Carrozza J P, Kuntz R E, Levine M J, Pomerantz R M, Fishman R F, Mansour M, Gibson C M, Senerchia C C, Diver D J, Safian R D
Harvard-Thorndike Laboratory, Beth Israel Hospital, Boston, Massachusetts 02215.
J Am Coll Cardiol. 1992 Aug;20(2):328-37. doi: 10.1016/0735-1097(92)90098-8.
The purpose of this study was to determine the immediate and long-term angiographic and clinical results of coronary stenting.
Although preliminary trials of endovascular stenting have demonstrated promising results, lack of long-term follow-up has limited the critical evaluation of the role of coronary stenting in the treatment of obstructive coronary artery disease.
A total of 250 procedures using the Palmaz-Schatz stent, performed in 220 patients between June 1988 and July 1991, were examined. Minimal lumen diameter of the treated segments was measured on angiograms obtained before, after and 6 months after intervention.
Stent placement was successful in 246 (98%) of 250 lesions, reducing diameter stenosis from 77% to -2.5%. There were no deaths or Q wave myocardial infarctions. One patient (0.4%) required emergency bypass surgery and one (0.4%) developed subacute thrombosis. Femoral vascular complications occurred in 36 patients (16%). Six-month angiographic follow-up was obtained in 91% of eligible patients. The overall angiographic restenosis rate (stenosis greater than or equal to 50%) was 25%. By univariable analysis, the rate of restenosis was significantly higher for stents in the left anterior descending versus the right coronary artery (44% vs. 12%; p = 0.002); in diabetic patients (56% vs. 20%; p = 0.006), and in vessels with post-stent lumen diameter less than 3.31 mm (34% vs. 16%; p = 0.05). Stenting of the left anterior descending artery was the strongest predictor (p = 0.01) of restenosis in a multivariable model. Total survival was 97% and event-free survival (freedom from death, myocardial infarction or revascularization) was 70% at 36 months.
Palmaz-Schatz stents can be placed successfully with a low incidence of major complications. The angiographic restenosis rate was 25%, and 70% of patients remained free of cardiovascular events at 3 years. Diabetes, small postprocedure lumen diameter and stenting of the left anterior descending artery are associated with higher rates of restenosis.
本研究旨在确定冠状动脉支架置入术的即刻和长期血管造影及临床结果。
尽管血管内支架置入术的初步试验已显示出有前景的结果,但缺乏长期随访限制了对冠状动脉支架置入术在治疗阻塞性冠状动脉疾病中作用的关键评估。
对1988年6月至1991年7月期间在220例患者中进行的共250例使用帕尔马兹-沙茨支架的手术进行了检查。在干预前、干预后及干预后6个月获得的血管造影片上测量治疗节段的最小管腔直径。
250处病变中有246处(98%)支架置入成功,直径狭窄率从77%降至-2.5%。无死亡或Q波心肌梗死发生。1例患者(0.4%)需要急诊搭桥手术,1例(0.4%)发生亚急性血栓形成。36例患者(16%)发生股血管并发症。91%的符合条件患者获得了6个月的血管造影随访。总体血管造影再狭窄率(狭窄大于或等于50%)为25%。单变量分析显示,左前降支支架的再狭窄率显著高于右冠状动脉支架(44%对12%;p = 0.002);糖尿病患者中(56%对20%;p = 0.006),以及支架后管腔直径小于3.31 mm的血管中(34%对16%;p = 0.05)。在多变量模型中,左前降支动脉支架置入是再狭窄的最强预测因素(p = 0.01)。36个月时总生存率为97%,无事件生存率(无死亡、心肌梗死或血运重建)为70%。
帕尔马兹-沙茨支架能够成功置入,主要并发症发生率低。血管造影再狭窄率为25%,3年时70%的患者无心血管事件。糖尿病、术后管腔直径小以及左前降支动脉支架置入与较高的再狭窄率相关。