Maresta A, Balducelli M, Cantini L, Casari A, Chioin R, Fabbri M, Fontanelli A, Monici Preti P A, Repetto S, De Servi S
Department of Clinical and Interventional Cardiology, Ospedale per gli Infermi, Faenza (RA), Italy.
Circulation. 1994 Dec;90(6):2710-5. doi: 10.1161/01.cir.90.6.2710.
Trapidil is an antiplatelet drug with specific platelet-derived growth factor antagonism and antiproliferative effects in the rat and rabbit models after balloon angioplasty.
The Studio Trapidil versus Aspirin nella Restenosi Coronarica (STARC) is a multicentric, randomized, double-blind trial to assess the effects of trapidil in angiographic restenosis prevention after percutaneous transluminal coronary angioplasty (PTCA). Patients received either trapidil 100 mg TID or aspirin at the same dosage at least 3 days before angioplasty and for 6 months thereafter. Coronary angiograms before PTCA, after PTCA, and at 6-month follow-up were quantitatively analyzed with manual calipers. Of the initial 384 patients recruited, 254 were evaluable for restenosis analysis (128 trapidil, 126 aspirin). Restenosis, defined as a loss of initial percent gain after PTCA of at least 50% (primary end point), occurred in 24.2% of the trapidil group and 39.7% of the aspirin group (P < .01). A similar result was obtained when restenosis per vessel was considered (trapidil, 23.3%; aspirin, 36.9%; P = .018). Clinical events at follow-up were similar in the two groups except that recurrent angina was significantly more frequent in the aspirin group, 43.7% versus 25.8% in the trapidil group (P < .01). Trapidil was well tolerated: only 6 patients had to discontinue the drug because of side effects, which was not different from the aspirin group.
Trapidil reduces restenosis after PTCA at the dosage of 100 mg TID and favorably influences the clinical outcome thereafter.
曲匹地尔是一种抗血小板药物，在大鼠和兔球囊血管成形术后模型中具有特异性血小板衍生生长因子拮抗作用和抗增殖作用。
曲匹地尔与阿司匹林预防冠状动脉再狭窄研究（STARC）是一项多中心、随机、双盲试验，旨在评估曲匹地尔在经皮腔内冠状动脉成形术（PTCA）后预防血管造影再狭窄中的作用。患者在血管成形术前至少3天接受每日3次100 mg曲匹地尔或相同剂量的阿司匹林治疗，并在术后持续6个月。采用手动卡尺对PTCA术前、术后及6个月随访时的冠状动脉造影进行定量分析。在最初招募的384例患者中，254例可进行再狭窄分析（128例曲匹地尔组，126例阿司匹林组）。再狭窄定义为PTCA后初始增益百分比至少降低50%（主要终点），曲匹地尔组发生率为24.2%，阿司匹林组为39.7%（P<0.01）。考虑每支血管的再狭窄情况时，结果相似（曲匹地尔组为23.3%，阿司匹林组为36.9%；P = 0.018）。随访期间两组临床事件相似，但阿司匹林组复发性心绞痛明显更频繁，分别为43.7%和曲匹地尔组的25.8%（P<0.01）。曲匹地尔耐受性良好：只有6例患者因副作用而停药，与阿司匹林组无差异。
每日3次100 mg剂量的曲匹地尔可降低PTCA后的再狭窄率，并对随后的临床结局产生有利影响。
