Carrozza J P, Kuntz R K, Schatz R A, Leon M, Goldberg S, Savage M, Fischman D, Senerchia C, Diver D J, Baim D S
Harvard-Thorndike Laboratory, Beth Israel Hospital, Boston, MA 02215.
Cathet Cardiovasc Diagn. 1994 Mar;31(3):173-8. doi: 10.1002/ccd.1810310303.
Restenosis rates following Palmaz-Schatz stenting vary between 13 and 36%. To determine whether the nearly three-fold interseries difference in restenosis rates reflects systematic factors (demographic and procedural variables such as post-treatment lumen diameter) rather than random variation, we pooled 486 lesions treated with the Palmaz-Schatz coronary stent in the U.S. Multicenter Registry (n = 259) with the single-center Beth Israel Hospital experience (n = 227) and analyzed the combined series using a continuous geometric model of restenosis. A greater proportion of lesions (66 vs. 50%; P < 0.001) in the Multicenter cohort represented restenosis after a prior intervention. The Multicenter experience also showed a smaller minimum lumen diameter following stent placement (2.61 vs. 3.43 mm; P < 0.001), higher post-stent percent stenosis (16 vs. -2%; P < 0.001), and less acute gain (1.79 vs. 2.67 mm; P < 0.001) than lesions treated in the Beth Israel cohort. At 6-month follow-up, the angiographic restenosis rate (> or = 50% diameter stenosis) was significantly higher in the Multicenter group (35 vs. 27%; P = 0.05), despite the development of less absolute late loss (0.96 vs. 1.32 mm; P < 0.001). Multivariable modeling, however, showed that the only independent predictors of restenosis were a post-procedure lumen diameter < 2.80 mm (odds ratio = 1.57; P = 0.04), diabetes mellitus (odds ratio = 3.55; P < 0.001), and prior restenosis (odds ratio = 1.84; P = 0.008).(ABSTRACT TRUNCATED AT 250 WORDS)
Palmaz-Schatz支架置入术后的再狭窄率在13%至36%之间。为了确定再狭窄率近三倍的系列间差异反映的是系统性因素(人口统计学和手术变量,如治疗后管腔直径)而非随机变异,我们将美国多中心注册研究(n = 259)中486例接受Palmaz-Schatz冠状动脉支架治疗的病变与贝斯以色列医院单中心经验(n = 227)进行汇总,并使用再狭窄的连续几何模型分析合并后的系列。多中心队列中更大比例的病变(66%对50%;P < 0.001)代表先前干预后的再狭窄。与贝斯以色列队列中治疗的病变相比,多中心经验还显示支架置入后最小管腔直径更小(2.61对3.43 mm;P < 0.001),支架后置入狭窄百分比更高(16%对 -2%;P < 0.001),急性增益更小(1.79对2.67 mm;P < 0.001)。在6个月随访时,多中心组的血管造影再狭窄率(直径狭窄≥50%)显著更高(35%对27%;P = 0.05),尽管绝对晚期丢失更少(0.96对1.32 mm;P < 0.001)。然而,多变量建模显示,再狭窄的唯一独立预测因素是术后管腔直径<2.80 mm(优势比 = 1.57;P = 0.04)、糖尿病(优势比 = 3.55;P < 0.001)和先前再狭窄(优势比 = 1.84;P = 0.008)。(摘要截断于250字)