Orlando，FL---来自ACC58届年会i2峰会的报道：迄今最大的有关真实世界支架植入的研究证实在保护患者免受严重的心血管疾病方面，药物洗脱支架（DES）优于金属裸支架（BMS），而且二者的安全性相似。

    这项研究显示，在三年的随访过程中，同BMS相比，DES明显减少了心脏病的发作、死亡和再次手术的几率，并且没有增加卒中或出血的风险。

    来自杜克大学的Pamela S.Douglas教授说：“以往一些研究认为DES与长期死亡率的增加有关，但同时其他研究的结论却相反。这次最大规模的研究给我们带来的信息是：‘药物洗脱支架是安全的。’”

    支架是一种可膨胀的有网眼的细小金属管。将其植入冠脉病变处以保持球囊预扩张后该处管腔保持通畅状态。药物洗脱支架能够缓慢的释放药物涂层以防止动脉内壁上组织的过度增生而导致支架内堵塞和冠脉血流中断。

    几个随机对照实验表明DES在防止冠状动脉由于瘢痕组织增生导致的狭窄方面优于BMS，但是在长期安全性方面几个实验的结论不一致。需要指出的是，随机对照实验在入选的患者类型上是有很强的选择性的。

    Douglas 认为：“很少一部分接受支架术的病人能够符合随机对照实验的要求----大约只占病人数的20%，我们需要来自真实世界的数据来评价支架在剩余的80%人群中的安全性和有效性。”

    在这项实验中，Douglas和同事们分析了来自ACC-NCDR（American College of Cardiology ’s National Cardiovascular Data Registry ）中从2004-2006年龄大于65岁的接受支架治疗的患者，其中217657名患者接受了DES而45025名患者接受了BMS。随访资料通过医疗保险体系获得。将这两部分数据综合之后建立了一个新的有说服力的数据库来评价在公众背景下上市支架的性能。

    研究者根据102项诸如性别、年龄、同时存在的其他疾病等特征调整数据。他们发现接受DES的患者死亡率（HR：0.75）、非致命性的心脏事件（HR：0.76）、再次手术的风险（HR0.91）较接受BMS的患者明显降低。另外在卒中（HR：0.96）、大出血（HR0.91）方面二者没有差异。

    研究这不能直接评价出支架血栓的发生率。但是Douglas等所提到的“暗示性”的数据说明1年以后与支架血栓有关的心脏病发作（ST段抬高型心肌梗死）在DES组并不比BMS组常见。另外，关于STEMI和NSTEMI的长期风险比也都倾向有利于DES。
Carolyn M.Clancy（AHRQ Director ）说：“这项研究的结果为心脏病患者和他们的主治医生们选择治疗方案提供了新的证据。这些发现能够帮助人们解决一直困扰我们的关于DES的安全性问题。

（谭凯 吕树铮  首都医科大学附属北京安贞医院）

英文原文

“REAL-WORLD” STUDY FINDS DRUG-ELUTING STENTS SAFE， EFFECTIVE
Largest-Ever Registry Provides Answers for Wide Range of Patients Orlando， FL – The largest-ever study to evaluate stenting in “real-world” patients has confirmed that drug-eluting stents are better than bare-metal stents at protecting patients against serious cardiovascular illness， and are equally safe， according to research presented during the i2 Summit at the American College of Cardiology’s 58th annual scientific session.

The study found that during three years of follow-up， drug-eluting stents significantly reduced the risk of heart attack， death and additional heart procedures when compared to bare-metal stents， while provoking no increased risk of stroke or major bleeding.

 “Some previous studies have suggested that drug-eluting stents are associated with an excess long-term death rate， whereas others have not，” said Pamela S. Douglas， M.D.， Geller professor of medicine at Duke University. “The biggest take home message of our study is: Drug-eluting stents are safe.”

Stents are tiny metal tubes with an expandable， mesh-like design. They are placed in a diseased coronary artery to prop it open after it has been widened through inflation of a small balloon. Drug-eluting stents slowly release a medicated coating that prevents excessive tissue growth from the inner wall of the artery， which could clog the stent and block blood flow to the heart.

Several randomized controlled trials have shown that drug-eluting stents are better than bare-metal stents at keeping the coronary artery from constricting with scar tissue， but their findings on long-term safety have been inconsistent. Equally important， randomized controlled trials are very selective about the types of patients they enroll.

 “Few patients who currently require stenting would be considered eligible for a randomized controlled trial – only about 20 percent in our population，” Douglas said. “Real-world data are required to assess stent safety and performance in the other 80 percent.

For the study， Dr. Douglas and her colleagues analyzed data from the American College of Cardiology’s National Cardiovascular Data Registry (ACC-NCDR) on patients over the age of 65 who had a stenting procedure performed from 2004 to 2006. Of these， 217，675 were treated with drug-eluting stents and 45，025 were treated with bare-metal stents. Follow-up information for each patient was obtained from Medicare claims data. The combination of these two data sets created a novel and powerful resource for assessment of post-marketing stent performance in a community setting.

Researchers adjusted the data for 102 patient characteristics such as sex， age and co-existing medical conditions. They found that patients who received drug-eluting stents had significantly lower rates of death (hazard ratio [HR]， 0.75)， nonfatal heart attack (HR， 0.76) and repeat heart procedures (HR， 0.91) when compared to patients who received bare-metal stents. In addition， there were essentially no differences in rates of stroke (HR， 0.96) or major bleeding (HR 0.91).

The investigators were not able to directly assess rates of stent thrombosis. However， data that Douglas characterized as “suggestive” showed that after one year， the type of heart attack (known as STEMI) that is associated with stent thrombosis was no more common with drug-eluting stents than bare-metal stents. In addition， the long-term hazard ratio favored drug-eluting stents for both STEMI and non-STEMI heart attacks. 

 “Today’s findings provide important new evidence for decision-making by heart disease patients and their physicians，” said AHRQ Director Carolyn M. Clancy， M.D. “These findings should help resolve many lingering questions regarding the safety of drug-eluting stents in recent years.”