Desmet W, Vrolix M, De Scheerder I, Van Lierde J, Willems J L, Piessens J
Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium.
Circulation. 1994 Jan;89(1):385-92. doi: 10.1161/01.cir.89.1.385.
Several angiotensin-converting enzyme inhibitors have antiproliferative effects in a rat model after carotid artery balloon injury.
We conducted a randomized, double-blind, placebo-controlled trial to assess the effect of fosinopril, a novel angiotensin-converting enzyme inhibitor, in restenosis prevention after percutaneous transluminal coronary angioplasty (PTCA). Patients received fosinopril or matched placebo 10 mg at least 18 hours before PTCA, 20 mg at least 4 hours before PTCA, and 40 mg daily for 6 months. In addition, all patients received aspirin. Coronary angiograms before PTCA and immediately after PTCA as well as at 6-month follow-up were quantitatively analyzed. A total of 509 patients were recruited. The final per-protocol population consisted of 153 fosinopril-treated and 151 placebo-treated patients. Restenosis rates according to the National Heart, Lung, and Blood Institute criterion 4 (loss of > or = 50% of the initial gain [primary end point]) were 45.7% and 40.7% in the fosinopril and control groups, respectively (not significant). The respective mean differences in minimal coronary luminal diameter between post-PTCA and follow-up angiograms were -0.59 +/- 0.71 mm and -0.51 +/- 0.67 mm (not significant). Clinical events during the 6-month follow-up period, analyzed on an on-treatment basis, were ranked according to the most serious event. The respective numbers in the fosinopril and the control groups were for death, 0 and 0; myocardial infarction, 0 and 0; coronary artery bypass graft surgery, 1 and 3; repeat PTCA, 35 and 35; recurrent signs of ischemia necessitating early repeat coronary angiography and managed medically, 6 and 7; and none of the above, 111 and 106. All these differences were significant.
Administration of fosinopril in a dose of 40 mg daily during 6 months after PTCA does not prevent restenosis and has no effect on overall clinical outcome.
几种血管紧张素转换酶抑制剂在大鼠颈动脉球囊损伤模型中具有抗增殖作用。
我们进行了一项随机、双盲、安慰剂对照试验，以评估新型血管紧张素转换酶抑制剂福辛普利在经皮腔内冠状动脉成形术（PTCA）后预防再狭窄中的作用。患者在PTCA前至少18小时服用福辛普利或匹配的安慰剂10毫克，PTCA前至少4小时服用20毫克，然后每天服用40毫克，持续6个月。此外，所有患者均服用阿司匹林。对PTCA前、PTCA后即刻以及6个月随访时的冠状动脉造影进行定量分析。共招募了509例患者。最终符合方案人群包括153例接受福辛普利治疗的患者和151例接受安慰剂治疗的患者。根据美国国立心肺血液研究所标准4（初始增益丧失≥50%[主要终点]），福辛普利组和对照组的再狭窄率分别为45.7%和40.7%（无显著性差异）。PTCA后与随访血管造影之间最小冠状动脉腔直径的各自平均差异分别为-0.59±0.71毫米和-0.51±0.67毫米（无显著性差异）。在6个月随访期内，按治疗情况分析的临床事件根据最严重事件进行排序。福辛普利组和对照组的相应数字分别为：死亡，0例和0例；心肌梗死，0例和0例；冠状动脉搭桥手术，1例和3例；重复PTCA，35例和35例；因缺血复发体征需要早期重复冠状动脉造影并进行药物治疗，6例和7例；以及上述情况均无，111例和106例。所有这些差异均具有显著性。
PTCA后6个月每天服用40毫克福辛普利不能预防再狭窄，对总体临床结局也无影响。
