TCT2008回顾：荟萃分析显示，与BMS相比DES是安全有效的
来源：医心网 发布时间：2008-11-04 10:17
TCT2008回顾：荟萃分析显示，与BMS相比DES是安全有效的
From TCT 2008: Pooled Meta-Analysis Shows DES Safe, Effective vs. BMS
要点：
* 5年死亡率、心梗率和复合死亡/心梗率在Cypher和BMS之间没有差别。
* 糖尿病患者应用Cypher其5年死亡率更高。
根据华盛顿TCT2008会议上公布的数据，随机对照试验和大型注册研究的2项荟萃分析结果显示，与裸金属支架（BMS）相比，药物洗脱支架（DES）可使长期死亡率、心梗率（MI）和靶血管血运重建率（TVR）降低。
纽约心血管研究基金（CRF）的Adriano Caixeta教授及同事，研究了4项关于Cypher西罗莫司洗脱支架（佛罗里达·迈阿密·强生Cordis）与BMS相对比的随机临床试验：RAVEL（238例）、SIRIUS（1,058例）、E-SIRIUS（352例）和C-SIRIUS（100例）。荟萃分析了从2000年8月到2002年4月间入选的1,748例患者。这些患者或者置入Cypher（878例），或者置入BMS（870例）。
5年死亡率、心梗率和复合死亡/心梗发生率在Cypher组（14.4%）和BMS组（13.9%；P=0.63）没有差别。而且，5年时TVR发生率的明显差别（29% vs. 15.2%; P<0.00001）支持患者选择Cypher进行治疗。
但是，Caixeta教授说，Cypher用于糖尿病患者其5年死亡率更高（16.1% vs. 9.9%; P=0.03）。他报告说，学术研究协会（ARC）定义的明确/很有可能的支架血栓率在Cypher组和BMS组没有明显差别（1.9% vs. 2.8%; P=0.63）。
荟萃分析
纽约哥伦比亚大学医学中心的Ajay J. Kirtane教授，公布了对于22项已发表随机对照试验（9,470例）和34项注册研究（182,901例）进行的系统评价和荟萃分析的结果。这些对照试验和注册研究均是比较DES和BMS的，并且随访时间在1年以上。
分析揭示的有利结果“强烈显示，适应症和非适应症情况下，DES是安全的，且在随机试验和真实世界中疗效相似。”
随机对照试验分析显示，与BMS相比，DES死亡率下降3%，MI率下降5%，差别不显著，但是TVR下降了55%，差别显著。类似地，注册分析显示，与BMS相比，DES死亡率、MI和TVR率明显降低（见表格）。
注释：Caixeta和Kirtane教授都是CRF主席团成员，CRF拥有并运营TCTMD网站。
（source：www.tctmd.com）
（《医心评论》 刘瑞琦 翻译 陆卫 校对）
From TCT 2008: Pooled Meta-Analysis Shows DES Safe, Effective vs. BMS
Key Points:
* Death, MI and composite death/MI did not differ between Cypher and BMS at 5 years
* Cypher yields higher mortality at 5 years among patients with diabetes
By TCT Daily Staff
Findings from 2 analyses of pooled data from randomized controlled trials and large registries demonstrate that drug-eluting stents (DES) are associated with long-term reductions in death, myocardial infarction (MI), and target vessel revascularization (TVR), compared with bare-metal stents (BMS).
The data were presented at the TCT 2008 symposium in Washington, D.C.
Adriano Caixeta, MD, of the Cardiovascular Research Foundation (New York, NY), and colleagues analyzed data from 4 randomized clinical trials of the Cypher sirolimus-eluting stent (Cordis, Johnson & Johnson, Miami Lakes, FL) vs. BMS: RAVEL (n = 238), SIRIUS (n = 1,058), E-SIRIUS (n = 352) and C-SIRIUS (n = 100). The pooled analysis included 1,748 patients enrolled in the studies between August 2000 and April 2002. Patients were assigned to either Cypher (n = 878) or BMS (n = 870).
The incidence of death, MI and composite death/MI did not differ between Cypher (14.4%) and BMS (13.9%; P = 0.63) at 5 years. In addition, there was a significant difference in TVR favoring patients treated with Cypher at 5 years (29% vs. 15.2%; P<0.00001).
However, Cypher was associated with a statistically higher incidence of death at 5 years among patients with diabetes (16.1% vs. 9.9%; P = .03), Dr. Caixeta said.
He reported no significant difference in rates of Academic Research Consortium-defined definite/probable stent thrombosis between Cypher and BMS (1.9% vs. 2.8%; P = 0.63).
Meta-Analysis
Ajay J. Kirtane, MD, SM, of Columbia University Medical Center (New York, NY) presented the results of a systematic review and meta-analysis of 22 published randomized controlled trials (n = 9,470) and 34 registries (n = 182,901) that compared DES and BMS with more than 1 year of follow-up.
The analysis revealed favorable results that “strongly suggest that DES are safe for both on-label and off-label use, and have comparable efficacy in both randomized controlled trials and in the real world,” Dr. Kirtane said.
Based on the randomized controlled trials, the analysis revealed a nonsignificant 3% reduction in mortality and 5% reduction in MI with DES compared with BMS. DES were also associated with a significant 55% reduction in TVR.
Similarly, registry analysis revealed that DES were associated with significant reductions in mortality, MI and TVR compared with BMS (see Figure).
Note: Drs. Caixeta and Kirtane are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.
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