Mieres Juan, Fernandez-Pereira Carlos, Risau Gustavo, Solorzano Leonardo, Pauletto Ricardo, Rodriguez-Granillo Alfredo Matias, Rubilar Bibiana, Stella Pieter, Rodriguez Alfredo E
Otamendi Hospital, Buenos Aires, Argentina.
Cardiovasc Revasc Med. 2012 Sep-Oct;13(5):265-71. doi: 10.1016/j.carrev.2012.06.001. Epub 2012 Jul 15.
Percutaneous coronary interventions (PCI) in patients with diabetes mellitus (DM) are associated with a high incidence of coronary restenosis, myocardial infarction (MI) and death. This study was to assess the potential role of a paclitaxel-eluting balloon (PEB) treatment in patients with DM with coronary lesions compared to those treated either with bare-metal stents (BMS) or drug-eluting stents (DES).
The Diabetic Argentina Registry (DEAR) was an observational, prospective, non-randomised, open-label study that enrolled 92 patients with diabetes mellitus in three centers from Buenos Aires, Argentina, between April 2009 and March 2011, to be treated with PEB. Results were compared with previous outcome data in all patients with DM treated with DES (n=129 pts) or BMS (n=96 pts) in clinical studies conducted at our institutions. At one-year follow-up, patients with DM who received PEB followed by BMS implantation (96%) had a significantly lower incidence of major adverse cardiac events (MACE) compared to the BMS group (BMS 32.3%, PEB 13.2%; P=.003). The incidence of target-vessel failure (TVF) was 30.2% (BMS) and 11% (PEB) (P=.003), that of target-vessel revascularization (TVR) was 22.9% (BMS) and 8.3% (PEB) (P=.005) and the composite of death/MI occurred in 13.5% (BMS) and in 2.2% for PEB (P=.05). These positive results are persistent even after subgroups analysis. When comparing with previous DES patients, TVF was 18.6% in DES vs. 11.0% in PEB (P=.13), MACE was 18.6% in DES vs. 13.2% in PEB (P=.29), TVR rate was 14.0% in DES vs. 8.3% in PEB (P=.14) and the composite death/MI was 9.3% in DES vs. 4.4% in PEB (0.18)
Diabetic patients treated with PEB followed by BMS resulted in a significantly better outcome than BMS alone and appeared to be comparable to DES treatment.
糖尿病（DM）患者经皮冠状动脉介入治疗（PCI）与冠状动脉再狭窄、心肌梗死（MI）及死亡的高发生率相关。本研究旨在评估与接受裸金属支架（BMS）或药物洗脱支架（DES）治疗的患者相比，紫杉醇洗脱球囊（PEB）治疗在患有冠状动脉病变的糖尿病患者中的潜在作用。
阿根廷糖尿病注册研究（DEAR）是一项观察性、前瞻性、非随机、开放标签研究，于2009年4月至2011年3月在阿根廷布宜诺斯艾利斯的三个中心纳入了92例糖尿病患者，接受PEB治疗。将结果与我们机构在临床研究中接受DES（n = 129例）或BMS（n = 96例）治疗的所有糖尿病患者的既往结局数据进行比较。在一年的随访中，接受PEB后植入BMS的糖尿病患者（96%）与BMS组相比，主要不良心脏事件（MACE）的发生率显著更低（BMS为32.3%，PEB为13.2%；P = 0.003）。靶血管失败（TVF）的发生率为30.2%（BMS）和11%（PEB）（P = 0.003），靶血管血运重建（TVR）的发生率为22.9%（BMS）和8.3%（PEB）（P = 0.005），死亡/MI的复合发生率在BMS组为13.5%，在PEB组为2.2%（P = 0.05）。即使在亚组分析后，这些阳性结果仍然持续存在。与既往DES患者相比，DES组的TVF为18.6%，PEB组为11.0%（P = 0.13），DES组的MACE为18.6%，PEB组为13.2%（P = 0.29），DES组的TVR率为14.0%，PEB组为8.3%（P = 0.14），DES组的死亡/MI复合发生率为9.3%，PEB组为4.4%（P = 0.18）
接受PEB后再植入BMS治疗的糖尿病患者的结局明显优于单纯BMS治疗，且似乎与DES治疗相当。
