Cataldo G, Heiman F, Lavezzari M, Marubini E
Centro A. De Gasperis, Ospedale Niguarda Ca Granda, Università di Milano, Milan, Italy.
Coron Artery Dis. 1998;9(4):217-22. doi: 10.1097/00019501-199809040-00007.
Two prospective, randomized, double-blind clinical trials, performed in the UK and Italy, showed that indobufen, a reversible cyclo-oxygenase inhibitor, is as effective as, and safer than, a combination of aspirin with dipyridamole in preventing occlusion of saphenous vein coronary artery bypass grafts (CABG) 1 year after surgery.
To obtain, in a larger patient population, a more precise estimate of the possible differences in efficacy and safety between the two treatments.
We performed a combined analysis of the results of the two studies, based on the 1-year angiography data, on a total of 934 patients with 2258 saphenous vein distal anastomoses.
Patients in the UK and Italy had similar baseline clinical characteristics. The analysis confirmed that there were no significant differences between the two treatment groups in the proportion of patients with one or more occluded grafts and in the proportion of occluded distal anastomoses. The combined analysis showed that the difference in response frequency (indobufen compared with aspirin and dipyridamole) was close to 0: 2.0% (95% confidence interval (CI) -4.2 to 8.2) in terms of patients, and 0.8% (95% CI -2.5 to 4.2) in terms of distal anastomoses. The 1-year incidence of postoperative major cardiovascular events was not statistically different between the treatment groups (19/694 indobufen compared with 25/678 aspirin and dipyridamole).
Two multicentre CABG studies performed in different countries in patients with similar characteristics showed similar results in terms of graft patency. On the basis of the combined analysis, the two treatments can reasonably be considered to be equally effective in the prevention of graft occlusion.
在英国和意大利进行的两项前瞻性、随机、双盲临床试验表明，可逆性环氧化酶抑制剂吲哚布芬在预防隐静脉冠状动脉旁路移植术（CABG）术后1年的移植血管闭塞方面，与阿司匹林联合双嘧达莫的疗效相当且更安全。
在更大的患者群体中，更精确地评估两种治疗方法在疗效和安全性方面可能存在的差异。
我们基于两项研究的1年血管造影数据，对总共934例患者的2258个隐静脉远端吻合口进行了联合分析。
英国和意大利的患者具有相似的基线临床特征。分析证实，在有一个或多个移植血管闭塞的患者比例以及闭塞的远端吻合口比例方面，两个治疗组之间没有显著差异。联合分析显示，反应频率的差异（吲哚布芬与阿司匹林和双嘧达莫相比）接近0：就患者而言为2.0%（95%置信区间（CI）-4.2至8.2），就远端吻合口而言为0.8%（95%CI -2.5至4.2）。治疗组之间术后主要心血管事件的1年发生率在统计学上没有差异（吲哚布芬组694例中有19例，阿司匹林和双嘧达莫组678例中有25例）。
在不同国家对特征相似的患者进行的两项多中心CABG研究在移植血管通畅性方面显示出相似的结果。基于联合分析，可合理认为两种治疗方法在预防移植血管闭塞方面同样有效。
