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 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.


OBJECTIVE
To obtain, in a larger patient population, a more precise estimate of the possible differences in efficacy and safety between the two treatments.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Cataldo
G
G
Centro A. De Gasperis, Ospedale Niguarda Ca Granda, Università di Milano, Milan, Italy.
Heiman
F
F
Lavezzari
M
M
Marubini
E
E
D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001026:Coronary Artery Bypass; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004176:Dipyridamole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000517:prevention & control*; D006801:Humans; D054833:Isoindoles; D008297:Male; D008875:Middle Aged; D010654:Phenylbutyrates / Q000009:adverse effects / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011859:Radiography; D016032:Randomized Controlled Trials as Topic
D016861:Cyclooxygenase Inhibitors; D054833:Isoindoles; D010654:Phenylbutyrates; D010975:Platelet Aggregation Inhibitors; D004176:Dipyridamole; C020371:indobufen; D001241:Aspirin