Buszman Pawel E, Buszman Piotr P, Banasiewicz-Szkróbka Iwona, Milewski Krzysztof P, Żurakowski Aleksander, Orlik Bartłomiej, Konkolewska Magda, Trela Błażej, Janas Adam, Martin Jack L, Kiesz R Stefan, Bochenek Andrzej
American Heart of Poland, Center for Cardiovascular Research and Development, Katowice, Poland; Medical University of Silesia, Katowice, Poland.
American Heart of Poland, Center for Cardiovascular Research and Development, Katowice, Poland; IIIrd Clinical Department of Cardiology of Medical University of Silesia, Silesian Center for Heart Diseases, Zabrze, Poland.
JACC Cardiovasc Interv. 2016 Feb 22;9(4):318-327. doi: 10.1016/j.jcin.2015.10.044.
This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial.
The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown.
In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients.
At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99).
In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.
本研究报告了参加前瞻性随机LE MANS（左主干支架置入）试验患者的10年临床随访情况。
与外科血运重建相比，左主干支架置入后的长期结局仍不明确。
在这项前瞻性多中心试验中，我们根据SYNTAX（紫杉醇药物洗脱支架冠状动脉介入与心脏手术协同作用）评分，将105例存在低至中度复杂性共存冠状动脉疾病的无保护左主干冠状动脉狭窄患者随机分为接受支架置入的经皮冠状动脉介入治疗（PCI）组（n = 52）或冠状动脉旁路移植术（CABG）组（n = 53）。35%的患者植入了药物洗脱支架，而81%的患者使用了左前降支动脉的动脉移植物。目前，平均长期随访时间为9.8±1.0年。全因死亡率的随访已完成，而90%的患者报告了主要不良心血管和脑血管事件（MACCE）的发生率。46例（43.9%）患者完成了门诊随访。
10年时，与手术相比，支架置入组的射血分数有升高趋势（54.9±8.3%对49.8±10.3%；p = 0.07）。两组间的死亡率（21.6%对30.2%；p = 0.41）和MACCE（51.1%对64.4%；p = 0.28）在统计学上无差异；然而，从数值上看，差异有利于支架置入组。同样，心肌梗死发生率（8.7%对10.4%；p = 0.62）、中风发生率（4.3%对6.3%；p = 0.68）和再次血运重建率（26.1%对31.3%；p = 0.64）也无差异。PCI和CABG组长达14年的长期生存率相当（74.2%对67.5%；p = 0.34；风险比：1.45，95%置信区间：0.67至3.13）；然而，PCI组无MACCE生存率有升高趋势（34.7%对22.1%；p = 0.06；风险比：1.71，95%置信区间：0.97至2.99）。
对于存在低至中度复杂性共存冠状动脉疾病的无保护左主干冠状动脉狭窄患者，就安全性和有效性结局指标而言，支架置入在长达10年的时间里提供了数值上有利但统计学上无显著差异的长期结局，因此，可作为CABG的替代治疗方法。
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