Maupas Eric, Lipiecki Janusz, Levy Raphy, Faurie Benjamin, Karsenty Bernard, Moulichon Marc Eric, Brunelle François, Maillard Luc, de Poli Fabien, Lefèvre Thierry
Clinique Les Franciscaines, Nîmes, France.
Pôle Santé République, Clermont Ferrand, France.
Catheter Cardiovasc Interv. 2017 Nov 15;90(6):890-897. doi: 10.1002/ccd.27081. Epub 2017 May 22.
The French Ebiomatrix registry aimed to confirm the results of the Leaders trial in an all-comer population in France.
The Leaders trial showed the Biolimus-eluting-sent (BES) to be equivalent to the Cypher stent in terms of safety and efficacy at 1 year and superior regarding stent thrombosis after 1 year.
BES recipients were enrolled in 42 French centers with up to 24-month clinical follow up.
2365 patients were included. Mean age: 65.7 ±11.2 years, 76.1% males, 31.8% had diabetes, 36.5% ACS (28.7% non-ST-elevation MI and 7.8% with ST-elevation MI). 1.7 ± 1.0 stents/patient were implanted and procedural success was 99.5%. 12-month follow-up was completed in 94.3% patients and 24 months in 91.4%. MACCE rates at 12 and 24 months were 5.8% and 9% (all cause-death 1.5% and 2.2%; stent thrombosis definite/probable 0.4% and 0.6%), respectively. MACCE were not significantly higher in diabetic patients compared with non-diabetics but cardiac death was higher (1.6% vs. 0.6%, P = 0.01 at 1 year and 1.9% vs. 0.6, P = 0.005 at 2 years) as was stent thrombosis (0.9% vs. 0.2%, P = 0.009 and 1.2 vs. 0.3% P = 0.008). Compared with non-ACS patients, MACCE was significantly higher in the ACS subgroup (7.5% vs. 4.8%, P = 0.001 at 1 year and 10.3% vs.8.1%, P = 0.07 at 2 years).
In this large real-world registry, the BES with biodegradable polymer showed excellent acute and mid-term outcomes with a 5.8% and 9% rate of MACCE at one and 2 years and a very low rate of stent thrombosis between 1 and 2 years (0.2%), thus demonstrating the replicability of the LEADERS trial in a registry population. © 2017 The Authors Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.
法国Ebiomatrix注册研究旨在在法国所有患者群体中证实Leaders试验的结果。
Leaders试验表明，生物雷帕霉素洗脱支架（BES）在1年时的安全性和有效性与Cypher支架相当，且在1年后支架血栓形成方面更具优势。
BES植入患者入组法国42个中心，进行长达24个月的临床随访。
纳入2365例患者。平均年龄：65.7±11.2岁，男性占76.1%，31.8%患有糖尿病，36.5%为急性冠状动脉综合征（28.7%为非ST段抬高型心肌梗死，7.8%为ST段抬高型心肌梗死）。每位患者植入1.7±1.0枚支架，手术成功率为99.5%。94.3%的患者完成了12个月随访，91.4%的患者完成了24个月随访。12个月和24个月时主要不良心血管和脑血管事件（MACCE）发生率分别为5.8%和9%（全因死亡分别为1.5%和2.2%；明确/可能的支架血栓形成分别为0.4%和0.6%）。与非糖尿病患者相比，糖尿病患者的MACCE发生率无显著更高，但心脏性死亡更高（1年时为1.6%对0.6%，P = 0.01；2年时为1.9%对0.6%，P = 0.005），支架血栓形成情况也是如此（0.9%对0.2%，P = 0.009；1.2%对0.3%，P = 0.008）。与非急性冠状动脉综合征（ACS）患者相比，ACS亚组的MACCE发生率显著更高（1年时为7.5%对4.8%，P = 0.001；2年时为10.3%对8.1%，P = 0.07）。
在这项大型真实世界注册研究中，具有可生物降解聚合物的BES显示出优异的急性和中期结果，1年和2年时MACCE发生率分别为5.8%和9%，1至2年期间支架血栓形成发生率极低（0.2%），从而证明了Leaders试验在注册研究人群中的可重复性。©2017作者。导管插入术和心血管介入。由Wiley Periodicals, Inc.出版
