雷帕霉素洗脱支架和紫杉醇洗脱支架置入在冠状动脉病变治疗中的生物安全性:2年随访

Biological safety of Firebird^(TM) and Taxus Express2^(TM) in the percultaneous coronary intervention of coronary artery disease:Two-year follow-up

背景:多项研究表明,雷帕霉素洗脱支架与紫杉醇洗脱支架能有效降低患者的支架内及支架所在节段的再狭窄发生率。但对比两类洗脱支架的远期疗效方面国内相关资料较少,中长期随访的研究更少。目的:观察雷帕霉素洗脱支架(FirebirdTM)与紫杉醇洗脱支架(Taxus Express2TM)在冠状动脉病变支架置入治疗中的安全性以及生物相容性。设计、时间及地点:非随机同期对照临床观察,2005-04/2008-04牡丹江医学院红旗医院心内科。对象:选择233例(共有268处病变)接受冠状动脉成形及支架置入治疗的患者,雷帕霉素洗脱支架组(雷帕霉素组)82例,紫杉醇洗脱支架组(紫杉醇组)80例和不锈钢裸支架组(裸支架组)71例。方法:所有患者采取股动脉或桡动脉途径行冠状动脉造影。采用定量计算机分析法系统测量血管内径。以标准技术分别置入裸支架及雷帕霉素洗脱支架与紫杉醇洗脱支架。出院后每2～4周定期门诊复查及电话主动跟踪随访,置入后9～12个月复查冠状动脉造影,此后每4周定期门诊复查及电话主动跟踪随访,有缺血相关症状再次复查冠状动脉造影直至随访满24个月结束。主要观察指标:①3组冠状动脉造影特征及支架置入情况。②支架与宿主的生物相容性。③住院期间和随访期间主要不良心脏事件,包括死亡、心绞痛发作、心力衰竭。④随访期间复查冠状动脉造影,冠状动脉直径减少≥50%,则视为再狭窄。结果:雷帕霉素组置入支架101枚,紫杉醇组置入支架98枚,普通组置入支架85枚。3组患者无支架脱落、移位、断裂、置入位置不良等现象,随访观察中未发现明显血小板减少、溶血、白细胞增多等。3组冠状动脉造影特征及支架置入情况比较差异无显著性意义。主要心脏不良事件、血管内再狭窄,雷帕霉素组和紫杉醇组均少于裸支架组(P<0.05);雷帕霉素组略少于紫杉醇组,但差异无显著性意义(P>0.05)。结论:雷帕霉素洗脱支架与紫杉醇洗脱支架在冠状动脉病变治疗中无特殊生物相容性反应,在降低血管再狭窄发生率方面优于金属裸支架。两种药物洗脱支架疗效和安全性相当。

BACKGROUND： Many studies have demonstrated that Firebird^TM and Taxus Express2^TM can effectively reduce intrastent restenosis. However, there are few data about long-term efficacy of two stents, and reports about middle and long-term follow up are rare. OBJECTIVE： To observe the safety and biocompatibility of FirebirdTM and Taxus Express2TM in percutaneous coronary intervention （PCI） for coronary artery disease. DESIGN, TIME AND SETTING： Non-randomized concurrent control clinical observation was performed at Department of Cardiology, Hongqi Hospital of Mudanjiang Medical College from April 2005 to April 2008. PARTICIPANTS： 233 patients （268 lesions） undergoing PCI were divided into Firebird^TM （n =82）, Taxus Express2^TM group （n =80） and bare metal stent group （n =71）. METHODS： Coronary arteriography was performed through femoral artery or radial artery. Vascular inner diameter was determined using quantitative computer analysis. The patients underwent Firebird^TM, Taxus Express2^TM and bare metal stenting, respectively. The patients were reexamined and followed-up using telephone every 2-4 weeks after discharging and examined using coronary arteriongraphy after 9-12 months. The follow-up lasted for 24 months. MAIN OUTCOME MEASURES： Characteristics of arteriongraphy and stenting condition of all patients; biocompatibility of stent to host; major adverse cardiac events during hospitalization and follow-up, including death, angina pectoris attacks or heart failure; coronary artery diameter decreased ≥ 50% was regarded as restenosis. RESULTS： 101 stents were implanted in Firebird group, 98 in Taxus Express2 group and 85 in bare metal stent group. There was no stent defluxion, dislocation, or breakage. No noticeable platelet decrease, hemolysis or white blood cell increase was found. There were no significant differences among three groups in terms of Characteristics of arteriongraphy and stenting condition. The incidence of major adverse cardiac events and intravascular restenosis in Firebird and Taxus Express2 groups was fewer than bare metal stent group （P 〈 0.05）; although the incidence in Firebird group was fewer than Taxus Express2 group, the differences were not statistically significant （P 〉 0.05）. CONCLUSION： No specific biocompatibility responses in treatment of coronary artery diseases using Firebird^TM and Taxus Express2^TM. The two drug-eluting stents are superior over bare metal stent in reducing restenosis. The safety and efficacy of two drug-eluting stents are similar.