Chen Ji-lin, Gao Run-lin, Yang Yue-jin, Qiao Shu-bing, Qin Xue-wen, Yao Min, Liu Hai-bo, Xu Bo, Wu Yong-jian, Yuan Jin-qing, Chen Jue, Dai Jun, You Shi-jie, Ma Wei-hua
Cardiovascular Institute and Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.
Chin Med J (Engl). 2006 Jan 5;119(1):21-5.
Drug-eluting stent (DES) could obviously reduce in-stent restenosis, which has been proved by international multi-center clinical trials. However, the types of the lesions for stenting were highly selected in these trials. Up to now, there has been no large scale study on the effect of DES in treating complex lesions in real world. Although REALITY trial was just reported during American College of Cardiology Congress 2005, the entry criteria for lesions were limited to one or two de novo lesions. This study was conducted to compare the short- and mid-term clinical outcomes between sirolimus-eluting stent (CYPHER stent) and paclitaxel-eluting stent (TAXUS stent) in patients with complex lesion.
This is a retrospective study. From April 2002 to June 2004, a total of 1061 patients were treated with DES in Fu Wai Hospital, of which, 611 patients (642 lesions with 698 CYPHER stents) were in CYPHER group, and 450 patients (534 lesions with 600 TAXUS stents) were in TAXUS group. There was no significant difference in clinical data and lesion types between CYPHER group and TAXUS group.
Success rates of stent implantation were 99.2% and 98.8% in CYPHER and TAXUS stent groups respectively. The major adverse cardiac events (MACE) during in-hospital and 6-8-month follow-up were 0.7% and 2.3% in CYPHER stent group versus 1.3% and 3.2% in TAXUS stent group. There was no significant difference in MACE rate between these two groups. Restenosis rate was a little higher in TAXUS stent group than that in CYPHER stent group (14.0% vs 7.3%), but there was no significant difference. The incidence of acute occlusion of side branch after implanting DES in main vessel was 6.9% in CYPHER group and 11.9% in TAXUS group (P < 0.05).
CYPHER and TAXUS DES were safe and effective in patients with complex lesion. Clinical outcomes of CYPHER stent were better than TAXUS stent in bifurcation lesions. There was an increasing tendency in restenosis rate and late thrombosis in TAXUS group as compared with that of CYPHER group.
药物洗脱支架（DES）可显著降低支架内再狭窄，这已得到国际多中心临床试验的证实。然而，这些试验中支架置入的病变类型经过了高度筛选。迄今为止，尚无关于DES在现实世界中治疗复杂病变效果的大规模研究。尽管“REALITY试验”刚刚在2005年美国心脏病学会大会上报道，但病变的入选标准仅限于一两个原发性病变。本研究旨在比较西罗莫司洗脱支架（CYPHER支架）和紫杉醇洗脱支架（TAXUS支架）治疗复杂病变患者的短期和中期临床结果。
这是一项回顾性研究。2002年4月至2004年6月，共有1061例患者在阜外医院接受了DES治疗，其中，CYPHER组有611例患者（642处病变，置入698枚CYPHER支架），TAXUS组有450例患者（534处病变，置入600枚TAXUS支架）。CYPHER组和TAXUS组在临床资料和病变类型方面无显著差异。
CYPHER支架组和TAXUS支架组的支架置入成功率分别为99.2%和98.8%。CYPHER支架组住院期间及6 - 8个月随访时的主要不良心脏事件（MACE）发生率分别为0.7%和2.3%，TAXUS支架组分别为1.3%和3.2%。两组之间的MACE发生率无显著差异。TAXUS支架组的再狭窄率略高于CYPHER支架组（14.0%对7.3%），但无显著差异。主血管置入DES后分支血管急性闭塞的发生率，CYPHER组为6.9%，TAXUS组为11.9%（P < 0.05）。
CYPHER和TAXUS DES对复杂病变患者安全有效。在分叉病变中，CYPHER支架的临床结果优于TAXUS支架。与CYPHER组相比，TAXUS组的再狭窄率和晚期血栓形成有上升趋势。
