Uva Miguel Sousa, Matias Fernando, Cavaco Sara, Magalhães Manuel Pedro
Departamento da Circulação, Serviço de Cirurgia Cardíaca, Hospital da Cruz Vermelha, Lisboa, 1549-008, Portugal.
Trials. 2008 Jul 17;9:44. doi: 10.1186/1745-6215-9-44.
Off-pump coronary artery bypass grafting has been accused of possibly compromising graft patency. Sixteen slice computed tomography has shown good diagnostic accuracy in the assessment of coronary bypass graft patency when compared with conventional coronary artery angiography and is less invasive. The study hypothesis is that coronary artery bypass grafting (CABG) performed without cardiopulmonary bypass (Off-Pump) has equivalent early graft patency as if performed with cardiopulmonary bypass (On-Pump) and may have reduced complication rate.
METHODS/DESIGN: The Prospective Randomized Comparison of Off-Pump and On-Pump MultI-vessel Coronary Artery BypasS Surgery (PROMISS) is a controlled, single blinded, single centre clinical trial, comparing early graft patency using 16-slice computed tomography in patients with multi-vessel coronary artery disease operated either without or with extracorporeal circulation. Inclusion criteria are multivessel disease with an indication for first time, isolated, non emergent coronary artery bypass grafting with a minimum of three distal anastomoses. Secondary end points are peri-operative mortality, combined morbidity, length of stay, neuro-cognitive testing at 6 weeks and adverse events, stress test and quality of life at 6 months and one year. The sample size of one hundred and fifty patients was calculated in order to enable the detection of a 5% difference in graft patency, with 80% power, considering a minimum of 3 distal anastomoses per patient. Enrollment started in April 2005 and ended July 2007 with study closure in July 2008.
The PROMISS trial aims to shed new light on the effect of Off-Pump as compared to On-Pump coronary artery bypass surgery on graft patency, assessed by multidetector computed tomography, in unselected patients with multivessel coronary artery disease.
Current Controlled Trials ISRCTN58800729.
非体外循环冠状动脉搭桥术被指责可能会影响移植血管通畅率。与传统冠状动脉造影相比，16层计算机断层扫描在评估冠状动脉搭桥移植血管通畅性方面显示出良好的诊断准确性，且侵入性较小。本研究的假设是，非体外循环下进行的冠状动脉搭桥术（CABG）与体外循环下进行的冠状动脉搭桥术具有相同的早期移植血管通畅率，且并发症发生率可能更低。
方法/设计：非体外循环与体外循环多支冠状动脉搭桥手术的前瞻性随机对照研究（PROMISS）是一项对照、单盲、单中心临床试验，比较在有或无体外循环的多支冠状动脉疾病患者中使用16层计算机断层扫描评估早期移植血管通畅率。纳入标准为多支血管疾病且首次有指征进行孤立的、非急诊冠状动脉搭桥术，至少有三个远端吻合口。次要终点包括围手术期死亡率、合并症、住院时间、6周时的神经认知测试和不良事件、6个月和1年时的压力测试和生活质量。计算了150名患者的样本量，以便在80%的检验效能下，能够检测到移植血管通畅率5%的差异，考虑到每位患者至少有3个远端吻合口。入组于2005年4月开始，2007年7月结束，研究于2008年7月结束。
PROMISS试验旨在阐明在未选择的多支冠状动脉疾病患者中，与体外循环冠状动脉搭桥手术相比，非体外循环对移植血管通畅率的影响，通过多排计算机断层扫描进行评估。
Current Controlled Trials ISRCTN58800729。
