Souza Cristiano Freitas de, El Mouallem Anwar Mohamed, de Brito Júnior Fábio Sândoli, Abizaid Alexandre Antônio Cunha, Almeida Breno Oliveira, Almeida Amanda Gonçalves, Nascimento Teresa Cristina Dias Cunha, Perin Marco Antonio, Caixeta Adriano
Einstein (Sao Paulo). 2013 Jul-Sep;11(3):350-6. doi: 10.1590/s1679-45082013000300015.
To evaluate the incidence of major adverse cardiac events (cardiac death, or acute myocardial infarct, or target vessel revascularization) at one year in "real world" patients.
The EINSTEIN registry is an observational, prospective, single center study that consecutively included 103 patients (152 lesions) treated with the BiomatrixTM stent, a biolimus A9-eluting stent with biodegradable polymer.
The mean age was 65.0±12.4 years; male gender represented 83.5% of the patients; and 37.9% of them were diabetic. At one-year, major adverse cardiac events occurred in 11.7% of the patients, including 2.9% of cardiac death, 4.9% of with non ST- segment elevation acute myocardial infarction, and 3.9% of target vessel revascularization. Stent thrombosis occurred in only 1% (1 patient) at one-yearfollow-up.
The present Registry suggests that new generation biolimus A9 drug-eluting stents are safe and effective in a "real world", all-comers patients, showing low rates of major cardiac adverse events on long-term follow-up.
评估“真实世界”患者一年内心脏主要不良事件(心脏死亡、急性心肌梗死或靶血管血运重建)的发生率。
爱因斯坦注册研究是一项观察性、前瞻性、单中心研究,连续纳入了103例患者(152处病变),这些患者接受了BiomatrixTM支架治疗,这是一种带有可生物降解聚合物的生物雷帕霉素A9洗脱支架。
平均年龄为65.0±12.4岁;男性占患者的83.5%;其中37.9%为糖尿病患者。一年时,11.7%的患者发生了心脏主要不良事件,包括2.9%的心脏死亡、4.9%的非ST段抬高急性心肌梗死和3.9%的靶血管血运重建。在一年的随访中,支架血栓形成仅发生在1%(1例患者)。
本注册研究表明,新一代生物雷帕霉素A9药物洗脱支架在“真实世界”的所有患者中是安全有效的,在长期随访中显示出较低的心脏主要不良事件发生率。