Left Main Stenting in Comparison With Surgical Revascularization: 10-Year Outcomes of the (Left Main Coronary Artery Stenting) LE MANS Trial

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• 作者：Pawel E. Buszman ; MD ; PhD^a ; ^b ; Piotr P. Buszman ; MD ; PhD^a ; ^c ; ^{p.buszman@ahp-ccrd.org" class="auth_mail" title="E-mail the corresponding author} ; Iwona Banasiewicz-Szkró ; bka ; MD ; PhD^a ; Krzysztof P. Milewski ; MD ; PhD^a ; Aleksander Żurakowski ; MD ; PhD^a ; Bartłomiej Orlik ; MD ; PhD^a ; Magda Konkolewska ; MD^a ; Błażej Trela ; MD^a ; Adam Janas ; MD^a ; Jack L. Martin ; MD^d ; R. Stefan Kiesz ; MD^e ; Andrzej Bochenek ; MD ; PhD^a ; ^b
• 关键词：coronary artery bypass surgery ; left main disease ; stenting ; ten-year outcome
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2016
• 出版时间：22 February 2016
• 年：2016
• 卷：9
• 期：4
• 页码：318-327
• 全文大小：1103 K

文摘

This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial.

Background

The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown.

Methods

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.

Results

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).

Conclusions

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.