 0.008), a difference which was no longer present after multivariable adjustment (HR 1.27, 95% CI 0.93-1.74; P = 0.13). Sternal wound dehiscence within 30 days did not occur more often in the BITA group compared to the SITA group (1.8% vs 2.2%, P > 0.99).

CONCLUSIONS

In the EXCEL trial, there were no clinical differences at 3 years between SITA or BITA revascularization in patients with left main coronary artery disease.

摘要

目的

观察性数据表明,与双侧内乳动脉(BITA)相比,使用单根内乳动脉(SITA)可能导致冠状动脉旁路移植术(CABG)的结果较差——这一发现尚未得到随机试验结果的支持。然而,在左主干冠状动脉疾病患者中,最佳的内乳动脉移植数量尚未得到研究。

方法

EXCEL 试验将 1905 例左主干冠状动脉疾病患者随机分为经皮冠状动脉介入治疗与依维莫司洗脱支架组与 CABG 组。在接受 CABG 的 905 例患者中,688 例(76.0%)接受 SITA,217 例(24.0%)接受 BITA。采用 Kaplan-Meier 法估计临床事件发生率,并与对数秩检验进行比较。采用多变量 Cox 回归调整基线协变量的差异。

结果

与 SITA 相比,接受 BITA 治疗的患者年龄更小(66.1±9.5 岁 vs 64.5±9.3 岁,P=0.020),女性(24.3% vs 14.3%,P=0.002)和糖尿病(28.8% vs 15.2%,P<0.001)的可能性较小,且外周血管疾病的患病率较低(10.2% vs 5.5%,P=0.040)。未经调整的 3 年复合主要终点为死亡、卒中和心肌梗死(MI),SITA 组为 15.6%,BITA 组为 11.6%(P=0.17)。SITA 组的 3 年全因死亡率较 BITA 组高(6.7% vs 3.3%;P=0.070)。两组间卒中、MI 和缺血驱动的血运重建结局无显著差异。在调整基线差异后,死亡、卒中和 MI 的复合终点[风险比(HR)1.12,95%置信区间(CI)0.71-1.78;P=0.62]和死亡率(HR 1.36,95% CI 0.60-3.12;P=0.46)均无显著差异。SITA 组 3 年后的再住院率较高(35.8% vs 26.0%,P=0.008),但经多变量调整后,这一差异不再存在(HR 1.27,95% CI 0.93-1.74;P=0.13)。SITA 组与 BITA 组相比,30 天内胸骨切开愈合不良的发生率无显著差异(1.8% vs 2.2%,P>0.99)。

结论

在 EXCEL 试验中,左主干冠状动脉疾病患者中,SITA 或 BITA 血运重建 3 年后无临床差异。

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