Tranilast is an antiallergic drug used widely in Japan that also inhibits the migration and proliferation of vascular smooth muscle cells. This pilot study was undertaken to determine the effectiveness of tranilast on restenosis after successful directional coronary atherectomy. After the procedure, 40 patients (56 lesions, tranilast group) were treated with oral tranilast for 3 months, and 152 patients (188 lesions, control group) did not receive tranilast. Angiographic and clinical variables were compared between the two groups. The minimal lumen diameter was significantly larger in the tranilast group than in the control group at both 3-month (2.08 vs 1.75 mm, p = 0.004) and 6-month follow-up (2.04 vs 1.70 mm, p = 0.003). The diameter stenosis in the tranilast group was smaller than that in the control group both 3 months (28% vs 40%, p = 0.0007) and 6 months (30% vs 43%, p = 0.0001) after the procedure, with a lower restenosis rate (percent diameter stenosis > or =50) in the tranilast group at 3 months (11 % vs 26%, p = 0.03). The number of clinical events over the 12-month period after the procedure was significantly reduced by tranilast administration (p = 0.013). These findings suggest that the oral administration of tranilast strongly prevents restenosis after directional coronary atherectomy.