Haiek Carlos, Fernández-Pereira Carlos, Santaera Omar, Mieres Juan, Rifourcat Ignacio, Lloberas Juan, Larribau Miguel, Pocoví Antonio, Rodriguez-Granillo Alfredo M, Sarmiento Ricardo A, Antoniucci David, Rodriguez Alfredo E
Interventional Cardiology Department, Sanatorio De La Trinidad, Quilmes, Buenos Aires Province, Argentina.
Interventional Cardiology Department, Clinica IMA, Adrogué, Buenos Aires Province, Argentina.
Catheter Cardiovasc Interv. 2017 Jan;89(1):37-46. doi: 10.1002/ccd.26468. Epub 2016 Mar 7.
To compare second generation drug eluting stents (2DES) with first generation (1DES) for the treatment of patients (pts) with multiple coronary vessel disease (MVD).
Although 2DES improved safety and efficacy compared to 1DES, MVD remains a challenge for percutaneous coronary interventions.
ERACI IV was a prospective, observational, and controlled study in pts with MVD including left main and treated with 2DES (Firebird 2, Microport). We included 225 pts in 15 sites from Argentina. Primary endpoint was the incidence of major adverse cardiovascular events (MACCE) defined as death, myocardial infarction (MI), cerebrovascular accident (CVA) and unplanned revascularization; and to compare with 225 pts from ERACI III study (1DES). PCI strategy was planned to treat lesions ≥70% in vessels ≥ 2.00 mm, introducing a modified Syntax score (SS) where severe lesions in vessels < 2.0 mm and intermediate lesions were not scored.
Baseline characteristics showed that compared to ERACI III, ERACI IV pts had higher number of diabetics (P = 0.02), previous revascularization (P = 0.007), unstable angina IIb/IIIc (P < 0.001) and three vessels/left main disease (P = 0.003). Modified SS was 22.2 ± 11. At 2 years of follow-up ERACI IV group had significantly lower incidence of death+ MI + CVA, (P = 0.01) and MACCE (P = 0.001). MACCE rate was similar in diabetics, (5.8%) and nondiabetics (7.0%). After performing a matched propensity score, MACCE remain significantly lower in ERACI IV (P = 0.005).
This registry showed that 2DES in MVD has a remarkable low incidence of MACCE in unadjusted and adjusted analysis. © 2016 Wiley Periodicals, Inc.
比较第二代药物洗脱支架（2DES）与第一代药物洗脱支架（1DES）治疗多支冠状动脉疾病（MVD）患者的效果。
尽管与1DES相比，2DES提高了安全性和有效性，但MVD仍然是经皮冠状动脉介入治疗面临的一项挑战。
ERACI IV是一项针对MVD患者（包括左主干病变）且采用2DES（火鸟2，微创）治疗的前瞻性、观察性对照研究。我们纳入了来自阿根廷15个地点的225例患者。主要终点是主要不良心血管事件（MACCE）的发生率，定义为死亡、心肌梗死（MI）、脑血管意外（CVA）和非计划性血管重建；并与ERACI III研究中的225例患者（1DES）进行比较。PCI策略计划用于治疗直径≥2.00 mm血管中病变≥70%的情况，引入了改良的Syntax评分（SS），其中直径<2.0 mm血管中的严重病变和中度病变未计分。
基线特征显示，与ERACI III相比，ERACI IV患者中糖尿病患者数量更多（P = 0.02）、既往有血管重建史（P = 0.007）、不稳定型心绞痛IIb/IIIc（P < 0.001）以及三支血管/左主干病变（P = 0.003）。改良SS为22.2±11。在随访2年时，ERACI IV组死亡+MI+CVA的发生率显著较低（P = 0.01），MACCE发生率也较低（P = 0.001）。糖尿病患者和非糖尿病患者的MACCE发生率相似（分别为5.8%和7.0%）。在进行匹配倾向评分后，ERACI IV组的MACCE发生率仍然显著较低（P = 0.005）。
该注册研究表明，在未经调整和调整后的分析中，MVD患者使用2DES时MACCE的发生率显著较低。©2016威利期刊公司。
