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相关会议：经导管心血管治疗（TCT）2006
由Debra L. Beck报道
华盛顿讯——在最大的一项雷帕霉素洗脱Cypher支架和紫杉醇洗脱Taxus支架直接对比研究中， 主要研究终点——9个月的临床或患者驱动的MACE发生率并没有显著性差异。
MACE定义为第一次出现的心源性死亡、急性心肌梗死、靶病变或靶血管血运重建、或靶血管失败。
“两者的9个月无MACE生存曲线几乎没有差异”，Galloe博士说道。9个月时，Cypher组7.8%的患者发生MACE，Taxus组8.6％的患者发生MACE，两者之间只有9次事件/患者或者说是0.8％的差异。
SORT OUT II研究结果由丹麦Hellerup的Copenhagen County医院的Anders M. Galloe博士在TCT 2006Late Breaking临床试验部分公布。该研究由Cordis Endovascular和波士顿科学公司赞助。
“SORT OUT II是一项“真正的”现实世界研究”，Galloe博士说道，“该研究中没有6个月或9个月的造影随访。MACE的发生是临床的或者说是由患者驱动的，像丹麦的日常实践一样，只对有症状的患者复查冠脉造影。”
“自2004年8月至2006年1月期间，丹麦5个PCI中心的准备接受药物洗脱支架治疗的患者被随机分组植入Cypher或Taxus支架。一共2,098例患者入选，SORT OUT II 研究的规模要比REALITY大15％，是目前最大型的一项直接比较Taxus和Cypher支架的研究。”Dr. Galloe博士说道。
研究人群的平均年龄大约为64岁，男性占75%，糖尿病者大约占15%。大约有一半患者的PCI指征为稳定型心绞痛，而大约有17％的患者是ST段抬高型心肌梗死，另外33％是不稳定型心绞痛或者非ST段抬高型心肌梗死。
LAD（44%）是最多见的支架植入部位（n=2889个病变），32%的支架植入RCA。两种装置的平均支架长度为18mm。
SORT OUT II: Cypher vs. Taxus Equal at 9 months
Associated Meeting: Transcatheter Cardiovascular Therapeutics (TCT) 2006
Reported by: Debra L. Beck
Washington, DC – In the largest ever head-to-head comparison of the sirolimus-eluting Cypher stent and the paclitaxel-eluting Taxus stent, no significant difference was seen in the primary endpoint of clinically- or patient-driven MACE at 9 months.
MACE was defined as the first occurrence of cardiac death, acute myocardial infarction, target lesion or vessel revascularization, or target vessel failure.
“There was almost no difference between the nine-month MACE-free survival curves,” reported Dr. Galloe. Proportionally, 7.8% of patients in the Cypher arm and 8.6% of the Taxus group experienced a MACE event by nine months, a nonsignificant absolute difference of only 9 events/patients or 0.8%.
The SORT OUT II results were presented during a TCT 2006 Late Breaking Clinical Trials session by Dr. Anders M. Galloe of the Copenhagen County Hospital in Hellerup, Denmark. The study was sponsored by Cordis Endovascular and Boston Scientific Corporation.
SORT OUT II represents a “true” real world study, said Dr. Galloe, in that there was no angiographic follow-up at 6 or 9 months. The MACE rates were clinically and patient-driven, with angiography reserved only for symptomatic patients, as is the usual practice in Denmark.
Patients scheduled for treatment with a drug-eluting stent at one of Denmark’s five PCI centers were randomly assigned to either a Cypher or Taxus stent between August 2004 and January 2006. A total of 2,098 patients were enrolled, making SORT OUT II about 15% larger than the REALITY trial and the largest-yet head-to-head comparison of the Taxus and Cypher stents, said Dr. Galloe.
Mean age of the studied population was about 64 years; 75% were male, and about 15% had diabetes. In almost half of patients, the indication for PCI was for stable angina pectoris, but about 17% were referred for ST-segment elevation MI, and an additional 33% for unstable angina/non-ST-segment elevation MI.
The most common site for implantation (n=2889 lesions) was the LAD (44%); 32% of stents were implanted into the RCA. Mean stent length for both devices was 18 mm.