The impact of tranilast on restenosis after coronary angioplasty: the Second Tranilast Restenosis Following Angioplasty Trial (TREAT-2).
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 > or = 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).


CONCLUSIONS
The oral administration of tranilast for 3 months markedly reduced the restenosis rate after PTCA, even in restenotic lesions.
Tamai
Hideo
H
Department of Cardiology, Shiga Medical Center for Adults, Moriyama, Shiga, Japan.
Katoh
Kazuzo
K
Yamaguchi
Tetsu
T
Hayakawa
Hirokazu
H
Kanmatsuse
Katsuo
K
Haze
Kazuo
K
Aizawa
Tadanori
T
Nakanishi
Shigemoto
S
Suzuki
Shin
S
Suzuki
Takahiko
T
Takase
Shinichi
S
Nishikawa
Hideo
H
Katoh
Osamu
O
D000284:Administration, Oral; D015906:Angioplasty, Balloon, Coronary; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D003327:Coronary Disease / Q000628:therapy; D023903:Coronary Restenosis / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D013223:Statistics as Topic; D062367:ortho-Aminobenzoates / Q000009:adverse effects / Q000627:therapeutic use*
D018926:Anti-Allergic Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D062367:ortho-Aminobenzoates; C012293:tranilast