Impact of tranilast on restenosis after coronary angioplasty: Tranilost restenosis following angioplasty trial (TREAT)

Background Tranilast is an antiallergic drug that suppresses the release of cytokines such as platelet-derived growth factor, transforming growth fact or-beta 1, and interlevkin-1 beta and prevents keloid formation after skin injury. Treatment with this drug reduced the restenosis rate after percutan eous transluminal coronary angioplasty in a preliminary study. Methods and Results We conducted a multicenter, randomized, double-blind, p lacebo-controlled trial. A total of 255 patients with 289 lesions were rand omly assigned to treatment with the oral administration of 600 mg/d tranila st, 300 mg/d tranilast, or a placebo for 3 months after successful angiopla sty. Angiographic follow-up was done at 3 months, and a clinical follow-up examination was performed at 12 months, Two hundred ten (72.7%) lesions of 188 (73.7%) of the patients met the criteria and were eligible for the asse ssment of restenosis. The restenosis rates defined as greater than or equal to 50% loss of the initial gain were 14.7% in the 600 mg/d tranilast group , 35.2% in the 300 mg/d tranilast group, and 46.5% in the placebo group (P < .0001 for 600 mg/d tranilast vs placebo). The restenosis rates defined as percent diameter stenosis of greater than or equal to 50% at follow-up wer e 17.6% in the 600 mg/d tranilast group, 38.6% in the 300 mg/d tranilast gr oup, and 39.4% in the placebo group (P = .005 for 600 mg/d tranilast vs pla cebo). Conclusions The oral administration of 600 mg/d of tranilast for 3 months m arkedly reduced the restenosis rate after percutaneous transluminal coronar y angioplasty.