雷帕霉素药物洗脱支架治疗冠状动脉小血管病变的临床即刻效果

目的评价国产雷帕霉素药物洗脱支架(Firebird支架)治疗冠状动脉小血管病变(直径≤2.5mm)的临床即刻效果。方法采用前瞻性、非随机对比研究方法,根据入选和剔除标准,连续入选2004年6月~2007年2月我院行冠状动脉造影(CAG)确诊,首次接受经皮冠状动脉介入治疗(PCI)的靶血管为小血管病变且达到完全血运重建的160例患者,根据所置入的支架分为Firebird组(82例)和Cypher组(78例);支架置入后以相同的方法进行CAG,观察对比反映临床即刻效果的相关参数。结果术中全部Cypher及Firebird支架均顺利到达并释放于靶病变部位。两组支架的PCI手术成功率均为100%。Firebird组病变部位狭窄程度由术前的(78.7±15.6)%减至(7.20±10.69)%,P=0.0005;而Cypher组病变部位狭窄程度由术前的(79.8±15.8)%减至(7.10±10.61)%,P=0.0004。在急性管腔直径获得方面,Firebird组(1.76±0.52)mm与Cypher组(1.77±0.53)mm之间无显著差异(P=0.46)。结论Cypher和Firebird支架治疗冠状动脉小血管病变安全可行,临床即刻效果好。

Safety and efficacy of the sirolimus-eluting stent in the treatment of patients with lesions in small native coronary arteries

Objective To evaluate the safety and immediate efficacy of sirolimus-eluting stent (DES, Firebird stent) in treating lesions in small native coronary arteries(vessel diameter ≤2.5 mm). Methods In this prospective, non-randomized comparative study, 160 consecutive patients with small coronary artery lesions undergoing coronary stenting procedures from June 2004 to February 2006 were enrolled. Eighty-two patients were in Firebird group and 78 patients in Cypher group. The coronary angiography(CAG)and stenting procedure were performed identically. The safety and immediate efficacy of Firebird and Cypher stents were evaluated with major adverse cardiac event(MACE) and immediate angiographic results as criteria. Results The success rate of PCI was 100% in both groups. There were no differences in baseline lesion characteristics and success rate of procedure in the two groups. The stenosis (%) of lesion site in Firebird group changed from baseline (78.7±15.6)% to post-intervention (7.20±10.69)%,P=0.0005; in Cypher group it changed from baseline (79.8±15.8)% to post-intervention (7.10±10.61)%,P=0.0004. There was no difference in acute lumen gain between the Firebird group (1.76±0.52) mm and Cypher group (1.77±0.53) mm (P=0.46). Conclusion Cypher stent and Firebird stent have equal safety and immediate efficacy when they are used for treating lesions in small coronary vessels.