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
Department of Cardiology, Shiga Medical Center for Adults, Moriyama, Shiga, Japan.
Am Heart J. 2002 Mar;143(3):506-13. doi: 10.1067/mhj.2002.120770.
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.
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.
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).
The oral administration of tranilast for 3 months markedly reduced the restenosis rate after PTCA, even in restenotic lesions.
曲尼司特血管成形术后再狭窄试验表明，口服曲尼司特600毫克/天，持续3个月，可显著降低初发病变经皮腔内冠状动脉成形术（PTCA）后的再狭窄率。
我们进行了第二项多中心、随机、双盲、安慰剂对照试验。共有297例患者的329处病变在成功进行PTCA治疗初发和再狭窄病变后，被随机分配接受曲尼司特或安慰剂治疗3个月。在3个月时进行血管造影随访检查，并采用定量方法解读血管造影图像。
216例患者（72.7%）中的239处病变（72.6%）符合标准，并被纳入再狭窄评估。病变再狭窄定义为初始增益丧失50%或更多，曲尼司特组（n = 112）的再狭窄率为18.8%，安慰剂组（n = 127）为44.1%（P =.00005）。在随访检查中定义为狭窄率≥50%的再狭窄率，曲尼司特组也显著更低（25.9%对41.9%；P =.012）。曲尼司特组再狭窄病变数量为38处（112处中的33.9%），安慰剂组为30处（127处中的23.6%）。在再狭窄病变中，曲尼司特亚组的病变再狭窄率显著更低（按照首个再狭窄标准，分别为18.4%对53.3%；P =.004）。
口服曲尼司特3个月可显著降低PTCA后的再狭窄率，即使在再狭窄病变中亦是如此。
