国产与进口西罗莫司洗脱支架置入后血管内超声随访的对比

目的 利用血管内超声对比观察国产与进口西罗莫司洗脱支架对冠心病患者支架术后新生内膜增生的抑制作用.方法 2003年5月至2007年3月,对215例冠心病患者(317处病变)置入西罗莫司洗脱支架,并在术后1年行冠状动脉造影和血管内超声(IVUS)检查.其中Firebird组108例患者(147处病变)置入国产西罗莫司洗脱支架(Firebird支架),Cypher组107例患者(138处病变)置入进121西罗莫司洗脱支架(Cypher支架).结果 两组患者一般临床情况差异无统计学意义.两组靶病变部位、病变长度、狭窄程度及病变类型差异均无统计学意义,但Firebird组术后最小管腔直径大于Cypher组(2.88±0.43)mm比(2.78±0.33)mm,P＜0.05].随访定量冠状动脉造影分析显示,Firebird组与Cypher组支架内晚期管腔丢失(0.17±0.29)mm比(0.16±0.27)mm,P＞0.05]和节段内晚期管腔丢失(0.18±0.36)mm比(0.20±0.32)mm,P＞0.05]差异均无统计学意义.IVUS分析显示,与Cypher组比较,尽管Firebird组支架面积(6.99±2.25)mm~2比(6.46±1.71)mm~2,P＜0.05]、管腔面积(6.89±2.30)nm~2比(6.36±1.73)mm~2,P＜0.05]、支架体积(162.5±68.9)mm~3比(140.8±57.9)mm~3,P＜0.01]、管腔体积(160.4±69.5)mm~3比(138.6±57.6)mm~3,P＜0.01]及最小支架面积(5.40±1.85)mm~2比(4.92±1.43)mm~2,P＜0.05]均较大,但两组的内膜增生容积(2.09±5.46)mm~3比(2.23±6.50)mm~3,P＞0.05]和内膜增生容积百分数(1.68±5.84)%比(1.59±4.10)%,P＞0.05]差异均无统计学意义.结论 Firebird支架置人后再狭窄的发生率较低,抑制内膜增生作用与Cypher支架相似.

Intravascular ultrasound evaluation on the efficacy of national made Firebird stents comparing with Cypher stents

Objective Intravascular ultrasound(IVUS)was used to compare the effects on neointimal hyperplasia inhibition between national made Firebird stents and Cypher stents in patients with coronary artery disease.Methods From May 2003 to March 2007,215 patients with 317 native lesions received either Firebird stent(147 lesions of 108 patients,Firebird group)or Cypher stent implantation (138 lesions of 107 patients,Cypher group).Quantitative coronary angiography(QCA)and IVUS were performed at one-year follow-up.Results The baseline clinical and angiographic characteristics between the two groups were similar,but post procedural minimal lumen diameter was significantly lager in Firebird group than that in Cypher group(2.88±0.43)mm vs.(2.78±0.33)mm,P＜0.05].follow-up QCA results showed that in-stent late loss(0.17±0.29)mm vs.(0.16±0.27)mm,P＞0.05]and in-segment late loss(0.18±0.36)mm vs.(0.20±0.32)mm,P＞0.05]was similar between Firebird group and Cypher group,while stent cross sectional area(CSA)(6.99±2.25)mm~2 vs.(6.46±1.71)mm~2,P＜0.05],lumen CSA(6.89±2.30)mm~2 vs,(6.36±1.73)mm~2,P＜0.05],stent volume(162.5±68.9)m~3 vs.(140.8±57.9)mm~3,P＜0.01],lumen volume(160.4±69.5)mm~3 vs.(138.6±57.6)mm~3,P＜0.01]and minimal stent CSA(5.40±1.85)mm~2 vs.(4.92±1.43)mm~2,P＜0.05]were larger in Firebird group than those in Cypher group.IVUS analysis showed that there was no significant difference in neointimal hyperplasia volume(2.09±5.46)mm~3 vs.(2.23±6.50)mm~3,P＞0.05]and percentage of volume obstruction(1.68±5.84)%vs.(1.59±4.10)%,P＞0.05]between the two groups.Conclusion Implantation of Firebird stent was associated with low restenosis rate and both Firebird and Cypher stents equally and effectively inhibited neointimal hyperplasia.