Impact of tranilast on restenosis after coronary angioplasty: tranilast 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 factor-beta1, and interleukin-1beta and prevents keloid formation after skin injury. Treatment with this drug reduced the restenosis rate after percutaneous transluminal coronary angioplasty in a preliminary study.


RESULTS
We conducted a multicenter, randomized, double-blind, placebo-controlled trial. A total of 255 patients with 289 lesions were randomly assigned to treatment with the oral administration of 600 mg/d tranilast, 300 mg/d tranilast, or a placebo for 3 months after successful angioplasty. 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 assessment of restenosis. The restenosis rates defined as >/=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 >/=50% at follow-up were 17. 6% in the 600 mg/d tranilast group, 38.6% in the 300 mg/d tranilast group, and 39.4% in the placebo group (P =.005 for 600 mg/d tranilast vs placebo).


CONCLUSIONS
The oral administration of 600 mg/d of tranilast for 3 months markedly reduced the restenosis rate after percutaneous transluminal coronary angioplasty.
Tamai
H
H
Department of Cardiology, Shiga Medical Center, Japan.
Katoh
O
O
Suzuki
S
S
Fujii
K
K
Aizawa
T
T
Takase
S i
Si
Kurogane
H
H
Nishikawa
H
H
Sone
T
T
Sakai
K
K
Suzuki
T
T
D000284:Administration, Oral; D000787:Angina Pectoris / Q000000981:diagnostic imaging / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery; D012008:Recurrence; D012189:Retrospective Studies; D016896:Treatment Outcome; D062367:ortho-Aminobenzoates / Q000008:administration & dosage / Q000627:therapeutic use*
D010975:Platelet Aggregation Inhibitors; D062367:ortho-Aminobenzoates; C012293:tranilast