Effect of ticlopidine on the long-term patency of saphenous-vein bypass grafts in the legs

Background Optimal therapy to prevent late occlusion of arterial bypass grafts in the legs has not been determined. We assessed the effect of ticlopidine, an inhibitor of platelet aggregation, on the long-term patency of saphenous-vein bypass grafts for the treatment of peripheral vascular disease. Methods A total of 243 patients with femoropopliteal or femorotibial saphenous-vein bypass grafts were randomly assigned to receive either ticlopidine (250 mg twice a day) or matching placebo for two years. The primary end point was graft patency at two years, as assessed by physical examination, measurement of the ankle brachial index, and duplex ultrasonography or arteriography. The incidence of death and major ischemic events was also analyzed in the two groups. Results After two years, 66.4 percent of the patients were alive with a patent graft in the ticlopidine group, as compared with 51.2 percent in the placebo group (95 percent confidence interval for the difference between the two groups, 2.9 to 27.4 percent; P = 0.02). The two-year cumulative patency rate was 82 percent in the ticlopidine group and 63 percent in the placebo group (P = 0.002). There was no significant difference between groups in overall mortality or major ischemic events. Conclusions Ticlopidine significantly improved the long-term patency of saphenous-vein bypass grafts in the legs. Since the drug was well tolerated, its use can be recommended after peripheral-vein bypass surgery. (C) 1997, Massachusetts Medical Society.