Hermans W R, Rensing B J, Foley D P, Tijssen J G, Rutsch W, Emanuelsson H, Danchin N, Wijns W, Chappuis F, Serruys P W
Thoraxcenter, Dijkzigt, Rotterdam, The Netherlands.
J Cardiovasc Pharmacol. 1993;22 Suppl 4:S45-57.
Follow-up angiography at 6 months was obtained in 94% of the 693 patients (778 successfully dilated coronary lesions) enrolled in the Multicenter European Research trial with Cilazapril after Angioplasty to prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) trial--a double-blind, placebo-controlled trial--to study the effects of cilazapril 5 mg b.i.d. on restenosis [defined as the mean loss in minimal luminal diameter during follow-up, assessed by an interpolated edge detection technique (coronary angiography analysis system)] and long-term clinical outcome. No statistically significant difference could be detected between treatment and placebo groups with regard to clinical outcome or restenosis. The purpose of this ancillary study was to determine which, if any, patient, lesion, or procedural factors were predictive of restenosis. The identification of such factors could be helpful in the selection of lesions suitable for angioplasty and, if modifiable or controllable, potentially reduce restenosis. A stepwise multiple linear regression analysis was performed to identify independent predictors of restenosis. The following variables were retained in the model in order of significance: (a) relative gain (difference between the minimal luminal diameter pre- and post-percutaneous transluminal coronary angioplasty (PTCA), normalized for vessel size), (b) minimal luminal diameter post-PTCA, and (c) dilatation of another vessel than right coronary artery. The fit of the model was poor; where the predicted change in minimal luminal diameter was < 0.1 mm, 0.1-0.3 mm, > 0.3 mm, the corresponding percent correct classification was 30, 52, and 55%. The present study illustrates that the restenosis phenomenon cannot accurately be predicted by patient, lesion, and procedural variables.
在欧洲多中心血管成形术后应用西拉普利预防经腔冠状动脉阻塞和再狭窄(MERCATOR)试验(一项双盲、安慰剂对照试验)中,693例患者(778处成功扩张的冠状动脉病变)中有94%在6个月时进行了随访血管造影,以研究每日两次服用5 mg西拉普利对再狭窄[定义为随访期间最小管腔直径的平均损失,通过内插边缘检测技术(冠状动脉血管造影分析系统)评估]和长期临床结局的影响。在临床结局或再狭窄方面,治疗组和安慰剂组之间未检测到统计学上的显著差异。这项辅助研究的目的是确定哪些患者、病变或手术因素(如果有的话)可预测再狭窄。识别这些因素可能有助于选择适合血管成形术的病变,并且如果这些因素是可改变或可控的,则有可能减少再狭窄。进行了逐步多元线性回归分析以识别再狭窄的独立预测因素。以下变量按重要性顺序保留在模型中:(a)相对增益(经皮腔内冠状动脉成形术(PTCA)前后最小管腔直径的差异,按血管大小进行标准化),(b)PTCA后最小管腔直径,以及(c)除右冠状动脉外另一血管的扩张情况。该模型的拟合效果较差;当预测的最小管腔直径变化<0.1 mm、0.1 - 0.3 mm、>0.3 mm时,相应的正确分类百分比分别为30%、52%和55%。本研究表明,再狭窄现象无法通过患者、病变和手术变量准确预测。