国产西罗莫司洗脱支架与紫杉醇洗脱支架抑制血管内膜增生的血管内超声比较研究

目的利用血管内超声（IVUS）方法比较国产西罗莫司洗脱支架（Firebird^TM）与紫杉醇洗脱支架（Taxus^TM）对冠心病患者新生内膜增生的抑制作用。方法自2003年5月至2007年6月,203例冠心病患者（283处病变）行药物洗脱支架术并在术后1年行冠状动脉造影和血管内超声（IVUS）检查。其中136例患者（185处病变）置入Firebird^TM支架（Firebird组）,67例患者（98处病变）置入TaxusTM支架（Taxus组）。结果203例患者（283处病变）中168例患者（236处病变）接受了一年随访造影和血管内超声检查,其中Firebird组108例患者（147处病变）,Taxus组60例患者（89处病变）。两组患者基础临床情况及造影特征相似。Firebird组支架内晚期管腔丢失（0.17±0.29mm比0.43±0.51mm,P〈0.0001）和节段内晚期管腔丢失（0.18±0.36mm比0.38±0.33mm,P=0.003）明显小于Taxus组,而两组近端参考血管晚期管腔丢失（0.11±0.27mm比0.15±0.32mm,P=0.321）和远端参考血管晚期管腔丢失（0.08±0.10mm比0.09±0.16mm,P=0.483）差异并无统计学意义。IVUS分析显示,两组间平均支架面积、平均管腔面积、最小支架面积、平均支架体积、平均管腔体积比较,差异均无统计学意义。但Firebird组平均内膜增生面积（0.35±0.58mm^2比1.29±1.26mm^2,P〈0.0001）、平均内膜增生面积百分数（5.45%±9.26%比17.38%±13.75%,P〈0.0001）、内膜增生最大面积百分数（9.41%±14.15%比31.56%±20.99%,P〈0.0001）、平均内膜增生容积（2.09±5.46mm^3比13.43±18.59mm^3,P〈0.0001）和平均内膜增生容积百分数（1.68%±5.84%比8.62%±9.90%,P〈0.0001）较Taxus组均明显减少。结论国产西罗莫司洗脱支架（Firebird^TM）置入术后再狭窄发生率较低,与TaxusTM支架相比,抑制内膜增生作用更显著。

Comparative intravascular ultrasound study on neointimal hyperplasia after implantation of FirebirdTM stent and TaxusTM stent

Objective To compare the effect of inhibiting neointimal hyperplasia between domestic sirolimus eluting stent （ Firebird ^TM stent） and the TaxusTM stent by IVUS. Methods From May 2003 to June 2007, 168 patients with 236 native lesions underwent DES implantation, of which, 108 patients （147 lesions） were implanted with the FirebirdTM stents and the other 60 patients （89 lesions） were implanted with the TaxusTM stent. Quantitative angiography （QCA） and intravascular ultrasound （IVUS） analysis were performed at one-year follow-up. Results The baseline clinical and angiographic characteristics between the two groups were similar. There were less in-stent late loss （ 0. 17 ± 0. 29 mm vs 0. 43 ± 0. 51 mm, P 〈 0. 0001 ） and in-segment late loss （0. 18 ＋0. 36 mm vs 0. 38 ±0. 33 mm,P 〈0. 003）in the Firebird TM stent group than in the Taxus^TM stent group. But the late loss in the 5-mm vessel segments immediately proximal and distal to the stent were comparable between the two groups. IVUS follow-up measurements showed no significant difference between the 2 group in stent CSA, lumen CSA, minimal stent CSA, stent volume and lumen volume. （ all P 〉 0. 05）. But the absolute and relative measwements of intimal hyperplasia including manifested as intimal hyperplasia area （ 0. 35 ± 0. 58 mm^2 vs 1.29 ± 1.26 mm^2 ）, percentage of intimal hyperplasia area（5.45% ± 9. 26% vs 17.38% ± 13.75% ） , percentage of maximal intimal hyperplasia area （9.41% ±14. 15% vs 31.56% ±20.99%）, intimal hyperplasia volume（2.09 ±5.46 mm^3 vs 13.43 ± 18. 59 mm^3 ） and percentage of intimal hyperplasia volume （ 1.68% ± 5.84% vs 8.62% ± 9.90% ） were lower in the Firebird stent group than those in the Taxus stent group （ all P 〈 0. 05 ）. Conduslon Implantation of the Firebird TM stent has shown lower restenosis rate compared with the Taxus^ TM stent in terms of the effect of inhibiting the neointimal hyperplasia.