Straka Zbynek, Widimsky Petr, Jirasek Karel, Stros Petr, Votava Jan, Vanek Tomas, Brucek Petr, Kolesar Miroslav, Spacek Rudolf
Department of Cardiac Surgery, Kralovske Vinohrady University Hospital, 3rd Medical School of Charles University, Prague, Czech Republic.
Ann Thorac Surg. 2004 Mar;77(3):789-93. doi: 10.1016/j.athoracsur.2003.08.039.
Off-pump coronary artery bypass surgery is becoming increasingly popular despite the lack of sufficient evidence from randomized trials. The aim of our prospective, randomized, single-center study was to examine the role of off-pump revascularization among nonselected patients.
A total of 400 consecutive nonselected patients (mean age 63 years) scheduled for isolated coronary revascularization were randomized by a cardiologist into two groups: A (on-pump) and B (off-pump). The cardiac surgeon was allowed to change the operative technique at any time after randomization. The only exclusion criterion was an emergency procedure. The primary end point was any of the following within 30 days: death, myocardial infarction, stroke, or new renal failure requiring hemodialysis. The study was analyzed on the intention-to-treat principle.
The primary end point occurred in 4.9% of patients in group A versus 2.9% in group B (not significant). Mortality was 1.1% in group A versus 2.0% in group B (not significant). Preoperative crossover occurred in 5.4% of patients in each group (not significant). Intraoperative conversion was necessary in 9.8% of patients in group B versus 1.1% of patients in group A (p < 0.001). Group B patients had fewer distal anastomoses (2.3 versus 2.7 in group A; p < 0.001), less blood loss (560 versus 680 mL; p < 0.001), lower postoperative creatine kinase MB levels (0.15 versus 0.56 microkat/L; p < 0.001) and lower total hospital costs (3,451 versus 4,387; p < 0.001).
In our study off-pump technique was applicable in 85% of nonselected patients and is at least as clinically safe and effective as on-pump surgery.
尽管随机试验缺乏充分证据，但非体外循环冠状动脉搭桥手术正变得越来越流行。我们这项前瞻性、随机、单中心研究的目的是探讨非体外循环血运重建在未经过筛选的患者中的作用。
共有400例计划进行单纯冠状动脉血运重建的连续未经过筛选的患者（平均年龄63岁）由一名心脏病专家随机分为两组：A组（体外循环）和B组（非体外循环）。随机分组后心脏外科医生可在任何时间改变手术技术。唯一的排除标准是急诊手术。主要终点是30天内发生以下任何一种情况：死亡、心肌梗死、中风或需要血液透析的新发肾衰竭。该研究按照意向性分析原则进行分析。
主要终点在A组患者中的发生率为4.9%，而B组为2.9%（无统计学意义）。A组死亡率为1.1%，B组为2.0%（无统计学意义）。每组有5.4%的患者术前发生交叉（无统计学意义）。B组9.8%的患者术中需要转为体外循环，而A组为1.1%（p<0.001）。B组患者的远端吻合口较少（A组为2.7个，B组为2.3个；p<0.001），失血量较少（560ml对680ml；p<0.001），术后肌酸激酶MB水平较低（0.15微卡/升对0.56微卡/升；p<0.001），总住院费用较低（3451对4387；p<0.001）。
在我们的研究中，非体外循环技术适用于85%的未经过筛选的患者，并且在临床安全性和有效性方面至少与体外循环手术相当。
