INDOBUFEN COMPARED WITH ASPIRIN AND DIPYRIDAMOLE ON GRAFT PATENCY AFTER CORONARY-ARTERY BYPASS-SURGERY - RESULTS OF A COMBINED ANALYSIS

Background Two prospective, randomized, double-blind clinical trials, performed in the UK and Italy, showed that indobufen, a reversible cyc lo-oxygenase inhibitor, is as effective as, and safer than, a combinat ion of aspirin with dipyridamole in preventing occlusion of saphenous vein coronary artery bypass grafts (CABG) 1 year after surgery. Object ive To obtain, in a larger patient population, a more precise estimate of the possible differences in efficacy and safety between the two tr eatments. Methods We performed a combined analysis of the results of t he two studies, based on the 1-year angiography data, on a total of 93 4 patients with 2258 saphenous vein distal anastomoses. Results Patien ts in the UK and Italy had similar baseline clinical characteristics. The analysis confirmed that there were no significant differences betw een the two treatment groups in the proportion of patients with one or more occluded grafts and in the proportion of occluded distal anastom oses, The combined analysis showed that the difference in response fre quency (indobufen compared with aspirin and dipyridamole) was close to 0: 2.0% (95% confidence interval (CI) -4.2 to 8.2) in terms of patien ts, 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), Conclusions Two multi centre CABG studies performed in different countries in patients with similar characteristics showed similar results in terms of graft paten cy, On the basis of the combined analysis, the two treatments can reas onably be considered to be equally effective in the prevention of graf t occlusion. Coronary Artery Dis 9:217-222 (C) 1998 Lippincott-Raven P ublishers.