Effect of Ticlopidine on Graft Patency Following Arterial Reconstructive Surgery in the Lower Extremity: A Multicenter Three-Year Prospective Study

Abstract

A multicenter, randomized, prospective trial was conducted to determine the clinical efficacy of ticlopidine, an antiplatelet agent, in the prevention of graft occlusion following vascular reconstructive surgery of the lower extremity for arteriosclerosis obliterans. Ticlopidine was administered for two years to one group of patients (112 reconstructed arterial segments) while a control group received no antithrombotic therapy (108 segments). There was no significant difference between the treated and control groups in the overall cumulative patency rates for both suprainguinal and infrainguinal reconstructions. In the treated group, however, there was a significant reduction of occlusions in pa tients with rest pain or ischemic gangrene (p < 0.1) and in those with hyperlipi demia (p < 0.05). Ticlopidine-treated patients with infrainguinal arterial reconstructions developed more occlusions than controls between three and twelve months after surgery, but the controls had more occlusions both immedi ately after surgery and in the second postoperative year. It appeared, therefore, that ticlopidine reduced graft failure due to neointimal fibrous hyperplasia or progression of the underlying condition but caused an adverse effect by delaying graft healing. The clinical usefulness of antiplatelet therapy is limited, but it may be effective in the prevention of graft occlusion when administered to the selected patient groups above mentioned. Controversy about antiplatelet ther apy and future research on adjuvant drug therapy after arterial reconstruction are discussed.