比较Cypher^(TM)和Taxus^(TM)支架在冠心病合并糖尿病患者中应用的安全性和有效性

Comparison of the safety and efficacy for application of cypher^(TM) and Taxus^(TM) coronary stent in patients with coronary heart disease and concurrent diabetis

背景与裸支架相比,药物洗脱支架可以显著降低冠心病合并糖尿病患者PCI术后再狭窄率和靶病变重建率。但目前尚未见关于直接比较雷帕霉素洗脱支架(CypherTM)和紫杉醇洗脱支架(TaxusTM)在治疗冠心病合并糖尿病患者中安全性和有效性的研究。目的观察和比较两种药物洗脱支架在冠心病合并糖尿病患者中应用的安全性和有效性。方法自2002年6月~2004年2月新加坡国立大学医院心脏中心所有置入Cypher或Taxus支架冠心病合并糖尿病患者,观察:术后6个月的主要不良心脏事件(包括死亡、心肌梗死、靶病变重建)。结果共计122例患者(Cypher组为31例,Taxus组为91例)。B2和C型病变75%。两组患者基本特征无显著差异。与Taxus组相比Cypher组有更小参照血管直径(2.4±0.6 mm和2.6±0.7 mm,P<0.01),Cypher组和Taxus组术后急性和亚急性支架内血栓发生率(0%和1.1%)、6个月靶病变重建率(3.2%和3.3%)和主要不良心脏事件(6.4%和5.5%)都没有差异。结论两种药物洗脱支架在冠心病合并糖尿病患者中的临床应用安全、有效的,在降低6个月临床再狭窄率、靶病变重建率和主要不良心脏事件上无明显差异。

Objective To compare the relative safety and efficacy of Cypher and Taxus stent in coronary heart diseaese complicated with diabetis. Methods A retrospective study of our hospital＇ s Cardiology database containing one hundred and twenty-two CHD complicated with diabetis undergone selective or urgent implantation of DES stem between June 2002 and February 2004 were divided into Cypher stent group（ n=31 ） and Taxus stent group （n = 91）. The endpoints included cardiac death, myocardial infarction （MI） and TLR at 6-month. Results 122 patients with majority of males （80 % ） and mean age of 56 ±11 years. The baseline characteristics were similar in both groups. Majority lesions treated were consisted of AHA/ACC Type B2/C （75 % ）. Compared to the Taxus group, the Cypher group had a smaller mean reference diameter （2.4 ± 0.6 mm versus 2.6 ± 0.7 ram, P 〈 0.01 ）. No differences were seen in acute and subacute stent thrombosis （0% versusl. 1% ）,TLR（3.2% versus 3.3% ） and major adverse cardiac event（MACE） （6.4% versus 5. 5%） at 6-month between Cypher and Taxus group. Conclusions CypherTM and TaxusTM coronary stents are proved to be equally safe and effective with Iow rate of clinical restenosis , TLR and MACE at 6-month in coronary heart disease complicated with diabetis patients.