―――DES峰会上专家组议题
Concerns Over Drug-eluting Stent Safety Should Not Preclude Their Use

　　自2003年开始，药物洗脱支架（DES）的使用逐渐风靡冠心病介入治疗领域，临床医生认为找到了一种治疗再狭窄、减轻患者症状的有效方法。由于DES明显降低靶病变重建（TLR）和靶血管重建（TVR）使其用量明显增加，与此同时关于DES（包括Cypher 和TAXUS支架）长期安全性以及有效性的担忧和争议在2006 TCT会议上达到白热化程度。

　　2007年CRF邀请来自世界各地的专家再次聚首TCT，就DES的安全性及介入领域的其他问题再次展开精彩的演讲和讨论，并重点讨论了糖尿病患者置入DES的安全性、有效性和费用－效益间的关系。来自瑞士的Stephan Windecker医生报道了一项包括38个随机对照试验荟萃分析，指出DES与金属裸支架（BMS）在死亡或心肌梗死发生率方面无统计学差异。该荟萃分析还包括了糖尿病患者亚组分析，也得出同样结论。
　　
　　美国波士顿的Donald Cutlip医生指出，因以往支架内血栓定义并不统一，所以任何一种手段分析支架内血栓问题都不是一件容易的事情。ARC在2006年12月统一了支架内血栓的定义并建议以后所有临床试验使用该定义。

　　DES峰会同时公布了“真实世界”注册研究包括ARTS-Ⅱ, EVENT , DESIRE等资料。相关文章见TCT daily news。

　　（阜外心血管病医院　高立建　编译）
　　
　　（医心网为TCT DAILY NEWS独家授权网站，转载请标明转自医心网）

Concerns Over Drug-eluting Stent Safety Should Not Preclude Their Use
Experts address issues at the DES Summit.

Since 2003, drug-eluting stents have dominated the field of interventional cardiology, as clinicians have sought ways to treat restenosis and relieve patients’ symptoms.

Yet, as the use of DES has increased dramatically and rates of TLR and TVR have fallen, questions have been raised about the long-term safety of stents such as Taxus (Boston Scientific), Cypher (Cordis, Johnson & Johnson), and others. These concerns peaked at TCT 2006.

Experts gathered by the Cardiovascular Research Foundation revisited these and other issues at the Drug-eluting Stent Summit this year at TCT 2007.

One of the questions involved the safety, efficacy, and cost-effectiveness of DES in diabetic patients.

In a meta-analysis of 38 randomized controlled trials, Stephan Windecker, MD, head of invasive cardiology at University Hospital Bern in Switzerland, said there were no differences in death or MI between DES and bare-metal stents. Windecker’s meta-analysis included a subgroup analysis of patients with diabetes that showed similar results

Donald Cutlip, MD, a cardiologist at the Beth Israel Deaconess Medical Center in Boston, said any measurements of stent thrombosis are complicated by the lack of a standardized definition. However, the Academic Research Consortium has developed definitions of stent thrombosis for use in future trials

The Drug-eluting Stent Summit also included data presentations on a number of real-world registries including ARTS-II, MATRIX, EVENT, DESIRE, and others.