920-51 Indobufen Versus ASA + Dipyridamole on Coronary Artery Bypass Graft Patency: Combined Analysis of Two Multicenter Trials

Abstract

Two prospective randomized double blind clinical trials, performed in United Kingdom (UK) and in Italy (IT) showed that Indobufen (INB) reversible cyclooxygenase inhibitorl is as effective as, and safer than, the association of Aspirin plus Dipyridamole in preventing the occlusion of saphenous vein (SV) coronary artery bypass grafts (CABG). The power of each of the two trials was 80% for a difference in graft occlusion of 10%. We present the results of the analysis, carried out by properly combining the information given by the two trials in order to increase the precision of the estimates both of efficacy and of safety. The analysis was performed on total 934 patients who underwent 1 year angiography (2258 SV distal anastomosis). UK and IT patients had similar clinical characteristics, UK pts had higher number of grafts per patient and smaller vessel diameters, distal anastomosis occlusion rates were 19.8% (UK) and 20.9% (IT), small vessel diameter (< 1.5 mm) and right coronary artery location adversely affected graft patency in both groups. Combined analysis showed that: al the Odds Ratio of distal anastomosis occlusion of INB vs ASA + DIP group is: OR = 1.05 (95% CL: 0.85–1.291 suggesting that the efficacy of the two treatments is comparable and b) INB had significantly fewer side effects than ASA + DIP. – two multicenter CABG studies performed in different countries accruing patients with similar clinical characteristics showed similar graft patency: – combined analysis confirmed on a wide population that INB is as effective as the association of ASA + DIP on graft patency and is much better tolerated.