The impact of tranilast on restenosis after coronary angioplasty: The second tranilast restenosis following angioplasty trial (TREAT-2)

• Published in: The American heart journal Vol. 143; no. 3; pp. 506 - 513
• Main Authors: Tamai, Hideo, Katoh, Kazuzo, Yamaguchi, Tetsu, Hayakawa, Hirokazu, Kanmatsuse, Katsuo, Haze, Kazuo, Aizawa, Tadanori, Nakanishi, Shigemoto, Suzuki, Shin, Suzuki, Takahiko, Takase, Shinichi, Nishikawa, Hideo, Katoh, Osamu
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01-03-2002; Elsevier; Elsevier Limited
• Subjects: Administration, Oral; Angina pectoris; Angioplasty; Angioplasty, Balloon, Coronary; Anti-Allergic Agents - adverse effects; Anti-Allergic Agents - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Biological and medical sciences; Coronary Disease - therapy; Coronary Restenosis - prevention & control; Coronary vessels; Double-Blind Method; Female; Follow-Up Studies; Heart attacks; Humans; Male; Medical sciences; Middle Aged; ortho-Aminobenzoates - adverse effects; ortho-Aminobenzoates - therapeutic use; Statistics as Topic; Stents; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the heart; Japan; Human; Coronary artery; Instrumentation therapy; Stenosis; Cardiovascular disease; Instrumental dilatation; Coronary heart disease; Arterial disease; Vascular disease; Restenosis; Chemotherapy; Tranilast; Treatment; Complication
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1067/mhj.2002.120770

Background The Tranilast Restenosis Following Angioplasty Trial showed that oral administration of 600 mg/day of tranilast for 3 months markedly reduced the restenosis rate after percutaneous transluminal coronary angioplasty (PTCA) for de novo lesions. Methods We conducted the second multicenter, randomized, double-blinded placebo-controlled trial. A total of 297 patients with 329 lesions were randomly assigned to treatment with tranilast or a placebo for 3 months after successful PTCA for both de novo and restenotic lesions. Angiographic follow-up examination was done at 3 months, and angiograms were interpreted with a quantitative approach. Results Two hundred thirty-nine lesions (72.6%) in 216 of the patients (72.7%) met the criteria and were included in the assessment of restenosis. Lesion restenosis was defined as a loss of 50% or more of the initial gain, and the restenosis rates were 18.8% in the tranilast group (n = 112) and 44.1% in the placebo group (n = 127; P =.00005). The restenosis rate, defined as a percent stenosis of ≥50% at follow-up examination, was also significantly lower in the tranilast group (25.9% versus 41.9%; P =.012). The numbers of restenotic lesions were 38 (33.9% of 112) in the tranilast group and 30 (23.6% of 127) in the placebo group. In restenotic lesions, the lesion restenosis rate was significantly lower in the tranilast subgroup (18.4% versus 53.3% with the first restenosis criterion; P =.004). Conclusion The oral administration of tranilast for 3 months markedly reduced the restenosis rate after PTCA, even in restenotic lesions. (Am Heart J 2002;143:506-13.)